Clinical trials

Study title: safety and immunogenicity of immovax polio vaccine in Korean infants, whn given at 2, 4 and 6 months of age

Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32)

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Document reference: 41182

Study title: Safety and immunogenicity of PMSV diphtheria, tetanus, acellular pertussis, polio (DTacP-IPV) vaccine given mixed or separately with Haemophilus influenzae type b (Act-HIB®) vaccine, as a primary series. Comparison of three lots of DTacP-IPV vaccine given combined or separately with Act-HIB®

Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32)

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Document reference: 41189

Study title: Safety and immunogenicity of two inactivated poliovirus vaccines in combination with an acellular pertussis vaccine and diphtheria and tetanus toxoids in seventeen-to nineteen-month-old infants

Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32)

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Document reference: 41192

Study title: Safety and immunogenicity of Vi CPS vaccine in teenagers

Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32)

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Document reference: 21209

Study title: Safety of IPV of one or two doses in chinese infants

Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32)

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Document reference: 41183

Study title: Study of the booster effect of IPV vaccination on children

Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32)

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Document reference: 41196

Study title: The immune response after two doses of a new killed poliomyelitis vaccine

Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32)

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Document reference: 41202

Study title: Trial on the persistence of antibodies 4 years after a first booster with PENTAVAC® vaccine and the immunogenicity and safety of a second booster with TETRAVAC ACELLULAIRE® vaccine at the age of 5-6 years

Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32)

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Document reference: 41195

Study title: Open label study to evaluate the safety and immunogenicity of a hepatitis A vaccine (Avaxim 160U)

Active substance: Inactivated Hepatitis A vaccine adsorbed for adults (160 U)

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Document reference: 47625

Study title: OPEN STUDY OF IMMUNOGENICITY AND SAFETY OF THE P.M.sv. (160 U) HEPATlTlS A VACCINE ON CHILDREN AND ADULTS

Active substance: Inactivated Hepatitis A vaccine adsorbed for adults (160 U)

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Document reference: 47624

Study title: Open study of immunogenicity and safety of the P.M.sv. Hepatitis A vaccine (160 antigen units) in children

Active substance: Inactivated Hepatitis A vaccine adsorbed for adults (160 U)

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Document reference: 47623

Study title:

Active substance: Inactivated hepatitis A virus

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Document reference: 41107

Study title:

Active substance: Inactivated hepatitis A virus

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Document reference: 41108

Study title:

Active substance: Inactivated hepatitis A virus

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Document reference: 41110

Study title:

Active substance: Inactivated hepatitis A virus

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Document reference: 41113

Study title:

Active substance: Inactivated hepatitis A virus

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Document reference: 41114

Study title: A comparative study of fenbufen and indomethacin in patients with rheumatoid arthritis.

Active substance: INDOMETHACIN

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Document reference: 29796

Study title: A comparative trial of large doses of ketoprofen and indomethacin in the treatment of rheumatoid arthritis.

Active substance: INDOMETHACIN

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Document reference: 29797

Study title: A comparison of ibuprofen and indomethacin for closure of patent ductus arteriosus.

Active substance: INDOMETHACIN

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Document reference: 29798

Study title: A comparison of indoprofen and indomethacin in the supportive treatment of soft-tissue injuries in football players: a pilot study.

Active substance: INDOMETHACIN

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Document reference: 29799

Study title: A controlled clinical trial of TAI-284 acid in rheumatoid arthritis (author's transl)a

Active substance: INDOMETHACIN

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Document reference: 29800

Study title: A controlled clinical trial with indomethacin as an antipyretic in children.

Active substance: INDOMETHACIN

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Document reference: 29801

Study title: A double-blind cross-over study of niflumic acid and indomethacin in rheumatoid arthritis.

Active substance: INDOMETHACIN

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Document reference: 29802

Study title: Therapeutic effect of non-steroidal anti-inflammatory agents in eye disease

Active substance: INDOMETHACIN

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Document reference: 30041

Study title: Therapeutic effectiveness of paracetamol in rheumatoid arthritis.

Active substance: INDOMETHACIN

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Document reference: 30042

Study title: Therapeutic interventions to prevent intracerebral hemorrhage in preterm infants.

Active substance: INDOMETHACIN

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Document reference: 30043

Study title: Tocolysis in advanced preterm labor: impact on neonatal outcome.

Active substance: INDOMETHACIN

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Document reference: 30044

Study title: Treatment of acute pain due to ureteral calculi with intravenous indomethacin or pethidine

Active substance: INDOMETHACIN

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Document reference: 30045

Study title: Treatment of nephrogenic diabetes insipidus with prostaglandin synthesis inhibitors.

Active substance: INDOMETHACIN

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Document reference: 30046

Study title: Treatment of patent ductus arteriosus with ibuprofen.

Active substance: INDOMETHACIN

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Document reference: 30047

Study title: Treatment of premature labor with indomethacin.

Active substance: INDOMETHACIN

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Document reference: 30048

Study title: Treatment of renal colic by prostaglandin synthetase inhibitors and avafortan (analgesic antispasmodic).

Active substance: INDOMETHACIN

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Document reference: 30049

Study title: Treatment of renal colic by prostaglandin synthetase inhibitors and avafortan (analgesic antispasmodic).

Active substance: INDOMETHACIN

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Document reference: 30050

Study title: Treatment of ureteral and biliary pain with an injectable salt of indomethacin.

Active substance: INDOMETHACIN

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Document reference: 30051

Study title: Treatment of ureteric colic. Intravenous versus rectal administration of indomethacin.

Active substance: INDOMETHACIN

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Document reference: 30052

Study title: Early administration of indomethacin to preterm infants.

Active substance: INDOMETHACIN

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Document reference: 29867

Study title: Early closure of ductus arteriosus with indomethacina

Active substance: INDOMETHACIN

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Document reference: 29868

Study title: Early closure of patent ductus arteriosus with indomethacin in preterm infants with idiopathic respiratory distress syndrome.

Active substance: INDOMETHACIN

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Document reference: 29869

Study title: Early closure of the patent ductus arteriosus in very low-birth-weight infants: a controlled trial.

Active substance: INDOMETHACIN

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Document reference: 29870

Study title: Early versus late indomethacin treatment for patent ductus arteriosus in premature infants with respiratory distress syndrome.

Active substance: INDOMETHACIN

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Document reference: 29872

Study title: Early-onset intraventricular hemorrhage in preterm neonates: incidence of neurodevelopmental handicap.

Active substance: INDOMETHACIN

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Document reference: 29873

Study title: Echocardiographic flow pattern of patent ductus arteriosus: a guide to indomethacin treatment in premature infants.

Active substance: INDOMETHACIN

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Document reference: 29874

Study title: Effect in man of aspirin, standard indomethacin, and sustained release indomethacin preparations on gastric bleeding.

Active substance: INDOMETHACIN

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Document reference: 29875

Study title: Effect of dopamine on failure of indomethacin to close the patent ductus arteriosus.

Active substance: INDOMETHACIN

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Document reference: 29876

Study title: Effect of early targeted indomethacin on the ductus arteriosus and blood flow to the upper body and brain in the preterm infant.

Active substance: INDOMETHACIN

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Document reference: 29877

Study title: Effect of graduated intravenous and standard rectal doses of indomethacin on cerebral blood flow in healthy volunteers.

Active substance: INDOMETHACIN

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Document reference: 29878

Study title: Effect of high dose ramipril with or without indomethacin on glomerular selectivity.

Active substance: INDOMETHACIN

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Document reference: 29879

Study title: Effect of indometacin in a child with pseudohypoaldosteronism

Active substance: INDOMETHACIN

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Document reference: 29880

Study title: Effect of indomethacin on adenosine-induced bronchoconstriction.

Active substance: INDOMETHACIN

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Document reference: 29881

Study title: Cornaglia-Farraris P, Pasino M, Maggio A, Barabino A, Perlino GF, Massimo L. In: Le immunodeficienze primitive in Italia. Rome, Italy: Acta Medica, Field Educational Italia SpA; 1982. Chapter 4. Therapeutic success with methisoprinol in a case of congenital immune deficiency: clinical and immunological observations after one year of clinical therapy.Cornaglia-Farraris P, Pasino M, Maggio A, Barabino A, Perlino GF, Massimo L. In: Le immunodeficienze primitive in Italia. Rome, Italy: Acta Medica, Field Educational Italia SpA; 1982. Chapter 4. Therapeutic success with methisoprinol in a case of congenital immune deficiency: clinical and immunological observations after one year of clinical therapy.

Active substance: INOSINE

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Document reference: 30092

Study title: Cornaglia-Ferraris P, Koverech A.. International Journal of Immunopharmacology. [UK]. 1980; 2(3):193. (Abstract No. 23). Successful treatment with methisoprinol in a case of congenital immunodeficiencyCornaglia-Ferraris P, Koverech A.. International Journal of Immunopharmacology. [UK]. 1980; 2(3):193. (Abstract No. 23). Successful treatment with methisoprinol in a case of congenital immunodeficiency

Active substance: INOSINE

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Document reference: 30093

Study title: Correlation between the adverse reactions to intravenous iodinated contrast media and IgE levels; Gurses C et al; Diagn. Interv. Radiol.; 2005 vol.11 p.74 76Correlation between the adverse reactions to intravenous iodinated contrast media and IgE levels; Gurses C et al; Diagn. Interv. Radiol.; 2005 vol.11 p.74 76

Active substance: INOSINE

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Document reference: 30181

Study title: Combined treatment with ipratropium bromide and beta-2 adrenoceptor stimulating agents in chronic childhood asthma.

Active substance: IPRATROPIUM AND SALBUTAMOL

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Document reference: 30753

Study title: Combivent vs. salbutamol in patients with metacholine-induced bronchospasm.

Active substance: IPRATROPIUM AND SALBUTAMOL

Study summary document link (including results): Ipratropium bromide_salbutamol sulphate_U00-0040_synopsis.pdf

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Document reference: 30748

Study title: Statistical report: Comparison of the use of salbutamol solution and the combination of salbutamol and ipratropium solution in the treatment of acute asthma attacks in children.

Active substance: IPRATROPIUM AND SALBUTAMOL

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Document reference: 30750

Study title: Effectiveness and Safety of the Angiotensin II Antagonist Irbesartan in Children With Chronic Kidney Diseases

Active substance: irbesartan

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Document reference: 41533

Study title: Experience with Irbesartan Use in Children 16 Years of Age and Younger: A Descriptive Study in Two Medical Claims Databases

Active substance: irbesartan

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Document reference: 45089

Study title: Effects of pH-neutral, bicarbonate-buffered dialysis fluid on peritoneal transport kinetics in children, 2002 Reduced Advanced Glycation Endproduct (AGE) Levels in Children on Automated Peritoneal Dialysis (PD) with PD-Fluids Containing Less Glucose Degradation Products (GDPs), 2003

Active substance: ISOTONIC SOLUTIONS

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Document reference: 30758

Study title: Statistical report: A dose response and duration of action study of Duovent nebuliser solution in paediatrics.

Active substance: ISOTONIC SOLUTIONS

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Document reference: 30759

Study title: A double-blind, placebo-controlled trial to evaluate the efficacy and safety of topically applied 0.1% isotretinoin cream for the treatment of acne vulgaris.

Active substance: ISOTRETINOIN

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Document reference: 30761

Study title: Open-label, Randomized, Dose Ranging Study of Three Different Doses of Ritonavir in Combination with 3TC+d4T in Children Infected with HIV

Active substance: ritonavir

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Document reference: 41580

Study title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Cholesterol-Lowering Efficacy and Safety of Simvastatin as an Adjunct to Diet in Children and Adolescents With Familial Hypercholesterolemia

Active substance: SIMVASTATIN

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Document reference: 42224

Study title: Double blind comparison of Sertraline and Placebo in children and adolescents with obsessive compulsive disorder.

Active substance: SERTRALINE

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Document reference: 42126

Study title: Duraphat varnish a 2 year clinical trial in 5 year old childeren1977-murray, Brit. Dental J

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1977-murray-Duraphat varnish a 2 year clinical trial in 5 year old childeren.pdf

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Document reference: 49103

Study title: Effect of a partial substitution of invert sugar for surcose in combination with Duraphat treatment in caries development in pre-school children1991-frostell

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1991-frostell-Effect of a partial substitution of invert sugar for surcose in combination with Duraphat treatment in caries development in pre-scho...

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Document reference: 49116

Study title: Effect of fluoride varnish (Duraphat) treatment every 6 months compared with weekly mouthrinsing with 02 percent NaF solution on dental caries1979-koch

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1979-koch-Effect of fluoride varnish (Duraphat) treatment every 6 months compared with weekly mouthrinsing with 02 percent NaF solution on dental c...

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Document reference: 49105

Study title: Effect of topical applied stannous fluoride on dental caries experience children1955-Howell

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1955-Howell-Effect of topical applied stannous fluoride on dental caries experience children.pdf

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Document reference: 49132

Study title:

Active substance: Inactivated hepatitis A virus

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Document reference: 41117

Study title: Long term treatment of rheumatoid arthritis. Experiences with D-penicillamine in comparison with gold and immunosuppressive drugs (author's transl)a

Active substance: INDOMETHACIN

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Document reference: 29962

Study title: Long-term effects of indomethacin prophylaxis in extremely-low-birth-weight infants.

Active substance: INDOMETHACIN

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Document reference: 29963

Study title: Long-term variability of heart rate increases with successful closure of patent ductus arteriosus in preterm infants.

Active substance: INDOMETHACIN

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Document reference: 29964

Study title: Low-dose indomethacin and prevention of intraventricular hemorrhage: a multicenter randomized trial.

Active substance: INDOMETHACIN

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Document reference: 29965

Study title: Low-dose indomethacin therapy and extension of intraventricular hemorrhage: a multicenter randomized trial.

Active substance: INDOMETHACIN

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Document reference: 29966

Study title: Low-dose irradiation and indomethacin prevent heterotopic ossification after acetabular fracture surgery.

Active substance: INDOMETHACIN

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Document reference: 29967

Study title: Mannheimer lecture.

Active substance: INDOMETHACIN

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Document reference: 29968

Study title: Modification by drugs of urinary fibrin/fibrinogen degradation products in glomerulonephritis.

Active substance: INDOMETHACIN

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Document reference: 29969

Study title: Modulation of the immediate allergic wheal reaction in the skin by drugs inhibiting the effects of leukotriene C4 and prostaglandin D2.

Active substance: INDOMETHACIN

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Document reference: 29970

Study title: Near-infrared spectroscopy as a screening tool for patent ductus arteriosus in extremely low birth weight infants.

Active substance: INDOMETHACIN

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Document reference: 29972

Study title: Neonatal consequences of the use of indomethacin during pregnancy. A prospective study of 83 pregnant women and 115 neonates

Active substance: INDOMETHACIN

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Document reference: 29973

Study title: Neonatal limb ischemia following maternal indomethacin treatment in twin pregnancies.

Active substance: INDOMETHACIN

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Document reference: 29974

Study title: Neurodevelopmental follow-up at 36 months' corrected age of preterm infants treated with prophylactic indomethacin.

Active substance: INDOMETHACIN

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Document reference: 29975

Study title: Neurodevelopmental outcome at 36 months' corrected age of preterm infants in the Multicenter Indomethacin Intraventricular Hemorrhage Prevention Trial.

Active substance: INDOMETHACIN

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Document reference: 29976

Study title: Neurodevelopmental outcome with early indomethacin.

Active substance: INDOMETHACIN

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Document reference: 29977

Study title: Neurosensory impairment after surgical closure of patent ductus arteriosus in extremely low birth weight infants: results from the Trial of Indomethacin Prophylaxis in Preterms.

Active substance: INDOMETHACIN

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Document reference: 29978

Study title: Night medication in rheumatoid arthritis.

Active substance: INDOMETHACIN

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Document reference: 29979

Study title: Oligohydramnios, renal insufficiency, and ileal perforation in preterm infants after intrauterine exposure to indomethacin

Active substance: INDOMETHACIN

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Document reference: 29980

Study title: A non-randomised, single-centre, retrospective, controlled trial using stored serum samples to investigate the immunogenicity of NovoRapid® and Actrapid® in children and adolescents from onset of Type 1 diabetes.

Active substance: insulin detemir

Study summary document link (including results): ANA-1676 synopsis.pdf

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Document reference: 47338

Study title: A single-centre, randomised, double-blind, cross-over trial comparing the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in children and adolescents with type 1 diabetes, LPLV October 2005

Active substance: insulin detemir

Study summary document link (including results): NN304-1633-synopsis.pdf

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Document reference: 41577

Study title: 28-Week multicenter, controlled, randomized, open clinical trial comparing HOE 901 insulin with NPH human insulin in children with type 1 diabetes mellitus

Active substance: INSULIN GLARGINE

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Document reference: 47339

Study title: Invest Radiol. 1984 Nov-Dec;19(6 Suppl):S301-5 Low-osmolality contrast media in cardiac radiology. Cumberland DC Invest Radiol. 1984 Nov-Dec;19(6 Suppl):S301-5 Low-osmolality contrast media in cardiac radiology. Cumberland DC

Active substance: IOHEXOL

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Document reference: 30375

Study title: Invest Radiol. 1991 Jul;26(7):665-70 A comparison of iohexol and diatrizoate-meglumine in children undergoing cardiac catheterization. Pelech AN, Allard SM, Hurd RT, Giddins NG, Collins GF Invest Radiol. 1991 Jul;26(7):665-70 A comparison of iohexol and diatrizoate-meglumine in children undergoing cardiac catheterization. Pelech AN, Allard SM, Hurd RT, Giddins NG, Collins GF

Active substance: IOHEXOL

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Document reference: 30376

Study title: J Comput Assist Tomogr. 2000 Mar-Apr;24(2):327-31 Gadolinium-enhanced magnetic resonance dacryocystography in patients with epiphora. Kirchhof K, Hähnel S, Jansen O, Zake S, Sartor K. J Comput Assist Tomogr. 2000 Mar-Apr;24(2):327-31 Gadolinium-enhanced magnetic resonance dacryocystography in patients with epiphora. Kirchhof K, Hähnel S, Jansen O, Zake S, Sartor K.

Active substance: IOHEXOL

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Document reference: 30377

Study title: J Comput Assist Tomogr. 2007 Jul-Aug;31(4):493-8. Iodixanol: risk of subsequent contrast nephropathy in cancer patients with underlying renal insufficiency undergoing diagnostic computed tomography examinations. Cheruvu B, Henning K, Mulligan J, Klippenstein D, Lawrence D, Gurtoo L, Gottlieb RH. J Comput Assist Tomogr. 2007 Jul-Aug;31(4):493-8. Iodixanol: risk of subsequent contrast nephropathy in cancer patients with underlying renal insufficiency undergoing diagnostic computed tomography examinations. Cheruvu B, Henning K, Mulligan J, Klippenstein D, Lawrence D, Gurtoo L, Gottlieb RH.

Active substance: IOHEXOL

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Document reference: 30378

Study title: Open uncontrolled clinical trial of iotrolan 300 for gastrointestinal diagnosis in childrenTurk J Pediatr. 1995 Oct-Dec;37(4):305-13 The effects of contrast media on renal function in children: comparison of ionic and non-ionic agents. Buyan N, Arab M, Hasanoğlu E, Gökçora N, Ercan S

Active substance: IOHEXOL

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Document reference: 30382

Study title: A comparision of Iopromide and Iopamidol in computer tomography (CT) scanning of pediatric patients

Active substance: IOPROMIDE

Study summary document link (including results): Bayer Pharma_Iopromide_1114_study_synopsis.pdf

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Document reference: 46898

Study title: A comparison of iopromide and iopamidol in CT scanning of pediatric patients

Active substance: IOPROMIDE

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Document reference: 30385

Study title: Effect of oral iodized oil on thyroid size and thyroid hormone metabolism in children with concurrent selenium and iodine deficiency. ; Zimmermann-M-B. European Journal of Clinical Nutrition, 2000, Vol /Iss/Pg. 54/3 (209-213)Effect of oral iodized oil on thyroid size and thyroid hormone metabolism in children with concurrent selenium and iodine deficiency. ; Zimmermann-M-B. European Journal of Clinical Nutrition, 2000, Vol /Iss/Pg. 54/3 (209-213)

Active substance: IODINE

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Document reference: 30234

Study title: Effect of supplementing iodine on child intellectual development in iodine deficient areas. ;Chen-Z-H. Chinese Journal of Endemiology, 2006, Vol/Iss/Pg. 25 /1 (75-77)Effect of supplementing iodine on child intellectual development in iodine deficient areas. ;Chen-Z-H. Chinese Journal of Endemiology, 2006, Vol/Iss/Pg. 25 /1 (75-77)

Active substance: IODINE

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Document reference: 30235

Study title: Effectiveness of preoperative transarterial chemoembolization in presumed inoperable hepatoblastoma. Han-Y-M. Journal of Vascular and Interventional Radiology, 1999, Vol/Iss/Pg. 10/9 (1275-1280)Effectiveness of preoperative transarterial chemoembolization in presumed inoperable hepatoblastoma. Han-Y-M. Journal of Vascular and Interventional Radiology, 1999, Vol/Iss/Pg. 10/9 (1275-1280)

Active substance: IODINE

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Document reference: 30236

Study title: Effects of salt iodization in the treatment of endemic goiter in school children of rural origin in Cameroon. ;Ngogang-J. Annales d'Endocrinologie, 1993, Vol/Iss/Pg. 54/3 (191-196)Effects of salt iodization in the treatment of endemic goiter in school children of rural origin in Cameroon. ;Ngogang-J. Annales d'Endocrinologie, 1993, Vol/Iss/Pg. 54/3 (191-196)

Active substance: IODINE

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Document reference: 30237

Study title: Effects on school children of prophylaxis of mothers with iodized oil in an area of iodine deficiency. ; Fierro-Benitez-R. Journal of Endocrinological Investigation, 1988, Vol/Iss/Pg. 11/5 (327-335)Effects on school children of prophylaxis of mothers with iodized oil in an area of iodine deficiency. ; Fierro-Benitez-R. Journal of Endocrinological Investigation, 1988, Vol/Iss/Pg. 11/5 (327-335)

Active substance: IODINE

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Document reference: 30238

Study title: Efficacy of oral iodised oil is associated with anthropometric status in severely iodine-deficient schoolchildren in rural Malawi. ; Furnee-C-A. British Journal of Nutrition, 2000, Vol/Iss/Pg. 84/3 (345-352)Efficacy of oral iodised oil is associated with anthropometric status in severely iodine-deficient schoolchildren in rural Malawi. ; Furnee-C-A. British Journal of Nutrition, 2000, Vol/Iss/Pg. 84/3 (345-352)

Active substance: IODINE

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Document reference: 30239

Study title: Embolization and intra-vascular therapy in thoracic, abdominal and peripheral pediatric diseases. ; Brunelle-F. Annales de Pediatrie, 1983, Vol/Iss/Pg. 30/3 (189-193)Embolization and intra-vascular therapy in thoracic, abdominal and peripheral pediatric diseases. ; Brunelle-F. Annales de Pediatrie, 1983, Vol/Iss/Pg. 30/3 (189-193)

Active substance: IODINE

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Document reference: 30240

Study title: Embolization of arteriovenous malformations of the brain: Preliminary experience. ;Wilms-G. Journal Belge de Radiologie, 1993, Vol/Iss/Pg. 76/5 (299-303)Embolization of arteriovenous malformations of the brain: Preliminary experience. ;Wilms-G. Journal Belge de Radiologie, 1993, Vol/Iss/Pg. 76/5 (299-303)

Active substance: IODINE

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Document reference: 30241

Study title: Embolization of rolandic cortex arteriovenous malformations. ;Paulsen-R-D. Neurosurgery, 1999, Vol/Iss/Pg. 44/3 (479-486)Embolization of rolandic cortex arteriovenous malformations. ;Paulsen-R-D. Neurosurgery, 1999, Vol/Iss/Pg. 44/3 (479-486)

Active substance: IODINE

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Document reference: 30242

Study title: Emergency endovascular embolization of traumatic intrarenal arterial pseudoaneurysms with N-Butyl cyanoacrylate. 02/12/2010Emergency endovascular embolization of traumatic intrarenal arterial pseudoaneurysms with N-Butyl cyanoacrylate. 02/12/2010

Active substance: IODINE

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Document reference: 30243

Study title: Emergent embolization for control of massive hemorrhage from a splanchnic artery with a new coaxial catheter system. ;Okazaki-M. Acta Radiologica, 1992, Vol/Iss/Pg. 33/1 (57-62)Emergent embolization for control of massive hemorrhage from a splanchnic artery with a new coaxial catheter system. ;Okazaki-M. Acta Radiologica, 1992, Vol/Iss/Pg. 33/1 (57-62)

Active substance: IODINE

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Document reference: 30244

Study title: Treatment of acute infectious diarrhoea in infants and children with a mixture of three Lactobacillus rhamnosus strains: a randomized, double-blind, placebo-controlled trial – SZYMANSKI H., PEJCZ J. and al. – 2006.Treatment of acute infectious diarrhoea in infants and children with a mixture of three Lactobacillus rhamnosus strains: a randomized, double-blind, placebo-controlled trial – SZYMANSKI H., PEJCZ J. and al. – 2006.

Active substance: LACTIC ACID PRODUCING ORGANISMS AND COMBINATIONS

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Document reference: 30973

Study title: “Clinical report on the effect of lactitol for the treatment of intestinal stasis in newborns and toddlers" Investigator: Prof. M. T. Duillo Report date: 23.05.1986“Clinical report on the effect of lactitol for the treatment of intestinal stasis in newborns and toddlers" Investigator: Prof. M. T. Duillo Report date: 23.05.1986

Active substance: LACTITOL

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Document reference: 30986

Study title: Comparative study beween lactitol and placebo in infants less than 2 years presenting constipationBaudon, J.J :, Bouillie, C. et al. (1995) A controlled study of lactitol in the treatment of constipation in dhildren. Rev. Pediatr., 4, 1-8.

Active substance: LACTITOL

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Document reference: 30984

Study title: Piepsz A, Hahn K, Roca I, Ciofetta G, Toth G, Gordon I et al. A radiopharmaceuticals schedale for imaging in paediatrics. [piepsz-1990]Eur J Nucl Med 1990;17 : 127 – 129. Piepsz A 1990

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48690

Study title: Pirotte B, Goldman S, Dewitte O, Massager N, Wikler D, Lefranc F, et al.. Integrated positron emission tomography and magnetic resonance imaging-guided resection of brain tumors: a report of 103 consecutive procedures. [pirotte-2006]J Neurosurg. 2006 Feb;104(2):238-53. Pirotte B 2006

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48691

Study title: Procedure Guideline for Tumor Imaging Using Fluorine- 1 8-FDGJ Nucl Med 1998; 3&13&1305. Heinrich R. Schelbert, Carl K. Hoh, Henry D. Royal, Manuel Brown, Magnus N. Dahlbom, Farrokh Dehdashti and Richard L. Wahl

Active substance: Steripet

Study summary document link (including results): schelbert-1998.pdf

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Document reference: 48744

Study title: Mirmiran-P. International Journal for Vitamin and Nutrition Research, 2003, Vol/Iss/Pg. 73/3 (187-191)Mirmiran-P. International Journal for Vitamin and Nutrition Research, 2003, Vol/Iss/Pg. 73/3 (187-191)

Active substance: IODINE

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Document reference: 30289

Study title: Monographie Jod, Bundesanzeiger Nr. 236 vom 16.12.1989; Azizi-F. Journal of Endocrinological Investigation, 2001, Vol/Iss/Pg. 24/2 (72-77)Monographie Jod, Bundesanzeiger Nr. 236 vom 16.12.1989; Azizi-F. Journal of Endocrinological Investigation, 2001, Vol/Iss/Pg. 24/2 (72-77)

Active substance: IODINE

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Document reference: 30290

Study title: Multidetector CT in evaluating blood supply of hepatocellular carcinoma after transcatheter arterial chemoembolization. ; Guan-Y-S. World Journal of Gastroenterology, 15 JUL 2004, Vol/Iss/Pg. 10/14 (2127-2129)Multidetector CT in evaluating blood supply of hepatocellular carcinoma after transcatheter arterial chemoembolization. ; Guan-Y-S. World Journal of Gastroenterology, 15 JUL 2004, Vol/Iss/Pg. 10/14 (2127-2129)

Active substance: IODINE

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Document reference: 30291

Study title: Neonatal screening for congenital hypothyroidism results and perspectives; François Delange. Horm Res 1997; 48:51-61Neonatal screening for congenital hypothyroidism results and perspectives; François Delange. Horm Res 1997; 48:51-61

Active substance: IODINE

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Document reference: 30292

Study title: Nervous endemic cretinism in Eastern Nepal. ; White-N-J. Developmental Medicine and Child Neurology, 1977, Vol/Iss/Pg. 19/2 (208-212).Nervous endemic cretinism in Eastern Nepal. ; White-N-J. Developmental Medicine and Child Neurology, 1977, Vol/Iss/Pg. 19/2 (208-212).

Active substance: IODINE

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Document reference: 30293

Study title: Notwendigkeit einer individuelen Jodprophylaxe, Ranke, M.; Kinderarzt 22, 617-622, 1991Notwendigkeit einer individuelen Jodprophylaxe, Ranke, M.; Kinderarzt 22, 617-622, 1991

Active substance: IODINE

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Document reference: 30294

Study title: Optimal Strategy of Preoperative Transcatheter Arterial Chemoembolization for Hepatoblastoma. ; Ohtsuka-Y. Surgery Today, 2004, Vol/Iss/Pg. 34/2 (127-133)Optimal Strategy of Preoperative Transcatheter Arterial Chemoembolization for Hepatoblastoma. ; Ohtsuka-Y. Surgery Today, 2004, Vol/Iss/Pg. 34/2 (127-133)

Active substance: IODINE

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Document reference: 30295

Study title: Pediatric thoraco-lumbar paraspinal arteriovenous fistulas along the segmental nerve: Diagnosis and endovascular treatment. ; Niimi-Y. Interventional Neuroradiology, 2006, Vol/Iss /Pg. 12/SUPPL. 1 (158-162)Pediatric thoraco-lumbar paraspinal arteriovenous fistulas along the segmental nerve: Diagnosis and endovascular treatment. ; Niimi-Y. Interventional Neuroradiology, 2006, Vol/Iss /Pg. 12/SUPPL. 1 (158-162)

Active substance: IODINE

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Document reference: 30296

Study title: Percutaneous direct puncture glue embolization of high-flow craniofacial arteriovenous lesions: A new circular ring compression device with a beveled edge. ; Ryu-C-W. American Journal of Neuroradiology, 2007, Vol/Iss /Pg. 28/3 (528-530)Percutaneous direct puncture glue embolization of high-flow craniofacial arteriovenous lesions: A new circular ring compression device with a beveled edge. ; Ryu-C-W. American Journal of Neuroradiology, 2007, Vol/Iss /Pg. 28/3 (528-530)

Active substance: IODINE

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Document reference: 30297

Study title: Percutaneous embolization of a scalp arteriovenous malformation: Case report. ; Nistri-M. Rivista di Neuroradiologia, 2002, Vol/Iss/Pg. 15/6 (773-778)Percutaneous embolization of a scalp arteriovenous malformation: Case report. ; Nistri-M. Rivista di Neuroradiologia, 2002, Vol/Iss/Pg. 15/6 (773-778)

Active substance: IODINE

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Document reference: 30298

Study title: Percutaneous embolization with Ethiblocregistered trade mark of lymphatic cystic malformations with a review of the experience in 70 patients. ;Herbreteau-D. International Angiology, 1993, Vol/Iss/Pg. 12/1 (34-39)Percutaneous embolization with Ethiblocregistered trade mark of lymphatic cystic malformations with a review of the experience in 70 patients. ;Herbreteau-D. International Angiology, 1993, Vol/Iss/Pg. 12/1 (34-39)

Active substance: IODINE

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Document reference: 30299

Study title: The dental caries experience of 12 year old children in England and Wales2002-Pitts, Community Dental Health 2002 19, 46-53

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 2002-Pitts-the dental caries experience of 12 year old children in England and Wales.pdf

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Document reference: 49089

Study title: The effect of a fluoride gel used for supervising toothbrushing 15 to 30 times per yearMarthaler 1970

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Marthaler 1970 The effect of a fluoride gel.pdf

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Document reference: 49172

Study title: The effect on human dental caries of weekly oral rinsing with a sodium fluoride mouth wash duraphat rinse clinical1971-Horowitz

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1971-Horowitz-the effect on human dental caries of weekly oral rinsing with a sodium fluoride mouthwashduraphat rinse clinical.pdf

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Document reference: 49127

Study title: The effects of aminfluoride on nibition of caries in pre-school children and school children in rijekaOstric 1977

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Ostric 1977 The effects of aminfluoride.pdf

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Document reference: 49173

Study title: The rationale for the administration of a NaF tablet supplement during pregnancy and postnatally in a private practice setting.Frances B. Glenn 1981, Journal of Dentistry for Children

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1981-Glenn-The Rationale for the Administration od a NaF Tablet Supple,ment during Pregnancy and Postnatally in a private practice setting.pdf

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Document reference: 48778

Study title: The reduction of dental caries through use of a sodium fluoride mouthwash1960-Weisz

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1960-Weisz-the reduction of deental caries through use of a sodium fluoride mouthwash.pdf

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Document reference: 49125

Study title: The relative anticaries effectiveness of three fluoride-containing dentifrices in Puerto Rico2004-stookey, caries research

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 2004-stookey-the relative anticaries effectiveness of three fluoride-containing dentifrices in Puerto Rico.pdf

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Document reference: 49090

Study title: The results of 3 year prophylaxis of caries through fluoride preparations in a solinger kindergarden G. Stolte, Aus dem Gesundheitsamt der Stadt Solingen

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1968-stolte-Ergebnisse dreijähriger Kariesprophylaxe durch orale Fluoridgaben in Solinger Kindergarten.pdf

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Document reference: 48783

Study title: Use of fluorides by Finnish adolescentsHonkala ., Nyssonen V, Rimpela A, Scand J Dent Res 1984; 92: 517-23

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1984-honkala-Use of fluoride by finnish adolescents.pdf

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Document reference: 48769

Study title: use of professionally administered flouride among Danish children1992-ambjerg

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1992-ambjerg-use of professionally administered flouride among Danish children.pdf

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Document reference: 49118

Study title: Variation in caries prevalence related to combinations of dietary andoral hygiene habits and chewing fluoride tablets in 4 year old childrenLars-Eric Granath, Holger Rootzen, Elso Liljegren, Kerstin Hoist, Lennart Kohler 1978. Caries Res 12: 83-92

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1978-granath-Caries prevalence related to combinations of dietary and oral hygiene habits and chewing fluoride tablets in 4 years old children.pdf

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Document reference: 48781

Study title: Bowel preparation for colonoscopy with sodium picosulphate and magnesium citrate in children and adolescentsKawakami E, Portorreal A, Scuissiatto ML, Machado RS, Raguza D, Lozano L. , 2004, Arq Gastroenterol 2004; 41: 33 – 36

Active substance: SODIUM PICOPSULPHATE

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48902

Study title: Is Bowel Preparation Required Before Cystoplasty in Children?Gundeti MS, Godpol PP, Wilcox DT. , 2006, The Journal of Urology 2006; 176: 1574 – 1577

Active substance: SODIUM PICOPSULPHATE

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48901

Study title: Double-blind comparative study of Ultravist®, Solutrast® and Omnipaque® in excretory urography in children.

Active substance: IOPROMIDE

Study summary document link (including results): Bayer Pharma_Iopromide_85205_study_synopsis.pdf

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Document reference: 46900

Study title: IOPROMIDE (SH L 414 C) in excretion urography in children.

Active substance: IOPROMIDE

Study summary document link (including results): Bayer Pharma_Iopromide_83111_study_synopsis.pdf

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Document reference: 46899

Study title: Contrast quality and tolerability of iotrolan 300 in the diagnostic work-up of the upper gastrointestinal tract of infants and toddlers

Active substance: IOTROLAN

Study summary document link (including results): Bayer Pharma_Iotrolan_88058_study_synopsis.pdf

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Document reference: 30390

Study title: Non-comparative open-label study of iotrolan 320 in angiocardiography in children up to 12 years of age

Active substance: IOTROLAN

Study summary document link (including results): Bayer Pharma_Iotrolan_94063_study_synopsis.pdf

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Document reference: 30389

Study title: Open uncontrolled clinical trial of iotrolan 300 for gastrointestinal diagnosis in children

Active substance: IOTROLAN

Study summary document link (including results): Bayer Pharma_Iotrolan_86180_study_synopsis.pdf

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Document reference: 30388

Study title: Open-label clinical study of iotrolan for assessment of subarachnoidal space in children

Active substance: IOTROLAN

Study summary document link (including results): Bayer Pharma_Iotrolan_85332_study_synopsis.pdf

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Document reference: 30391

Study title:

Active substance: IOVERSOL

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Document reference: 30393

Study title: Evaluation of the accuracy of steady-state krypton-81m method for calculating right ventricular ejection fraction.Ham HR 1986, J Nucl Med. 1986 May;27(5):593-601.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): Ham 1986.pdf

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Document reference: 48787

Study title: Evaluation of the effects of nasal septal deviation and its surgery on nasal mucociliary clearance in both nasal cavities.Am J Rhinol. 2007 Mar-Apr;21(2):180-3. Ulusoy B 2007

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48790

Study title: Evaluation of the ventilation-perfusion ratio in lung diseases by simultaneous anterior and posterior image acquisition. Ann Nucl Med. 1994 Nov;8(4):269-76. Nakata Y 1994

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48818

Study title: Excretion of radionuclides in human breast milk after the administration of radiopharmaceuticals. J Nucl Med. 1985 Sep;26(9): 1085-90.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): Ahlgren 1985.pdf

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Document reference: 48786

Study title: Extravasation from venous catheter: a serious complication potentially missed by lung imaging.Spicer KM 1983 J Nucl Med. 1983Nov;24(11):1023-6.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): Spicer 1983.pdf

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Document reference: 48788

Study title: Fatality immediately following rapid infusion of macroaggregates of 99mTc albumin (MAA) for lung scan. Radiology. 1968 Dec;91(6):1180-4 Vincent WR 1968

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48831

Study title: Hepatopulmonary syndrome in Gaucher disease with right-to-left shunt: evaluation and measurement using Tc-99m MAA. Clin Nucl Med. 1999 Mar;24(3):164-6. Kim JH 1999

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48809

Study title: Bone scanning in the adductor insertion avulsion syndrome ("thigh splints"). Charkes ND, Siddhivarn N, Schneck CD. J Nucl Med. 1987 Dec;28(12):1835-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48839

Study title: Bone scans in neuroblastoma.Bhogate BM, Samuel AM, Ramanathan P. Indian J Cancer 1993 Mar;30(1):5-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48571

Study title: "Controlled, randomised, parallel-group, single-centre clinical trial in patients; Duration: Expected treatment duration was 15 days. " Durand 1986

Active substance: Lactitol

Study summary document link (including results): 2011_EMAspreadsheet_Importal_Durand 1986.xls

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Document reference: 48149

Study title: Controlled, randomised, single-blind, parallel-group, single-centre clinical trial in patients; Duration: Treatment was 4 weeks (28 consecutive days). Report 1744

Active substance: Lactitol

Study summary document link (including results): 2011_EMAspreadsheet_Importal_Report 1744.xls

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Document reference: 48152

Study title: Gallet, J.P. (1990) Lactitol monohydrate (Importal) for treatment of constipation in children. Results of a clinical investigation. Rev. Pediatr, 26 (8), 1-8.Gallet, J.P. (1990) Lactitol monohydrate (Importal) for treatment of constipation in children. Results of a clinical investigation. Rev. Pediatr, 26 (8), 1-8.

Active substance: LACTITOL

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Document reference: 30987

Study title: Kokki H, Tuomilehto H, Karvinen M. Pharmacokinetics of ketoprofen following oral and intramuscular administration in young children. Eur J Clin Pharmacol. 2001 Nov;57(9):643-7.Kokki H, Tuomilehto H, Karvinen M. Pharmacokinetics of ketoprofen following oral and intramuscular administration in young children. Eur J Clin Pharmacol. 2001 Nov;57(9):643-7.

Active substance: LACTITOL

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Document reference: 30988

Study title: “Metabolism of lactitol” Investigator: Prof. H. Doorenbos Report date: NR“Metabolism of lactitol” Investigator: Prof. H. Doorenbos Report date: NR

Active substance: LACTITOL

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Document reference: 30985

Study title: Open-label, non-comparative clinical trial in patients and healthy subjects. Doorenbos H

Active substance: Lactitol

Study summary document link (including results): 2011_EMAspreadsheet_Importal_Doorenbos H.xls

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Document reference: 48147

Study title: Open-label, non-comparative clinical trial in patients Gallet JP 1990

Active substance: Lactitol

Study summary document link (including results): Importal_Gallet JP_1990.xls

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Document reference: 48155

Study title: Open-label, non-comparative clinical trial in patients Duillo MT 1986

Active substance: Lactitol

Study summary document link (including results): 2011_EMAspreadsheet_Importal_Duillo MT_1986.xls

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Document reference: 48148

Study title: Open-label, non-comparative clinical trial in patients. D'Apuzzo 1986

Active substance: Lactitol

Study summary document link (including results): 2011_EMAspreadsheet_Importal_D'Apuzzo V_1986.xls

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Document reference: 48146

Study title: Open-label, non-comparative clinical trial in patients. Gallet 1986

Active substance: Lactitol

Study summary document link (including results): 2011_EMAspreadsheet_Importal_Gallet_JP_1986.xls

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Document reference: 48150

Study title: Open-label, non-comparative clinical trial in patients. Giambonini S_1986

Active substance: Lactitol

Study summary document link (including results): 2011_EMAspreadsheet_Importal_Giambonini S_1986.xls

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Document reference: 48151

Study title: Placebo controlled, randomised, double-blind, parallel-group, multicentre clinical trial in patients; Duration: Treatment was 14 consecutive days;Medication: Sachets containing 2.5 g lactitol or 2.5 g placebo. Report Zy 15060 BG-95-F7

Active substance: Lactitol

Study summary document link (including results): 2011_EMAspreadsheet_Importal_Report Zy 15060 BG-95-F7.xls

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Document reference: 48153

Study title: Experimental use of macrodex as a prophylaxis against post-operative thrombo-embolism.KOEKENBERG LJ. Bull Soc Int Chir. 1962 Sep-Oct;21:501-12.

Active substance: Dextran

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Document reference: 48938

Study title: Prevention of dextran-induced anaphylactic reactions by hapten inhibition. III. A Scandinavian multicenter study on the effects of 20 ml dextran 1, 15%, administered before dextran 70 or dextran 40.Renck H, Ljungström KG, Hedin H, Richter W. Acta Chir Scand. 1983;149(4):355-60.

Active substance: Dextran

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Document reference: 48941

Study title: Percutaneous puncture and pre-operative cyanoacrylate obliteration of a traumatic false aneurysm of an angular artery branch. ;Huang-F. British Journal of Radiology, 2003, Vol/Iss/Pg. 76/910 (746-749)Percutaneous puncture and pre-operative cyanoacrylate obliteration of a traumatic false aneurysm of an angular artery branch. ;Huang-F. British Journal of Radiology, 2003, Vol/Iss/Pg. 76/910 (746-749)

Active substance: IODINE

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Document reference: 30300

Study title: Percutaneous sclerotherapy for lymphatic malformations: A retrospective analysis of patient-evaluated improvement. Alomari-A-I. Journal of Vascular and Interventional Radiology, 2006, Vol/Iss/Pg. 17/10 (1639-1648), 0443.Percutaneous sclerotherapy for lymphatic malformations: A retrospective analysis of patient-evaluated improvement. Alomari-A-I. Journal of Vascular and Interventional Radiology, 2006, Vol/Iss/Pg. 17/10 (1639-1648), 0443.

Active substance: IODINE

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Document reference: 30301

Study title: Persistence of goiter despite oral iodine supplementation in goitrous children with iron deficiency anemia in Cote d'Ivoire. ;Zimmermann-M. American Journal of Clinical Nutrition, 2000, Vol/Iss /Pg. 71/1 (88-93)Persistence of goiter despite oral iodine supplementation in goitrous children with iron deficiency anemia in Cote d'Ivoire. ;Zimmermann-M. American Journal of Clinical Nutrition, 2000, Vol/Iss /Pg. 71/1 (88-93)

Active substance: IODINE

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Document reference: 30302

Study title: Persistence of lipiodol for 13 months in metastatic deposits in the liver on computed tomography. ;Fairlie-N-C. Clinical Radiology, 1991, Vol/Iss/Pg. 44/4 (273-274)Persistence of lipiodol for 13 months in metastatic deposits in the liver on computed tomography. ;Fairlie-N-C. Clinical Radiology, 1991, Vol/Iss/Pg. 44/4 (273-274)

Active substance: IODINE

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Document reference: 30303

Study title: Efficacy and safety of loratadina-betamethasone combination in the initial treatment of severe perennial allergic rhinitis in children

Active substance: LARATADINE

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Document reference: 31019

Study title: Efficacy and Safety of SCH 29851 8 mg in Subjects with Allergic Rhinitis

Active substance: LARATADINE

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Document reference: 31017

Study title: Efficacy and Safety of SCH 29851 in 8 mg in Subjects with Allergic Rhinitis

Active substance: LARATADINE

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Document reference: 31015

Study title: Efficacy and Safety of SCH 29851 in 8 mg in Subjects with Allergic Rhinitis

Active substance: LARATADINE

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Document reference: 31018

Study title: HEALTH ECONOMIC DRUG UTILIZATION OBSERVATION "XPENSE" FOR COMPARISON OF THE COSTS OF DIFFERENT MEDICAL GLAUCOMA THERAPIES

Active substance: LATANOPROST/LATANOPROST AND TIMOLOL

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Document reference: 31021

Study title: Björklund SI. Miniture enema in children’s practice. The Swedish Medical Journal 1961:58:2763-2766. Devaux j, Bernard JL, Mouly-Bandini a, Raybaud CI. Use of a peptisant gel in a pediatric ward. Méditerranée Médicale 1975:3:65-68 No.67 (English translation). Björklund SI. Miniture enema in children’s practice. The Swedish Medical Journal 1961:58:2763-2766. Devaux j, Bernard JL, Mouly-Bandini a, Raybaud CI. Use of a peptisant gel in a pediatric ward. Méditerranée Médicale 1975:3:65-68 No.67 (English translation).

Active substance: LAURYL SULPHATE AND SORBITOL

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Document reference: 31024

Study title: Grosse K-P, Keller KM, Behrens R, Becker M. Chronische Obstipation im Kindesalter. Monatsschr Kinderheilk 1990:138:231-233. Grosse K-P, Keller KM, Behrens R, Becker M. Chronische Obstipation im Kindesalter. Monatsschr Kinderheilk 1990:138:231-233.

Active substance: LAURYL SULPHATE AND SORBITOL

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Document reference: 31026

Study title: Nolan T, Debelle G, Oberklaid F, Coffey C. Randomised trial of laxatives in treatment of childhood encopresis. Lancet 1991:338:523-527. Nolan T, Debelle G, Oberklaid F, Coffey C. Randomised trial of laxatives in treatment of childhood encopresis. Lancet 1991:338:523-527.

Active substance: LAURYL SULPHATE AND SORBITOL

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Document reference: 31025

Study title: Pharmacia Consumer Pharma report on the Clinical Documenation on Microlax Enema; Helsingborg May 1995, Jan RundegrenPharmacia Consumer Pharma report on the Clinical Documenation on Microlax Enema; Helsingborg May 1995, Jan Rundegren

Active substance: LAURYL SULPHATE AND SORBITOL

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Document reference: 31027

Study title: Rett A. Die Obstipaton als Klinisch-terapeutishes Problem hirngeschädigter Kinder. Therapeutische Umschau 1996:23:165-169. Rett A. Die Obstipaton als Klinisch-terapeutishes Problem hirngeschädigter Kinder. Therapeutische Umschau 1996:23:165-169.

Active substance: LAURYL SULPHATE AND SORBITOL

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Document reference: 31022

Study title: Strauss P. Die Behandlung der kindlichen Obstipation unter Verwendung eies neuen Mikroklistiers. Deut Med J 1965:16:476-478. Strauss P. Die Behandlung der kindlichen Obstipation unter Verwendung eies neuen Mikroklistiers. Deut Med J 1965:16:476-478.

Active substance: LAURYL SULPHATE AND SORBITOL

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Document reference: 31023

Study title:

Active substance: LEFLUNOMIDE

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Document reference: 47352

Study title: Randomised trial of two pharmacological methods of bowel preparation for day case colonoscopyPinfield A, Stringer MD., 1999, Arch Dis child 1999; 80: 181 - 183

Active substance: SODIUM PICOPSULPHATE

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48903

Study title: Safety of Picolax in inflammatory bowel disease.Evans M, Walker-Smith J, Williams Ch., 1989, BMJ 1989; 299: 1101 – 1102

Active substance: SODIUM PICOPSULPHATE

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48900

Study title: The superiority of topical application of stannous fluoride on primary teeth1957-McDonald

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1957-McDonald-the superiority of topical application of stannous fluoride on primary teeth.pdf

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Document reference: 49135

Study title: The use of a sodium fluoride mouthwash in reducing the dental caries increment in eleven year old english school children1972-Brandt

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1972-Brandt-the use of a sodium fluoride mouthwash in reducing the dental caries increment in eleven year old english school children.pdf

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Document reference: 49128

Study title: Three year report on caries prevention using I fluoride varnish for caries risk children in a community with fluoridated water1982-seppa

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1982-seppa-Three year report on caries prevention using I fluoride varnish for caries risk children in a community with fluoridated water.pdf

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Document reference: 49109

Study title: Topical application of a fluoride protective varnish for caries prophylaxis1973-maiwald

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1973-maiwald-Topical application of a fluoride protective varnish for caries prophylaxis.pdf

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Document reference: 49101

Study title: Trends in total caries experience2000-Brown

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 2000-Brown-trends in total caries experience.pdf

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Document reference: 49097

Study title: Two-year clinical tests with different methods of local caries-preventive fluorine application in swedish school-children1965-Torell

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1965-Torell-two-year clinical tests with different methods of local caries-preventive fluorine application in swedish school-children.pdf

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Document reference: 49126

Study title: Fluorine concentration in primary tooth enamel in 6 year olds after 3 years of daily intake of fluoride-containing tablets.J. Widenheim, Lars G Petersson, Goran Koch 1984, Swed Dent J

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1984-widenheim-Fluoide concentration in primary tooth enamel in 6 years oldy after 3 years of daily intake of fluoridecontaining tablets.pdf

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Document reference: 48777

Study title: Fluroide in the prevention of caries in the pre-school childRugg 19990. J. Dent

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1990-Rugg_Gunn-Fluoride in the Prevention of Caries in the Pre-school Child.pdf

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Document reference: 48774

Study title: Four year study of caries inhibition of intensive Duraphat application in 11-15 year old children1994-skold, Community Dent. Oral Epidemiol. 1994 22:18-24

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1994-skold-Four year study of caries inhibition of intensive Duraphat application in 11-15 year old children.pdf

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Document reference: 49119

Study title: Gingival recession and wedge-shaped defects with regular use of an amine fluoride-containing gel applied with a toothbrushSchiffner 1995

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Schiffner 1995 Gingival recession and wedge-shaped.pdf

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Document reference: 49177

Study title: High-fluoride toothpaste and no post-brushing water rinsing on enamel demineralization using an in-sit caries model with orthodontic bands2010-AlMulla

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 2010-AlMulla-high-fluoride toothpaste and no post-brushing water rinsing on enamel demineralization using an in-sit caries model with orthodontic b...

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Document reference: 49098

Study title: Bone scintigraphy in calcific discitis of childhood. Delpassand ES, Barron BJ, Gundzik JM. J Nucl Med. 1990 Feb;31(2):234-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48843

Study title: Bone scintigraphy in testicular tumors.Braga FJ, Arbex MA, Haddad J, Maes A. Clin Nucl Med 2001 Feb;26(2):117-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48577

Study title: K.E.E.P.E.R. (KEPPRA(R) EPILEPSY EVALUATION OF PATIENT TIME TO RESPONSE). A PHASE IV, OPEN-LABEL, MULTI-CENTER, COMMUNITY-BASED TRIAL STUDYING THE SAFETY AND EFFICACY OF LEVETIRACETAM AS ADD-ON THERAPY IN ADULT PATIENTS WITH TREATMENT-RESISTANT, PARTIAL-ONSET EPILEPSY.

Active substance: levetiracetam

Study summary document link (including results): N01030 - Levetiracetam - RRCE02E1301.pdf

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Document reference: 31147

Study title: Bone scintigraphy in the diagnosis and follow up of Perthes' disease.Cavailloles F, Bok B, Bensahel H. Eur J Nucl Med 1982;7(7):327-30.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48588

Study title: Gallium-67 and technetium-99m-methylene diphosphonate skeletal scintigraphy in determining prognosis for children with stage IV neuroblastomaMacdonald WB. Stevens MM. Dalla Pozza L. Bergin M. Menser MA. Howman-Giles R. et al. J Nucl Med 1993Jul;34(7):1082-6

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48502

Study title: Hepatopulmonary syndrome: a prospective study of relationships between severity of liver disease, PaO(2) response to 100% oxygen, and brain uptake after (99m)Tc MAA lung scanning. Chest. 2000 Sep;118(3):615-24. Krowka MJ 2000

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48803

Study title: Irreversible long-term pulmonary functional impairments after adenovirus type-7 pneumonia: assessment with xenon-133 ventilation and Tc-99m MAA perfusion studies. Eur Radiol. 2000;10(9):1411-5. Suga K 2000

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48802

Study title: Krypton-81m ventilation and technetium-99m macroaggregated albumin perfusion scintigraphy for detection of pulmonary embolism: the first experience in Taiwan. Zhonghua Yi Xue Za Zhi (Taipei). 2000 Dec;63(12):876-84. Cherng SC 2000

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48801

Study title: Late pulmonary scintigraphic defects after uneventful recovery from focal pneumonia in children: comparison with initial radiograph. Med Sci. 2002 Jul;18(7):334-9. Kaohsiung J 2002

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48798

Study title: Late pulmonary scintigraphic defects after uneventful recovery from simple focal pneumonia of childhood. Br J Radiol. 1993 Nov;66(791):1031-4. Kenney IJ 1993

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48819

Study title: Gastric uptake of Tc-99m MDP in a child treated with isotretinoin.Franco A, Hampton WR, Greenspan BS, Holm AL, O'Mara RE. Clin Nucl Med 1993 18(6):510-1.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48723

Study title: Acute asthma management of children in the emergency department.

Active substance: IPRATROPIUM

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Document reference: 30563

Study title: Low dose oral iodized oil for control of iodine deficiency in children. ; Zimmermann-M. British Journal of Nutrition, 2000, Vol/Iss/Pg. 84/2 (139-141)Low dose oral iodized oil for control of iodine deficiency in children. ; Zimmermann-M. British Journal of Nutrition, 2000, Vol/Iss/Pg. 84/2 (139-141)

Active substance: IODINE

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Document reference: 30283

Study title: Dal Monte. Gastroenterology Dept Bellaria Hospital, Regional Hospital Institution-Hospital of Bologna Dal Monte. Gastroenterology Dept Bellaria Hospital, Regional Hospital Institution-Hospital of Bologna

Active substance: INOSINE

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Document reference: 30095

Study title: AN 05134405 Medline 20070101. TI (Use of cyproheptadine to obtain recovery of the weight curve after tonsillectomy. Clinico-statistical observations on 91 cases). TT Sull'impiego della ciproeptadina per l'ottenimento di una ripresa della curva ponderale dopo l'intervento di tonsillectomia. Osservazioni clinico-statistich su 91 casi. SO Minerva otorinolaringologica, {Minerva-Otorinolaringol}, Sep-Oct 1971, vol. 21, no. 5, p. 191-5, ISSN: 0026-4938. AU Fior-R. YR 1971.AN 05134405 Medline 20070101. TI (Use of cyproheptadine to obtain recovery of the weight curve after tonsillectomy. Clinico-statistical observations on 91 cases). TT Sull'impiego della ciproeptadina per l'ottenimento di una ripresa della curva ponderale dopo l'intervento di...

Active substance: CYPROHEPTADINE

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Document reference: 25204

Study title: Phase IV Efficacy and Safety Study of Reformulated CoTylenol Tablets. Nov 1978.

Active substance: DEXTROMETHOPRHAN AND PSEUDOEPHEDRINE

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Document reference: 25797

Study title: Benefit of intensified therapy for patients with local or regional embryonal rhabdomyosarcoma: results from the Intergroup Rhabdomyosarcoma Study IV.

Active substance: DACTINOMYCIN

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Document reference: 25301

Study title: Efficacy and morbidity of Daunomycin (NSC-82151) added to vincristine (NSC-67574) and Prednisone (NSC-10023) for remission induction of childhood acute lymphocytic leukemia - Verzosa, M., Fite, A. - 1971 (Cancer Chemotherapy Reports Part.1 Vol. 55 n°1, 79-82) - Publication in the dos. Allemand jan 1981 - Efficacy and morbidity of Daunomycin (NSC-82151) added to vincristine (NSC-67574) and Prednisone (NSC-10023) for remission induction of childhood acute lymphocytic leukemia - Verzosa, M., Fite, A. - 1971 (Cancer Chemotherapy Reports Part.1 Vol. 55 n°1, 79-82) - Publication in the dos. Allemand jan 1981 -

Active substance: DAUNORUBICIN

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Document reference: 25617

Study title: No advantages in the addition of ifosfamide and VP-16 to the standard four-drug regimen in the maintenance phase of neoadjuvant chemotherapy of Ewing's sarcoma of bone: results of two sequential studies.

Active substance: DACTINOMYCIN

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Document reference: 25401

Study title: Paul IM et al. Dose-response relationship with increasing doses of dextromethorphan for children with cough. Clin Ther 2004; 26(9):1508-1514

Active substance: Dextromethorphan + GUAFENESIN

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Document reference: 25913

Study title: Gikas P, Mokbel K. Management of gynaecomastia: an update [Review]. International Journal of Clinical Practice 2007; 61(7):1209-1215.Gikas P, Mokbel K. Management of gynaecomastia: an update [Review]. International Journal of Clinical Practice 2007; 61(7):1209-1215.

Active substance: TAMOXIFEN

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Document reference: 43085

Study title: AN OPEN STUDY OF CEFOPERAZONE PLUS SULBACTAM IN THE TREATMENT OF SEVERE SKIN AND SKIN STRUCTURE INFECTIONS OF BACTERIAL ETIOLOGY

Active substance: SULBACTAM

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Document reference: 42638

Study title: CLINICAL USEFULNESS OF SULTAMICILLIN FINE GRANULES FOR TONSILLITIS AND ACUTE BRONCHITIS OF CHILDREN

Active substance: SULTAMICILLIN

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Document reference: 43006

Study title: Addition of 18F-FDG-PET scans to radiotherapy planning of thoracic lymphomaRadiotherapy and Oncology 73 (2004) 277–283. Young K. Leea,e,*, Gary Cookb, Maggie A. Flowera, Carl Rowbottomc, Mehdi Shahidid, Bhupinder Sharmab, Steve Webba

Active substance: Steripet

Study summary document link (including results): lee-2004.pdf

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Document reference: 48736

Study title: Application of Intravenous Contrast in PET/CT:Does It Really Introduce Significant Attenuation Correction Error?J Nucl Med 2005; 46:283–291. Yat-Yin Yau, MD1; Wing-Sze Chan, BSc1; Yat-Man Tam, MSc1; Phil Vernon, PhD2; So Wong1; Marc Coel, MD3; and Simon Kwok-Fai Chu1

Active substance: Steripet

Study summary document link (including results): yau-2005.pdf

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Document reference: 48747

Study title: ARSAC (Administration of Radioactive Substances Advisory Committee). Notes for Guidance on the Clinical Administration of Radiopharmaceuticals and Use of Sealed Radioactive Sources.Chilton, Didcot, 2006. [arsac-2006]. ARSAC 2006

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48626

Study title:

Active substance: LEFLUNOMIDE

Study summary document link (including results):

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Document reference: 47353

Study title:

Active substance: LEFLUNOMIDE

Study summary document link (including results):

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Document reference: 47354

Study title: Double-blind, eight-month extension study to collect durability of efficacy data and additional safety data in patients with juvenile rheumatoid arthritis completing the double-blind comparison study HWA486/3503 of leflunomide versus methotrexate

Active substance: LEFLUNOMIDE

Study summary document link (including results): Leflunomide-Study 3.pdf

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Document reference: 47350

Study title: Efficacy and safety of leflunomide versus methotrexate in the treatment of pediatric patients with juvenile rheumatoid arthritis (JRA)

Active substance: LEFLUNOMIDE

Study summary document link (including results): Leflunomide-Study 2.pdf

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Document reference: 47349

Study title: Phase IB Trial of Leflunomide in Pediatric Subjects with Polyarticular Course Juvenile Rheumatoid Arthritis (JRA)

Active substance: LEFLUNOMIDE

Study summary document link (including results): Leflunomide-Study 1.pdf

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Document reference: 47348

Study title: Population pharmacokinetics of A77 1726 (M1) after oral administration of leflunomide in pediatric subjects with polyarticular course juvenile rheumatoid arthritis

Active substance: LEFLUNOMIDE

Study summary document link (including results): Leflunomide-Study 4.pdf

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Document reference: 47351

Study title: Compatibility of Lomaherpan Cream in children with herpes simplex labialis 1995

Active substance: Lemon balm dry extract

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Document reference: 40047

Study title: Q Clinical impact of fluorine-18fluorodeoxyglucose positron emission tomography in cancer patients. A comparative study between dedicated camera and dual-head coincidence gamma camera.JNucl Med Mol Imaging. 2006 Mar;50(1):68-77. Andrieux A 2006

Active substance: SteriPET

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48624

Study title: Rigacci L, Castagnoli A, Dini C, Carpaneto A, Matteini M, Alterini R. FDG-positron emission tomography in post treatment evaluation of residual mass in Hodgkin's lymphoma: long-term results. [rigacci-2005]Oncol Rep. 2005 Nov;14(5):1209-14. 18. Rigacci L 2005

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48692

Study title: Rini JN, Manalili EY, Hoffman MA, Karayalcin G, Mehrotra B, Tomas MB, et alFDG versus Ga-67 for detecting splenic involvement in Hodgkin's disease. [rini-2002]Clin Nucl Med. 2002 Aug;27(8):572-7. F-18. Rini JN 2002

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48693

Study title: Rixham PA, Roberts G. The new EANM paediatric dosage card : how does it affect UK centres working under the ARSAC guidelines? [rixham-2009]Nucl Med Comm 2009; 319 – 321. Rixham PA 2009

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48694

Study title: Schifter T, Hoffman JM, Hatten HP Jr, Hanson MW, Coleman RE, DeLong GR.. Neuroimaging in infantile autism. [schifter-1994]J Child Neurol. 1994 Apr;9(2):155-61. Schifter T 1994

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48695

Study title: Schmitz A, Risse JH, Grünwald F, Gassel F, Biersack HJ, Schmitt O.. Fluorine-18 fluorodeoxyglucose positron emission tomography findings in spondylodiscitis: preliminary results. [schmitz-2001]Eur Spine J. 2001 Dec;10(6):534-9. Schmitz A 2001

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48696

Study title: Shulkin BL, Goodin GS, McCarville MB, Kaste SC, Krasin MJ, Hudson MM, Metzger M.. Bone and [18F]fluorodeoxyglucose positron-emission tomography/computed tomography scanning for the assessment of osseous involvement in Hodgkin lymphoma in children and young adults. [shulkin-2009 Leuk Lymphoma. 2009 Nov;50(11):1794-802. Shulkin BL 2009

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48698

Study title: Shulkin BL, Hutchinson RJ, Castle VP, Yanik GA, Shapiro B, Sisson JC.. Neuroblastoma: positron emission tomography with 2-[fluorine-18]-fluoro-2-deoxy-D-glucose compared with metaiodobenzylguanidine scintigraphy. [shulkin-1996]Radiology. 1996 Jun;199(3):743-50. Shulkin BL 1996

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48697

Study title: Incremental rates of dental caries after repeated topical sodium fluoride applications in children with lifelong consumption of fluoridated water1971-Englander

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1971-Englander-incremental rates of dental caries after repeated topical sodium fluoride applications in children with lifelong consumption of fluo...

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Document reference: 49093

Study title: Jarman underproveleged area scores, tooth decay and the effect of water fluoridation1997-jones

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1997-jones-Jarman underproveleged area scores, tooth decay and the effect of water fluoridation.pdf

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Document reference: 49123

Study title: Kollective Karies pravention in Vorchulatter unter Verwendung eines Fluoridhaltingen lackes1980-treide

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1980-treide-Kollective Karies pravention in Vorchulatter unter Verwendung eines Fluoridhaltingen lackes.pdf

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Document reference: 49107

Study title: Kollektive VorbeugungsprogrammeMagri 1986

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Magri 1986 Kollektive Vorbeugungsprogramme.pdf

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Document reference: 49169

Study title: Long term evaluation of a SnF2 gel for control of gingivitis and decalcification in adolescent orthodontic patients1994-boyd

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1994-boyd - long term evaluation of a SnF2 gel for control of gingivitis and decalcification in adolescent orthodontic patients.pdf

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Document reference: 49157

Study title: NHS dental epidemology programme for England2010-Rooney

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 2010-Rooney-NHS dental epidemology programme for England.pdf

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Document reference: 49092

Study title: Perspectives on the use of Prenatal Fluoride Administration for Prevention of Dental Caries: a reactors comments1981-Stamm. Journal of Dentistry for Children, March - April, 1951

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1981-Stamm-Perspectives on the use of Prenatal Fluoride Administration for Prevention of Dental Caries.pdf

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Document reference: 48772

Study title: Pharmacokinetics of Fluoride gelsEkstrand 1981, Caries Res 15:213 - 220 (1981)

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Ekstrand 1981 Pharmacokinetics of Fluoride gels.pdf

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Document reference: 49163

Study title: Pilot caries prevention- Modellversuch der KariesprophylaxeStöhr 1979

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Steiner 1984 Enamel opacities in the incisors of school children.pdf

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Document reference: 49181

Study title: Plasma fluoride concentration and urinary fluoride excretion in children following application of the fluoride containing varnish Duraphat1980-ekstrand, Caries Res, 14: 185-189 1980

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1980-ekstrand-Plasma fluoride concentration and urinary fluoride excretion in children following application of the fluoride containing varnish Dur...

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Document reference: 49106

Study title: Pre-eruptive effect of NaF tablets on caries in children from 12 to 17 years of ageJ. Widenheim, Dowen Birked, Lars Granath, Georg Lindgren 1986. Community Dent Oral Epidemiol

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1986-Widenheim-Preeruptive effect of NaF Tablets on Caries in Children from 12 to 17 years of age.pdf

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Document reference: 48776

Study title: Pretreatment of teeth with sodium fluoride prior to stannous fluoride applications1959-Abdul-Gaffar, J DENT RES 1959 38: 901 H. Abdul-Ghaffar and Joseph C. Muhler

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1959-Abdul-Gaffar- Pretreatment of teeth with sodium fluoride prior to stannous fluoride applications.pdf

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Document reference: 49136

Study title: Prevention of caries progress in xerostomic patients by topical fluoride applicationsMarkitziu 1982

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Markitziu 1982 Prevention of caries progress.pdf

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Document reference: 49171

Study title: L'Ipratropium bromide in the treatment of asthma-like bronchitis in babies.Clin.Ped. 1981,63,1-7Corrias A. et al ClinPed 1981, Corrias

Active substance: IPRATROPIUM

Study summary document link (including results): ClinPed 1981, Corrias.pdf

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Document reference: 48889

Study title: Measurements on the rapid and medium-acting bronchodilating effect of ipratropium bromide administered by aerosol in children with allergic bronchial asthma. Arch Med Int 1981,33,25-40Capristo A. et al ArchMedInterna 1981, Capristo

Active substance: IPRATROPIUM

Study summary document link (including results): ArchMedInterna 1981, Capristo.pdf

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Document reference: 48888

Study title: Role of buclizine hydrochloride in promoting weight gain in children

Active substance: Buclizine

Study summary document link (including results): DE81G307P - Buclizine hydrochloride.pdf

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Document reference: 42007

Study title: A comparison of iohexol and diatrizoate-meglumine in children undergoing cardiac catheterization. Investigative radiology (1991), 26(7), 665-70 Pelech AN 1991

Active substance: IOHEXOL

Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc

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Document reference: 48863

Study title: A) Open non-comparative pilot study B) randomized, double-blind, parallel study using Amipaque (metrizamide) 300 mgI/ml as comparison in pediatric urography to assess the safety, tolerability and image effectiveness of iohexol 300 mgI/ml firstly in an open study and later compared to Amipaque 300 mgI/ml.Applicant's study report

Active substance: IOHEXOL

Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls

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Document reference: 48887

Study title: Impact of ibuprofen administration on renal drug clearance in the first weeks of life.

Active substance: INDOMETHACIN

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Document reference: 29913

Study title: A comparative study to compare the effects of BDP and BUD of symptoms, peak-flow diaries. Lung function and hypothalamic-adrenal function

Active substance: BUDESONIDE

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Document reference: 48892

Study title: Comparison of the risk of nocturnal hypoglycemia in adolescents with type 1 diabetes mellitus given either HOE901 with lispro or NPH insulin with regular human insulin, as multiple injection regimens

Active substance: INSULIN GLARGINE

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Document reference: 47341

Study title: Morning Lantus® (insulin glargine [rDNA origin] injection) vs. intermediateacting insulin twice daily as basal insulin in a multiple daily injection regimen with Humalog® (insulin lispro injection [rDNA Origin]) in pediatrics with type 1 diabetes mellitus: an activeontrolled, open, randomized, gender-stratified, two arm, parallel-group study.

Active substance: INSULIN GLARGINE

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Document reference: 47342

Study title: Multicenter, open, uncontrolled clinical extension trial of HOE901 in type 1 diabetic children previously participating in study HOE901/3003.

Active substance: INSULIN GLARGINE

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Document reference: 47340

Study title: Lai C.L. Open, pilot (phase II) study comparing patients treated with interferon alfa-2a with an untreated control group, in chinese chidren with chronic hepatitis B (Protocol 0-10002); 30th May 1988 (Leitz G.J., Rochefort E., Ryff J.C.)

Active substance: INTERFERON ALPHA (2A)

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Document reference: 30188

Study title: V. Carreno M.D. Open, single centre pilot (phase II) study comparing patients treated with interferon alfa-2a with an untreated control group in children with chronic hepatitis B (Protocol 0-10002); 30th May 1988 (Leitz G.J., Rochefort E., Ryff J.C.)

Active substance: INTERFERON ALPHA (2A)

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Document reference: 30189

Study title: Treatment of Early Onset Mulitple Sclerosis with Suboptimal Dose of Interferon Beta-1a (Pakdaman et al)

Active substance: Interferon beta-1a

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Document reference: 41483

Study title:

Active substance: INTERFERON GAMMA (1B

Study summary document link (including results):

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Document reference: 47176

Study title: 107.162, 107.235 - A Population pharmacokinetic analysis for meloxicam in pediatric juvenile rheumatoid arthritis patients – A combined analysis of pharmacokinetic data obtained in studies 107.162 and 107.235

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30200

Study title: 137158 - Clinical efficacy of recombinant human interferon-gamma in chronic granulomatous disease.

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30192

Study title: ARSAC website http://www.arsac.org.uk/newsletter/newsletters.htm ; accessed 27 January 2010 [arsac-2009]ARSAC 2009

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48627

Study title: Bar-Shalom R, Gaitini D, Keidar Z, Israel O.. Non-malignant FDG uptake in infradiaphragmatic adipose tissue: a new site of physiological tracer biodistribution characterised by PET/CT. [bar-shalam-2004Eur J Nucl Med Mol Imaging. 2004 Aug;31(8):1105-13. Epub 2004 Mar 9. Bar-Shalom R 2004

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48628

Study title: Barrington SF, Begent J, Lynch T, Schleyer P, Biassoni L, Ramsden W, et al.. Guidelines for the use of PET–CT in children. [barrington-2008]Nucl Med Commun 2008; 29:418–424. Barrington SF 2008

Active substance: Steripet

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Document reference: 48629

Study title: Bastiaannet E, Oyen WJ, Meijer S, Hoekstra OS, Wobbes T, Jager PL, et al.. Impact of 18F] fluorodeoxyglucose positron emission tomography on surgical management of melanoma patients. [bastiaannet-2006]Br J Surg. 2006 Feb;93(2):243-9. Bastiaannet E 2006

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48631

Study title: Bestic JM, Peterson JJ, Bancroft LW.. Review. Erratum in: Radiographics. 2010 Jan-Feb;30(1):301. Pediatric FDG PET/CT: Physiologic uptake, normal variants, and benign conditions [corrected]. [bestic-2009] Radiographics. 2009 Sep-Oct;29(5):1487-500. Bestic JM 2009

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48632

Study title: Boellaard R, Oyen WJ, Hoekstra CJ, Hoekstra OS, Visser EP, Willemsen AT, Arends B, Verzijlbergen FJ, Zijlstra J, Paans AM, Comans EF,. The Netherlands protocol for standardisation and quantification of FDG whole body PET studies in multi-centre trials. [boellaard-2008]Pruim J Eur J Nucl Med Mol Imaging 2008 12:2320–2333. Boellaard R 2008

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48633

Study title: Borgwardt L, Højgaard L, Carstensen H, Laursen H, Nowak M, Thomsen C, et al.. Increased fluorine-18 2-fluoro-2-deoxy-Dglucose (FDG) uptake in childhood CNS tumors is correlated with malignancy grade: a study with FDG positron emission tomography/magnetic resonance imaging coregistration and image fusion. [borgwardt-2005]J Clin Oncol. 2005 May 1;23(13):3030-7. Borgwardt L 2005

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48634

Study title: Brenner W, Friedrich RE, Gawad KA, Hagel C, von Deimling A, de Wit M, et al.. Epub 2006 Jan 11. Prognostic relevance of FDG PET in patients with neurofibromatosis type-1 and malignant peripheral nerve sheath tumours. [brenner-2006]Eur J Nucl Med Mol Imaging. 2006 Apr;33(4):428-32. Brenner W 2006

Active substance: Steripet

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Document reference: 48635

Study title: Buchmann I, Reinhardt M, Elsner K, Bunjes D, Altehoefer C, Finke J, et al.. 2-(fluorine-18)fluoro-2-deoxy-D-glucose positron emission tomography in the detection and staging of malignant lymphoma. A bicenter trial. [buchmann-2001]Cancer. 2001 Mar 1;91(5):889-99. Buchmann I, 2001

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48636

Study title: Endemic goiter in rural peru: Effect of iodized oil on prevalence and size of goiter and on thyroid iodine metabolism in known endemic goitres populations; E.A. Pretell. Pan American Health Organization: Chapter 34 :419-437Endemic goiter in rural peru: Effect of iodized oil on prevalence and size of goiter and on thyroid iodine metabolism in known endemic goitres populations; E.A. Pretell. Pan American Health Organization: Chapter 34 :419-437

Active substance: IODINE

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Document reference: 30245

Study title: Endoscopic sclerotherapy of gastric variceal bleeding with N-butyl-2- cyanoacrylate. ; Dhiman-R-K. Journal of Clinical Gastroenterology, 2002, Vol /Iss/Pg. 35/3 (222-227)Endoscopic sclerotherapy of gastric variceal bleeding with N-butyl-2- cyanoacrylate. ; Dhiman-R-K. Journal of Clinical Gastroenterology, 2002, Vol /Iss/Pg. 35/3 (222-227)

Active substance: IODINE

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Document reference: 30246

Study title: Strategy of goitre and cretinism control in Central Africa; C H Thilly. International journal of epidemiology Vol. 6 n0. 1: 43-54Strategy of goitre and cretinism control in Central Africa; C H Thilly. International journal of epidemiology Vol. 6 n0. 1: 43-54

Active substance: IODINE

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Document reference: 30325

Study title: Strumatherapie heute, Köbberling; Med. Klein. 87, 374-377, 1992Strumatherapie heute, Köbberling; Med. Klein. 87, 374-377, 1992

Active substance: IODINE

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Document reference: 30326

Study title: Successful left hepatectomy for hepatocellular carcinoma in a child after transcatheter arterial chemoembolization: Report of a survival. ; Uemura-S, T. European Journal of Pediatric Surgery, 1993, Vol /Iss/Pg. 3/1 (54-56)Successful left hepatectomy for hepatocellular carcinoma in a child after transcatheter arterial chemoembolization: Report of a survival. ; Uemura-S, T. European Journal of Pediatric Surgery, 1993, Vol /Iss/Pg. 3/1 (54-56)

Active substance: IODINE

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Document reference: 30327

Study title: Successful left trisegmentectomy for ruptured hepatoblastoma using intraoperative transarterial embolization. ; Kitahara-S. Journal of Pediatric Surgery, 1995, Vol/Iss/Pg. 30/12 (1709-1712)Successful left trisegmentectomy for ruptured hepatoblastoma using intraoperative transarterial embolization. ; Kitahara-S. Journal of Pediatric Surgery, 1995, Vol/Iss/Pg. 30/12 (1709-1712)

Active substance: IODINE

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Document reference: 30328

Study title: Technique of the lipiodol test in pediatrics (Russian). ; Livshitz-E-G. LAB-DELO, 1973, Vol/Iss/Pg. 12/- (740-741). Technique of the lipiodol test in pediatrics (Russian). ; Livshitz-E-G. LAB-DELO, 1973, Vol/Iss/Pg. 12/- (740-741).

Active substance: IODINE

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Document reference: 30329

Study title: Techniques and Applications of Transcatheter Embolization Procedures in Pediatric Cardiology. ; Sim-J-Y. Journal of Interventional Cardiology, 2003, Vol /Iss/Pg. 16/5 (425-448)Techniques and Applications of Transcatheter Embolization Procedures in Pediatric Cardiology. ; Sim-J-Y. Journal of Interventional Cardiology, 2003, Vol /Iss/Pg. 16/5 (425-448)

Active substance: IODINE

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Document reference: 30330

Study title: The effect of varying doses of oral iodized oil in the prophylaxis of endemic goitre in elementary schools children. ; Abuye-C. Ethiopian Medical Journal, 1995, Vol/Iss/Pg. 33/2 (115-123)The effect of varying doses of oral iodized oil in the prophylaxis of endemic goitre in elementary schools children. ; Abuye-C. Ethiopian Medical Journal, 1995, Vol/Iss/Pg. 33/2 (115-123)

Active substance: IODINE

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Document reference: 30331

Study title: The huon peninsula endemic: The effectiveness of an intramuscular depot of iodized oil in the control of endemic goitre.;Mc Cullagh. The medicinal journal of Australia 769-777The huon peninsula endemic: The effectiveness of an intramuscular depot of iodized oil in the control of endemic goitre.;Mc Cullagh. The medicinal journal of Australia 769-777

Active substance: IODINE

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Document reference: 30332

Study title: A dose-finding study of a super-long acting luteinizing hormone releasing hormone analogue in the treatment of central precocious puberty

Active substance: LEUPRORELIN

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Document reference: 31052

Study title: A study of clinical utility of a sustained release injection of leuprorelin acetate in the treatment of patients with central precocious puberty

Active substance: LEUPRORELIN

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Document reference: 31051

Study title: Clinical trial to evaluate efficacy and tolerability of subcutaneously administered leuprorelin acetate as a 1-month depot in a weight-dependent dosage in female patients with central precocious puberty + Biometrical report- interim results on bone metabolism

Active substance: LEUPRORELIN

Study summary document link (including results): 2011-08-11 Leuprorelin EC08(128)_EC108 Synopsis.pdf

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Document reference: 31043

Study title: Efficacy and safety of leuprorelin 3.75 mg administered by subcutanous injection every 28 days in the treatment of central precocious puberty

Active substance: LEUPRORELIN

Study summary document link (including results): 2011-08-11 Leuprorelin TAP-III-90-004 Synopsis.pdf

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Document reference: 31050

Study title: Leuproreline acetate in the treatment of central precocious puberty: a 12-month, multicenter, randomised, equivalence trial of two different depot formulations

Active substance: LEUPRORELIN

Study summary document link (including results): Leuprorelin_LEUb_CPP3M14_Synopsis.pdf

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Document reference: 31048

Study title: Leuproreline acetate in the treatment of central precocious puberty: a 12-month, multicenter, randomised, equivalence trial of two different depot formulations

Active substance: LEUPRORELIN

Study summary document link (including results): Leuprorelin_LEUb_CPP3M14_Synopsis.pdf

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Document reference: 31045

Study title: Lupron Injection (Lupron depot) combined results of independent investigators' studies of Leuprolide acetate in the treatment of central precocious puberty

Active substance: LEUPRORELIN

Study summary document link (including results): 2011-08-11 Leuprorelin P-90-053 Synopsis.pdf

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Document reference: 31049

Study title: Prevention of decalcification in orthodontic patients by daily self treatment with 0.4 percent SnF2 gel1979-shannon

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1979-shannon - prevention of decalcification in orthodontic patients by daily self treatment with 0.4 percent SnF2 gel.pdf

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Document reference: 49154

Study title: Preventive effect of high-fluoride dentifrice in caries-active adolescents2010-Nordstrom

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 2010-Nordstrom-preventive effect of high-fluoride dentifrice in caries-active adolescents.pdf

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Document reference: 49099

Study title: Reduction in dental caries with four concentrations of sodium fluoride in a dentifrice: a meta-analysis evaluation2001-Bartizek, The journal of clinical dentistry

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 2001-Bartizek-reduction in dental caries with four concentrations of sodium fluoride in a dentifrice.pdf

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Document reference: 49087

Study title: Relative anti-caries efficacy of 1100, 1700, 2200 and 2800 ppm fluoride ion in a sodium fluoride dentifrice over 1 year2001-Biesbrock, Community dentistry and oral epidemiology

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 2001-Biesbrock-relative anti-caries efficacy of 1100, 1700, 2200 and 2800 ppm fluoride ion in a sodium fluoride dentifrice over 1 year.pdf

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Document reference: 49088

Study title: Results of a 3-year oral hygiene programmeDénes 1991, european Journal of Orthodontics 13 (1991) 129-133

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Dénes 1991 Results of a 3-year oral hygiene programme.pdf

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Document reference: 49161

Study title: Results of a group prophylaxis programmeBüttner 1985

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Büttner 1985 Results of a group prophylaxis programme.pdf

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Document reference: 49158

Study title: Results of a three-year investigation about Zahneputzen with an amine fluoride gels - Ergebnisse einer dreijährigen untersuchung uber Zahneputzen mit einem Aminfluorid-geleSzöke 1989

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Szöke 1989 Ergebnisse einer dreijährigen.pdf

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Document reference: 49182

Study title: Results of the Sherbrooke-Lac Megtanic fluoride varnish study after 20 months1985-clark

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1985-clark-Results of the Sherbrooke-Lac Megtanic fluoride varnish study after 20 months.pdf

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Document reference: 49112

Study title: Sodium fluoride tablets for childrenFrancis A. Arnold, F.J. McClure, Carl. L. White. Dental Vol 1. No. 1. October 1960

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1960-Arnold-Sodium fluoride tablets for children.pdf

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Document reference: 48766

Study title: stannous fluoride topically applied os effective-data at the end of a five years study1965-Rothhaar

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1965-Gish-Effect on dental caries in children in a natural fluoride area of combined use of three agents containing stannous fluoride.pdf

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Document reference: 49148

Study title: Stannous fluoride versus sodium fluoride in preventive treatment of orthodontic patients1977-shannon

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1977-shannon - stannous fluoride versus sodium fluoride in preventive treatment of orthodontic patients.pdf

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Document reference: 49153

Study title: No title

Active substance: Somatropin

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Document reference: 41752

Study title: Rovamycine (Spiramycine) RP5337 - Etude clinique nationale de la rovamycine sirop pediatrique

Active substance: SPIRAMYCIN

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Document reference: 42590

Study title: A TWO YEAR MULTI-CENTRE STUDY OF GENOTROPIN TREATMENT OF SHORT PUBERTAL CHILDREN WITH INTRAUTERINE GROWTH RETARDATION

Active substance: Somatropin

Study summary document link (including results): 93-8122-002 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41681

Study title: 137163 - To study the effect duration of two different doses of IFN-gamma in patients with chronic granulomatous disease (CGD) on functional responses of neutrophils (PMN).

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30193

Study title: 137177 - The immunomodulatory impact of Imukin (IFNgamma-1b) on clinical and laboratory data in the treatment of atopic dermatitis.

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30194

Study title: A phase III randomized, controlled open label trial of actimmune (Interferon gamma-1b, rIFN-alpha1b) in patients with severe, congenital (malignant) osteopetrosis.

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30205

Study title: An open phase III follow-up (5 years) trial of recombinant human interferon gamma-1b in patients with chronic granulomatous disease (CGD) to evaluate safety and efficacy of long-term interferon gamma-1b treatment - 5-year-follow-up safety report.

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30191

Study title: BL 103836,GCGD4-002 - Long-term safety and efficacy of Actimmune therapy in children with chronic granulomatous disease (CGD): Summary of data from the National Institutes of Health cohort in children initiating Actimmune prior to 1 year of age and prior to 3 years of age, respectively.

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30198

Study title: Clinical efficacy of recombinant human interferon-gamma in chronic granulomatous disease.

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30202

Study title: EBI 4.20,IP 137.3,137.3 - Interferon gamma-1b (IF-RC 1001 XX G): Safety, Efficacy and Pharmacokinetics of 0.1 mg/sqm, 0.25 mg/sqm and 0.5 mg/sqm Interferon gamma-1b for 2 or more Weeks Subcutaneaously Administered to Patients with Lymphomas, Plasmocytomas and Solid Tumors.

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30199

Study title: I0016g(A),CH 9903,137.41 - An open phase III follow-up (5 years) trial of recombinant human interferon gamma-1b in patients with chronic granulomatous disease (CGD) to evaluate safety and efficacy of long-term interferon gamma-1b treatment - 5-year-follow-up safety report.

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30196

Study title: I0286n - Post marketing surveillance study of Actimmune (recombinant human interferon gamma-Ib) in patients with chronic granulomatous disease.

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30195

Study title: I0681s - A phase III randomized, controlled open label trial of actimmune (Interferon gamma-1b, rIFN-alpha1b) in patients with severe, congenital (malignant) osteopetrosis.

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30197

Study title:

Active substance: IOVERSOL

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Document reference: 30394

Study title:

Active substance: IOVERSOL

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Document reference: 30395

Study title: 3 D CT angiography for detection of vascular complications in pediatric liver transplantation; CHENG YF; C Liver Transplant.; 2004 vol.10 n.2 p.248 2523 D CT angiography for detection of vascular complications in pediatric liver transplantation; CHENG YF; C Liver Transplant.; 2004 vol.10 n.2 p.248 252

Active substance: IOVERSOL

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Document reference: 30402

Study title: Appendicitis in children : low dose CT with a phantom based simulation technique initial observations; FEFFERMAN NR; Radiology; 2005 vol.237 p.641 646Appendicitis in children : low dose CT with a phantom based simulation technique initial observations; FEFFERMAN NR; Radiology; 2005 vol.237 p.641 646

Active substance: IOVERSOL

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Document reference: 30396

Study title: Benefit of fluoroscopically guided intraarticular, long-acting corticosteroid injection for subtalar arthritis in juvenile idiopathic arthritis.; CAHILL AM; Pediatr. Radiol.; 2007 vol.37 p544 548Benefit of fluoroscopically guided intraarticular, long-acting corticosteroid injection for subtalar arthritis in juvenile idiopathic arthritis.; CAHILL AM; Pediatr. Radiol.; 2007 vol.37 p544 548

Active substance: IOVERSOL

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Document reference: 30397

Study title: Blunt trauma in intoxicated patients: is computed tomography of the abdomen always necessary?; MAVRIDIS SP; South. Med. J.; 2000 vol.93 n.4 p.403 405Blunt trauma in intoxicated patients: is computed tomography of the abdomen always necessary?; MAVRIDIS SP; South. Med. J.; 2000 vol.93 n.4 p.403 405

Active substance: IOVERSOL

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Document reference: 30398

Study title: Children with macrocrania : clinical and imaging predictors of disorders requiring surgery; MEDINA LS; AJNR; 2001 vol.22 p.564 570Children with macrocrania : clinical and imaging predictors of disorders requiring surgery; MEDINA LS; AJNR; 2001 vol.22 p.564 570

Active substance: IOVERSOL

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Document reference: 30399

Study title: Endovascular Therapy for Priapism Secondary to Perineal Trauma; Ayrton C. J Trauma. 2001;50:571-584Endovascular Therapy for Priapism Secondary to Perineal Trauma; Ayrton C. J Trauma. 2001;50:571-584

Active substance: IODINE

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Document reference: 30247

Study title: Endovascular treatment in vein of Galen aneurysms. Case report. ;Battistella-P-A. Rivista di Neuroradiologia, 1994, Vol/Iss/Pg. 7/4 (671-681)Endovascular treatment in vein of Galen aneurysms. Case report. ;Battistella-P-A. Rivista di Neuroradiologia, 1994, Vol/Iss/Pg. 7/4 (671-681)

Active substance: IODINE

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Document reference: 30248

Study title: Endovascular treatment of arteriovenous fistulas complicating percutaneous renal biopsy in three paediatric cases. ;Bilge-I. Nephrology Dialysis Transplantation, 1999, Vol/Iss/Pg. 14/11 (2726-2730)Endovascular treatment of arteriovenous fistulas complicating percutaneous renal biopsy in three paediatric cases. ;Bilge-I. Nephrology Dialysis Transplantation, 1999, Vol/Iss/Pg. 14/11 (2726-2730)

Active substance: IODINE

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Document reference: 30250

Study title: Endovascular treatment of spinal arteriovenous fistula in a young child with hereditary hemorrhagic telangiectasia. Case report. ;Stephan-M-J. Journal of Neurosurgery, 2005, Vol/Iss/Pg. 103 PEDIATRICS/SUPPL. 5 (462-465)Endovascular treatment of spinal arteriovenous fistula in a young child with hereditary hemorrhagic telangiectasia. Case report. ;Stephan-M-J. Journal of Neurosurgery, 2005, Vol/Iss/Pg. 103 PEDIATRICS/SUPPL. 5 (462-465)

Active substance: IODINE

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Document reference: 30251

Study title: Etude de deux foyers d’endémie goitreuse au Niger : Belley-Koira et Tiguey-Tallawal; R. Aquaron. Annales d’Endocrinologie (Paris) 1990, 51, 231-240Etude de deux foyers d’endémie goitreuse au Niger : Belley-Koira et Tiguey-Tallawal; R. Aquaron. Annales d’Endocrinologie (Paris) 1990, 51, 231-240

Active substance: IODINE

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Document reference: 30252

Study title: Evaluation of the intra-hepatic arterial injection therapy of cisplatin (CDDP)-Lipiodol suspension in a child with hepatoblastoma. Ohtsubo-K. Journal of Japan Society for Cancer Therapy, 1990, Vol/Iss/Pg. 25/1 (31-39)Evaluation of the intra-hepatic arterial injection therapy of cisplatin (CDDP)-Lipiodol suspension in a child with hepatoblastoma. Ohtsubo-K. Journal of Japan Society for Cancer Therapy, 1990, Vol/Iss/Pg. 25/1 (31-39)

Active substance: IODINE

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Document reference: 30253

Study title: Facial intraosseous arteriovenous malformations: CT and MR features. ; Remonda-L. Journal of Computer Assisted Tomography, 1995, Vol/Iss/Pg. 19/2 (277-281)Facial intraosseous arteriovenous malformations: CT and MR features. ; Remonda-L. Journal of Computer Assisted Tomography, 1995, Vol/Iss/Pg. 19/2 (277-281)

Active substance: IODINE

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Document reference: 30254

Study title: Goitre and cretinism in the high Himalayas; H.K Ibbertson. NZ med. J 1974, 80: 484-488Goitre and cretinism in the high Himalayas; H.K Ibbertson. NZ med. J 1974, 80: 484-488

Active substance: IODINE

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Document reference: 30255

Study title: Guidelines For Iodine Prophylaxis Following Nuclear Accidents, WHO 1989Guidelines For Iodine Prophylaxis Following Nuclear Accidents, WHO 1989

Active substance: IODINE

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Document reference: 30256

Study title: Hemobilia: Transcatheter Occlusive Therapy and Long-term Follow-up;Renan Uflacker. Cardiovasc Intervent Radiol (1989) 12:136-141Hemobilia: Transcatheter Occlusive Therapy and Long-term Follow-up;Renan Uflacker. Cardiovasc Intervent Radiol (1989) 12:136-141

Active substance: IODINE

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Document reference: 30257

Study title: Hepatocellular carcinoma after transcatheter hepatic arterial embolization: A histopathologic study of 84 resected cases. Higuchi-T. Cancer , 1994, Vol/Iss/Pg. 73/9 (2259-2267)Hepatocellular carcinoma after transcatheter hepatic arterial embolization: A histopathologic study of 84 resected cases. Higuchi-T. Cancer , 1994, Vol/Iss/Pg. 73/9 (2259-2267)

Active substance: IODINE

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Document reference: 30258

Study title: Hepatocellular carcinoma and portal vein invasion: Results of treatment with transcatheter oily chemoembolization. ;Jin-Wook-Chung, J. American Journal of Roentgenology, 1995, Vol/Iss/Pg. 165/2 (315-321)Hepatocellular carcinoma and portal vein invasion: Results of treatment with transcatheter oily chemoembolization. ;Jin-Wook-Chung, J. American Journal of Roentgenology, 1995, Vol/Iss/Pg. 165/2 (315-321)

Active substance: IODINE

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Document reference: 30259

Study title: Hepatocellular carcinoma outcomes based on indicated treatment strategy. ; Rose-A-T. American Surgeon, 1998, Vol/Iss/Pg. 64/12 (1128-1135)Hepatocellular carcinoma outcomes based on indicated treatment strategy. ; Rose-A-T. American Surgeon, 1998, Vol/Iss/Pg. 64/12 (1128-1135)

Active substance: IODINE

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Document reference: 30260

Study title: "Randomised, multi-centric, open-label, comparative clinical trial in patients; Duration: Treatment was 3 weeks." Baudon JJ 1995

Active substance: Lactitol

Study summary document link (including results): Importal_Baudon JJ_1995-OK.xls

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Document reference: 48154

Study title: Tuomilehto H, et all. Comparison of intravenous and oral ketoprofen for postoperative pain after adenoidectomy in children. Br J Anaesth. 2000 Aug;85(2):224-7. Tuomilehto H, et all. Comparison of intravenous and oral ketoprofen for postoperative pain after adenoidectomy in children. Br J Anaesth. 2000 Aug;85(2):224-7.

Active substance: LACTITOL

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Document reference: 30989

Study title: Husz S, Kriza J, Dobozy A Presented at the Roundtable Symposium on Immunology, Hungarian Immunology Congress; October 25-28, 1989; Szeged, Hungary. (English translation) . Immunological studies in atopic dermatitis before and after Isoprinosine® treatmentHusz S, Kriza J, Dobozy A Presented at the Roundtable Symposium on Immunology, Hungarian Immunology Congress; October 25-28, 1989; Szeged, Hungary. (English translation) . Immunological studies in atopic dermatitis before and after Isoprinosine® treatment

Active substance: INOSINE

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Document reference: 30122

Study title: Husz S, Kriza J, Kiss M, Oobozy A Gygyszereink [Hungary]; 1991; 41 :217-220. Prolonged Isoprinosine® treatment in atopic dermatitisHusz S, Kriza J, Kiss M, Oobozy A Gygyszereink [Hungary]; 1991; 41 :217-220. Prolonged Isoprinosine® treatment in atopic dermatitis

Active substance: INOSINE

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Document reference: 30123

Study title: Huttenlocher, P:. Subacute Sclerosing Panencephalitis, 2nd Inti. Symp. SSPE, 1985:176-184. Follow-up of SSPE Patients on Long- Term Therapy with InosiplexHuttenlocher, P:. Subacute Sclerosing Panencephalitis, 2nd Inti. Symp. SSPE, 1985:176-184. Follow-up of SSPE Patients on Long- Term Therapy with Inosiplex

Active substance: INOSINE

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Document reference: 30124

Study title: Ink J, Andres FJ, Antonini GM, Scarpiello V, Stefano JC, Coronel N, Genoves MH, Spataro R, Natelli C, Buey O, Ink RL, Goijman I, Pernas N, Andres RJ, Sumay OR, Casal I, Cudemo OLa Prensa Medica Argentina; January 8, 1971; 45(57):2050-2064. NPT10.381 Antiviral AgentInk J, Andres FJ, Antonini GM, Scarpiello V, Stefano JC, Coronel N, Genoves MH, Spataro R, Natelli C, Buey O, Ink RL, Goijman I, Pernas N, Andres RJ, Sumay OR, Casal I, Cudemo OLa Prensa Medica Argentina; January 8, 1971; 45(57):2050-2064. NPT10.381 Antiviral Agent

Active substance: INOSINE

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Document reference: 30125

Study title: Ink J, Antonini GM. NPT10381: Prensa Universitaria [Argentina]. September 8, 1970; 324:6121-6124.Ink J, Antonini GM. NPT10381: Prensa Universitaria [Argentina]. September 8, 1970; 324:6121-6124.

Active substance: INOSINE

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Document reference: 30126

Study title: Ink J. Buenos Aires, Argentina: Teodoro Alvarez Hospital and Del Carmen Hospital. 1972. (Summary expert clinical report to Newport Pharmaceuticals International, Inc.) Isoprinosine® syrup against different acute viral diseasesInk J. Buenos Aires, Argentina: Teodoro Alvarez Hospital and Del Carmen Hospital. 1972. (Summary expert clinical report to Newport Pharmaceuticals International, Inc.) Isoprinosine® syrup against different acute viral diseases

Active substance: INOSINE

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Document reference: 30127

Study title: Janeczko J, Baranowska M, Romanowska B. (1991) Przeglad Epidemiologiczny.; 45(4):267-271. Effect of Isoprinosine® and acyclovir on the clinical course of chickenpox and herpes zosterJaneczko J, Baranowska M, Romanowska B. (1991) Przeglad Epidemiologiczny.; 45(4):267-271. Effect of Isoprinosine® and acyclovir on the clinical course of chickenpox and herpes zoster

Active substance: INOSINE

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Document reference: 30128

Study title: The role and limitation of living donor liver transplantation for hepatocellular carcinoma. ; Lo-C-M. Liver Transplantation, 2004, Vol/Iss/Pg. 10/3 (440-447)The role and limitation of living donor liver transplantation for hepatocellular carcinoma. ; Lo-C-M. Liver Transplantation, 2004, Vol/Iss/Pg. 10/3 (440-447)

Active substance: IODINE

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Document reference: 30333

Study title: The use of iodized oil in goiter prevention.;John Kevany. American Journal of Public Health 1970 60 919-925The use of iodized oil in goiter prevention.;John Kevany. American Journal of Public Health 1970 60 919-925

Active substance: IODINE

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Document reference: 30334

Study title: The value of embolization in the prognosis of renal cell carcinoma.; Basche-S. Annales de Radiologie, 1988, Vol/Iss/Pg. 31/6 (333-336) The value of embolization in the prognosis of renal cell carcinoma.; Basche-S. Annales de Radiologie, 1988, Vol/Iss/Pg. 31/6 (333-336)

Active substance: IODINE

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Document reference: 30335

Study title: Therapeutic arterial embolization of tumors and vascular lesions in the maxillofacial region and skull base. ; Heuser-L. RoFo Fortschritte auf dem Gebiete der Rontgenstrahlen und der Neuen Bildgebenden Verfahren, 1990, Vol/Iss/Pg. 152/5 (544-549)Therapeutic arterial embolization of tumors and vascular lesions in the maxillofacial region and skull base. ; Heuser-L. RoFo Fortschritte auf dem Gebiete der Rontgenstrahlen und der Neuen Bildgebenden Verfahren, 1990, Vol/Iss/Pg. 152/5 (544-549)

Active substance: IODINE

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Document reference: 30336

Study title: Transarterial chemoembolization in the treatment of hepatoblastoma in children.; Vogl-T-J. European Radiology, 2006, Vol/Iss/Pg. 16/6 (1393-1396) Transarterial chemoembolization in the treatment of hepatoblastoma in children.; Vogl-T-J. European Radiology, 2006, Vol/Iss/Pg. 16/6 (1393-1396)

Active substance: IODINE

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Document reference: 30337

Study title: Transarterial embolization of aneurysms associated with spinal cord arteriovenous malformations. Report of four cases. ; Konan-A-V. Journal of Neurosurgery, 1999, Vol/Iss/Pg. 90/1 SUPPL. (148-154)Transarterial embolization of aneurysms associated with spinal cord arteriovenous malformations. Report of four cases. ; Konan-A-V. Journal of Neurosurgery, 1999, Vol/Iss/Pg. 90/1 SUPPL. (148-154)

Active substance: IODINE

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Document reference: 30338

Study title: Transcatheter arterial chemoembolization in the treatment of hepatoblastoma. ; Oue-T. Journal of Pediatric Surgery, 1998, Vol/Iss/Pg. 33/12 (1771-1775)Transcatheter arterial chemoembolization in the treatment of hepatoblastoma. ; Oue-T. Journal of Pediatric Surgery, 1998, Vol/Iss/Pg. 33/12 (1771-1775)

Active substance: IODINE

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Document reference: 30339

Study title: Optimal imaging strategy for community-acquired Staphylococcus aureus musculoskeletal infections in children.Browne LP, Mason EO, Kaplan SL, Cassady CI, Krishnamurthy R, Guillerman RP. Pediatr Radiol 2008;38:841-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48583

Study title: Osteoma: a diagnoiss for radicular pain of extremities.Ebrahimzadeh MH, Ahmadzadeh-Chabock H, Ebrahimzadeh AR. Osteoid Orthopedics 2009; 32(11):821.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48718

Study title: Osteosarcoma of the proximal humerus.Belasco J, Watts H. Med Pediatr Oncol 1983;11(1):46-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48569

Study title: Peroperative isotopic detection in the treatment of osteoid osteoma in childrenLacheretz M, Herbaux B. Hossein-Foucher C. Lecouffe P. Richir M. Chirurgie 1989;115(7):413-6

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48494

Study title: Pitfalls and solutions in neuroblastoma diagnosis using radioiodine MIBG: our experience about 50 cases.Bouvier JF, Philip T, Chauvot P, Brunat Mentigny M, Ducrettet F, Maïassi N, et al. Prog Clin Biol Res 1988;271:707-20.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48575

Study title: Potentially misleading bone scan findings in patients with hepatoblastoma.Archer D, Babyn P, Gilday D, Greenberg MA. Clin Nucl Med 1993 Dec;18(12):1026-31

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48529

Study title: Presacral tumor associated with the Currarino triad in an adolescent.Horii T. Tsuchiya H. Tomita K. Surg 2001;121{1-2):114-6

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48488

Study title: Primary septic arthritis in heroin users: early diagnosis by radioisotopic imaging and geographic variations in the causative agentsLopez-Longo FJ. Menard HA. Carreno L. eosin J. Ballesteros R. Monteagudo I. J Rheumatol 1987 Oct;14(5):991-4

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48499

Study title: Prognostic significance of (18)F-FDG and (99m)Tc-methylene diphosphonate uptake in prim ry osteosarcoma.Franzius C. Bielack S. Flege S, Sciuk J, Jurgens H. Schober 0. Nucl Med 2002 Aug;43(8):1012-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48483

Study title: Publication 53: Radiation dose to patients from radiopharmaceuticalsICRP (lnternation Commission on Radiological Protection). Pergamon Press 1987

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48489

Study title: Publication 80: Radiation dose to patients from radiopharmaceuticalsICRP (lnternation Commission on Radiological Protection). Addendum to ICRP Publication 53. Pergamon Press 1998

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48490

Study title: Publication of result-related information on paediatric studies submitted under Article 45 of the Regulation (EC) No 1901/2006 (‘Paediatric Regulation’) Amerscan Medronate ra.gehealthcare@ge.com

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48833

Study title: Pyogenic sacroiliitis - a comparison between paediatric and adult patientsWu M-S, Chang S-S, Lee S-H, Lee C-C. Rheumatology 2007;46:1684-7

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48765

Study title: Pyogenic sacroiliitis, the missed diagnosis?Abbott GT, Carty H. Br J Radiol 1993 Feb;66(782):120-2.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48520

Study title: Lytic bone lesion in a 12-year-old.Blackmore CC, Perkins A. Acad Radiol 1995 Jun;2(6):541-3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48573

Study title: Lytic Bone Lesion in a 12-Year-OldC. Craig Blackmore, MD, and Anthony Perkins, MD Acad Radiol. 1995 Jun;2(6):541-3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48835

Study title: Chronic inflammatory appendiceal conditions that mimic acute appendicitis on helical CT; CHECKOFF JL; AJR; 2002 vol.179 p.731 734Chronic inflammatory appendiceal conditions that mimic acute appendicitis on helical CT; CHECKOFF JL; AJR; 2002 vol.179 p.731 734

Active substance: IOVERSOL

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Document reference: 30400

Study title: Clinical doses of contrast media; OLDER RA in : trends in contrast media; springer; berlin; 1999 p.75 80Clinical doses of contrast media; OLDER RA in : trends in contrast media; springer; berlin; 1999 p.75 80

Active substance: IOVERSOL

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Document reference: 30401

Study title: Computed tomographic findings of distensible orbital venous anomalies; WOO KI; Ophtalm. Plast. Reconstr. Surg.; 2002 vol.18 n.2 p.114 120Computed tomographic findings of distensible orbital venous anomalies; WOO KI; Ophtalm. Plast. Reconstr. Surg.; 2002 vol.18 n.2 p.114 120

Active substance: IOVERSOL

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Document reference: 30403

Study title: Contrast agents in neuroimaging; BYRD SE; Neuroimaging Clinics North America; 1994 vol.4 n.1 p.9 26Contrast agents in neuroimaging; BYRD SE; Neuroimaging Clinics North America; 1994 vol.4 n.1 p.9 26

Active substance: IOVERSOL

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Document reference: 30404

Study title: Contrast media use in paediatrics; BABYN PS; Adv. X Ray Contrast; 1993 vol.1 p.74 85Contrast media use in paediatrics; BABYN PS; Adv. X Ray Contrast; 1993 vol.1 p.74 85

Active substance: IOVERSOL

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Document reference: 30405

Study title: CT depiction of portal vein thrombi after creation of ileal pouch-anal anastomosis; BAKER ME; Radiology; 2003 vol.227 p.73 79CT depiction of portal vein thrombi after creation of ileal pouch-anal anastomosis; BAKER ME; Radiology; 2003 vol.227 p.73 79

Active substance: IOVERSOL

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Document reference: 30406

Study title: CT of appendicitis in children; CALLAHAN MJ; Radiology; 2002 vol.224 p.325 332CT of appendicitis in children; CALLAHAN MJ; Radiology; 2002 vol.224 p.325 332

Active substance: IOVERSOL

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Document reference: 30407

Study title: CT of small bowel ischemia associated with obstruction in emergency department patients ; diagnostic performance evaluation; SHEEDY SP; Radiology; 2006 vol.241 n.3 p.729 736CT of small bowel ischemia associated with obstruction in emergency department patients ; diagnostic performance evaluation; SHEEDY SP; Radiology; 2006 vol.241 n.3 p.729 736

Active substance: IOVERSOL

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Document reference: 30408

Study title: Double Blind, parallel group study to compare the efficacy and safety of Ioversol 350 and Iohexol 350 in Pediatric Patients undergoing Angiocardiography

Active substance: IOVERSOL

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Document reference: 30392

Study title: Acta Radiol. 1989 Nov-Dec;30(6):643-6 Influence of urography on renal function in children. A double blind study with metrizoate and iohexol. Stake G, Monn E, Rootwelt K, Golman K, Monclair T Acta Radiol. 1989 Nov-Dec;30(6):643-6 Influence of urography on renal function in children. A double blind study with metrizoate and iohexol. Stake G, Monn E, Rootwelt K, Golman K, Monclair T

Active substance: IOHEXOL

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Document reference: 30362

Study title: Can plasma iohexol disappearance be used to measure GFR in children with chronic kidney disease? Nature Clinical Practice Nephrology (2006), 2(11), 608- 609, Schwartz GJ 2006

Active substance: IOHEXOL

Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc

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Document reference: 48861

Study title: Comparative evaluation of iohexol and inulin clearance for glomerular filtration rate determinations Acta paediatrica (1994), 83(4), 418-22 Lindblad HG 1994

Active substance: IOHEXOL

Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc

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Document reference: 48859

Study title: Comparison of intravenous contrast agents for CT studies in children Acta radiologica (Stockholm, Sweden : 1987) (1992), 33(6), 592-5 Cohen MD 1987

Active substance: IOHEXOL

Study summary document link (including results): Cohen MD 1987.pdf

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Document reference: 48868

Study title: A comparative study: the efficacy of liquid paraffin and lactulose in management of chronic functional constipation. Urganci N, Akyildiz B, Polat TB. Pediatr Int. 2005 Feb;47(1):15-9.A comparative study: the efficacy of liquid paraffin and lactulose in management of chronic functional constipation. Urganci N, Akyildiz B, Polat TB. Pediatr Int. 2005 Feb;47(1):15-9.

Active substance: LACTULOSE

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Document reference: 30997

Study title: A DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY OF LACTULOSE IN THE TREATMENT OF ENCOPRESIS IN CHILDREN WITH CHRONIC CONSTIPATION

Active substance: LACTULOSE

Study summary document link (including results): Lactulose-RH105.0101.pdf

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Document reference: 31005

Study title: A pilot, open, parallel group study of the effect of lactulose on stool bacterial composition in children suffering from cystic fibrosis (antibiotic-treated and untreated) and healthy childrenConstipation in childood: a controlled comparison between lactulose and standardized senna.; Perkin J.M. - Current Medical Research and Opinion, 1977; 4(8): 540-543

Active substance: LACTULOSE

Study summary document link (including results): lactulose-s1053101.pdf

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Document reference: 30991

Study title: An open, group comparative study with Duphalac syrup versus lactulose crystalline in constipated children

Active substance: LACTULOSE

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Document reference: 30990

Study title: An open, randomized group comparative study with lactulose syrup (Duphalac~ versus lactulose crystalline in constipated children.

Active substance: LACTULOSE

Study summary document link (including results): Lactulose-H.105.910NL.pdf

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Document reference: 31006

Study title: Clinical efficacy of duphalac in the treatment of functional constipations. Shevtsov SA. Eksp Klin Gastroenterol. 2005;(6):58-60.Clinical efficacy of duphalac in the treatment of functional constipations. Shevtsov SA. Eksp Klin Gastroenterol. 2005;(6):58-60.

Active substance: LACTULOSE

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Document reference: 30994

Study title: Comparison of polyethylene glycol 3350 and lactulose for treatment of chronic constipation in children. Gremse DA, Hixon J, Crutchfield A. Clin Pediatr (Phila). 2002 May;41(4):225-9.Comparison of polyethylene glycol 3350 and lactulose for treatment of chronic constipation in children. Gremse DA, Hixon J, Crutchfield A. Clin Pediatr (Phila). 2002 May;41(4):225-9.

Active substance: LACTULOSE

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Document reference: 30999

Study title: Double blind randomised controlled trial of topical glyceryl trinitrate in anal fissure. Kenny SE, Irvine T, Driver CP, Nunn AT, Losty PD, Jones MO, Turnock RR, Lamont; GL, Lloyd DA. Arch Dis Child. 2001 Nov;85(5):404-7.Double blind randomised controlled trial of topical glyceryl trinitrate in anal fissure. Kenny SE, Irvine T, Driver CP, Nunn AT, Losty PD, Jones MO, Turnock RR, Lamont; GL, Lloyd DA. Arch Dis Child. 2001 Nov;85(5):404-7.

Active substance: LACTULOSE

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Document reference: 31004

Study title: Double-blind randomized evaluation of clinical and biological tolerance of polyethylene glycol 4000 versus lactulose in constipated children. Dupont C, Leluyer B, Maamri N, Morali A, Joye JP, Fiorini JM, Abdelatif A, Baranes C, Benoît S, Benssoussan A, Boussioux JL, Boyer P, Brunet E, Delorme J, François-Cecchin S, Gottrand F, Grassart M, Hadji S, Kalidjian A, Languepin J, Leissler C, Lejay D, Livon D, Lopez JP, Mougenot JF, Risse JC, Rizk C, Roumaneix D, Schirrer J, Thoron B, Kalach N. J Pediatr Gastroenterol Nutr. 2005 Nov;41(5):625-33.Double-blind randomized evaluation of clinical and biological tolerance of polyethylene glycol 4000 versus lactulose in constipated children. Dupont C, Leluyer B, Maamri N, Morali A, Joye JP, Fiorini JM, Abdelatif A, Baranes C, Benoît S, Benssoussan A, ...

Active substance: LACTULOSE

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Document reference: 30996

Study title: Effects of early enteral feeding on the prevention of enterogenic infection in severely burned patients. Peng YZ, Yuan ZQ, Xiao GX. Burns. 2001 Mar;27(2):145-9.Effects of early enteral feeding on the prevention of enterogenic infection in severely burned patients. Peng YZ, Yuan ZQ, Xiao GX. Burns. 2001 Mar;27(2):145-9.

Active substance: LACTULOSE

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Document reference: 31002

Study title: Choi SJ, Kim JS, Kim JH, Oh SJ, Lee JG, Kim CJ, et al.. Epub 2005 Feb 15. [18F]3'-deoxy-3'- fluorothymidine PET for the diagnosis and grading of brain tumors. [choi-2005]Eur J Nucl Med Mol Imaging. 2005 Jun;32(6):653-9. Choi SJ 2005

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48637

Study title: Clinical Implications of Different Image Reconstruction Parameters for Interpretation of Whole-Body PET Studies in Cancer Patients.J Nucl Med 2004; 45:559–566. Heiko Scho¨der, MD1; Yusuf E. Erdi, DSc2; Kenneth Chao, BS1; Mithat Gonen, PhD3; Steven M. Larson, MD1; and Henry W.D. Yeung, MD1.

Active substance: Steripet

Study summary document link (including results): schulte-1999.pdf

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Document reference: 48746

Study title: Immunosuppressive therapy using antithymocyte globulin, cyclosporine, and danazol with or without human granulocyte colony-stimulating factor in children with acquired aplastic anemia - Kojima S. et al - 2000 (Blood 96: 2049 - 2054) - Publication - Ref18 of Clinical Expert Report -

Active substance: LENOGRASTIM

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Document reference: 31034

Study title: Limited mobilization effect of G-CSF (Lenograstim) for blood stem cells in children with solid tumors - Kawano Y. et al (Eur J Cancer - 31:238)Limited mobilization effect of G-CSF (Lenograstim) for blood stem cells in children with solid tumors - Kawano Y. et al (Eur J Cancer - 31:238)

Active substance: LENOGRASTIM

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Document reference: 31041

Study title: Myelodysplastic syndrome and acute myelogenous leukemia as a late clonal complication in children with acquired aplastic anemia - Ohara A. et al - 1997 (Blood 90: 1009 - 1013) - Publication - Ref22 of Clinical Expert Report -

Active substance: LENOGRASTIM

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Document reference: 31035

Study title: rG-CSF injection. Protocol for double blind controlled clinical trial. Bone Marow Transplantation - by The Japanese rG-CSF clinical study group.

Active substance: LENOGRASTIM

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Document reference: 31036

Study title: rG-CSF injection. Protocol for phase II clinical trial. Bone Marow Transplantation - by The Japanese rG-CSF clinical study group.

Active substance: LENOGRASTIM

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Document reference: 31037

Study title: Toxicity study by intravenous administration to rhesus Monkey for 13 weeks

Active substance: LENOGRASTIM

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Document reference: 31038

Study title: Retrospective survey for documentation of appllication and dosage of CM Leptandra comp. (drops) in children < 12 years of age [Bef-016]

Active substance: Leptandra compositum

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Document reference: 40046

Study title: A Dose Finding Study of a Super Long-Acting Luteinizing Hormone-Releasing Hormone Analog (Leuprolide Acetate Depot, TAP-144-SR) in the Treatment of Central Precocious Puberty

Active substance: LEUPRORELIN

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Document reference: 31046

Study title: Fluorides in community programms-A study of four years of various fluorides applied topically to the teeth of children in fluoridated communities1972-Swejda

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1972-Swejda-Fluorides in community programms-A study of four years of various fluorides applied topically to the teeth of children in fluoridated c...

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Document reference: 49150

Study title: Fluorine concentration in primary tooth enamel in 6 year old after 3 years of daily intake1984-Widenheim

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1984-Widenheim-Fluorine concentration in primary tooth enamel in 6 year old after 3 years of daily intake.pdf

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Document reference: 49155

Study title: Effect on a 30 second topical stannous fluoride treatement on dental caries reductions in children1964-Mercer

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1964-Mercer-Effect on a 30 second topical stannous fluoride treatement on dental caries reductions in children.pdf

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Document reference: 49146

Study title: Effect on dental caries in children in a natural fluoride area of combined use of three agents containing stannous fluoride1965-Gish

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1965-Gish-Effect on dental caries in children in a natural fluoride area of combined use of three agents containing stannous fluoride.pdf

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Document reference: 49147

Study title: Effect on dental caries in children in a non fluoride area of combined use of three agents containing stannous fluoride1964-Bixler

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1964-Bixler-Effect on dental caries in children in a non fluoride ares of combined use of three agents containing stannous fluoride.pdf

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Document reference: 49145

Study title: Effectiveness of fornightly tooth brushing with amine fluorides in caries-prone subjectsRan 1991

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Ran 1991 Effectiveness of fornightly tooth brushing.pdf

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Document reference: 49176

Study title: Effectiveness of visible light fissure sealant (Delton) versus fluoride varnish (Duraphat) 24 month clinical trial1996-bravo, Community Dent. Oral Epidemiol. 1996: 24: 42-6

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1995-seppa-Fluoride varnish versus acidulated phosphate fluoride gel.pdf

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Document reference: 49121

Study title: Neuroblastoma presenting clinically as hip osteomyelitis: a "signature" diagnosis on skeletal scintigraphy.Applegate K, Connolly LP, Treves ST. Pediatr Radiol 1995 Nov;25 Suppl 1:S93-6

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48528

Study title: Nonspecific osteomyelitis in childhood and adolescence. The contribution of imaging diagnosisUrso S, Pacciani E, Fariello G, Colajacomo M, Fassari FM, Randisi F, et al. Radiol Med 1995 Sep;90(3):212-8

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48763

Study title: Normal anatomic variant: scintigraphy of the ischiopubic synchondrosis. Kevin A. Cawley, Allen D. Dvorak, and Michael D. Wilmot J NucÃMed 24: 14-16,1983

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48838

Study title: Normal anatomic variant: scintigraphy of the ischiopubic synchondrosis.Cawley KA, Dvorak AD, Wilmot MD. J Nucl Med 1983 Jan;24(1):14-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48589

Study title: Nuclear medicine studies of aging--IV. Femoral proximal to distal radionuclide uptake gradientGrimmond AP. Hosain F. Spencer RP. lnt J Rod Appllnstrum B 1988;15(5):529-30

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48486

Study title: Nonsurgical rapid maxillary expansion effects on craniofacial structures in young adult females.Baydas B, Yavuz I, Uslu H, Dagsuyu IM, Ceylan I. Angle Ortho 2006;76:759-67.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48568

Study title: Wu PS, Chiu NT, Lee BF, Yao WJ, W Chen HH. Clinical significance of solitary rib hot spots on bone scans in patients with extraskeletal cancer: correlation with other clinical manifestations. Clin Nucl Med. 2002 Aug;27(8):567-71. Wu PS, Chiu NT, Lee BF, Yao WJ, W Chen HH. Clinical significance of solitary rib hot spots on bone scans in patients with extraskeletal cancer: correlation with other clinical manifestations. Clin Nucl Med. 2002 Aug;27(8):567-71.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43444

Study title: Kokyu To Junkan. 1989 Sep;37(9):1003-7. [Significance of decreased washout rate in hypertrophic cardiomyopathy by exercise Tl-201 myocardial scintigraphy] [Article in Japanese] Inoue S, Nezuo S, Tadaoka S, Hasegawa K, Kawahara Y, Kakumae S, Nakamura T,Kokyu To Junkan. 1989 Sep;37(9):1003-7. [Significance of decreased washout rate in hypertrophic cardiomyopathy by exercise Tl-201 myocardial scintigraphy] [Article in Japanese] Inoue S, Nezuo S, Tadaoka S, Hasegawa K, Kawahara Y, Kakumae S, Nakamura T,

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44656

Study title: Quantitative bone SPECT in young males with delayed puberty and hypogonadism: implications for treatment of low bone mineral densityLubushitzky R. Front D. losi levsky G. Bettman L. Frenkel A. Kolodny GM. et al. J Nucl Med 1998 Jan;39(1):104-7

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48500

Study title: Radionuclide imaging in bilateral os trigonum syndrome in a young athlete. Minoves M, Company A, Ardevol J, Matas RB, Costansa JM, Setoain J, Domenech-Torné FM. Clin Nucl Med. 2001 Mar;26(3):237-8. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43458

Study title: Radionuclide imaging in the evaluation of osteomyelitis and septic arthritis.Kim EE, Haynie TP, Lowry PA, Harle TS. Crit Rev Diagn Imaging 1989; 29(3):257-305

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48751

Study title: Tc-99m MDP, thallium- 201 chloride and Tc-99m MAG3 renal uptake in subacute and chronic radiation nephritis compared.Degirmenci B, Uysal K, Bekis R, Cetingoz R, Kaya GC, Durak H. Ann Nucl Med 2001 Oct;15(5):447-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48599

Study title: Natural history and distribution of bone and bone marrow infarction in sickle hemoglobinopathiesKim SK. Miller JH. J Nucl Med 2002 Jul;43(7):896-900

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48493

Study title: COMPARISON OF INTRAVENOUS CONTRAST AGENTS FOR CT STUDIES IN CHILDRENM.D. CoHEN, E. HERMAN, D. HERRON, S. J. WHITE and J. A. SMITH Acta Radiol. 1992 Nov;33(6):592-5.

Active substance: IOHEXOL

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Document reference: 48851

Study title: Comparison of low-osmolar contrast media in paediatric cardiac angiography. The British journal of radiology (1987), 60(710), 133-5 Rubin CME 1987

Active substance: IOHEXOL

Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc

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Document reference: 48865

Study title: Comparison of iohexol with barium in gastrointestinal studies of infants and children Am J Roentgenol. 1991 Feb; 156(2): 345-50 Cohen MD 1991

Active substance: IOHEXOL

Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc

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Document reference: 48855

Study title: Excretory urography with iohexol: evaluation in children Radiology (1986), 161(3), 625-30 Magill HL 1986

Active substance: IOHEXOL

Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc

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Document reference: 48860

Study title: Experiences with iohexol (Omnipaque) at urography Pediatr Radio! (1987) 17: 491-492 Fjelldal A 1987 Pediatr Radio! (1987) 17: 491-492 Fjelldal A 1987

Active substance: IOHEXOL

Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc

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Document reference: 48867

Study title: Phase 1 Pilot Trial of Interferon alfa-2a in Children with Japanese Viral Encephalitis

Active substance: INTERFERON ALPHA (2A)

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Document reference: 30187

Study title: HyRhabdomyolysis after intraoperative myelography Paediatr Anaesth 2004 Jun; 14(6):509-13 Canbay O 2004

Active substance: IOHEXOL

Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc

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Document reference: 48853

Study title: Influence of urography on renal function in children. A double blind study with metrizoate and iohexol. Acta Radiol. 1989 Nov-Dec; 30(6):643-6 Stake G 1989

Active substance: IOHEXOL

Study summary document link (including results): Stake G 1989.pdf

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Document reference: 48872

Study title: Iodine in contrast agents and skin disinfectants is the major cause for hypothyroidism in premature infants during intensive care Horm Res. 1987;28(1):42-9 l'Allemand D 1987

Active substance: IOHEXOL

Study summary document link (including results): l'Allemand D 1987.pdf

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Document reference: 48869

Study title: Hypothyroidism in neonates post-iodinated contrast media: a systematic review. Acta Paediatrica (Oxford, United Kingdom) (2009), 98(10), 1568-1574 Ahmet A 2009

Active substance: IOHEXOL

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Document reference: 48852

Study title: Iohexol and metrizamide for urography in infants and children. Acta Radiol Suppl. 1983; 366: 39-41 Stake G 1983

Active substance: IOHEXOL

Study summary document link (including results): Stake G 1983.pdf

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Document reference: 48871

Study title: Iohexol for contrast enhancement of bowel in paediatric abdominal CT. Acta Radiol. 1990 Nov; 31(6): 601-4 Smevik B 1990

Active substance: IOHEXOL

Study summary document link (including results): Smevik B 1990.pdf

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Document reference: 48870

Study title: Iohexol in paediatric myelography. An open non-comparative trial Neuroradiology (1986), 28(1), 65-8 Kendall B 1986

Active substance: IOHEXOL

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Document reference: 48858

Study title: Myelography with iohexol (Omnipaque); a clinical report with special reference to the adverse effects. Neuroradiology. 1988; 30(2):169-74 Skalpe IO 1988

Active substance: IOHEXOL

Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc

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Document reference: 48866

Study title: Myelography with Omnipaque (Iohexol) using basic radiographic facilities: the main adverse effects. The Central African journal of medicine (1996), 42(7), 192-5. Ndosi BN 1996

Active substance: IOHEXOL

Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc

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Document reference: 48862

Study title: Open, non-comparative study in angiocardiography in children, Angiocardiography: evaluate safety, tolerance and the radiographic properties of of iohexol in pediatric use. Systolic blood pressure, ECG parameters, body temperature, visualization and adverse reactions were recorded.Applicant's study report

Active substance: IOHEXOL

Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls

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Document reference: 48882

Study title: Clinical Performance of PET/CT in Evaluation of Cancer: Additional Value for Diagnostic Imaging and Patient ManagementRachel Bar-Shalom, MD1; Nikolai Yefremov, MD1; Ludmila Guralnik, MD2; Diana Gaitini, MD2,3; Alex Frenkel, DSc1; Abraham Kuten, MD3,4; Hernan Altman, MBA5; Zohar Keidar, MD, PhD1; and Ora Israel, MD1,3. THE JOURNAL OF NUCLEAR MEDICINE • Vol. 44 • No. 8 • August 2003

Active substance: Steripet

Study summary document link (including results): bar-shalom-2003.pdf

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Document reference: 48623

Study title: Clinical Usefulness of 18F-FDG PET in Nasopharyngeal Carcinoma Patients with Questionable MRI Findings for Recurrence Biomedicine & Pharmacotherapy 60 (2006) 593–606. C. Nannia, D. Rubellob,*, P. Castelluccia, M. Farsada, R. Franchia, L. Rampinb M.D. Grossc, A. Al-Nahhasd, S. Fantia

Active substance: Steripet

Study summary document link (including results): ng-2004-b.pdf

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Document reference: 48739

Study title: Comparison of 18F-FDG and 11C-Methionine for PET-Guided Stereotactic Brain Biopsy of GliomasJ Nucl Med 2004; 45:1293–1298. Benoit Pirotte, MD1; Serge Goldman, MD, PhD2; Nicolas Massager, MD1; Philippe David, MD3; David Wikler, MS1; Arlette Vandesteene, MD, PhD4; Isabelle Salmon, MD, PhD5; Jacques Brotchi, MD, PhD1; and Marc Levivier, MD, PhD1

Active substance: Steripet

Study summary document link (including results): pirotte-2004.pdf

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Document reference: 48742

Study title: Connolly LP, Connolly SA.. Thymic uptake of radiopharmaceuticals. [connolly-2003]Clin Nucl Med. 2003 Aug;28(8):648-51. Connolly LP 2003

Active substance: Steripet

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Document reference: 48638

Study title: De González AB, Mahesh M, Kim K-P, Bhargavan M, Lewis R, Mettler F, Land C. Arch Projected cancer risks from computed tomographic scans performed in the United States in 2007. [de-gonzalez-2009]Intern Med 2009; 169 : 2071 - 2077. De González AB 2009

Active substance: Steripet

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Document reference: 48639

Study title: Developmental hemispheric asymmetry of interregional metabolic correlation of the auditory cortex in deaf subjects.NeuroImage 19 (2003) 777–783 .E. Kang,a D.S. Lee,a,* J.S. Lee,a H. Kang,a C.H. Hwang,b S.H. Oh,b C.S. Kim,b J.-K. Chung,a M.C. Lee,a M.J. Jang,a,c Y.J. Lee,c P. Morosan,d and K. Zillesd

Active substance: Steripet

Study summary document link (including results): kang-2003.pdf

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Document reference: 48734

Study title: Dietlein M, Krug B, Groth W, Smolarz K, Scheidhauer K, Psaras T, et al.. Positron emission tomography using 18Ffluorodeoxyglucose in advanced stages of malignant melanoma: a comparison of ultrasonographic and radiological methods of diagnosis. [dietlein-1999]Nucl Med Commun. 1999 Mar;20(3):255-61. Dietlein M 1999

Active substance: Steripet

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Document reference: 48640

Study title: Dizendorf EV, Baumert BG, von Schulthess GK, Lütolf UM, Steinert HC.. Impact of whole-body 18F-FDG PET on staging and managing patients for radiation therapy. [dizendorf-2003]J Nucl Med. 2003 Jan;44(1):24-9. Dizendorf EV 2003

Active substance: Steripet

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Document reference: 48641

Study title: Dobbeleir A, Ham H, Goethals I, Keppens J, D'Asseler Y, Van de Wiele C.. F-18 FDG-PET in children: do we have enough counts? [dobbeleir-2010]Nucl Med Commun. 2010 Mar;31(3):190-4. Dobbeleir A 2010

Active substance: Steripet

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Document reference: 48642

Study title: Early Irradiation Effects Observed on Magnetic Resonance Imaging and Angiography, and Positron Emission Tomography for Arteriovenous Malformations Treated by Gamma Knife Radiosurgery. Stereotact Funct Neurosurg 1995;61(suppl1):25S-269. 1VY Glio? D.H.C. Pollb, R.S. Lilic, 1VY Cll~i~lCg.Y~ ,S llio1~~, S.S. Cllalgc, C.Y Cllo~lgK~;,Y CIze~zS~.,H . Yellc, L.S. Leeb

Active substance: Steripet

Study summary document link (including results): guo-1994.pdf

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Document reference: 48730

Study title: Effect of Whole-Body 18F-FDG PET Imaging on Clinical Staging and Management of Patients with Malignant LymphomaJ Nucl Med 2001; 42:1139–1143. Heiko Scho¨der, Joubin Meta, Cecilia Yap, Maryam Ariannejad, Jyotsna Rao, Michael E. Phelps, Peter E. Valk, Jim Sayre, and Johannes Czernin

Active substance: Steripet

Study summary document link (including results): schoder-2001.pdf

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Document reference: 48745

Study title: Treatment of goitrous hypothyroidism with iodized oil supplementation in an area of iodine deficiency. ; Azizi-F. Experimental and Clinical Endocrinology and Diabetes, 1996, Vol/Iss/Pg. 104/5 (387-391)Treatment of goitrous hypothyroidism with iodized oil supplementation in an area of iodine deficiency. ; Azizi-F. Experimental and Clinical Endocrinology and Diabetes, 1996, Vol/Iss/Pg. 104/5 (387-391)

Active substance: IODINE

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Document reference: 30340

Study title: Treatment of IDJWI Island endemic goiter by iodized oil; F. Delange. In. Endemic goiter. J.B Stanbury Ed. Pan American Health Organization. Scientific publication n° 193 : 118-131, 1968Treatment of IDJWI Island endemic goiter by iodized oil; F. Delange. In. Endemic goiter. J.B Stanbury Ed. Pan American Health Organization. Scientific publication n° 193 : 118-131, 1968

Active substance: IODINE

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Document reference: 30341

Study title: Treatment of Unresectable Primary Liver Cancer: With Reference to Cytoreduction and Sequential Resection.; Zhao-You Tang. World J. Surg. 19, 47-52, 1995.Treatment of Unresectable Primary Liver Cancer: With Reference to Cytoreduction and Sequential Resection.; Zhao-You Tang. World J. Surg. 19, 47-52, 1995.

Active substance: IODINE

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Document reference: 30342

Study title: Uptake of Lipiodol(trademark) -cytotoxic conjugates by hepatoblastoma cells. ;Towu-E. British Journal of Surgery, 2002, Vol/Iss/Pg. 89/4 (437-441)Uptake of Lipiodol(trademark) -cytotoxic conjugates by hepatoblastoma cells. ;Towu-E. British Journal of Surgery, 2002, Vol/Iss/Pg. 89/4 (437-441)

Active substance: IODINE

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Document reference: 30343

Study title: Use of lipiodol, an iodinated oil preparation, in regions with moderate iodine deficiency. ; Sviridenko-Yu-N. Problemy Endokrinologii, 1995, Vol/Iss/Pg. 41/6 (8-11)Use of lipiodol, an iodinated oil preparation, in regions with moderate iodine deficiency. ; Sviridenko-Yu-N. Problemy Endokrinologii, 1995, Vol/Iss/Pg. 41/6 (8-11)

Active substance: IODINE

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Document reference: 30344

Study title: A bi-centre randomised, parallel group, double-blind phase III comparison between iodixanol (VISIPAQUE) 150 mg I/ml and 270 mg I/ml and iohexal (Omnipaque) 140 mg I/ml and 300 mg I/ml Report DXC064 (date Jun 1999)

Active substance: IODIXANOL

Study summary document link (including results): DXC064 Redacted.pdf

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Document reference: 48211

Study title: A comparison of iopromide and iopamidol in CT scanning of pediatric patientsJ Radiol. 1999 Jul;80(7):727-32. [Comparison of iodixanol (Visipaque) and ioxaglate (Hexabrix) in coronary angiography and ventriculography: a double-blind randomized study] [Article in French] Roriz R, de Gevigney G, Finet G, Nantois-Collet C, Borch KW, Amiel M, Beaune J.

Active substance: IODIXANOL

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Document reference: 30380

Study title: A PHASE IV, OPEN-LABEL, MULTI-CENTER COMMUNITY-BASED TRIAL STUDYING THE SAFETY AND EFFICACY OF KEPPRA. AS ADJUNCTIVE THERAPY IN ADULT PATIENTS WITH UNCONTROLLED PARTIAL EPILEPSY. S.K.A.T.E. : SAFETY OF KEPPRA. AS ADJUNCTIVE THERAPY IN EPILEPSY.

Active substance: levetiracetam

Study summary document link (including results): N01031 - Levetiracetam - RRCE04G2602.pdf

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Document reference: 41540

Study title: ANWENDUNG DER IN DEUTSCHLAND ZUGELASSENEN KEPPRA(R) - TABLETTEN ALS ZUSATZBEHANDLUNG BEI ERWACHSENEN PATIENTEN MIT FOKALEN EPILEPSIEN.

Active substance: levetiracetam

Study summary document link (including results): ARVD02L1406 - Levetiracetam.pdf

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Document reference: 41539

Study title: BRIDGING STUDY OF L059 (LEVETIRACETAM) IN PATIENTS WITH EPILEPSY BY DOUBLE BLIND METHOD.

Active substance: levetiracetam

Study summary document link (including results): N165 - Levetiracetam - RRCE04C3001.pdf

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Document reference: 41541

Study title: A study to compare the efficacy and safety of 0.0625% Levobupivacaine, 1 IJg.mr1 fentanyl, 0.0625% levobupivacaine plus1 IJg.mr1 fentanyl and 0.125% Levobupivacaine when administered as an extradural infusion in paediatric patients undergoing elective abdominal or urological surgery

Active substance: LEVOBUVICAINE HCL

Study summary document link (including results): Levobupivacaine-30716.pdf

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Document reference: 47651

Study title: Reflex sympathetic dystrophy associated with deep peroneal nerve entrapment.Para no E. Pavone V. Greco F. Majorana M. Trifiletti RR. Brain Dev 1998 Mar;20(2):80-2

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48509

Study title: Reiman RE, Rosen G, Gelbard AS, Benua RS, Laughlin JS. Imaging of primary Ewing sarcoma with 13N-L-glutamate. Radiology. 1982 Feb;142(2):495-500. Reiman RE, Rosen G, Gelbard AS, Benua RS, Laughlin JS. Imaging of primary Ewing sarcoma with 13N-L-glutamate. Radiology. 1982 Feb;142(2):495-500.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44093

Study title: Clin Nucl Med. 1999 Jun;24(6):435-9. Tc-99m DTPA used as reference imaging to evaluate the distribution of other tumor-seeking tracers in tumors associated with neurofibromatosis. Suga K, Hirabayashi A, Kishimoto K, Kume N, Matsumoto T, Matsunaga N. Clin Nucl Med. 1999 Jun;24(6):435-9. Tc-99m DTPA used as reference imaging to evaluate the distribution of other tumor-seeking tracers in tumors associated with neurofibromatosis. Suga K, Hirabayashi A, Kishimoto K, Kume N, Matsumoto T, Matsunaga N.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44556

Study title: Technetium 99m-methylene diphosphonate bone scans in children with reflex neurovascular dystrophy.Laxer RM. Allen RC. Malleson PN. Morrison RT. Petty RE. J Pediatr 1985Mar;106(3):437-40

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48496

Study title: Technetium-99 m-MDP scintigraphy and long-term follow-up of musculoskeletal sarcoma reconstructed with pasteurized autologous bone graft.Ahmed AR. Arch Orthop Trauma Surg 2009;129:475-482

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48524

Study title: Technetium-99m-methylene diphosphonate uptake in the fetal skeleton at 30 weeks gestationMcKenzie AF. Budd RS. Yang C. Shapiro B. Hicks RJ. J Nucl Med 1994 Aug;35(8):1338-41

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48506

Study title: Thallium-201 scintigraphy in childhood osteosarcoma: Comparison with Technituim-99m MDP and magnetic resonance imaging in the evaluation of chemotherapeutic response.Ilhan IE, Gulin V, Berberoglu S, Kapucuoglu N, Cila A, Eke S. Quantitative Hematol Oncol 2005;22(2):153-62

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48725

Study title: The bone scan in desseminated BCGitis.Alavi M, Safavi S. Hell J Nucl Med 2008;11(1):46-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48526

Study title: Role of skeletal scintigraphy in soft tissue sarcoma: Improving the diagnostic yieldBarai S, Bandopadhayaya GP, Chumber S, Gupta DK, Patel CD, Dhanpati H. J Postgrad Med 2004a Jul-Sep;50(3):180-3; discussion 183-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48562

Study title: [The diagnostic importance of a quantitative evaluation of gamma scintigraphy in Perthes' disease in children]. Russian. Dmitrienkov BN, Fedin AV, Zhvaniia TG, Subbotina EN. Med Radiol (Mosk). 1989 Jul;34(7):19-23. Russian.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43784

Study title: The role of 99Tcmsestamibi scintigraphy in the staging and prediction of the therapeutic response of stage IV neuroblastoma: comparison with 131I-MIBG and 99Tcm-MDP scintigraphy.Burak Z, Yuksel DA, Cetingul N, Kantar M, Ozkilic H, Moretti JL. Nucl Med Comm 1999; 20(11):991-1000.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48586

Study title: Open Study to determine the concentration of telithromycin in middle ear fluid and plasma in infants/children with acute otitis media or otitis media with effusion after single oral administration of 20mg/kg or 30mg/kg of a telithromycin pediatric suspension

Active substance: telithromycin

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Document reference: 41566

Study title: Sacro-iliitis in infants: a difficult diagnosis. 4 casesPratte L. Docquier P- L. Joint Bone Spine 2009: 76:313 -5

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48510

Study title: The role of ultrasound and isotope scanning in the management of irritable hipsGopakumar TS. Vaishya R. Klenerman L. Carty H. Eur J Radiol 1992 Sep;15(2):113-7

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48484

Study title: Open, non-comparative study in the GI tract in children and infants to evaluate the suitability/tolerability of iohexol in the GI tract in infants/children by monitoring patient reactions, taste acceptance and visualization.Applicant's study report

Active substance: IOHEXOL

Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls

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Document reference: 48885

Study title: Open, non-comparative study Myelography study: evaluate safety, tolerance and image quality of iohexol in pediatric use.Applicant's study report

Active substance: IOHEXOL

Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls

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Document reference: 48884

Study title: Open, non-comparative study to evaluate the suitability/tolerability of iohexol in abdominal CT in infants/children by monitoring patient reactions, taste acceptance and image qualityApplicant's study report

Active substance: IOHEXOL

Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls

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Document reference: 48886

Study title: Paediatric angiocardiography with iohexol Invest Radiol 1985 Jan-Feb; 20(1 Suppl): S75-8 Carlsson EC 1985

Active substance: IOHEXOL

Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc

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Document reference: 48854

Study title: Paediatric myelography with iohexol Paediatric radiology (1992), 22(4), 290-2. Fjelldal et al. Experiences with iohexol (Omnipaque) at urography Paediatric radiology (1987), 17(6), 491-2 Dube LJ 1987

Active substance: IOHEXOL

Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc

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Document reference: 48857

Study title: Randomized double-blind, parallel study(open two-group comparison on consecutive patients) in pediatric angiography. Angiocardiography: the aim of the study was to compare iohexol to the best tolerated contrast medium in angiocardiography at present approved for routing use.Applicant's study report

Active substance: IOHEXOL

Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls

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Document reference: 48883

Study title: Randomized, single-blind, parallel study in pediatric urography to study the safety, tolerance and radiographic properties of iohexol 300 mg I/ml compared to a conventional ionic CM, Urografin 290 mg I/ml, in pediatric urography.Applicant's study report

Active substance: IOHEXOL

Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls

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Document reference: 48880

Study title: The use of low osmolality water soluble (LOWS) contrast media in the paediatric gastro-intestinal tract. A report of 115 examinations Paediatric radiology (1986), 16(1), 47-52 Ratcliffe JF 1986

Active substance: IOHEXOL

Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc

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Document reference: 48864

Study title: Tracheobronchography in children Laryngoscope. 1996 Oct; 106(10): 1248-54 Deutsch ES 1996

Active substance: IOHEXOL

Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc

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Document reference: 48856

Study title: Renal prostaglandin E2 in nephrogenic diabetes insipidus: Effects of inhibition of prostaglandin synthesis by indomethacin

Active substance: INDOMETHACIN

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Document reference: 30013

Study title: Interferon gamma-1b (IF-RC 1001 XX G): Safety, Efficacy and Pharmaco- kinetics of 0.1 mg/sqm, 0.25 mg/sqm and 0.5 mg/sqm Interferon gamma-1b for 2 or more Weeks Sub- cutaneaously Administered to Patients with Lympho- mas, Plasmo- cytomas and Solid Tumors.

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30201

Study title: Long-term safety and efficacy of Actimmune therapy in children with chronic granulomatous disease (CGD): Summary of data from the National Institutes of Health cohort in children initiating Actimmune prior to 1 year of age and prior to 3 years of age, respectively.

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30206

Study title: Long-term safety and efficay of Actimmune therapy in young children with chronic granulomatous disease (CGD): An integrated summary of data extracted from Studies I0016g, I0016g(A),I0034g, and I0286n in children initiating Actimmune therapy prior to 1 year of age and prior to 3 years of age, respectively.

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30207

Study title: Post marketing surveillance study of Actimmune (recombinant human interferon gamma-Ib) in patients with chronic granulomatous disease.

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30190

Study title: The immunomodulatory impact of Imukin (IFNgamma-1b) on clinical and laboratory data in the treatment of atopic dermatitis.

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30204

Study title: Falk MS, Truitt AK, Coakley FV, Kashani-Sabet M, Hawkins RA, Franc B.. Interpretation, accuracy and management implications of FDG PET/CT in cutaneous malignant melanoma. [falk-2007]Nucl Med Commun. 2007 Apr;28(4):273-80. Falk MS 2007

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48643

Study title: Fisher RS, Frost JJ. J Nucl Med.. [fisher-1991]1991 Apr;32(4):651-9. Epilepsy. Fisher RS 1991

Active substance: Steripet

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Document reference: 48644

Study title: Franzius C, Daldrup-Link HE, Wagner-Bohn A, Sciuk J, Heindel WL, Jurgens H, et al.. FDG-PET for detection of recurrences from malignant primary bone tumors: comparison with conventional imaging. [franzius-2002]Franzius C 2002. Ann Oncol. 2002 Jan;13(1):157-60

Active substance: Steripet

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Document reference: 48645

Study title: Franzius C, Schober O.. Assessment of therapy response by FDG PET in pediatric patients. [franzius-2003]Q J Nucl Med. 2003 Mar;47(1):41-5. Franzius C 2003

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48646

Study title: Franzius C, Schulte M, Hillmann A, Winkelmann W, Jürgens H, Bockisch A, et al.. [Clinical value of positron emission tomography (PET) in the diagnosis of bone and soft tissue tumors. 3rd Interdisciplinary Consensus Conference "PET in Oncology": results of the Bone and Soft Tissue Study Group] [Article in German] [franzius-2001]Chirurg. 2001 Sep;72(9):1071-7. Franzius C 2001

Active substance: Steripet

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Document reference: 48647

Study title: Friedberg JW, Fischman A, Neuberg D, Kim H, Takvorian T, Ng AK, et al.. FDG-PET is superior to gallium scintigraphy in staging and more sensitive in the follow-up of patients with de novo Hodgkin lymphoma: a blinded comparison. [friedberg-2004]Leuk Lymphoma. 2004 Jan;45(1):85-92. Friedberg JW 2004

Active substance: Steripet

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Document reference: 48650

Study title: RM2002/00111/00 An open label long term observational study of the safety and tolerability of sumatriptan nasal spray in the treatment of migraine in adolescents.

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-SUM40276-ICHE3.pdf

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Document reference: 43075

Study title: Furth C, Denecke T, Steffen I, Ruf J, Voelker T, Misch D, et al.. Correlative imaging strategies implementing CT, MRI, and PET for staging of childhood Hodgkin disease. [furth-2006]J Pediatr Hematol Oncol. 2006 Aug;28(8):501-12. Furth C 2006

Active substance: Steripet

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Document reference: 48652

Study title: Furth C, Steffen IG, Amthauer H, Ruf J, Misch D, Schönberger S, Kobe C, Denecke T, Stöver B, Hautzel H, Henze G, Hundsdoerfer P.. Epub 2009 Aug 10.Early and late therapy response assessment with [18F]fluorodeoxyglucose positron emission tomography in pediatric Hodgkin's lymphoma: analysis of a prospective multicenter trial. [furth-2009]J Clin Oncol. 2009 Sep 10;27(26):4385-91. Furth C 2009

Active substance: Steripet

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Document reference: 48651

Study title: Gaillard WD, Bhatia S, Bookheimer SY, Fazilat S, Sato S, Theodore WH.. FDG-PET and volumetric MRI in the evaluation of patients with partial epilepsy. [gaillard-1995]Neurology. 1995 Jan;45(1):123-6. Gaillard WD 1995

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48653

Study title: Hypothyroid patients showing shortened responsiveness to oral iodized oil have paradoxically low serum thyroglobulin and low thyroid reserve. Thyroglobulin/thyrotropin ratio as a measure of thyroid damage. ;Contempre-B. European Journal of Endocrinology, 1996, Vol/Iss /Pg. 134/3 (342-351)Hypothyroid patients showing shortened responsiveness to oral iodized oil have paradoxically low serum thyroglobulin and low thyroid reserve. Thyroglobulin/thyrotropin ratio as a measure of thyroid damage. ;Contempre-B. European Journal of Endocrinology, 1996, Vol/Iss /Pg. 134/3 (342-351)

Active substance: IODINE

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Document reference: 30261

Study title: effects of self-applied topical fluoride preparations in orthodontic patients2000-alexander

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 2000-alexander-effects of self-applied topical fluoride preparations in orthodontic patients.pdf

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Document reference: 49096

Study title: Enamel changes and dental caries in 7 years old children given fluoride tablets from shortly after birthA. Thylstrup, O. Fejerskov, C. Brunn, J. Kann 1979. Brit Dent.

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1979-thylstrup-Enamel Changes and Dental Caries in 7-Year-Old children fiven fluoride tablets from shortly after birth.pdf

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Document reference: 48779

Study title: A 3 year oral health dose response study of sodium monofluorophosphate dentifrices with and without zinc citrate1988-Stephen, Community Dent Oral Epidemiology 16:321-5

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1988-Stephen-a 3 year oral health dose response study of sodium monofluorophosphate dentifrices with and without zinc citrate.pdf

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Document reference: 49085

Study title: A 48-month survival analysis comparing sealant (Delton) with fluoride varnish (Duraphat) in 6-8 year old children1997-bravo

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1996-bravo-Effectiveness of visible light fissure sealant (Delton) versus fluoride varnish (Duraphat) 24 month clinical trial.pdf

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Document reference: 49122

Study title: A Community Study of Fluoride Tablets for School Children in Portsmouth1982-Allmark. Br Dent J 1982: 153: 426

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1982-Allmark-A Community Study od Fluoride Tablets for School Children in Portsmouth.pdf

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Document reference: 48773

Study title: A home care program of chemical preventive dentistry for orthodontic patients1973-landry

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1973-landry-a home care program of chemical preventive dentistry for orthodontic patients.pdf

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Document reference: 49151

Study title: a new approach to the topical application of fluorides for the reduction od dental caries in children-results at the end of five years1962-Gish

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1962-Gish-a new approach to the topical application of fluorides for the reduction od dental caries in children-results at the end of five years.pdf

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Document reference: 49143

Study title: A new approach to the topical application of fluorides for the reduction of dental caries in children1957-gish

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1957-gish-a new approach to the topical application of fluorides for the reduction of dental caries in children.pdf

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Document reference: 49133

Study title: A new approach to the topical application of fluorides in children with results at the end of four years1959-Gish

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1959-Gish-A new approach to the topical application of fluorides in children with results at the end of four years.pdf

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Document reference: 49137

Study title: A newapproach to the topical application of fluorides in children with results at the end of two years1957-gish

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1957-Gish-A newapproach to the topical application of fluorides in children with results at the end of two years.pdf

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Document reference: 49134

Study title: A study of a single application of eight persent stannous fluoride1959-Jordan

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1959-Jordan-A study of a single application of eight persent stannous fluoride.pdf

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Document reference: 49138

Study title: A three year clinical comparison of a sodium monofluorophosphate dentifrice with sodium fluoride dentifrices on dental caries in children1987-Lu, Journal of dentistry for children, July-August 1987

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1987-Lu-a three year clinical comparison of a sodium monofluorophosphate dentifrice with sodium fluoride dentifrices on dental caries in children.pdf

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Document reference: 49083

Study title: The suspected scaphoid fracture and isotope bone imaging. Brown JN. Injury. 1995 Sep;26(7):479-82.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48836

Study title: The suspected scaphoid fracture and isotope bone imaging.Brown JN. Injury 1995 Sep;26(7):479-82.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48582

Study title: The symptomatic hip in childhood: scintigraphic findings in the presence of a normal radiograph. Gordon I, Peters AM, Nunn R. Skeletal Radiol. 1987;16(5):383-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43880

Study title: Three-phase radionuclide bone imaging in stress injury of the anterior iliac crestRockett JF. J Nucl Med 1990 Sep;31(9):1554-6

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48512

Study title: Scintigraphic and radiographic findings in eosinophilic granuloma.Benz-Bohm G, Georgi P. Radiologe 1981 Apr;21(4):195-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48570

Study title: Scintigraphic differentiation of bone infarction from osteomyelitis in children with sickle cell diseaseRoo S. Solomon N. MillerS. Dunn E. J Pediatr 1985 Nov;107(5):685-8

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48511

Study title: Scintigraphic evaluation of calcinosis in juvenile dermatomyositis with Tc-99m MDP.Bar-Sever Z, Mukamel M, Harel L, Hardoff R. Clin Nucl Med 2000 Dec;25(12):1013-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48565

Study title: Scintigraphic findings in progressive diaphyseal dysplasiaLundy MM. Billingsley JL. Redwine MD. Turnbull GL. Brown T J. J Nucl Med 1982 Apr;23(4):324-5

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48501

Study title: Scintigraphic findings of osteomyelitis after intraosseous infusion in a child.Barron BJ, Tran HD, Lamki LM. Clin Nucl Med 1994 Apr;19(4):307-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48564

Study title: Unexpected stomach uptake of technetium-99m-MDPSpicer JA. Slaton CK. Raveill TG. Baxter KG. Preston DF. Hladik WB. J Nucl Med Tech 1999 27(1):43-4

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48517

Study title: Unusual Tc-99m MDP and I-123 MIBG images in focal pyelonephritisJacobs A, Lenoir P, Delree M, Ramet J, Piepsz A. Clin Nucl Med 1990 15(11):821-4

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48749

Study title: Scintigraphy of lower extremity cadaveric bone allografts in osteosarcoma patients.Bar-Sever Z, Connolly LP, Gebhardt MC, Treves ST. Clin Nucl Med 1997 Aug;22(8):532-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48567

Study title: Scintigraphy of Toddler's FractureJohn H. Miller and Ronald A. Sanderson. J Nucl Med 29:2001-2003,1988

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48846

Study title: Scintigraphy of toddler's fractureMiller JH. Sanderson RA. J Nucl Med 1988 Dec;29(12):2001-3

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48507

Study title: Scintimetric evaluation of posttraumatic and postoperative growth disturbance using 99Tcm MDP.Bylander B, Hansson LI, Kärrholm J, Naversten Y. Acta Radiol Diagn 1983;24(1):85-96.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48587

Study title: Serum osteocalcin and other indices of bone formation: an 8-decade population study in healthy men and womenWorsfold M. Sharp CA. Davie MW. Clinica Chimica Acta 1988 178(2):225-35

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48518

Study title: Use of 99m-Tc-MDP Spect for assessment of mandibular growth: development of normal values.Fahey FH, Abramson ZR, Padwa BL, Zimmerman RE, Zurakowski D, Nissenbaum M, et al. Eur J Nucl Med Mol Imaging 2010;37:1002-10.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48722

Study title: International Commission on Radiological Protection, Radiation Dose to Patients from RadiopharmaceuticalsICRP Pergamon Press 1998) - Publication 80

Active substance: Iobenguane

Study summary document link (including results): ICPR-1998.pdf

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Document reference: 48116

Study title: A case of postoperative recurrence of fibrolamellar hepatocellular carcinoma with increased vitamin B(12) binding capacity in a young Japanese female. ; Kanai-T. Japanese Journal of Clinical Oncology, 01 JUN 2004, Vol/Iss/Pg. 34/6 (346-351)A case of postoperative recurrence of fibrolamellar hepatocellular carcinoma with increased vitamin B(12) binding capacity in a young Japanese female. ; Kanai-T. Japanese Journal of Clinical Oncology, 01 JUN 2004, Vol/Iss/Pg. 34/6 (346-351)

Active substance: IOBITRITOL

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Document reference: 30213

Study title: Detection of coronary complications after the arterial switch operation for transposition of the great arteries : first experience with multislice computed tomography in children; Ou P et al; Thorac.Cardiovasc. Surg.; 2006 vol.131 p.639 643Detection of coronary complications after the arterial switch operation for transposition of the great arteries : first experience with multislice computed tomography in children; Ou P et al; Thorac.Cardiovasc. Surg.; 2006 vol.131 p.639 643

Active substance: IOBITRITOL

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Document reference: 30211

Study title: Intravenous contrast media in uroradiology : evaluation of safety and tolerability in almost 50,000 patients; Wendt M. et al; Med. Princ. Pract.; 2006 vol.15 p.358 361Intravenous contrast media in uroradiology : evaluation of safety and tolerability in almost 50,000 patients; Wendt M. et al; Med. Princ. Pract.; 2006 vol.15 p.358 361

Active substance: IOBITRITOL

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Document reference: 30210

Study title: Iodine supplementation improves cognition in iodine-deficient schoolchildren in Albania: A randomized, controlled, double-blind study. ; Zimmermann-M-B.American Journal of Clinical Nutrition, 01 JAN 2006, Vol/Iss/Pg. 83/1 (108-114)Iodine supplementation improves cognition in iodine-deficient schoolchildren in Albania: A randomized, controlled, double-blind study. ; Zimmermann-M-B.American Journal of Clinical Nutrition, 01 JAN 2006, Vol/Iss/Pg. 83/1 (108-114)

Active substance: IOBITRITOL

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Document reference: 30212

Study title: Results of the Safety and Efficiency of Iobitridol in more than 61,000 Patients; Petersein J. et al. / Eur Radiol (2003) 13: 2006-2011Results of the Safety and Efficiency of Iobitridol in more than 61,000 Patients; Petersein J. et al. / Eur Radiol (2003) 13: 2006-2011

Active substance: IOBITRITOL

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Document reference: 30209

Study title: Safety of iobitridol in the general population and at-risk patients; Hammerstingl RM et al; Eur. Radiol.; 2006 vol.16 n.6 p.1288 1297Safety of iobitridol in the general population and at-risk patients; Hammerstingl RM et al; Eur. Radiol.; 2006 vol.16 n.6 p.1288 1297

Active substance: IOBITRITOL

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Document reference: 30208

Study title: A case of undifferentiated sarcoma of the liver in which chemo- embolization with cisplatin-lipiodol suspension was effective. ; Araki-T. Japanese Journal of Clinical Radiology, 1994, Vol /Iss/Pg. 39/3 (419-422)A case of undifferentiated sarcoma of the liver in which chemo- embolization with cisplatin-lipiodol suspension was effective. ; Araki-T. Japanese Journal of Clinical Radiology, 1994, Vol /Iss/Pg. 39/3 (419-422)

Active substance: IODINE

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Document reference: 30214

Study title: erste erfahrungen mit hexabrix bei der ausscheidungsurographie im kindesalter; Reither M., Fortschr. Med.; 1981 vol.99 n.20 p.771 773erste erfahrungen mit hexabrix bei der ausscheidungsurographie im kindesalter; Reither M., Fortschr. Med.; 1981 vol.99 n.20 p.771 773

Active substance: IOVERSOL

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Document reference: 30438

Study title: Evaluation de l'efficacite diagnostique et de la tolerance clinique du ioversol en tomodensitometrie "corps entier" chez l'enfant : essai non comparatif de phase III; PANUEL M; Ann. Radiol.; 1992 vol.35 n.4 bis p.280-283Evaluation de l'efficacite diagnostique et de la tolerance clinique du ioversol en tomodensitometrie "corps entier" chez l'enfant : essai non comparatif de phase III; PANUEL M; Ann. Radiol.; 1992 vol.35 n.4 bis p.280-283

Active substance: IOVERSOL

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Document reference: 30409

Study title: Evaluation of the post-shunt status with electron beam computed tomography in cyanotic congenital heart disease; CHOI BW; Yonsei Med. J.; 2003 vol.44 n.2 p.249 258Evaluation of the post-shunt status with electron beam computed tomography in cyanotic congenital heart disease; CHOI BW; Yonsei Med. J.; 2003 vol.44 n.2 p.249 258

Active substance: IOVERSOL

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Document reference: 30410

Study title: Extrahepatic metastases of hepatocellular carcinoma; KATYAL S; Radiology; 2000 vol.216 p.698 703Extrahepatic metastases of hepatocellular carcinoma; KATYAL S; Radiology; 2000 vol.216 p.698 703

Active substance: IOVERSOL

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Document reference: 30411

Study title: Interpreting the results of pediatric central venous catheter studies; KIM FM; Radiographics; 1996 vol.16 n.4 p.747 754Interpreting the results of pediatric central venous catheter studies; KIM FM; Radiographics; 1996 vol.16 n.4 p.747 754

Active substance: IOVERSOL

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Document reference: 30412

Study title: Hypothyroidism in an area of endemic goiter and cretinism in Central Java, Indonesia;G. Hennemann. J. Clin. Endocrinology metabolism 1997 44 3 481-490Hypothyroidism in an area of endemic goiter and cretinism in Central Java, Indonesia;G. Hennemann. J. Clin. Endocrinology metabolism 1997 44 3 481-490

Active substance: IODINE

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Document reference: 30262

Study title: Hypothyroidism in cretins and non-cretinous subjects in an area of severe iodine deficiency in Central Java;Robbins J. et Coll. Thyroid research. Amsterdam excerpta medica 1975 378: 501-504Hypothyroidism in cretins and non-cretinous subjects in an area of severe iodine deficiency in Central Java;Robbins J. et Coll. Thyroid research. Amsterdam excerpta medica 1975 378: 501-504

Active substance: IODINE

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Document reference: 30263

Study title: Infant Survivals is improved by Oral Iodine supplementation; Claudine Cobra. J. Nutr. 127 : 574-578, 1997Infant Survivals is improved by Oral Iodine supplementation; Claudine Cobra. J. Nutr. 127 : 574-578, 1997

Active substance: IODINE

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Document reference: 30264

Study title: Influence of iodine supplementation on serum insulin-like growth factor-I (IGF-I) and IGF-binding protein-3 (IGFBP-3) levels in severe iodine deficiency. ;Özön-A. Turkish Journal of Pediatrics, 2004, Vol/Iss/Pg. 46/4 (303-308)Influence of iodine supplementation on serum insulin-like growth factor-I (IGF-I) and IGF-binding protein-3 (IGFBP-3) levels in severe iodine deficiency. ;Özön-A. Turkish Journal of Pediatrics, 2004, Vol/Iss/Pg. 46/4 (303-308)

Active substance: IODINE

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Document reference: 30265

Study title: Influence of nutritional state on the disposal of orally and intramuscularly administered iodized oil to iodine repleted older children and adult women. Fierro-Benitez-R. Journal of Endocrinological Investigation, 1989, Vol/Iss/Pg. 12/6 (405-407)Influence of nutritional state on the disposal of orally and intramuscularly administered iodized oil to iodine repleted older children and adult women. Fierro-Benitez-R. Journal of Endocrinological Investigation, 1989, Vol/Iss/Pg. 12/6 (405-407)

Active substance: IODINE

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Document reference: 30266

Study title: Intraarterial chemotherapy with Lipiodol for initially unresectable hepatoblastomas in children. ;Ogita-S. Regional Cancer Treatment, 1992, Vol/Iss/Pg. 5/3-4 (106-109)Intraarterial chemotherapy with Lipiodol for initially unresectable hepatoblastomas in children. ;Ogita-S. Regional Cancer Treatment, 1992, Vol/Iss/Pg. 5/3-4 (106-109)

Active substance: IODINE

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Document reference: 30267

Study title: Intrahepatic Arterial Injections of Cisplatin-Phosphatidylcholine-Lipiodol Suspension in Two Unresectable Hepatoblastoma Cases;Kohji Sue. Medical and Pediatric Oncology 17:496-500 (1989)Intrahepatic Arterial Injections of Cisplatin-Phosphatidylcholine-Lipiodol Suspension in Two Unresectable Hepatoblastoma Cases;Kohji Sue. Medical and Pediatric Oncology 17:496-500 (1989)

Active substance: IODINE

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Document reference: 30268

Study title: Investigation report of iodine deficiency disorders in Linxia, Gansu Province. Su-X-H. Chinese Journal of Endemiology , 2005, Vol/Iss/Pg. 24 /3 (297-299)Investigation report of iodine deficiency disorders in Linxia, Gansu Province. Su-X-H. Chinese Journal of Endemiology , 2005, Vol/Iss/Pg. 24 /3 (297-299)

Active substance: IODINE

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Document reference: 30269

Study title: Iodine supplementation in a goitre endemic area.;Babikir Elnagar. Comprehensive summaries of Uppsala Dissertations from the Faculty of Medicines 608: 20-26Iodine supplementation in a goitre endemic area.;Babikir Elnagar. Comprehensive summaries of Uppsala Dissertations from the Faculty of Medicines 608: 20-26

Active substance: IODINE

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Document reference: 30270

Study title: Iodine supplementation: A comparison of oral and intramuscular methods in the improvement of thyroid function and prophylaxis of goitre. ; Malone-F-J. Trace Elements and Electrocytes, 1996, Vol /Iss/Pg. 13/3 (133-135)Iodine supplementation: A comparison of oral and intramuscular methods in the improvement of thyroid function and prophylaxis of goitre. ; Malone-F-J. Trace Elements and Electrocytes, 1996, Vol /Iss/Pg. 13/3 (133-135)

Active substance: IODINE

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Document reference: 30271

Study title: Iodine-induced hypothyroidism and goiter following lipiodol(TM) lymphography. ;Heidemann-P-H. European Journal of Pediatrics, 1982, Vol/Iss/Pg. 138 /1 (82-83)Iodine-induced hypothyroidism and goiter following lipiodol(TM) lymphography. ;Heidemann-P-H. European Journal of Pediatrics, 1982, Vol/Iss/Pg. 138 /1 (82-83)

Active substance: IODINE

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Document reference: 30272

Study title: Iodine-induced hypothyroidism following lymphography. ;Heidemann-P. Pediatric Research, 1981, Vol/Iss/Pg. 15/12 (No. 192)Iodine-induced hypothyroidism following lymphography. ;Heidemann-P. Pediatric Research, 1981, Vol/Iss/Pg. 15/12 (No. 192)

Active substance: IODINE

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Document reference: 30273

Study title: Iodized oil as a complement to iodized salt in schoolchildren in endemic goiter in Romania. ;Simescu-M Hormone Research, 2002, Vol/Iss/Pg. 58/2 (78-82)Iodized oil as a complement to iodized salt in schoolchildren in endemic goiter in Romania. ;Simescu-M Hormone Research, 2002, Vol/Iss/Pg. 58/2 (78-82)

Active substance: IODINE

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Document reference: 30275

Study title: Amounts of fluorides in self administered dental products: safety considerations for childrenStanley B Heifetz, Herschel S Horowitz. Pediatrics Vol 77No. 6 June 1986

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1986-heifetz-Amounts of fluoride in self-administered dental products-safety consideration for children.pdf

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Document reference: 48770

Study title: An assessment of two dental health education programmes for school children in the Lothian region of ScotlandC. Wight, A.S. Blinkhorn 1988. Journal of Pediatric Dentistry

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1988-wight-An Assessment of Two Dental Health Education programmes for school children in the lothian region of scotland.pdf

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Document reference: 48775

Study title: An open study to investigate what happens with a lozenge that is given to a 3-5 year old child that are told to leave it be in their mouth.Mejàre et al. (1987-09-23)

Active substance: SODIUM FLUORIDE

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Document reference: 48943

Study title: Assessment of the effectiveness of supervised oral hygiene programmes by means of different indicesMaiwald 1993

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Maiwald 1993 Assessment of the effectiveness.pdf

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Document reference: 49170

Study title: Caries epidemiological studies- Kariesepidemiologische UntersuchungenBüttner 1995

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Büttner 1995 Kariesepidemiologische Untersuchungen.pdf

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Document reference: 49160

Study title: Caries increment in primary teeth after application of Duraphat fluoride varnish1982-grogzka

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1982-grogzka-Caries increment in primary teeth after application of Duraphat fluoride varnish.pdf

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Document reference: 49108

Study title: Fries P.. Final Report. Munich, Germany; Dermatological Clinic and Polyclinic of Technical University of Munich; 04 February.1985. Treatment of herpes simplex virus infection with Delimmun®. Fries P.. Final Report. Munich, Germany; Dermatological Clinic and Polyclinic of Technical University of Munich; 04 February.1985. Treatment of herpes simplex virus infection with Delimmun®.

Active substance: INOSINE

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Document reference: 30103

Study title: Fukuyama Y, Nihei K, Matsumoto S, Ebina T, Kamoshita S, Sato T et al. Brain and Development. 1987; 9(3):270-282. Clinical effects of MND-19 (inosiplexl on subacute sclerosing panencephalitis: a multi-institutional collaborative study.Fukuyama Y, Nihei K, Matsumoto S, Ebina T, Kamoshita S, Sato T et al. Brain and Development. 1987; 9(3):270-282. Clinical effects of MND-19 (inosiplexl on subacute sclerosing panencephalitis: a multi-institutional collaborative study.

Active substance: INOSINE

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Document reference: 30104

Study title: Gadoth M et al. Beilinson Hospital 1980. . Stimulation of interferon production by inospilex in SSPEGadoth M et al. Beilinson Hospital 1980. . Stimulation of interferon production by inospilex in SSPE

Active substance: INOSINE

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Document reference: 30105

Study title: Gallais H, Kadio A, Odehouri K, Moreau J, Bertrand EDBulletin of the Society of Exotic Pathology. September- October, 1981; 74(5):553-561. . Effect of Isoprinosine in tropical measles: double-blind study (200 cases)Gallais H, Kadio A, Odehouri K, Moreau J, Bertrand EDBulletin of the Society of Exotic Pathology. September- October, 1981; 74(5):553-561. . Effect of Isoprinosine in tropical measles: double-blind study (200 cases)

Active substance: INOSINE

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Document reference: 30106

Study title: Gallet J-P. Bulletin Officiel du Ministere de la Sante [Official gazette of the Ministry ofHealth, Paris]. June 3, 1986; 86(19): 1-12. Expert Clinician in Pediatrics report. Endorsement report concerning double-blind study of Isoprinosine and a placebo for the treatment of severe or complicated measles Gallet J-P. Bulletin Officiel du Ministere de la Sante [Official gazette of the Ministry ofHealth, Paris]. June 3, 1986; 86(19): 1-12. Expert Clinician in Pediatrics report. Endorsement report concerning double-blind study of Isoprinosine and a placebo for the treatment of severe or complicated measles

Active substance: INOSINE

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Document reference: 30107

Study title: Galli M, Lazzarin A, Moroni M, Zanussi C. In: Immunomodulation: New Frontiers and Advances. Fudenberg HH, Whitten HD, Ambrogi F, eds. New York, New York, USA; Plenum Press; 1984; 385-397. Treatment of recurrent viral infectious diseases by methisoprinol.Galli M, Lazzarin A, Moroni M, Zanussi C. In: Immunomodulation: New Frontiers and Advances. Fudenberg HH, Whitten HD, Ambrogi F, eds. New York, New York, USA; Plenum Press; 1984; 385-397. Treatment of recurrent viral infectious diseases by methisoprinol.

Active substance: INOSINE

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Document reference: 30108

Study title: Uterine blush in multiphase bone imaging.Mandell GA. Harcke HT. Sharkey C. Brooks K. J Nucl Med 1986a Jan;27(1):51-5

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48503

Study title: Utility of delayed whole-body bone scintigraphy after directed three-phase scintigraphyDavenport MS, Brown RKJ, Frey KA. AJR 2009;193:338-42.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48596

Study title: Shoulder Pain in a young break-dancer evaluated with bone scintigraphy.Khoury JJ, Laberant N, Jerushalmi J. Clin Nucl Med 2009;34:916-7

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48750

Study title: A report on the method of treatment of chronic osteomyelitis at the Clinic of Infectious Diseases in Lund, which is both general and local in antibiotics administration. Comparisons are made with reports on the same general, but without the local treatment.Moilanen et al.

Active substance: testa triticum

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Testa triticum tricum_1.xlsx

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Document reference: 49079

Study title: A report on the method of treatment of chronic osteomyelitis at the Clinic of Infectious Diseases in Lund, which is both general and local in antibiotics administration. Comparisons are made with reports on the same general, but without the local treatment.Moilanen et al.

Active substance: testa triticum

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Testa triticum tricum_1.xlsx

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Document reference: 49080

Study title: Skeletal assessment in neuroblastoma--the pitfalls of iodine-123-MIBG scans.Gordon I. Peters AM. Gutman A, Morony S. Dicks-Mireaux C. Pritchard J. J Nucl Med 1990Feb;31(2):129-34

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48485

Study title: Skeletal assessment in neuroblastoma--the pitfalls of iodine-123-MIBG scansGordon I, Peters AM, Gutman A, Morony S, Dicks-Mireaux C, Pritchard J. J Nucl Med 1990Feb;31(2):129-34

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48724

Study title: Skeletal scintigraphy of young patients with low-back pain and a lumbosacral transitional vertebra. Connolly LP, d'Hemecourt PA, Connolly SA, Drubach LA, Micheli LJ, Treves ST. J Nucl Med. 2003 Jun;44(6):909-14.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48842

Study title: Small rounded B-cell lymphoma of bone presented by limp, with a positive multifocal 99mTC MDP bone scintigraphy pattern and a negative 99mTc HMPAO-labled leukocytes studyPerez RH, Farto JCA, Arias IA, Regi AR, Vazquez JMP. J Pediatr Hematol Oncol 2008:30:443-446

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48753

Study title: Adrenocortical suppression increases the risk of relapse in nephrotic syndromeAdrenocortical suppression increases the risk of relapse in nephrotic syndrome

Active substance: TETRACOSACTIDE

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Document reference: 44459

Study title: Prediction of myocutaneous adverse side effect due to intra-arterial chemotherapy by intra-arterial (99m)Tc-macroaggregated albumin administration in patients with bone and soft-tissue tumors. J Nucl Med. 2002 Nov;43(11):1452-6. Taki J 2002

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48797

Study title: Preoperative diagnosis of bronchial atresia presenting with recurrent respiratory symptoms in an infant. Turk J Pediatr. 2000 Oct-Dec;42(4):348-51. Yüksel H 2000

Active substance: TECHNETIUM (99m)

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Document reference: 48800

Study title: Prevalence of deep venous thrombosis in the lower limbs and the pelvis and pulmonary embolism in patients with positive antiphospholipid antibodies. Ann Nucl Med. 2001 Dec;15(6):495-7. Kinuya K 2001

Active substance: TECHNETIUM (99m)

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Document reference: 48799

Study title: Pulmonary perfusion after endovascular stenting of pulmonary artery stenosis. J Nucl Med. 1995 Nov;36(11):2006-8. Oyen WJ 2006

Active substance: TECHNETIUM (99m)

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Document reference: 48817

Study title: Intravenous digital subtraction angiography for the evaluation of renal artery blood flow following the removal of a neuroblastoma; YAMAGIWA I; Surg. Today; 1994 vol.24 p.973-977Intravenous digital subtraction angiography for the evaluation of renal artery blood flow following the removal of a neuroblastoma; YAMAGIWA I; Surg. Today; 1994 vol.24 p.973-977

Active substance: IOVERSOL

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Document reference: 30413

Study title: Intravenous use of ionic and nonionic contrast agents in children; COHEN MD; Radiology; 1994 vol.191 p.793-794Intravenous use of ionic and nonionic contrast agents in children; COHEN MD; Radiology; 1994 vol.191 p.793-794

Active substance: IOVERSOL

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Document reference: 30414

Study title: Iodine and hypothyroidism in neonates with congenital heart disease; LINDER N; Arch. Dis. Child.; 1997 vol.77 p.239 240Iodine and hypothyroidism in neonates with congenital heart disease; LINDER N; Arch. Dis. Child.; 1997 vol.77 p.239 240

Active substance: IOVERSOL

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Document reference: 30415

Study title: Ioversol (optiray) a new contrast media in the pediatric praxis; LOMBAY B; in : year book of pediatric radiology ; current problems of pediatric radiology ; Borsod County Teaching Hospital Hongrie ; 1994 vol.6 p.43 47Ioversol (optiray) a new contrast media in the pediatric praxis; LOMBAY B; in : year book of pediatric radiology ; current problems of pediatric radiology ; Borsod County Teaching Hospital Hongrie ; 1994 vol.6 p.43 47

Active substance: IOVERSOL

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Document reference: 30416

Study title: Ioversol 300 : etude clinique en urographie intraveineuse pediatrique; MONTAGNE JP; Ann. Radiol.; 1992 vol.35 n.4 bis p.307-310Ioversol 300 : etude clinique en urographie intraveineuse pediatrique; MONTAGNE JP; Ann. Radiol.; 1992 vol.35 n.4 bis p.307-310

Active substance: IOVERSOL

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Document reference: 30417

Study title: Is administration of enteric contrast material safe before abdominal CT in children who require sedation ? experience with chloral hydrate and pentobarbital; ZIEGLER MA; AJR; 2003 vol.180 p.13 15Is administration of enteric contrast material safe before abdominal CT in children who require sedation ? experience with chloral hydrate and pentobarbital; ZIEGLER MA; AJR; 2003 vol.180 p.13 15

Active substance: IOVERSOL

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Document reference: 30418

Study title: Mechanisms of severe immediate reactions to iodinated contrast material; LAROCHE D; Radiology; 1998 vol.209 p.183 190Mechanisms of severe immediate reactions to iodinated contrast material; LAROCHE D; Radiology; 1998 vol.209 p.183 190

Active substance: IOVERSOL

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Document reference: 30419

Study title: Nonoperative management of blunt liver trauma : the value of follow-up abdominal computed tomography scans; CUFF RF; Am. Surg.; 2000 vol.66 p.332 336Nonoperative management of blunt liver trauma : the value of follow-up abdominal computed tomography scans; CUFF RF; Am. Surg.; 2000 vol.66 p.332 336

Active substance: IOVERSOL

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Document reference: 30420

Study title: Oral contrast agents for CT of abdominal trauma in pediatric patients : a comparison of dilute hypaque and water; HALSTED MJ; AJR; 2004 vol.182 p.1555 1559Oral contrast agents for CT of abdominal trauma in pediatric patients : a comparison of dilute hypaque and water; HALSTED MJ; AJR; 2004 vol.182 p.1555 1559

Active substance: IOVERSOL

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Document reference: 30421

Study title: Pediatr cardiol. 2005 Jul-Aug: 26(4):413-7: Safety and Efficacy of Itravenous Contrast Imaging in Pediatrich Echocardiography.Pediatr cardiol. 2005 Jul-Aug: 26(4):413-7: Safety and Efficacy of Itravenous Contrast Imaging in Pediatrich Echocardiography.

Active substance: Perflutren

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Document reference: 41585

Study title: Controlling conditioning-related emesis in children undergoing bone marrow transplantationOncol Nurs Forum 1997; 24 (9): 1539-44; Mehta NH., 1997

Active substance: PERPHENAZINE

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48910

Study title: Preoperative oral antiemetics for reducing postoperative vomiting after tonsillectomy in childrenFujii Y., 1999, Anesth Analg. 1999 Jun; 88 (6): 1298-30

Active substance: PERPHENAZINE

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48911

Study title: A controlled clinical comparison of nasal decongestants in acute rhinitis.Curr Ther Res 1966; 8: 91-3, Haines HL., 1966

Active substance: OXYMETAZOLINE

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Document reference: 48916

Study title: Intestinal permeability and effects of Lactobacillus rhamnosus therapy in children with short bowel syndrome.Sentongo TA, Cohran V, Korff S, Sullivan C, Iyer K, Zheng X. J Pediatr Gastroenterol Nutr. 2008 Jan;46(1):41-7.Intestinal permeability and effects of Lactobacillus rhamnosus therapy in children with short bowel syndrome.Sentongo TA, Cohran V, Korff S, Sullivan C, Iyer K, Zheng X. J Pediatr Gastroenterol Nutr. 2008 Jan;46(1):41-7.

Active substance: LACTULOSE

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Document reference: 30992

Study title: Intestinal permeability in newborns with necrotizing enterocolitis and controls: Does the sugar absorption test provide guidelines for the time to (re-)introduce enteral nutrition? Piena-Spoel M, Albers MJ, ten Kate J, Tibboel D. J Pediatr Surg. 2001 Apr;36(4):587-92.Intestinal permeability in newborns with necrotizing enterocolitis and controls: Does the sugar absorption test provide guidelines for the time to (re-)introduce enteral nutrition? Piena-Spoel M, Albers MJ, ten Kate J, Tibboel D. J Pediatr Surg. 2001 Apr;36(4):587-92.

Active substance: LACTULOSE

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Document reference: 31001

Study title: PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial. Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Mäkel W, Taminiau J, Benninga M. Gut. 2004 Nov;53(11):1590-4.PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial. Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Mäkel W, Taminiau J, Benninga M. Gut. 2004 Nov;53(11):1590-4.

Active substance: LACTULOSE

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Document reference: 30998

Study title: Polyethylene glycol 4000 vs. lactulose for the treatment of neurogenic constipation in myelomeningocele children: a randomized-controlled clinical trial.Rendeli C, Ausili E, Tabacco F, Focarelli B, Pantanella A, Di Rocco C, Genovese O, Fundarò C. Aliment Pharmacol Ther. 2006 Apr 15;23(8):1259-65.Polyethylene glycol 4000 vs. lactulose for the treatment of neurogenic constipation in myelomeningocele children: a randomized-controlled clinical trial.Rendeli C, Ausili E, Tabacco F, Focarelli B, Pantanella A, Di Rocco C, Genovese O, Fundarò C. Aliment Pharmacol Ther. 2006 Apr 15;23(8):1259-65.

Active substance: LACTULOSE

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Document reference: 30995

Study title: Simultaneous HPLC determination with light-scattering detection of lactulose and mannitol in studies of intestinal permeability in pediatrics.Marsilio R, D'Antiga L, Zancan L, Dussini N, Zacchello F. Clin Chem. 1998 Aug;44(8 Pt 1):1685-91.Simultaneous HPLC determination with light-scattering detection of lactulose and mannitol in studies of intestinal permeability in pediatrics.Marsilio R, D'Antiga L, Zancan L, Dussini N, Zacchello F. Clin Chem. 1998 Aug;44(8 Pt 1):1685-91.

Active substance: LACTULOSE

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Document reference: 31003

Study title: The sugar absorption test in the evaluation of the gastrointestinal intolerance to bisphosphonates: studies with oral pamidronate.Twiss IM, Burggraaf J, Schoemaker RC, van Elburg RM, den Hartigh J, Cohen AF, Vermeij P. Clin Pharmacol Ther. 2001 Jun;69(6):431-7.The sugar absorption test in the evaluation of the gastrointestinal intolerance to bisphosphonates: studies with oral pamidronate.Twiss IM, Burggraaf J, Schoemaker RC, van Elburg RM, den Hartigh J, Cohen AF, Vermeij P. Clin Pharmacol Ther. 2001 Jun;69(6):431-7.

Active substance: LACTULOSE

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Document reference: 31000

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Lamioflur (drops) [AWB-AT]

Active substance: Lamioflur

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Document reference: 40045

Study title: A Multi-Center, Double-blind, Placebo-controlled, Parallel Evaluation of LAMICTAL as Add-on Therapy with Valproic Acid for the Treatment of Generalized Seizures in Paediatric and Adult Patients.

Active substance: LAMOTRIGINE

Study summary document link (including results): Study SCAA3001-Lamotrigine.xls

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Document reference: 31009

Study title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Evaluation of Lamotrigine Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures [Data from the Open-label Continuation Phase]

Active substance: LAMOTRIGINE

Study summary document link (including results): Lamotrigine-Lamotrigine-LAM40097-ICHE3.pdf

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Document reference: 31007

Study title: A multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of lamotrigine in subjects with neuropathic pain and inadequate pain relief with gabapentin, tricyclic antidepressants or non-narcotic analgesics.

Active substance: LAMOTRIGINE

Study summary document link (including results): Lamotrigine-Lamotrigine-NPP30010-ICHE3.pdf

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Document reference: 31008

Study title: Lamotrigine: a single-blind dose-ranging study in patients with epilepsy.

Active substance: LAMOTRIGINE

Study summary document link (including results): Lamotrigine-Lamotrigine-UK25-ICHE3.pdf

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Document reference: 31010

Study title: Open, multicentre study to evaluate the efficacy and tolerability of leuprorelin acetate 3,75 mg (enantone depot) in central precocious puberty treatment

Active substance: LEUPRORELIN

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Document reference: 31054

Study title: Open, multicentre, study to evaluate the efficacy and tolerability of leuprorelin acetate 3,75 mg (enantone depot) in central precocious puberty treatment

Active substance: LEUPRORELIN

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Document reference: 31044

Study title: Study of Lupron Depot in the treatment of central precocious puberty, interim summary

Active substance: LEUPRORELIN

Study summary document link (including results): Leuprorelin_M90-516_synopsis.pdf

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Document reference: 31053

Study title: A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY: 16-WEEK EVALUATION OF THE EFFICACY AND SAFETY OF LEVETIRACETAM (LEV) AS ADD-ON THERAPY IN ADULTS AND ADOLESCENTS OLDER THAN 16 YEARS SUFFERING FROM PARTIAL SEIZURES.

Active substance: levetiracetam

Study summary document link (including results): N01102 - Levetiracetam - RRCE05F1502.pdf

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Document reference: 41537

Study title: A KOREAN OPEN-LABEL, MULTI-CENTER, COMMUNITY-BASED TRIAL ASSESSING THE EFFICACY AND SAFETY OF LEVETIRACETAM AS ADJUNCTIVE THERAPY IN ADULT SUBJECTS WITH UNCONTROLLED PARTIAL EPILEPSY FOR BRIDGING PURPOSE WITH A SIMILAR STUDY ON CAUCASIAN EPILEPTIC SUBJECTS.

Active substance: levetiracetam

Study summary document link (including results): N01099 - Levetiracetam - RRCE05B2803.pdf

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Document reference: 41536

Study title: A MULTICENTER, DOUBLE-BLIND, FOLLOW-UP TRIAL EVALUATING THE LONG-TERM SAFETY OF LEVETIRACETAM (1000 TO 3000 MG/DAY B.I.D.) AND CARBAMAZEPINE (400 TO 1200 MG/DAY ORAL B.I.D.), USED AS MONOTHERAPY IN SUBJECTS ( 16 YEARS) COMING FROM THE N01061 TRIAL.

Active substance: levetiracetam

Study summary document link (including results): N01093 - Levetiracetam - RRCE05L2109.pdf

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Document reference: 41534

Study title: A PHASE IV - PHARMACOVIGILANCE STUDY OF KEPPRA(R) GREECE - S.K.A.T.E. : SAFETY OF KEPPRA(R) AS ADJUNCTIVE THERAPY IN EPILEPSY.

Active substance: levetiracetam

Study summary document link (including results): N01035 - Levetiracetam - RRCE05J1501.pdf

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Document reference: 41535

Study title: Caries increments-tooth discoloration-and state of oral hygiene in children1965-Wellock

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1965-Wellock-Caries increments-tooth discoloration-and state of oral hygiene in children.pdf

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Document reference: 49149

Study title: Caries inhibiting effect of different modes of Duraphat reapplication-A three year radiographic study1991-peterson, Caries Res. 1991:25:70-73

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1991-peterson-Caries inhibiting effect of different modes of Duraphat reapplication-A three year radiographic study.pdf

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Document reference: 49117

Study title: Caries inhibition of mixed NaF-Na2PO3F dentifrices containing 1000 and 2500 ppmF1988-Ripa- JADA Volume 116, January 1988

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1988-Ripa-caries inhibition of mixed NaF-Na2PO3F dentifrices containing 1000 and 2500 ppmF.pdf

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Document reference: 49084

Study title: Caries prevention by daily fluoride mouthrinsingRugg-Gunn 1973

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Rugg-Gunn 1973 Caries prevention by daily fluoride mouthrinsing.pdf

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Document reference: 49129

Study title: Caries preventive effect of Duraphat Varnish versus fluoride mouthrinses-5 year data1986-kirkegaard

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1986-kirkegaard-Caries preventive effect of Duraphat Varnish versus fluoride mouthrinses-5 year data.pdf

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Document reference: 49113

Study title: Caries preventive effect of fluoride varnish application performed two or four times a year1990-seppa

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1990-seppa-Caries preventive effect of fluoride varnish application performed two or four times a year.pdf

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Document reference: 49115

Study title: Pulmonary scintigraphic findings in children with pectus excavatum by the comparison of chest radiograph indices. Clin Nucl Med. 1992 Nov;17(11):874-6 Kao CH 1992

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48820

Study title: Pulmonary ventilation/perfusion and reverse mismatches in an infant. Clin Nucl Med. 1985 Oct;10(10):708-9. Slavin JD 1985

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48828

Study title: Quantitative lung perfusion scintigraphy in postoperative evaluation of congenital right ventricular outflow tract obstructive lesions. Clin Nucl Med. 1996 Jun;21(6):471-6. Kim JH 1996

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48814

Study title: Radioimmunodetection of melanoma: preliminary results of a prospective study. Int J Biol Markers. 1986 Jan-Apr;1(1):47-54. Buraggi G 1986

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48827

Study title: Guidelines for paediatric bone scanning with 99mTc-labelled radiopharmaceuticals and 18F-fluoride. Stauss J, Hahn K, Mann M, De Palma D. Eur J Nucl Med Mol Imaging. (8 pages) Published online: www.eanm.org/scientific_info/guidelines/EJNMMI_Bone_Scintigraphy_in_Children.pdf

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48759

Study title: Renal uptake on lung perfusion scintigraphy in a patient with primary pulmonary hypertension. Clin Nucl Med. 2005 May;30(5):329-30. Kaya M 2005

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48792

Study title: Reversal of intrapulmonary shunting in cirrhosis after liver transplantation demonstrated by perfusion lung scan. J Nucl Med. 1991 May;32(5):862-4. Levin DP 1991

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48823

Study title: Reversed intrapulmonary right-to-left shunt after banding of the patent ductus venosus. Clin Nucl Med. 2003 Oct;28(10):827-33. Suga K 2003

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48795

Study title: Scintigraphic evaluation of the Eustachian tube functions. Rev Laryngol Otol Rhinol (Bord). 1999;120(2):123-5. Celen Z 1999

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48807

Study title: Spontaneous abrupt changes in the distribution of ventilation: a cause for apparent mismatching on ventilation/perfusion scintigraphy. Br J Radiol. 1989 Jun;62(738):536-43. Peters AM 1989

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48825

Study title: Surgery of congenital heart disease assessed by radionuclide scintigraphy. J Thorac Cardiovasc Surg. 1975 May;69(5):767-75. Gates GF 1975

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48830

Study title: Tc-99m MAA perfusion lung scanning in hepatopulmonary syndrome. Clin Nucl Med. 1999 Aug;24(8):616-7. Nishiyama Y 1999

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48808

Study title: Reflux of nasopharyngeal content into middle ear through the eustachian tube Eur Arch Otorhinolaryngol. 2004 Sep;261(8):439-44. Epub 2003 Nov 18. Ayanoglu E 2003

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48794

Study title: Chapter 7: Radionuclide techniques. In: Resnick D and Kransdorf MJ eds. Bone and joint imaging. 3rd Ed. Philidelphia. PA.Schneider R. Elsevier Saunders; 2005:86-117

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48515

Study title: A topical decongestant for children.The Eye, Ear, Nose and Throat Monthly 1968; 47: 121-3, Neffson AH., 1976

Active substance: OXYMETAZOLINE

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48923

Study title: A topical nasal decongestant for children.J Med Soc New Jersey 1976; 64: 260-1, Weimann ML., 1976

Active substance: OXYMETAZOLINE

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48924

Study title: Aikman PM, Bremner AD, de Burca B, et al.,1975, The Practitioner 1975; 214: 685-8

Active substance: OXYMETAZOLINE

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Document reference: 48913

Study title: An open, not-controlled study to assess the safety and efficacy of oxymetazoline 0.01 % in infants suffering from rhinitisPlease see report

Active substance: OXYMETAZOLINE

Study summary document link (including results): 6529-660-59-190375 - Nasivin 0.01% (Oxymetazoline hydrochloride) - Semmelmayer 1972 - EUdraCT_reduced datafields for Interim publication.xls

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Document reference: 48992

Study title: Clinical note: Double-blind comparison of the duration of effect of oxymetazoline and phenylephrine in children..Ann Allergy 1966; 24: 250-1, Neidorff AH., 1966

Active substance: OXYMETAZOLINE

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48919

Study title: Double-blind study of nasal decongestion with oxymetazoline and phenylephrine in asthmatic children with rhinitis.Rev Allergy 1966; 20: 863-8, Green M., 1966

Active substance: OXYMETAZOLINE

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Document reference: 48918

Study title: En klinisk prövning av näsdroppar för spädbarn. (Clinical trials of nosedrops for infants).Z Allg Med 1974; 11: 535-7, Rüggeberg F., 1974

Active substance: OXYMETAZOLINE

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Document reference: 48926

Study title: Essais cliniques du chlorhydrate d’oxymétazoline. (Clinical trials with oxymetazoline hydrochloride).Le Progrès Medical. 1965; 93: 321-3, Chatelet J., 1965

Active substance: OXYMETAZOLINE

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Document reference: 48921

Study title: Evaluation of oxymetazoline paediatric in the treatment of congestion.J Matern Child Health 1976; 1: 32-3, Cannon NL., Dalgleisch J., Franks HL. et al., 1976

Active substance: OXYMETAZOLINE

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Document reference: 48920

Study title: A single-blind trial to investigate the ethiology of bacterial respiratory tract infections and the efficacy of penicillin V (Kåvepenin) and erythromycin (Ery-Max) in these infections.Hovelius et al

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_10.xlsx

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Document reference: 49041

Study title: An open, randomized trila to evaluate if dose and frequency given bt American Heart Association coul be reduced (250 000 units x3 for 10 days)for streptococcal pharyngitis.Breese et al

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_3.xlsx

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Document reference: 49034

Study title: Compare the effect of treatment with penicillin V in children with AOM for 5 and 10 days respectively and to investigate whether a higher dose of penicillin V is associated with a beneficial result.Ingvarsson et al

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_11.xlsx

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Document reference: 49042

Study title: Gaillard WD. Ment Retard Dev Disabil Res. Structural and functional imaging in children with partial epilepsy. [gaillard-2000]Rev. 2000;6(3):220-6. Gaillard WD 2000

Active substance: Steripet

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Document reference: 48654

Study title: Gallamini A, Rigacci L, Merli F, Nassi L, Bosi A, Capodanno I et al.. The predictive value of positron emission tomography scanning performed after two courses of standard therapy on treatment outcome in advance stage Hodgkin's disease. [gallamini-2006]Haematologica 2006 Apr;91(4):475-81. Gallamini A 2006

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48655

Study title: Hain SF, O'Doherty MJ, Lucas JD, Smith MA. Nucl Med Commun. 1999 Sep;20(9):845-8. Fluorodeoxyglucose PET in the evaluation of amputations for soft tissue sarcoma. [hain-1999] Hain SF, O'Doherty MJ, Timothy AR, Leslie MD, Harper PG,. Fluorodeoxyglucose positron emission tomography in the evaluation of germ cell tumours at relapse. [hain-2000]Huddart RA. Br J Cancer. 2000 Oct;83(7):863-9. Hain SF 2000

Active substance: Steripet

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Document reference: 48656

Study title: Hikima A, Mochizuki H, Oriuchi N, Endo K, Morikawa A..Semiquantitative analysis of interictal glucose metabolism between generalized epilepsy and localization related epilepsy. [hikima-2004]Ann Nucl Med. 2004 Oct;18(7):579-84. Hikima A 2004

Active substance: Steripet

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Document reference: 48657

Study title: Hoegerle S, Juengling F, Otte A, Altehoefer C, Moser EA, Nitzsche EU.. Combined FDG and [F-18]fluoride whole-body PET: a feasible two-in-one approach to cancer imaging? [hoegerle 1998]Radiology. 1998 Oct;209(1):253-8. Hoegerle S 1998

Active substance: Steripet

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Document reference: 48658

Study title: Holm S, Borgwardt L, Loft A, Graff J, Law I, Højgaard L. Paediatric doses – a critical appraisal of the EANM paediatric dosage card. [holm-2007]Eur J Nucl Med Mol Imaging 2007; 34 : 1713 - 1718. Holm S 2007

Active substance: Steripet

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Document reference: 48659

Study title: Hostility differentiates the brain metabolic effects of nicotine.Cognitive Brain Research 18 (2004) 142–148. James H. Fallona, David B. Keatorb, James Mbogoric, Jessica Turnerd, Steven G. Potkine.

Active substance: Steripet

Study summary document link (including results): fallon-2004.pdf

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Document reference: 48728

Study title: Hudson MM, Krasin MJ, Kaste SC.. Epub 2004 Jan 27. PET imaging in pediatric Hodgkin's lymphoma. [hudson-2004]Pediatr Radiol. 2004 Mar;34(3):190-8. Hudson MM 2004

Active substance: Steripet

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Document reference: 48660

Study title: Hutchings M, Mikhaeel NG, Fields PA, Nunan T, Timothy AR.. Epub 2005 Jun 6. Prognostic value of interim FDG-PET after two or three cycles of chemotherapy in Hodgkin lymphoma. [hutchings-2005]Ann Oncol. 2005 Jul;16(7):1160-8. Hutchings M 2005

Active substance: Steripet

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Document reference: 48661

Study title: COMPARISON OF AMPICILLIN PLUS SULBACTAM VS CEFOXITIN/DOXYCYCLINE OR CLINDAMYCIN/GENTAMICIN IN THE TREATMENT OF GYNECOLOGICAL OR OBSTETRICAL INFECTIONS OF BACTERIAL ETIOLOGY

Active substance: SULBACTAM

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Document reference: 42626

Study title: Imaging the epileptic brain with positron emission tomography.Neuroimag Clin N Am 13 (2003) 705– 716. Csaba Juha´sz, MD, PhDa,b,*, Harry T. Chugani, MDa,b

Active substance: Steripet

Study summary document link (including results): juhasz-2003.pdf

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Document reference: 48733

Study title: Jacobs F, Thierens H, Piepsz A, Bacher K, van de Wiele C, Ham H et al. Optimised tracer-dependent dosage cards to obtain weight-independent effective doses. [jacobs 2005Eur J Nucl Med Mol Imaging 2005; 32 : 581 - 588. Jacobs F 2005

Active substance: Steripet

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Document reference: 48662

Study title: Jasper N, Däbritz J, Frosch M, Loeffler M, Weckesser M, Foell D.. Epub. Diagnostic value of [(18)F]-FDG PET/CT in children with fever of unknown origin or unexplained signs of inflammation. [jasper-2010] Eur J Nucl Med Mol Imaging. 2010 Jan;37(1):136-45. Jasper N 2010

Active substance: Steripet

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Document reference: 48663

Study title: Caries preventive effect of high fluoride and xylitol containing dentifrices1992-Cutress-

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1992-Cutress-caries preventive effect of high fluoride and xylitol containing dentifrices.pdf

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Document reference: 49094

Study title: Caries preventive effect of three topical fluorides_1% years clinical trial in Chandigarh schoolchildren of North India1984-tewari-

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1984-tewari-Caries preventive effect of three topical fluorides_1% years clinical trial in Chandigarh schoolchildren of North India.pdf

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Document reference: 49111

Study title: Caries preventive effect of two fluoride varnishes and a fluoride mouthrinse1987-seppa, Caries Res. 1987:21: 375-379

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1987-seppa-Caries preventive effect of two fluoride varnishes and a fluoride mouthrinse.pdf

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Document reference: 49114

Study title: Caries preventive effort of a fluoride-containing varnish (Duraphat) after 1 year s study1975-koch, Community Dentl Oral Epidemiol, 1975: 3: 262-266

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1975-koch-Cariespreventive effort of a fluoride-containing varnish (Duraphat) after 1 year s study.pdf

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Document reference: 49102

Study title: Caries rate, enamel fluoride concentration after fortnightly brushing with aminfluoride gelRan 1987

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Ran 1987 Caries rate, enamel fluoride concentration.pdf

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Document reference: 49175

Study title: Postoperative adjuvant locoregional chemotherapy in patients with hepatocellular carcinoma. ; Izumi-R. Hepato-Gastroenterology, 1996, Vol/Iss/Pg. 43/12 (1415-1420)Postoperative adjuvant locoregional chemotherapy in patients with hepatocellular carcinoma. ; Izumi-R. Hepato-Gastroenterology, 1996, Vol/Iss/Pg. 43/12 (1415-1420)

Active substance: IODINE

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Document reference: 30304

Study title: Preliminary experience with arterial chemoembolization for hepatoblastoma and hepatocellular carcinoma in children. ;Czauderna-P. Pediatric Blood and Cancer, 2006, Vol/Iss/Pg. 46/7 (825-828)Preliminary experience with arterial chemoembolization for hepatoblastoma and hepatocellular carcinoma in children. ;Czauderna-P. Pediatric Blood and Cancer, 2006, Vol/Iss/Pg. 46/7 (825-828)

Active substance: IODINE

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Document reference: 30306

Study title: Preoperative Chemoembolization for Hepatocellular Carcinoma.02/12/2010Mario Morino. Journal of Surgical Oncology Supplement 3:91-93 (1993)Preoperative Chemoembolization for Hepatocellular Carcinoma.02/12/2010Mario Morino. Journal of Surgical Oncology Supplement 3:91-93 (1993)

Active substance: IODINE

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Document reference: 30307

Study title: Preoperative percutaneous portal vein embolization: Evaluation of adverse events in 188 patients. ; Di-Stefano-D-R. Radiology, 2005, Vol/Iss/Pg. 234/2 (625-630)Preoperative percutaneous portal vein embolization: Evaluation of adverse events in 188 patients. ; Di-Stefano-D-R. Radiology, 2005, Vol/Iss/Pg. 234/2 (625-630)

Active substance: IODINE

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Document reference: 30308

Study title: Preoperative Porgal Vein Embolization for Extension of Hepatectomy Indications.;Thierry de Baere. Hepatology Vol. 24, No. 6, 1996.Preoperative Porgal Vein Embolization for Extension of Hepatectomy Indications.;Thierry de Baere. Hepatology Vol. 24, No. 6, 1996.

Active substance: IODINE

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Document reference: 30309

Study title: Preparation of two dosage forms containing antitumor prostaglandin and their antitumor effect in vitro and in vivo: Lipiodol solution for I.A. administration and lipid microspheres for I.P. or I.V. administration.;Fukushima Shoji. Eicosanoids and Other Bioactive Lipids in Cancer, Inflammation and Radiation Injury 2, Edited by K.V. Honn et al., Plenum Press, New York 1997Preparation of two dosage forms containing antitumor prostaglandin and their antitumor effect in vitro and in vivo: Lipiodol solution for I.A. administration and lipid microspheres for I.P. or I.V. administration.;Fukushima Shoji. Eicosanoids and Other Bioactive Lipids in Cancer, Inflammation and Radiation Injury 2, Edited by K.V. Honn et al., Plenum Press, New York 1997

Active substance: IODINE

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Document reference: 30310

Study title: Prevalence of goitre and hypothyroidism in Southern Tanzania: Effect of iodised oil on thyroid hormone deficiency. ; Wachter-W. Journal of Epidemiology and Community Health, 1986, Vol/Iss/Pg. 40/1 (86-91)Prevalence of goitre and hypothyroidism in Southern Tanzania: Effect of iodised oil on thyroid hormone deficiency. ; Wachter-W. Journal of Epidemiology and Community Health, 1986, Vol/Iss/Pg. 40/1 (86-91)

Active substance: IODINE

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Document reference: 30311

Study title: Caries reduction and cost benefit after 3 years of sucking fluoride tablets daily at schoolK.W. Stephen, D. Campbell 1978. Brit Dent J 1978 144, 202

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1978-stephen-Caries Reduction and Cost Benefit After 3 Years of Sucking Fluoride Tablets Daily at school.pdf

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Document reference: 48780

Study title: Cherubism: diagnostic imaging and review of the literature in JapanHitomi G. Nishide N. Mitsui K. Ora l Surg Oral Med Oral Pathol Oral Radial Endod 1996 May;81(5):623-8

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48487

Study title: Tc-99m MAA total-body imaging to detect intrapulmonary right-to-left shunts and to evaluate the therapeutic effect in pulmonary arteriovenous shunts. Clin Nucl Med. 1996 Mar;21(3):197-202. Lu G 1996

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48815

Study title: The contribution of perfusion scintigraphy in the evaluation of children suffering from recurrent localized pneumonia. Eur J Nucl Med. 1990;17(3-4):152-5. Hardoff R 1990

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48824

Study title: The incidence and severity of hypoxia associated with 99Tcm Technegas ventilation scintigraphy and 99Tcm MAA perfusion scintigraphy. Br J Radiol. 1992 May;65(773):403-8. James JM 1992

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48821

Study title: Transcatheter infusion of 99mTc MAA for predicting response of intra-arterial chemotherapy in osteogenic sarcoma. Eur J Cancer Clin Oncol. 1985 Jan;21(1):35-42. Kim EE 1985

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48829

Study title: Tc-99m MAA SPECT in pectus excavatum: assessment of perfusion volume changes after correction by the Nuss procedure. Clin Nucl Med. 2005 Dec;30(12):779-82. Kinuya K 2005

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48791

Study title: Use of macroaggregated albumin lung perfusion scan to diagnose hepatopulmonary syndrome: a new approach. Gastroenterology. 1998 Feb;114(2):305-10. Abrams GA 1998

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48812

Study title: Chronic recurrent multifocal osteomyelitis (CRMO) with symmetric involvement of both femora: X-ray, bone scintigram, and MR imaging findings in one case. Buck FM, Treumann TC, Winiker H, Strobel K. J Magn Reson Imaging. 2007 Aug;26(2):422-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48837

Study title: Chronic recurrent multifocal osteomyelitis involving the mandible in a 4-year-old girl: a case report and a review of the literatureOtsuka K. Hamakawa H. Kayahara H. Tanioka H. J Oral Maxillofac Surg 1999 Aug;57(8):1013-6

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48508

Study title: Hematogenous pyogenic vertebral osteomyelitis: diagnostic value of radionuclide bone imaging.Adatepe MH, Powell OM, Isaacs GH, Nichols K, Cefola R. J Nucl Med 1986 Nov;27(11):1680-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48523

Study title:

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48495

Study title:

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48504

Study title: 131I-MIBG in the diagnosis of primary and metastatic neuroblastoma.El-Maghraby T. Gulf J Oncol 2007 (2):33-41.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48720

Study title: 201Tl scintigraphic evaluation of tumor mass and viability of bone and soft-tissue tumors.Tsuda T, Kubota M, Yoshida S, Shibata M, Wakabayashi J, Obata H, et al. Kaku Igaku 1994 Dec;31(12):1477-94

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48762

Study title: (99m)Tc-MDP scintigraphic findings in children with leukemia: value of early and delayed whole-body imagingShalaby-Rana E, Majd M. J Nucl Med 2001 Jun;42(6):878-83

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48514

Study title: "Cold spots" in pediatric bone imagingRosovsky M. Goldfarb CR. Finestone H. Ongseng F. Semin Nucl Med 1994 Apr;24(2):184-6

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48513

Study title: Determine concentration of pcV in serum and in middle ear exudate and to isolate bacteria in the ear exsudate during the course of treatment with penicillin V in acute otitis media in children.Ingvarsson et al

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_15.xlsx

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Document reference: 49046

Study title: determine concentration of pcV in serum and in middle ear exudate at various intervals of administration of different doses and to correlate the susceptibility in vitro of H Infl to pcVKamme et al

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_5.xlsx

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Document reference: 49036

Study title: Double-blinded, Randomized parallel groups design trial, the primary objective of the study was to evaluate the taste of two formulations of phenoxymethylpenicillin suspension in children. The secondary objectives were to study age-related differences in taste perception, to evaluate the acceptability of the suspensions, and to determine patient compliance.Bagger-Sjöbäck et al

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_12.xlsx

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Document reference: 49043

Study title: Klinische Prüfung von Oxymetazolin-HCl-Nasentropfen für Säuglinge (Nasivin™ 0.01 %). (Clinical trials of oxymetazoline hydrochloride nasal drops for babies (Nasivin™ 0.01 %)).Draco por Medico 1968; 9: 6-8, Svenningsen N., 1968

Active substance: OXYMETAZOLINE

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48925

Study title: Oxymetazoline spray in otorhinolaryngology.Curr Ther Res 1966; 8: 91-3, Haines HL., 1966

Active substance: OXYMETAZOLINE

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Document reference: 48915

Study title: Physiological and clinical estimate of the relief of nasal flow obstruction in allergic rhinitis: effects of topical decongestant (oxymetazoline).J Asthma Res 1969; 7: 65-73, Cohen BM, Duffy EP., 1969

Active substance: OXYMETAZOLINE

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Document reference: 48922

Study title: A novel approach to flow quantification in brain arteriovenous malformations prior to enbucrilate embolization: Use of insoluble contrast (Ethiodol droplet) angiography. ; Wakhloo-A-K. Journal of Neurosurgery, 1998, Vol/Iss/Pg. 89/3 (395-404)A novel approach to flow quantification in brain arteriovenous malformations prior to enbucrilate embolization: Use of insoluble contrast (Ethiodol droplet) angiography. ; Wakhloo-A-K. Journal of Neurosurgery, 1998, Vol/Iss/Pg. 89/3 (395-404)

Active substance: IODINE

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Document reference: 30215

Study title: Accidental successful treatment of a rare case of diffuse peritoneal lymphangiomatosis; G. Silecchia. British Journal of Surgery 1994, 81, 1286-1289Accidental successful treatment of a rare case of diffuse peritoneal lymphangiomatosis; G. Silecchia. British Journal of Surgery 1994, 81, 1286-1289

Active substance: IODINE

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Document reference: 30216

Study title: Accurate preoperative evaluation of liver mass lesions without fine- needle biopsy. ; Torzilli-G. Hepatology, 1999, Vol/Iss/Pg. 30/4 (889-893)Accurate preoperative evaluation of liver mass lesions without fine- needle biopsy. ; Torzilli-G. Hepatology, 1999, Vol/Iss/Pg. 30/4 (889-893)

Active substance: IODINE

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Document reference: 30217

Study title: Adjuvant intra-arterial iodine-131-labelled lipiodol for resectable hepatocellular carcinoma: A prospective randomised trial. ; Lau-W-Y. Lancet, 06 MAR 1999, Vol/Iss/Pg. 353/9155 (797-801)Adjuvant intra-arterial iodine-131-labelled lipiodol for resectable hepatocellular carcinoma: A prospective randomised trial. ; Lau-W-Y. Lancet, 06 MAR 1999, Vol/Iss/Pg. 353/9155 (797-801)

Active substance: IODINE

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Document reference: 30218

Study title: Kabickova E, Sumerauer D, Cumlivska E, Drahokoupilova E, Nekolna M, ChanovaM, et al.. The predictive value of positron emission tomography scanning performed after two courses of standard therapy on treatment outcome in advanced stage Hodgkin's disease. [kabickova-2006]Haematologica. 2006 Apr;91(4):475-81. Kabickova E 2006

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48664

Study title: Kamel E, Hany TF, Burger C, Treyer V, Lonn AH, von Schulthess GK, et al.. CT vs 68Ge attenuation correction in a combined PET/CT system: evaluation of the effect of lowering the CT tube current. [kamel-2002]Eur J Nucl Med Mol Imaging. 2002 Mar;29(3):346-50. Kamel E 2002

Active substance: Steripet

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Document reference: 48665

Study title: Kaneta T, Hakamatsuka T, Yamada T, Takase K, Sato A, Higano S, et al.. FDG PET in solitary metastastic/secondary tumor of the kidney: a report of three cases and a review of the relevant literature. [kaneta-2006]Ann Nucl Med. 2006 Jan;20(1):79-82. Kaneta T 2006

Active substance: Steripet

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Document reference: 48666

Study title: Kaplan AM, Bandy DJ, Manwaring KH, Chen K, Lawson MA, Moss SD, et al.. Functional brain mapping using positron emission tomography scanning in preoperative neurosurgical planning for pediatric brain tumors. [kaplan-1999]J Neurosurg. 1999 Nov;91(5):797-803. Kaplan AM 1999

Active substance: Steripet

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Document reference: 48667

Study title: Kaste SC, Howard SC, McCarville EB, Krasin MJ, Kogos PG, Hudson MM.. Epub 2004 Nov 16. 18F-FDG-avid sites mimicking active disease in pediatric Hodgkin's. [kaste-2005]Pediatr Radiol. 2005 Feb;35(2):141-54. Kaste SC 2005

Active substance: Steripet

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Document reference: 48668

Study title: Koga H, Sasaki M, Kuwabara Y, Nakagawa M, Hayashi K, Kaneko K, et al.. Lesion detectability of a gamma camera based coincidence system with FDG in patients with malignant tumors: a comparison with dedicated positron emission tomography. [koga-2004]Ann Nucl Med. 2004 Apr;18(2):131-6. Koga H 2004

Active substance: Steripet

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Document reference: 48669

Study title: Kostakoglu L, Leonard JP, Kuji I, Coleman M, Vallabhajosula S, Goldsmith SJ.. Comparison of fluorine-18 fluorodeoxyglucose positron emission tomography and Ga-67 scintigraphy in evaluation of lymphoma. [kostakaglu-2002]Cancer. 2002 Feb 15;94(4):879-88. Kostakoglu L 2002

Active substance: Steripet

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Document reference: 48670

Study title: Krug B, Heidenreich A, Dietlein M, Lackner K. Rofo.. [The lymph node staging of malignant testicular germ-cell tumors] [Translated] [krug-1999-en]1999 Aug;171(2):87-94. Krug B 1999

Active substance: Steripet

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Document reference: 48671

Study title: Lamusuo S, Ruottinen HM, Knuuti J, Härkönen R, Ruotsalainen U, Bergman J, et al.. Comparison of [18F]FDGPET, [99mTc]-HMPAO-SPECT, and [123I]-iomazenil-SPECT in localising the epileptogenic cortex. [lamusuo-1997]J Neurol Neurosurg Psychiatry. 1997 Dec;63(6):743-8. Lamusuo S 1997

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48672

Study title: Lassmann M, Biassoni L, Monsieurs M, Franzius C, Jacobs F, EANM Dosimetry and Paediatrics Committees.. The new EANM paediatric dosage card. [lassman-2007]Eur J Nucl Med Mol Imaging 2007; 34:796–798. Lassmann M 2007

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48673

Study title: Galli V, Canonaco F, Rozzi N.(1980) Clinica Pediatrica.; 62:1-11. Therapy with methisoprinol in pediatric pathologiesGalli V, Canonaco F, Rozzi N.(1980) Clinica Pediatrica.; 62:1-11. Therapy with methisoprinol in pediatric pathologies

Active substance: INOSINE

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Document reference: 30109

Study title: Gascon G, Yamani S, Crowell J, Stigsby B, Nester M, Kanaan I, Jallu A. Brain Dev. 1993 Sep-Oct;15(5):346-55. Combined oral isoprinosine-intraventricular alpha-interferon therapy for subacute sclerosing panencephalitis.Gascon G, Yamani S, Crowell J, Stigsby B, Nester M, Kanaan I, Jallu A. Brain Dev. 1993 Sep-Oct;15(5):346-55. Combined oral isoprinosine-intraventricular alpha-interferon therapy for subacute sclerosing panencephalitis.

Active substance: INOSINE

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Document reference: 30110

Study title: Gascon GG, Yamani S, Cafege A, Flock L, al-Sedairy S, Parhar RS, Crowell J, Nester M, Kanaan I, Jallu MA. Ann Neurol. 1991 Aug;30(2):227-8. Treatment of subacute sclerosing panencephalitis with alpha interferon.Gascon GG, Yamani S, Cafege A, Flock L, al-Sedairy S, Parhar RS, Crowell J, Nester M, Kanaan I, Jallu MA. Ann Neurol. 1991 Aug;30(2):227-8. Treatment of subacute sclerosing panencephalitis with alpha interferon.

Active substance: INOSINE

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Document reference: 30111

Study title: Geiger S, Peuten M. Inform Artz 1985;2:30-35. Treatment of herpetic and recurrent apthae with inosiplex.Geiger S, Peuten M. Inform Artz 1985;2:30-35. Treatment of herpetic and recurrent apthae with inosiplex.

Active substance: INOSINE

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Document reference: 30112

Study title: Ginsberg T. Third Int Symposium on SSPE, India 30-31 Oct 1989. Isoprinosine in subacute sclerosing panencephalitis: Confirmation and extension of beneficial clinical results in the US and Canada by a recent study in Japan.Ginsberg T. Third Int Symposium on SSPE, India 30-31 Oct 1989. Isoprinosine in subacute sclerosing panencephalitis: Confirmation and extension of beneficial clinical results in the US and Canada by a recent study in Japan.

Active substance: INOSINE

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Document reference: 30113

Study title: Grasso E. (1979) Isoprinosina; April 28,; Rome, Italy; 87-93. Isoprinosina treatment in viral mononucleosis and epidemic parotitis [in English]. Presented at del Convegno Internazionale sullaGrasso E. (1979) Isoprinosina; April 28,; Rome, Italy; 87-93. Isoprinosina treatment in viral mononucleosis and epidemic parotitis [in English]. Presented at del Convegno Internazionale sulla

Active substance: INOSINE

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Document reference: 30114

Study title: Gross G, Jogerst C, Schőpf.. Acta Derm Venereol. 1986;66(1):76-80. Systemic treatment of mollusca contagiosa with inosiplexGross G, Jogerst C, Schőpf.. Acta Derm Venereol. 1986;66(1):76-80. Systemic treatment of mollusca contagiosa with inosiplex

Active substance: INOSINE

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Document reference: 30115

Study title: Radiological aspects of a case of Waldmann's disease. ; Guery-V. Journal de Radiologie, 1990, Vol/Iss/Pg. 71/10 (535-538)Radiological aspects of a case of Waldmann's disease. ; Guery-V. Journal de Radiologie, 1990, Vol/Iss/Pg. 71/10 (535-538)

Active substance: IODINE

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Document reference: 30319

Study title: Radiological aspects of a case of Waldmann's disease. Guery-V. Journal de Radiologie, 1990, Vol/Iss/Pg. 71/10 (535-538)Radiological aspects of a case of Waldmann's disease. Guery-V. Journal de Radiologie, 1990, Vol/Iss/Pg. 71/10 (535-538)

Active substance: IODINE

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Document reference: 30318

Study title: Randomized clinical trial comparing different iodine interventions in school children. ; Zhao-J. Public Health Nutrition, 1999, Vol/Iss/Pg. 2/2 (173-178)Randomized clinical trial comparing different iodine interventions in school children. ; Zhao-J. Public Health Nutrition, 1999, Vol/Iss/Pg. 2/2 (173-178)

Active substance: IODINE

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Document reference: 30320

Study title: Reversibility of severe hypothyroidism with supplementary iodine in patients with endemic cretinism. ; Vanderpas-J-B. New England Journal of Medicine, 1986, Vol/Iss/Pg. 315/13 (791-795).Reversibility of severe hypothyroidism with supplementary iodine in patients with endemic cretinism. ; Vanderpas-J-B. New England Journal of Medicine, 1986, Vol/Iss/Pg. 315/13 (791-795).

Active substance: IODINE

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Document reference: 30321

Study title: Selenium deficiency mitigates hypothyroxinemia in iodine-deficient subjects; Jean B Vanderpas. Am J Clin Nutr Suppl 1993 ;57 :271S-5S.Selenium deficiency mitigates hypothyroxinemia in iodine-deficient subjects; Jean B Vanderpas. Am J Clin Nutr Suppl 1993 ;57 :271S-5S.

Active substance: IODINE

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Document reference: 30322

Study title: Serum thyroglobulin and urinary iodine concentration are the most appropriate indicators of iodine status and thyroid function under conditions of increasing iodine supply in schoolchildren in Benin. ; Briel-T-V-D. Journal of Nutrition, 2001, Vol/Iss/Pg. 131/10 (2701-2706), ISSN: 0022-3166Serum thyroglobulin and urinary iodine concentration are the most appropriate indicators of iodine status and thyroid function under conditions of increasing iodine supply in schoolchildren in Benin. ; Briel-T-V-D. Journal of Nutrition, 2001, Vol/Iss/Pg. 131/10 (2701-2706), ISSN: 0022-3166

Active substance: IODINE

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Document reference: 30323

Study title: Spontaneous scalp arteriovenous fistula in a child with Hartnup disease. ; Kim-D-M. Journal of Endovascular Therapy, 2004, Vol/Iss/Pg. 11/3 (348-350)Spontaneous scalp arteriovenous fistula in a child with Hartnup disease. ; Kim-D-M. Journal of Endovascular Therapy, 2004, Vol/Iss/Pg. 11/3 (348-350)

Active substance: IODINE

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Document reference: 30324

Study title: Comparison of bone and gallium-67 imaging in heroin users' arthritis.Bittini A, Dominguez PL, Martinez Pueyo ML, López Longo FJ, Monteagudo I, Carreño L. J Nucl Med 1985 Dec;26(12):1377-81.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48572

Study title: Comparison of planar scintigraphy alone and with SPECT for the initial evaluation of femoral neck stress fracture.Bryant LR, Song WS, Banks KP, Bui-Mansfield LT, Bradley YC. AJR 2008;191:1010-1015.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48584

Study title: Hip pain in an 18-year-old manRajaram A, Tamurian RM, Reith JD, Bush CH. Clin Orthop Relat Res 2008;466:248-54

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48754

Study title: Hematogenous Pyogenic Vertebral Osteomyelitis:Diagnostic Value of Radionucide Bone ImagingMustafa H. Adatepe, Oscar M. Powell, Gilbert H. Isaacs, Kenneth Nichols, and Raymond Cefola. J Nucl Med 27:1680-1685, 1986

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48832

Study title: A protocol of plain radiographs, hip ultrasound, and triple phase bone scans in the evaluation of the painful pediatric hip.Alexander JE, Seibert JJ, Aronson J, Williamson SL, Glasier CM, Rodgers AB, et al. Clin Pediatr 1988 Apr;27(4):175-81.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48527

Study title: A report of two cases of brucellar sacroiliitis without systematic manifestations in GreeceThoma S, Patsiogiannis N, Dempegiotis P, Filiopoulos K. J Pediatr Orthop 2009 29:375-79

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48761

Study title: Accumulation of Tc-99m MDP in diaphragm and retroperitoneum of a battered child. Sty JR, Carmody TJ, Ruiz ME. Clin Nucl Med. 1995 Oct;20(10):931. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43583

Study title: Computerized blood flow analysis for decision making in the treatment of osteochondritis dissecansLitchman HM, McCullough RW, Gandsman EJ, Schatz SL. J Pediatr Orthop 1988 Mar;8(2):208-12

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48752

Study title: Computerized skeletal scintigraphy for assessment of mandibular asymmetry. Cisneros GJ, Kaban LB. J Oral Maxillofac Surg. 1984 Aug;42(8):513-20.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48840

Study title: Acute hematogenous osteomyelitis of children: assessment of skeletal scintigraphy-based diagnosis in the era of MRI. Connolly LP, Connolly SA, Drubach LA, Jaramillo D, Treves ST. J Nucl Med. 2002 Oct;43(10):1310-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48841

Study title: Activation of the growth plates on three-phase bone scintigraphy: the explanation for the overgrowth of fractured femurs.Elba CSC, Etchebehere EC, Caron M, Pereira JA, Lima MC, Santos AO, et al. Eur J Nucl Med 2001 Jan;28(1):72-80.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48719

Study title: Age- and sex-related bone uptake of Tc-99m-HDP measured by whole-body bone scanning.Brenner W, Sieweke N, Bohuslavizki KH, Kampen WU, Zuhayra M, Clausen M, et al. Nuklearmedizin 2000 Aug;39(5):127-32.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48578

Study title: Age-related changes in skull uptake on bone scintigraphy: a quantitative study.Sadeghi R, Zakavi SR, Ghasemov M, Kakhki VRD. Nucl Med Rev 2008; 11 (2):67-69

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48756

Study title: DECREASED TRACER UPTAKE IN BONE TISSUE IN PAEDIATRIC REFLEX SYMPATHETIC DYSTROPHYX. Le Loet, J. Lefort, A. Daragon, B. Derumeaux, P. Deshayes Rheumatology Department, La Prévotière, Hôpital de Bois Guillaume, BP 100, F 76230 Bois Guillaume

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48845

Study title: Assessment of an intervention study on iodine deficiency in Burkina Faso (1990-1993). ; Casas-C-A. Atencion Primaria, 30 APR 1998, Vol/Iss/Pg. 21/7 (462-465)Assessment of an intervention study on iodine deficiency in Burkina Faso (1990-1993). ; Casas-C-A. Atencion Primaria, 30 APR 1998, Vol/Iss/Pg. 21/7 (462-465)

Active substance: IODINE

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Document reference: 30219

Study title: Äthiopathogenese und Therapie der Jodmangelstruma, Gärtner, R.; Z. ärtzl. Fortbildung 89, 27-31, 1995Äthiopathogenese und Therapie der Jodmangelstruma, Gärtner, R.; Z. ärtzl. Fortbildung 89, 27-31, 1995

Active substance: IODINE

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Document reference: 30220

Study title: Cerebral av angiomas: 3-dimensional demonstration by spiral CT. ; Rieger-J. RoFo Fortschritte auf dem Gebiete der Rontgenstrahlen und der Neuen Bildgebenden Verfahren, 1994, Vol/Iss/Pg. 161/6 (489-494)Cerebral av angiomas: 3-dimensional demonstration by spiral CT. ; Rieger-J. RoFo Fortschritte auf dem Gebiete der Rontgenstrahlen und der Neuen Bildgebenden Verfahren, 1994, Vol/Iss/Pg. 161/6 (489-494)

Active substance: IODINE

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Document reference: 30221

Study title: Chemical pneumonitis with iodoliposputosis following lymphangiography in children.; Stoegmann-W. Fortschritte auf den Gebiete der Rontgenstrahlen und der Nuklearmedizin, 1974, Vol/Iss/Pg. 121/1 (43-48). Chemical pneumonitis with iodoliposputosis following lymphangiography in children.; Stoegmann-W. Fortschritte auf den Gebiete der Rontgenstrahlen und der Nuklearmedizin, 1974, Vol/Iss/Pg. 121/1 (43-48).

Active substance: IODINE

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Document reference: 30222

Study title: Cognitive and motor functions of iodine-deficient but euthyroid children in Bangladesh do not benefit from iodized poppy seed oil (Lipiodol). ; Huda-S-N. Journal of Nutrition, 2001, Vol/Iss/Pg. 131/1 (72-77)Cognitive and motor functions of iodine-deficient but euthyroid children in Bangladesh do not benefit from iodized poppy seed oil (Lipiodol). ; Huda-S-N. Journal of Nutrition, 2001, Vol/Iss/Pg. 131/1 (72-77)

Active substance: IODINE

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Document reference: 30223

Study title: Combination therapy consisting of arterial infusion chemotherapy (EPF, EAP) and transcatheter arterial embolization (TAE). ; Yodono-H. Cancer Chemotherapy and Pharmacology, Supplement, 1994, Vol/Iss/Pg. 33/- (S79-S83)Combination therapy consisting of arterial infusion chemotherapy (EPF, EAP) and transcatheter arterial embolization (TAE). ; Yodono-H. Cancer Chemotherapy and Pharmacology, Supplement, 1994, Vol/Iss/Pg. 33/- (S79-S83)

Active substance: IODINE

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Document reference: 30224

Study title: Combined fibrolamellar carcinoma and cholangiocarcinoma exhibiting biphenotypic antigen expression: a case report; K. Tanaka. J Clin Pathol 2005;58:884-887.Combined fibrolamellar carcinoma and cholangiocarcinoma exhibiting biphenotypic antigen expression: a case report; K. Tanaka. J Clin Pathol 2005;58:884-887.

Active substance: IODINE

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Document reference: 30225

Study title: Coverage and cost of iodized oil capsule distribution in Tanzania. ;Peterson-S. Health Policy and Planning, 1999, Vol/Iss/Pg. 14 /4 (390-399)Coverage and cost of iodized oil capsule distribution in Tanzania. ;Peterson-S. Health Policy and Planning, 1999, Vol/Iss/Pg. 14 /4 (390-399)

Active substance: IODINE

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Document reference: 30226

Study title: Craniofacial cavernous venous malformations: Percutaneous sclerotherapy with use of ethanolamine oleate. ;Choi-Y-H. Journal of Vascular and Interventional Radiology, 2002, Vol/Iss/Pg. 13/5 (475-482)Craniofacial cavernous venous malformations: Percutaneous sclerotherapy with use of ethanolamine oleate. ;Choi-Y-H. Journal of Vascular and Interventional Radiology, 2002, Vol/Iss/Pg. 13/5 (475-482)

Active substance: IODINE

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Document reference: 30227

Study title: Diagnosis and management of vein of Galen aneurysmal malformations. ; Gailloud-P. Journal of Perinatology, 2005, Vol/Iss/Pg. 25/8 (542-551)Diagnosis and management of vein of Galen aneurysmal malformations. ; Gailloud-P. Journal of Perinatology, 2005, Vol/Iss/Pg. 25/8 (542-551)

Active substance: IODINE

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Document reference: 30228

Study title: Diagnostic and therapeutic value of lymphography in persistent postoperative chylothorax. ; Thambo-J-B. Archives des Maladies du Coeur et des Vaisseaux, 2004, Vol/Iss/Pg. 97/5 (546-548)Diagnostic and therapeutic value of lymphography in persistent postoperative chylothorax. ; Thambo-J-B. Archives des Maladies du Coeur et des Vaisseaux, 2004, Vol/Iss/Pg. 97/5 (546-548)

Active substance: IODINE

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Document reference: 30229

Study title: Pediatric hepatic CT : an injection protocol;ROCHE KJ; Pediatr. Radiol.; 1996 vol.26 p.502 507Pediatric hepatic CT : an injection protocol;ROCHE KJ; Pediatr. Radiol.; 1996 vol.26 p.502 507

Active substance: IOVERSOL

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Document reference: 30422

Study title: Perforated versus non perforated acute appendicitis : accuracy of multidetector CT detection; BIXBY SD; Radiology ; 2006 vol.241 n.3 p.780 786Perforated versus non perforated acute appendicitis : accuracy of multidetector CT detection; BIXBY SD; Radiology ; 2006 vol.241 n.3 p.780 786

Active substance: IOVERSOL

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Document reference: 30423

Study title: Iodized oil in the prophylaxis of endemic goiter in Argentina;Tomas Watanabe. Reprint from Endemic Goiter and cretinism: continuing threats to world health PAHO scientific publication 292, 1974: 231-240 Iodized oil in the prophylaxis of endemic goiter in Argentina;Tomas Watanabe. Reprint from Endemic Goiter and cretinism: continuing threats to world health PAHO scientific publication 292, 1974: 231-240

Active substance: IODINE

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Document reference: 30276

Study title: Iron supplementation in goitrous, iron-deficient children improves their response to oral iodized oil. ;Zimmermann-M. European Journal of Endocrinology, 2000, Vol/Iss /Pg. 142/3 (217-223)Iron supplementation in goitrous, iron-deficient children improves their response to oral iodized oil. ;Zimmermann-M. European Journal of Endocrinology, 2000, Vol/Iss /Pg. 142/3 (217-223)

Active substance: IODINE

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Document reference: 30277

Study title: J Comput Assist Tomogr. 2007 Jul-Aug;31(4):493-8. Iodixanol: risk of subsequent contrast nephropathy in cancer patients with underlying renal insufficiency undergoing diagnostic computed tomography examinations. Cheruvu B, Henning K, Mulligan J, Klippenstein D, Lawrence D, Gurtoo L, Gottlieb RH. J Comput Assist Tomogr. 2007 Jul-Aug;31(4):493-8. Iodixanol: risk of subsequent contrast nephropathy in cancer patients with underlying renal insufficiency undergoing diagnostic computed tomography examinations. Cheruvu B, Henning K, Mulligan J, Klippenstein D, Lawrence D, Gurtoo L, Gottlieb RH.

Active substance: IODINE

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Document reference: 30345

Study title: J Invasive Cardiol. 2003 Mar;15(3):133-8. Early and late reactions following the use of iopamidol 340, iomeprol 350 and iodixanol 320 in cardiac catheterization. Sutton AG, Finn P, Campbell PG, Price DJ, Hall JA, Stewart MJ, Davies A, Linker NJ, De Belder MA. J Invasive Cardiol. 2003 Mar;15(3):133-8. Early and late reactions following the use of iopamidol 340, iomeprol 350 and iodixanol 320 in cardiac catheterization. Sutton AG, Finn P, Campbell PG, Price DJ, Hall JA, Stewart MJ, Davies A, Linker NJ, De Belder MA.

Active substance: IODINE

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Document reference: 30346

Study title: Jodblockade der Schilddrüse, Schicha H.; Gustav Fischer Verlag, 1994Jodblockade der Schilddrüse, Schicha H.; Gustav Fischer Verlag, 1994

Active substance: IODINE

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Document reference: 30278

Study title: Jodmangelstruma: Medikamentöse Therapie bei Kindern, Jugendlichen, jungen Erwachsenen und Schwangeren, Hehrmann, R.; Apotheker J. 8, 29-34, 1994Jodmangelstruma: Medikamentöse Therapie bei Kindern, Jugendlichen, jungen Erwachsenen und Schwangeren, Hehrmann, R.; Apotheker J. 8, 29-34, 1994

Active substance: IODINE

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Document reference: 30279

Study title: Jodprophylaxe und Strumatherapie mit Jodid, Finke R. et al.; Z.Allg. Med. 68, 984-989, 1992Jodprophylaxe und Strumatherapie mit Jodid, Finke R. et al.; Z.Allg. Med. 68, 984-989, 1992

Active substance: IODINE

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Document reference: 30280

Study title: Lipiodol computerized tomography: How sensitive and specific is the technique in the diagnosis of hepatocellular carcinoma? ; Ngan-H. British Journal of Radiology, 1990, Vol/Iss/Pg. 63/754 (771-775)Lipiodol computerized tomography: How sensitive and specific is the technique in the diagnosis of hepatocellular carcinoma? ; Ngan-H. British Journal of Radiology, 1990, Vol/Iss/Pg. 63/754 (771-775)

Active substance: IODINE

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Document reference: 30281

Study title: Liver transplantation in the therapy of hepatocellular carcinoma: A revision of our series. ; Lucena-de-la-Poza-J-L. Transplantation Proceedings, 2002, Vol/Iss/Pg. 34/1 (260-261)Liver transplantation in the therapy of hepatocellular carcinoma: A revision of our series. ; Lucena-de-la-Poza-J-L. Transplantation Proceedings, 2002, Vol/Iss/Pg. 34/1 (260-261)

Active substance: IODINE

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Document reference: 30282

Study title: Lymphangiography, therapeutic method of a surgical wound of the thoracic canal: Report of a case (1). ; Tiemtaoure-B. Journal de Radiologie, 2007, Vol/Iss/Pg. 88/1 C1 (69-71)Lymphangiography, therapeutic method of a surgical wound of the thoracic canal: Report of a case (1). ; Tiemtaoure-B. Journal de Radiologie, 2007, Vol/Iss/Pg. 88/1 C1 (69-71)

Active substance: IODINE

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Document reference: 30284

Study title: Lymphography in primary lymphooedema of the leg in children. With reference to seven lymphographies. Manlot-G. Annales de Radiologie, 1976, Vol/Iss/Pg. 19/1 (41-55)Lymphography in primary lymphooedema of the leg in children. With reference to seven lymphographies. Manlot-G. Annales de Radiologie, 1976, Vol/Iss/Pg. 19/1 (41-55)

Active substance: IODINE

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Document reference: 30285

Study title: Clinical assessment of the latrogenicGatto 1988

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Gatto 1988 Clinical assessment of the latrogenic.pdf

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Document reference: 49166

Study title: Clinical evaluations on the biocompatibility- Valutazioni cliniche sulla biocompatibilitaGatto 1989

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Gatto 1989 Valutazioni cliniche sulla biocompatibilita.pdf

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Document reference: 49167

Study title: Clinical study of an amine fluoride gel and acidulated phosphate fluoride gelShern 1976

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Shern 1976 Clinical study of an amine fluoride.pdf

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Document reference: 49178

Study title: Collective preschool caries prevention using a fluoride-containing varnish] [Article in German]

Active substance: SODIUM FLUORIDE

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Document reference: 42543

Study title: Comments on the biocompatibility - Osservazioni sulla biocompatibilitaGallusi 1988

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Gallusi 1988 Osservazioni sulla biocompatibilita.pdf

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Document reference: 49165

Study title: Comparision of a single application of stannous fluoride with a single application of sodium fluoride or two applications of stannous fluoride1961-Mercer

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1961-Mercer-Comparision of a single application of stannous fluoride with a single application of sodium fluoride or two applications of stannous f...

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Document reference: 49141

Study title: Comparision of three self applied topical fluoride preparationsfor control of decalcification1993-boyd

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1993-boyd - comparision of three self applied topical fluoride preparationsfor control of decalcification.pdf

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Document reference: 49156

Study title: Comparison of three prevention programs -Vergleich dreier Prophylaxe ProgrammeBüttner 1987

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Büttner 1987 Vergleich dreier Prophylaxe Programme.pdf

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Document reference: 49159

Study title: Haddad FS, Dhib-Jalbut S.. 1986 Elsevier Science Publishers Inopsiplex in the treatment of SSPEHaddad FS, Dhib-Jalbut S.. 1986 Elsevier Science Publishers Inopsiplex in the treatment of SSPE

Active substance: INOSINE

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Document reference: 30117

Study title: Han CY, Lin HF, Shin PY, Liu CK, Liu CS. Kaohsiung J Med Sci. 2003 Aug;19(8):416-20. Combined interferon-alpha and inosiplex treatment of subacute sclerosing panencephalitis: a case report Han CY, Lin HF, Shin PY, Liu CK, Liu CS. Kaohsiung J Med Sci. 2003 Aug;19(8):416-20. Combined interferon-alpha and inosiplex treatment of subacute sclerosing panencephalitis: a case report

Active substance: INOSINE

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Document reference: 30118

Study title: Himawan T, Kho LKAbstracts of Scientific Papers: Asian Congress of Pediatrics; May 1-2, 1974; Manila, Philippines: Philippines Pediatric Society; 1974. Abstract 64. Experiences in the treatment of dengue hemorrhagic fever with Isoprinosine.Himawan T, Kho LKAbstracts of Scientific Papers: Asian Congress of Pediatrics; May 1-2, 1974; Manila, Philippines: Philippines Pediatric Society; 1974. Abstract 64. Experiences in the treatment of dengue hemorrhagic fever with Isoprinosine.

Active substance: INOSINE

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Document reference: 30119

Study title: Horiguchi Y, Ohya T. No To Hattatsu. 1995 May;27(3):231-7. Successful treatment of subacute sclerosing panencephalitis with long-term intrathecal large dose of alpha-interferon--a case reportHoriguchi Y, Ohya T. No To Hattatsu. 1995 May;27(3):231-7. Successful treatment of subacute sclerosing panencephalitis with long-term intrathecal large dose of alpha-interferon--a case report

Active substance: INOSINE

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Document reference: 30120

Study title: Hosoya M, Shigeta S et alAntimicrob Agents Chemother Mar 2001;45(3):943-5. High-dose intravenous ribavirin therapy for subacute sclerosing panencephalitis.Hosoya M, Shigeta S et alAntimicrob Agents Chemother Mar 2001;45(3):943-5. High-dose intravenous ribavirin therapy for subacute sclerosing panencephalitis.

Active substance: INOSINE

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Document reference: 30121

Study title: Hypertrophic osteoarthropathy in a child with follicular bronchiolitis.Boas SR, Charron M, Ledesma-Medina J, Noyes BE, Kurland G. Clin Nucl Med 1995 Jan;20(1):49- 51.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48574

Study title: I-131 MIBG imaging after bone marrow transplantation for neuroblastoma.Englaro EE, Gelfand MJ, Harris RE, Smith HS. Radiology 1992 182(2):515-20

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48721

Study title: Detection of adrenal metastasis from osteosarcoma by Tc-99m MOP scintigraphyKauffman WM. Winer-Muram H. Sandlund JT. Clin Nucl Med 1995 20(8):741

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48492

Study title: Diffuse femoral uptake on bone scan after fracture in an infantRoach J, Höschl R. Q J Nucl Med 1996 Jun;40(2):194-6

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48755

Study title: Diffuse hepatic uptake of technetium-99m methylene diphosphonate in a patient receiving high dose methotrexate.Flynn BM. Treves ST. J Nucl Med 1987 Apr;28(4):532-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48482

Study title: Discovery of a renal medullary carcinoma in an adolescent male with sickle cell trait by Tc-99m methylene disphosponate bone scintigraphy.Brown JM, Berkey BD, Brooks JA. Clin Nucl Med 2008;33:896-900.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48581

Study title: Does I- 131-MIBG underestimate skeletal disease burden in neuroblastoma?Barai S, Bandopadhayaya GP, Malhotra A, Agarwal S, Kumar R, Dhanapathi H. J Postgrad Med 2004b Oct-Dec;50(4):257-61.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48563

Study title: Increased activity on immediate phase of bone imaging does not always indicate increased blood volume.Webster DL, Hurwitz GA, DeVeber LL, Troster M, Driedger AA. Clin Nucl Med 1986 Nov;11(11):749-50

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48764

Study title: Intense muscle uptake of Ga-67 citrate and Tc-99m MDP in a patient with aplastic anemia.Batte WG Jr., Yeh SD, Rosenblum MK, Larson SM. Clin Nucl Med 1991 Jun;16(6):421-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48566

Study title: Intraoperative radionuclide detection in the treatment of paediatric osteoid osteoma.M. Lacheretz, B. Herbaux, C. Hossein-Foucher, P. Lecouffe, M. Richir.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48844

Study title: Iodine-131-metaiodobenzylguanidine and bone scintigraphy for the detection of neuroblastomaShulkin BL. Shapiro B. Hutchinson RJ. J Nucl Med 1992 Oct;33(10):1735-40

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48516

Study title: Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44191

Study title: Assessment of mandibular growth by skeletal scintigraphyKaban LB. Cisneros GJ. Heyman S. Treves S. J Oral Maxillofac Surg 1982 Jan;40(1):18-22

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48491

Study title: Bandopadhyaya G. Malhotra A. Soft tissue uptake of Tc99m-MDP in acute lymphoblastic leukemia.Marwah A. Kumar R. Dasan J B. Choudhury S. Bandopadhyaya G. Malhotra A. Cl in Imaging 2002 May-Jun;26(3):206-8

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48505

Study title: Effects of renal failure and metabolic diseases upon bone scanning in children.Schumichen C. Annales de Radiologie 1983 26(6):498-504

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48758

Study title: peritoneographie : utilisation d'un nouveau produit de contraste faiblement hyperosmolaire (AG 62-27)progres en peritoneographie grace a l'utilisationd'un nouveau produit de contraste faiblement hyperosmolaire (hexabrix); Rozenberg R., J. Radiol.; 1981 vol.62 n.2 p.123-126 J. Belge Radiol.; 1981 vol.64 p.151-155peritoneographie : utilisation d'un nouveau produit de contraste faiblement hyperosmolaire (AG 62-27)progres en peritoneographie grace a l'utilisationd'un nouveau produit de contraste faiblement hyperosmolaire (hexabrix); Rozenberg R., J. Radiol.; 1981 vol.62 n.2 p.123-126 J. Belge Radiol.; 1981 vol.64 p.151-155

Active substance: IOVERSOL

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Document reference: 30439

Study title: Reduced radiation dose helical chest CT : effect on reader evaluation of structures and lung findings;MAYO JR; Radiology; 2004 vol.232 p.749 756Reduced radiation dose helical chest CT : effect on reader evaluation of structures and lung findings;MAYO JR; Radiology; 2004 vol.232 p.749 756

Active substance: IOVERSOL

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Document reference: 30425

Study title: Lactobacillus GG in the prevention of antibiotic-associated diarrhea in children – VANDERHOOF J.A., WHITNEY D.B. and al. – 1999.Lactobacillus GG in the prevention of antibiotic-associated diarrhea in children – VANDERHOOF J.A., WHITNEY D.B. and al. – 1999.

Active substance: LACTIC ACID PRODUCING ORGANISMS AND COMBINATIONS

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Document reference: 30966

Study title: Lactobacillus reuteri as a therapeutic agent in acute diarrhea in young children – SHORNIKOVA A.V., CASAS I.A. and al. – 1997. Lactobacillus reuteri as a therapeutic agent in acute diarrhea in young children – SHORNIKOVA A.V., CASAS I.A. and al. – 1997.

Active substance: LACTIC ACID PRODUCING ORGANISMS AND COMBINATIONS

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Document reference: 30967

Study title: Lactobacillus therapy for acute infectious diarrhea in children: a meta analysis – VAN NIEL C.W., FEUDTNER C. and al. – 2005. Lactobacillus therapy for acute infectious diarrhea in children: a meta analysis – VAN NIEL C.W., FEUDTNER C. and al. – 2005.

Active substance: LACTIC ACID PRODUCING ORGANISMS AND COMBINATIONS

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Document reference: 30968

Study title: Limitations of probiotic therapy in acute, severe dehydrating diarrhea – COSTA-RIBEIRO H., RIBEIRO T.C. and al. – 2003. Limitations of probiotic therapy in acute, severe dehydrating diarrhea – COSTA-RIBEIRO H., RIBEIRO T.C. and al. – 2003.

Active substance: LACTIC ACID PRODUCING ORGANISMS AND COMBINATIONS

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Document reference: 30969

Study title: Oral bacterial therapy reduces the duration of symptoms and of viral excretion in children with mild diarrhea – GUARINO A., BERNI CANANI R. and al. – 1997.Oral bacterial therapy reduces the duration of symptoms and of viral excretion in children with mild diarrhea – GUARINO A., BERNI CANANI R. and al. – 1997.

Active substance: LACTIC ACID PRODUCING ORGANISMS AND COMBINATIONS

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Document reference: 30970

Study title: Prevention of diarrhea by the probiotic, Lactobacillus GG – DUPONT H. – 1999Prevention of diarrhea by the probiotic, Lactobacillus GG – DUPONT H. – 1999

Active substance: LACTIC ACID PRODUCING ORGANISMS AND COMBINATIONS

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Document reference: 30974

Study title: Probiotics for pediatric antibiotic-associated diarrhea: a meta analysis of randomized placebo-controlled trials – JOHNSTON B.C., SUPINA A.L. and al. – 2006.Probiotics for pediatric antibiotic-associated diarrhea: a meta analysis of randomized placebo-controlled trials – JOHNSTON B.C., SUPINA A.L. and al. – 2006.

Active substance: LACTIC ACID PRODUCING ORGANISMS AND COMBINATIONS

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Document reference: 30971

Study title: Short report: a placebo-controlled study of Lactobacillus GG colonization in one-to-three-year-old Peruvian children – SHEEN P., OBERHELMAN R.A. and al. – 1995.Short report: a placebo-controlled study of Lactobacillus GG colonization in one-to-three-year-old Peruvian children – SHEEN P., OBERHELMAN R.A. and al. – 1995.

Active substance: LACTIC ACID PRODUCING ORGANISMS AND COMBINATIONS

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Document reference: 30972

Study title: Vergleichende Doppel-Blindprüfung zwischen Neseril™, einem neuen Nasentropfenpräparat, und Ephedrin. (Comparative double-blind trial between Neseril™ (Nasivin), a new nasal-drop formulation, and ephedrine).Särtryck ur Svenska Läkartidningen 1964; 61: 3204-13, Thulin A, Walther BW., 1964

Active substance: OXYMETAZOLINE

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Document reference: 48917

Study title: Management of pediatric liver tumors. ; Bowman-L-C. Surgical Oncology Clinics of North America, 1996, Vol/Iss/Pg. 5/2 (451-459)Management of pediatric liver tumors. ; Bowman-L-C. Surgical Oncology Clinics of North America, 1996, Vol/Iss/Pg. 5/2 (451-459)

Active substance: IODINE

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Document reference: 30286

Study title: Management of Pericentral Arteriovenous Malformations; James I. Ausman. Neurol Med Chir Suppl (Tokyo) 38, 208 ~ 216, 1998Management of Pericentral Arteriovenous Malformations; James I. Ausman. Neurol Med Chir Suppl (Tokyo) 38, 208 ~ 216, 1998

Active substance: IODINE

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Document reference: 30287

Study title: Mild iodine deficiency is associated with elevated hearing thresholds in children in Benin. ; Van-den-Briel-T European Journal of Clinical Nutrition, 2001, Vol /Iss/Pg. 55/9 (763-768)Mild iodine deficiency is associated with elevated hearing thresholds in children in Benin. ; Van-den-Briel-T European Journal of Clinical Nutrition, 2001, Vol /Iss/Pg. 55/9 (763-768)

Active substance: IODINE

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Document reference: 30288

Study title: A study to test the efficacy of E45 Cream on nappy rash

Active substance: LANOLIN SOFT PARAFFIN AND FAT PRODUCTS

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Document reference: 31012

Study title: Efficacy and tolerability of lactitol solution versus lactulose syrup in patients (children) suffering from chronic functional constipation. Investigator: Dr. Med. A.C. Douwes Report date: 04.11.1996

Active substance: LANREOTIDE

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Document reference: 31014

Study title: Evaluation of the efficacy and safety of Somatuline sustained release form in adolescent with constitutive tall stature

Active substance: LANREOTIDE

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Document reference: 31013

Study title: A double blind, multi-centre, randomised, placebo-controlled study to assess the efficacy,tolerability and compliance profile of a triple therapy regimen (lansoprazole, amoxicilline and tinidazole) in comparison with the standard double therapy (amoxicilline and tinidazole), given for one week to children with Hpylori gastritis.

Active substance: LANSOPRAZOLE

Study summary document link (including results): Lansoprazole_HP-AG-97-01-EC428-Synopsis.pdf

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Document reference: 47614

Study title: A phase I, multi-centre, double-blind, randomized study consisting of a 7-day pre-treatment period and a 5-day treatment period of either lansoprazole 15mg or 30mg (capsules) in 12-17 year-olds with symptomatic, endoscopically (oesophagitis grade ³1) and/or histologically proven (borderline or abnormal from oesophageal biopsies) GERD.

Active substance: LANSOPRAZOLE

Study summary document link (including results): Lansoprazole_M97-640-Synopsis.pdf

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Document reference: 47612

Study title: A phase I, multi-centre, randomised, parallel group, open-label, single- and repeated-dose studies to evaluate the pharmacokinetic and pharmacodynamic profile of lansoprazole in neonates with clinically-evident GERD

Active substance: LANSOPRAZOLE

Study summary document link (including results): Lansoprazole_c03-042-synopsis.pdf

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Document reference: 47606

Study title: A Phase II, open-label, parallel group, 8-12 weeks study to assess the safety and efficacy of once daily administration of lansoprazole 15 mg or 30 mg in male and female adolescents aged 12 to 17 years with GERD including non-erosive GERD and erosive oesophagitis.

Active substance: LANSOPRAZOLE

Study summary document link (including results): Lansoprazole_M00-158-Synopsis.pdf

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Document reference: 47613

Study title: A phase II, single-centre, open-label pharmacokinetic and pharmacodynamic study of lansoprazole 30mg/1.73m2 in children aged 18 days to 14 years who required anti-secretory treatment

Active substance: LANSOPRAZOLE

Study summary document link (including results): Lansoprazole_FH-93-749-54 Synopsis _EC430__English.pdf

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Document reference: 47609

Study title: A phase II, two-centre, open-label study in patients aged 3 months to 13 years with endoscopically-proven reflux oesophagitis.

Active substance: LANSOPRAZOLE

Study summary document link (including results): Lansoprazole_AG-II-95-028-Synopsis.pdf

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Document reference: 47610

Study title: "Four- week intraveinous study of AG-1749 in rats - H. Miajyiama et al. - 25/07/1990 - Lanzor 30 mg-preclinical studies-"

Active substance: LANSOPRAZOLE

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Document reference: 47616

Study title: Intravenous single dose toxicology study of AG-1749 - IV Formulation in mice and rats - H. Miajyima et al. - 19/08/1991 - Lanzor 30 mg-preclinical studies-"

Active substance: LANSOPRAZOLE

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Document reference: 47615

Study title: Prevention and control of iodine deficiency: A review of a study on the effectiveness of oral iodized oil in Malawi. ;Furnee-C-A. European Journal of Clinical Nutrition, 1997, Vol /Iss/Pg. 51/SUPPL. 4 (9-10)Prevention and control of iodine deficiency: A review of a study on the effectiveness of oral iodized oil in Malawi. ;Furnee-C-A. European Journal of Clinical Nutrition, 1997, Vol /Iss/Pg. 51/SUPPL. 4 (9-10)

Active substance: IODINE

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Document reference: 30312

Study title: Prophylaxis and treatment of endemic goiter in Peru with iodized oil; E. A. Pretell. J. Clin Endocr 29: 1586-1969Prophylaxis and treatment of endemic goiter in Peru with iodized oil; E. A. Pretell. J. Clin Endocr 29: 1586-1969

Active substance: IODINE

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Document reference: 30313

Study title: Pulmonary complications after hepatic artery chemoembolization or infusion via the inferior phrenic artery for primary liver cancer. ; Tajima-T. Journal of Vascular and Interventional Radiology, 01 SEP 2002, Vol/Iss/Pg. 13/9 I (893-900)Pulmonary complications after hepatic artery chemoembolization or infusion via the inferior phrenic artery for primary liver cancer. ; Tajima-T. Journal of Vascular and Interventional Radiology, 01 SEP 2002, Vol/Iss/Pg. 13/9 I (893-900)

Active substance: IODINE

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Document reference: 30314

Study title: Pulmonary embolism: A fatal complication of arterial chemoembolization for advanced hepatocellular carcinoma. ;Czauderna-P. Journal of Pediatric Surgery, 2005, Vol/Iss/Pg. 40/10 (1647-1650)Pulmonary embolism: A fatal complication of arterial chemoembolization for advanced hepatocellular carcinoma. ;Czauderna-P. Journal of Pediatric Surgery, 2005, Vol/Iss/Pg. 40/10 (1647-1650)

Active substance: IODINE

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Document reference: 30315

Study title: Pulmonary lesions following lymphography in childhood. ;Pollak-A. Rontgen-Blatter, 1973, Vol/Iss/Pg. 26/7 (296-300). Pulmonary lesions following lymphography in childhood. ;Pollak-A. Rontgen-Blatter, 1973, Vol/Iss/Pg. 26/7 (296-300).

Active substance: IODINE

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Document reference: 30316

Study title: Pulmonary lipiodol embolism during transcatheter arterial chemoembolization for hepatoblastoma under general anaesthesia. Yamaura-K. European Journal of Anaesthesiology 2000, Vol /Iss/Pg. 17/11 (704-708)Pulmonary lipiodol embolism during transcatheter arterial chemoembolization for hepatoblastoma under general anaesthesia. Yamaura-K. European Journal of Anaesthesiology 2000, Vol /Iss/Pg. 17/11 (704-708)

Active substance: IODINE

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Document reference: 30317

Study title: A Multi-Institutional Study of Optimal Use of Recombinant Granulocyte Colony Stimulating Factor (Lenograstim) in Pediatric Malignancies-III - Kawa K. et al - 1999 (Biotherapy - 13(4):361-367)A Multi-Institutional Study of Optimal Use of Recombinant Granulocyte Colony Stimulating Factor (Lenograstim) in Pediatric Malignancies-III - Kawa K. et al - 1999 (Biotherapy - 13(4):361-367)

Active substance: LENOGRASTIM

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Document reference: 31040

Study title: A multicenter European randomized parallel-group phase III study to evaluate safety and efficacy of rHuG-CSF (lenograstim) in the first 12 weeks of the treatment of de novo severe aplastic anemia - 1998 (Blood, 92 (10) suppl 1 : abs 1551, p 376 a)

Active substance: LENOGRASTIM

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Document reference: 31028

Study title: A multicenter non-randomized open-label dose-escalating phase I-II study (pharmakokinetic and dose-ranging) of intravenous or subcutaneous administration of rG-CSF for a maximum of 21 days to reduce duration of neutropenia in children having received COPAdM1 and / or COPAdM2 chemotherapy course for advanced lymphoma

Active substance: LENOGRASTIM

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Document reference: 31029

Study title: A Phase III multicenter, double blind, randomized, parallel-group, vehicle controlled study to evaluate the safety and efficacy of 5µg/kg/day recombinant Granulocyte Colony Stimulating Factor (rHuG-CSF) in the treatment of patients who have undergone bone marrow transplantation (BMT).

Active substance: LENOGRASTIM

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Document reference: 31030

Study title: An open label, multicenter study to evaluate the pharmacokinetics of 5uG / KG / day of recombinant granulocyte colony stimulating factor (rHuG-CSF) in the treatment of pediatric patients who have undergone bone marrow transplantation (BMT) - No author - No date - Clinical study documentation GHBA 271 study - Vol. 6 -

Active substance: LENOGRASTIM

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Document reference: 31031

Study title: Antilymphocyte globulin, cyclosporine, prednisolone, and granulocyte colony-stimulating factor for severe aplastic anemia: an update of the GITMO / EBMT study on 100 patients. European Group for Blood and Marrow Transplantation (EBMT) Working party on Severe Aplastic Anemia and the Gruppo Italiano Trapianti di Midolio Osseo (GITMO). - Bacigalupo A. et al - 2000 (Blood 95: 1931 - 1931) - Publication - Ref17 of Clinical Expert Report -

Active substance: LENOGRASTIM

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Document reference: 31032

Study title: European Pjhase II study of open label administration of subcutaneous rHuG-CSF treatment in congenital agranulocytosis in children.

Active substance: LENOGRASTIM

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Document reference: 31033

Study title: Granulocyte colony-stimulating factor in induction treatment of children with non-Hodgkin's lymphoma: a randomized study of the French Society of Pediatric Oncology - Patte C. et al - 2002 (J Clin Oncol. Jan 15;20(2):441-8)Granulocyte colony-stimulating factor in induction treatment of children with non-Hodgkin's lymphoma: a randomized study of the French Society of Pediatric Oncology - Patte C. et al - 2002 (J Clin Oncol. Jan 15;20(2):441-8)

Active substance: LENOGRASTIM

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Document reference: 31039

Study title: Efficiency of the bone scan for occult limping toddlers.Aronson J, Garvin K, Seibert J, Glasier C, Tursky EA. J Pediatr Orthop 1992 Jan;12(1):38-44

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48530

Study title: Isotope bone scans in the assessment of children with hip pain or limp.Bower GD, Sprague P, Geijsel H, Holt K, Lovegrove FT. Pediatr Radiol 1985;15(5):319-23.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48576

Study title: Esthesioneuroblastoma imaged with bone scintigraphy.Acker R, Leonard JC. Clin Nucl Med 1986 Sep;11(9):670-1.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48522

Study title: 99Tcm-MAA lung scintigraphy in patients with Behçet's disease: its value and correlation with clinical course and other diagnostic modalities. Nucl Med Commun. 2000 Feb;21(2):171-9. Caglar M 2000

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48804

Study title: Abnormal brain perfusion demonstrated by Tc-99m MAA total-body scan in two children with complex congenital heart disease. Ann Nucl Med. 1998 Oct;12(5):297-302. Suga K 1998

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48810

Study title: Acute paraquat intoxication: using nuclear pulmonary studies to predict patient outcome. Chest. 1999 Sep;116(3):709-14. Kao CH 1999

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48806

Study title: Arteriovenous shunt measurement during endovascular therapy for cerebrospinal lesions. AJNR Am J Neuroradiol. 1997 Oct;18(9):1679-89. Mariani L 1997

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48813

Study title: Aspiration of nasal secretions into the lungs in patients with acute sinonasal infections. Laryngoscope. 2000 Jan;110(1):107-10. Ozagar A 2000

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48805

Study title: Evaluation of growth in children using quantitative bone scintigraphy.Celen Z, Zincirkeser S, Ozkiliç S, Nacar F. J Int Med Res 1999;27(6):286-91.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48590

Study title: Extraosseous accumulation of (99m)Tc-HMDP to radiation nephropathy, mimicking recurrent neuroblastoma.Abe K, Sasaki M, Kuwabara Y, Koga H, Baba S, Kaneko K, et al. Ann Nucl Med 2005 Feb;19(1):35-40.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48521

Study title: Bilateral pulmonary artery aneurysms in a patient with Behcet syndrome: evaluation with radionuclide angiography and V/Q lung scanning. Clin Nucl Med. 1998 Nov;23(11):735-8. Basoglu T 1998

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48811

Study title: Clinical studies of alveolar-capillary permeability using technetium-99m DTPA aerosol. Ann Nucl Med. 1995 Nov;9(4):171-8. Sundram FX 1995

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48816

Study title: Correlation of diagnostic imaging and subsequent autopsy findings in patients with pulmonary embolism. Patriquin L, Khorasani R, Polak JF. AJR Am J Roentgenol. 1998 Aug;171(2):347-9 Comment in: AJR Am J Roentgenol. 1998 Aug;171(2):293. AJR Am J Roentgenol. 1999 Jun;172(6):1691-3.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48244

Study title: Bhogate BM, Samuel AM, Ramanathan P. Bone scans in neuroblastoma. Indian J Cancer. 1993 Mar;30(1):5-9. Bhogate BM, Samuel AM, Ramanathan P. Bone scans in neuroblastoma. Indian J Cancer. 1993 Mar;30(1):5-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43671

Study title: Wirksames und sicheres Rhinologi­kum für Säuglinge. (Effective and safe rhinological agent for infants).Pädiatrische Nachrichten 2000; 3: 14-15, Teichmann B, Tschaikin M., 2000

Active substance: OXYMETAZOLINE

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48927

Study title: Klinische Erfahrungen mit Nasivin. (Clinical experience with Nasivin)..,The Practitioner 1975; 214: 685-8, Aikman PM, Bremner AD, de Burca B, et al., 1975

Active substance: OXYMETAZOLINE

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48914

Study title: Evaluate in children the taste of two different phenoxymethylpenicillins, one containing aspartame.Norstedt

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_13.xlsx

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Document reference: 49044

Study title: Investigate how absorption is influenced by volume, composition and food intake.Forsman et al

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_1.xlsx

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Document reference: 49031

Study title: Investigate how absorption is influenced by volume, composition and food intake.Forsman et al

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_1.xlsx

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Document reference: 49032

Study title: investigate serum concentrations achieved with potassium salt of penicillin V i n2 different galenic forms.Perlhagen et al

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_2.xlsx

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Document reference: 49033

Study title: Investigate the minimum age limit in children accepting penicillin administered as tablets instead of mixture.Edvardsson et al

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_14.xlsx

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Document reference: 49045

Study title: Investigate the possibility to administer penicillin V in a twice daily dosage regimen.Edlund et al

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_6.xlsx

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Document reference: 49037

Study title: "Infantile anorexia treated with degreased whole bone substance", Vidal Perez Fernandez, Medicina, 1969, 49 : 169-171"Infantile anorexia treated with degreased whole bone substance", Vidal Perez Fernandez, Medicina, 1969, 49 : 169-171

Active substance: OSSEIN HYDROXYAPATITE COMPOUND

Study summary document link (including results): Ossopan nr1.xls

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Document reference: 47590

Study title: Open-label, single-arm, multicenter study to evaluate the efficacy and tolerability of Creon for children in infants with pancreatic exocrine insufficiency caused by cystic fibrosis

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-S248-3003.pdf

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Document reference: 47673

Study title: Efficacy of acrivastine with pseudoephedrine in treatment of allergic rhinitis due to ragweed. Ann Allergy Asthma Immunol 1996; 76(2):204-8 Efficacy of acrivastine with pseudoephedrine in treatment of allergic rhinitis due to ragweed. Ann Allergy Asthma Immunol 1996; 76(2):204-8

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33636

Study title: Valuatazioni su pazienti pediatrici recoverati per diarrea acuta dal 1990 al 1996 (valuations about paeditric admissions inhospital for acute diarrhea from 1990 to 1996) - Casini T. and al. - 1997 (Ped. Med. Chir., 1997, 19: 31-5)Valuatazioni su pazienti pediatrici recoverati per diarrea acuta dal 1990 al 1996 (valuations about paeditric admissions inhospital for acute diarrhea from 1990 to 1996) - Casini T. and al. - 1997 (Ped. Med. Chir., 1997, 19: 31-5)

Active substance: NIFUROXAZIDE

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Document reference: 47064

Study title: Phase I, multi-centre, randomised, parallel group, open-label, single- and repeated-dose studies to evaluate the pharmacokinetic and pharmacodynamic profile of lansoprazole in infants with clinically-evident GERD

Active substance: LANSOPRAZOLE

Study summary document link (including results): Lansoprazole_c03-043-synopsis.pdf

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Document reference: 47608

Study title: Assessment of the efficacy and safety of Somatuline sustained release form in adolescent with constitutive tall stature

Active substance: LARATADINE

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Document reference: 31020

Study title: Lee JK, Liu RS, Shiang HR, Pan DH.. Usefulness of semiquantitative FDG-PET in the prediction of brain tumor treatment response to gamma knife radiosurgery. [lee-2003]J Comput Assist Tomogr. 2003 Jul-Aug;27(4):525-9. Lee JK 2003

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48674

Study title: Levivier M, Goldman S, Pirotte B, Brucher JM, Balériaux D, Luxen A, et al.. Diagnostic yield of stereotactic brain biopsy guided by positron emission tomography with [18F]fluorodeoxyglucose. [levivier-1995]J Neurosurg. 1995 Mar;82(3):445-52. Levivier M 1995

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48675

Study title: McCarville MB.. Review. PET-CT imaging in pediatric oncology. [mccarville-2009]Cancer Imaging. 2009 Jun 29;9:35-43. McCarville MB 2009

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48676

Study title: Metz-Lutz MN, Filippini M.. Neuropsychological findings in Rolandic epilepsy and Landau-Kleffner syndrome. [metz-lutz-2006]Epilepsia. 2006;47 Suppl 2:71-5. Metz-Lutz MN 2006

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48677

Study title: Modafinil-induced hippocampal activation in narcolepsyNeuroscience Letters 422 (2007) 91–96. Yu Kyeong Kima, In-Young Yoon b,∗, Yoon-Kyung Shin b, Sang Soo Choa, Sang Eun Kima.

Active substance: Steripet

Study summary document link (including results): kim-2007.pdf

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Document reference: 48735

Study title: Mody RJ, Bui C, Hutchinson RJ, Yanik GA, Castle VP, Frey KA, Shulkin BL.. FDG PET imaging of childhood sarcomas. [mody-2010]Pediatr Blood Cancer. 2010 Feb;54(2):222-7. Mody RJ 2010

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48678

Study title: Moll AC, Hoekstra OS, Imhof SM, Comans EF, Schouten-van Meeteren AY, van der Valk P, et al. Ophthalmic Genet. 2004 Mar;25(1):31-5. Fluorine-18 fluorodeoxyglucose positron emission tomography (PET) to detect vital retinoblastoma in the eye: preliminary experience. [moll-2004]Moll AC 2004

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48679

Study title: Muzik O, Pourabdollah S, Juhasz C, Chugani DC, Janisse J, Draghici S.. Application of an objective method for localizing bilateral cortical FDG PET abnormalities to guide the resection ofepileptic foci. [muzik-2005]IEEE Trans Biomed Eng. 2005 Sep;52(9):1574-81. Muzik O 2005

Active substance: Steripet

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Document reference: 48680

Study title: Myocardial Viability Assessed by Positron Emission Tomography in Infants and Children After the Arterial Switch Operation and Suspected Infarction(J Am Coll Cardiol 2000;36:1676–83). Carsten Rickers, MD,* Karin Sasse, MD,* Ralph Buchert, PHD,† Heiko Stern, MD,* Jo¨rg van den Hoff, PHD,‡ Martin Lu¨beck, MD,† Jochen Weil, MD*

Active substance: Steripet

Study summary document link (including results): rickers-2000.pdf

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Document reference: 48743

Study title: Natsume J, Kumakura Y, Bernasconi N, Soucy JP, Nakai A, Rosa P, et al.. Alpha-[11C] methyl-L-tryptophan and glucose metabolism in patients with temporal lobe epilepsy. [natsume-2003]Neurology. 2003 Mar 11;60(5):756-61. Natsume J 2003

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48681

Study title: Control of decalcification in orthodontic patients by daily self administered application of a water free 0.4 percent stannous fluoride gel1974-stratemann

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1974-stratemann - control of decalcification in orthodontic patients by daily self administered application of a water free 0.4 percent stannous fl...

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Document reference: 49152

Study title: Controlled trial of fluoride in vitamin drops for prevention of caries in childrenLars-Eric Granath, Holger Rootzen, Elso Liljegren, Kerstin Hoist, Lennart Kohler 1978. Caries Res 12: 83-92lENNART hAMBERG 1971, THE LANCET, February 27

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1971-hamberg-Controlled trial of Fluoride in Vitamins Drops for Prevention od Caries in Children.pdf

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Document reference: 48782

Study title: Djelovanje aminofluorida - elmex gelee na: Effect of amine fluorideRajic 1977

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Rajic 1977 Djelovanje aminofluorida - elmex gelee na.pdf

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Document reference: 49174

Study title: Decrease in DMF tooth numbersSigrist 1975

Active substance: SODIUM FLUORIDE

Study summary document link (including results): Sigrist 1975 Decrease in DMF tooth numbers.pdf

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Document reference: 49179

Study title: The anticariogenic effectiveness od a single application of stannous fluoride in children residing in an optimum fluoride area1960-Muhler

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1960-Muhler-The anticariogenic effectiveness od a single application of stannous fluoride in children residing in an optimum fluoride area.pdf

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Document reference: 49140

Study title: the anticariogenic effects of one and two X application of stannous fluoride on the deciduous and permanent teeth of children1962-Salter

Active substance: SODIUM FLUORIDE

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Document reference: 49144

Study title: The caries inhibitory effect of a fluoride gel (PreviDent) ina self-brushing home based programm for shoolchildren1994-DePaola

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1994-DePaola-the caries inhibitory effect of a fluoride gel (PreviDent) ina self-brushing home based programm for shoolchildren.pdf

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Document reference: 49095

Study title: The caries preventing effect of mouthrinsing with 0.025 percent sodium fluoride solution in Swedish children. Forsman B. Community Dent Oral Epidemiol. 1974;2(2):58-65.

Active substance: SODIUM FLUORIDE

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Document reference: 48944

Study title: The caries preventive effect of a fluoride varnish in the fissures of the first permanent molar1984-holm

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1984-holm-The caries preventive effect of a fluoride varnish in the fissures of the first permanent molar.pdf

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Document reference: 49110

Study title: The caries prophylactic effect of Fluorlack after years of use in paediatric/adolescent dental care: Karies prophylaktische Wirkung von Fluorlack nach mehrjahriger Anwendung in der Jugendzahnpflege1978-leiser

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1978-leiser-Karies prophylaktische Wirkung von Fluorlack nach mehrjahriger Anwendung in der Jugendzahnpflege.pdf

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Document reference: 49104

Study title: The caries-preventive effect of a fluoride varnish in the fissures of the first permanent molar.

Active substance: SODIUM FLUORIDE

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Document reference: 42369

Study title: The clinical anticariogenic effectiveness of supplementary fluoride vitamin preparations - result at the end of four yearsDavid K. Hennon, Georg K Stookey, Joseph C Muhler 1967. Journal of dentistry for children.

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1967-hennon-Ciinical Anticariogenic Effectivenoss of Supplementary Fluoride-Vitamin Preparations-Results at the end of four years.pdf

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Document reference: 48785

Study title: The combined antocariogenic effeccts of a single stannous fluoride treatement and the unsupervised use of stannous fluoride dentifrice1959-Muhler, J DENT RES 1959 38: 994

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1959-Muhler-The combined antocariogenic effeccts of a single stannous fluoride treatement and the unsupervised use of stannous fluoride dentifrice.pdf

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Document reference: 49139

Study title: Correlation of pulmonary 99mTc-DTPA ventilation and 99mTc-MAA perfusion scans with pulmonary function tests in asymptomatic asthmatic children. Nucl Med Commun. 2003 Jul;24(7):819-24. Dai ZK 2003

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48796

Study title: Diagnosis of thrombosis of the deep veins of the lower extremities and pelvis and pulmonary thromboembolism using 99Tcm human serum albumin macroaggregates. Nucl Med Commun. 1989 Mar;10(3):141-7. Stevan M 1989

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48826

Study title: Diffusing capacity is not measurably affected by routine lung perfusion scanning.Morris T A 1988, J Nucl Med. 1988 Jul;29(7):1268-71.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): Morris 1988.pdf

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Document reference: 48789

Study title: Bone imaging for lower extremity pain in athletes.Brill DR. Clin Nucl Med 1983 Mar;8(3):101-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48579

Study title: The Therapeutic Efficacy of Human Insulin (recombinant DNA) in Patients with Insulin-dependent Diabetes Mellitus: A Comparative Study with Purified Porcine Insulin

Active substance: INSULIN (HUMAN)

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Document reference: 30182

Study title: Use of Biosynthetic Human Insulin (BHI), Mixed Beef-Pork (MBP) or Purified Pork (PPI), NPH or Lente Alone, or in Combination with Neutral Regular Insulin in Type I and Type II Diabetic Patients

Active substance: INSULIN (HUMAN)

Study summary document link (including results): Human insulin - B5K-MC-IBAL redacted CSR.PDF

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Document reference: 30185

Study title: A 24-week, randomised, multi-centre, open-labelled, parallel-group trial to investigate the safety of NN304 (insulin detemir) and Neutral protamine hagedorn (NPH) human insulin in children with type 1 diabetes on a basal-bolus regimen

Active substance: insulin detemir

Study summary document link (including results): NN304-1604 ICTR Synopsis.pdf

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Document reference: 47337

Study title: A 32 Week, Open-labelled, Randomised, Cross-over Trial comparing Efficacy and Safety of Insulin Detemir and Insulin Semilente, both administered at bedtime, in Children, Adolescents and Young Adults with Type 1 Diabetes on Basal-Bolus Regimen, LPLV November 2005

Active substance: insulin detemir

Study summary document link (including results): NN304-1630-synopsis.pdf

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Document reference: 41576

Study title: [Bone isotope hypofixation in algodystrophy in children]Le Loet X, Lefort J, Daragon A, Derumeaux B, Deshayes P. Rev Rhum Mal Osteoartic. 1987 Jan;54(1):53. French. No abstract available

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43881

Study title: Bone isotope hypofixation in algodystrophy in childrenLe Loet X. Lefort J. Daragon A. Derumeaux B. Deshayes P. Rev Rhum Mal Osteoartic 1987 Jan;54(1):53

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48497

Study title: Fone-scan-like pattern with 99TcM(V)-DMSA scintigraphy in patients with osteomalacia and primary hyperparathyroidism.Akbunar AT, Orhan B, Alper E. Nucl Med Commun 2000;21:181-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48525

Study title: "Oxybutynin Chlorhydrate for the Treatment of Urinary Incontinence and Hyperactive Bladder in Children. - Aubert D et al. - Ann Pediatr (Paris). 1986 (33 (7): 629-634) - Publication in UK registration file -" "Oxybutynin Chlorhydrate for the Treatment of Urinary Incontinence and Hyperactive Bladder in Children. - Aubert D et al. - Ann Pediatr (Paris). 1986 (33 (7): 629-634) - Publication in UK registration file -"

Active substance: OXYBUTYNIN

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Document reference: 32987

Study title: The comparative antipyretic efffect of N-acetyl-P-aminophenol and acetylsalicylic acid" - Margaret T. Colgan and A.A. Mitz, Houston, Texas, USA - The Journal of PediatricsThe comparative antipyretic efffect of N-acetyl-P-aminophenol and acetylsalicylic acid" - Margaret T. Colgan and A.A. Mitz, Houston, Texas, USA - The Journal of Pediatrics

Active substance: PARACETAMOL

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Document reference: 45755

Study title: Use of the antiseptic Octenisept in children at the Fachklinik Hornheide.1996.

Active substance: OCTENIDINE

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Document reference: 32736

Study title: Treatment of Wilms tumor relapsing after initial treatment with vincristine and actinomycin D: a report from the National Wilms Tumor Study Group.

Active substance: DACTINOMYCIN

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Document reference: 25501

Study title: EA O'Neil, WJ Chwals, MD O'Shea, CS Turner. Dexamethasone Treatment During Ventilator Dependency: Possible Life Threatening Gastrointestinal Complications. Archives of Disease in Childhood 1992 67:10-11 USA

Active substance: DEXAMETHASONE

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Document reference: 25690

Study title: An open study to Investigating the safety and efficiacy of Dextran-Ringer after blood loss during surgery.Zetterström et al. (1986-03-09)

Active substance: Dextran

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Document reference: 48940

Study title: Clinical evaluation of priming solutions for pump oxygenator perfusion. Ann Thorac Surg. 1975 May;19(5):529-36. Lee WH Jr, Rubin JW, Huggins MP.

Active substance: Dextran

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Document reference: 48899

Study title: Dextran therapy for pregnancy-associated deep thrombophlebitis.Wallach RC. Am J Obstet Gynecol. 1972 Mar;112(5):613-8.

Active substance: Dextran

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Document reference: 48939

Study title: Effect of dextran on blood volume and interactions with volume regulatory systems.Haldemann G, Schaer H, Spring C, Frey P, Gebauer U, Hossli G. Intensive Care Med. 1979 Mar;5(1):11-4.

Active substance: Dextran

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Document reference: 48937

Study title: Diffuse lymphatic dysplasia with hepatic oil embolism. Tatezawa-T. American Journal of Roentgenology, 1978, Vol/Iss/Pg. 131/5 (898-900)Diffuse lymphatic dysplasia with hepatic oil embolism. Tatezawa-T. American Journal of Roentgenology, 1978, Vol/Iss/Pg. 131/5 (898-900)

Active substance: IODINE

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Document reference: 30230

Study title: Effect of 10 yr of the iodine supplementation on the hearing threshold of iodine deficient schoolchildren. ; Azizi-F. Journal of Endocrinological Investigation, 2005, Vol/Iss/Pg. 28/7 (595-598)Effect of 10 yr of the iodine supplementation on the hearing threshold of iodine deficient schoolchildren. ; Azizi-F. Journal of Endocrinological Investigation, 2005, Vol/Iss/Pg. 28/7 (595-598)

Active substance: IODINE

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Document reference: 30231

Study title: Effect of intestinal parasite treatment on the efficacy of oral iodized oil for correcting iodine deficiency in schoolchildren. ; Furnee-C-A. American Journal of Clinical Nutrition, 1997, Vol/Iss /Pg. 66/6 (1422-1427)Effect of intestinal parasite treatment on the efficacy of oral iodized oil for correcting iodine deficiency in schoolchildren. ; Furnee-C-A. American Journal of Clinical Nutrition, 1997, Vol/Iss /Pg. 66/6 (1422-1427)

Active substance: IODINE

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Document reference: 30232

Study title: Effect of iodized oil treatment on the development of thyroid autoimmunity in adolescent females. ; Hashim-F-A Annals of Saudi Medicine, 2000, Vol/Iss/Pg. 20/5-6 (445-446)Effect of iodized oil treatment on the development of thyroid autoimmunity in adolescent females. ; Hashim-F-A Annals of Saudi Medicine, 2000, Vol/Iss/Pg. 20/5-6 (445-446)

Active substance: IODINE

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Document reference: 30233

Study title: Naumann R, Beuthien-Baumann B, Reiß A, Schulze J, Hänel A, Bredow J, et al.. Substantial impact of FDG PET imaging on the therapy decision in patients with early-stage Hodgkin's lymphoma. [naumann-2004]BrJ Cancer. 2004 Feb 9;90(3):620-5. Naumann R 2004

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48682

Study title: Newberg A, Hassan A,. Cerebral metabolic changes associated with Lyme disease. [newberg-2002]Alavi A. Nucl Med Commun. 2002 Aug;23(8):773-7. Newberg A 2002

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48683

Study title: Ng SH, Chang JT, Chan SC, Ko SF, Wang HM, Liao CT, et al.. Epub 2004 Mar 9. Nodal metastases of nasopharyngeal carcinoma: patterns of disease on MRI and FDG PET. [ng-2004-a]Eur J Nucl Med Mol Imaging. 2004 Aug;31(8):1073-80. Ng SH 2004

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48684

Study title: Novak L, Emri M, Molnar P, Balkay L, Lengyel Z. Subcortical [18F]fluorodeoxyglucose uptake in lesional epilepsy in patients with intracranial tumour. [novak-2004]Tron L. Nucl Med Commun. 2004 Feb;25(2):123-8. Novak L 2004

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48685

Study title: Nuclear Medicine in Pediatric Neurology and Neurosurgery: Epilepsy and Brain Tumors.Semin Nucl Med 37:357-381. Shekhar Patil, MD,* Lorenzo Biassoni, MD,† and Lise Borgwardt, MD, PhD

Active substance: Steripet

Study summary document link (including results): patil-2007.pdf

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Document reference: 48741

Study title: O'Connell MT, Seal A, Nortje J, Al-Rawi PG, Coles JP, Fryer TD, et al.. Glucose metabolism in traumatic brain injury: a combined microdialysis and [18F]-2-fluoro-2-deoxy-D-glucose-positron emission tomography (FDG-PET) study. [oconnell-2005]Acta Neurochir Suppl. 2005;95:165-8. O'Connell MT 2005

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48686

Study title: Otsuka H, Graham MM, Kubo A, Nishitani H.. The effect of oral contrast on large bowel activity in FDG-PET/CT. [otsuka-2005]Ann Nucl Med. 2005 Apr;19(2):101- 8. Otsuka H 2005

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48687

Study title: Papathanassiou D, Becker S, Amir R, Menéroux B, Liehn JC.. Epub 2005 Aug 31. Respiratory motion artefact n the liver dome on FDG PET/CT: comparison of attenuation correction with CT and a caesium external source. [papathanassiou-2005]Eur J Nucl Med Mol Imaging. 2005 Dec;32(12):1422-8. Papathanassiou D 2005

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48688

Study title: PET and PET/CT in Pediatric Oncology.Semin Nucl Med 37:316-331. Hossein Jadvar, MD, PhD, MPH, MBA,* Leonard P. Connolly, MD,† Frederic H. Fahey, DSc,† and Barry L. Shulkin, MD, MBA‡

Active substance: Steripet

Study summary document link (including results): jadvar-2007.pdf

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Document reference: 48732

Study title: PET in pediatric diseasesRadiol Clin N Am 43 (2005) 135 – 152 .Hossein Jadvar, MD, PhDa,b,*, Abass Alavi, MDc, Ayse Mavi, MDd, Barry L. Shulkin, MD, MBAe

Active substance: Steripet

Study summary document link (including results): jadvar-2005.pdf

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Document reference: 48731

Study title: Picardi M, De Renzo A, Pane F, Nicolai E, Pacelli R, Salvatore M, et al.. Randomized comparison of consolidation radiation versus observation in bulky Hodgkin's lymphoma with post-chemotherapy negative positron emission tomography scans. [picardi-2007]Leuk Lymphoma. 2007 Sep;48(9):1721-7. Picardi M 2007

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48689

Study title: Chicaud P, Demange J, Drouin P, Debry G. Action du fénofibrate chez des enfants hypercholestérolémiques. Recul de 18 mois. La Presse médicale 1984; 13:417-419Chicaud P, Demange J, Drouin P, Debry G. Action du fénofibrate chez des enfants hypercholestérolémiques. Recul de 18 mois. La Presse médicale 1984; 13:417-419

Active substance: FENOFIBRATE

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Document reference: 27028

Study title: Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44113

Study title: Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44190

Study title: Smith MA, Jones EA, Strachan RK, Nicoll JJ, Best JJ, Tothill P, Hughes SP. Prediction of fracture healing in the tibia by quantitative radionuclide imaging. J Bone Joint Surg Br. 1987 May;69(3):441-7. Smith MA, Jones EA, Strachan RK, Nicoll JJ, Best JJ, Tothill P, Hughes SP. Prediction of fracture healing in the tibia by quantitative radionuclide imaging. J Bone Joint Surg Br. 1987 May;69(3):441-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43863

Study title: So Y, Chung JK, Seong SC, Sohn YJ, Kang HS, Lee DS, Lee MC. Usefulness of 99Tcm-MDP knee SPET for pre-arthroscopic evaluation of patients with internal derangements of the knee. Nucl Med Commun. 2000 Jan;21(1):103-9. So Y, Chung JK, Seong SC, Sohn YJ, Kang HS, Lee DS, Lee MC. Usefulness of 99Tcm-MDP knee SPET for pre-arthroscopic evaluation of patients with internal derangements of the knee. Nucl Med Commun. 2000 Jan;21(1):103-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43490

Study title: Tc-99m MDP bone and Ga-67 citrate scintigraphy of Erdheim-Chester disease in a child. Sohn MH, Kim MW, Kang YH, Jeong HJ. Clin Nucl Med. 2006 Feb;31(2):90-2. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43379

Study title: Solav S. Bone scintiscanning in osteolytic lesions. Clin Nucl Med. 2004 Jan;29(1):12-20. Solav S. Bone scintiscanning in osteolytic lesions. Clin Nucl Med. 2004 Jan;29(1):12-20.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43407

Study title: Sommer HJ, Knop J, Heise U, Winkler K, Delling G. Histomorphometric changes of osteosarcoma after chemotherapy. Correlation with 99mTc methylene diphosphonate functional imaging. Cancer. 1987 Jan 15;59(2):252-8. Sommer HJ, Knop J, Heise U, Winkler K, Delling G. Histomorphometric changes of osteosarcoma after chemotherapy. Correlation with 99mTc methylene diphosphonate functional imaging. Cancer. 1987 Jan 15;59(2):252-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43876

Study title: Spencer JD, Maisey M. A prospective scintigraphic study of avascular necrosis of bone in renal transplant patients. Clin Orthop Relat Res. 1985 Apr;(194):125-35. Spencer JD, Maisey M. A prospective scintigraphic study of avascular necrosis of bone in renal transplant patients. Clin Orthop Relat Res. 1985 Apr;(194):125-35.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43948

Study title: Magill HL, Strang MS. Paraspinal metastasis of Wilm's tumor visualized on bone imaging. J Nucl Med. 1981 May;22(5):481-2. No abstract available. Magill HL, Strang MS. Paraspinal metastasis of Wilm's tumor visualized on bone imaging. J Nucl Med. 1981 May;22(5):481-2. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44126

Study title: Ultrasonic signs of pelvic osteomyelitis in children. Mah ET, LeQuesne GW, Gent RJ, Paterson DC. Pediatr Radiol. 1994;24(7):484-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43639

Study title: Mahan S, Jolles PR. MAI osteomyelitis. 18-year scintigraphic follow-up. Clin Nucl Med. 1995 Jul;20(7):594-8. Mahan S, Jolles PR. MAI osteomyelitis. 18-year scintigraphic follow-up. Clin Nucl Med. 1995 Jul;20(7):594-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43597

Study title: Maigne JY, Boulahdour H, Chatellier G. Value of quantitative radionuclide bone scanning in the diagnosis of sacroiliac joint syndrome in 32 patients with low back pain. Eur Spine J. 1998;7(4):328-31. Maigne JY, Boulahdour H, Chatellier G. Value of quantitative radionuclide bone scanning in the diagnosis of sacroiliac joint syndrome in 32 patients with low back pain. Eur Spine J. 1998;7(4):328-31.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43524

Study title: Malik MH. Simultaneous dual isotope studies in the diagnosis of infection. J Nucl Med. 1985 Jul;26(7):722-5. Malik MH. Simultaneous dual isotope studies in the diagnosis of infection. J Nucl Med. 1985 Jul;26(7):722-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43938

Study title: Malizos KN, Soucacos PN, Vragalas V, Dailiana ZH, Schina I, Fotopoulos A. Three phase bone scanning and digital arteriograms for monitoring vascularized fibular grafts in femoral head necrosis. Int Angiol. 1995 Sep;14(3):319-26. Malizos KN, Soucacos PN, Vragalas V, Dailiana ZH, Schina I, Fotopoulos A. Three phase bone scanning and digital arteriograms for monitoring vascularized fibular grafts in femoral head necrosis. Int Angiol. 1995 Sep;14(3):319-26.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43586

Study title: [Osteochondrosis deformans coxae juvenilis (Legg-Calvé-Perthes disease) in the MR tomogram: diagnosis and follow-up assessment correlated with x-rays and skeletal scintigraphy] Ranner G. Rofo. 1990 Aug;153(2):124-30. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43757

Study title: Scintigraphic differentiation of bone infarction from osteomyelitis in children with sickle cell disease. Rao S, Solomon N, Miller S, Dunn E. J Pediatr. 1985 Nov;107(5):685-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43929

Study title: Raymond J, Dumas JM, Lisbona R. Nuclear imaging as a screening test for patients referred for intraarticular facet block. J Can Assoc Radiol. 1984 Sep;35(3):291-2. Raymond J, Dumas JM, Lisbona R. Nuclear imaging as a screening test for patients referred for intraarticular facet block. J Can Assoc Radiol. 1984 Sep;35(3):291-2.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43984

Study title: Reddy MS, Palcanis KG, Barnett ML, Haigh S, Charles CH, Jeffcoat MK. Efficacy of meclofenamate sodium (Meclomen) in the treatment of rapidly progressive periodontitis. J Clin Periodontol. 1993 Oct;20(9):635-40. Reddy MS, Palcanis KG, Barnett ML, Haigh S, Charles CH, Jeffcoat MK. Efficacy of meclofenamate sodium (Meclomen) in the treatment of rapidly progressive periodontitis. J Clin Periodontol. 1993 Oct;20(9):635-40.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43649

Study title: [Metastatic calcifications detected by Tc-99m MDP bone scanning in patients with hypercalcemia: case report] Japanese. Sugita R, Nakamura M, Sakamoto K, Watabe N. Rinsho Hoshasen. 1990 Mar;35(3):419-22. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43766

Study title: Sun SS, Tsai SC, Su CC, Kao CH. Diffuse liver and spleen accumulation on Tc-99m methylene diphosphonate bone scan. Semin Nucl Med. 2001 Jul;31(3):253-4. No abstract available. Sun SS, Tsai SC, Su CC, Kao CH. Diffuse liver and spleen accumulation on Tc-99m methylene diphosphonate bone scan. Semin Nucl Med. 2001 Jul;31(3):253-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43451

Study title: Sundram FX, Chua ET, Goh AS, Toh HJ, Khor TH, Chua EJ. Bone scintigraphy in nasopharyngeal carcinoma. Clin Radiol. 1990 Sep;42(3):166-9. Sundram FX, Chua ET, Goh AS, Toh HJ, Khor TH, Chua EJ. Bone scintigraphy in nasopharyngeal carcinoma. Clin Radiol. 1990 Sep;42(3):166-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43755

Study title: Sternal uptake on bone scintigraphy: age-related variants. Syed GM, Fielding HW, Collier BD. Nucl Med Commun. 2005 Mar;26(3):253-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43390

Study title: Sziklas JJ, Vento JA, Spencer RP, Rosenberg RJ. Radiogallium accumulation in heterotopic bone. Clin Nucl Med. 1985 May;10(5):376. No abstract available. Sziklas JJ, Vento JA, Spencer RP, Rosenberg RJ. Radiogallium accumulation in heterotopic bone. Clin Nucl Med. 1985 May;10(5):376. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43945

Study title: Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44228

Study title: Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44275

Study title: Kroiss A, Böck F, Perneczky G, Auinger C, Weidlich G, Kleinpeter G, Brenner H. [Immunoscintigraphy for the detection of inflammation foci in bone and joint diseases] Wien Klin Wochenschr. 1990 Dec 21;102(24):713-7. German. Kroiss A, Böck F, Perneczky G, Auinger C, Weidlich G, Kleinpeter G, Brenner H. [Immunoscintigraphy for the detection of inflammation foci in bone and joint diseases] Wien Klin Wochenschr. 1990 Dec 21;102(24):713-7. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43751

Study title: Prolonged low-back pain in young athletes: a prospective case series study of findings and prognosis. Kujala UM, Kinnunen J, Helenius P, Orava S, Taavitsainen M, Karaharju E. Eur Spine J. 1999;8(6):480-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43496

Study title: A randomized, double-blind, double dummy, parallel group comparison of fluticasone propionate inhalation powder (50mcg BID) via DiskusTM with oral montelukast (5mg QD) chewable tablets in children 6–12 years of age with persistent asthma

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FPD40013-ICHE3.pdf

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Document reference: 28428

Study title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Trial Assessing the Efficacy and Safety of Fluticasone Propionate 50 or 100mcg BID via the Multi-Dose Powder Inhaler, Fluticasone Propionate 50 or 100mcg BID via the Diskhaler and Placebo in Subjects Aged 4 to 11 Years with Chronic Asthma

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FLTA2006-ICHE3.pdf

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Document reference: 28423

Study title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, 12-Week Trial of Inhaled Fluticasone Propionate 88mcg BID versus Placebo in Propellant GR106642X in Pediatric Subjects 4 to 11 Years of Age With Asthma

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FAP30010-ICHE3.pdf

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Document reference: 28391

Study title: A randomized, double-blind, placebo-controlled study examining the effect of fluticasone propionate aqueous nasal spray in antibiotic therapy in the treatment of chronic rhinosinusitis in paediatric patients.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FNS30003-ICHE3.pdf

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Document reference: 28368

Study title: A Randomized, Open-Label, 2-Way Crossover, Repeat-Dose Study in Pediatric Subjects with Asthma, Age 4-11 Years, to Compare Systemic Exposure of Fluticasone Propionate 2x44mcg Following Administration by Metered-Dose Inhalers Containing Hydrofluoroalkane or Chlorofluorocarbon Propellants

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FAP10006-ICHE3.pdf

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Document reference: 28417

Study title: A Randomized, Open-Label, 2-Way Crossover, Repeat-Dose Study in Pediatric Subjects with Asthma, Age 4-11 Years, to Compare Systemic Exposure of Fluticasone Propionate 2x44mcg Following Administration by Metered-Dose Inhalers Containing Hydrofluoroalkane or Chlorofluorocarbon Propellants

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FAP10006-ICHE3.pdf

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Document reference: 28441

Study title: A single centre, randomised, double blind, cross over study to investigate longitudinal growth using knemometry in children with seasonal and perennial rhinitis during treatment with fluticasone propionate aqueous nasal spray (FPANS) 100mcg/day and placebo.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FNM40181-ICHE3.pdf

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Document reference: 28415

Study title: A Study to Determine the Systemic Activity of a Single Dose of Fluticasone Propionate via the Diskus in Asthmatic Children Inhaling at Different Inspiratory Flows

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FLTB4009-ICHE3.pdf

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Document reference: 28382

Study title: Comparison of fluticasone powder 1mg/day to budesonide powder 1mg/day in deterioration of severe asthma in children: a double-blind, randomised, multicentre study with parallel groups.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone -Propionate-FLPB0145-ICHE3.pdf

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Document reference: 28404

Study title: "Calello DP, Osterhoudt KC, Henretig FM.New and novel antidotes in pediatrics.Pediatr Emerg Care. 2006 Jul;22(7):523-30. Review. Erratum in: Pediatr Emerg Care. 2007 Feb;23(2):82. " "Calello DP, Osterhoudt KC, Henretig FM.New and novel antidotes in pediatrics.Pediatr Emerg Care. 2006 Jul;22(7):523-30. Review. Erratum in: Pediatr Emerg Care. 2007 Feb;23(2):82. "

Active substance: FOMEPIZOLE

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Document reference: 28466

Study title: "Caravati EM, Heileson HL, Jones M. Treatment of severe pediatric ethylene glycol intoxication without hemodialysis. J Toxicol Clin Toxicol. 2004;42(3):255-9. " "Caravati EM, Heileson HL, Jones M. Treatment of severe pediatric ethylene glycol intoxication without hemodialysis. J Toxicol Clin Toxicol. 2004;42(3):255-9. "

Active substance: FOMEPIZOLE

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Document reference: 28469

Study title: "Casavant MJ. Fomepizole in the treatment of poisoning. Pediatrics. 2001 Jan;107(1):170. " "Casavant MJ. Fomepizole in the treatment of poisoning. Pediatrics. 2001 Jan;107(1):170. "

Active substance: FOMEPIZOLE

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Document reference: 28472

Study title: Pan MH, Wu YW, Yen RF, Tzen KY, Liao SL, Kao CH. Different fibrovascularization rate between coralline hydroxyapatite and high density porous polyethylene (Medpore) measured by 99mTc-MDP bone scintigraphy 6 months after intraorbital implantation. Nucl Med Commun. 2003 Dec;24(12):1237-41. Pan MH, Wu YW, Yen RF, Tzen KY, Liao SL, Kao CH. Different fibrovascularization rate between coralline hydroxyapatite and high density porous polyethylene (Medpore) measured by 99mTc-MDP bone scintigraphy 6 months after intraorbital implantation. Nucl Med Commun. 2003 Dec;24(12):1237-41.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44245

Study title: Panoutsopoulos G, Ilias I, Parcharidou A, Christakopoulou I. [Intense uptake of 99mTc-MDP in primary abdominal neuroblastoma] Rev Esp Med Nucl. 2002 Jul;21(4):294-5. Spanish. No abstract available. Panoutsopoulos G, Ilias I, Parcharidou A, Christakopoulou I. [Intense uptake of 99mTc-MDP in primary abdominal neuroblastoma] Rev Esp Med Nucl. 2002 Jul;21(4):294-5. Spanish. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43437

Study title: Ibis E, Erbay G, Aras G, Isitman AT, Krasnow AZ, Collier BD. Three-phase bone scintigraphy in Maffucci's syndrome. Clin Nucl Med. 1992 Jun;17(6):505-6. No abstract available. Ibis E, Erbay G, Aras G, Isitman AT, Krasnow AZ, Collier BD. Three-phase bone scintigraphy in Maffucci's syndrome. Clin Nucl Med. 1992 Jun;17(6):505-6. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43696

Study title: ICRP (lnternation Commission on Radiological Protection). Publication 53: Radiation dose to patients from radiopharmaceuticals.ICRP (lnternation Commission on Radiological Protection). Publication 53: Radiation dose to patients from radiopharmaceuticals.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 47920

Study title: ICRP Publication 80: Radiation dose to patients from radiopharmaceuticals (Addendum to ICRP Publication 53)..ICRP Publication 80: Radiation dose to patients from radiopharmaceuticals (Addendum to ICRP Publication 53)..

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 47921

Study title: Ikawa G, dos Santos PA, Yamaguchi KT, Stroh-Recor C, Ibello R. Frostbite and bone scanning: the use of 99m-labeled phosphates in demarcating the line of viability in frostbite victims. Orthopedics. 1986 Sep;9(9):1257-61. Ikawa G, dos Santos PA, Yamaguchi KT, Stroh-Recor C, Ibello R. Frostbite and bone scanning: the use of 99m-labeled phosphates in demarcating the line of viability in frostbite victims. Orthopedics. 1986 Sep;9(9):1257-61.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43897

Study title: A follow-up study using iodine-131 metaiodobenzylguanidine imaging in a patient with neuroblastoma. Ikekubo K, Habuchi Y, Jeong S, Yamaguchi H, Saiki Y, Ito H, Hino M, Higa T. Clin Nucl Med. 1986 Nov;11(11):777-80.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43888

Study title: Findings on magnetic resonance imaging of the spine and femur in a case of McCune-Albright syndrome. Inamo Y, Hanawa Y, Kin H, Okuni M. Pediatr Radiol. 1993;23(1):15-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43674

Study title: Efficacy of Ambroxol (Surbronc) in acute respiratory exacerbation in cystic fibrosis.

Active substance: AMBROXOL

Study summary document link (including results): Ambroxol Hydrochloride_U92-0170_Synopsis.pdf

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Document reference: 46548

Study title: Miraglia del Giudice et al On the use of an extemporary combination of ambroxol and beclometasone dipropionate by aerosol in childhood allergic asthma. Comparative measurements. Riv.Pat.Clin.Tuberc.Pneumol.1985,56,37-48RivPatClinTub Pneumol 1985, Miraglia del Giudice. RivPatClinTub Pneumol 1985, Miraglia del Giudice

Active substance: AMBROXOL

Study summary document link (including results): RivPatClinTub Pneumol 1985, Miraglia del Giudice.pdf

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Document reference: 48875

Study title: Reinert S, Widlitzek H, Venderink DJ. The value of magnetic resonance imaging in the diagnosis of mandibular osteomyelitis. Br J Oral Maxillofac Surg. 1999 Dec;37(6):459-63. Reinert S, Widlitzek H, Venderink DJ. The value of magnetic resonance imaging in the diagnosis of mandibular osteomyelitis. Br J Oral Maxillofac Surg. 1999 Dec;37(6):459-63.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43493

Study title: Rencus T, Smith J, Munn S, Elgazzar A. Displaced uterus simulating aneurysm on a multiphase bone scan. Clin Nucl Med. 2003 Jul;28(7):574-6. No abstract available. Rencus T, Smith J, Munn S, Elgazzar A. Displaced uterus simulating aneurysm on a multiphase bone scan. Clin Nucl Med. 2003 Jul;28(7):574-6. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43418

Study title: Rhoad RC, Davidson RS, Heyman S, Dormans JP, Drummond DS. Pretreatment bone scan in SCFE: a predictor of ischemia and avascular necrosis. J Pediatr Orthop. 1999 Mar-Apr;19(2):164-8. Rhoad RC, Davidson RS, Heyman S, Dormans JP, Drummond DS. Pretreatment bone scan in SCFE: a predictor of ischemia and avascular necrosis. J Pediatr Orthop. 1999 Mar-Apr;19(2):164-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43511

Study title: Riebel T, Knop J, Winkler K, Delling G. [Comparative x-ray and nuclear medical studies of osteosarcomas to evaluate the effectiveness of preoperative chemotherapy] Rofo. 1986 Oct;145(4):365-72. German. Riebel T, Knop J, Winkler K, Delling G. [Comparative x-ray and nuclear medical studies of osteosarcomas to evaluate the effectiveness of preoperative chemotherapy] Rofo. 1986 Oct;145(4):365-72. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43891

Study title: Quantitative sacroiliac joint scintigraphy in normal subjects and patients with sacroiliitis. Kaçar G, Kaçar C, Karayalçin B, Güngör F, Tuncer T, Erkiliç M. Ann Nucl Med. 1998 Jun;12(3):169-73.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43530

Study title: Imaging of McCune-Albright syndrome using bone single photon emission computed tomography. Kairemo KJ, Verho S, Dunkel L. Eur J Pediatr. 1999 Feb;158(2):123-6. Review.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43513

Study title: Specific or superfluous? Doubtful clinical value of granulocyte scintigraphy in osteomyelitis in children. Kaiser S, Jacobsson H, Hirsch G. J Pediatr Orthop B. 2001 Apr;10(2):109-12.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43453

Study title: Early detection of subperiosteal abscesses by ultrasonography. A means for further successful treatment in pediatric osteomyelitis. Kaiser S, Rosenborg M. Pediatr Radiol. 1994;24(5):336-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43641

Study title: Estimate plasma peak concentrations of ampicillin obtained after rectal administration of single doses of ampicillin suppositories given to children.Movin et al. (1987-06-15)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_25.xlsx

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Document reference: 49024

Study title: Evaluate the safety of ampicillin suppositories with special emphasis on local intolerance reactions in pediatric patients. The secondary objective was to evaluate the short term efficiacy in the treatment of acute otitis media. The study was comparative against amoxycillin suspension.Bagger-Sjöbäck et al. (1986-11-28)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_19.xlsx

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Document reference: 49018

Study title: Investigate the rapidity of change in excretion rate of Ampicillin and Methicillin in the days after birth and demonstrate the effect of premature birth upon the excretion rates.Boe et al. (Pediatrics, vol. 39, no. 2, Feb 1967)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_8.xlsx

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Document reference: 49001

Study title: The role of bone scintigraphy in osteogenic sarcoma. Rees CR, Siddiqui AR, duCret R. Skeletal Radiol. 1986;15(5):365-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43924

Study title: Progressive diaphyseal dysplasia (Engelmann disease(: scintigraphic-radiographic-clinical correlations. Kumar B, Murphy WA, Whyte MP. Radiology. 1981 Jul;140(1):87-92.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44121

Study title: Multifocal non-Hodgkin lymphoma in an infant with cardiac involvement: whole-body MR imaging. Kumar J, Seith A, Bakhshi S, Sharma R, Kumar A. Pediatr Radiol. 2007 Mar;37(3):321-4. Epub 2007 Jan 30.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43367

Study title: Kumar R, Balachandran S. Unilateral septic sacro-iliitis. Importance of the anterior view of the bone scan. Clin Nucl Med. 1983 Sep;8(9):413-5. Kumar R, Balachandran S. Unilateral septic sacro-iliitis. Importance of the anterior view of the bone scan. Clin Nucl Med. 1983 Sep;8(9):413-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44031

Study title: Kumar R, Dilip S, Padhy AK, Malhotra R, Malhotra A, Machineni S, Sharma R. Three-phase bone imaging in the early diagnosis of osteochondritis dissecans of the patella. Clin Nucl Med. 1998 Aug;23(8):540-1. No abstract available. Kumar R, Dilip S, Padhy AK, Malhotra R, Malhotra A, Machineni S, Sharma R. Three-phase bone imaging in the early diagnosis of osteochondritis dissecans of the patella. Clin Nucl Med. 1998 Aug;23(8):540-1. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43528

Study title: Nielsen PT, Hedeboe J, Thommesen P. Bone scintigraphy in the evaluation of fracture of the carpal scaphoid bone. Acta Orthop Scand. 1983 Apr;54(2):303-6. Nielsen PT, Hedeboe J, Thommesen P. Bone scintigraphy in the evaluation of fracture of the carpal scaphoid bone. Acta Orthop Scand. 1983 Apr;54(2):303-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44042

Study title: Nishiyama Y, Yamamoto Y, Toyama Y, Satoh K, Ohkawa M, Tanabe M. Diagnostic value of TI-201 and three-phase bone scintigraphy for bone and soft-tissue tumors. Clin Nucl Med. 2000 Mar;25(3):200-5. Nishiyama Y, Yamamoto Y, Toyama Y, Satoh K, Ohkawa M, Tanabe M. Diagnostic value of TI-201 and three-phase bone scintigraphy for bone and soft-tissue tumors. Clin Nucl Med. 2000 Mar;25(3):200-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43491

Study title: Nishiyama Y, Yamamoto Y, Yokoe K, Kawaguchi Y, Toyama Y, Satoh K, Ohkawa M. A comparative study of 201Tl scintigraphy and three-phase bone scintigraphy following therapy in patients with bone and soft-tissue tumors. Ann Nucl Med. 2004 May;18(3):235-41. Nishiyama Y, Yamamoto Y, Yokoe K, Kawaguchi Y, Toyama Y, Satoh K, Ohkawa M. A comparative study of 201Tl scintigraphy and three-phase bone scintigraphy following therapy in patients with bone and soft-tissue tumors. Ann Nucl Med. 2004 May;18(3):235-41.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43402

Study title: Noel AW, Heyman S. Scintigraphic findings in infantile hemangioendothelioma. Clin Nucl Med. 1986 Jun;11(6):413-6. Noel AW, Heyman S. Scintigraphic findings in infantile hemangioendothelioma. Clin Nucl Med. 1986 Jun;11(6):413-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43908

Study title: Normal anatomic variant: scintigraphy of the ischiopubic synchondrosis. Cawley KA, Dvorak AD. Wilmot MD. Nucl Med 1983 Jan;24{1):14-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48468

Study title: Isotope scanning with Tc99m-MDP of the spine and the costosternal junctions of patients with idiopathic scoliosis. Normelli H, Lewander R. Acta Radiol Diagn (Stockh). 1985 Jul-Aug;26(4):397-401.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43936

Study title: "De Brabander N, Wojciechowski M, De Decker K, De Weerdt A, Jorens PG. Fomepizole as a therapeutic strategy in paediatric methanol poisoning. A case report and review of the literature. Eur J Pediatr. 2005 Mar;164(3):158-61. Epub 2004 Dec 1. Review. " "De Brabander N, Wojciechowski M, De Decker K, De Weerdt A, Jorens PG. Fomepizole as a therapeutic strategy in paediatric methanol poisoning. A case report and review of the literature. Eur J Pediatr. 2005 Mar;164(3):158-61. Epub 2004 Dec 1. Review. "

Active substance: FOMEPIZOLE

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Document reference: 28468

Study title: "Harry P, Jobard E, Briand M, Caubet A, Turcant A. Ethylene glycol poisoning in a child treated with 4-methylpyrazole. Pediatrics. 1998 Sep;102(3):E31. " "Harry P, Jobard E, Briand M, Caubet A, Turcant A. Ethylene glycol poisoning in a child treated with 4-methylpyrazole. Pediatrics. 1998 Sep;102(3):E31. "

Active substance: FOMEPIZOLE

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Document reference: 28475

Study title: "Shannon M. Toxicology reviews: fomepizole--a new antidote. Pediatr Emerg Care. 1998 Apr;14(2):170-2. " "Shannon M. Toxicology reviews: fomepizole--a new antidote. Pediatr Emerg Care. 1998 Apr;14(2):170-2. "

Active substance: FOMEPIZOLE

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Document reference: 28476

Study title: "Tenenbein M. Recent advancements in pediatric toxicology. Pediatr Clin North Am. 1999 Dec;46(6):1179-88, vii. Review. " "Tenenbein M. Recent advancements in pediatric toxicology. Pediatr Clin North Am. 1999 Dec;46(6):1179-88, vii. Review. "

Active substance: FOMEPIZOLE

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Document reference: 28473

Study title: "Wiley JF 2nd. Novel therapies for ethylene glycol intoxication. Curr Opin Pediatr. 1999 Jun;11(3):269-73. Review. " "Wiley JF 2nd. Novel therapies for ethylene glycol intoxication. Curr Opin Pediatr. 1999 Jun;11(3):269-73. Review. "

Active substance: FOMEPIZOLE

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Document reference: 28474

Study title: A 12 month multi-center, randomized, dbdd trial to examine the long-term tolerability of formoterol 1mg via the mddpi, both as b.i.d maintenance therapy and as on-demand-use on top of maintenane, in patients with persistent asthma.

Active substance: FORMOTEROL

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Document reference: 47791

Study title: A 12 week randomized, double-blind, double-dummy, placebo controlled, parallel group study in adolescents and adults with persistent asthma comparing the safety and efficacy of two doses of formoterol fumarate b.i.d. administered from the multi-dose powder

Active substance: FORMOTEROL

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Document reference: 47792

Study title: A 12-month comparison of Oxis® (formoterol) Turbuhaler® and Bricanyl® (terbutaline)Turbuhaler both used as needed in subjects with asthma not using anti-inflammatory treatment

Active substance: FORMOTEROL

Study summary document link (including results): SD-037-0716 Study Synopsis.pdf

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Document reference: 47793

Study title: A 12-month comparison of Oxis® (formoterol) Turbuhaler® and Bricanyl®(terbutaline) Turbuhaler® both used as needed in patients with asthma on anti-inflammatory treatment

Active substance: FORMOTEROL

Study summary document link (including results): SD-037-0714 Study Synopsis.pdf

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Document reference: 47794

Study title: A 12-week randomized, multicenter, double-blind, double-dummy, placebo and active controlled, parallel group study evaluating the safety and efficacy of Formoterol fumarate (10 µg b.i.d.) delivered by the multi-dose dry powder inhaler (MDDPI) versus place

Active substance: FORMOTEROL

Study summary document link (including results): FOR258F2302 Art45 listing 2011.xls

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Document reference: 47795

Study title: A 12-week randomized, multicenter, double-blind, double-dummy, placebo and active controlled, parallel group study evaluating the safety, efficacy, and pharmacokinetics of Foradil (formoterol fumarate) (10 mg bid) delivered by the multi-dose dry powder in

Active substance: FORMOTEROL

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Document reference: 47796

Study title: Effects on the respiratory tract and male reproductive organs in young rats given formoterol fumarate (D2522) in lactose by the inhalation route for 3 months

Active substance: FORMOTEROL

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Document reference: 47838

Study title: Efficacy and safety of budesonide/formoterol Turbuhaler in a fixed combination in steroid-using asthmatic children – COMIC.

Active substance: FORMOTEROL

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Document reference: 47839

Study title: Efficacy and tolerability of four single doses of formoterol Turbuhaler compared to salmeterol Diskhaler 50μg and placebo in children with bronchial asthma.

Active substance: FORMOTEROL

Study summary document link (including results): SD-037-0002 Study Synopsis.pdf

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Document reference: 47840

Study title: Intenzo C, Kim S, Millin J, Park C. Scintigraphic patterns of the reflex sympathetic dystrophy syndrome of the lower extremities. Clin Nucl Med. 1989 Sep;14(9):657-61. Intenzo C, Kim S, Millin J, Park C. Scintigraphic patterns of the reflex sympathetic dystrophy syndrome of the lower extremities. Clin Nucl Med. 1989 Sep;14(9):657-61.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43780

Study title: Ishibashi K, Miyamae T. [Classification of bone scintigrams in hemodialysis patients] Kaku Igaku. 1985 Mar;22(3):367-76. Japanese. No abstract available. Ishibashi K, Miyamae T. [Classification of bone scintigrams in hemodialysis patients] Kaku Igaku. 1985 Mar;22(3):367-76. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43952

Study title: Septic arthritis of a lumbar facet joint due to pyonex. Ishibe M, Inoue M, Saitou K. Arch Orthop Trauma Surg. 2001;121(1-2):90-2.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43464

Study title: Isotope bone scanning for acute osteomyelitis and septic arthritis in children. Tuson CE, Hoffman EB, Mann MD. J Bone Joint Surg Br. 1994 Mar;76(2):306-10.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43633

Study title: Uterine blush mimicking a hypervascular tumour in the pelvis as demonstrated by a triple-phase bone scan. Tzen KY, Yen TC. Nucl Med Commun. 1998 Jun;19(6):605-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43509

Study title: Uno K, Uchida Y, Sakata S, Minoshima S, Okada J, Yoshikawa K, Arimizu N, Karikomi M, Kitakata Y, Suzuki Y. [Visualization of the female breast in bone scintigraphy] Kaku Igaku. 1992 Oct;29(10):1201-6. Japanese. Uno K, Uchida Y, Sakata S, Minoshima S, Okada J, Yoshikawa K, Arimizu N, Karikomi M, Kitakata Y, Suzuki Y. [Visualization of the female breast in bone scintigraphy] Kaku Igaku. 1992 Oct;29(10):1201-6. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43685

Study title: Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43732

Study title: Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44173

Study title: Assessment of growth activity in the mandibular condyles by single-photon emission computed tomography (SPECT). Kajan ZD, Motevasseli S, Nasab NK, Ghanepour H, Abbaspur F. Aust Orthod J. 2006 Nov;22(2):127-30.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43368

Study title: Age-related normal variants of sternal uptake on bone scintigraphy.Kakhki VD, Zakavi SR. Clin Nucl Med. 2006 Feb;31(2):63-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43380

Study title: Kaneda K, Kurakami C, Minami A. Free vascularized fibular strut graft in the treatment of kyphosis. Spine. 1988 Nov;13(11):1273-7. Kaneda K, Kurakami C, Minami A. Free vascularized fibular strut graft in the treatment of kyphosis. Spine. 1988 Nov;13(11):1273-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43804

Study title: Kantarjian HM, Bledin AG, Kim EE, Gutierrez CR, Haynie TP. Uptake of 99mTc-methylene disphosphonate in calcinosis cutis. J Am Acad Dermatol. 1982 Dec;7(6):804-6. No abstract available. Kantarjian HM, Bledin AG, Kim EE, Gutierrez CR, Haynie TP. Uptake of 99mTc-methylene disphosphonate in calcinosis cutis. J Am Acad Dermatol. 1982 Dec;7(6):804-6. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44065

Study title: Kao PF, Tzen KY, Chang LY, You DL, Yang JY. 99Tcm-MDP scintigraphy in high-voltage electrical burn patients. Nucl Med Commun. 1997 Sep;18(9):846-52. Erratum in: Nucl Med Commun 1998 Jan;19(1):90. Kao PF, Tzen KY, Chang LY, You DL, Yang JY. 99Tcm-MDP scintigraphy in high-voltage electrical burn patients. Nucl Med Commun. 1997 Sep;18(9):846-52. Erratum in: Nucl Med Commun 1998 Jan;19(1):90.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43541

Study title: Safety and Immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (TdcP) Vaccine Compared to Tetanus and Diphtheria Toxoids Adsorbed (Td) in Adolescents and Adults 11-64 Years of Age

Active substance: purif tetan toxoid,purif dipht toxoid,purif pert toxoid,purif filamentous haemaggl,purif fimbriae (agglutinogens 2 & 3),purif pertactin (69kda membrane protein)-inact polio vacc

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Document reference: 41432

Study title: Safety of four acellular pertussis combination vaccines (Infantrix-IPV, Boostrix, Covaxis and repevax) given a booster dose to six-year-old Finnish children

Active substance: purif tetan toxoid,purif dipht toxoid,purif pert toxoid,purif filamentous haemaggl,purif fimbriae (agglutinogens 2 & 3),purif pertactin (69kda membrane protein)-inact polio vacc

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Document reference: 41433

Study title: Double blind, controlled trial testing the immunogenicity and side effects of parenteral Vi polysaccharide typhoid vaccine in Indonesian children and adults

Active substance: Purified Vi capsular polysaccharide of Salmonella typhi (Ty2 strain)

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Document reference: 21216

Study title: Effectiveness of a Vi capsular polysaccharide vaccine

Active substance: Purified Vi capsular polysaccharide of Salmonella typhi (Ty2 strain)

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Document reference: 41448

Study title: Prevention of typhoid fever in Nepal with the Vi capsular polysaccharide of Salmonella typhi

Active substance: Purified Vi capsular polysaccharide of Salmonella typhi (Ty2 strain)

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Document reference: 41447

Study title: Safety and immunogenicity of Vi CPS vaccine in teenagers

Active substance: Purified Vi capsular polysaccharide of Salmonella typhi (Ty2 strain)

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Document reference: 21215

Study title: ANTHELMINTIC EFFICACY OF PYRANTEL PAMOATE VS. MEBENDAZOLE IN PATIENTS WITH ASCARIASIS.

Active substance: PYRANTEL PAMOATE

Study summary document link (including results): PRT-II-84-001-002-003 EMA Paediatrics Web Synopsis.pdf

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Document reference: 46148

Study title: EFFICACY AND SAFETY OF OXANTEL-PYRANTEL PAMOATE TAB. AGAINST MULTIPLE INTESTINAL HELNINTHIC/NEMATODE INFECTIONS WITH TRICHURIS TRICHURIA.

Active substance: PYRANTEL PAMOATE

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Document reference: 46146

Study title: EFFICACY AND SAFETY OF OXANTEL/PYRANTEL PAMOATE TABLET AGAINST MULTIPLE INTESTINAL HELMINTHIC/NEMATODE INFECTIONS WITH TRICHURIS TRICHURIA.

Active substance: PYRANTEL PAMOATE

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Document reference: 46145

Study title: Fibrodysplasia ossificans progressiva: case report. Nucci A, Queiroz LD, Santos AD, Camargo EE, Moura-Ribeiro MV. Arq Neuropsiquiatr. 2000 Jun;58(2A):342-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43482

Study title: Bone stress lesions in ballet dancers: scintigraphic assessment. Nussbaum AR, Treves ST, Micheli L. AJR Am J Roentgenol. 1988 Apr;150(4):851-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43821

Study title: Nuti R, Vattimo A, Turchetti V, Righi G. 25-Hydroxycholecalciferol as an antagonist of adverse corticosteroid effects on phosphate and calcium metabolism in man. J Endocrinol Invest. 1984 Oct;7(5):445-8. Nuti R, Vattimo A, Turchetti V, Righi G. 25-Hydroxycholecalciferol as an antagonist of adverse corticosteroid effects on phosphate and calcium metabolism in man. J Endocrinol Invest. 1984 Oct;7(5):445-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43980

Study title: O'Duffy EK, Clunie GP, Gacinovic S, Edwards JC, Bomanji JB, Ell PJ. Foot pain: specific indications for scintigraphy. Br J Rheumatol. 1998 Apr;37(4):442-7. O'Duffy EK, Clunie GP, Gacinovic S, Edwards JC, Bomanji JB, Ell PJ. Foot pain: specific indications for scintigraphy. Br J Rheumatol. 1998 Apr;37(4):442-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43533

Study title: Herndon WA, Alexieva BT, Schwindt ML, Scott KN, Shaffer WO. Nuclear imaging for musculoskeletal infections in children. J Pediatr Orthop. 1985 May-Jun;5(3):343-7. Herndon WA, Alexieva BT, Schwindt ML, Scott KN, Shaffer WO. Nuclear imaging for musculoskeletal infections in children. J Pediatr Orthop. 1985 May-Jun;5(3):343-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43946

Study title: Herrera M, Silverman ED, Cole RL. Hepatic abscess detected on a three-phase bone scan. Clin Nucl Med. 2002 Apr;27(4):307-8. No abstract available. Herrera M, Silverman ED, Cole RL. Hepatic abscess detected on a three-phase bone scan. Clin Nucl Med. 2002 Apr;27(4):307-8. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43449

Study title: Hersek N, Canay S, Caner B, Ulutuncel N. Bone SPECT imaging of patients with internal derangement of temporomandibular joint before and after splint therapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Nov;94(5):576-80. Hersek N, Canay S, Caner B, Ulutuncel N. Bone SPECT imaging of patients with internal derangement of temporomandibular joint before and after splint therapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Nov;94(5):576-80.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43431

Study title: Hervás Benito I, González Cabezas P, Saura Quiles A, Pérez Velasco R, Bello Arques P, Mateo Navarro A. [Visualization of pulmonary metastasis of osteosarcoma with 99mTc-HMDP] Rev Esp Med Nucl. 2001 Dec;20(7):558-9. Spanish. No abstract available. Hervás Benito I, González Cabezas P, Saura Quiles A, Pérez Velasco R, Bello Arques P, Mateo Navarro A. [Visualization of pulmonary metastasis of osteosarcoma with 99mTc-HMDP] Rev Esp Med Nucl. 2001 Dec;20(7):558-9. Spanish. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43450

Study title: Cherubism: diagnostic imaging and review of the literature in Japan. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 May;81(5):623-8. Review. Hitomi G, Nishide N, Mitsui K. Cherubism: diagnostic imaging and review of the literature in Japan. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 May;81(5):623-8. Review.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43567

Study title: Hod N, Horne T. "Cold" and "hot" osteomyelitis on bone scintigraphy. Clin Nucl Med. 2003 Nov;28(11):927-8. Hod N, Horne T. "Cold" and "hot" osteomyelitis on bone scintigraphy. Clin Nucl Med. 2003 Nov;28(11):927-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43412

Study title: EFFICACY AND TOLERABILITY STUDY IN CHILDREN OVER A 15 DAY PERIOD

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 DFOR C6 II (DFORC6Y) Art45 listing 2011.xls

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Document reference: 47841

Study title: EFFICACY OF FORMOTEROL (BD 40A) WITH SINGLE DOSE FOR BRONCHIAL ASTHMA IN CHILDREN: CLINICAL RESULTS IN 8 INSTITUTIONS

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 YBDG 3-3 Art45 listing 2011.xls

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Document reference: 47842

Study title: Eformoterol versus salmeterol: reduction in short acting bronchodilator usage in asthmatic children treated with inhaled steroids: FACT.

Active substance: FORMOTEROL

Study summary document link (including results): BU-037-0004 Study Synopsis.pdf

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Document reference: 47843

Study title: INFLUENCE ON BRONCHIAL HYPERRESPONSIVENESS USING A LONG ACTING (FORMOTEROL) AND A SHORT ACTING (SALBUTAMOL) BETA-2 SYMPATHOMIMETIC IN CHILDREN WITH BRONCHIAL ASTHMA

Active substance: FORMOTEROL

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Document reference: 45268

Study title: INFLUENCE ON BRONCHIAL HYPERRESPONSIVENESS USING A LONG ACTING (FORMOTEROL) AND A SHORT ACTING (SALBUTAMOL) BETA-2 SYMPATHOMIMETIC IN CHILDREN WITH BRONCHIAL ASTHMA

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 DFORD2 Art45 listing 2011.xls

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Document reference: 47845

Study title: Investigation on the safety and efficacy of miflonide together with foradil in patients with moderate to severe asthma bronchiale which is not adequately controlled by other inhalative combinations of long-acting beta 2-agonists and corticosteroids.

Active substance: FORMOTEROL

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Document reference: 45269

Study title: Investigation on the safety and efficacy of miflonide together with foradil in patients with moderate to severe asthma bronchiale which is not adequately controlled by other inhalative combinations of long-acting beta 2-agonists and corticosteroids.

Active substance: FORMOTEROL

Study summary document link (including results): FOR258DDE03 Art45 listing 2011.xls

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Document reference: 47846

Study title: MULTI-CENTRE, DOUBLE-BLIND, BETWEEN-PATIENT COMPARISON OF MULTIPLE DOSES OF 12 UG FORMOTEROL METERED DOSE AEROSOL VERSUS MULTIPLE DOSES OF 200 MYG SALBUTAMOL METERED-DOSE AEROSOL IN CHILDREN WITH BRONCHIAL ASTHMA

Active substance: FORMOTEROL

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Document reference: 45270

Study title: MULTI-CENTRE, DOUBLE-BLIND, BETWEEN-PATIENT COMPARISON OF MULTIPLE DOSES OF 12 UG FORMOTEROL METERED DOSE AEROSOL VERSUS MULTIPLE DOSES OF 200 MYG SALBUTAMOL METERED-DOSE AEROSOL IN CHILDREN WITH BRONCHIAL ASTHMA

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 BA-RP1 Art45 listing 2011.xls

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Document reference: 47847

Study title: MULTI-CENTRE, DOUBLE-BLIND, THREE-MONTH, BETWEEN-PATIENT COMPARISON OF 6 UG B.I.D. AND 12 UG B.I.D. DAILY FORMOTEROL AEROSOL VERSUS 200 UG T.I.D. DAILY SALBUTAMOL AEROSOL IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASES (E.G. BRONCHIAL ASTHMA)

Active substance: FORMOTEROL

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Document reference: 45271

Study title: MULTI-CENTRE, DOUBLE-BLIND, THREE-MONTH, BETWEEN-PATIENT COMPARISON OF 6 UG B.I.D. AND 12 UG B.I.D. DAILY FORMOTEROL AEROSOL VERSUS 200 UG T.I.D. DAILY SALBUTAMOL AEROSOL IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASES (E.G. BRONCHIAL ASTHMA)

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 SP PD2 Art45 listing 2011.xls

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Document reference: 47848

Study title: Report on an Open Cross-Over Comparison of Flurbiprofen and Naproxen in Juvenile Spondylitis, Definite and Probable

Active substance: FLURBIPROFEN

Study summary document link (including results): Flurbiprofen-M84-121.pdf

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Document reference: 47461

Study title: Serum Concentrations of Flurbiprofen in Children After a Single Oral Dose of 22.5 mg or 27 mg of the Drug, following a Multidose Regime

Active substance: FLURBIPROFEN

Study summary document link (including results): flurbiprofen-dm7620.pdf

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Document reference: 48075

Study title:

Active substance: FLURIBUPROFEN

Study summary document link (including results):

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Document reference: 28346

Study title:

Active substance: FLURIBUPROFEN

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Document reference: 28347

Study title: Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44220

Study title: Levine E, De Smet AA, Neff JR, Martin NL. Scintigraphic evaluation of giant cell tumor of bone. AJR Am J Roentgenol. 1984 Aug;143(2):343-8. Levine E, De Smet AA, Neff JR, Martin NL. Scintigraphic evaluation of giant cell tumor of bone. AJR Am J Roentgenol. 1984 Aug;143(2):343-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43991

Study title: Levinsohn EM, Sternick A, Echeverria TS, Yuan HA. Acute hematogenous osteomyelitis of the rib. Skeletal Radiol. 1982;8(4):291-3. Levinsohn EM, Sternick A, Echeverria TS, Yuan HA. Acute hematogenous osteomyelitis of the rib. Skeletal Radiol. 1982;8(4):291-3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44097

Study title: Acute osteomyelitis in children: combined Tc-99m and Ga-67 imaging. Lewin JS, Rosenfield NS, Hoffer PB, Downing D. Radiology. 1986 Mar;158(3):795-804.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43915

Study title: A "harness" distribution pattern on pediatric Ga-67 scintigraphy. Lewis GW, Mansberg R, Howman-Giles R. Clin Nucl Med. 1999 Jul;24(7):527-8. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43505

Study title: [The application radionuclide bone imaging in the treatment of hallux valgus] Li W, Peng JJ, Zhou YX. Zhonghua Wai Ke Za Zhi. 1994 Dec;32(12):757-9. Chinese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43607

Study title: Lim ST, Sohn MH, Park SA. Tc-99m MDP three-phase bone scintigraphy in disciplinary exercise-induced rhabdomyolysis. Clin Nucl Med. 2000 Jul;25(7):558-9. No abstract available. Lim ST, Sohn MH, Park SA. Tc-99m MDP three-phase bone scintigraphy in disciplinary exercise-induced rhabdomyolysis. Clin Nucl Med. 2000 Jul;25(7):558-9. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43480

Study title: Lin D, Alavi A, Dalinka M. Bone scan evaluation of patellar activity. Int J Nucl Med Biol. 1981;8(1):105-9. No abstract available. Lin D, Alavi A, Dalinka M. Bone scan evaluation of patellar activity. Int J Nucl Med Biol. 1981;8(1):105-9. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44135

Study title: Lin D, Alavi A, Dalinka M. Scintigraphic evaluation of the hyoid bone and the thyroid--cricoid cartilage. Int J Nucl Med Biol. 1981;8(1):96-104. No abstract available. Lin D, Alavi A, Dalinka M. Scintigraphic evaluation of the hyoid bone and the thyroid--cricoid cartilage. Int J Nucl Med Biol. 1981;8(1):96-104. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

Study summary document link (including results):

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Document reference: 44133

Study title: Open comparative trial to evaluate the effectiveness of gonorrhae in males.Fluker

Active substance: AMOXICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_9.xlsx

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Document reference: 48999

Study title: Open multicentre trial to evaluate the efficacy of amoxicllin in GP.Leigh et al

Active substance: AMOXICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_10.xlsx

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Document reference: 48996

Study title: Open parallell group to evalutate the efficacy for 2 different dose regimens for untreated maxillar sinuitis.Sydow et al.

Active substance: AMOXICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_13.xlsx

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Document reference: 48998

Study title: TO ASSESS THE COMPARATIVE ANTHELMINTIC EFFICACY OF PYRANTEL PAMOATE AND MEBENDAZOLE IN ENTEROBIASIS AND ASCARIASIS.

Active substance: PYRANTEL PAMOATE

Study summary document link (including results): PRT-II-84-001-002-003 EMA Paediatrics Web Synopsis.pdf

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Document reference: 46149

Study title: TO ASSESS THE EFFECT OF QUARTERLY TREATMENTS OVER A PERIOD OF ONE YEAR ON THE PREVALENCE OF ASCARIASIS, ANCYLOSTOMIASIS AND ENTEROBIASIS IN A RESIDENTIAL INSTITUTE FOR CHILDREN.

Active substance: PYRANTEL PAMOATE

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Document reference: 46151

Study title: TO ESTIMATE THE PERCENTAGE OF AT-RISK FAMILIES IN A HIGH-PREVALENCE AREA HAVING TWO OR MORE MEMBERS WITH ROUND-WORM HOOKWORM INFECTION. "AT-RISK" FAMILIES HAS ONE MEMBER INFECTED. "AFFECTED" FAMILIES HAS 2 OR MORE INFECTED MEMBERS.

Active substance: PYRANTEL PAMOATE

Study summary document link (including results): PRT-II-85-002 EMEA Pediatric Web Synopsis.pdf

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Document reference: 46150

Study title: R.Ammer, Penka Demirova Drumeva, A.Völp: Nicht toxische Alternative zur Behandlung von Kopfläusen, päd (9) 2003

Active substance: Pyrethrum extract, Pyrethrins content 25% (m/m) (HERB)

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Document reference: 40147

Study title: Afifi AK, Bell WE: Tests for juvenile myastenia gravis: comparative diagnostic yield and prediction of outcome. J Child Neurol 8, 403 – 411 (1993) Afifi AK, Bell WE: Tests for juvenile myastenia gravis: comparative diagnostic yield and prediction of outcome. J Child Neurol 8, 403 – 411 (1993)

Active substance: PYRIDOSTIGMINE

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Document reference: 35224

Study title: Afifi AK, Bell WE. Tests for juvenile myasthenia gravis: comparative diagnostic yield and prediction of outcome. J Child Neurol 1993;8:403-11.Afifi AK, Bell WE. Tests for juvenile myasthenia gravis: comparative diagnostic yield and prediction of outcome. J Child Neurol 1993;8:403-11.

Active substance: PYRIDOSTIGMINE

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Document reference: 35228

Study title: Alhalel A et al. Ocular effects of hyoscine in double dose transdermal administration and its reversal by low dose pyridostigmine. Aviat Space Environ Med. 1995 Nov;66(11):1037-40Alhalel A et al. Ocular effects of hyoscine in double dose transdermal administration and its reversal by low dose pyridostigmine. Aviat Space Environ Med. 1995 Nov;66(11):1037-40

Active substance: PYRIDOSTIGMINE

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Document reference: 35198

Study title: Tam YH, Yeung CK, Lee KH. Seven-day is more effective than 4-day ranitidine bismuth citrate-based triple therapy in eradication of Helicobacter pylori in children: a prospective randomized study. Aliment Pharmacol Ther. 2006 Jul 1;24(1):81-6.Tam YH, Yeung CK, Lee KH. Seven-day is more effective than 4-day ranitidine bismuth citrate-based triple therapy in eradication of Helicobacter pylori in children: a prospective randomized study. Aliment Pharmacol Ther. 2006 Jul 1;24(1):81-6.

Active substance: RANITIDINE

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Document reference: 35277

Study title: Wells TG, Heulitt MJ, Taylor BJ, Fasules JW, Kearns GL. Pharmacokinetics and pharmacodynamics of ranitidine in neonates treated with extracorporeal membrane oxygenation. J Clin Pharmacol. 1998 May;38(5):402-7.Wells TG, Heulitt MJ, Taylor BJ, Fasules JW, Kearns GL. Pharmacokinetics and pharmacodynamics of ranitidine in neonates treated with extracorporeal membrane oxygenation. J Clin Pharmacol. 1998 May;38(5):402-7.

Active substance: RANITIDINE

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Document reference: 35280

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Ranunculus-Homaccord (drops) [AWB-AT]

Active substance: Ranunculus-Homaccord

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Document reference: 40150

Study title: A Multicenter Safety Study of SR29142 in Cancer Patients (LTS3025).

Active substance: rasburicase

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Document reference: 47279

Study title: A Phase II, Open-Label, Multicenter Study of SR29142 as a Uricolytic Therapy for the Prophylaxis and Treatment of Hyperuricemia in Patients With Leukemias or Lymphomas (ACT2511)

Active substance: rasburicase

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Document reference: 47275

Study title: A Phase II, Open-Label, Multicenter Study of SR29142 as a Uricolytic Therapy for the Prophylaxis and Treatment of Hyperuricemia in Patients with Leukemias or Lymphomas (ACT2694)

Active substance: rasburicase

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Document reference: 47276

Study title: An open-label, randomized, multicenter comparison of SR29142 versus allopurinol for the prophylaxis and treatment of hyperuricemia in pediatric patients with leukemia or lymphoma (EFC2975)

Active substance: rasburicase

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Document reference: 47277

Study title: Hod N, Horne T. Interesting presentation of renal and adjacent rib infection on bone scintigraphy: the additive value of tissue phase images. Clin Nucl Med. 2004 Nov;29(11):720-2. No abstract available. Hod N, Horne T. Interesting presentation of renal and adjacent rib infection on bone scintigraphy: the additive value of tissue phase images. Clin Nucl Med. 2004 Nov;29(11):720-2. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43395

Study title: Hodder SC, Rees JI, Oliver TB, Facey PE, Sugar AW. SPECT bone scintigraphy in the diagnosis and management of mandibular condylar hyperplasia. Br J Oral Maxillofac Surg. 2000 Apr;38(2):87-93. Hodder SC, Rees JI, Oliver TB, Facey PE, Sugar AW. SPECT bone scintigraphy in the diagnosis and management of mandibular condylar hyperplasia. Br J Oral Maxillofac Surg. 2000 Apr;38(2):87-93.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43481

Study title: Hoefnagel CA, Bruning PF, Cohen P, Marcuse HR, van der Schoot JB. Detection of lung metastases from osteosarcoma by scintigraphy using 99mTc-methylene diphosphonate. Diagn Imaging. 1981;50(5):277-84. Hoefnagel CA, Bruning PF, Cohen P, Marcuse HR, van der Schoot JB. Detection of lung metastases from osteosarcoma by scintigraphy using 99mTc-methylene diphosphonate. Diagn Imaging. 1981;50(5):277-84.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44132

Study title: [Scintigraphic aspect of infantile cortical hyperostosis (Caffey's disease)] French. Taillefer R, Danais S, Marton D. J Can Assoc Radiol. 1983 Mar;34(1):12-5. French.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44046

Study title: Takahashi T, Kakuhara N, Katsuragawa S, Kojima Y, Hirose A, Nakasato T, Yoshioka K, Kato K, Yanagisawa T. [Quantitative study of diffuse increased 99mTc-methylene diphosphonate accumulation of both kidneys] Radioisotopes. 1987 Oct;36(10):519-22. Japanese. Takahashi T, Kakuhara N, Katsuragawa S, Kojima Y, Hirose A, Nakasato T, Yoshioka K, Kato K, Yanagisawa T. [Quantitative study of diffuse increased 99mTc-methylene diphosphonate accumulation of both kidneys] Radioisotopes. 1987 Oct;36(10):519-22. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43847

Study title: Takahashi T, Kakuhara N, Katsuragawa S, Kojima Y, Hirose A, Nakasato T, Yoshioka K, Kato K, Yanagisawa T. [Quantitative study of diffuse increased 99mTc-methylene diphosphonate accumulation of both kidneys] Radioisotopes. 1987 Oct;36(10):519-22. Japanese. Takahashi T, Kakuhara N, Katsuragawa S, Kojima Y, Hirose A, Nakasato T, Yoshioka K, Kato K, Yanagisawa T. [Quantitative study of diffuse increased 99mTc-methylene diphosphonate accumulation of both kidneys] Radioisotopes. 1987 Oct;36(10):519-22. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44180

Study title: Takahashi T, Kakuhara N, Katsuragawa S, Kojima Y, Hirose A, Nakasato T, Yoshioka K, Kato K, Yanagisawa T. [Quantitative study of diffuse increased 99mTc-methylene diphosphonate accumulation of both kidneys] Radioisotopes. 1987 Oct;36(10):519-22. Japanese. Takahashi T, Kakuhara N, Katsuragawa S, Kojima Y, Hirose A, Nakasato T, Yoshioka K, Kato K, Yanagisawa T. [Quantitative study of diffuse increased 99mTc-methylene diphosphonate accumulation of both kidneys] Radioisotopes. 1987 Oct;36(10):519-22. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44227

Study title: Takahashi T, Kakuhara N, Katsuragawa S, Kojima Y, Hirose A, Nakasato T, Yoshioka K, Kato K, Yanagisawa T. [Quantitative study of diffuse increased 99mTc-methylene diphosphonate accumulation of both kidneys] Radioisotopes. 1987 Oct;36(10):519-22. Japanese. Takahashi T, Kakuhara N, Katsuragawa S, Kojima Y, Hirose A, Nakasato T, Yoshioka K, Kato K, Yanagisawa T. [Quantitative study of diffuse increased 99mTc-methylene diphosphonate accumulation of both kidneys] Radioisotopes. 1987 Oct;36(10):519-22. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

Study summary document link (including results):

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Document reference: 44274

Study title:

Active substance: FLURIBUPROFEN

Study summary document link (including results):

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Document reference: 28348

Study title:

Active substance: FLURIBUPROFEN

Study summary document link (including results):

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Document reference: 28349

Study title:

Active substance: FLURIBUPROFEN

Study summary document link (including results):

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Document reference: 28350

Study title:

Active substance: FLURIBUPROFEN

Study summary document link (including results):

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Document reference: 28351

Study title:

Active substance: FLURIBUPROFEN

Study summary document link (including results):

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Document reference: 28352

Study title:

Active substance: FLURIBUPROFEN

Study summary document link (including results):

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Document reference: 28353

Study title:

Active substance: FLURIBUPROFEN

Study summary document link (including results):

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Document reference: 28354

Study title:

Active substance: FLURIBUPROFEN

Study summary document link (including results):

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Document reference: 28355

Study title:

Active substance: FLURIBUPROFEN

Study summary document link (including results):

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Document reference: 28356

Study title:

Active substance: FLURIBUPROFEN

Study summary document link (including results):

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Document reference: 28357

Study title:

Active substance: FLURIBUPROFEN

Study summary document link (including results):

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Document reference: 28358

Study title:

Active substance: FLURIBUPROFEN

Study summary document link (including results):

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Document reference: 28359

Study title:

Active substance: FLUTICASONE

Study summary document link (including results):

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Document reference: 28360

Study title:

Active substance: FLUTICASONE

Study summary document link (including results):

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Document reference: 28361

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Synopsis-Fluticasone Propionate-CUTIVATE-FPO40003.pdf

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Document reference: 28362

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-DENB4016-ICHE3.pdf

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Document reference: 28369

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Study FAD101-Fluticasone Propionate-Flixotide Diskus.xls

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Document reference: 28370

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Study FAD102-Fluticasone Propionate-Flixotide Diskus.xls

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Document reference: 28371

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FAS30006-ICHE3.pdf

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Document reference: 28372

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FAS40019-ICHE3.pdf

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Document reference: 28373

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Study Fluticasone_Propionate-PED-FLTA2008.xlsx

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Document reference: 28377

Study title:

Active substance: FLUTICASONE

Study summary document link (including results):

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Document reference: 28378

Study title:

Active substance: FLUTICASONE

Study summary document link (including results):

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Document reference: 28381

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Study FMS40016-Fluticasone.xls

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Document reference: 28385

Study title: Due to the lack of good diagnostic techniques it can be difficult to diagnose asthma in young children. The symptoms can be such that anti-inflammatory medication is given as test medication; however there is a lack of clinical data in a large group of wheezy infants using objective endpoints. The aim of this study was to evaluate the effects of fluticasone propionate on lung function and symptom scores in infants with recurrent and persistent wheeze.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FMS30060-ICHE3.pdf

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Document reference: 28398

Study title: Lin DS, Alavi A. Bone scan evaluation of degenerative joint disease of the spine. Int J Nucl Med Biol. 1982;9(1):63-4. No abstract available. Lin DS, Alavi A. Bone scan evaluation of degenerative joint disease of the spine. Int J Nucl Med Biol. 1982;9(1):63-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44104

Study title: Evaluation of arthritis in Reiter's disease by bone scintigraphy and radiography. Lin WY, Wang SJ, Lan JL. Clin Rheumatol. 1995 Jul;14(4):441-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43596

Study title: Lin WY, Wang SJ, Lang JL, Hsu CY, Kao CH, Liao SQ, Yeh HW. Bone scintigraphy in evaluation of heel pain in Reiter's disease: compared with radiography and clinical examination. Scand J Rheumatol. 1995;24(1):18-21. Lin WY, Wang SJ, Lang JL, Hsu CY, Kao CH, Liao SQ, Yeh HW. Bone scintigraphy in evaluation of heel pain in Reiter's disease: compared with radiography and clinical examination. Scand J Rheumatol. 1995;24(1):18-21.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

Study summary document link (including results):

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Document reference: 43605

Study title: Papanicolaou N. Osteoid osteoma: operative confirmation of complete removal by bone scintigraphy. Radiology. 1985 Mar;154(3):821-2. Papanicolaou N. Osteoid osteoma: operative confirmation of complete removal by bone scintigraphy. Radiology. 1985 Mar;154(3):821-2.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43957

Study title: Paramsothy M, Peng LH, Samuel D. Diagnostic value of radionuclide technetium 99m-MDP skeletal survey in acute leukaemia. Australas Radiol. 1983 Nov;27(3):295-6. No abstract available. Paramsothy M, Peng LH, Samuel D. Diagnostic value of radionuclide technetium 99m-MDP skeletal survey in acute leukaemia. Australas Radiol. 1983 Nov;27(3):295-6. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44023

Study title: Reflex sympathetic dystrophy associated with deep peroneal nerve entrapment. Parano E, Pavone V, Greco F, Majorana M, Trifiletti RR. Brain Dev. 1998 Mar;20(2):80-2.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43534

Study title: Park CH, Kapadia D, O'Hara AE. Three phase bone scan findings in stress fracture. Clin Nucl Med. 1981 Dec;6(12):587-8. No abstract available. Park CH, Kapadia D, O'Hara AE. Three phase bone scan findings in stress fracture. Clin Nucl Med. 1981 Dec;6(12):587-8. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44106

Study title: Park HM, Hunt-Reimann A, Appledorn CR, Siddiqui A. A comet-tail imaging artifact. Due to a "hot" point source and faulty electronics. Clin Nucl Med. 1993 Apr;18(4):341-2. No abstract available. Park HM, Hunt-Reimann A, Appledorn CR, Siddiqui A. A comet-tail imaging artifact. Due to a "hot" point source and faulty electronics. Clin Nucl Med. 1993 Apr;18(4):341-2. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43669

Study title: Early scintigraphic findings of occult femoral and tibial fractures in infants. Park HM, Kernek CB, Robb JA. Clin Nucl Med. 1988 Apr;13(4):271-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43819

Study title: Scintigraphic evaluation of extremity pain in children: its efficacy and pitfalls. Park HM, Rothschild PA, Kernek CB. AJR Am J Roentgenol. 1985 Nov;145(5):1079-84.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43930

Study title: Open pilot study to evaluate different dosages in various infections.Murdoch

Active substance: AMOXICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_8.xlsx

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Document reference: 48997

Study title: Open single centertrial to evaluate efficacy and safety of amoxicillin for treatment of UTIParsons et al

Active substance: AMOXICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_11.xlsx

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Document reference: 48995

Study title: Role of bone scans in assessment of skeletal age. Spencer RP, Sami S, Karimeddini M, Sziklas JJ, Rosenberg R. Int J Nucl Med Biol. 1981;8(1):33-8. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44134

Study title: Spencer RP, Sziklas JJ, Rosenberg R, Yoo JH, Weidner FA. Hemivertebral "disappearance" on bone scan. J Nucl Med. 1981 May;22(5):454-6. Spencer RP, Sziklas JJ, Rosenberg R, Yoo JH, Weidner FA. Hemivertebral "disappearance" on bone scan. J Nucl Med. 1981 May;22(5):454-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44125

Study title: Long-term scintigraphic appearance of extremities following bone tumor resection and allograft reconstruction. Smith JT, Smith LM, Rinsky L, Goris ML. Clin Nucl Med. 1991 Dec;16(12):907-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43722

Study title: Effect of growth hormone on metaphyseal uptake of 99mTc-methylene diphosphonate. Klingensmith WC 3rd, Klingensmith GJ, Tollefsen SE, Schalch DS. J Clin Endocrinol Metab. 1981 Jun;52(6):1162-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44123

Study title: Kloos RT, Rufini V, Gross MD, Shapiro B. Bone scans in neurofibromatosis: neurofibroma, plexiform neuroma and neurofibrosarcoma. J Nucl Med. 1996 Nov;37(11):1778-83. Kloos RT, Rufini V, Gross MD, Shapiro B. Bone scans in neurofibromatosis: neurofibroma, plexiform neuroma and neurofibrosarcoma. J Nucl Med. 1996 Nov;37(11):1778-83.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43558

Study title: Knop J, Delling G, Heise U, Winkler K. Parametric imaging of 99mTc methylene diphosphonate biokinetics in osteosarcoma for preoperative evaluation of chemotherapy-induced necrosis. Chir Organi Mov. 1990;75(1 Suppl):36-7. No abstract available. Knop J, Delling G, Heise U, Winkler K. Parametric imaging of 99mTc methylene diphosphonate biokinetics in osteosarcoma for preoperative evaluation of chemotherapy-induced necrosis. Chir Organi Mov. 1990;75(1 Suppl):36-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43773

Study title: Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43774

Study title: Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44176

Study title: Takebayashi S, Ono Y, Matsui K. [The changes in renal uptake of 99mTc-MDP after radiotherapy in the neuroblastoma (author's transl)] Kaku Igaku. 1981 Jul;18(6):859-62. Japanese. No abstract available. Takebayashi S, Ono Y, Matsui K. [The changes in renal uptake of 99mTc-MDP after radiotherapy in the neuroblastoma (author's transl)] Kaku Igaku. 1981 Jul;18(6):859-62. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44120

Study title: Battered child syndrome. Uncommon pelvic fractures detected by bone scintigraphy. Tan TX, Gelfand MJ. Clin Nucl Med. 1997 May;22(5):321-2. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43552

Study title: Craniofacial fibrous dysplasia showing marked involution postoperatively. Tanaka Y, Tajima S, Maejima S, Umebayashi M. Ann Plast Surg. 1993 Jan;30(1):71-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43678

Study title: Osteoid osteoma of the proximal femur: new techniques in diagnosis and treatment. Kumar SJ, Harcke HT, MacEwen GD, Ger E. J Pediatr Orthop. 1984 Nov;4(6):669-72.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43978

Study title: [Algodystrophy, a little known disease in children. General review apropos of 4 cases] French. Labenne M, Bertrand AM, Wendling D, Onimus M, Laurain JM, Amsallem D. Ann Pediatr (Paris). 1987 Oct;34(8):603-8. Review. French. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43850

Study title: [Peroperative isotopic detection in the treatment of osteoid osteoma in children] French. Lacheretz M, Herbaux B, Hossein-Foucher C, Lecouffe P, Richir M. Chirurgie. 1989;115(7):413-6. French.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43798

Study title: Lagard D, Dupont S, Boutry N, Delfaut E, Cotten A. [Cortical septic osteitis: two cases] J Radiol. 2000 Jan;81(1):54-8. French. Lagard D, Dupont S, Boutry N, Delfaut E, Cotten A. [Cortical septic osteitis: two cases] J Radiol. 2000 Jan;81(1):54-8. French.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43494

Study title: Lamki L, Willis RB. Radionuclide findings of pyomyositis. Clin Nucl Med. 1982 Oct;7(10):465-7. No abstract available. Lamki L, Willis RB. Radionuclide findings of pyomyositis. Clin Nucl Med. 1982 Oct;7(10):465-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44073

Study title: Lammer J, Fueger GF, Fotter R, Nicoletti R. [A computer macro-programme for osteoscintimetry and activity profile in Perthe's disease (author's transl)] Rofo. 1982 Jan;136(1):14-21. German. Lammer J, Fueger GF, Fotter R, Nicoletti R. [A computer macro-programme for osteoscintimetry and activity profile in Perthe's disease (author's transl)] Rofo. 1982 Jan;136(1):14-21. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44103

Study title: To determine the blood and tonsil levels of ampicillin after rectal and oral administration.Baba et al. (1983-05-04)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_9.xlsx

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Document reference: 49009

Study title: To investigate the absorption and excretion of ampicillin from supporitories given to children.Iwai et al. (1983-05-04)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_12.xlsx

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Document reference: 49010

Study title: To investigate the absorption and excretion of ampicillin from supporitories given to children.Nakazawa et al. (1983-05-16)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_16.xlsx

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Document reference: 49015

Study title: To investigate the absorption of ampicillin from suppositories in children.Motohiro et al. (1983-05-09)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_15.xlsx

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Document reference: 49012

Study title: Effect of long-term treatment with fluticasone propionate on bone density, growth and lung function in childhood asthma.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FMS40175-ICHE3.pdf

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Document reference: 28388

Study title: Efficacy of treatment with inhaled fluticasone and the effect of priming and activation of PMN cells in children with allergy and asthma.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FMS40229-ICHE3.pdf

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Document reference: 28405

Study title: FLU9705: a multi-centre, parallel group, randomised, double-blind study to investigate the efficacy of fluticasone propionate 100 mcg MDI bd versus placebo MDI bd both via Babyhaler™ spacer in 1 to 5 year old children with asthma or asthma-like symptoms during a 6 months study period.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FMS40256-ICHE3.pdf

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Document reference: 28395

Study title: Nebulised Fluticasone propionate in an upper respiratory tract inflammatory disorder (rhinopharyngitis): a multicentre, randomised, blinded, parallel group study of the efficacy and safety of nebulised fluticasone propionate 0.5mg daily compared with nebulised beclomethasone dipropionate 0.8mg daily in children suffering from acute rhinopharyngitis.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FLIC09-ICHE3.pdf

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Document reference: 28422

Study title: Pharmacodynamics of the 88mcg BID dose of the Hydrofluoroalkane propellant formulation of inhaled Fluticasone Propionate following Administration via the Metered-dose Inhaler in Pediatric Subjects 4 to 11 years of age with Asthma

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FAP19052-ICHE3.pdf

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Document reference: 28390

Study title: Prevention of Otitis media in children." 6) "A randomized, double-blind, placebo-controlled study examining the effect of fluticasone propionate aqueous nasal spray in antibiotic therapy in the treatment of chronic rhinosinusitis in paediatric patients."

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FNM40083-ICHE3.pdf

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Document reference: 28367

Study title: Report on a multicentre, randomised, double-blind, parallel-group clinical trial to compare the efficacy and safety of the dry powder formulation of fluticasone proprionate (FP) 200μg/day with fluticasone proprionate 400μg/day administered for 6 weeks from a multidose powder device (Diskus™) to paediatric patients with chronic asthma.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FLTB3051-ICHE3.pdf

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Document reference: 28380

Study title: Systemic exposure of the fluticasone propionate from the hydrofluoroalkane propellant formulation via the metered-dose inhaler with and without a spacer in pediatric subjects 4 to 11 years of age with asthma.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FAP19058-ICHE3.pdf

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Document reference: 28418

Study title: Treatment with inhaled corticosteroids in wheezing pre-school children: is there a predictable effect?

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone -Propionate-FMS40257-ICHE3.pdf

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Document reference: 28396

Study title: A multi-centre, randomised, open-label, parallel group clinical trial to assess the efficacy and safety of Salmeterol/Fluticasone Propionate combination product (2x 25/125μg/actuation, bd) via a hydrofluoroalkane metereddose inhaler compared with Salmeterol/Fluticasone Propionate Accuhaler™ (50/250μg bd) in adult Chinese patients with mild to moderate asthma.

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAS30021-ICHE3.pdf

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Document reference: 28452

Study title: A 12-week randomized, multicenter, double-blind, placebo controlled, parallel group study in children (aged 5-12, inclusive) with persistent asthma evaluating the safety, efficacy and pharmacokinetics of Foradil (formoterol fumarate) 10 mg bid delivered b

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 0604 Art45 listing 2011.xls

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Document reference: 47797

Study title: Paulsen HU, Rabøl A, Sørensen SS. Bone scintigraphy of human temporomandibular joints during Herbst treatment: a case report. Eur J Orthod. 1998 Aug;20(4):369-74. Paulsen HU, Rabøl A, Sørensen SS. Bone scintigraphy of human temporomandibular joints during Herbst treatment: a case report. Eur J Orthod. 1998 Aug;20(4):369-74.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43525

Study title: Paulus G, Hirschfelder U, Feistel H. [Computer-assisted quantitative bone scintigraphy in the treatment planning of condylar hyperplasia] Fortschr Kiefer Gesichtschir. 1987;32:180-1. German. No abstract available. Paulus G, Hirschfelder U, Feistel H. [Computer-assisted quantitative bone scintigraphy in the treatment planning of condylar hyperplasia] Fortschr Kiefer Gesichtschir. 1987;32:180-1. German. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43884

Study title: Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44118

Study title: Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44238

Study title: Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44285

Study title: Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44086

Study title: Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44187

Study title: Parker BR. Neuroblastoma with extraosseous uptake of bone-seeking radionuclide. AJR Am J Roentgenol. 1981 May;136(5):1032-4. No abstract available. Parker BR. Neuroblastoma with extraosseous uptake of bone-seeking radionuclide. AJR Am J Roentgenol. 1981 May;136(5):1032-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44124

Study title: Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44223

Study title: Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44270

Study title: Minoves M, Bassa P, Clemente A, Rivas A, Riera E, Setoain J, Costansa JM. Incidental finding of varicocele detected on a blood-pool image on Tc-99m HMDP bone scintigraphy. Clin Nucl Med. 2000 Nov;25(11):947-8. No abstract available. Minoves M, Bassa P, Clemente A, Rivas A, Riera E, Setoain J, Costansa JM. Incidental finding of varicocele detected on a blood-pool image on Tc-99m HMDP bone scintigraphy. Clin Nucl Med. 2000 Nov;25(11):947-8. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43472

Study title: Becker muscular dystrophy associated with focal myositis on bone scintigraphy. Minshew PT, Silverman ED, Samuels-Botts C. Clin Nucl Med. 2000 Dec;25(12):1010-2.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43470

Study title: Sacroiliitis as a sole manifestation of Brucella melitensis infection in a child. Miron D, Garty I, Tal I, Horovitz Y, Kedar A. Clin Nucl Med. 1987 Jun;12(6):466-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43860

Study title: The value of quantitative sacroiliac scintigraphy in detection of sacroiliitis. Miron SD, Khan MA, Wiesen EJ, Kushner I, Bellon EM. Clin Rheumatol. 1983 Dec;2(4):407-14.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44020

Study title: Osteomyelitis in the neonate. Clinical aspects and the role of radiography and scintigraphy in diagnosis and management. Mok PM, Reilly BJ, Ash JM. Radiology. 1982 Dec;145(3):677-82.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44066

Study title: Mondal A, Bhatnagar A, Sharma R, Behari V, Sawroop K, Khanna CM. Evaluation of the healing process in fractures using early and delayed bone scanning. Australas Radiol. 1994 Nov;38(4):284-7. Mondal A, Bhatnagar A, Sharma R, Behari V, Sawroop K, Khanna CM. Evaluation of the healing process in fractures using early and delayed bone scanning. Australas Radiol. 1994 Nov;38(4):284-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43608

Study title: Investigate the relationship between relapses in H. influenzae meningitis and the ability of ampicillin to penetrate to the CSF.Coleman et al. (The journal of pediatrics May 1969)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_7.xlsx

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Document reference: 49008

Study title: Single-blind trial to evaluate the efficacy and safety of ampicillin suppositories in bacterial pneumonia in children using i.v. ampicillin as reference drug.Motohiro et al. (1983-05-09)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_21.xlsx

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Document reference: 49020

Study title: Study plasma concentrations after rectal administration of ampicillin suppositories to children.Movin et al. (1987-06-15)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_23.xlsx

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Document reference: 49022

Study title: Lammer J, Nicoletti R, Fueger GF, Fink W. Osteoscintimetry--a method of semiquantitative evaluation of skeletal scintigrams by use of profiles and a macro function for computer processing. Eur J Nucl Med. 1982;7(8):364-9. Lammer J, Nicoletti R, Fueger GF, Fink W. Osteoscintimetry--a method of semiquantitative evaluation of skeletal scintigrams by use of profiles and a macro function for computer processing. Eur J Nucl Med. 1982;7(8):364-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44099

Study title: LaMont RL, Muz J, Heilbronner D, Bouwhuis JA. Quantitative assessment of femoral head involvement in Legg-Calvé-Perthes disease. J Bone Joint Surg Am. 1981 Jun;63(5):746-52. LaMont RL, Muz J, Heilbronner D, Bouwhuis JA. Quantitative assessment of femoral head involvement in Legg-Calvé-Perthes disease. J Bone Joint Surg Am. 1981 Jun;63(5):746-52.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44122

Study title: Transient severe metastatic calcification in acute renal failure. Landau D, Krymko H, Shalev H, Agronovich S. Pediatr Nephrol. 2007 Apr;22(4):607-11. Epub 2006 Dec 21.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43369

Study title: O'Reilly RJ, Cook DJ, Gaffney RD, Angel KR, Paterson DC. Can serial scintigraphic studies detect delayed fracture union in man? Clin Orthop Relat Res. 1981 Oct;(160):227-32. O'Reilly RJ, Cook DJ, Gaffney RD, Angel KR, Paterson DC. Can serial scintigraphic studies detect delayed fracture union in man? Clin Orthop Relat Res. 1981 Oct;(160):227-32.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44110

Study title: Review of spondylolisthesis and spondylolysis in paediatric practice. Oakley RH, Carty H. Br J Radiol. 1984 Oct;57(682):877-85.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43981

Study title: Oates E, Sarno RC. Imaging of pelvic rhabdomyosarcoma by bone scintigraphy. Eur J Nucl Med. 1987;13(6):297-9. Oates E, Sarno RC. Imaging of pelvic rhabdomyosarcoma by bone scintigraphy. Eur J Nucl Med. 1987;13(6):297-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43879

Study title: Oesterreich FU, Jend-Rossmann I, Jend HH, Triebel HJ. [Semiquantitative SPECT of anterior dislocation of the temporomandibular joint disk] Rofo. 1987 Jan;146(1):13-7. German. Erratum in: ROFO 1987 Apr;146(4):487. Oesterreich FU, Jend-Rossmann I, Jend HH, Triebel HJ. [Semiquantitative SPECT of anterior dislocation of the temporomandibular joint disk] Rofo. 1987 Jan;146(1):13-7. German. Erratum in: ROFO 1987 Apr;146(4):487.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43886

Study title: Oesterreich FU, Jend-Rossmann I, Jend HH, Triebel HJ. Semiquantitative SPECT imaging for assessment of bone reactions in internal derangements of the temporomandibular joint. J Oral Maxillofac Surg. 1987 Dec;45(12):1022-8. Oesterreich FU, Jend-Rossmann I, Jend HH, Triebel HJ. Semiquantitative SPECT imaging for assessment of bone reactions in internal derangements of the temporomandibular joint. J Oral Maxillofac Surg. 1987 Dec;45(12):1022-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43840

Study title: Oh SN, Jee WH, Cho SM, Kim SH, Kang HS, Ryu KN, Cho CS. Osteonecrosis in patients with systemic lupus erythematosus: MR imaging and scintigraphic evaluation. Clin Imaging. 2004 Jul-Aug;28(4):305-9. Oh SN, Jee WH, Cho SM, Kim SH, Kang HS, Ryu KN, Cho CS. Osteonecrosis in patients with systemic lupus erythematosus: MR imaging and scintigraphic evaluation. Clin Imaging. 2004 Jul-Aug;28(4):305-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43400

Study title: A 3-month, placebo-controlled efficacy study of formoterol Turbuhaler 4.5μg and 9μg b.i.d. (corresponding to the metered doses 6μg and 12μg, respectively) in asthmatic children aged 6 to 17 years.

Active substance: FORMOTEROL

Study summary document link (including results): SD-037-0003 Study Synopsis.pdf

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Document reference: 47798

Study title: A 3-week, multicenter study investigating patient use and functionality of the Foradil Certihaler device in patients with asthma.

Active substance: FORMOTEROL

Study summary document link (including results): FOR258F2309 Art45 listing 2011.xls

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Document reference: 47799

Study title: A 3-week, open-label, uncontrolled, multicenter study evaluating the functionality of the Foradil Certihaler device in patients with Asthma.

Active substance: FORMOTEROL

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Document reference: 47801

Study title: A 6 months comparison of the safety and efficacy profiles of OXIS (formoterol) Turbuhaler as needed and BRICANYL (terbutaline) Turbuhaler as needed in children with asthma on anti-inflammatory treatment.

Active substance: FORMOTEROL

Study summary document link (including results): SD-037-0695 Study Synopsis.pdf

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Document reference: 47802

Study title: A double-blind, placebo-controlled efficacy study of formoterol Turbuhaler 4.5μg and 9μg (corresponding to the metered doses of 6μg and 12μg, respectively) in asthmatic children.

Active substance: FORMOTEROL

Study summary document link (including results):

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Document reference: 47803

Study title: A NEW BRONCHODILATOR, IN THE PEDIATRIC PATIENTS WITH NON-ASTHMATIC RESPIRATORY DISORDERS.

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 YBDG 5-4 Art45 listing 2011.xls

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Document reference: 47804

Study title: A RANDOMISED, DOUBLE-BLIND, CROSS-OVER, MULTI-CENTRE STUDY COMPARING THE EFFICACY AND TOLERABILITY OF FORMOTEROL 12 UG INHALED TWICE DAILY WITH SALBUTAMOL 100 UG INHALED FOUR TIMES DAILY IN THE TREATMENT OF ASTHMA IN CHILDREN

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 NBG 8937 Art45 Listing.xls

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Document reference: 47805

Study title: A randomized double-blind, cross-over comparison of inhaled formoterol 12 ug and salbutamol 200 ug in children with exercise induced asthma

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 FO-DK1Art45 listing 2011.xls

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Document reference: 47807

Study title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTIPLE DOSE (1 WEEK) FINDING, MULTICENTER, CROSSOVER STUDY IN CHILDREN AGED 5 TO 12 WITH PERSISTENT ASTHMA COMPARING 4 DOSES (5, 10, 15 AND 30 UG) OF FORMOTEROL BID ADMINISTERED FROM THE MULTIPLE DOSE DRY

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 0602 Art45 listing 2011.xls

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Document reference: 47808

Study title: A randomized, multi-centre, double-blind, double-dummy placebo controlled single-dose cross-over study to demonstrate that 12 and 24 mg of formoterol delivered by concept1 has a bronchodilator efficacy which is equivalent to the same dose of formoterol de

Active substance: FORMOTEROL

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Document reference: 47811

Study title: A randomized, multicenter, double-blind, double-dummy, placebo controlled, cross-over dose ranging study to evaluate the safety and efficacy of single doses of formoterol fumarate (6,12 and 24 ug) via an hfa pmdi versus placebo and versus formoterol fumar

Active substance: FORMOTEROL

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Document reference: 47809

Study title: MULTI-CENTRE, OPEN LABEL, NON COMPARATIVE STUDY OF MULTIPLEDOSES OF 12 MYG FORMOTEROL METERED DOSE AEROSOL IN CHILDREN WITH BROCHIAL ASTHMA

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 BA-RP1F Art45 listing 2011.xls

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Document reference: 47849

Study title: Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44234

Study title: Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44281

Study title: Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44267

Study title: Urman M, Ammann W, Sisler J, Lentle BC, Llyod-Smith R, Loomer R, Fisher C. The role of bone scintigraphy in the evaluation of talar dome fractures. J Nucl Med. 1991 Dec;32(12):2241-4. Urman M, Ammann W, Sisler J, Lentle BC, Llyod-Smith R, Loomer R, Fisher C. The role of bone scintigraphy in the evaluation of talar dome fractures. J Nucl Med. 1991 Dec;32(12):2241-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43720

Study title: [Nonspecific osteomyelitis in childhood and adolescence. The contribution of imaging diagnosis] Italian. Urso S, Pacciani E, Fariello G, Colajacomo M, Fassari FM, Randisi F, Certo A, Liberatore M, Pagnotta G. Radiol Med (Torino). 1995 Sep;90(3):212-8. Italian.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43589

Study title: Usui K, Yamamoto W, Shuke N, Aburano T, Yamanaka Y, Tokusashi Y, Miyokawa N. Scintigraphic findings of tibial adamantinoma on a three-phase bone scan. Clin Nucl Med. 2000 Dec;25(12):1057-8. No abstract available. Usui K, Yamamoto W, Shuke N, Aburano T, Yamanaka Y, Tokusashi Y, Miyokawa N. Scintigraphic findings of tibial adamantinoma on a three-phase bone scan. Clin Nucl Med. 2000 Dec;25(12):1057-8. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43467

Study title: Vade A, Jeske J. Infiltrating lipoma of the chest wall. Pediatr Radiol. 1993;23(6):469-70. No abstract available. Vade A, Jeske J. Infiltrating lipoma of the chest wall. Pediatr Radiol. 1993;23(6):469-70. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43679

Study title: Moore AE, Blake GM, Fogelman I. A study to determine the dependence of 99mTc-MDP protein binding on plasma clearance and serum albumin concentration. Nucl Med Commun. 2007 Mar;28(3):187-92. Moore AE, Blake GM, Fogelman I. A study to determine the dependence of 99mTc-MDP protein binding on plasma clearance and serum albumin concentration. Nucl Med Commun. 2007 Mar;28(3):187-92.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43366

Study title: Moragas M, Lomeña F, Herranz R, García A, Piera C, Muxí A, Bassa P, Catafau A, Pavía A, Setoain J. 99Tcm-HMPAO leucocyte scintigraphy in the diagnosis of bone infection. Nucl Med Commun. 1991 May;12(5):417-27. Moragas M, Lomeña F, Herranz R, García A, Piera C, Muxí A, Bassa P, Catafau A, Pavía A, Setoain J. 99Tcm-HMPAO leucocyte scintigraphy in the diagnosis of bone infection. Nucl Med Commun. 1991 May;12(5):417-27.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43736

Study title: Morrison SC, Makley JT, O'Donnell J. Skeletal scintigraphic appearance of an auto-transplanted osteoarticular plug: epiphyseal transplant. Pediatr Radiol. 2003 Jul;33(7):482-4. Epub 2003 Apr 26. Morrison SC, Makley JT, O'Donnell J. Skeletal scintigraphic appearance of an auto-transplanted osteoarticular plug: epiphyseal transplant. Pediatr Radiol. 2003 Jul;33(7):482-4. Epub 2003 Apr 26.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43423

Study title: Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44237

Study title: Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44284

Study title: Age-related changes in the hemodynamics of the femoral head as evaluated by early phase of bone scintigraphy. Hamaguchi H, Fujioka M, Takahashi KA, Hirata T, Ishida M, Sakao K, Ushijima Y, Kubota T, Nishimura T, Kubo T. Ann Nucl Med. 2006 Jan;20(1):35-40.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43378

Study title: Ohta H, Hojo M, Shintaku M, Komibuchi T, Okamoto S. Tc-99m HMDP and Ga-67 imaging along with CT and MRI in fibrous dysplasia of the temporal bone. Clin Nucl Med. 1997 May;22(5):328-30. No abstract available. Ohta H, Hojo M, Shintaku M, Komibuchi T, Okamoto S. Tc-99m HMDP and Ga-67 imaging along with CT and MRI in fibrous dysplasia of the temporal bone. Clin Nucl Med. 1997 May;22(5):328-30. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43551

Study title: Okimura T, Higashi K, Nakagawa T, Kobayashi S, Tohda N. [A case of myositis ossificans with abnormal uptake of 99mTc-MDP and 67Ga-citrate] Rinsho Hoshasen. 1985 Jan;30(1):157-9. Japanese. No abstract available. Okimura T, Higashi K, Nakagawa T, Kobayashi S, Tohda N. [A case of myositis ossificans with abnormal uptake of 99mTc-MDP and 67Ga-citrate] Rinsho Hoshasen. 1985 Jan;30(1):157-9. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43968

Study title: Okuyama T, Suzuki H, Nakamoto K, Suzuki S. [Evaluation of bone scintigraphy in differential diagnosis of benign bone tumors] Kaku Igaku. 1982 Dec;19(10):1519-30. Japanese. No abstract available. Okuyama T, Suzuki H, Nakamoto K, Suzuki S. [Evaluation of bone scintigraphy in differential diagnosis of benign bone tumors] Kaku Igaku. 1982 Dec;19(10):1519-30. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44063

Study title: Holder LE, Michael RH. The specific scintigraphic pattern of "shin splints in the lower leg": concise communication. J Nucl Med. 1984 Aug;25(8):865-9. Holder LE, Michael RH. The specific scintigraphic pattern of "shin splints in the lower leg": concise communication. J Nucl Med. 1984 Aug;25(8):865-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43988

Study title: Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44107

Study title: Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44188

Study title: Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44235

Study title: Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

Study summary document link (including results):

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Document reference: 44282

Study title: ONSET OF ACTION IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 DFORC3 Art45 listing 2011.xls

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Document reference: 47851

Study title: OPEN LONG TERM TRIAL ON FORMOTEROL METERED DOSE AEROSOL IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 DFORE6 - D 042 Art45 listing 2011.xls

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Document reference: 47852

Study title: Open-label, multi-center, non-controlled follow-up study over 3 months on the safety of Formoterol Easyhaler in approximately 35 asthmatic pediatric patients initially treated in study

Active substance: FORMOTEROL

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Document reference: 47855

Study title: Open, 12-month, follow-up of a 3-month, comparative, multi-centre, double-blind trial to assess the long-term tolerability and efficacy of formoterol 12 ug dry powder capsules in children with reversible obstructive airways diseases

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 DP-PD2F Art45 listing 2011.xls

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Document reference: 47853

Study title: Open, multi-center, randomized, two fold crossover safety study comparing Formoterol Easyhaler vs. Foradil Aerolizer over a treatment period comprising two times 3-months in 70 asthmatic pediatric patients.

Active substance: FORMOTEROL

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Document reference: 47854

Study title: PLACEBO-CONTROLLED, COMPARATIVE, SINGLE-CENTER, DOUBLE-BLIND, WITHIN-PATIENT, TRIAL TO COMPARE THE MAGNITUDE AND DURATION OF PROTECTION AGAINST EXERCISE-INDUCED BRONCHOCONSTRICTION OF INHALED FORMOTEROL DRY POWDER CAPSULES 12 UG WITH THAT OF SALBUTAMOL DR

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 DPPD3 Art45 listing 2011.xls

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Document reference: 47856

Study title: PLACEBO-CONTROLLED, COMPARATIVE, SINGLE-CENTRE, DOUBLE-BLIND, WITHIN-PATIENT TRIAL TO COMPARE THE EXTENT AND DURATION OF PROTECTION AGAINST EXERCISE-INDUCED BRONCHOCONSTRICTION OF 12 UG INHALED FORMOTEROL AEROSOL WITH THAT OF 200 UG INHALED SALBUTAMOL AER

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 SP PD4 Art45 listing 2011.xls

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Document reference: 47857

Study title: PLACEBO-CONTROLLED, DOSE-FINDING, SINGLE-CENTRE, DOUBLE-BLIND, WITHIN-PATIENT TRIAL OF DIFFERENT DOSES OF INHALED FORMOTEROL DRY POWDER (6, 12, 24 UG) AND 400 UG INHALED SALBUTAMOL DRY POWDER IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 DP-PD6 Art45 listing 2011.xls

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Document reference: 47858

Study title: Preliminary 14 day pilot inhalation study of an HFA-propelled Foradil inhalation aerosol in juvenile beagle dogs

Active substance: FORMOTEROL

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Document reference: 47859

Study title: PREVENTIVE EFFECT AND TOLERABILITY OF FORMOTEROL COMPARED WITH THAT OF SALBUTAMOL IN CHILDREN WITH EXERCISE-INDUCED ASTHMA

Active substance: FORMOTEROL

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Document reference: 47860

Study title: Protective effect of single doses of formoterol Turbuhaler 4.5μg and 9μg (corresponding to the metered doses 6μg and 12μg, respectively) compared with terbutaline Turbuhelr 0.5mg and placebo in children with exercise-induced bronchoconstriction (EIB).

Active substance: FORMOTEROL

Study summary document link (including results): SD-037-0149 Study Synopsis.pdf

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Document reference: 47861

Study title: RESULTS OF CLINICAL USE OF BD 40A DRY SYRUP FOR PEDIATRIC BRONQUIAL-ASTHMA

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 YBDG 3-6 Art45 listing 2011.xls

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Document reference: 47862

Study title: Single dose toxicity of formoterol fumarate (D2522) in young rats after oral administration.

Active substance: FORMOTEROL

Study summary document link (including results):

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Document reference: 47863

Study title:

Active substance: FLUTICASONE

Study summary document link (including results):

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Document reference: 28386

Study title:

Active substance: FLUTICASONE

Study summary document link (including results):

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Document reference: 28387

Study title:

Active substance: FLUTICASONE

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Document reference: 28392

Study title: Behrendt H et alMitoxantrone is effective in treating childhood T-cell lymphoma/T-cell acute lymphoblastic leukemiaCancer. 1995 Jul 15;76(2):339-42.Behrendt H et alMitoxantrone is effective in treating childhood T-cell lymphoma/T-cell acute lymphoblastic leukemiaCancer. 1995 Jul 15;76(2):339-42.

Active substance: MITOXANTRONE

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Document reference: 32083

Study title: Van Campenhout A, Moens P, Fabry G. Serial bone scintigraphy in Legg-Calvé-Perthes disease: correlation with the Catterall and Herring classification. J Pediatr Orthop B. 2006 Jan;15(1):6-10. Van Campenhout A, Moens P, Fabry G. Serial bone scintigraphy in Legg-Calvé-Perthes disease: correlation with the Catterall and Herring classification. J Pediatr Orthop B. 2006 Jan;15(1):6-10.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43382

Study title: van den Oever M, Merrick MV, Scott JH. Bone scintigraphy in symptomatic spondylolysis. J Bone Joint Surg Br. 1987 May;69(3):453-6. van den Oever M, Merrick MV, Scott JH. Bone scintigraphy in symptomatic spondylolysis. J Bone Joint Surg Br. 1987 May;69(3):453-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43865

Study title: Generalized soft tissue calcification in children and adolescents with end stage renal failure. van Diemen-Steenvoorde R, Donckerwolcke RA, de Haas G. Eur J Pediatr. 1986 Sep;145(4):293-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43893

Study title: Influence of age and gender on quantitative sacroiliac joint scintigraphy. Lin WY, Wang SJ. J Nucl Med. 1998 Jul;39(7):1269-72.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43531

Study title: Litchman HM, McCullough RW, Gandsman EJ, Schatz SL. Computerized blood flow analysis for decision making in the treatment of osteochondritis dissecans. J Pediatr Orthop. 1988 Mar-Apr;8(2):208-12. Litchman HM, McCullough RW, Gandsman EJ, Schatz SL. Computerized blood flow analysis for decision making in the treatment of osteochondritis dissecans. J Pediatr Orthop. 1988 Mar-Apr;8(2):208-12.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43824

Study title: Liu JX. [Early quantitative detection of vascularity of the reduced femoral head of congenital hip dislocation by scintigraphy] Zhonghua Wai Ke Za Zhi. 1990 May;28(5):292-4, 318. Chinese. Liu JX. [Early quantitative detection of vascularity of the reduced femoral head of congenital hip dislocation by scintigraphy] Zhonghua Wai Ke Za Zhi. 1990 May;28(5):292-4, 318. Chinese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43764

Study title: Hypertrophic pulmonary osteoarthropathy in nasopharyngeal carcinoma: an early sign of pulmonary metastasis. Liu RS, Chen YK, Yen SH, Chu YK, Chu LS, Chen KY, Yeh SH. Nucl Med Commun. 1995 Sep;16(9):785-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43591

Study title: Liu RS, Chou CS, Yeh SH. Three-phase bone scintigraphy in Pellegrini-Stieda disease. Clin Nucl Med. 1987 Jan;12(1):47-9. Liu RS, Chou CS, Yeh SH. Three-phase bone scintigraphy in Pellegrini-Stieda disease. Clin Nucl Med. 1987 Jan;12(1):47-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43877

Study title: Primary septic arthritis in heroin users: early diagnosis by radioisotopic imaging and geographic variations in the causative agents. Lopez-Longo FJ, Ménard HA, Carreño L, Cosin J, Ballesteros R, Monteagudo I. J Rheumatol. 1987 Oct;14(5):991-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43846

Study title: A double blind trial to evaluate the incidence of diarrhea and C. difficile toxin (CDT) folloing therapy with ampicillin (AMP), amoxicillin (AMOX), or trimethoprim-sulfamethoxazole (TMP-SMX) for otitis media.Hyams et al. (Pediatr Infect Dis. 1984 Sep-Oct;3(5):433-6)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_30.xlsx

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Document reference: 49029

Study title: Hamscho N, Grünwald F. Prognosis of primary osteosarcoma. J Nucl Med. 2003 Jun;44(6):996-7; author reply 997. No abstract available. Hamscho N, Grünwald F. Prognosis of primary osteosarcoma. J Nucl Med. 2003 Jun;44(6):996-7; author reply 997. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43420

Study title: Han CS, Wood MB, Bishop AT, Cooney WP 3rd. Vascularized bone transfer. J Bone Joint Surg Am. 1992 Dec;74(10):1441-9. Han CS, Wood MB, Bishop AT, Cooney WP 3rd. Vascularized bone transfer. J Bone Joint Surg Am. 1992 Dec;74(10):1441-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43681

Study title: Unexpected stomach uptake of technetium-99m-MDP. Spicer JA, Slaton CK, Raveill TG, Baxter KG, Preston DF, Hladik WB. J Nucl Med Technol. 1999 Mar;27(1):43-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43508

Study title: Spitz J, Becker C, Tittel K, Weigand H. [Clinical relevance of whole body skeletal scintigraphy in multiple injury and polytrauma patients] Unfallchirurgie. 1992 Jun;18(3):133-47. German. Spitz J, Becker C, Tittel K, Weigand H. [Clinical relevance of whole body skeletal scintigraphy in multiple injury and polytrauma patients] Unfallchirurgie. 1992 Jun;18(3):133-47. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43695

Study title: Spitz J, Lauer I, Tittel K, Wiegand H. Scintimetric evaluation of remodeling after bone fractures in man. J Nucl Med. 1993 Sep;34(9):1403-9. Spitz J, Lauer I, Tittel K, Wiegand H. Scintimetric evaluation of remodeling after bone fractures in man. J Nucl Med. 1993 Sep;34(9):1403-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43654

Study title: [The age dependence of traumatically induced bone remodeling as studied in the bone scintigram] German Spitz J, Lauer I, Tittel K. Nuklearmedizin. 1991 Oct;30(5):155-60. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43726

Study title: Springorum HW, Bostel F, Puhl W, Georgi P. [Spinal scintigraphy following Harrington's spondylodesis] Z Orthop Ihre Grenzgeb. 1984 May-Jun;122(3):255-9. German. Springorum HW, Bostel F, Puhl W, Georgi P. [Spinal scintigraphy following Harrington's spondylodesis] Z Orthop Ihre Grenzgeb. 1984 May-Jun;122(3):255-9. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44001

Study title: Occult fracture of the calcaneus--another toddler's fracture. Starshak RJ, Simons GW, Sty JR. Pediatr Radiol. 1984;14(1):37-40.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44017

Study title: Horii T, Tsuchiya H, Tomita K. Presacral tumor associated with the Currarino triad in an adolescent. Arch Orthop Trauma Surg. 2001;121(1-2):114-6. Horii T, Tsuchiya H, Tomita K. Presacral tumor associated with the Currarino triad in an adolescent. Arch Orthop Trauma Surg. 2001;121(1-2):114-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43465

Study title: Horne T, Mogle P, Finsterbush A, Gordin M. Increased uptake of 99mTc-MDP in calcified synovial sarcoma. Eur J Nucl Med. 1983;8(2):75-6. No abstract available. Horne T, Mogle P, Finsterbush A, Gordin M. Increased uptake of 99mTc-MDP in calcified synovial sarcoma. Eur J Nucl Med. 1983;8(2):75-6. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44054

Study title: The technetium phosphate bone scan in the diagnosis of osteomyelitis in childhood. Howie DW, Savage JP, Wilson TG, Paterson D. J Bone Joint Surg Am. 1983 Apr;65(4):431-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44041

Study title: Multifocal pyomyositis. Diagnosis on technetium-99m MDP bone scan. Howman-Giles R, McCauley D, Brown J. Clin Nucl Med. 1984 Mar;9(3):149-51.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44004

Study title: Taylor GA, Shea N, O'Brien T, Hall JE, Treves ST. Osteoid osteoma: localization by intraoperative magnification scintigraphy. Pediatr Radiol. 1986;16(4):313-6. PMID: 3725449 [PubMed - indexed for MEDLINE] Taylor GA, Shea N, O'Brien T, Hall JE, Treves ST. Osteoid osteoma: localization by intraoperative magnification scintigraphy. Pediatr Radiol. 1986;16(4):313-6. PMID: 3725449 [PubMed - indexed for MEDLINE]

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43922

Study title: [Osteomyelitis in children: sometimes hard to recognize] Dutch. te Pas AB, Feith SW, Wit JM. Ned Tijdschr Geneeskd. 2002 Aug 17;146(33):1547-50. Dutch.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43438

Study title: Teixeira AB, Sá de Camargo Etchebehere EC, Santos AO, Lima MC, Ramos CD, Camargo EE. Scintigraphic findings of dysplasia epiphysealis hemimelica: a case report. Clin Nucl Med. 2001 Feb;26(2):162. No abstract available. Teixeira AB, Sá de Camargo Etchebehere EC, Santos AO, Lima MC, Ramos CD, Camargo EE. Scintigraphic findings of dysplasia epiphysealis hemimelica: a case report. Clin Nucl Med. 2001 Feb;26(2):162. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43460

Study title: Rectus femoris muscle bone-image uptake in a sprinter. Telepak RJ, Hartshorne MF, Bauman JM, Cawthon MA. Clin Nucl Med. 1986 May;11(5):365. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43911

Study title: Thämmig R, Schulze K, Niederle J. [Display of a primary neuroblastoma in the bone scintigram] Rofo. 1981 Aug;135(2):239-40. German. No abstract available. Thämmig R, Schulze K, Niederle J. [Display of a primary neuroblastoma in the bone scintigram] Rofo. 1981 Aug;135(2):239-40. German. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44116

Study title: To investigate the absorption of ampicillin from suppositories.Kida et al. (1983-05-04)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_13.xlsx

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Document reference: 49013

Study title: To study changes in fecal bacterial flora, including its sensitivity to ampicillin, after rectal and oral administration of ampicillin. Fecal ampicillin concetrations were also studied.Motohiro et al. (1986-10-17)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_14.xlsx

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Document reference: 49014

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone -Propionate-FAS30007-ICHE3.pdf

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Document reference: 28393

Study title:

Active substance: FLUTICASONE

Study summary document link (including results):

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Document reference: 28400

Study title:

Active substance: FLUTICASONE

Study summary document link (including results):

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Document reference: 28401

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Study FLIC22 Fluticasone Propionate Fixotide nebules.xls

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Document reference: 28402

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Study FMDT08-Fluticasone Propionate-Flixotide Diskus.xls

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Document reference: 28403

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Study FPC40002-Fluticasone propionate-Cutivate - approved.xls

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Document reference: 28406

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Study FLNT52-Fluticasone_Flixonase.xls

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Document reference: 28410

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Study FLNT59-Fluticasone_Flixonase.xls

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Document reference: 28411

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Study FLNT60-FNM30026-Fluticasone_Flixonase.xls

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Document reference: 28412

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Study FPC40001-Fluticasone propionate-Cutivate - approved.xls

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Document reference: 28427

Study title:

Active substance: FLUTICASONE

Study summary document link (including results):

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Document reference: 28429

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Synopsis-Fluticasone Propionate-CUTIVATE-FLT411.pdf

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Document reference: 28430

Study title:

Active substance: FLUTICASONE

Study summary document link (including results):

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Document reference: 28431

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Synopsis-Fluticasone Propionate-CUTIVATE-FLT412.pdf

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Document reference: 28433

Study title:

Active substance: FLUTICASONE

Study summary document link (including results):

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Document reference: 28439

Study title:

Active substance: FLUTICASONE

Study summary document link (including results):

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Document reference: 28440

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Synopsis-Fluticasone Propionate-CUTIVATE-FPL10005.pdf

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Document reference: 47739

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Synopsis-Fluticasone Propionate-CUTIVATE-FPL30004.pdf

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Document reference: 47740

Study title: Intense gallbladder uptake associated with chemotherapy. An unusual finding in pediatric skeletal scintigraphy. Lowry PA, Carstens C. Clin Nucl Med. 1995 Nov;20(11):976-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43579

Study title: Quantitative bone SPECT in young males with delayed puberty and hypogonadism: implications for treatment of low bone mineral density. Lubushitzky R, Front D, Iosilevsky G, Bettman L, Frenkel A, Kolodny GM, Israel O. J Nucl Med. 1998 Jan;39(1):104-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43538

Study title: Lucchi A, Tani G, Mancini AM, Rossi C, Mancuso A, De Florio L. [Morphologic and scintigraphic correlations in the cranial localization of neuroblastoma. Study of 29 cases] Radiol Med (Torino). 1984 Sep;70(9):639-40. Italian. No abstract available. Lucchi A, Tani G, Mancini AM, Rossi C, Mancuso A, De Florio L. [Morphologic and scintigraphic correlations in the cranial localization of neuroblastoma. Study of 29 cases] Radiol Med (Torino). 1984 Sep;70(9):639-40. Italian. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43983

Study title: Principles of staging of soft-tissue sarcomas. Peabody TD, Simon MA. Clin Orthop Relat Res. 1993 Apr;(289):19-31. Review.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43670

Study title: Peller PJ, Ho VB, Kransdorf MJ. Extraosseous Tc-99m MDP uptake: a pathophysiologic approach. Radiographics. 1993 Jul;13(4):715-34. Peller PJ, Ho VB, Kransdorf MJ. Extraosseous Tc-99m MDP uptake: a pathophysiologic approach. Radiographics. 1993 Jul;13(4):715-34.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43659

Study title: Clinical impact and prognostic value of metaiodobenzylguanidine imaging in children with metastatic neuroblastoma. Perel Y, Conway J, Kletzel M, Goldman J, Weiss S, Feyler A, Cohn SL. J Pediatr Hematol Oncol. 1999 Jan-Feb;21(1):13-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43514

Study title: Pevarski DJ, Drane WE, Scarborough MT. The usefulness of bone scintigraphy with SPECT images for detection of pulmonary metastases from osteosarcoma. AJR Am J Roentgenol. 1998 Feb;170(2):319-22. Pevarski DJ, Drane WE, Scarborough MT. The usefulness of bone scintigraphy with SPECT images for detection of pulmonary metastases from osteosarcoma. AJR Am J Roentgenol. 1998 Feb;170(2):319-22.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43537

Study title: Phillips CD, Williamson BR. Osteosarcoma with pericardial metastases seen on bone scan. Clin Nucl Med. 1987 Nov;12(11):899-900. No abstract available. Phillips CD, Williamson BR. Osteosarcoma with pericardial metastases seen on bone scan. Clin Nucl Med. 1987 Nov;12(11):899-900. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43841

Study title: Comparison of radiographic and radionuclide skeletal surveys in battered children. Pickett WJ, Faleski EJ, Chacko A, Jarrett RV. South Med J. 1983 Feb;76(2):207-12.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44049

Study title: A Double-blind, Placebo-controlled trial: comparison of the clinical and bacteriological effectiveness of ampicillin and a placebo.Nelson et al. (Ann NY Acad Sci 145 1967)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_6.xlsx

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Document reference: 49006

Study title: A prospective study of rash incidence in 532 patients treated with Amipicillin intravenously is reported.Scioli et al. (Boll 1st Sieroter Milan 1983;62;287-91)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_1.xlsx

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Document reference: 49000

Study title: A Single-blind, randomized trial to Evaluate the efficacy and safety of ampicillin suppositories in the treatment of acute suppurative otitis media by a well controlled method using ampicillin dry syrup as control.Baba et al. (1985-09-27)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_20.xlsx

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Document reference: 49019

Study title: Spencer RP, Sziklas JJ, Zubi SM. Disassociation of splenic accumulation of Tc-99m MDP and radiocolloid. Clin Nucl Med. 1991 Oct;16(10):747-9. Spencer RP, Sziklas JJ, Zubi SM. Disassociation of splenic accumulation of Tc-99m MDP and radiocolloid. Clin Nucl Med. 1991 Oct;16(10):747-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43728

Study title: Stauss J, Connolly LP, Perez-Rossello J, Treves ST. Pediatric acute pyelonephritis: diagnosis facilitated by skeletal scintigraphy. Clin Nucl Med. 2003 Oct;28(10):855-7. No abstract available. Stauss J, Connolly LP, Perez-Rossello J, Treves ST. Pediatric acute pyelonephritis: diagnosis facilitated by skeletal scintigraphy. Clin Nucl Med. 2003 Oct;28(10):855-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43413

Study title: A reassessment of bone scintigraphy and commonly tested pretreatment biochemical parameters in newly diagnosed osteosarcoma. Stokkel MP, Linthorst MF, Borm JJ, Taminiau AH, Pauwels EK. J Cancer Res Clin Oncol. 2002 Jul;128(7):393-9. Epub 2002 Jun 13.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43446

Study title: Strömqvist B, Brismar J, Hansson LI, Palmer J. Technetium-99m-methylenediphosphonate scintimetry after femoral neck fracture. A three-year follow-up study. Clin Orthop Relat Res. 1984 Jan-Feb;(182):177-89. Strömqvist B, Brismar J, Hansson LI, Palmer J. Technetium-99m-methylenediphosphonate scintimetry after femoral neck fracture. A three-year follow-up study. Clin Orthop Relat Res. 1984 Jan-Feb;(182):177-89.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44018

Study title: Kobayashi H, Tanaka K, Sakuma S. [99mTc-MDP abnormal uptake in the femur shaft in hemi-lateral hip joint disorders] Kaku Igaku. 1990 Aug;27(8):833-40. Japanese. Kobayashi H, Tanaka K, Sakuma S. [99mTc-MDP abnormal uptake in the femur shaft in hemi-lateral hip joint disorders] Kaku Igaku. 1990 Aug;27(8):833-40. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43756

Study title: Kobayashi Y, Ozaki T, Takeda Y, Kawai A, Inoue H. Evaluation of the effect of preoperative chemotherapy in bone sarcomas. 99mTc-HMDP scintigraphy in 34 cases. Acta Orthop Scand. 1998 Dec;69(6):611-6. Kobayashi Y, Ozaki T, Takeda Y, Kawai A, Inoue H. Evaluation of the effect of preoperative chemotherapy in bone sarcomas. 99mTc-HMDP scintigraphy in 34 cases. Acta Orthop Scand. 1998 Dec;69(6):611-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43519

Study title: Köhnlein S, Brinkmann G, Körner T, Kreusch T, Bohuslavizki KH, Heller M. [Magnetic resonance tomography in the diagnosis of mandibular osteomyelitis] Rofo. 1997 Jul;167(1):52-7. German. Köhnlein S, Brinkmann G, Körner T, Kreusch T, Bohuslavizki KH, Heller M. [Magnetic resonance tomography in the diagnosis of mandibular osteomyelitis] Rofo. 1997 Jul;167(1):52-7. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43547

Study title: Koo KH, Kim R, Cho SH, Song HR, Lee G, Ko GH. Angiography, scintigraphy, intraosseous pressure, and histologic findings in high-risk osteonecrotic femoral heads with negative magnetic resonance images. Clin Orthop Relat Res. 1994 Nov;(308):127-38. Koo KH, Kim R, Cho SH, Song HR, Lee G, Ko GH. Angiography, scintigraphy, intraosseous pressure, and histologic findings in high-risk osteonecrotic femoral heads with negative magnetic resonance images. Clin Orthop Relat Res. 1994 Nov;(308):127-38.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43609

Study title: Koppers B, Riel K. [3-phase scintigraphy in epicondylitis humeri radialis] Rofo. 1982 Aug;137(2):147-51. German. No abstract available. Koppers B, Riel K. [3-phase scintigraphy in epicondylitis humeri radialis] Rofo. 1982 Aug;137(2):147-51. German. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44077

Study title: The diagnostic importance of a quantitative evaluation of gamma scintigraphy in Perthes' disease in children.Dmitrienkov BN, Fed in AV, Zhvaniia TG, Subbotina EN. Med Radiol1989 Jul;34(7):19-23.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48477

Study title: [The early diagnosis of Perthes disease: the value of bone scintigraphy and magnetic resonance imaging in comparison with x-ray findings] German. Theissen P, Rütt J, Linden A, Smolarz K, Voth E, Schicha H. Nuklearmedizin. 1991 Dec;30(6):265-71. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43717

Study title: Thomas BP, Spottswood SE, Wushensky CA. The hot spur sign of diastematomyelia. Clin Nucl Med. 2007 Apr;32(4):292-4. No abstract available. Thomas BP, Spottswood SE, Wushensky CA. The hot spur sign of diastematomyelia. Clin Nucl Med. 2007 Apr;32(4):292-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43364

Study title: Tiel-van Buul MM, van Beek EJ, Broekhuizen AH, Bakker AJ, Bos KE, van Royen EA. Radiography and scintigraphy of suspected scaphoid fracture. A long-term study in 160 patients. J Bone Joint Surg Br. 1993 Jan;75(1):61-5. Tiel-van Buul MM, van Beek EJ, Broekhuizen AH, Bakker AJ, Bos KE, van Royen EA. Radiography and scintigraphy of suspected scaphoid fracture. A long-term study in 160 patients. J Bone Joint Surg Br. 1993 Jan;75(1):61-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43677

Study title: Routine bone scintigraphy is of limited value in the clinical assessment of untreated patients with Hodgkin's disease. Landgren O, Axdorph U, Jacobsson H, Johansson B, Grimfors G, Björkholm M. Med Oncol. 2000 Aug;17(3):174-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43478

Study title: Lange RH, Lange TA, Rao BK. Correlative radiographic, scintigraphic, and histological evaluation of exostoses. J Bone Joint Surg Am. 1984 Dec;66(9):1454-9. Lange RH, Lange TA, Rao BK. Correlative radiographic, scintigraphic, and histological evaluation of exostoses. J Bone Joint Surg Am. 1984 Dec;66(9):1454-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43975

Study title: Lange W, Wicke A, Stern W, Staudte H. [Osteoid osteoma of the spine. The current differential diagnostic aspects] Rofo. 1991 Apr;154(4):450-2. German. No abstract available. Lange W, Wicke A, Stern W, Staudte H. [Osteoid osteoma of the spine. The current differential diagnostic aspects] Rofo. 1991 Apr;154(4):450-2. German. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43743

Study title: Extremity osteosarcoma in childhood: prognostic value of radiologic imaging. Lawrence JA, Babyn PS, Chan HS, Thorner PS, Pron GE, Krajbich IJ. Radiology. 1993 Oct;189(1):43-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43647

Study title: The painful accessory navicular. Lawson JP, Ogden JA, Sella E, Barwick KW. Skeletal Radiol. 1984;12(4):250-62.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44012

Study title: Technetium 99m-methylene diphosphonate bone scans in children with reflex neurovascular dystrophy. Laxer RM, Allen RC, Malleson PN, Morrison RT, Petty RE. J Pediatr. 1985 Mar;106(3):437-40.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43956

Study title: To study the absorption and excretion of the 250 mg ampicillin supporitory in children.Nishimura et al. (1983-05-04)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_18.xlsx

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Document reference: 49017

Study title: To study the pharmacokinetics of ampicillin suppositories in children.Toyonaga et al. (1983-05-06)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_17.xlsx

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Document reference: 49016

Study title: A multicentre, randomised, double-blind, double-dummy, parallel group comparison of three treatments : 1) salmeterol/fluticasone propionate (SFC) (50/100mcg strength) bd via DISKUS/ACCUHALER inhaler, 2) fluticasone propionate 200mcg bd via DISKUS/ACCUHALER inhaler, 3) fluticasone propionate 100mcg bd via DISKUS/ACCUHALER inhaler in children aged 4-11 years with asthma

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAM40012-ICHE3.pdf

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Document reference: 28443

Study title: A pilot single centre, randomised, double-blind, crossover study to demonstrate the superiority of Salmeterol/fluticasone propionate combination product 50/100mcg bd versus fluticasone propionate 100mcg bd when treated for two weeks with respect to activity levels in children aged 7-15 years.

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAM40101-ICHE3.pdf

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Document reference: 28448

Study title: A Randomized, Double-Blind, 12-Week Trial Evaluating the Safety of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Symptomatic Pediatric Subjects (4-11 Years) With Asthma

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAS30031-ICHE3.pdf

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Document reference: 28453

Study title: A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and in Adolescent Subjects with Activity-Induced Bronchospasm

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-SFA100314-ICHE3.pdf

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Document reference: 28454

Study title: A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and in Adolescent Subjects with Activity-Induced Bronchospasm

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-SFA100316-ICHE3.pdf

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Document reference: 47594

Study title: An observational study to assess the health related quality of life impact of treating poorly controlled asthmatic children with Seretide(tm) 50/100mcg

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAM3802-ICHE3.pdf

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Document reference: 28442

Study title: Comparison of stepwise treatment of asthmatic children with salmeterol/fluticasone propionate (FP) combination product (Seretide) and/or fluticasone propionate (Flixotide) based on PD20 methacholine plus symptoms or based on symptoms only (Children Asthma Therapy Optimal”)

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAS30018-ICHE3.pdf

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Document reference: 28451

Study title: Prospective, parallel-group, randomized, open label study to evaluate the impact of additional guidance from the health professionals team on treatment compliance of children aged between 6 and 14 years old with persistent moderate or severe asthma, receiving the combination salmeterol/fluticasone propionate 50/250 mcg (Seretide) twice a day. ADERE PROJECT (Pediatric)

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-ADERE-PEDIATRIC-1-ICHE3.pdf

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Document reference: 28444

Study title: Randomised, double-blind, comparator study to demonstrate the superiority of salmeterol/fluticasone propionate combination DISKUS™ 50/100mcg bd over fluticasone propionate DISKUS™/ACCUHALER™ 200mcg bd with respect to airway physiology in asthmatic children treated for 6 weeks.

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAM40100-ICHE3.pdf

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Document reference: 28447

Study title: Ashraf MS et al Late reversibility of chronic ifosfamide-associated nephrotoxicity in a child Med Pediatr Oncol. 1997 Jan;28(1):62-4Ashraf MS et al Late reversibility of chronic ifosfamide-associated nephrotoxicity in a child Med Pediatr Oncol. 1997 Jan;28(1):62-4

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 24737

Study title: Pickuth D, McCready VR. Focal areas of increased renal tracer uptake on bone scans can mimic metastases in the lower ribs. Br J Radiol. 1996 May;69(821):407-9. Pickuth D, McCready VR. Focal areas of increased renal tracer uptake on bone scans can mimic metastases in the lower ribs. Br J Radiol. 1996 May;69(821):407-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43568

Study title: Reduced perfusion and uptake of Tc-99m HDP in the iliac bone. A rare presentation of pelvic osteomyelitis. Pijpers R, Ekkelkamp S, Roos JC, Teule GJ. Clin Nucl Med. 1994 Jun;19(6):516-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43623

Study title: The role of radioisotopic methods in imaging of intervertebral disc inflammation in children. Pilecki S, Gierach M, Drobik P, Kurylak A, Trzcinska I, Hagner W, et al. Nucl Med Rev Cent East Eur. 2006;9(1):72-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43375

Study title: Quantitative sacro-iliac scintigraphy. I. Methodological aspects. Pitkänen M, Lahtinen T, Hyödynmaa S, Mutru O, Länsimies E. Scand J Rheumatol. 1982;11(4):199-202.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44096

Study title: Israel O, Gips S, Jerushalmi J, Frenkel A, Front D. Osteomyelitis and soft-tissue infection: differential diagnosis with 24 hour/4 hour ratio of Tc-99m MDP uptake. Radiology. 1987 Jun;163(3):725-6. Israel O, Gips S, Jerushalmi J, Frenkel A, Front D. Osteomyelitis and soft-tissue infection: differential diagnosis with 24 hour/4 hour ratio of Tc-99m MDP uptake. Radiology. 1987 Jun;163(3):725-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43861

Study title: Bone SPET of symptomatic lumbar spondylolysis. Itoh K, Hashimoto T, Shigenobu K, Yamane S, Tamaki N. Nucl Med Commun. 1996 May;17(5):389-96. Erratum in: Nucl Med Commun 1996 Aug;17(8):732-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43566

Study title: Neonatal adrenal haemorrhage at bone scintigraphy: a case report. Jacobsson H, Kaiser S, Granholm T, Ringertz HG. Pediatr Radiol. 1998 Nov;28(11):896-8. Review.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43522

Study title: Routine bone scintigraphy in primary staging of soft tissue sarcoma; Is it worthwhile? Jager PL, Hoekstra HJ, Leeuw J, van Der Graaf WT, de Vries EG, Piers D. Cancer. 2000 Oct 15;89(8):1726-31.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43475

Study title: Bone scan in diagnosis of lymphoma with extensive bone marrow necrosis--a case report. Jain D, Pattari S, Rajesh LS, Varma N, Mittal BR. Indian J Pathol Microbiol. 2004 Jul;47(3):394-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43381

Study title: A Single-blinded, Randomized trial to evaluate the efficacy and safety of 125 mg ampicillin suppositories in the treatment of acute respiratory tract infections in pediatric patients using ampicillin dry syrup as control.Nishimura et al. (1983-05-04)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_22.xlsx

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Document reference: 49021

Study title: Clarify the effects of age, dosage, and route of administration on ampicillin-associated diarrhea in pediatric patients.Phillips et al. (PEDIATRICS Vol. 58 No. 6 Dec. 1976)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_5.xlsx

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Document reference: 49004

Study title: Compare ampicillin and choramphenicol, both being given by the parenteral route in the therapyt of typhoid fever.Kaye et al. (Annals Ney York Academy of Sciences 145, 1967)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_3.xlsx

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Document reference: 49002

Study title: Koppers B. [Axial and semi-axial views of the pelvis in bone scintigraphy. Technic, anatomy, limitations, possibilities] Rofo. 1983 Jun;138(6):722-31. German. Koppers B. [Axial and semi-axial views of the pelvis in bone scintigraphy. Technic, anatomy, limitations, possibilities] Rofo. 1983 Jun;138(6):722-31. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44035

Study title: [Early diagnosis of bone infarction in children with sickle cell anemia by MDP 99m Tc scanning] Koren A, Fedchteyn S, Katsuni E. Harefuah. 1982 Mar 1;102(5):182-5. Hebrew. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44090

Study title: Koren A, Garty I, Ben-Ami M, Katzuni E. Uncommon orbital bone infarctions in a sickle cell anemia patient. Clin Nucl Med. 1984 Dec;9(12):721-2. No abstract available. Koren A, Garty I, Ben-Ami M, Katzuni E. Uncommon orbital bone infarctions in a sickle cell anemia patient. Clin Nucl Med. 1984 Dec;9(12):721-2. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43973

Study title: Knop J, Stritzke P, Montz R, Delling G, Winkler K. [Bone scintigraphy in assessing the success of chemotherapy in osteosarcoma] Nuklearmedizin. 1985 Apr;24(2):75-81. German. Knop J, Stritzke P, Montz R, Delling G, Winkler K. [Bone scintigraphy in assessing the success of chemotherapy in osteosarcoma] Nuklearmedizin. 1985 Apr;24(2):75-81. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43950

Study title: Morrison WB, Schweitzer ME, Bock GW, Mitchell DG, Hume EL, Pathria MN, Resnick D. Diagnosis of osteomyelitis: utility of fat-suppressed contrast-enhanced MR imaging. Radiology. 1993 Oct;189(1):251-7. Morrison WB, Schweitzer ME, Bock GW, Mitchell DG, Hume EL, Pathria MN, Resnick D. Diagnosis of osteomyelitis: utility of fat-suppressed contrast-enhanced MR imaging. Radiology. 1993 Oct;189(1):251-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43650

Study title: The role of bone scintigraphy in predicting femoral head collapse following cervical fractures in children. Mortensson W, Rosenborg M, Gretzer H. Acta Radiol. 1990 May;31(3):291-2.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43763

Study title: Scintigraphy in the diagnosis of occult fractures of the calcaneus. Moss EH, Carty H. Skeletal Radiol. 1990;19(8):575-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43772

Study title: Tc-99m nanocolloid and Tc-99m MDP three-phase bone imaging in osteomyelitis and septic arthritis. A comparative study. Mudun A, Unal S, Aktay R, Akmehmet S, Cantez S. Clin Nucl Med. 1995 Sep;20(9):772-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43587

Study title: Murayama T, Munakata A, Narita K, Fujita K, Fujii K. [Retrospective study of renal images on bone scans] Rinsho Hoshasen. 1989 Mar;34(3):335-8. Japanese. Murayama T, Munakata A, Narita K, Fujita K, Fujii K. [Retrospective study of renal images on bone scans] Rinsho Hoshasen. 1989 Mar;34(3):335-8. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43793

Study title: Murray IP, Ford JC. Tc-99m medronate scintigraphy in mandibular condylar hyperplasia. Clin Nucl Med. 1982 Oct;7(10):474-5. No abstract available. Murray IP, Ford JC. Tc-99m medronate scintigraphy in mandibular condylar hyperplasia. Clin Nucl Med. 1982 Oct;7(10):474-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44072

Study title: Leckie RG, Watabe JT, Shanley DJ, Werner M. Tc-99m HDP bone scintigraphy of ameloblastoma with panorex, CT, MRI, and gross correlation. Clin Nucl Med. 1993 Apr;18(4):350-2. No abstract available. Leckie RG, Watabe JT, Shanley DJ, Werner M. Tc-99m HDP bone scintigraphy of ameloblastoma with panorex, CT, MRI, and gross correlation. Clin Nucl Med. 1993 Apr;18(4):350-2. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43668

Study title: Lee BE, Robinson JL. The use of technetium-99m-labeled white blood cell scan in the management of a case of group A streptococcus necrotizing fasciitis with polymyositis. Clin Infect Dis. 1999 Jan;28(1):153-4. No abstract available. Lee BE, Robinson JL. The use of technetium-99m-labeled white blood cell scan in the management of a case of group A streptococcus necrotizing fasciitis with polymyositis. Clin Infect Dis. 1999 Jan;28(1):153-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43515

Study title: Lee DY, Seong SC, Choi IH, Chung CY, Chang BS. Changes of blood flow of the femoral head after subtrochanteric osteotomy in Legg-Perthes' disease: a serial scintigraphic study. J Pediatr Orthop. 1992 Nov-Dec;12(6):731-4. Lee DY, Seong SC, Choi IH, Chung CY, Chang BS. Changes of blood flow of the femoral head after subtrochanteric osteotomy in Legg-Perthes' disease: a serial scintigraphic study. J Pediatr Orthop. 1992 Nov-Dec;12(6):731-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43684

Study title: Okuyama T, Suzuki H, Umehara I, Kuwabara Y, Suzuki S, Takagi M. Diagnosis of aneurysmal bone cyst of the mandible. A report of two cases with emphasis on scintigraphic approaches. Clin Nucl Med. 1985 Nov;10(11):786-90. Okuyama T, Suzuki H, Umehara I, Kuwabara Y, Suzuki S, Takagi M. Diagnosis of aneurysmal bone cyst of the mandible. A report of two cases with emphasis on scintigraphic approaches. Clin Nucl Med. 1985 Nov;10(11):786-90.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43928

Study title: Ongolo-Zogo P, Thiesse P, Sau J, Desuzinges C, Blay JY, Bonmartin A, Bochu M, Philip T. Assessment of osteosarcoma response to neoadjuvant chemotherapy: comparative usefulness of dynamic gadolinium-enhanced spin-echo magnetic resonance imaging and technetium-99m skeletal angioscintigraphy. Eur Radiol. 1999;9(5):907-14. Ongolo-Zogo P, Thiesse P, Sau J, Desuzinges C, Blay JY, Bonmartin A, Bochu M, Philip T. Assessment of osteosarcoma response to neoadjuvant chemotherapy: comparative usefulness of dynamic gadolinium-enhanced spin-echo magnetic resonance imaging and technetium-99m skeletal angioscintigraphy. Eur Radiol. 1999;9(5):907-14.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43506

Study title: Oni OO, Graebe A, Pearse M, Gregg PJ. Prediction of the healing potential of closed adult tibial shaft fractures by bone scintigraphy. Clin Orthop Relat Res. 1989 Aug;(245):239-45. Oni OO, Graebe A, Pearse M, Gregg PJ. Prediction of the healing potential of closed adult tibial shaft fractures by bone scintigraphy. Clin Orthop Relat Res. 1989 Aug;(245):239-45.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43782

Study title: Tc-99m MDP uptake secondary to soft tissue extravasation of calcium gluconate in a newborn thought to have osteomyelitis. Orellana P, Velasquez C, Meneses L, Urioste A, Carreño JE, Garcíia CJ, Sabroso F, Cruces P. Clin Nucl Med. 2002 Sep;27(9):653-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44246

Study title: Orzel JA, Rudd TG. Heterotopic bone formation: clinical, laboratory, and imaging correlation. J Nucl Med. 1985 Feb;26(2):125-32. Orzel JA, Rudd TG. Heterotopic bone formation: clinical, laboratory, and imaging correlation. J Nucl Med. 1985 Feb;26(2):125-32.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43958

Study title: A randomized, multicenter, placebo-controlled parallel group study of four months duration per patient to evaluate the safety and efficacy of treatment with 24 µg b.i.d. and 12 µg b.i.d. formoterol, double-blind, and 12 µg b.i.d. formoterol with additio

Active substance: FORMOTEROL

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Document reference: 47810

Study title: A SINGLE CENTRE, DOUBLE-BLIND, WITHIN-PATIENT COMPARATIVE TRIAL WITH CUMULATIVE DOSES OF FORMOTEROL AND SALBUTAMOL METERED DOSE AEROSOLS IN CHILDREN WITH ASTHMA.INTEGRATED STUDY REPORT (CLINICAL AND STATISTICAL)

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 GS 19 Art45 listing 2011.xls

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Document reference: 47812

Study title: A single dose study evaluating peak inspiratory flow rate and forced inspiratory vital capacity in children and adults with asthma of differing severity after administration of a placebo capsule for inhalation when using the aerolizer device

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 0061 Art45 listing 2011.xls

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Document reference: 47813

Study title: A single dose, randomised, double blind, double dummy, placebo controlled, three-period crossover clinical study, comparing the efficacy, safety and tolerability of FormoterolHFA pMDI 12 mcg per actuation administered by means of a "spacer"device (AeroCha

Active substance: FORMOTEROL

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Document reference: 47814

Study title: A Single Dose, Randomized, Double-Blind, Double-Dummy, 4-way Crossover Trial Comparing 12 mcg and 24 mcg of Foradil Aerolizer, 180 mcg Albuterol Metered-Dose Inhaler (MDI) Versus Placebo in the Prevention of Exercise-Induced Bronchospasm in Pediatric Pati

Active substance: FORMOTEROL

Study summary document link (including results): FOR258D 0402 Art45 listing 2011.xls

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Document reference: 47815

Study title: A SINGLE-CENTRE, DOUBLE-BLIND STUDY COMPARING FORMOTEROL AND SALBUTAMOL DRY POWDER CAPSULES FOR INHALATION WITH REGARD TO DURATION OF BRONCHODILATORY EFFECT, ASTHMA SYMPTOMS, ADVERSE REACTIONS, AND PREFERENCE IN THE TREATMENT OF CHILDREN WITH ASTHMA

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 DP PD5 Art45 listing 2011.xls

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Document reference: 47816

Study title: A six months, randomised, open, parallel group, multicentre study to examine efficacy and safety of as needed versus maintenance use of Oxis® Turbuhaler® (formoterol) 9 μg in subjects well controlled on maintenance treatment with inhaled corticosteroids a

Active substance: FORMOTEROL

Study summary document link (including results): SD-037-0739 Study Synopsis.pdf

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Document reference: 47817

Study title: A three month, double blind, double dummy, parallel group, controlled study comparing the efficacy and safety between 12 mcg twice daily of Formoterol-HFA and 12 mcg twice daily of Formoterol-DPI (Foradil Aerolizer) in childrem with persistent asthma

Active substance: FORMOTEROL

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Document reference: 47818

Study title: A twelve-month, double-blind, between-patient, placebo-controlled trial comparing the safety, tolerability and efficacy of 12 ug and 25 ug twice daily formoterol dry powder capsules for inhalation delivered by a single -dose inhaler (aeroliser) in childre

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 2702049 Art45 listing 2011.xls

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Document reference: 47819

Study title: A twelve-week, double-blind, parallel group trial comparing the safety, tolerability and efficacy of formoterol dry powder capsules for inhalation delivered by a single-dose inhaler versus albuterol metered-dose inhaler (mdi) versus placebo in patients wi

Active substance: FORMOTEROL

Study summary document link (including results): FOR258D0040 Art45 listing 2011.xls

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Document reference: 47820

Study title: A twelve-week, double-blind, parallel group trial comparing the safety, tolerability and efficacy of formoterol dry powder capsules for inhalation delivered by a single-dose inhaler versus albuterol metered-dose inhaler (mdi) versus placebo in patients wi

Active substance: FORMOTEROL

Study summary document link (including results): FOR258D0041 Art45 listing 2011.xls

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Document reference: 47821

Study title: BIOMETRIC REPORT ON A CLINICAL STUDY WITH FORMOTEROL (TWO 6-UG PUFFS) VERSUS FENOTEROL (TWO 0.2-MG PUFFS) IN CHILDREN WITH REVERSIBLE DISEASES OF THE AIRWAYS

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 DFORB5 Art45 listing 2011.xls

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Document reference: 47822

Study title: Sweeney LE Hypophosphataemic rickets after ifosfamide treatment in children Clin Radiol. 1993 May;47(5):345-7Sweeney LE Hypophosphataemic rickets after ifosfamide treatment in children Clin Radiol. 1993 May;47(5):345-7

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 25142

Study title: Jánoskuti L, Szilvási I, Papp G, Róna E, Benedek S, Fekete S. Bone scanning and radiography in the evaluation of patients with malignant lymphoma. Rofo. 1988 Oct;149(4):427-8. Jánoskuti L, Szilvási I, Papp G, Róna E, Benedek S, Fekete S. Bone scanning and radiography in the evaluation of patients with malignant lymphoma. Rofo. 1988 Oct;149(4):427-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43808

Study title: Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21. Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43731

Study title: Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21. Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44172

Study title: Vattimo A, Martini G, Pisani M. Bone uptake of 99mTc-MDP in man: its relationship with local blood flow. J Nucl Med Allied Sci. 1982 Jul-Sep;26(3):173-9. No abstract available. Vattimo A, Martini G, Pisani M. Bone uptake of 99mTc-MDP in man: its relationship with local blood flow. J Nucl Med Allied Sci. 1982 Jul-Sep;26(3):173-9. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44185

Study title: Vattimo A, Martini G, Pisani M. Bone uptake of 99mTc-MDP in man: its relationship with local blood flow. J Nucl Med Allied Sci. 1982 Jul-Sep;26(3):173-9. No abstract available. Vattimo A, Martini G, Pisani M. Bone uptake of 99mTc-MDP in man: its relationship with local blood flow. J Nucl Med Allied Sci. 1982 Jul-Sep;26(3):173-9. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44232

Study title: Vattimo A, Martini G, Pisani M. Bone uptake of 99mTc-MDP in man: its relationship with local blood flow. J Nucl Med Allied Sci. 1982 Jul-Sep;26(3):173-9. No abstract available. Vattimo A, Martini G, Pisani M. Bone uptake of 99mTc-MDP in man: its relationship with local blood flow. J Nucl Med Allied Sci. 1982 Jul-Sep;26(3):173-9. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44279

Study title: Velchik MG, Heyman S, Makler PT Jr, Goldstein HA, Alavi A. Bone scintigraphy: differentiating benign cortical irregularity of the distal femur from malignancy. J Nucl Med. 1984 Jan;25(1):72-4. Velchik MG, Heyman S, Makler PT Jr, Goldstein HA, Alavi A. Bone scintigraphy: differentiating benign cortical irregularity of the distal femur from malignancy. J Nucl Med. 1984 Jan;25(1):72-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44015

Study title: Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44141

Study title: Murray IP, Rossleigh MA, Dixon J. Clin Nucl Med. 1995 Jun;20(6):560-1. No abstract available. Murray IP, Rossleigh MA, Dixon J. Clin Nucl Med. 1995 Jun;20(6):560-1. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43599

Study title: Photopenia in skeletal scintigraphy of suspected bone and joint infection. Murray IP. Clin Nucl Med. 1982 Jan;7(1):13-20.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44095

Study title: [Osteoscintigraphy in the evaluation of a bone transplant in cranioplasty in children] Russian. Mytnikov AM, Smirnov IuN, Ivanov LB, Eshankulov GS, Bukhanov VE. Med Radiol (Mosk). 1989 Apr;34(4):46-9. Russian.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43790

Study title: Han JS, Kim YG, Kim S, Lee MC, Lee JS, Kim SH. Bone scintigraphy in acute renal failure with severe loin pain and patchy renal vasoconstriction. Nephron. 1991;59(2):254-60. Han JS, Kim YG, Kim S, Lee MC, Lee JS, Kim SH. Bone scintigraphy in acute renal failure with severe loin pain and patchy renal vasoconstriction. Nephron. 1991;59(2):254-60.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43750

Study title: Hanash KA, Bissada NK, Abla A, Esmail D, Dowling A. Predictive value of excretory urography, ultrasonography, computerized tomography, and liver and bone scan in the staging of bilharzial bladder cancer in Saudi Arabia. Cancer. 1984 Jul 1;54(1):172-6. Hanash KA, Bissada NK, Abla A, Esmail D, Dowling A. Predictive value of excretory urography, ultrasonography, computerized tomography, and liver and bone scan in the staging of bilharzial bladder cancer in Saudi Arabia. Cancer. 1984 Jul 1;54(1):172-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43993

Study title: Hanna SL, Fletcher BD, Fairclough DL, Jenkins JH 3rd, Le AH. Magnetic resonance imaging of disseminated bone marrow disease in patients treated for malignancy. Skeletal Radiol. 1991;20(2):79-84. Hanna SL, Fletcher BD, Fairclough DL, Jenkins JH 3rd, Le AH. Magnetic resonance imaging of disseminated bone marrow disease in patients treated for malignancy. Skeletal Radiol. 1991;20(2):79-84.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43749

Study title: Harcke HT, Conway JJ, Tachdjian MO, Dias LS, Noble HB, MacEwen GD, Weiss S. Scintigraphic localization of bone lesions during surgery. Skeletal Radiol. 1985;13(3):211-6. Harcke HT, Conway JJ, Tachdjian MO, Dias LS, Noble HB, MacEwen GD, Weiss S. Scintigraphic localization of bone lesions during surgery. Skeletal Radiol. 1985;13(3):211-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43966

Study title: Angular deformity of the lower extremity: evaluation with quantitative bone scintigraphy. Work in progress. Harcke HT, Zapf SE, Mandell GA, Sharkey CA, Cooley LA. Radiology. 1987 Aug;164(2):437-40.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43854

Study title: Study the antibacterial and clinical efficacy of ampicillin as well as of its side-effects in comparison with penicillin V, our hitherto best peroral penicillin for scarlet fever therapy.Ström (Acta Paediatr Scand. 1968 Jul;57(4):285-8)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_31.xlsx

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Document reference: 49030

Study title: The primary objective was to evaluate the safety of ampicillin suppositories with special emphasis on local intolerance reactions in pediatric patients. The secondary objective was to evaluate short term efficacy in the treatment of acute otitis media. The study was comparative against amoxIcillin suspension.Bagger-Sjöbäck et al. (1987-07-22)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_24.xlsx

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Document reference: 49023

Study title: Murray IP, Frater CJ. Prominence of the C2 vertebra on SPECT. A normal variant. Clin Nucl Med. 1994 Oct;19(10):855-9. Murray IP, Frater CJ. Prominence of the C2 vertebra on SPECT. A normal variant. Clin Nucl Med. 1994 Oct;19(10):855-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43614

Study title: Intraoperative use of the mobile gamma camera in localizing and excising osteoid osteomas of the spine. Osebold WR, Lester EL, Hurley JH, Vincent RL. Spine. 1993 Oct 1;18(13):1816-28.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43648

Study title: Oshiro N, Bito S, Ito H, Morimoto Y, Ikekubo K, Ishihara T, Mori T. [Fundamental and clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Kaku Igaku. 1982 Mar;19(2):305-11. Japanese. No abstract available. Oshiro N, Bito S, Ito H, Morimoto Y, Ikekubo K, Ishihara T, Mori T. [Fundamental and clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Kaku Igaku. 1982 Mar;19(2):305-11. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44091

Study title: Templeton JE, Bauer TW, Lietman SA. Chronic bilateral thigh and knee disconfort in an 18-year-old manTempleton JE, Bauer TW, Lietman SA. Clin Orthop Relat Res 2008;466:507-13

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44205

Study title: Howman-Giles R, Rahilly PM. Technetium-99m methylene diphosphonate accumulation in the diaphragm after severe ischemia. Clin Nucl Med. 1983 Sep;8(9):416-7. No abstract available. Howman-Giles R, Rahilly PM. Technetium-99m methylene diphosphonate accumulation in the diaphragm after severe ischemia. Clin Nucl Med. 1983 Sep;8(9):416-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44030

Study title: Partial growth plate closure: apex view on bone scan. Howman-Giles R, Trochei M, Yeates K, Middleton R, Barrett I, Scougall J, Whiteway D. J Pediatr Orthop. 1985 Jan-Feb;5(1):109-11.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43970

Study title: Multifocal osteomyelitis in childhood. Review by radionuclide bone scan. Howman-Giles R, Uren R. Clin Nucl Med. 1992 Apr;17(4):274-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43700

Study title: Target imaging diagnosis of human brain glioma. Clinical analysis of 40 cases. Huang Q, He G, Lan Q, Li X, Qian Z, Chen J, Lu Z, Du Z. Chin Med J (Engl). 1996 Jan;109(1):93-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43572

Study title: Hudson TM. Scintigraphy of aneurysmal bone cysts. AJR Am J Roentgenol. 1984 Apr;142(4):761-5. Hudson TM. Scintigraphy of aneurysmal bone cysts. AJR Am J Roentgenol. 1984 Apr;142(4):761-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44002

Study title: Hui C, Lau KK. Intracranial Tc99m MDP uptake in Sturge-Weber syndrome. Australas Radiol. 2003 Mar;47(1):75-7. Hui C, Lau KK. Intracranial Tc99m MDP uptake in Sturge-Weber syndrome. Australas Radiol. 2003 Mar;47(1):75-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43428

Study title: Humphry A, Gilday DL, Brown RG. Bone scintigraphy in chondroblastoma. Radiology. 1980 Nov;137(2):497-9. Humphry A, Gilday DL, Brown RG. Bone scintigraphy in chondroblastoma. Radiology. 1980 Nov;137(2):497-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44138

Study title: Aoyama R, Nagata K, Clinical results with ampicillin-cloxacillin for intravenous drip (author's transl.) The Japanese Journal of antibiotics, (Jpn-J_Antiot.), Nov.1978, vol. 31, no. 11, p. 681-4Aoyama R, Nagata K, Clinical results with ampicillin-cloxacillin for intravenous drip (author's transl.) The Japanese Journal of antibiotics, (Jpn-J_Antiot.), Nov.1978, vol. 31, no. 11, p. 681-4

Active substance: AMPICILLIN AND CLOXACILLIN

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Document reference: 46646

Study title: To study the absorption of ampicillin suppositories in children.Jozaki et al. (1983-03-10)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_11.xlsx

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Document reference: 49011

Study title: SINGLE-CENTRE, DOUBLE-BLIND WITHIN-PATIENT COMPARISON OF THE PROTECTIVE EFFECT OF INHALED PLACEBO, SALBUTAMOL (200 MCG), AND FORMOTEROL (12 AND 24 MCG) ON METHACHOLINE-INDUCED BRONCHOCONSTRICTION IN CHILDREN WITH BRONCHIAL ASTHMA

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 BA-EP1 Art45 listing 2011.xls

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Document reference: 47864

Study title: Single-dose, double-blind, double dummy, mono-center, randomized two fold crossover study to assess the therapeutic equivalence of Formoterol versus Foradil Aerolizer 12 μg/dose in asthmatic pediatric subjects followed by a 1 month open-label period with

Active substance: FORMOTEROL

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Document reference: 47865

Study title: STATISTICAL REPORT ON AN OPEN, NON-COMPARATIVE STUDY WITH FORMOTEROL-METERED DOSE AEROSOL (2 X DAILY 12 MCG) IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE DISEASES OF THE RESPIRATORY TRACT

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 DFORC5 Art45 listing 2011.xls

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Document reference: 47866

Study title: Testicular effects of formoterol fumarate (D2522) given orally to young rats for three months, using salbutamol sulphate as a reference compound

Active substance: FORMOTEROL

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Document reference: 47867

Study title: THE EFFECT OF INHALED BETA-AGONISTS ON CHRONIC NONALLERGIC AIRWAY RESPONSIVENESS IN CHILDREN WITH ASTHMA

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 BA-EP4 Art45 listing 2011.xls

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Document reference: 47868

Study title: TO COMPARE THE BRONCHODILATOR EFFICACY, DURATION OF EFFECT,AND SYSTEMIC TOLERABILITY OF SINGLE INHALED DOSES OF FORMOTEROL, SALBUTAMOL ANF PLACEBO IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE (ASTHMA). CLINICAL TRIAL SUMMARY AND REPORT

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 DFORC4 Art45 listing 2011.xls

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Document reference: 47869

Study title: Tolerability of high dose formoterol vs. high dose terbutaline in asthmatic children after inhalation via Turbuhaler

Active substance: FORMOTEROL

Study summary document link (including results): SD-037-0738 Study Synopsis.pdf

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Document reference: 47870

Study title:

Active substance: FOSCARNET

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Document reference: 21230

Study title:

Active substance: FOSCARNET

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Document reference: 28556

Study title:

Active substance: FOSCARNET

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Document reference: 28557

Study title:

Active substance: Foscarnet

Study summary document link (including results): Griffiths PD. et al 1993.pdf

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Document reference: 39621

Study title:

Active substance: Foscarnet

Study summary document link (including results): Kocoshis SA et al 1993.pdf

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Document reference: 39623

Study title:

Active substance: Foscarnet

Study summary document link (including results): Jacobson MA_Wulfsohn M etal 1994.pdf

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Document reference: 39634

Study title:

Active substance: Foscarnet

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Document reference: 39680

Study title: Abdel-Haq NM, Asmar BI. Human herpesvirus 6 (HHV6) infection. Indian Journal of Pediatrics~ 71(1):89-96, January 2004 2004;(1):-96, January 2004. Abdel-Haq NM, Asmar BI. Human herpesvirus 6 (HHV6) infection. Indian Journal of Pediatrics~ 71(1):89-96, January 2004 2004;(1):-96, January 2004.

Active substance: FOSCARNET

Study summary document link (including results): Abdel-Haq NM et al 2004.pdf

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Document reference: 28585

Study title: AIDS Clinical Trials Group of the National Institute of Allergy and Infectious diseases. AIDS 8(4), 451-459. 1994.MCGRATH BJ, NEWMAN CL. AIDS Clinical Trials Group of the National Institute of Allergy and Infectious diseases. AIDS 8(4), 451-459. 1994.MCGRATH BJ, NEWMAN CL.

Active substance: FOSCARNET

Study summary document link (including results): MCGRATH BJ and Newman CL 1994.pdf

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Document reference: 28572

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Study FLU-KI-4186-Fluticasone propionate-Cutivate - approved.xls

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Document reference: 47741

Study title: Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44192

Study title: Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44239

Study title: Vattimo A, Martini G, Pisani M. Bone uptake of 99mTc-MDP in man: its relationship with local blood flow. J Nucl Med Allied Sci. 1982 Jul-Sep;26(3):173-9. No abstract available. Vattimo A, Martini G, Pisani M. Bone uptake of 99mTc-MDP in man: its relationship with local blood flow. J Nucl Med Allied Sci. 1982 Jul-Sep;26(3):173-9. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44082

Study title: Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43828

Study title: Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44179

Study title: Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44226

Study title: Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44273

Study title: Multifocal osteoarticular tuberculosis resembling skeletal metastatic disease. Evaluation with Tc-99m MDP and Ga-67 citrate. Hardoff R, Efrat M, Gips S. Clin Nucl Med. 1995 Mar;20(3):279-81. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43603

Study title: Harris SA, Quayle AA, Testa HJ. Radionuclide bone scanning in the diagnosis and management of condylar hyperplasia. Nucl Med Commun. 1984 Jun;5(6):373-80. Harris SA, Quayle AA, Testa HJ. Radionuclide bone scanning in the diagnosis and management of condylar hyperplasia. Nucl Med Commun. 1984 Jun;5(6):373-80.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43994

Study title: Scintimetry in transient synovitis of the hip in the child.Hasegawa Y, Wingstrand H, Gustafson T. Acta Orthop Scand. 1988 Oct;59(5):520-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43806

Study title: Hasegawa Y. [Quantitative assessment of bone scintigraphy in hip joint disease] Nippon Seikeigeka Gakkai Zasshi. 1985 May;59(5):517-32. Japanese. Hasegawa Y. [Quantitative assessment of bone scintigraphy in hip joint disease] Nippon Seikeigeka Gakkai Zasshi. 1985 May;59(5):517-32. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43944

Study title: Strömqvist B, Hansson LI, Nilsson LT, Thorngren KG. Prognostic precision in postoperative 99mTc-MDP scintimetry after femoral neck fracture. Acta Orthop Scand. 1987 Oct;58(5):494-8. Erratum in: Acta Orthop Scand 1988 Apr;59(2):244. Strömqvist B, Hansson LI, Nilsson LT, Thorngren KG. Prognostic precision in postoperative 99mTc-MDP scintimetry after femoral neck fracture. Acta Orthop Scand. 1987 Oct;58(5):494-8. Erratum in: Acta Orthop Scand 1988 Apr;59(2):244.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43849

Study title: Strömqvist B. Femoral head vitality after intracapsular hip fracture. 490 cases studied by intravital tetracycline labeling and Tc-MDP radionuclide imaging. Acta Orthop Scand Suppl. 1983;200:1-71. No abstract available. Strömqvist B. Femoral head vitality after intracapsular hip fracture. 490 cases studied by intravital tetracycline labeling and Tc-MDP radionuclide imaging. Acta Orthop Scand Suppl. 1983;200:1-71. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44059

Study title: Stulberg BN, Levine M, Bauer TW, Belhobek GH, Pflanze W, Feiglin DH, Roth AI. Multimodality approach to osteonecrosis of the femoral head. Clin Orthop Relat Res. 1989 Mar;(240):181-93. Stulberg BN, Levine M, Bauer TW, Belhobek GH, Pflanze W, Feiglin DH, Roth AI. Multimodality approach to osteonecrosis of the femoral head. Clin Orthop Relat Res. 1989 Mar;(240):181-93.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43792

Study title: Intraoperative 99m technetium bone imaging in the treatment of benign osteoblastic tumors. Sty J, Simons G. Clin Orthop Relat Res. 1982 May;(165):223-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44085

Study title: Sty JR, Boedecker RA, Babbitt DP. Skull scintigraphy in infantile hypophosphatasia. J Nucl Med. 1979 Apr;20(4):305-6. No abstract available. Sty JR, Boedecker RA, Babbitt DP. Skull scintigraphy in infantile hypophosphatasia. J Nucl Med. 1979 Apr;20(4):305-6. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44145

Study title: The primary objective was to evaluate the safety of ampicillin suppositories with special emphasis on local intolerance reactions in pediatric patients. The secondary objective was to evaluate efficacy of a twice daily dosage regimen in the treatment of acute otitis media. The study was comparative against amoxIcillin suspension.Albertini et al. (1987-09-11)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_26.xlsx

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Document reference: 49025

Study title: The primary objective was to evaluate the safety of ampicillin suppositories with special emphasis on local intolerance reactions. The study was comparative against amoxIcillin suspension.Albertini et al. (1987-09-11)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_27.xlsx

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Document reference: 49026

Study title: Hung GL, Stewart CA, Yeo E, Ansari AN, Wang A, Greenfield L. Incidental demonstration of cerebral infarction on bone scintigraphy in sickle cell disease. Clin Nucl Med. 1990 Oct;15(10):671-2. No abstract available. Hung GL, Stewart CA, Yeo E, Ansari AN, Wang A, Greenfield L. Incidental demonstration of cerebral infarction on bone scintigraphy in sickle cell disease. Clin Nucl Med. 1990 Oct;15(10):671-2. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43752

Study title: Hung WT, Su CT. Diagnosis of atretic prolonged obstructive jaundice; technetium 99m hepatolite excretion study. J Pediatr Surg. 1990 Jul;25(7):797-800. Hung WT, Su CT. Diagnosis of atretic prolonged obstructive jaundice; technetium 99m hepatolite excretion study. J Pediatr Surg. 1990 Jul;25(7):797-800.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43759

Study title: Tindale WB, Martel AL, Barber DC. The use of image registration in the analysis of bone scans for the assessment of temporomandibular joint uptake. Nucl Med Commun. 1999 Jan;20(1):49-59. Tindale WB, Martel AL, Barber DC. The use of image registration in the analysis of bone scans for the assessment of temporomandibular joint uptake. Nucl Med Commun. 1999 Jan;20(1):49-59.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43517

Study title: Accumulation of Tc-99m HMDP in bony structures of immature teratoma in a child. Tohyama J, Ohba S, Sugie C, Ogino H, Hara M, Shibamoto Y. Clin Nucl Med. 2003 Apr;28(4):334-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43424

Study title: Tonami N. [Role of nuclear medicine in orthopedic surgery] Nippon Seikeigeka Gakkai Zasshi. 1987 Apr;61(4):411-24. Japanese. No abstract available. Tonami N. [Role of nuclear medicine in orthopedic surgery] Nippon Seikeigeka Gakkai Zasshi. 1987 Apr;61(4):411-24. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43870

Study title: Muscular injury in a child diagnosed by 99mTc-MDP bone scan. Tondeur M, Haentjens M, Piepsz A, Ham HR. Eur J Nucl Med. 1989;15(6):328-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43797

Study title: Tondeur M, Sand A, Ham H. Interobserver reproducibility in the interpretation of bone scans from patients suspected of having reflex sympathetic dystrophy. Clin Nucl Med. 2005 Jan;30(1):4-10. Tondeur M, Sand A, Ham H. Interobserver reproducibility in the interpretation of bone scans from patients suspected of having reflex sympathetic dystrophy. Clin Nucl Med. 2005 Jan;30(1):4-10.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43393

Study title: Tovi F, Gatot A. Bone scan diagnosis of masked mastoiditis. Ann Otol Rhinol Laryngol. 1992 Aug;101(8):707-9. No abstract available. Tovi F, Gatot A. Bone scan diagnosis of masked mastoiditis. Ann Otol Rhinol Laryngol. 1992 Aug;101(8):707-9. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43693

Study title: Toxey J, Achong DM. Skeletal angiomatosis limited to the hand: radiographic and scintigraphic correlation. J Nucl Med. 1991 Oct;32(10):1912-4. Toxey J, Achong DM. Skeletal angiomatosis limited to the hand: radiographic and scintigraphic correlation. J Nucl Med. 1991 Oct;32(10):1912-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43724

Study title: A double blind, double dummy, crossover study to compare the systemic pharmacodynamic effects and safety of inhaled fluticasone propionate Nebules™ 1mg bd with oral prednisolone administered for 7 days to children aged 4 to 16 years with asthma

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FLTB3055-ICHE3.pdf

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Document reference: 28421

Study title: A double blind, double dummy, placebo controlled trial of Fluticasone propionate aqueous nasal spray and oral Ketotifen in children with perennial rhinitis aged between 2 and 4 years.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FLNQ12-ICHE3.pdf

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Document reference: 28364

Study title: A double-blind, 2x2 Factohal Study to evaluate the effects of treatment with intranasal fluticasone propionate and use of Otovent mechanical ventilation of the middle ear on the need for surgery in children aged 4-8 with chronic or recurrent otitis media.

Active substance: FLUTICASONE

Study summary document link (including results): Study FLNL45-Fluticasone_Flixonase.xls

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Document reference: 28363

Study title: A Double-Blind, Double-Dummy, Placebo-Controlled, Crossover Study to Compare the Potential Short-Term Growth Effect of Fluticasone Propionate Aqueous Nasal Spray, Beclomethasone Dipropionate Aqueous Nasal Spray, and Placebo in Adolescents with Perennial Allergic Rhinitis.

Active substance: FLUTICASONE

Study summary document link (including results): Study FNM40007-Fluticasone_Flixonase.xls

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Document reference: 28365

Study title: A double-blind, randomized, placebo-controlled study of the efficacy and safety of aqueous fluticasone propionate given once- versus twice-daily versus placebo for two weeks in adolescent patients with seasonal allergic rhinitis

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FLN-305-ICHE3.pdf

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Document reference: 28407

Study title: A double-blind, randomized, placebo-controlled study of the efficacy and safety of aqueous fluticasone propionate given once daily versus placebo for two weeks in pediatric patients with seasonal allergic rhinitis

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FLN-320-ICHE3.pdf

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Document reference: 28408

Study title: A double-blind, randomized, placebo-controlled study of the efficacy and safety of aqueous fluticasone propionate versus placebo for four weeks in pediatric patients with seasonal allergic rhinitis

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FNM30008-ICHE3.pdf

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Document reference: 28409

Study title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Assess the Potential Growth Effects of a One-Year Course of Fluticasone Propionate Aqueous Nasal Spray (200mcg QD) Versus Placebo in Prepubescent, Pediatric Subjects with Perennial Allergic Rhinitis

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FNM40017-ICHE3.pdf

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Document reference: 28414

Study title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Potential Effects of a Six-Week Course of Fluticasone Propionate Aqueous Nasal Spray (200mcg QD) on the HPA-Axis in ≥2 and <4 Year Old Subjects with Allergic Rhinitis.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FNM40183-ICHE3.pdf

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Document reference: 28416

Study title: A multi-centre, randomised, double-blind, double-dummy, parallel-group study to compare the efficacy and safety of fluticasone propionate 400μg daily with budesonide 400μg daily in children with asthma.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FMS30037-ICHE3.pdf

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Document reference: 28426

Study title: A multi-centre, randomised, double-blind, double-dummy, parallel-group study to determine the clinical equivalence between fluticasone propionate 100μg twice daily delivered via a multidose powder inhaler (MDPI) and the Diskhaler™ in adult and paediatric patients with reversible airways disease.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-propionate-FMDT02-ICHE3.pdf

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Document reference: 28424

Study title: Effect of the combination of ipratropium bromide and fenoterol (berodual) in patients with asthmatic crises comparative study with fenoterol (Berotec).

Active substance: IPRATROPIUM

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Document reference: 30682

Study title: Scintigraphic findings in progressive diaphyseal dysplasia. Lundy MM, Billingsley JL, Redwine MD, Turnbull GL, Brown TJ. J Nucl Med. 1982 Apr;23(4):324-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44087

Study title: Lusins JO, Elting JJ, Cicoria AD, Goldsmith SJ. SPECT evaluation of lumbar spondylolysis and spondylolisthesis. Spine. 1994 Mar 1;19(5):608-12. Lusins JO, Elting JJ, Cicoria AD, Goldsmith SJ. SPECT evaluation of lumbar spondylolysis and spondylolisthesis. Spine. 1994 Mar 1;19(5):608-12.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43631

Study title: Lusins JO, Elting JJ, Cicoria AD, Goldsmith SJ. SPECT evaluation of unilateral spondylolysis. Clin Nucl Med. 1994 Jan;19(1):1-5. Lusins JO, Elting JJ, Cicoria AD, Goldsmith SJ. SPECT evaluation of unilateral spondylolysis. Clin Nucl Med. 1994 Jan;19(1):1-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43636

Study title: Lytic bone lesion in a 12-year-old. Blackmore CC. Perkins A. Acad Radiol1995 Jun;2(6):541-3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48465

Study title: Gallium-67 and technetium-99m-methylene diphosphonate skeletal scintigraphy in determining prognosis for children with stage IV neuroblastoma. Macdonald WB, Stevens MM, Dalla Pozza L, Bergin M, Menser MA, Howman-Giles R, Uren RF. J Nucl Med. 1993 Jul;34(7):1082-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43662

Study title: Podrasky AE, Stark DD, Hattner RS, Gooding CA, Moss AA. Radionuclide bone scanning in neuroblastoma: skeletal metastases and primary tumor localization of 99mTc-MDP. AJR Am J Roentgenol. 1983 Sep;141(3):469-72. Podrasky AE, Stark DD, Hattner RS, Gooding CA, Moss AA. Radionuclide bone scanning in neuroblastoma: skeletal metastases and primary tumor localization of 99mTc-MDP. AJR Am J Roentgenol. 1983 Sep;141(3):469-72.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44033

Study title: Pogrel MA, Kopf J, Dodson TB, Hattner R, Kaban LB. A comparison of single-photon emission computed tomography and planar imaging for quantitative skeletal scintigraphy of the mandibular condyle. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1995 Aug;80(2):226-31. Pogrel MA, Kopf J, Dodson TB, Hattner R, Kaban LB. A comparison of single-photon emission computed tomography and planar imaging for quantitative skeletal scintigraphy of the mandibular condyle. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1995 Aug;80(2):226-31.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44261

Study title: Pseudomonas sacroiliac osteomyelitis: diagnosis by gallium citrate Ga 67 scan. Pope TL, Teague WG, Kossack R, Bray ST, Flannery DB. Am J Dis Child. 1982 Jul;136(7):649-50. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44081

Study title: Large cell lymphoma of bone presented by limp. Postovsky S, Bialik V, Keidar Z, Eppelman M, Militianu D, Ben Izhak OB, Ben Arush MW. J Pediatr Orthop B. 2001 Jan;10(1):81-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43455

Study title: Compare the achieved ampicillin concentrations in CSF following intravenous and intramuscular routes of administration, and to correlate the clinical and laboratory responses in patients treated by the two routes.Wilson et al. (AM J Dis Child/Vol 129, Feb 1975)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_4.xlsx

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Document reference: 49003

Study title: Compare the tolerability of Ampicillin, Amoxicillin and Trimethoprim-Sulfamethoxazole in children with otitis media.Feder (Antimicrobial agents and chemotherapy, Mar. 1982. p. 426-427)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_29.xlsx

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Document reference: 49028

Study title: Sty JR, Starshak RJ, Casper JT. Extraosseous accumulation of Tc-99m MDP. Metastatic intracranial neuroblastoma. Clin Nucl Med. 1983 Jan;8(1):26-7. No abstract available. Sty JR, Starshak RJ, Casper JT. Extraosseous accumulation of Tc-99m MDP. Metastatic intracranial neuroblastoma. Clin Nucl Med. 1983 Jan;8(1):26-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44061

Study title: Accumulation of Tc-99m MDP in the spleen of a battered child. Sty JR, Starshak RJ, Hubbard A. Clin Nucl Med. 1982 Jun;7(6):292. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44083

Study title: Sty JR, Starshak RJ, Oechler HW. Extraosseous uptake of Tc-99m-MDP in congenital fibromatosis. Clin Nucl Med. 1981 Mar;6(3):123. No abstract available. Sty JR, Starshak RJ, Oechler HW. Extraosseous uptake of Tc-99m-MDP in congenital fibromatosis. Clin Nucl Med. 1981 Mar;6(3):123. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44129

Study title: Sty JR, Starshak RJ. Abnormal Tc-99m MDP renal images associated with myoglobinuria. Clin Nucl Med. 1982 Oct;7(10):476. No abstract available. Sty JR, Starshak RJ. Abnormal Tc-99m MDP renal images associated with myoglobinuria. Clin Nucl Med. 1982 Oct;7(10):476. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44071

Study title: The role of bone scintigraphy in the evaluation of the suspected abused child. Sty JR, Starshak RJ. Radiology. 1983 Feb;146(2):369-75.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44051

Study title: Bone infarction in children with sickle cell disease: early diagnosis and differentiation from osteomyelitis. Koren A, Garty I, Katzuni E. Eur J Pediatr. 1984 Jun;142(2):93-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43995

Study title: Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44084

Study title: Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44186

Study title: Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44233

Study title: Tumeh SS, Aliabadi P, Weissman BN, McNeil BJ. Disease activity in osteomyelitis: role of radiography. Radiology. 1987 Dec;165(3):781-4. Tumeh SS, Aliabadi P, Weissman BN, McNeil BJ. Disease activity in osteomyelitis: role of radiography. Radiology. 1987 Dec;165(3):781-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43838

Study title: Tuncel M, Erbas B, Mahmoudian B. Gamut: soft tissue uptake of bone radiopharmaceuticals. Semin Nucl Med. 2003 Oct;33(4):334-7. No abstract available. Tuncel M, Erbas B, Mahmoudian B. Gamut: soft tissue uptake of bone radiopharmaceuticals. Semin Nucl Med. 2003 Oct;33(4):334-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43410

Study title: Turba E, Fagioli G, Mancini AF, Rosito P, Galli A, Alvisi P. Evaluation of stage 4 neuroblastoma patients by means of MIBG and 99mTc-MDP scintigraphy. J Nucl Biol Med. 1993 Sep;37(3):107-14. Turba E, Fagioli G, Mancini AF, Rosito P, Galli A, Alvisi P. Evaluation of stage 4 neuroblastoma patients by means of MIBG and 99mTc-MDP scintigraphy. J Nucl Biol Med. 1993 Sep;37(3):107-14.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43655

Study title: Fibrous dysplasia in the spine: prevalence of lesions and association with scoliosis. Leet AI, Magur E, Lee JS, Wientroub S, Robey PG, Collins MT. J Bone Joint Surg Am. 2004 Mar;86-A(3):531-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43405

Study title: Left distal femoral diaphysis metaphyseal injury in a 13-year-old patient.Delgado Garcia M, Mitjavila Casanovas M, Balsa Breton MA, Castillejos Rodriguez L, Alonso Garcia P, Canamaque Garcia L, et al. Rev Esp Med Nucl 2000 Sep;19{5):356-60. [in Spanish]

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48474

Study title: [An unusual bone scintigram in osteomyelitis. A case report] Lehner G, Kessel HF, Hoffmann D. Radiologe. 1992 Sep;32(9):441-3. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43689

Study title: Leslie WD, Reinhold C, Rosenthall L, Tau C, Glorieux FH. Panostotic fibrous dysplasia. A new craniotubular dysplasia. Clin Nucl Med. 1992 Jul;17(7):556-60. Leslie WD, Reinhold C, Rosenthall L, Tau C, Glorieux FH. Panostotic fibrous dysplasia. A new craniotubular dysplasia. Clin Nucl Med. 1992 Jul;17(7):556-60.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43694

Study title: Levin TL, Berdon WE, Haller JO, Ruzal-Shapiro C, Hurlet-Jenson A. Intrasplenic masses of "preserved" functioning splenic tissue in sickle cell disease: correlation of imaging findings (CT, ultrasound, MRI, and nuclear scintigraphy). Pediatr Radiol. 1996 Sep;26(9):646-9. Levin TL, Berdon WE, Haller JO, Ruzal-Shapiro C, Hurlet-Jenson A. Intrasplenic masses of "preserved" functioning splenic tissue in sickle cell disease: correlation of imaging findings (CT, ultrasound, MRI, and nuclear scintigraphy). Pediatr Radiol. 1996 Sep;26(9):646-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43562

Study title: Levin TL, Berdon WE, Haller JO, Ruzal-Shapiro C, Hurlet-Jenson A. Intrasplenic masses of "preserved" functioning splenic tissue in sickle cell disease: correlation of imaging findings (CT, ultrasound, MRI, and nuclear scintigraphy). Pediatr Radiol. 1996 Sep;26(9):646-9. Levin TL, Berdon WE, Haller JO, Ruzal-Shapiro C, Hurlet-Jenson A. Intrasplenic masses of "preserved" functioning splenic tissue in sickle cell disease: correlation of imaging findings (CT, ultrasound, MRI, and nuclear scintigraphy). Pediatr Radiol. 1996 Sep;26(9):646-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44165

Study title: The imaging diagnosis of nonpyogenic discitis in children.Grünebaum M, Horodniceanu C, Mukamel M, Varsano I, Lubin E. Pediatr Radiol. 1982;12(3):133-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44102

Study title: False positive bone scan secondary to sympathectomy following resection of a ganglioneuroblastoma or affect of unilateral sympathectomy of bone scan in the pediatric patient. Haggstrom JA, Brown JC. Nebr Med J. 1988 Mar;73(3):67-9. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43823

Study title: Siegel Y, Golan H, Thein R. 99mTc-methylene diphosphonate single photon emission tomography of the knees: intensity of uptake and its correlation with arthroscopic findings. Nucl Med Commun. 2006 Sep;27(9):689-93. Siegel Y, Golan H, Thein R. 99mTc-methylene diphosphonate single photon emission tomography of the knees: intensity of uptake and its correlation with arthroscopic findings. Nucl Med Commun. 2006 Sep;27(9):689-93.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43372

Study title: Silva F, Laguna R, Acevedo M, Ruíz C, Orduña E. Clin Nucl Med. 1995 Oct;20(10):913-5. Silva F, Laguna R, Acevedo M, Ruíz C, Orduña E. Clin Nucl Med. 1995 Oct;20(10):913-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43584

Study title: Silvestro L, Bona G, Leonessa M, Giusti M, Mussa GC. [Importance of bone scintigraphy in skeletal diseases] Minerva Pediatr. 1983 Nov 15;35(21):1051-7. Italian. No abstract available. Silvestro L, Bona G, Leonessa M, Giusti M, Mussa GC. [Importance of bone scintigraphy in skeletal diseases] Minerva Pediatr. 1983 Nov 15;35(21):1051-7. Italian. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44022

Study title: Silvestro L, Savant Levet P, Gallina MR. [Role of sequential Tc99m-MDP and Ga-67 scintigraphy in the diagnosis of osteoarticular infections] Minerva Pediatr. 1988 Feb;40(2):103-8. Italian. No abstract available. Silvestro L, Savant Levet P, Gallina MR. [Role of sequential Tc99m-MDP and Ga-67 scintigraphy in the diagnosis of osteoarticular infections] Minerva Pediatr. 1988 Feb;40(2):103-8. Italian. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43826

Study title: [Scintigraphy in the diagnosis and follow-up of bone neoplasms in childhood] Silvestro L, Testa A, Mussa GC. Minerva Pediatr. 1987 May 31;39(10):463-70. Italian. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43862

Study title: Sires BS, Benda PM, Stanley RB Jr, Rosen CE. Orbital osteoid osteoma. Arch Ophthalmol. 1999 Mar;117(3):414-5. No abstract available. Sires BS, Benda PM, Stanley RB Jr, Rosen CE. Orbital osteoid osteoma. Arch Ophthalmol. 1999 Mar;117(3):414-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43510

Study title: Skeletal scintigraphy of young patients with low-back pain and a lumbosacral transitional vertebra. Connolly LP, d'Hemecourt PA, Connolly SA, Drubach LA, Micheli U, Treves ST. J Nucl Med 2003 Jun;44{6):909-14.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48473

Study title: "Relationships between amiodarone dosage, drug concentrations, and adverse side effects. Heger J et al. - 1983 (Am. Hearth J., 106: 931-935) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" "Relationships between amiodarone dosage, drug concentrations, and adverse side effects. Heger J et al. - 1983 (Am. Hearth J., 106: 931-935) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -"

Active substance: AMIODARONE

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Document reference: 45156

Study title: Baldini G. et al Controlled clinical study on the activity of a new formulation of Ambroxol in asthma-like bronchitis in children.MinervaPed,1989,Baldini

Active substance: AMBROXOL

Study summary document link (including results): MinervaPed,1989,Baldini.pdf

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Document reference: 48876

Study title: [Articular complications in sickle cell-thalassemia after childhood. Diagnostic problems] Italian. Potente G. Radiol Med (Torino). 1988 Nov;76(5):409-13. Italian.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43805

Study title: Sacro-iliitis in infants: a difficult diagnosis. 4 cases.Pratte L. Docquier P- L. Joint Bone Spine 2009; 76:313-5

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 47922

Study title: Intense muscle uptake of Tc-99m MDP and Ga-67 citrate in massive rhabdomyolysis. Provan I, Murray C, Mansberg VJ, Rossleigh MA. Clin Nucl Med. 1997 Jul;22(7):463-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43548

Study title: Solitary infantile myofibromatosis of the skull. Queralt JA, Poirier VC. AJNR Am J Neuroradiol. 1995 Mar;16(3):476-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43602

Study title: Ramseyer LT, Leonard JC, Stacy TM. Bone scan findings in craniometaphyseal dysplasia. Clin Nucl Med. 1993 Feb;18(2):137-9. Ramseyer LT, Leonard JC, Stacy TM. Bone scan findings in craniometaphyseal dysplasia. Clin Nucl Med. 1993 Feb;18(2):137-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43673

Study title: Magnetic resonance imaging in children with acute hip pain. Ranner G, Ebner F, Fotter R, Linhart W, Justich E. Pediatr Radiol. 1989;20(1-2):67-71.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43799

Study title: Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21. Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44219

Study title: Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21. Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44266

Study title: Johnson RP, Collier BD, Carrera GF. The os trigonum syndrome: use of bone scan in the diagnosis. J Trauma. 1984 Aug;24(8):761-4. Johnson RP, Collier BD, Carrera GF. The os trigonum syndrome: use of bone scan in the diagnosis. J Trauma. 1984 Aug;24(8):761-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43987

Study title: Describing three children, two with meningitis and one with septicemia, from whom ampicillin-resistant Haemophilus influenzae type B were isolated from the CSF, blood or both. At least one case represents ampicillin failure in the treatment of H. influenzae meningitis because of resistence of the organism to the drug.Ousama et al. (JAMA, July 15 1974, Vol 229, No 3)

Active substance: AMPICILLIN

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Document reference: 49007

Study title: Determine the plasma concentrations after rectal administration of ampicillin suppositories in children, and when possible to estimate the urine concentrations of ampicillin and the bioavailability of the suppository.Eriksson et al. (1991-08-12)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_28.xlsx

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Document reference: 49027

Study title: Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44280

Study title: Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43855

Study title: Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44181

Study title: [Advantages and disadvantages of peroperative isotopic localization in the excision of osteoid osteoma. Considerations apropos of 6 cases] French. Nachin P, Gille P, Aubert D, De La Salle R, Giordan H, Cardot JC. Chir Pediatr. 1986;27(2):65-8. French.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43921

Study title: Cost-appropriateness of whole body vs limited bone imaging for suspected focal sports injuries. Clin Nucl Med. 1986 Jul;11(7):469-73. Nagle CE. Clin Nucl Med. 1986 Jul;11(7):469-73.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43904

Study title: Nair N, Goyal V, Nair CN. Uptake of Tc-99m MDP by a primitive neuroectodermal tumor of the liver. Clin Nucl Med. 1998 Aug;23(8):548-9. No abstract available. Nair N, Goyal V, Nair CN. Uptake of Tc-99m MDP by a primitive neuroectodermal tumor of the liver. Clin Nucl Med. 1998 Aug;23(8):548-9. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43527

Study title: Nair N. Bone scanning in Ewing's sarcoma. J Nucl Med. 1985 Apr;26(4):349-52. Nair N. Bone scanning in Ewing's sarcoma. J Nucl Med. 1985 Apr;26(4):349-52.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43947

Study title: Nakayama T, Saitoh Y, Yatabe K, Sueishi M, Kawai M. [Diagnosis of inflammatory myopathy; usefulness of 99mTc MDP scintigraphy and muscle MRI for determination of affected sites] Rinsho Shinkeigaku. 1999 Nov;39(11):1114-7. Japanese. Nakayama T, Saitoh Y, Yatabe K, Sueishi M, Kawai M. [Diagnosis of inflammatory myopathy; usefulness of 99mTc MDP scintigraphy and muscle MRI for determination of affected sites] Rinsho Shinkeigaku. 1999 Nov;39(11):1114-7. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43492

Study title: Levin TL, Berdon WE, Haller JO, Ruzal-Shapiro C, Hurlet-Jenson A. Intrasplenic masses of "preserved" functioning splenic tissue in sickle cell disease: correlation of imaging findings (CT, ultrasound, MRI, and nuclear scintigraphy). Pediatr Radiol. 1996 Sep;26(9):646-9. Levin TL, Berdon WE, Haller JO, Ruzal-Shapiro C, Hurlet-Jenson A. Intrasplenic masses of "preserved" functioning splenic tissue in sickle cell disease: correlation of imaging findings (CT, ultrasound, MRI, and nuclear scintigraphy). Pediatr Radiol. 1996 Sep;26(9):646-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44212

Study title: Otsuka N, Morita R, Yamamoto T, Muranaka A, Tomomitsu T, Yanagimoto S, Sone T, Fukunaga M. A case of synovial sarcoma with bone metastasis identified by bone marrow scintigraphy. Clin Nucl Med. 1985 Apr;10(4):260-3. Otsuka N, Morita R, Yamamoto T, Muranaka A, Tomomitsu T, Yanagimoto S, Sone T, Fukunaga M. A case of synovial sarcoma with bone metastasis identified by bone marrow scintigraphy. Clin Nucl Med. 1985 Apr;10(4):260-3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43949

Study title: Otsuka N, Yoneda M, Sawai M, Saito J, Nagai K, Muranaka A, Terashima H, Yanagimoto S, Ito Y. [Clinical studies on bone deposition of 99mTc-labeled-DPD (dicarboxypropane diphosphonate): a comparison with 99mTc-methylene diphosphonate] Kaku Igaku. 1982 Dec;19(10):1573-8. Japanese. No abstract available. Otsuka N, Yoneda M, Sawai M, Saito J, Nagai K, Muranaka A, Terashima H, Yanagimoto S, Ito Y. [Clinical studies on bone deposition of 99mTc-labeled-DPD (dicarboxypropane diphosphonate): a comparison with 99mTc-methylene diphosphonate] Kaku Igaku. 1982 Dec;19(10):1573-8. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44278

Study title: Oza UD, Oates E. Rhabdomyolysis of bilateral teres major muscles. Clin Nucl Med. 2003 Feb;28(2):126-7. No abstract available. Oza UD, Oates E. Rhabdomyolysis of bilateral teres major muscles. Clin Nucl Med. 2003 Feb;28(2):126-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43430

Study title: Ozcan Z, Burak Z, Kumanlioğlu K, Sabah D, Başdemir G, Bilkay B, Cetingül N, Ozkiliç H. Assessment of chemotherapy-induced changes in bone sarcomas: clinical experience with 99Tcm-MDP three-phase dynamic bone scintigraphy. Nucl Med Commun. 1999 Jan;20(1):41-8. Ozcan Z, Burak Z, Kumanlioğlu K, Sabah D, Başdemir G, Bilkay B, Cetingül N, Ozkiliç H. Assessment of chemotherapy-induced changes in bone sarcomas: clinical experience with 99Tcm-MDP three-phase dynamic bone scintigraphy. Nucl Med Commun. 1999 Jan;20(1):41-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44256

Study title: Ozcan Z, Erenel G, Aksoylar S, Kansoy S, Burak Z, Ozkiliç H. False-negative scintigraphy with Tc-99m sestamibi in stage IV neuroblastoma. Clin Nucl Med. 1999 Apr;24(4):267-70. Ozcan Z, Erenel G, Aksoylar S, Kansoy S, Burak Z, Ozkiliç H. False-negative scintigraphy with Tc-99m sestamibi in stage IV neuroblastoma. Clin Nucl Med. 1999 Apr;24(4):267-70.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43501

Study title: Palestro C, Lawrence LP, Strashun AM, Goldsmith SJ. Technetium-99m MDP accumulation in hepatic metastasis from osteogenic sarcoma. Clin Nucl Med. 1987 Apr;12(4):329-30. No abstract available. Palestro C, Lawrence LP, Strashun AM, Goldsmith SJ. Technetium-99m MDP accumulation in hepatic metastasis from osteogenic sarcoma. Clin Nucl Med. 1987 Apr;12(4):329-30. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43867

Study title: Smirnov IuN, Mytnikov AM, Ivanov LB, Suchkov VV, Strunin EG. [Distant compression fracture in a child with dysplastic changes in the spine] Med Radiol (Mosk). 1988 Jul;33(7):79-80. Russian. No abstract available. Smirnov IuN, Mytnikov AM, Ivanov LB, Suchkov VV, Strunin EG. [Distant compression fracture in a child with dysplastic changes in the spine] Med Radiol (Mosk). 1988 Jul;33(7):79-80. Russian. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43813

Study title: Primary neuroblastoma uptake of 99mtechnetium methylene diphosphonate. Smith FW, Gilday DL, Ash JM, Reid RH. Radiology. 1980 Nov;137(2):501-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44137

Study title: Smith FW, Gilday DL. Scintigraphic appearances of osteoid osteoma. Radiology. 1980 Oct;137(1 Pt 1):191-5. Smith FW, Gilday DL. Scintigraphic appearances of osteoid osteoma. Radiology. 1980 Oct;137(1 Pt 1):191-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44140

Study title: Detection of adrenal metastasis from osteosarcoma by Tc-99m MDP scintigraphy. Kauffman WM, Winer-Muram H, Sandlund JT. Clin Nucl Med. 1995 Aug;20(8):741. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43592

Study title: Kawano M, Taki J, Tsuchiya H, Tomita K, Tonami N. Predicting the outcome of distraction osteogenesis by 3-phase bone scintigraphy. J Nucl Med. 2003 Mar;44(3):369-74. Kawano M, Taki J, Tsuchiya H, Tomita K, Tonami N. Predicting the outcome of distraction osteogenesis by 3-phase bone scintigraphy. J Nucl Med. 2003 Mar;44(3):369-74.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43425

Study title: Cervical involvement in juvenile-onset ankylosing spondylitis with bone scintigraphy. Kekilli E, Yagmur C, Aydin OM. Rheumatol Int. 2004 May;24(3):164-5. Epub 2003 Sep 20.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43414

Study title: Multiple osteoid osteomas of the fifth lumbar vertebra. A case report. Keret D, Harcke HT, MacEwen GD, Bowen JR. Clin Orthop Relat Res. 1989 Nov;(248):163-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43777

Study title: Kerscher A, Fleiner B, Bohuslaviski KH, Clausen M. [Skeletal scintigraphy in the treatment planning for hemimandibular elongation] Nuklearmedizin. 1995 Jun;34(3):110-4. German. Kerscher A, Fleiner B, Bohuslaviski KH, Clausen M. [Skeletal scintigraphy in the treatment planning for hemimandibular elongation] Nuklearmedizin. 1995 Jun;34(3):110-4. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43600

Study title: Kim HC, Alavi A, Russell MO, Schwartz E. Differentiation of bone and bone marrow infarcts from osteomyelitis in sickle cell disorders. Clin Nucl Med. 1989 Apr;14(4):249-54. Kim HC, Alavi A, Russell MO, Schwartz E. Differentiation of bone and bone marrow infarcts from osteomyelitis in sickle cell disorders. Clin Nucl Med. 1989 Apr;14(4):249-54.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43788

Study title: Kim JW, Nam KW, Yoo JJ, Kim HJ. The role of preoperative bone scan for determining the treatment method for femoral neck fracture. Int Orthop. 2007 Feb;31(1):61-4. Epub 2006 May 13.Kim JW, Nam KW, Yoo JJ, Kim HJ. The role of preoperative bone scan for determining the treatment method for femoral neck fracture. Int Orthop. 2007 Feb;31(1):61-4. Epub 2006 May 13.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43376

Study title: Jones MM, Moore WH, Brewer EJ, Sonnemaker RE, Long SE. Radionuclide bone/joint imaging in children with rheumatic complaints. Skeletal Radiol. 1988;17(1):1-7. Jones MM, Moore WH, Brewer EJ, Sonnemaker RE, Long SE. Radionuclide bone/joint imaging in children with rheumatic complaints. Skeletal Radiol. 1988;17(1):1-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43832

Study title: Jonsson K, Jónsson A, Sloth M, Kopylov P, Wingstrand H. CT of the wrist in suspected scaphoid fracture. Acta Radiol. 1992 Sep;33(5):500-1. Jonsson K, Jónsson A, Sloth M, Kopylov P, Wingstrand H. CT of the wrist in suspected scaphoid fracture. Acta Radiol. 1992 Sep;33(5):500-1.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43691

Study title: Joyce JM, Conrad G, Shih WJ, Ryo UY. Arterial thrombosis and insufficiency causing diffusely decreased uptake by skeleton of a limb. Semin Nucl Med. 1991 Apr;21(2):165-6. No abstract available. Joyce JM, Conrad G, Shih WJ, Ryo UY. Arterial thrombosis and insufficiency causing diffusely decreased uptake by skeleton of a limb. Semin Nucl Med. 1991 Apr;21(2):165-6. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43742

Study title: Unilateral medullary sponge kidney detected on bone scan. Juweid M, Richards CH, Heyman S. Clin Nucl Med. 1993 Jan;18(1):73-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43675

Study title: Juweid ME, Menda Y, O'Dorisio MS, Bushnell D, Blake M, Madsen M, Johnson J, Graham MM. 111In-pentetreotide versus bone scintigraphy in the detection of bony metastases of neuroblastoma. Nucl Med Commun. 2002 Oct;23(10):983-9. Juweid ME, Menda Y, O'Dorisio MS, Bushnell D, Blake M, Madsen M, Johnson J, Graham MM. 111In-pentetreotide versus bone scintigraphy in the detection of bony metastases of neuroblastoma. Nucl Med Commun. 2002 Oct;23(10):983-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43435

Study title: Assessment of mandibular growth by skeletal scintigraphy. Kaban LB, Cisneros GJ, Heyman S, Treves S. J Oral Maxillofac Surg. 1982 Jan;40(1):18-22.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44094

Study title: Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44286

Study title: Veluvolu P, Zoch TW, Miller RW, Weir JG, Mulligan CM, Moen SL. Pseudo-bladder sign in an unsuspected pregnancy. Appearance in bone imaging. Clin Nucl Med. 1992 Dec;17(12):982-3. No abstract available. Veluvolu P, Zoch TW, Miller RW, Weir JG, Mulligan CM, Moen SL. Pseudo-bladder sign in an unsuspected pregnancy. Appearance in bone imaging. Clin Nucl Med. 1992 Dec;17(12):982-3. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43682

Study title: Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish. Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43404

Study title: Narang D, Bharati B, Bhattacharya A, Mittal BR. Radionuclide bone scintigraphy in Engelmann-Camurati disease. Arch Dis Child. 2004 Aug;89(8):737. No abstract available. Narang D, Bharati B, Bhattacharya A, Mittal BR. Radionuclide bone scintigraphy in Engelmann-Camurati disease. Arch Dis Child. 2004 Aug;89(8):737. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43399

Study title: Malignant fibrous histiocytoma of the mandible. Narvaez JA, Muntane A, Narvaez J, Martin F, Monfort JL, Pons LC. Skeletal Radiol. 1996 Jan;25(1):96-9. Review.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43573

Study title: Ncube BA. Pyogenic sacroiliitis in children. Br J Clin Pract. 1988 Apr;42(4):154-7. No abstract available. Ncube BA. Pyogenic sacroiliitis in children. Br J Clin Pract. 1988 Apr;42(4):154-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43822

Study title: Nepola JV, Seabold JE, Marsh JL, Kirchner PT, el-Khoury GY. Diagnosis of infection in ununited fractures. Combined imaging with indium-111-labeled leukocytes and technetium-99m methylene diphosphonate. J Bone Joint Surg Am. 1993 Dec;75(12):1816-22. Nepola JV, Seabold JE, Marsh JL, Kirchner PT, el-Khoury GY. Diagnosis of infection in ununited fractures. Combined imaging with indium-111-labeled leukocytes and technetium-99m methylene diphosphonate. J Bone Joint Surg Am. 1993 Dec;75(12):1816-22.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43644

Study title: Nicholson RL, Manglal-Lan B, Wilkins K. Reverse oblique reconstruction for SPECT of the spine. Clin Nucl Med. 1991 Jul;16(7):478-81. Nicholson RL, Manglal-Lan B, Wilkins K. Reverse oblique reconstruction for SPECT of the spine. Clin Nucl Med. 1991 Jul;16(7):478-81.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43733

Study title: Hashkes PJ, Gorenberg M, Oren V, Friedland O, Uziel Y. "Growing pains" in children are not associated with changes in vascular perfusion patterns in painful regions. Clin Rheumatol. 2005 Aug;24(4):342-5. Epub 2004 Nov 26. Hashkes PJ, Gorenberg M, Oren V, Friedland O, Uziel Y. "Growing pains" in children are not associated with changes in vascular perfusion patterns in painful regions. Clin Rheumatol. 2005 Aug;24(4):342-5. Epub 2004 Nov 26.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43386

Study title: Haskok SN, Konez O. Mixed form lymphatic malformation of the foot simulating acute soft-tissue lesion on 3-phase bone scintigraphy. Clin Nucl Med. 2004 Jan;29(1):48-50. No abstract available. Haskok SN, Konez O. Mixed form lymphatic malformation of the foot simulating acute soft-tissue lesion on 3-phase bone scintigraphy. Clin Nucl Med. 2004 Jan;29(1):48-50. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43406

Study title: Hayasaka K, Amoh K. [Extra-osseous tumor uptake of bone seeking agents] Kaku Igaku. 1982 Sep;19(8):1243-8. Japanese. No abstract available. Hayasaka K, Amoh K. [Extra-osseous tumor uptake of bone seeking agents] Kaku Igaku. 1982 Sep;19(8):1243-8. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44075

Study title: Hayasaka K, Arakawa K, Sugie H, Amoh K. [An experience with 99mTc-hydroxy methylene diphosphonate (99mTc-HMDP) as a new bone scanning agent] Radioisotopes. 1984 Oct;33(10):714-6. Japanese. No abstract available. Hayasaka K, Arakawa K, Sugie H, Amoh K. [An experience with 99mTc-hydroxy methylene diphosphonate (99mTc-HMDP) as a new bone scanning agent] Radioisotopes. 1984 Oct;33(10):714-6. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43979

Study title: Hayasaka K, Sugie H, Saitoh Y, Arakawa K, Amoh K. [Extraosseous tumor uptake of 99m-Tc-MDP] Rinsho Hoshasen. 1985 Jan;30(1):61-5. Japanese. No abstract available. Hayasaka K, Sugie H, Saitoh Y, Arakawa K, Amoh K. [Extraosseous tumor uptake of 99m-Tc-MDP] Rinsho Hoshasen. 1985 Jan;30(1):61-5. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43967

Study title: Phase IV Safety and Efficacy Study of C-30 Liquid Cough-Cold FormulaPhase IV Safety and Efficacy Study of C-30 Liquid Cough-Cold Formula

Active substance: GUAIFENESIN AND PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 29061

Study title: Pujet−J−C, Keddad−K, Sévenier−F, Jolivet−Landreau−I. Comparative study of two antitussive drugs in the treatment of acute dry cough of infectious origin (prospective, randomized, single blind study). Thérapie, {Therapie}, Sep−Oct 2002, vol. 57, no. 5, p. 457−63.Pujet−J−C, Keddad−K, Sévenier−F, Jolivet−Landreau−I. Comparative study of two antitussive drugs in the treatment of acute dry cough of infectious origin (prospective, randomized, single blind study). Thérapie, {Therapie}, Sep−Oct 2002, vol. 57, no. 5, p. 457−63.

Active substance: GUAIFENESIN AND PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 29053

Study title: Purello−D−Ambrosio−F, Tigano−F, Gallesio−M−T, Chevallier−P, Janssens− M. Astemizole−D compared with triprolidine−D (Actifedregistered trade mark) for acute treatment of perennial allergic rhinitis. Journal of Pharmaceutical Medicine {J−PHARM−MED}, 1994, Vol/Iss/Pg. 4 /1 (15−22). Purello−D−Ambrosio−F, Tigano−F, Gallesio−M−T, Chevallier−P, Janssens− M. Astemizole−D compared with triprolidine−D (Actifedregistered trade mark) for acute treatment of perennial allergic rhinitis. Journal of Pharmaceutical Medicine {J−PHARM−MED}, 1994, Vol/Iss/Pg. 4 /1 (15−22).

Active substance: GUAIFENESIN AND PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 29054

Study title: Kuhn JJ, Hendley JO, Adams KF, Clark JW, Gwaltney JM. Antitussive effect of guaifenesin in young adults with natural colds. Chest 1982 82;6: 713-718Kuhn JJ, Hendley JO, Adams KF, Clark JW, Gwaltney JM. Antitussive effect of guaifenesin in young adults with natural colds. Chest 1982 82;6: 713-718

Active substance: GUAIFENESIN OR GUAIFENESIN AND LEVOMENTHOL

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Document reference: 29063

Study title: Parvez−L, Vaidya−M, Sakhardande−A, Subburaj−S, Rajagopalan−T−G. Evaluation of antitussive agents in man. Pulmonary pharmacology, {Pulm−Pharmacol}, Oct−Dec 1996, vol. 9, no. 5−6, p. 299−308.Parvez−L, Vaidya−M, Sakhardande−A, Subburaj−S, Rajagopalan−T−G. Evaluation of antitussive agents in man. Pulmonary pharmacology, {Pulm−Pharmacol}, Oct−Dec 1996, vol. 9, no. 5−6, p. 299−308.

Active substance: GUAIFENESIN OR GUAIFENESIN AND LEVOMENTHOL

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Document reference: 29062

Study title: Pujet−J−C, Keddad−K, Sévenier−F, Jolivet−Landreau−I. Comparative study of two antitussive drugs in the treatment of acute dry cough of infectious origin (prospective, randomized, single blind study). Thérapie, {Therapie}, Sep−Oct 2002, vol. 57, no. 5, p. 457−63.Pujet−J−C, Keddad−K, Sévenier−F, Jolivet−Landreau−I. Comparative study of two antitussive drugs in the treatment of acute dry cough of infectious origin (prospective, randomized, single blind study). Thérapie, {Therapie}, Sep−Oct 2002, vol. 57, no. 5, p. 457−63.

Active substance: GUAIFENESIN OR GUAIFENESIN AND LEVOMENTHOL

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Document reference: 29064

Study title:

Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT)

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Document reference: 41161

Study title: A phase II, double-blind, randomized study to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals¿ Tritanrix¿-HepBlow thio/Hib2.5 Gödöllö to GSK Biologicals¿ Tritanrix¿-HepB/Hiberix¿Gödöllö when administered as a three-dose primary vaccination course to healthy infants at 6, 10 and 14 weeks of age. A dose of unconjugated Hib vaccine (plain PRP booster) will be administered at the age of 10 months to 50% of the subjects. Note: This report presents the results pertaining to the plain PRP challenge at 10 months of age.

Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT)

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Document reference: 41159

Study title: "Fluoxetine Vs Placebo In Obsessive Compulsive "

Active substance: FLUOXETINE

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Document reference: 28337

Study title: Fluoxetine Vs Placebo In Ocd Relapse Prevention

Active substance: FLUOXETINE

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Document reference: 28328

Study title: Fluoxetine Vs Placebo In Post Natal Depression

Active substance: FLUOXETINE

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Document reference: 28326

Study title: "Fluoxetine vs. Placebo in the Acute Treatment of Major Depressive Disorder in Children and Adolescents

Active substance: FLUOXETINE

Study summary document link (including results): fluoxetine B1Y-MC-X065 Clinical Study Synopsis.pdf

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Document reference: 28343

Study title: Natural history and distribution of bone and bone marrow infarction in sickle hemoglobinopathies. Kim SK, Miller JH. J Nucl Med. 2002 Jul;43(7):896-900.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43447

Study title: Kirchner B, Hillmann A, Lottes G, Sciuk J, Bartenstein P, Winkelmann W, Schober O. Intraoperative, probe-guided curettage of osteoid osteoma. Eur J Nucl Med. 1993 Jul;20(7):609-13. Kirchner B, Hillmann A, Lottes G, Sciuk J, Bartenstein P, Winkelmann W, Schober O. Intraoperative, probe-guided curettage of osteoid osteoma. Eur J Nucl Med. 1993 Jul;20(7):609-13.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43658

Study title: Kirchner PT, Simon MA. The clinical value of bone and gallium scintigraphy for soft-tissue sarcomas of the extremities. J Bone Joint Surg Am. 1984 Mar;66(3):319-27. Kirchner PT, Simon MA. The clinical value of bone and gallium scintigraphy for soft-tissue sarcomas of the extremities. J Bone Joint Surg Am. 1984 Mar;66(3):319-27.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44005

Study title: Comparison of whole-body STIR-MRI and 99mTc-methylene-diphosphonate scintigraphy in children with suspected multifocal bone lesions. Mentzel HJ, Kentouche K, Sauner D, Fleischmann C, Vogt S, Gottschild D, Zintl F, Kaiser WA. Eur Radiol. 2004 Dec;14(12):2297-302. Epub 2004 Jul 9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43401

Study title: Merkel KD, Brown ML, Dewanjee MK, Fitzgerald RH Jr. Comparison of indium-labeled-leukocyte imaging with sequential technetium-gallium scanning in the diagnosis of low-grade musculoskeletal sepsis. A prospective study. Merkel KD, Brown ML, Dewanjee MK, Fitzgerald RH Jr. Comparison of indium-labeled-leukocyte imaging with sequential technetium-gallium scanning in the diagnosis of low-grade musculoskeletal sepsis. A prospective study.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43951

Study title: Flare response in Ewing's sarcoma. Meyer JR, Shulkin BL. Clin Nucl Med. 1991 Nov;16(11):807-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43723

Study title: Middendorf PR, Marti RK. [Difficulties and possibilities in the detection and removal of osteoid osteoma] Ned Tijdschr Geneeskd. 1985 May 18;129(20):929-32. Dutch. No abstract available. Middendorf PR, Marti RK. [Difficulties and possibilities in the detection and removal of osteoid osteoma] Ned Tijdschr Geneeskd. 1985 May 18;129(20):929-32. Dutch. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43943

Study title: Milachowski KA, Keyl W, Zwingers T. [Scintigraphic findings in fracture of the vertebral body] Unfallchirurgie. 1987 Apr;13(2):93-8. German. Erratum in: Unfallchirurgie 1987 Aug;13(4):230. Milachowski KA, Keyl W, Zwingers T. [Scintigraphic findings in fracture of the vertebral body] Unfallchirurgie. 1987 Apr;13(2):93-8. German. Erratum in: Unfallchirurgie 1987 Aug;13(4):230.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43866

Study title: Scintigraphy of toddler's fracture. Miller JH, Sanderson RA. J Nucl Med. 1988 Dec;29(12):2001-3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43801

Study title: comparative single blind parallell clinical efficacy and tolerance with amoxicillin suspension 50 mg/mlx2 and compare with amoxicillin suspension 25 mg/ml x3.Olsson et al

Active substance: AMOXICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_12.xlsx

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Document reference: 48994

Study title: Effect and tolerance of amoxicillin with and without probenecid.Alergant.

Active substance: AMOXICILLIN

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Document reference: 48969

Study title: Efficacy in General PracticeJorna J Lees

Active substance: AMOXICILLIN

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Document reference: 48971

Study title: Evaluate efficacy in spefic infections and to compare amoxicillin 250 mg qid and 500 mg bd.Andrews et al

Active substance: AMOXICILLIN

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Document reference: 48972

Study title: Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish. Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44150

Study title: Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish. Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44197

Study title: Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish. Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44244

Study title: Vernigora IP, Prokopchuk VF, Gritsaĭ NP, Radchenko DP. [Scintigraphy in the prognosis of the outcome of a free autoplasty in cases of suppurative infection] Ortop Travmatol Protez. 1988 Sep;(9):62. Russian. No abstract available. Vernigora IP, Prokopchuk VF, Gritsaĭ NP, Radchenko DP. [Scintigraphy in the prognosis of the outcome of a free autoplasty in cases of suppurative infection] Ortop Travmatol Protez. 1988 Sep;(9):62. Russian. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43811

Study title: Vorne M, Saukko T. Detection of malignant soft tissue tumors in bone imaging. Eur J Nucl Med. 1984;9(4):180-4. Vorne M, Saukko T. Detection of malignant soft tissue tumors in bone imaging. Eur J Nucl Med. 1984;9(4):180-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44008

Study title: Unexpected myocardial uptake on bone scintigraphy in an infant with Kawasaki disease. Macdonald WB, Troedson RG. Clin Nucl Med. 2001 May;26(5):455. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43454

Study title: Machida K, Makita K, Nishikawa J, Ohtake T, Iio M. Scintigraphic manifestation of fibrous dysplasia. Clin Nucl Med. 1986 Jun;11(6):426-9. Machida K, Makita K, Nishikawa J, Ohtake T, Iio M. Scintigraphic manifestation of fibrous dysplasia. Clin Nucl Med. 1986 Jun;11(6):426-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43907

Study title: A rare cause of rickets in a young child. Machiels F, De Maeseneer M, Van Snick A, Rayen I, Desprechins B, Osteaux M. J Belge Radiol. 1995 Oct;78(5):276-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43585

Study title: Madsen JL. Scintigraphic detection of clavicular hyperostosis in a patient with fulminant acne. Clin Nucl Med. 1988 May;13(5):345. Madsen JL. Scintigraphic detection of clavicular hyperostosis in a patient with fulminant acne. Clin Nucl Med. 1988 May;13(5):345.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43818

Study title: Haynie TP. Prognosis by nuclear medicine: can functional staging of cancer patients predict therapeutic response and survival? J Nucl Med. 1993 Jul;34(7):1087-9. No abstract available. Haynie TP. Prognosis by nuclear medicine: can functional staging of cancer patients predict therapeutic response and survival? J Nucl Med. 1993 Jul;34(7):1087-9. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43661

Study title: Heinle A, Carrasquillo JA, Neumann RD. Two unusual cases of metastatic osteosarcoma detected by Tc-99m MDP bone scintigraphy. Clin Nucl Med. 1989 Dec;14(12):889-93. Heinle A, Carrasquillo JA, Neumann RD. Two unusual cases of metastatic osteosarcoma detected by Tc-99m MDP bone scintigraphy. Clin Nucl Med. 1989 Dec;14(12):889-93.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43776

Study title: Hejgaard N, Diemer H. Bone scan in the patellofemoral pain syndrome. Int Orthop. 1987;11(1):29-33. Hejgaard N, Diemer H. Bone scan in the patellofemoral pain syndrome. Int Orthop. 1987;11(1):29-33.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43882

Study title: Helms CA, Hattner RS, Vogler JB 3rd. Osteoid osteoma: radionuclide diagnosis. Radiology. 1984 Jun;151(3):779-84. Helms CA, Hattner RS, Vogler JB 3rd. Osteoid osteoma: radionuclide diagnosis. Radiology. 1984 Jun;151(3):779-84.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43998

Study title: Hematogenous pyogenic vertebral osteomyelitis: diagnostic value of radionuclide bone imaging. Adatepe MH. Powell OM. Isaacs GH. Nichols K. Cefola R. J Nucl Med 1986 Nov;27(11):1680-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48463

Study title: Abnormal Tc-99m MDP renal images associated with hemolytic streptococcal sepsis. Sty JR, Wells RG, Ruiz ME. Clin Nucl Med. 1995 Oct;20(10):944. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43582

Study title: Suematsu T, Yoshida S, Motohara T, Fujiwara H, Nishii H, Komiyama T, Yanase M, Mizutani M. [Diffusely increased uptake in the skull in normal bone scans] Kaku Igaku. 1992 May;29(5):599-605. Japanese. Suematsu T, Yoshida S, Motohara T, Fujiwara H, Nishii H, Komiyama T, Yanase M, Mizutani M. [Diffusely increased uptake in the skull in normal bone scans] Kaku Igaku. 1992 May;29(5):599-605. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43698

Study title: Infantile infectious sacroiliitis. Sueoka BL, Johnson JF, Enzenauer R, Kolina JS. Pediatr Radiol. 1985;15(6):403-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43960

Study title: Resolved splenic accumulation of Tc-99m HMDP after recovery of disseminated intravascular coagulation in a patient with rhabdomyosarcoma. Suga K, Matsunaga N, Kawamura T, Hara A, Kume N. Clin Nucl Med. 1999 Jun;24(6):414-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43507

Study title: Sugimura K, Narabayashi I, Yamazaki K, Fukugawa T, Sugimura C, Matsuo M, Nishiyama S, Kimura S. [Bone scintigraphic findings in 2 cases of myositis ossificans progressiva] Kaku Igaku. 1983 Jul;20(6):875-9. Japanese. No abstract available. Sugimura K, Narabayashi I, Yamazaki K, Fukugawa T, Sugimura C, Matsuo M, Nishiyama S, Kimura S. [Bone scintigraphic findings in 2 cases of myositis ossificans progressiva] Kaku Igaku. 1983 Jul;20(6):875-9. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44034

Study title: Fluoxetine: In Depression And Ocd (Compassionate Use)

Active substance: FLUOXETINE

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Document reference: 28332

Study title: Fluoxetine/Placebo In Panic Disorder

Active substance: FLUOXETINE

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Document reference: 28338

Study title: Impact Of Fluoxetine On Growth In Children And Adolescents

Active substance: FLUOXETINE

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Document reference: 28330

Study title: Pharmacokinetic Assessment of Fluoxetine and Norfluoxetine in Preadolescent and Adolescent Patients

Active substance: FLUOXETINE

Study summary document link (including results): fluoxetine B1Y-MC-HCIU Clinical Study Summary.pdf

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Document reference: 47357

Study title: "Prozac.Epidemiological Study In Obsessional Compulsive Disorder "

Active substance: FLUOXETINE

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Document reference: 28336

Study title: Tomoxetine + fluoxetine for Poor Metabolizer exposures

Active substance: FLUOXETINE

Study summary document link (including results): fluoxetine B4Z-MC-LYAQ Clinical Study Summary.pdf

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Document reference: 28333

Study title: Reimão R, Lefévre AB.: Evaluation of flurazepam and placebo on sleep disorders in childhood. Arq Neuropsiquiatr. 1982 Mar;40(1):1-13.

Active substance: FLURAZEPAM

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Document reference: 28345

Study title: VALUTAZIONE IN PEDIATRIA DELL'ATTIVITA' IPNOINDUCENTE DEL FLURAZEPAM GOCCE (VAL 779) Rapisarda V.; Germana B. Formazione Psichiatrica, December 1, 1980 , No. 4/- (181-190) Evaluation of flurazepam and placebo on sleep disorders in childhood. Reimão R, Lefévre AB. Arq Neuropsiquiatr. 1982 Mar;40(1):1-13.

Active substance: FLURAZEPAM

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Document reference: 28344

Study title:

Active substance: FLURBIPROFEN

Study summary document link (including results): Flurbiprofen-M87-097.pdf

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Document reference: 47460

Study title: Flurbiprofen in the Tretment of Juvenile Rheumatoid Arhtritis

Active substance: FLURBIPROFEN

Study summary document link (including results): flurbiprofen-m86055-bass.xls

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Document reference: 48078

Study title: Pharmacokinetics of Oral and Rectal Flurbiprofen in Childrene

Active substance: FLURBIPROFEN

Study summary document link (including results): flurbiprofen-m84016-scaroni.xls

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Document reference: 48076

Study title: Post-Tonsillectomy Treatment with Flurbiprofen and Phenylprenazone in Children

Active substance: FLURBIPROFEN

Study summary document link (including results): flurbiprofen-m84017-catalano.xls

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Document reference: 48077

Study title: A placebo controlled trial during the pollen season comparing the effects of intranasal Beclomethasone dipropionate and intranasal Fluticasone propionate in children and young adults with asthma and allergic rhinitis.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FNM40054-ICHE3.pdf

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Document reference: 28366

Study title: A randomised, double-blind, double-dummy, parallel group, multicentre study to compare the effect on growth measured by stadiometry of fluticasone propionate (100μg bd) administered via DISKUS™ with budesonide (200μg bd) administered via Turbuhaler in prepubescent children.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FMS40001-ICHE3.pdf

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Document reference: 28384

Study title: A Randomized, Double-Blind, Double Dummy, Parallel Group Comparison of Fluticasone Propionate Inhalation Powder (50mcg BID) via DiskusTM with Oral Montelukast (5mg QD) Chewable Tablets in Children 6–12 years of Age with Persistent Asthma

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FPD40012-ICHE3.pdf

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Document reference: 28389

Study title: Minematsu K, Tsuchiya H, Taki J, Tomita K. Blood flow measurement during distraction osteogenesis. Clin Orthop Relat Res. 1998 Feb;(347):229-35. Minematsu K, Tsuchiya H, Taki J, Tomita K. Blood flow measurement during distraction osteogenesis. Clin Orthop Relat Res. 1998 Feb;(347):229-35.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43535

Study title: Sequential radionuclide bone imaging in avascular pediatric hip conditions. Minikel J, Sty J, Simons G. Clin Orthop Relat Res. 1983 May;(175):202-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44038

Study title: 111In-labelled leucocyte and 99mTc-methylene diphosphonate bone scanning in pelvic osteomyelitis. Hall FM, Conybeare ME, Coakley AJ, Mountford PJ, Wells CP. Eur J Nucl Med. 1983;8(9):393-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44056

Study title: Metastatic neuroblastoma: new abnormalities on bone scintigraphy may not indicate tumour recurrence. Hall-Craggs MA, Shaw D, Pritchard J, Gordon I. Skeletal Radiol. 1990;19(1):33-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43770

Study title: Evaluate the efficacy of amoxicillin i ndifferent dosages i nthe treatment of gonococcal urethritis in the male. Compare the results with stnadard treatment.Watt et al.

Active substance: AMOXICILLIN

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Document reference: 48970

Study title: Controlled clinical study on the activity of a new mucoregulating drug in obstructive bronchial pathology with a marked hypersecretory feature. Paediatric experience. Min.Ped.1984,36(3),127-138. Romano C. et al. Minerva Pediatrica 1984, Romano

Active substance: AMBROXOL

Study summary document link (including results): Minerva Pediatrica 1984, Romano.pdf

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Document reference: 48874

Study title: Miller TW, Heck LL, Kight JL, McCarroll JR, Shelbourne KD, Van Hove ED. A clinical and radiological review of stress fractures in competitive and non-competitive athletes. Indiana Med. 1987 Oct;80(10):942-9. No abstract available. Miller TW, Heck LL, Kight JL, McCarroll JR, Shelbourne KD, Van Hove ED. A clinical and radiological review of stress fractures in competitive and non-competitive athletes. Indiana Med. 1987 Oct;80(10):942-9. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43848

Study title: A phase III, observer-blind, single-centre, randomized study to evaluate safety and immunogenicity of three lots of DTwPHib full liquid vaccine (Chiron Vaccines; now Novartis Vaccines) and of American Home Product (AHP-Wyeth) Tetramune (DTwPHib) vaccine administered to healthy infants at 2, 3 and 4 months of age.Please see report- sturdy report

Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)

Study summary document link (including results): V38P2.xlsx

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Document reference: 49184

Study title: A randomized, stratified, double blind trial to compare safety and efficacy of the Fluvirin® Vaccine (a purified surface antigen vaccine) with Connaught Inactivated Influenza Vaccine Fluzone® (a split virion vaccine) in healthy children aged 6 to 47 months of age.Nicolay 1999, Vaccine 17 (1999) 2223-2228

Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)

Study summary document link (including results): MPL-318-01.xlsx

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Document reference: 49190

Study title: Esomeprazole Magnesium: An 8 Week Oral (Gavage) Toxicity and Toxicokinetic Study in the Neonatal and Young Adult Beagle Dog (a Complementary Study). AstraZeneca R&D Södertälje, Safety Assessment, Sweden (Charles River Laboratories Preclinical Services Mo

Active substance: ESOMEPRAZOLE

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Document reference: 26610

Study title: Diptheria booster vaccination one or two injections_1999Nicolay 1999, Vaccine 17 (1999) 2223-2228

Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)

Study summary document link (including results): Nicolay_Diptheria booster vaccination one or two injections_1999.pdf

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Document reference: 49189

Study title: Pilar 1983Please see report- sturdy report

Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)

Study summary document link (including results): Pilar 1983.pdf

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Document reference: 49188

Study title: An open label, not randomized, age stratified trial to study safety and efficacy of the vaccine in subjects from 6 to 35 months of age.Please see report - study report

Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)

Study summary document link (including results): MEMUFL-95-001.xlsx

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Document reference: 49191

Study title: Publication_8T-201RAPlease see report- sturdy report

Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)

Study summary document link (including results): Publication_8T-201RA.pdf

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Document reference: 49187

Study title: Response to Diphtheria and Tetanus Booster Vaccination in pediatric renal transplantTransplantation, Issue: Volume 64(2),€27 July 1997,€pp 237-241, Enke

Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)

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Document reference: 49193

Study title: Safety and immunogenicity of anew fully liquid DTPw-HepB-Hib combination vaccine in infantsKanra_et_al_2006_Publication

Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)

Study summary document link (including results): Kanra_et_al_2006_Publication.pdf

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Document reference: 49192

Study title: Gregianin LJ et al Clinical and pharmacokinetic study of fractionated doses of oral etoposide in pediatric patients with advanced malignancies Med Sci Monit 2002 Sep;8(9):PI70-7Gregianin LJ et al Clinical and pharmacokinetic study of fractionated doses of oral etoposide in pediatric patients with advanced malignancies Med Sci Monit 2002 Sep;8(9):PI70-7

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 24913

Study title: Controlled study on the efficacy of Flour-Vigantoletten 1000 in prophylaxis of rachitis -Kontrollierte Studie zur rachitisprophylaktischen Wirkung von Flour-Vigantoletten 1000.Ther d Gegenw 1976; 115: 2076-2087 Pohlandt F., 1976

Active substance: COLECALCIFEROL AND SODIUM FLUORIDE

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Document reference: 48990

Study title: Casanova M et al Etoposide, cisplatin, epirubicin chemotherapy in the treatment of pediatric liver tumors Pediatr Hematol Oncol 2005 Apr-May;22(3):189-98Casanova M et al Etoposide, cisplatin, epirubicin chemotherapy in the treatment of pediatric liver tumors Pediatr Hematol Oncol 2005 Apr-May;22(3):189-98

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 24816

Study title: Schiavetti A et al Ten-day schedule oral etoposide therapy in advanced childhood malignancies J Pediatr Hematol Oncol 2000 Mar-Apr;22(2):119-24Schiavetti A et al Ten-day schedule oral etoposide therapy in advanced childhood malignancies J Pediatr Hematol Oncol 2000 Mar-Apr;22(2):119-24

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 25110

Study title: open uncontrolled study to evaluate the acceptance and tolerance of flucloxacillin suspension.Lidgren. Clinical trial on flucloxacillin suspension in children.

Active substance: FLUCLOXACILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Flukloxacillin_2.xlsx

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Document reference: 49075

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IV FCA IN THE TREATMENT OF CANDIDIASIS IN THE LEUKEMIC PATIENTS

Active substance: FLUCONAZOLE

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Document reference: 27941

Study title: EFFICACY AND SAFETY OF FLUCONAZOLE IN THE TREATMENT OF FUNGAL INFECTIONS.

Active substance: FLUCONAZOLE

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Document reference: 27663

Study title: Anticancer Res. 2003 Jul-Aug;23(4):3513-6. Differentiating recurrent or residual nasopharyngeal carcinomas from post-radiotherapy changes with 18-fluoro-2-deoxyglucose positron emission tomography and thallium-201 single photon emission computed tomography in patients with indeterminate computed tomography findings. Tsai MH, Huang WS, Tsai JJ, Chen YK, Changlai SP, Kao CH.

Active substance: FLUDEOXYGLUCOSE

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Document reference: 28141

Study title: JM Espadaler. Ensayo de la CDPcolina en el tratamiento de los trastornos del aprendizaje del niño. Med Clin (Barc), 71: 357-361, 1978JM Espadaler. Ensayo de la CDPcolina en el tratamiento de los trastornos del aprendizaje del niño. Med Clin (Barc), 71: 357-361, 1978

Active substance: CITICOLINE

Study summary document link (including results): Espadaler CITICOLINE MONOSODIUM_Ferrer Internacional.xls

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Document reference: 24296

Study title: Radionuclide studies in paediatric nephro-urologyPiepsz A. Eur J Radiol. 2002 Aug;43(2):146-53.

Active substance: CHROMIUM 51

Study summary document link (including results): Piepsz A 2002.pdf

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Document reference: 24091

Study title: Guillonneau M, Jacqz Aigrain E, Galliot M, Binet M-H, Darbois Y. Colchicine is excreted at high concentrations in human breast milk. European journal of obstetrics&Gynecology and Reproductive Biology 1995; 61:177-178Guillonneau M, Jacqz Aigrain E, Galliot M, Binet M-H, Darbois Y. Colchicine is excreted at high concentrations in human breast milk. European journal of obstetrics&Gynecology and Reproductive Biology 1995; 61:177-178

Active substance: COLCHICINE

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Document reference: 24588

Study title: FABIE M.;BARTHELEMY R. Clinical Study of a locally active solution. Rev. Odonto-stomatol. Midi Fr., 1969, 4, 267-273.

Active substance: CHLORHEXIDINE AND CHLOROBUTANOL

Study summary document link (including results): Eludril_Fabie.xls

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Document reference: 23897

Study title: De Martini et al Clofoctol: microbiological, pharmacological and clinical aspects. Farmaci,1999,23(6)202-208 -aspetti microbiologici, farmacologici e clinici.Farmaci vol. 23 n.6-'99, De Martini Farmaci,1999,23(6)202-208

Active substance: clofoctol

Study summary document link (including results): Art 45 EMA Chiesi Paediatric Studies.xls

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Document reference: 48991

Study title: TEST ON TERATOGENIC EFFECT - RATS, ORAL ADMINISTRATION

Active substance: CLOMIPRAMINE

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Document reference: 24381

Study title: Pitsiu−Maria, Hussein−Ziad, Majid−Oneeb, Aarons−Leon, de−Longueville− Marc, Stockis−Armel. Retrospective population pharmacokinetic analysis of cetirizine in children aged 6 months to 12 years. British journal of clinical pharmacology, {Br−J−Clin−Pharmacol}, Apr 2004, vol. 57, no. 4, p. 402−11.Pitsiu−Maria, Hussein−Ziad, Majid−Oneeb, Aarons−Leon, de−Longueville− Marc, Stockis−Armel. Retrospective population pharmacokinetic analysis of cetirizine in children aged 6 months to 12 years. British journal of clinical pharmacology, {Br−J−Clin−Pharmacol}, Apr 2004, vol. 57, no. 4, p. 402−11.

Active substance: CETIRIZINE

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Document reference: 23670

Study title: A report on the method of treatment of chronic osteomyelitis at the Clinic of Infectious Diseases in Lund, which is both general and local in antibiotics administration. Comparisons are made with reports on the same general, but without the local treatment.Hedström (Scand J Infec Dis 1: 175-180, 1969)

Active substance: CLOXACILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Cloxacillin_1.xlsx

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Document reference: 49082

Study title: symptomatic treatment of migraine in children: a systemic review of medications trials

Active substance: CHLORPHENAMINE AND PARACETAMOL

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Document reference: 24048

Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with sore throat pain. Dec 1992.

Active substance: CODEINE_AND_PARACETAMOL

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Document reference: 24563

Study title: Experience with rnebendazol in children with multiple intestinal helminthiasis. 1974

Active substance: MEBENDAZOLE

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Document reference: 31553

Study title: Compare the effectiveness in the treatment of chronic constipation of a lactulose preparation ("Duphalac") and "irritant" laxatives containing senna, anthraquinone derivatives or bisacodyl.Connolly et al

Active substance: LACTULOSE

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Lactulose_2.xlsx

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Document reference: 49067

Study title: Compare the effects of chemotherapy, chemotherapy combined with Lactulose, or Lactulose alone with regard to curtailing the pathological excretion of salmonellae.Sander-Treske et al

Active substance: LACTULOSE

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Lactulose_4.xlsx

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Document reference: 49069

Study title: Forlax in the treatment of childhood constipation: a randomized, controlled, multicenter clinical study. Wang BX, Wang MG, Jiang MZ, Xu CD, Shao CH, Jia LY, Huang ZH, Xu XH. Zhongguo Dang Dai Er Ke Za Zhi. 2007 Oct;9(5):429-32.Forlax in the treatment of childhood constipation: a randomized, controlled, multicenter clinical study. Wang BX, Wang MG, Jiang MZ, Xu CD, Shao CH, Jia LY, Huang ZH, Xu XH. Zhongguo Dang Dai Er Ke Za Zhi. 2007 Oct;9(5):429-32.

Active substance: LACTULOSE

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Document reference: 30993

Study title: Minuck M. Postoperative Analgesia - Comparison of Methotrimeprazine (Nozinan) and Meperidine (Demerol) as Postoperative Minuck M. Postoperative Analgesia - Comparison of Methotrimeprazine (Nozinan) and Meperidine (Demerol) as Postoperative

Active substance: LEVOPROMAZINE

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Document reference: 31164

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Cinnamomum-Homaccord N (drops) [AWB-AT]

Active substance: Cinnamomum-Homaccord N

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Document reference: 39829

Study title: A thyroxine dosage of 8 μg/kg per day is appropriate for the initial treatment of the majority of infants with congenital hypothyroidism. Eur J Pediatr 1997; 156: 94-98 Touati G et al., 1997

Active substance: LEVOTHYROXINE

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Document reference: 48951

Study title: Analysis of Physical and Mental Developmernt of Children With Aplasia, Hypoplasia and Ectopy of the Thyroid GlandEndocrine Reg 2006; 40: 7-14 Pniewska-Siark B., 2006

Active substance: LEVOTHYROXINE

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Document reference: 48978

Study title: Children With Congenital Hypothyroidism and Their Siblings: Do They Really Differ?Rovet JF., 2005 Horm Res 2006; 66: 240-248 Pediatrics 2005; 1145 (1): e52-e57

Active substance: LEVOTHYROXINE

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Document reference: 48956

Study title: Cognition and Behaviour at School Entry in Children With Congenital Hypothyroidism Treated Early With High-Dose LevothyroxineJ Pediatr 2004; 144: 747-752 Simoneau-Roy J., 2004

Active substance: LEVOTHYROXINE

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Document reference: 48980

Study title: Effect of long-term L-thyroxine treatment on bone mineral density in young adults with congenital hypothyroidismEur J Endocrinol 2004; 151: 689-694 Salerno M., 2004

Active substance: LEVOTHYROXINE

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Document reference: 48984

Study title: Investigate the clinical use of Lactulose as laxative in constipated children.Bush

Active substance: LACTULOSE

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Document reference: 49068

Study title: To compare lactulose with standardized senna syrup in treatment of constipated children.Perkin

Active substance: LACTULOSE

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Document reference: 49066

Study title: Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma Cancer2003; 98: 389-396 Van Santen HM., 2003

Active substance: LEVOTHYROXINE

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Document reference: 48986

Study title: Influence of timing and dose of thyroid hormone replacement on development in infants with congenital hypothyroidismJ Pediatr 2000; 136: 292-297 Bongers-Schokking JJ., 2000

Active substance: LEVOTHYROXINE

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Document reference: 48982

Study title: Levothyroxine in Euthyroid Autoimmune Thyroiditis and Type 1 Diabetes: A Randomized, Controlled TrialJ Clin Endocrinol Metab 2007; 92: 1647-1652 Karges B., 2007

Active substance: LEVOTHYROXINE

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Document reference: 48983

Study title: Longitudinal Assessment of L-T4 Therapy for Congenital Hypothyroidism: Differences Between Athyreosis vs Ectopia and Delayed vs Normal Bone Age, Garcia MF 2000 J Pediatr Endocrinol Metab 2000; 13: 63-69

Active substance: LEVOTHYROXINE

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Document reference: 48953

Study title: LT4-monopreparation versus LT4-LT3-compound preparation in the treatment of diffuse endemic goitreActa Endocrinologica (Copenh) 1986, 113: 242-248 Bongers H.; 1986

Active substance: LEVOTHYROXINE

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Document reference: 48988

Study title: Motor nerve conduction velocity in very preterm infants in relation to L-thyroxine supplementationJ Pediatr 1998; 132: 64-69 Smit BJ., 1998

Active substance: LEVOTHYROXINE

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Document reference: 48981

Study title: Pyridostigmine and metoclopramide do not restore the TSH response to TRH-inhibited by L-thyroxine treatment in children with goiter. J Endocrinol Invest 2000; 23: 744-747, Radetti G., 2000

Active substance: LEVOTHYROXINE

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Document reference: 48952

Study title: Relationship of Etiology to Treatment in Congenital HypothyoidismJ Clin Endocrinol Metab 2001; 86: 186-191 Hanukoglu A., 2001

Active substance: LEVOTHYROXINE

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Document reference: 48985

Study title: Effects of Early High-Dose Levothyroxine Treatment on Auditory Brain Even-Related Potentials at School Entry in children with Congenital Hypothyroidism Marti S., 2006

Active substance: LEVOTHYROXINE

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Document reference: 48955

Study title: Therapie der Jodmangelstruma bei Jugendlichen mit Jodid oder einer Kombination von Jodid und Levothyroxin unter besonderer Berücksichtigung der Lipidparameter. Rönnefarth G., 1996 Klin Pädiatr 1996; 208: 123-128

Active substance: LEVOTHYROXINE

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Document reference: 48954

Study title: Three-Year follow-up of borderline congenital hypothyroidismJ Pediatr 2000; 136: 53-56 Daliva AL., 2000

Active substance: LEVOTHYROXINE

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Document reference: 48979

Study title: Treatment for congenital hypothyroidism: Thyroxine alone or thyroxine plus triiodothyronine?Pediatrics 2003, 111, 5: 1055-60 Cassio A., 2003

Active substance: LEVOTHYROXINE

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Document reference: 48987

Study title: Triiodothyronine and thyroxine treatment of diffuse non-toxic goiter evaluated by ultrasonic scanningActa Endocrinol (Copenh) 1982; 100: 382-387 Perrild, H., 1982Acta Endocrinol (Copenh) 1982; 100: 382-387 Perrild, H., 1982

Active substance: LEVOTHYROXINE

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Document reference: 48989

Study title: LT4-monopreparation versus LT4-LT3-compound preparation in the treatment of diffuse endemic goitreActa Endocrinologica (Copenh) 1986, 113: 242-248 Bongers H.; 1986

Active substance: LIOTHYRONINE

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Document reference: 48976

Study title: Triiodothyronine and thyroxine treatment of diffuse non-toxic goiter evaluated by ultrasonic scanning Acta Endocrinol (Copenh) 1982; 100: 382-387 Perrild, H., 1982

Active substance: LIOTHYRONINE

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Document reference: 48977

Study title: Submission of result-related information on paediatric studies submitted under Article 45 of the Paediatric Regulation No 1901/2006. Product concerned by this submission: Claritine/Clarityn Syrup and Associated Tradenames (loratadine)Merck Sharp & Dohme (Europe), Inc. Clos du Lynx 5 Lynx Binnenhof B-1200 Brussels

Active substance: LORATADINE

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Document reference: 48848

Study title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Lovastatin as an Adjunct to Diet in the Treatment of Adolescent Males WitH Hypercholesterolemia of Familial Basis

Active substance: LOVASTATIN

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Document reference: 31473

Study title: Multicentre, randomised, comparative double-blind and double placebo study in two parallel groups, of the efficacy and safety of ketoprofen (0.5 mg/kg/dose), versus paracetamol (15 mg/kg/dose), in repeated doses, in the treatment of febrile conditions in children aged 6 months to 6 years.

Active substance: KETOPROFEN

Study summary document link (including results): Ketoprofen-Study 4.pdf

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Document reference: 30864

Study title: Comparison of the effects of fluticasone propionate, aqueous nasal spray and levocabastine on inflammatory cells in nasal lavage and clinical activity during the pollen season in seasonal rhinitis. Clinical and Experimental Allergy 29, p. 1367-1 377, 1999Comparison of the effects of fluticasone propionate, aqueous nasal spray and levocabastine on inflammatory cells in nasal lavage and clinical activity during the pollen season in seasonal rhinitis. Clinical and Experimental Allergy 29, p. 1367-1 377, 1999

Active substance: LEVOCABASTINE

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Document reference: 31137

Study title: Immunogenicity and safety of Rouvax vaccine in different age-group Thai children

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41242

Study title: A Kr-81m inhalation method for detection of absence of uniform ventilation in asthma.Clin Nucl Med. 1981 Oct;6(10):463-7. Kawakami K 1981

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48561

Study title: [A measurement of V/V distribution by intravenous injection of Kr-81m and Tc-99m-MAA--a comparative study with Xe-133 inhalation method] [Article in Japanese]Kaku Igaku. 1988 Apr;25(4):323-9. Ohtani Y 1988

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48542

Study title: A model for assessing bronchial mucus transport.Pediatr Radiol. 1985;15(3):161-4. Ham HR 1985

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48549

Study title: Airway responses to repeated exercises detected by krypton-81m in asthmatic children.J Asthma. 1992;29(6):375-81.Obata T 1992

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48537

Study title: Can dynamic krypton-81m imaging separate regional ventilation and volume?Lythgoe MF 1992. J Nucl Med. 1992 Nov;33(11):1935-9. Comment in:J Nucl Med. 1992 Nov;33(11):1939-42.

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48534

Study title: Donaldson SS et al. A multidisciplinary study investigating radiotherapy in Ewing's sarcoma: end results of POG #8346. Pediatric Oncology Group. Int J Radiat Oncol Biol Phys. 1998 Aug 1;42(1):125-35.Donaldson SS et al. A multidisciplinary study investigating radiotherapy in Ewing's sarcoma: end results of POG #8346. Pediatric Oncology Group. Int J Radiat Oncol Biol Phys. 1998 Aug 1;42(1):125-35.

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 24848

Study title: Study title not availableStudy title not available

Active substance: DICLOFENAC

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Document reference: 26005

Study title: Progression of localised Wilms' tumour during preoperative chemotherapy is an independent prognostic factor: A report from the SIOP 93-01 nephroblastoma trial and study

Active substance: DACTINOMYCIN

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Document reference: 25433

Study title: Comparative assessment of the effects of 6-methyl-prednisolone and deflazacort in the maintenance therapy of rheumatoid arthritis patients - Colombo B, Sinigaglia L, Cagnoli M and Imbimbo B - 1986 - Report (reference 39) in the Clinical Documentation Deflazacort 6mg tablet - 04/1991 -

Active substance: DEFLAZACORT

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Document reference: 25632

Study title: Medical examiner reports of dextromethorphan exposures in the drug abuse warning network. -McElwee NE. et al.- 1991 (J. Clin. Res. Pharmacoepidemiol.; 5: 167) - Publication of Part IV Dextromethorphan HBr Syrup 1% -

Active substance: DEXTROMETHORPHAN

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Document reference: 25835

Study title: Osborn, D.A., N. Evans, and M. Kluckow, Left ventricular contractility in extremely premature infants in the first day and response to inotropes. Pediatr Res, 2007. 61(3): p. 335-40. Osborn, D.A., N. Evans, and M. Kluckow, Left ventricular contractility in extremely premature infants in the first day and response to inotropes. Pediatr Res, 2007. 61(3): p. 335-40.

Active substance: DOBUTAMINE

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Document reference: 26290

Study title: Denhoff et al.: Treatment of spastic cerebral-palsied children with sodium dantrolene; Dev. Med. Child. Neurol. 17, 736-742 (1975)Denhoff et al.: Treatment of spastic cerebral-palsied children with sodium dantrolene; Dev. Med. Child. Neurol. 17, 736-742 (1975)

Active substance: DANTROLENE

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Document reference: 25533

Study title: Mehta V, Singhi P, Singhi S. Intravenous sodium valproate versus diazepam infusion for the control of refractory status epilepticus in children: a randomized controlled trial. J Child Neurol. 2007 Oct;22(10):1191-7.Mehta V, Singhi P, Singhi S. Intravenous sodium valproate versus diazepam infusion for the control of refractory status epilepticus in children: a randomized controlled trial. J Child Neurol. 2007 Oct;22(10):1191-7.

Active substance: DIAZEPAM

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Document reference: 25938

Study title: AN 15211696 Medline 20070101. TI Cyproheptadine is an effective appetite stimulant in cystic fibrosis. SO Pediatric pulmonology, {Pediatr-Pulmonol}, Aug 2004, vol. 38, no. 2, p. 129-34, ISSN: 8755-6863. AU Homnick-Douglas-N, Homnick-Benjamin-D, Reeves-Andrew-J, Marks-John-H, Pimentel-Ronald-S, Bonnema-Sally-K. IN Division of Pediatric Pulmonology, Department of Pediatrics, Kalamazoo Center for Medical Studies, Michigan State University, 49008, USA. Homnick@kcms.msu.edu. YR 2004.AN 15211696 Medline 20070101. TI Cyproheptadine is an effective appetite stimulant in cystic fibrosis. SO Pediatric pulmonology, {Pediatr-Pulmonol}, Aug 2004, vol. 38, no. 2, p. 129-34, ISSN: 8755-6863. AU Homnick-Douglas-N, Homnick-Benjamin-D, Reeves-Andrew-J, Marks-John-H, Pimentel-Ron...

Active substance: CYPROHEPTADINE

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Document reference: 25235

Study title: Doppler study of myometrium in invasive gestational trophoblastic disease.

Active substance: DACTINOMYCIN

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Document reference: 25333

Study title: Fon GT, Wong WS, Gold RH, Kaiser LR. Skeletal metastases of melanoma: radiographic, scintigraphic, and clinical review. AJR Am J Roentgenol. 1981 Jul;137(1):103-8. Fon GT, Wong WS, Gold RH, Kaiser LR. Skeletal metastases of melanoma: radiographic, scintigraphic, and clinical review. AJR Am J Roentgenol. 1981 Jul;137(1):103-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44119

Study title: Comparative study of angiotensin converting enzyme inhibitor and calcium channel blocker in the treatment of steroid−resistant idiopathic nephrotic syndrome.Kumar NS, Singh A K, Mishra RN, Prakash J. The Journal of the Association of Physicians of India, Jun 2004, vol. 52, p. 454−8, Comparative study of angiotensin converting enzyme inhibitor and calcium channel blocker in the treatment of steroid−resistant idiopathic nephrotic syndrome.Kumar NS, Singh A K, Mishra RN, Prakash J. The Journal of the Association of Physicians of India, Jun 2004, vol. 52, p. 454−8,

Active substance: VERAPAMIL

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Document reference: 45535

Study title: Comparative study of the efficacy of metoprolol and verapamil in patients with syncope and positive head−up tilt test response.Walton SA, Berk M, Brook S. The Journal of clinical psychiatry, Nov 1996, vol. 57, no. 11, p. 543−6, Comparative study of the efficacy of metoprolol and verapamil in patients with syncope and positive head−up tilt test response.Walton SA, Berk M, Brook S. The Journal of clinical psychiatry, Nov 1996, vol. 57, no. 11, p. 543−6,

Active substance: VERAPAMIL

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Document reference: 45545

Study title: Comparison of bisoprolol and verapamil in hypertension: influence on left ventricular mass and function−−a pilot study.Ostman−Smith I, Wettrell G, Riesenfeld T. Journal of the American College of Cardiology, 15 Nov 1999, vol. 34, no. 6, p.1813−22, Comparison of bisoprolol and verapamil in hypertension: influence on left ventricular mass and function−−a pilot study.Ostman−Smith I, Wettrell G, Riesenfeld T. Journal of the American College of Cardiology, 15 Nov 1999, vol. 34, no. 6, p.1813−22,

Active substance: VERAPAMIL

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Document reference: 45541

Study title: (Effect of verapamil with renal disease basic−prescription on hemorheology indexes of type II nephrotic syndrome).Liang D, Li DD. Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine / Zhongguo Zhong xi yi jie he xue hui Zhongguo Zhong yi yan jiu yuan zhu ban, Feb 1993, vol. 13, no. 2, p. 86−7, 68, (Effect of verapamil with renal disease basic−prescription on hemorheology indexes of type II nephrotic syndrome).Liang D, Li DD. Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine / Zhongguo Zhong xi yi jie he xue hui Zhongguo Zhong yi yan jiu yuan zhu ban, Feb 1993, vol. 13, no. 2, p. 86−7, 68,

Active substance: VERAPAMIL

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Document reference: 45551

Study title: Effectiveness of the combination verapamil and chlorpromazine in the treatment of severe manic or mixed patients.Lenzi A, Marazziti D, Raffaelli S, Cassano GB. Progress in neuro−psychopharmacology & biological psychiatry, May 1995, vol. 19, no. 3, p. 519−28, Effectiveness of the combination verapamil and chlorpromazine in the treatment of severe manic or mixed patients.Lenzi A, Marazziti D, Raffaelli S, Cassano GB. Progress in neuro−psychopharmacology & biological psychiatry, May 1995, vol. 19, no. 3, p. 519−28,

Active substance: VERAPAMIL

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Document reference: 45548

Study title: Effects of verapamil on anthracycline−induced cardiomyopathy: preliminary results of a prospective multicenter trial.Kraft J, Grille W, Appelt M, Hossfeld DK, Eichelbaum M, Koslowski B, Quabeck K, Kuse R, Büchner T, Hiddemann W, et al. Haematology and blood transfusion, 1990, vol. 33, p. 566−70,Effects of verapamil on anthracycline−induced cardiomyopathy: preliminary results of a prospective multicenter trial.Kraft J, Grille W, Appelt M, Hossfeld DK, Eichelbaum M, Koslowski B, Quabeck K, Kuse R, Büchner T, Hiddemann W, et al. Haematology and blood transfusion, 1990, vol. 33, p. 566−70,

Active substance: VERAPAMIL

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Document reference: 45560

Study title: Caustic ingestion and esophageal function.J Pediatr Gastroenterol Nutr. 1990 Feb;10(2):164-8. Cadranel S 1990

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48538

Study title: Clinical applications of radionuclide lung scanning in infants and children.Br J Radiol. 1981 Jul;54(643):576-85. Gordon I 1981

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48553

Study title: Determination of right ventricular ejection fraction in children with cystic fibrosis.Pediatr Pulmonol. 1987 Jan-Feb;3(1):24-8. Piepsz A 1987

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48543

Study title: Effect of posture on regional ventilation in children.Pediatr Pulmonol. 1992 Apr;12(4):227-32. Davies H 1992

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48536

Study title: Effects of posture on the distribution of pulmonary ventilation and perfusion in children and adults.Thorax. 1989 Jun;44(6):480-4.Bhuyan U 1989

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48540

Study title: Evaluation of esophageal transit in children and in infants by means of Krypton-81m.Pediatr Radiol. 1985;15(3):161-4. Ham HR 1985

Active substance: krypton

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Document reference: 48548

Study title: Evaluation of the Accuracy of Steady-State Krypton-Sim Method for Calculating Right Ventricular Ejection FractionHamphrey R. Ham. Philipe R. Franken, Bernard Georges, Eric Delcourt, Marcel Guillaume, and Amnon Piepsz.J NucÃMed 27:593-601, 1986

Active substance: krypton

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Document reference: 48531

Study title: Investigating the small lung: which imaging procedure?Arch Dis Child. 1982 Sep;57(9):696-701. Gordon I 1982

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48551

Study title: Krypton-81m ventilation and technetium-99m macroaggregated albumin perfusion scintigraphy for detection of pulmonary embolism: the first experience in Taiwan.

Active substance: krypton

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Document reference: 48532

Study title: Krypton-81m: a better radiopharmaceutical for assessment of regional lung function in children.Radiology. 1979 Mar;130(3):741-7. Li DK 1979

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48558

Study title: Late pulmonary scintigraphic defects after uneventful recovery from simple focal pneumonia of childhood.Kenney IJ 1993

Active substance: krypton

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Document reference: 48533

Study title: Provocation test for children with bronchial asthma monitored by 81mKr ventilation and perfusion lung scans.Eur J Nucl Med. 1985;10(1-2):81-3. Uchiyama G 1985

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48547

Study title: Bronchiectasis in childhood. Comparison of chest roentgenograms, bronchography and lung scintigraphy.Pediatr Radiol. 1980 Jul;9(4):193-8. Vandevivere J 1980

Active substance: krypton

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Document reference: 48556

Study title: Pulmonary ventilation and perfusion studies in infants and children.J Thorac Imaging. 1986 Oct;1(4):49-56. Gainey MA 1986

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48544

Study title: [Pulmonary ventilation studies of asthmatic children with Kr-81m (author's transl)] [Article in Japanese]Nippon Igaku Hoshasen Gakkai Zasshi. 1979 May 25;39(5):499-505.Uchiyama G 1979

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48557

Study title: Quantitative approach to the study of regional lung function in children using krypton 81m.Br J Radiol. 1980 Oct;53(634):950-9. Ciofetta G 1980

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48554

Study title: Assessment of lung perfusion impairment in patients with pulmonary artery-occlusive and chronic obstructive pulmonary diseases with noncontrast electrocardiogram-gated fast-spin-echo perfusion MR imaging. J Magn Reson Imaging. 2004 Oct;20(4):601-11. Ogasawara N 2004

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48793

Study title: COMPARATIVE STUDY OF AMPICILLIN/SULBACTAM VS CEFOTAXIME PLUS AMPICILLIN IN PREVENTING INFECTIONS OF BACTERIAL ETIOLOGY IN PATIENTS UNDERGOING ELECTIVE LIVER TRANSPLANTS

Active substance: SULBACTAM

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Document reference: 42657

Study title: Bilchik T, Heyman S, Siegel A, Alavi A. Osteoid osteoma: the role of radionuclide bone imaging, conventional radiography and computed tomography in its management. J Nucl Med. 1992 Feb;33(2):269-71. No abstract available. Bilchik T, Heyman S, Siegel A, Alavi A. Osteoid osteoma: the role of radionuclide bone imaging, conventional radiography and computed tomography in its management. J Nucl Med. 1992 Feb;33(2):269-71. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43707

Study title: Ansell BM, Hall MA, Loftus JK, Woo P, Neumann V, Harvey A, Sills JA, Swinson D, Insley J, Amos R, et al.; Clinical Research Center, Middlesex, U.K. Clin Exp Rheumatol 1991 Mar-Apr;9(2):201-3; A multicentre pilot study of sulphasalazine in juvenile chronic arthritis.Ansell BM, Hall MA, Loftus JK, Woo P, Neumann V, Harvey A, Sills JA, Swinson D, Insley J, Amos R, et al.; Clinical Research Center, Middlesex, U.K. Clin Exp Rheumatol 1991 Mar-Apr;9(2):201-3; A multicentre pilot study of sulphasalazine in juvenile chronic arthritis.

Active substance: SULFASALAZINE

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Document reference: 42879

Study title: Use of Tc-99m MAA in determining the etiology of increasing cyanosis following SVC-PA anastomosis for the hypoplastic left heart syndrome. Clin Nucl Med. 1991 Jun;16(6):410-2. Glass T 1991

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc

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Document reference: 48822

Study title: Comparison of Bone and Gallium-67 Imagingin Heroin Users'ArthritisA. Bittini, P L. Dominguez, M. L. Martinez Pueyo, F. J. Lopez Longo, I. Monteagudo, and L. Carreflo. J Nuci Med 26:1377—1381, 1985

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48834

Study title: AN OPEN, NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF SULTAMICILLIN IN PATIENTS WITH RECURRENT TONSILLITIS DUE TO GABHS.

Active substance: SULTAMICILLIN

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Document reference: 43022

Study title: Fucidin® ointment: survey of clinical trial. Fucidin® ointment was applied once daily to 10 children with impetigo, 2 patients with eczema and 20 adults with infected ulcers. Treatment was successful in all cases of impetigo and in patients with superficial leg ulcers whereas the treatment of 6 patients with 'deeper' ulcers was discontinued because of pain on application. Inflammation was also seen in another subject.

Active substance: FUSIDIC ACID

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Document reference: 28678

Study title: INTRAVENOUS FOSPHENYTOIN AND INTRAMUSCULAR FOSPHENYTOIN IN CHILDREN WITH SEIZURES.

Active substance: FOSPHENYTOIN

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Document reference: 28604

Study title: Chong AL, Clinton F, Breatnach F, O'Marcaigh A, Butler K, O'Meara A. Cytomegalovirus infection in paediatric haemopoietic stem cell transplantation.Ir Med J. 2008 Jan;101(1):17-21.Chong AL, Clinton F, Breatnach F, O'Marcaigh A, Butler K, O'Meara A. Cytomegalovirus infection in paediatric haemopoietic stem cell transplantation.Ir Med J. 2008 Jan;101(1):17-21.

Active substance: Foscarnet

Study summary document link (including results): Chong et al 2008.pdf

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Document reference: 39614

Study title: USE OF GABAPENTIN FOR SYMPTOM CONTROL IN CHILDREN WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER - A PILOT STUDY. (PELLOCK/WATEMBERG)

Active substance: GABAPENTIN

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Document reference: 28798

Study title: AN OPEN NONCOMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IM/IV SBT/CFP IN THE TREATMENT OF INTRAABDOMINAL INFECTIONS

Active substance: SULBACTAM

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Document reference: 42859

Study title: Efficacy and safety of verapamil SR 240 mg in essential hypertension: results of a multicentric phase IV study.Speders S, Sosna J, Schumacher A, Pfennigsdorf G. Journal of cardiovascular pharmacology, 1989, vol. 13 Suppl 4, p. S47−9,Efficacy and safety of verapamil SR 240 mg in essential hypertension: results of a multicentric phase IV study.Speders S, Sosna J, Schumacher A, Pfennigsdorf G. Journal of cardiovascular pharmacology, 1989, vol. 13 Suppl 4, p. S47−9,

Active substance: VERAPAMIL

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Document reference: 45561

Study title: Single-dose amoxicillin therapy with follow-up urine culture. Effective initial management for acute uncomplicated urinary tract infections. Savard-Fenton M, Fenton BW, Reller LB, Lauer BA, Byyny RL. Am J Med. 1982 Dec;73(6):808-13.

Active substance: AMOXICILLIN

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Document reference: 48968

Study title: Single-dose versus conventional therapy of urinary tract infections in female adolescents.Fine JS, Jacobson MS. Pediatrics. 1985 May;75(5):916-20.

Active substance: AMOXICILLIN

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Document reference: 48967

Study title: Investigating the neurotoxicity of penicillin G at different serum- and CSF-concentrations.Holloway et al. (The American journal of clinical pathology, 1969 Jun;51(6):705-8)

Active substance: BENZATHINE BENZYLPENICILLIN

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Document reference: 49070

Study title: Investigating the neurotoxicity of penicillin G at different serum- and CSF-concentrations.Lerner et al. (Ann NY Acad Sci 145, 310-8, no 2 1967)

Active substance: BENZATHINE BENZYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Benzylpenicillin sodium_2.xlsx

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Document reference: 49071

Study title: An Open-Label, Dose-Titration Safety Study of Atomoxetine Hydrochloride in Outpatient Japanese Children with Attention-Deficit/Hyperactivity Disorder

Active substance: ATOMOXETINE

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Document reference: 21979

Study title: The purpose uf this study was to determine what beneficiaI effect, if any, large doses of penicillin G procaine have on the treatment of hospitalized patients with pneumococcal pneumonia of varying severity, and to examine the effect of this treatment on the colonization and superinfection rates in these patients.Brewin et al. (JAMA 230:409-413, 1974)

Active substance: BENZATHINE BENZYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Benzylpenicillin sodium_3.xlsx

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Document reference: 49072

Study title:

Active substance: BENZENTHONIUM AND LIDOCAINE

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Document reference: 22286

Study title: A controlled trial of combined therapy for newly diagnosed severe childhood IgA nephropathy. The Japanese Pediatric IgA Nephropathy Treatment Study Group.Yoshikawa N, Ito H, Sakai T, Takekoshi Y, Honda M, Awazu M, Ito K, Iitaka K, Koitabashi Y, Yamaoka K, Nakagawa K, Nakamura H, Matsuyama S, Seino Y, Takeda N, Hattori S, Ninomiya M. J Am Soc Nephrol. 1999 Jan;10(1):101-9.

Active substance: Azathioprine

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Document reference: 49225

Study title: A multicenter, open-label, pharmacokinetic/pharmacodynamic safety, and tolerability study of basiliximab (Simulect) in pediatric de novo renal transplant recipients.Offner G, Broyer M, Niaudet P, Loirat C, Mentser M, Lemire J, Crocker JF, Cochat P, Clark G, Chodoff L, Korn A, Hall M. Transplantation. 2002 Oct 15;74(7):961-6.

Active substance: Azathioprine

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Document reference: 49257

Study title: A randomized multicenter trial of OKT3 mAbs induction compared with intravenous cyclosporine in pediatric renal transplantation.Benfield MR1, Tejani A, Harmon WE, McDonald R, Stablein DM, McIntosh M, Rose S; CCTPT Study Group. Pediatr Transplant. 2005 Jun;9(3):282-92.

Active substance: Azathioprine

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Document reference: 49267

Study title: Acute renal failure in paediatric systemic lupus erythematosus: treatment and outcome.Benseler SM, Bargman JM, Feldman BM, Tyrrell PN, Harvey E, Hebert D, Silverman ED. Rheumatology (Oxford). 2009 Feb;48(2):176-82

Active substance: Azathioprine

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Document reference: 49288

Study title: Adverse events leading to modification of therapy in a large cohort of patients with inflammatory bowel disease.Hindorf U, Lindqvist M, Hildebrand H, Fagerberg U, Almer S. Aliment Pharmacol Ther. 2006 Jul 15;24(2):331-42.

Active substance: Azathioprine

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Document reference: 49272

Study title: [Regional cerebral blood flow image by the method of single photon emission computed tomography: continuous intracarotid injection of krypton-81m (author's transl)] [Article in Japanese]Kaku Igaku. 1980 Aug;17(7):829-32. Maeda T 1980

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48555

Study title: Regional ventilation in infancy. Reversal of adult pattern.N Engl J Med. 1985 Dec 26;313(26):1626-8. Davies H, 1985

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48546

Study title: [Results of lung perfusion and lung ventilation scintigraphy following surgery of diaphragmatic defects] [Article in German]Z Kinderchir. 1983 Feb;38(1):28-30. Hofmann U 1983

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48550

Study title: Right ventricular performance and pulmonary haemodynamics in adolescent and adult patients with cystic fibrosisEur J Pediatr. 1988 Dec;148(3):187-92.Burghuber OC 1988

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48541

Study title: The use of Kr-81m in ventilation imaging.Clin Nucl Med. 1982 Mar;7(3):122-30. Pommet R 1982

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48560

Study title: Ventilation-perfusion scintigraphy in suspected pulmonary embolism: correlation with pulmonary angiography and refinement of criteria for interpretation.Radiology. 1986 May;159(2):383-90.Spies WG 1986

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48545

Study title: Uchida Y. Clinical efficacy of topical lomefloxacin (NY-198) in bacterial infections of the external eye – A multicenter double-blind phase III study. No report dateUchida Y. Clinical efficacy of topical lomefloxacin (NY-198) in bacterial infections of the external eye – A multicenter double-blind phase III study. No report date

Active substance: LOMEFLOXACIN

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Document reference: 31362

Study title: Radionuclide assessment of the effects of chest physical therapy on ventilation in cystic fibrosis.Phys Ther. 1982 Jun;62(6):820-7. DeCesare JA 1982

Active substance: krypton

Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc

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Document reference: 48552

Study title: Von Kleist-Retzow J-C et al., Klinik und Therapie d.Knollenblätterpilzverg. im Kindesalter. Clinical findings and treatment of Amanita phalloides poisoning in childhood); Monatsschrift fur Kinderheilkunde; 143/11 (1118-1127); 1995

Active substance: (HERB) Milk thistle fruit, dry extract, 36 - 44 : 1 (Silymarin 77.5 %) (Legalon)

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Document reference: 39712

Study title: Safety and immunogenicity of acellular pertussis combined with tetanus and diphtheria toxoids adsorbed and inactivated poliomyelitis vaccine (TdcP-IPV) in adolescents and adults compared to Td-mlPV and cP given separately in adolescents and compared to TdcP or Td given separately with IPV or cP in adults

Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32)

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Document reference: 21208

Study title: McIntyre−J, Hull−D. Comparing efficacy and tolerability of ibuprofen and paracetamol in fever. {Arch−Dis−Child}, Feb 1996, vol. 74, no. 2, p. 164−7McIntyre−J, Hull−D. Comparing efficacy and tolerability of ibuprofen and paracetamol in fever. {Arch−Dis−Child}, Feb 1996, vol. 74, no. 2, p. 164−7

Active substance: IBUPROFEN

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Document reference: 29580

Study title: Wirksamkeit von Ichthocortin® Gel auf grampositive Bakterien bei Patienten mit Neurodermitis

Active substance: HYDROCORTIZONE

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Document reference: 29188

Study title: A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. (Jan 1988)

Active substance: IBUPROFEN

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Document reference: 29380

Study title: A three month, double blind, double dummy, parallel group, controlled study comparing the efficacy and safety between 12 mcg twice daily of Formoterol-HFA and 12 mcg twice daily of Formoterol-DPI (Foradil Aerolizer) in childrem with persistent asthmaStudy report

Active substance: cur

Study summary document link (including results): RA-RS-3301-002-05 (Synopsis).doc

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Document reference: 49214

Study title: Comparison of the effect of atropine and cyclopentolate on myopia.Yen MY, Liu JH, Kao SC, Shiao CH. Ann Ophthalmol. 1989 May;21(5):180-2, 187. Comparison of the effect of atropine and cyclopentolate on myopia.Yen MY, Liu JH, Kao SC, Shiao CH. Ann Ophthalmol. 1989 May;21(5):180-2, 187.

Active substance: CYCLOPENTOLATE

Study summary document link (including results): Comparison of the effect of atropine and cyclopentolate on m.pdf

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Document reference: 24707

Study title: Maurer HM et al. The Intergroup Rhabdomyosarcoma Study-II. Cancer. 1993 Mar 1;71(5):1904-22Maurer HM et al. The Intergroup Rhabdomyosarcoma Study-II. Cancer. 1993 Mar 1;71(5):1904-22

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 25011

Study title: Clinical experiences with encephabol -Klinische Erfahrungen mit EncephabolMed Klin 1976; 45: 1958-1961, Glatzel J

Active substance: PYRITINOL

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48912

Study title: 37. Osimani et al., An Fac Med Montev 1963; 48: 34-41 37. Osimani et al., An Fac Med Montev 1963; 48: 34-41

Active substance: PYRVINIUM

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Document reference: 39566

Study title: James LP, Stowe CD, Farrar HC, Menendez AA, Argao EA. The pharmacokinetics of oral ranitidine in children and adolescents with cystic fibrosis. J Clin Pharmacol. 1999 Dec;39(12):1242-7.James LP, Stowe CD, Farrar HC, Menendez AA, Argao EA. The pharmacokinetics of oral ranitidine in children and adolescents with cystic fibrosis. J Clin Pharmacol. 1999 Dec;39(12):1242-7.

Active substance: RANITIDINE

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Document reference: 35279

Study title: Schellong-G. University Children's Hospital Muenster, Germany. Pediatric Hodgkin's disease: treatment in the late 1990s. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}, 1998, vol. 9 Suppl 5, p. S115-9, 28 refs, ISSN: 0923-7534.Schellong-G. University Children's Hospital Muenster, Germany. Pediatric Hodgkin's disease: treatment in the late 1990s. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}, 1998, vol. 9 Suppl 5, p. S115-9, 28 refs, ISSN: 0923-7534.

Active substance: PROCARBAZINE

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Document reference: 34836

Study title: To determine if systemic absorption of (pyrvinium pamoate) C1-316 occures in children following single oral doses of 5 mg/kg.Heffelfinger

Active substance: PYRVINIUM

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Pyrvin embonate_1.xls

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Document reference: 49077

Study title: Treatment of Refractory Arrhythmias with Propafenone in Pediatric Patients

Active substance: PROPAFENONE

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Document reference: 35058

Study title: ANTHELMINTIC EFFICACY OF PYRANTEL PAMOATE VS. MEBENDOZOLE IN PATIENTS WITH ASCARIASIS.

Active substance: PYRANTEL PAMOATE

Study summary document link (including results): PRT-II-84-001-002-003 EMA Paediatrics Web Synopsis.pdf

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Document reference: 46147

Study title: Healy-G-B. Dept. Otolaryngol., Harvard Med. Sch., Boston, Mass., United States. Malignant tumors of the head and neck in children: diagnosis and treatment. Otolaryngologic Clinics of North America {OTOLARYNGOL-CLIN-NORTH-AM}, 1980, Vol/Iss/Pg. 13/3 (483-488).Healy-G-B. Dept. Otolaryngol., Harvard Med. Sch., Boston, Mass., United States. Malignant tumors of the head and neck in children: diagnosis and treatment. Otolaryngologic Clinics of North America {OTOLARYNGOL-CLIN-NORTH-AM}, 1980, Vol/Iss/Pg. 13/3 (483-488).

Active substance: PROCARBAZINE

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Document reference: 34736

Study title: Evaluation of the effects of fixed combinations of sustained−release verapamil/trandolapril versus captopril/hydrochlorothiazide on metabolic and electrolyte parameters in patients with essential hypertension.Cifková R, Nakov R, Novozámská E, Hejl Z, Petrzílková Z, Poledne R, Stávek P, Compagnone D. Journal of human hypertension, Jun 2000, vol. 14, no. 6, p. 347−54, Evaluation of the effects of fixed combinations of sustained−release verapamil/trandolapril versus captopril/hydrochlorothiazide on metabolic and electrolyte parameters in patients with essential hypertension.Cifková R, Nakov R, Novozámská E, Hejl Z, Petrzílková Z, Poledne R, Stávek P, Compagnone D. Journal of human hypertension, Jun 2000, vol. 14, no. 6, p. 347−54,

Active substance: VERAPAMIL

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Document reference: 45539

Study title: Factors influencing the prediction of steady state concentrations of digoxin.Nakamura T, Kakumoto M, Yamashita K, Takara K, Tanigawara Y, Sakaeda T, Okumura K. Biological & pharmaceutical bulletin, Apr 2001, vol. 24, no. 4, p. 403−8,Factors influencing the prediction of steady state concentrations of digoxin.Nakamura T, Kakumoto M, Yamashita K, Takara K, Tanigawara Y, Sakaeda T, Okumura K. Biological & pharmaceutical bulletin, Apr 2001, vol. 24, no. 4, p. 403−8,

Active substance: VERAPAMIL

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Document reference: 45538

Study title: Gilligan DM, Chan WL, Joshi J, Clarke P, Fletcher A, Krikler S, Oakley CM. Journal of the American College of Cardiology, Jun 1993, vol. 21, no. 7, p. 1672−9, Gilligan DM, Chan WL, Joshi J, Clarke P, Fletcher A, Krikler S, Oakley CM. Journal of the American College of Cardiology, Jun 1993, vol. 21, no. 7, p. 1672−9,

Active substance: VERAPAMIL

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Document reference: 45552

Study title: Intravenous tetrandrine in terminating acute episodes of paroxysmal supraventricular tachycardia.Dai GZ, Zeng B, ZhangYL, Lu YX. Chinese medical journal, , Jun 1990, vol. 103, no. 6, p. 460−3, Intravenous tetrandrine in terminating acute episodes of paroxysmal supraventricular tachycardia.Dai GZ, Zeng B, ZhangYL, Lu YX. Chinese medical journal, , Jun 1990, vol. 103, no. 6, p. 460−3,

Active substance: VERAPAMIL

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Document reference: 45558

Study title: Kiowski W, Bühler FR, Fadayomi MO, Erne P, Müller FB, Hulthén UL, Bolli P. The American journal of cardiology, 6 Dec 1985, vol. 56, no. 16, p. 81H−85H, Kiowski W, Bühler FR, Fadayomi MO, Erne P, Müller FB, Hulthén UL, Bolli P. The American journal of cardiology, 6 Dec 1985, vol. 56, no. 16, p. 81H−85H,

Active substance: VERAPAMIL

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Document reference: 45564

Study title: Lechenie sindroma Reino blokatorami vkhoda kal'tsiia. (Treatment of Raynaud's syndrome with calcium entry blockers).Shcherbakov AB, Guseva NG, Mach ES. Terapevticheskii arkhiv, 1987, vol. 59, no. 4, p. 89−92, Lechenie sindroma Reino blokatorami vkhoda kal'tsiia. (Treatment of Raynaud's syndrome with calcium entry blockers).Shcherbakov AB, Guseva NG, Mach ES. Terapevticheskii arkhiv, 1987, vol. 59, no. 4, p. 89−92,

Active substance: VERAPAMIL

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Document reference: 45562

Study title: Otsenka vozmozhnosti individual'nogo podbora antiaritmicheskoi terapii. (Evaluation of the possibility of selection of individual anti− arrhythmia therapy).Antonchenko IV, Gimrikh EO, Popov SV, Chekhov AM, Borisova EV, Savenkova GM, Plekhanov IG. Kardiologiia, Mar 1991, vol. 31, no. 3, p. 43−5, Otsenka vozmozhnosti individual'nogo podbora antiaritmicheskoi terapii. (Evaluation of the possibility of selection of individual anti− arrhythmia therapy).Antonchenko IV, Gimrikh EO, Popov SV, Chekhov AM, Borisova EV, Savenkova GM, Plekhanov IG. Kardiologiia, Mar 1991, vol. 31, no. 3, p. 43−5,

Active substance: VERAPAMIL

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Document reference: 45554

Study title: Betaxolol in the treatment of arterial hypertension: summary of clinical studies - MR95, MR17, MR107 Betaxolol Core Dossier - April 1999 - Part IVB1 Clinical documentation Volume 2

Active substance: BETAXOLOL

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Document reference: 41926

Study title: Azathioprine as a treatment option for uveitis in patients with juvenile idiopathic arthritis.Goebel JC, Roesel M, Heinz C, Michels H, Ganser G, Heiligenhaus A. Br J Ophthalmol. 2011 Feb;95(2):209-13

Active substance: Azathioprine

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Document reference: 49293

Study title: Azathioprine for long-term maintenance of remission in autoimmune hepatitis.Johnson PJ, McFarlane IG, Williams R. N Engl J Med. 1995 Oct 12;333(15):958-63.

Active substance: Azathioprine

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Document reference: 49215

Study title: Azathioprine in patients with juvenile chronic arthritis: a longterm followup study.Savolainen HA1, Kautiainen H, Isomäki H, Aho K, Verronen P. J Rheumatol. 1997 Dec;24(12):2444-50.

Active substance: Azathioprine

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Document reference: 49222

Study title: Azathioprine maintains first remission in newly diagnosed pediatric Crohn's disease.Jaspers GJ, Verkade HJ, Escher JC, de Ridder L, Taminiau JA, Rings EH. Inflamm Bowel Dis. 2006 Sep;12(9):831-6.

Active substance: Azathioprine

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Document reference: 49274

Study title: Basiliximab: efficacy and tolerability in adults and children.Mocarquer A, Pinto V, Buckel E, Lagos E, Pefaur J, Ramirez K, Morales J, Rosatti P, Elberg A; Simulect Multicenter Study Group of Chile. Transplant Proc. 2003 Nov;35(7):2518-9.

Active substance: Azathioprine

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Document reference: 49259

Study title: Childhood-onset lupus nephritis: a single-center experience of pulse intravenous cyclophosphamide therapy.Barbano G, Gusmano R, Damasio B, Alpigiani MG, Buoncompagni A, Gattorno M, Perfumo F. J Nephrol. 2002 Mar-Apr;15(2):123-9.

Active substance: Azathioprine

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Document reference: 49253

Study title: Combinant human growth hormone improves growth in children receiving glucocorticoid treatment after liver transplantation.Sarna S, Sipilä I, Rönnholm K, Koistinen R, Holmberg C. J Clin Endocrinol Metab. 1996 Apr;81(4):1476-82.

Active substance: Azathioprine

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Document reference: 49217

Study title: Combined therapy with prednisolone, azathioprine, heparin-warfarin, and dipyridamole for paediatric patients with severe IgA nephropathy--is it relevant for adult patients?Yoshikawa N, Ito H. Nephrol Dial Transplant. 1999 May;14(5):1097-9.

Active substance: Azathioprine

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Document reference: 49227

Study title: Combined use of cyclosporine and azathioprine or 6-mercaptopurine in pediatric inflammatory bowel disease.Ramakrishna J1, Langhans N, Calenda K, Grand RJ, Verhave M. J Pediatr Gastroenterol Nutr. 1996 Apr;22(3):296-302.

Active substance: Azathioprine

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Document reference: 49218

Study title: Comparison between mycophenolate mofetil and azathioprine based immunosuppression in pediatric renal transplantation from living related donors.Antoniadis A, Papachristou F, Gakis D, Takoudas D, Sotiriou I. Transplant Proc. 1998 Dec;30(8):4085-6.

Active substance: Azathioprine

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Document reference: 49224

Study title: Assessment of thiopurine methyltransferase and metabolite formation during thiopurine therapy: results from a large Swedish patient population.Hindorf U1, Peterson C, Almer S. Ther Drug Monit. 2004 Dec;26(6):673-8.

Active substance: Azathioprine

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Document reference: 49266

Study title: Comparison of three different methods of estimating the glomerular filtration rate in children after renal transplantation.al-Harbi N, Lireman D. Am J Nephrol. 1997;17(1):68-71.

Active substance: Azathioprine

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Document reference: 49219

Study title: Controlled trial of pulse versus continuous prednisolone and cyclophosphamide in the treatment of systemic vasculitis.Adu D, Pall A, Luqmani RA, Richards NT, Howie AJ, Emery P, Michael J, Savage CO, Bacon PA. QJM. 1997 Jun;90(6):401-9.

Active substance: Azathioprine

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Document reference: 49221

Study title: A phase III comparative study of the pharmacokinetic/pharmacodynamic and safety profiles of ibuprofen extended release, ibuprofen regular release and placebo during a 12 hour observation in post-extraction dental painA phase III comparative study of the pharmacokinetic/pharmacodynamic and safety profiles of ibuprofen extended release, ibuprofen regular release and placebo during a 12 hour observation in post-extraction dental pain

Active substance: IBUPROFEN AND PSEUDOEPHEDRINE

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Document reference: 29681

Study title: American Association for Respiratory Care (AARC). Clinical practice guideline: Single-breath carbon monoxide diffusing capacity, 1999 update. Resp Care 1999 May;44(5):539-546American Association for Respiratory Care (AARC). Clinical practice guideline: Single-breath carbon monoxide diffusing capacity, 1999 update. Resp Care 1999 May;44(5):539-546

Active substance: HELIUM AND OXYGEN

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Document reference: 29067

Study title: Facilitation of delayed alternation performance in adult rats following chronic hydroxyzine treatment in infancy.

Active substance: HYDROXYZINE

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Document reference: 29273

Study title: A Single Dose, Randomized, Open-Label, Single Center, Two-Way Crossover Pharmacokinetic Study of Advil® Cold & Sinus Tablets in Children

Active substance: IBUPROFEN

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Document reference: 29539

Study title: Breitfeld PP et al Ifosfamide and etoposide are superior to vincristine and melphalan for pediatric metastatic rhabdomyosarcoma when administered with irradiation and combination chemotherapy: a report from the Intergroup Rhabdomyosarcoma Study Group.J Pediatr Hematol Oncol 2001 May;23(4):225-33

Active substance: ETOPOSIDE

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Document reference: 26691

Study title: Uptake pharmacokinetics of the Fentanyl Oralet in children scheduled for central venous access removal: implications for the timing of initiating painful procedures; Paediatr Anaesth 2002, 12(7):594-9

Active substance: FENTANYL

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Document reference: 27190

Study title: Submission of result-related information on paediatric studies submitted under Article 45 of the Paediatric Regulation No 1901/2006. Product concerned by this submission: Cedax Suspension/Keimax and Associated Tradenames (Ceftibuten)Merck Sharp & Dohme (Europe), Inc. Clos du Lynx 5 Lynx Binnenhof B-1200 Brussels

Active substance: CEFTIBUTEN

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Document reference: 48847

Study title: Submission of result-related information on paediatric studies submitted under Article 45 of the Paediatric Regulation No 1901/2006. Product concerned by this submission: Uroced/Cedax and Associated Tradenames (Ceftibuten)Merck Sharp & Dohme (Europe), Inc. Clos du Lynx 5 Lynx Binnenhof B-1200 Brussels

Active substance: CEFTIBUTEN

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Document reference: 48850

Study title: Oral Cefixime is Similar to Continued Intravenous Antibiotics in the Empirical (Clin Infect Dis 2001; 32: 36-43); Paganini HR. Oral Cefixime is Similar to Continued Intravenous Antibiotics in the Empirical (Clin Infect Dis 2001; 32: 36-43); Paganini HR.

Active substance: CEFIXIME

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Document reference: 23421

Study title: An open randomised multicentre comparison of cefuroxime axetil suspension and amoxycillin syrup in the treatment of children with pharyngitis and tonsillitis.

Active substance: CEFUROXIME

Study summary document link (including results): Study CAET94 Cefuroxime Axetil (Suspension).xls

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Document reference: 47731

Study title: Treatment of staphylococcal skin infections: a comparison of cephalexin and dicloxacillin. Dillon HC Jr. J Am Acad Dermatol. 1983 Feb;8(2):177-81.

Active substance: Cephalexin

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Document reference: 48898

Study title: Erfahrungen mit einem Faktor II-, IX- und X-Konzentrat. Laboratoriumsuntersuchungen, In-Vivo-Recovery und klinische Ergebnisse. Global-Druck und Verlag, Heidelberg, (1980).(Vinazzer H, Bergmann H.)

Active substance: FACTOR VIII INHIBITOR BYPASSING ACT

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Document reference: 26997

Study title: 99mTc-HMPAO single photon emission computed tomography (SPECT) in both asphyxiated and epileptic children with or without status epilepticusJ Child Neurol. 2005 Jul; 20(7):560-5. Oner n 2005

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48618

Study title: "Weir-J-H. Prazepam in the treatment of anxiety: a placebo-controlled multicenter evaluation. The Journal of clinical psychiatry, {J-Clin-Psychiatry}, Dec 1978, vol. 39, no. 12, p. 841-7, ISSN: 0160-6689. " "Weir-J-H. Prazepam in the treatment of anxiety: a placebo-controlled multicenter evaluation. The Journal of clinical psychiatry, {J-Clin-Psychiatry}, Dec 1978, vol. 39, no. 12, p. 841-7, ISSN: 0160-6689. "

Active substance: PRAZEPAM

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Document reference: 34644

Study title: Pilot study of pimecrolimus in vitiligo treatment

Active substance: PIMECROLIMUS

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Document reference: 34109

Study title: OPEN, NON-COMPARATIVE STUDY DAY THE EFFICACY AND TOLERATION OF PIROXICAM FAST DISSOLVING DOSAGE FROM (FDDF) IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS.

Active substance: PIROXICAM

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Document reference: 34387

Study title: Statistical report: the dose response curve of fenoterol in the range 3 mcg - 1000 mcg in asthmatic children.

Active substance: IPRATROPIUM

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Document reference: 30615

Study title: Study defined factors in the pathogenesis for relapse (bacteriological and clinical) in 337 children with URT infections with cultured group A beta hemolytic streptococci.Rosenstein et al

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_4.xlsx

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Document reference: 49035

Study title: Study the absorption of different salts of pc-V in syrup form and also to investigate whether gastrointestinal diseases, leading to malabsorption affects the absorption of pc in varying rates for different salts.Bolme et al

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_8.xlsx

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Document reference: 49039

Study title: Study the effects of a twice a day dosage of penicillin V instead of three times a day.Nordbring et el

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_7.xlsx

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Document reference: 49038

Study title: Study the effects of a twice a day dosage of potassium penicillin G, instead of three times a day.Vann et al

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_9.xlsx

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Document reference: 49040

Study title: To evaluate the efficacy and safety of penicillin V in the treatment of acute tonsillitis in adults, when given as two or three daily doses.Mosbaek et al

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_16.xlsx

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Document reference: 49047

Study title: To study the clinical efficacy of penicillin V given to children as a daily dosage of 50 mg/kg/day divided into two or three doses.Rundcrantz et al

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_17.xlsx

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Document reference: 49048

Study title: Palatal tremor in childhood: clinical and therapeutic considerations

Active substance: PIRACETAM

Study summary document link (including results): ADPE07D0626 - Piracetam.pdf

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Document reference: 45926

Study title: Treatment of recurrent bacteriuria with mecillinam; Verrier Jones E:R: and Asscher A.W:. 1975, JAC, 1: 193-196 LEO sponsored Treatment of recurrent bacteriuria with mecillinam; Verrier Jones E:R: and Asscher A.W:. 1975, JAC, 1: 193-196 LEO sponsored

Active substance: PIVMECILLINAM

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Document reference: 34526

Study title: Clinical investigator’s report (pediatrics).

Active substance: PHOLCODINE

Study summary document link (including results): Pholcodine_STUDY_640.6.003_Lajouanine.xls

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Document reference: 34034

Study title: Permanent junctional reciprocating tachycardia in children: a multicentre study on clinical profile and outcome.Vaksmann G, D−Hoinne C, Lucet V, Guillaumont S, Lupoglazoff JM, Chantepie A, Heart , Jan 2006 (epub: 14 Apr 2005) , vol. 92, no. 1, p. 101−4, Permanent junctional reciprocating tachycardia in children: a multicentre study on clinical profile and outcome.Vaksmann G, D−Hoinne C, Lucet V, Guillaumont S, Lupoglazoff JM, Chantepie A, Heart , Jan 2006 (epub: 14 Apr 2005) , vol. 92, no. 1, p. 101−4,

Active substance: VERAPAMIL

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Document reference: 45534

Study title: Prevention of atrial fibrillation after cardioversion: results of the PAFAC trial.Fetsch T, Bauer P, Engberding R, Koch−Hans P, Lukl J, Meinertz T, Oeff M, Seipel L, Trappe−Hans J, Treese N , Breithardt G. European heart journal, Aug 2004, vol. 25, no. 16, p. 1385−94, Prevention of atrial fibrillation after cardioversion: results of the PAFAC trial.Fetsch T, Bauer P, Engberding R, Koch−Hans P, Lukl J, Meinertz T, Oeff M, Seipel L, Trappe−Hans J, Treese N , Breithardt G. European heart journal, Aug 2004, vol. 25, no. 16, p. 1385−94,

Active substance: VERAPAMIL

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Document reference: 45536

Study title: Superiority of lithium over verapamil in mania: a randomized, controlled, single−blind trial.Walton SA, Berk M, Brook S. The Journal of clinical psychiatry, Nov 1996, vol. 57, no. 11, p. 543−6, Superiority of lithium over verapamil in mania: a randomized, controlled, single−blind trial.Walton SA, Berk M, Brook S. The Journal of clinical psychiatry, Nov 1996, vol. 57, no. 11, p. 543−6,

Active substance: VERAPAMIL

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Document reference: 45544

Study title: Swiss hypertension treatment programme with verapamil and/or enalapril in diabetic patients.Ferrier C, Ferrari P, Weidmann P, Keller U, Beretta PC, Riesen WF. Drugs, 1992, vol. 44 Suppl 1, p. 74−84,Swiss hypertension treatment programme with verapamil and/or enalapril in diabetic patients.Ferrier C, Ferrari P, Weidmann P, Keller U, Beretta PC, Riesen WF. Drugs, 1992, vol. 44 Suppl 1, p. 74−84,

Active substance: VERAPAMIL

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Document reference: 45553

Study title: Traitement médical de la myocardiopathie hypertrophique. Comparaison entre le propranolol et le vérapamil. (Medical treatment of hypertrophic myocardiopathy. Comparison of propranolol and verapamil).Bouhour JB, Potiron M, Chiffoleau S, Lefévre M, Louvet S. Archives des maladies du coeur et des vaisseaux, Jan 1987, vol. 80, no. 1, p. 76−82, Traitement médical de la myocardiopathie hypertrophique. Comparaison entre le propranolol et le vérapamil. (Medical treatment of hypertrophic myocardiopathy. Comparison of propranolol and verapamil).Bouhour JB, Potiron M, Chiffoleau S, Lefévre M, Louvet S. Archives des maladies du coeur et des vaisseaux, Jan 1987, vol. 80, no. 1, p. 76−82,

Active substance: VERAPAMIL

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Document reference: 45563

Study title: Uso del verapamil nel trattamento dell'emicrania senza aura. (The use of verapamil in the treatment of hemicrania without aura).Fonzari M, Santoloci D, Farinini D. La Clinica terapeutica, Apr 1994, vol. 144, no. 4, p. 329−32, Uso del verapamil nel trattamento dell'emicrania senza aura. (The use of verapamil in the treatment of hemicrania without aura).Fonzari M, Santoloci D, Farinini D. La Clinica terapeutica, Apr 1994, vol. 144, no. 4, p. 329−32,

Active substance: VERAPAMIL

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Document reference: 45549

Study title: Valutazione degli effetti indotti dall'uso di verapamile, flunarizina, diltiazem, nimodipina e placebo nella profilassi dell'emicrania. Studio a doppio cieco randomizzato cross−over. (Evaluation of the effects of verapamil, flunarizine, diltiazem, nimodipine and placebo in the prevention of hemicrania. A double−blind randomized cross−over study).Paterna S, Martino SG, Campisi D, Cascio IN, Marsala BA. La Clinica terapeutica, 31 Jul 1990, vol. 134, no. 2, p. 119−25, Valutazione degli effetti indotti dall'uso di verapamile, flunarizina, diltiazem, nimodipina e placebo nella profilassi dell'emicrania. Studio a doppio cieco randomizzato cross−over. (Evaluation of the effects of verapamil, flunarizine, diltiazem, nimodipine and placebo in the prevention of hemicrania. A double−blind random...

Active substance: VERAPAMIL

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Document reference: 45557

Study title: Differences between children and adults in thiopurine methyltransferase activity and metabolite formation during thiopurine therapy: possible role of concomitant methotrexate.Pettersson B1, Almer S, Albertioni F, Söderhäll S, Peterson C. Ther Drug Monit. 2002 Jun;24(3):351-8.

Active substance: Azathioprine

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Document reference: 49254

Study title: Effect of early immunomodulator use in moderate to severe pediatric Crohn disease.Punati J, Markowitz J, Lerer T, Hyams J, Kugathasan S, Griffiths A, Otley A, Rosh J, Pfefferkorn M, Mack D, Evans J, Bousvaros A, Moyer MS, Wyllie R, Oliva-Hemker M, Mezoff A, Leleiko N, Keljo D, Crandall W; Pediatric IBD Collaborative Research Group. Inflamm Bowel Dis. 2008 Jul;14(7):949-54

Active substance: Azathioprine

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Document reference: 49284

Study title: Efficacy and tolerability at 3 and 6 months following use of azathioprine for recalcitrant atopic dermatitis in children and young adults.Hon KL, Ching GK, Leung TF, Chow CM, Lee KK, Ng PC. J Dermatolog Treat. 2009;20(3):141-5.

Active substance: Azathioprine

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Document reference: 49287

Study title: Efficacy of long-term azathioprine for relapsing nephrotic syndrome.Hiraoka M, Tsukahara H, Hori C, Ohshima Y, Momoi T, Seo A, Mayumi M. Pediatr Nephrol. 2000 Aug;14(8-9):776-8.

Active substance: Azathioprine

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Document reference: 49248

Study title: Efficacy of methotrexate in pediatric Crohn's disease: a French multicenter study.Uhlen S, Belbouab R, Narebski K, Goulet O, Schmitz J, Cézard JP, Turck D, Ruemmele FM. Inflamm Bowel Dis. 2006 Nov;12(11):1053-7.

Active substance: Azathioprine

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Document reference: 49276

Study title: Favorable effects of immunosuppressive therapy in children with dilated cardiomyopathy and active myocarditis.Camargo PR, Snitcowsky R, da Luz PL, Mazzieri R, Higuchi ML, Rati M, Stolf N, Ebaid M, Pileggi F. Pediatr Cardiol. 1995 Mar-Apr;16(2):61-8.

Active substance: Azathioprine

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Document reference: 49216

Study title: Five-year outcome in pediatric patients with mycophenolate mofetil-based renal transplantation.Jungraithmayr TC, Wiesmayr S, Staskewitz A, Kirste G, Bulla M, Fehrenbach H, Dippell J, Greiner C, Griebel M, Helmchen U, Klaus G, Leichter HE, Mihatsch MJ, Michalk DV, Misselwitz J, Plank C, Tönshoff B, Weber LT, Zimmerhackl LB; German Pediatric Renal Transplantation Study Group. Transplantation. 2007 Apr 15;83(7):900-5.

Active substance: Azathioprine

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Document reference: 49279

Study title: Follow-up of children with autoimmune hepatitis treated with cyclosporine.Cuarterolo M, Ciocca M, Velasco CC, Ramonet M, González T, López S, Garsd A, Alvarez F. J Pediatr Gastroenterol Nutr. 2006 Nov;43(5):635-9.

Active substance: Azathioprine

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Document reference: 49277

Study title: Four-year data after pediatric renal transplantation: a randomized trial of tacrolimus vs. cyclosporin microemulsion. Filler G, Webb NJ, Milford DV, Watson AR, Gellermann J, Tyden G, Grenda R, Vondrak K, Hughes D, Offner G, Griebel M, Brekke IB, McGraw M, Balzar E, Friman S, Trompeter R. Pediatr Transplant. 2005 Aug;9(4):498-503.

Active substance: Azathioprine

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Document reference: 49268

Study title: Heart transplantation in patients with previous Fontan operations.Gamba A1, Merlo M, Fiocchi R, Terzi A, Mammana C, Sebastiani R, Ferrazzi P. J Thorac Cardiovasc Surg. 2004 Feb;127(2):555-62.

Active substance: Azathioprine

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Document reference: 49261

Study title: Improved efficacy of basiliximab over antilymphocyte globulin induction therapy in paediatric renal transplantation.Clark G1, Walsh G, Deshpande P, Koffman G. Nephrol Dial Transplant. 2002 Jul;17(7):1304-9.

Active substance: Azathioprine

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Document reference: 49255

Study title: Al-Kandari et al. Regional cerebral blood flow in patients with sickle cell disease: study with single photon emission computed tomographyAnnals of nuclear medicine (2007), 21(8), 439-45. Al-Kandari fa 2007

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48604

Study title: Altiay et al. 99mTc-HMPAO brain perfusion single-photon emission computed tomography in children with Down syndrome: relationship to epilepsy, thyroid functions, and congenital heart diseaseJournal of child neurology (2006), 21(7) 610-4. altiay s 2006

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48605

Study title: Brain Perfusion SPECT in Juvenile Neuro-Behc¸et’s DiseaseSilvia Vignola, Flavio Nobili, Paolo Picco, Marco Gattorno, Antonella Buoncompagni, Paolo Vitali, Giuliano Mariani, and Guido Rodriguez. THE JOURNAL OF NUCLEAR MEDICINE • Vol. 42 • No. 8 • August 2001

Active substance: CERETEC

Study summary document link (including results): vignola s 2001.pdf

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Document reference: 48603

Study title: Cerebral Perfusion in Children With Alice in Wonderland SyndromeYung-Ting Kuo, MD*†, Nan-Chang Chiu, MD†, Ein-Yiao Shen, MD†, Che-Sheng Ho, MD†, and Ming-Che Wu, MD‡ PEDIATRIC NEUROLOGY Vol. 19 No. 2

Active substance: CERETEC

Study summary document link (including results): kuo yt 1998.pdf

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Document reference: 48594

Study title: Chang et al. Comparison between technetium-99m hexamethylpropylene amineoxide labeled white blood cell abdomen scan and abdominal sonography to detect appendicitis in children with an atypical clinical presentation. Hepatogastroenterology.Hepatogastroenterology. 2003 Mar-Apr;50(50):426-9. Chen-chang c 2003

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48606

Study title: Charron et al. Assessment of terminal ileal and colonic inflammation in Crohn's disease with 99mTc-WBC.Acta Paediatr. 1999 Feb; 88(2):193-8 charron m 1999

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48607

Study title: Charron et al. Temporal correlation of the erythrocyte sedimentation rate with Tc-99m WBC uptake on children with inflammatory bowel diseasesClin Nucl Med. 2003 Nov; 28(11):905-7. charron m 2003

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48622

Study title: Comparison of brain perfusion SPECT and MRI findings in children with neuronal ceroid-lipofuscinosis and in their families.Ann Nucl Med. 2002 May; 16(3):201-6. sayit e 2002

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48620

Study title: Congenital Middle Fossa Arachnoid Cysts May Cause Global Brain Ischaemia: A Study with 99Tc-Hexamethylpropyleneamineoxime Single Photon Emission Computerised Tomography ScansS. Sgourosa S. Chapmanb. Pediatr Neurosurg 2001;35:188–194

Active substance: CERETEC

Study summary document link (including results): sgouros s 2001.pdf

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Document reference: 48601

Study title: De Camargo et al. Brain hypoperfusion in adolescents dependent of multiple drugs, Arquivos de neuro-psiquiatriaArquivos de neuro-psiquiatria (2010), 68(2), 161-7. de camargo ecs 2010

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48608

Study title: Diagnostic performance of 18F-FDG PET and ictal 99mTc-HMPAO SPET in pediatric temporal lobe epilepsy: Quantitative analysis by statistical parametric mapping, statistical probabilistic anatomical map, and subtraction ictal SPETJong Jin Lee a, Won Jun Kang a, Dong Soo Lee a,*, Jae Sung Lee a, Hee Hwang b, Ki Joong Kim b, Yong-Seung Hwang b, June-Key Chung a, Myung Chul Lee a. Seizure (2005) 14, 213—220

Active substance: CERETEC

Study summary document link (including results): lee jj 2005.pdf

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Document reference: 48595

Study title: Differences in 99mTc-HMPAO brain SPET perfusion imaging between Tourette’s syndrome and chronic tic disorder in childrenNan-Tsing Chiu1, Ying-Chao Chang2, Bi-Fang Lee1, Chao-Ching Huang3, Shan-Tair Wang4. European Journal of Nuclear Medicine Vol. 28, No. 2, February 2001

Active substance: CERETEC

Study summary document link (including results): nan-tsing chiu 2001.pdf

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Document reference: 48597

Study title: Decroix J, et al Oral itraconazole in the treatment of dermatomycosis. A multicenter evaluation of different treatment schedules. Clinical summary on R51211, August 1987. (10-86 years, LMD56447)Decroix J, et al Oral itraconazole in the treatment of dermatomycosis. A multicenter evaluation of different treatment schedules. Clinical summary on R51211, August 1987. (10-86 years, LMD56447)

Active substance: ITRACONAZOLE

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Document reference: 30789

Study title: A 2-year follow up of babies enrolled in a European multicentre trial of porcine surfactant replacement for severe neonatal respiratory distress syndromeEur J Pediatr (1992) 151 : 372-376, B. Robertson

Active substance: PORACTANT ALFA

Study summary document link (including results): EURO 1.pdf

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Document reference: 49240

Study title: A 2-year follow up of babies enrolled in a European multicentre trial of porcine surfactant replacement for severe neonatal respiratory distress syndromeEur J Pediatr (1992) 151 : 372-376, B. Robertson

Active substance: PORACTANT ALFA

Study summary document link (including results): EURO 1.pdf

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Document reference: 49241

Study title: A Randomized, Multicenter Masked Comparison Trial of Poractant Alfa (Curosurf) versus Beractant (Survanta) in the Treatment of Respiratory Distress Syndrome in Preterm InfantsRangasamy Ramanathan,

Active substance: PORACTANT ALFA

Study summary document link (including results): DL-032 publication.pdf

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Document reference: 49238

Study title: Comparison of Prophylaxis and Rescue Treatment With Curosurf in Neonates Less than 30 Weeks' Gestation: A Randomized TrialPediatrics 1993;92;768, Johannes Egberts,

Active substance: PORACTANT ALFA

Study summary document link (including results): 50.01-CT-02-93 publication.pdf

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Document reference: 49231

Study title: Follow up on Infants Treated with Porcine Surfactant Replacement for Severe Neonatal and Infant Respiratory Distress Syndrome: Antigenic Reactivity Evaluation(Marraro G.)

Active substance: PORACTANT ALFA

Study summary document link (including results): 50.01-CT-02-93 publication.pdf

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Document reference: 49232

Study title: Modifications of Surfactant Phospholipid Pattern in Premature Infants Treated with Curosurf. Clinical and Dietary Correlations.(Haumont D, Clercx A, Rossle C, Biver A, Carpentier Y A.)

Active substance: PORACTANT ALFA

Study summary document link (including results): Haumont D. (Published paper 910177).pdf

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Document reference: 49244

Study title: Multicentre randomised trial comparing high and low dose surfactant regimens for the treatment of respiratory distress syndrome (the Curo4 trial)Please see report

Active substance: PORACTANT ALFA

Study summary document link (including results): EURO VI publication.pdf

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Document reference: 49243

Study title: Nasal Continuous Positive Airway Pressure and Early Surfactant Therapy for Respiratory Distress Syndrome in Newborns of Less Than 30 Weeks’ GestationHenrik Verder,

Active substance: PORACTANT ALFA

Study summary document link (including results): Verder H (publication paper).pdf

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Document reference: 49247

Study title: Porcine surfactant replacement therapy in newborns of 25-3 1 weeks' gestation: a randomized, multicentre trial of prophylaxis versus rescue with multiple low dosesActa Paediatr 84: 913-21. 1995, H Walti

Active substance: PORACTANT ALFA

Study summary document link (including results): 50.01-CT-04-93 publication.pdf

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Document reference: 49234

Study title: Prophylactic or Early Selective Surfactant Combined With nCPAP in Very Preterm InfantsPediatrics 2010;125;e1402

Active substance: PORACTANT ALFA

Study summary document link (including results): DM.PR.5000.002.04 publication.pdf

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Document reference: 49239

Study title: Prophylaxis of respiratory distress syndrome by treatment with modified porcine surfactant at birth: a multicentre prospective randomized trialj. Pennat. Med, 24 (1996) 609-620, Giulio Bevilacqua1,

Active substance: PORACTANT ALFA

Study summary document link (including results): 50.00-CT-02-90 publication.pdf

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Document reference: 49228

Study title: Randomised ,multicentre,clinical study on the treatment with natural surfactant of neonatal respiratory distress syndrome in premature infants : comparison between early and late treatmentPediatrics, VOLUME 82 NOVEMBER 1988 NUMBER 5

Active substance: PORACTANT ALFA

Study summary document link (including results): CH-CUR-0003 publication..pdf

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Document reference: 49237

Study title: Randomised european multicentre trial of surfactant replacement therapy for severe neonatal respiratory distress syndrome : single vs multiple doses of CurosurfPediatrics 1992;89;13

Active substance: PORACTANT ALFA

Study summary document link (including results): EURO IV publication.pdf

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Document reference: 49242

Study title: Surfactant replacement therapy in severe neonatal respiratory distress syndrome (RDS)Pediatrics, VOLUME 82 NOVEMBER 1988 NUMBER 5

Active substance: PORACTANT ALFA

Study summary document link (including results): CH-CUR-001 publication.pdf

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Document reference: 49236

Study title: AN OPEN, NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF 0.5% TOPICAL PIROXICAM GEL IN THE TREATMENT OF ACUTE MUSCULOSKELETAL (AMS) DISORDERS.

Active substance: PIROXICAM

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Document reference: 34457

Study title: Infliximab for pediatric ulcerative colitis: a retrospective Italian multicenter study.Cucchiara S1, Romeo E, Viola F, Cottone M, Fontana M, Lombardi G, Rutigliano V, de'Angelis GL, Federici T. Dig Liver Dis. 2008 Jul;40 Suppl 2:S260-4

Active substance: Azathioprine

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Document reference: 49285

Study title: Infliximab heals intestinal inflammatory lesions and restores growth in children with Crohn's disease.Borrelli O, Bascietto C, Viola F, Bueno de Mesquita M, Barbato M, Mancini V, Bosco S, Cucchiara S. Dig Liver Dis. 2004 May;36(5):342-7.

Active substance: Azathioprine

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Document reference: 49264

Study title: Initial experience with FK506 (tacrolimus) in pediatric renal transplant recipients.McKee M, Segev D, Wise B, Case B, Neu A, Fivush B, Colombani P. J Pediatr Surg. 1997 May;32(5):688-90.

Active substance: Azathioprine

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Document reference: 49220

Study title: Interventions for idiopathic steroid-resistant nephrotic syndrome in children.Habashy D, Hodson E, Craig J. Cochrane Database Syst Rev. 2004;(2):CD003594.

Active substance: Azathioprine

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Document reference: 49263

Study title: Interventions for idiopathic steroid-resistant nephrotic syndrome in children.Habashy D, Hodson E, Craig J. Cochrane Database Syst Rev. 2004;(2):CD003594.

Active substance: Azathioprine

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Document reference: 49270

Study title: Low bone mineral density in children and adolescents with inflammatory bowel disease: a population-based study from Western Sweden.Schmidt S, Mellström D, Norjavaara E, Sundh SV, Saalman R. Inflamm Bowel Dis. 2009 Dec;15(12):1844-50

Active substance: Azathioprine

Study summary document link (including results):

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Document reference: 49290

Study title: Medical Therapy for Crohn's DiseaseHanauer SB. 1999

Active substance: Azathioprine

Study summary document link (including results):

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Document reference: 49275

Study title: Methotrexate treatment in pediatric Crohn disease patients intolerant or resistant to purine analogues.Weiss B, Lerner A, Shapiro R, Broide E, Levine A, Fradkin A, Bujanover Y. J Pediatr Gastroenterol Nutr. 2009 May;48(5):526-30

Active substance: Azathioprine

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Document reference: 49292

Study title: Monitoring 6-thioguanine nucleotide concentrations in Japanese children and adolescents with inflammatory bowel disease.Ohtsuka Y, Arai K, Aoyagi Y, Fujii T, Yamakawa Y, Ohtani K, Ikuse T, Baba Y, Inage E, Kudo T, Suzuki R, Nagata S, Shimizu T. J Gastroenterol Hepatol. 2010 Oct;25(10):1626-30

Active substance: Azathioprine

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Document reference: 49294

Study title: Monitoring azathioprine metabolite levels and thiopurine methyl transferase (TPMT) activity in children with inflammatory bowel disease.Paerregaard A, Schmiegelow K. Scand J Gastroenterol. 2002 Mar;37(3):371-2.

Active substance: Azathioprine

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Document reference: 49252

Study title: Multicentre prospective randomised trial of tacrolimus, azathioprine and prednisolone with or without basiliximab: two-year follow-up data.Webb NJ, Prokurat S, Vondrak K, Watson AR, Hughes DA, Marks SD, Moghal NE, Fitzpatrick MM, Milford DV, Saleem MA, Jones CA, Friman S, Van Damme-Lombaerts R, Janssen F, Hamer C, Rhodes S. Pediatr Nephrol. 2009 Jan;24(1):177-82

Active substance: Azathioprine

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Document reference: 49286

Study title: Myasthenia gravis in children: a longitudinal study.Ashraf VV, Taly AB, Veerendrakumar M, Rao S. Acta Neurol Scand. 2006 Aug;114(2):119-23.

Active substance: Azathioprine

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Document reference: 49273

Study title: Mycophenolate mofetil in pediatric renal transplantation.Benfield MR, Symons JM, Bynon S, Eckhoff D, Herrin J, Harmon W, Kohaut E. Pediatr Transplant. 1999 Feb;3(1):33-7.

Active substance: Azathioprine

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Document reference: 49229

Study title: Non-corticosteroid treatment for nephrotic syndrome in children (part I).Hodson EM, Willis NS, Craig JC. Cochrane Database Syst Rev. 2010, Issue 4

Active substance: Azathioprine

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Document reference: 49281

Study title: Effects of long-term methylphenidate treatment: A pilot follow-up clinical and SPECT studyAynur Pekcanlar Akaya,⁎, Gamze Çapa Kaya b, Neslihan İnal Emiroğlu a, Aysel Aydın b, E. Serap Monkulc,d, Cengiz Taşçı b, Süha Miral a, Hatice Durak b. Progress in Neuro-Psychopharmacology & Biological Psychiatry 30 (2006) 1219–1224

Active substance: CERETEC

Study summary document link (including results): akay ap 2006.pdf

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Document reference: 48592

Study title: Functional assessment of intracranial arachnoid cysts with TC99 m-HMPAO SPECT: a preliminary report.Childs Nerv Syst. 2006 Sep;22(9):1091-7. martínez-Lage jf 2006

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48614

Study title: Gibson et al. 99Tcm-HMPAO leucocyte labelling in orofacial granulomatosis and gastrointestinal Crohn's disease in childhood and early adulthoodNuclear medicine communications (2000), 21(2), 155-8. gibson j 2000

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48610

Study title: Griffiths et al. 99mTechnetium HMPAO imaging in children with the Sturge- Weber syndrome: a study of nine cases with CT and MRI correlationNeuroradiology (1997), 39(3), 219-24. Griffiths pd 1997

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48611

Study title: Hwang et al. Regional cerebral perfusion abnormalities in developmental language disorder. Statistical parametric mapping analysisEur Arch Psychiatry Clin Neurosci. 2006 Apr;256(3):131-7. hwang jw 2006

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48612

Study title: Improving the diagnosis of acute appendicitis in children with atypical clinical findings using the technetium-99m hexamethylpropylene amine oximelabelled white-blood-cell abdomen scan.Pediatr Radiol. 2002 Sep;32(9):663-6. yan dc 2002

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48621

Study title: La gammagrafía con leucocitos marcados con 99mTc-HMPAO en el diagnóstico y seguimiento de la enfermedad inflamatoria intestinalJ. Verdú Ricoa, M. Juste Ruizb, R. Jovera, J. Muñoz Acostaa, J. Muñoza, A. Martínez Caballeroa, A. Antón Leala y O. Caballero Carpenaa. An Pediatr (Barc). 2006;64(5):457-63

Active substance: CERETEC

Study summary document link (including results): verdu j 2006.pdf

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Document reference: 48602

Study title: Parietal lobe epileptic focus identified on SPECT-MRI fusion imaging in a case of epilepsia partialis continua.Clin Nucl Med. 2006 Dec;31(12):826-8. matthews r 2006

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48615

Study title: SPECT FINDINGS IN CHILDREN WITH SPECIFIC LANGUAGE IMPAIRMENTMarianne Ors1, Erik Ryding1, Magnus Lindgren2, Peik Gustafsson3, Gösta Blennow4 and Ingmar Rosén1. Cortex, (2005) 41, 316-326

Active substance: CERETEC

Study summary document link (including results): ors m 2005.pdf

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Document reference: 48598

Study title: Tc-99 HMPAO cerebral SPECT imaging in brain death patients with complex spinal automatismTurkish journal of trauma & emergency surgery : TJTES (2002), 8(4), 198-201. Kahveci sf 2002

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48613

Study title: Tc-99m HMPAO labeled white blood cell imaging in a child with eosinophilic lung diseaseClinical nuclear medicine (2008), 33(1), 38-40 moralidis r 2008

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48616

Study title: Kremens B et al, High-dose consolidation with local radiation and bone marrow rescue in patients with advanced neuroblastoma, Med Pediatr Oncol. 1994;23(6):470-5

Active substance: ETOPOSIDE

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Document reference: 26950

Study title: Diler et al. Pharmacotherapy and regional cerebral blood flow in children with obsessive compulsive disorder.Yonsei Med J. 2004 Feb 29; 45(1):90-9 diler rs 2004

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48609

Study title: Surfactant-A nti-Surfactant Immune Complexes in Infants With Respiratory Distress SyndromeDAVID S. STRAYER, MD, PhD,

Active substance: PORACTANT ALFA

Study summary document link (including results): Strayer DS et al;.pdf

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Document reference: 49246

Study title: Treatment of severe meconium aspiration syndrome with porcine surfactant: A multicentre, randomized, controlled trialActa Pædiatrica, 2005; 94: 896–902

Active substance: PORACTANT ALFA

Study summary document link (including results): IM.PR.5001.00 publication.pdf

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Document reference: 49245

Study title: A 5-year, multicenter, open-label, parallel group, randomized study to demonstrate the short and long-term safety of Elidel (pimecrolimus, ASM981) cream 1% in the treatment of mild to moderate atopic dermatitis in infants (3 − < 12 months of age)Study report

Active substance: PIMECROLIMUS

Study summary document link (including results): Pimecrolimus Art.45 study.pdf

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Document reference: 49194

Study title: Efficacy of hydroxyzine in the treatment of trichotillomania: an open-label study.

Active substance: HYDROXYZINE

Study summary document link (including results): ADPE03E2706.pdf

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Document reference: 29313

Study title: In vitro generation of cytotoxic effectors activated by interleukin 2 (IL-2): Comparison of autologous peripheral blood stem cells (PBSC) from adults and children. Valteau-Couanet D et al. Bone Marrow Transplant June. 13, 2001, 869-75

Active substance: FLUOROURACIL

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Document reference: 28274

Study title: A 3-week, open -label, uncontrolled, multicenter study evaluating the functionality of the Foradil Certihaler device in Patients with asthma

Active substance: FORMOTEROL

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Document reference: 47800

Study title: Retrospective survey for documentation of appllication and dosage of Gastricumeel (tablets) in children < 12 years of age [Bef-013]

Active substance: Gastricumeel

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Document reference: 40006

Study title: Randomized study to investigate the effects on growth and the safety of the treatment with recombinant growth hormone in 1 to 2-year-old children with growth retardation due to chronic kidney failure

Active substance: Somatropin

Study summary document link (including results): GHCRF-E-2_Norditropin.pdf

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Document reference: 41789

Study title: ADHD: new pharmacological treatments on the horizon. FA Lopez, Journal of Developmental and Behavioral Pediatrics - JDBP 2006, 27(5): 410-6 ADHD: new pharmacological treatments on the horizon. FA Lopez, Journal of Developmental and Behavioral Pediatrics - JDBP 2006, 27(5): 410-6

Active substance: MODAFINIL

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Document reference: 45670

Study title: "Long-Term Efficacy of Anticholinergic and Alpha-blocking Drugs in the Detrusor of Children with Myelomeningocele - Bouchot O et al. - Journal d'Urologie - 1988 (94(2): 83-86) - Publication in UK registration file - " "Long-Term Efficacy of Anticholinergic and Alpha-blocking Drugs in the Detrusor of Children with Myelomeningocele - Bouchot O et al. - Journal d'Urologie - 1988 (94(2): 83-86) - Publication in UK registration file - "

Active substance: OXYBUTYNIN

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Document reference: 32983

Study title: 18F-FDG PET/CT fusion imaging in paediatric solid extracranial tumours Biomedicine & Pharmacotherapy 60 (2006) 593–606. C. Nannia, D. Rubellob,*, P. Castelluccia, M. Farsada, R. Franchia, L. Rampinb M.D. Grossc, A. Al-Nahhasd, S. Fantia

Active substance: Steripet

Study summary document link (including results): nanni-2006.pdf

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Document reference: 48738

Study title: Détermination de la CMI avec Ercefuryl de 47 souches d’entérobactéries isolées chez des enfants diarrhéiques - Doucet Ch. - 1989 (Méd. Afr. Noire, 36 (12): 963-4) - Publication in Clinical Expert Report - Lassale C. - July 1998 -

Active substance: NIFUROXAZIDE

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Document reference: 47068

Study title: Surfactant therapy and Ig E levels in the neonatal period(Amato M, Markus HP)

Active substance: PORACTANT ALFA

Study summary document link (including results): Amato M, MArkus HP (publication paper).pdf

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Document reference: 49235

Study title: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short children with chronic renal insufficiency

Active substance: Somatropin

Study summary document link (including results): 91-003 and 91-004 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41709

Study title: Nabilone: an effective antiemetic in patients receiving cancer chemotherapy

Active substance: NABILONE

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Document reference: 32438

Study title: Non-corticosteroid treatment for nephrotic syndrome in children (part II).Hodson EM, Willis NS, Craig JC. Cochrane Database Syst Rev. 2010, Issue 4

Active substance: Azathioprine

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Document reference: 49282

Study title: Normal thiopurine methyltransferase levels do not eliminate 6-mercaptopurine or azathioprine toxicity in children with inflammatory bowel disease.Kader HA, Wenner WJ Jr, Telega GW, Maller ES, Baldassano RN. J Clin Gastroenterol. 2000 Jun;30(4):409-13.

Active substance: Azathioprine

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Document reference: 49233

Study title: Oral tacrolimus treatment of severe colitis in children.Bousvaros A1, Kirschner BS, Werlin SL, Parker-Hartigan L, Daum F, Freeman KB, Balint JP, Day AS, Griffiths AM, Zurakowski D, Ferry GD, Leichtner AM. J Pediatr. 2000 Dec;137(6):794-9.

Active substance: Azathioprine

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Document reference: 49249

Study title: Outcome of pediatric renal transplants in a developing country.Gulati S, Kumar A, Sharma RK, Gupta A, Bhandari M, Kumar A, Srivastava A. Pediatr Nephrol. 2004 Jan;19(1):96-100

Active substance: Azathioprine

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Document reference: 49260

Study title: Pediatric renal transplantation with mycophenolate mofetil-based immunosuppression without induction: results after three years.Jungraithmayr T, Staskewitz A, Kirste G, Böswald M, Bulla M, Burghard R, Dippell J, Greiner C, Helmchen U, Klare B, Klaus G, Leichter HE, Mihatsch MJ, Michalk DV, Misselwitz J, Plank C, Querfeld U, Weber LT, Wiesel M, Tönshoff B, Zimmerhackl LB; German Pediatric Renal Transplantation Study Group. Transplantation. 2003 Feb 27;75(4):454-61.

Active substance: Azathioprine

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Document reference: 49258

Study title: Premature atherosclerosis in pediatric systemic lupus erythematosus: risk factors for increased carotid intima-media thickness in the atherosclerosis prevention in pediatric lupus erythematosus cohort.Schanberg LE, Sandborg C, Barnhart HX, Ardoin SP, Yow E, Evans GW, Mieszkalski KL, Ilowite NT, Eberhard A, Levy DM, Kimura Y, von Scheven E, Silverman E, Bowyer SL, Punaro L, Singer NG, Sherry DD, McCurdy D, Klein-Gitelman M, Wallace C, Silver R, Wagner-Weiner L, Higgins GC, Brunner HI, Jung L, Soep JB, Reed A; Atherosclerosis Prevention in Pediatric Lupus Erythematosus Investigators. Arthritis Rheum. 2009 May;60(5):1496-507

Active substance: Azathioprine

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Document reference: 49289

Study title: Prospective randomized trial of azathioprine in cryopreserved valved allografts in children.Shaddy RE1, Lambert LM, Fuller TC, Profaizer T, Thompson DD, Baker SI, Osborne KA, Hawkins JA. Ann Thorac Surg. 2001 Jan;71(1):43-7; discussion 47-8.

Active substance: Azathioprine

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Document reference: 49250

Study title: Response of crescentic Henoch-Schoenlein purpura nephritis to corticosteroid and azathioprine therapy.Bergstein J, Leiser J, Andreoli SP. Clin Nephrol. 1998 Jan;49(1):9-14.

Active substance: Azathioprine

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Document reference: 49223

Study title: Safety and efficacy of TOR inhibitors in pediatric renal transplant recipients.Ettenger RB1, Grimm EM. Am J Kidney Dis. 2001 Oct;38(4 Suppl 2):S22-8.

Active substance: Azathioprine

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Document reference: 49251

Study title: Severe Henoch-Schönlein nephritis: resolution with azathioprine and steroids.Singh S1, Devidayal, Kumar L, Joshi K, Minz RW, Datta U. Rheumatol Int. 2002 Aug;22(4):133-7. Epub 2002 Jul 5.

Active substance: Azathioprine

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Document reference: 49256

Study title: Short-term cyclosporine induces a remission of autoimmune hepatitis in children.Alvarez F, Ciocca M, Cañero-Velasco C, Ramonet M, de Davila MT, Cuarterolo M, Gonzalez T, Jara-Vega P, Camarena C, Brochu P, Drut R, Alvarez E. J Hepatol. 1999 Feb;30(2):222-7.

Active substance: Azathioprine

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Document reference: 49226

Study title: The relationship between 99mTc-HMPAO brain SPECT and the scores of real life rating scale in autistic childrenMeryem Kayaa,*, Serap Karasalihog˘lub, Funda U¨ stu¨na, Aziz Gu¨ltekina, Tevfik Fikret C¸ ermika, Yes¸im Fazlıog˘lub, Mevlu¨t Tu¨rec, O¨ mer N. Yig˘itbas¸ıa, S¸ akir Berkardaa. Brain & Development 24 (2002) 77–81

Active substance: CERETEC

Study summary document link (including results): kaya m 2002.pdf

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Document reference: 48593

Study title: Transient Posterior Encephalopathy Induced by Chemotherapy in ChildrenRocı´o Sa´nchez-Carpintero, MD, PhD*, Juan Narbona, MD, PhD*, Reyes Lo´pez de Mesa, MD*, Javier Arbizu, MD‡, and Luis Sierrasesu´maga, MD, PhD†. Pediatr Neurol 2001;24:145-148.

Active substance: CERETEC

Study summary document link (including results): Sanchez r 2001.pdf

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Document reference: 48600

Study title: Usefulness of Tc-99m HMPAO-labeled WBC heart scan to predict impaired ventricular function and coronary artery dilation in children with Kawasaki diseaseHsiu-Bao Hsua, Yun-Ching Fub,c,*, Shih-Chuan Tsaid, Ruoh-Fang Yene, Betau Hwangc,f. International Journal of Cardiology 92 (2003) 65– 69

Active substance: CERETEC

Study summary document link (including results): hsiu-bao h 2003.pdf

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Document reference: 48591

Study title: Utility of Tc 99m HMPAO SPECT in the early diagnosis of Rasmussen's syndromeItalian journal of neurological sciences (1998), 19(4),217-20. paladin f 1998

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48619

Study title: Tc-99m-HMPAO SPECT in the diagnosis of brain death in childrenPediatrics international : official journal of the Japan Pediatric Society (2004), 46(6), 711-4. okuyaz c 2005

Active substance: CERETEC

Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc

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Document reference: 48617

Study title: Th 1165a metered aerosol: therapy.

Active substance: FENOTEROL

Study summary document link (including results): Fenoterol hydrobromide_U70-0143_synopsis.pdf

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Document reference: 27035

Study title: Evaluation of the efficacy and tolerance of RU51807 (cefpodoxime proxetil) in children with skin and soft tissue infections

Active substance: CEFPODOXIME

Study summary document link (including results): CEFPODOXIME STUDY FF8980740.xls

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Document reference: 47975

Study title: Ciprandi−G, Tosca−M, Ricca−V, Passalacqua−G, Fregonese−L, Fasce−L, Canonica−G−W. Cetirizine treatment of allergic cough in children with pollen allergy. Allergy, Jul 1997, vol. 52, no. 7, p. 752−4.Ciprandi−G, Tosca−M, Ricca−V, Passalacqua−G, Fregonese−L, Fasce−L, Canonica−G−W. Cetirizine treatment of allergic cough in children with pollen allergy. Allergy, Jul 1997, vol. 52, no. 7, p. 752−4.

Active substance: CETIRIZINE

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Document reference: 23659

Study title: Schellong G et al High cure rates and reduced long-term toxicity in pediatric Hodgkin's disease: the German-Austrian multicenter trial DAL-HD-90. The German-Austrian Pediatric Hodgkin's Disease Study Group.J Clin Oncol 1999 Dec;17(12):3736-44

Active substance: ETOPOSIDE

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Document reference: 26772

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A study of the safety and efficacy of RG 5029Y (triamcinolone acetonide) aqueous nasal spray in patients with perennial allergic rhinitis -Procaccini RL -24/02/1994

Active substance: TRIAMCINOLONE

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Document reference: 46853

Study title: Study the therapeutic action (control and prevention fo asthma attacks) and safety of Triamcinolone hexacetonide in 60 ambulatory patients exhibiting asthma, by means of a trial in which it would be compared with other steroids.Valdés

Active substance: TRIAMCINOLONE

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Document reference: 48965

Study title: Open, phase IIIb multicentric study of the immunogenicity and reactogenicity of the co-administration of Priorix (measles-mumps-rubella) and Infanrix Polio-Hib in each thigh to healthy infants aged 16 to 20 months.

Active substance: trivalent attenuated measles (Schwarz strain) - mumps (RIT 4385 and RIT 4386) - rubella (RA 27/3 strain)

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Document reference: 47872

Study title: Saletu, B., Simeon, J., Saletu, M., Itil, T. M., and DaSilva, J. Behavioral and visual evoked potential investigations during trihexyphenidyl and thiothixene treatment in psychotic boys Biol.Psychiatry 1974;8:177-189. Saletu, B., Simeon, J., Saletu, M., Itil, T. M., and DaSilva, J. Behavioral and visual evoked potential investigations during trihexyphenidyl and thiothixene treatment in psychotic boys Biol.Psychiatry 1974;8:177-189.

Active substance: ORPHENADINE

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Document reference: 32900

Study title: A multicentre double-blind group comparative study of the efficacy and safety of nedocromil sodium 2% ophthalmic solution in the treatment of Ragweed- induced seasonal allergic conjunctivitis - Melamed et al. - 1986 - Application for marketing autorisation - TILAVIST (Nedocromil Sodium 2% Eye drops) - Clinical documentation - OP Van Bijsterveld - 07/04/1993 -

Active substance: NEDOCROMIL

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Document reference: 46990

Study title: Surgery. 1985 Dec;98(6):1189-96. Localization of residual medullary thyroid cancer by thallium/technetium scintigraphy. Talpos GB, Jackson CE, Froelich JW, Kambouris AA, Block MA, Tashjian AH Jr Surgery. 1985 Dec;98(6):1189-96. Localization of residual medullary thyroid cancer by thallium/technetium scintigraphy. Talpos GB, Jackson CE, Froelich JW, Kambouris AA, Block MA, Tashjian AH Jr

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44708

Study title: J Nucl Med. 1987 Jan;28(1):47-52. Thallium-201 brain tumor imaging: a comparative study with pathologic correlation. Kaplan WD, Takvorian T, Morris JH, Rumbaugh CL, Connolly BT, Atkins HL. J Nucl Med. 1987 Jan;28(1):47-52. Thallium-201 brain tumor imaging: a comparative study with pathologic correlation. Kaplan WD, Takvorian T, Morris JH, Rumbaugh CL, Connolly BT, Atkins HL.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44608

Study title: Am J Cardiol. 1996 Jul 15;78(2):175-81. Evaluation of myocardial ischemia and infarction by signal-averaged electrocardiographic late potentials in children with Kawasaki disease. Ogawa S, Nagai Y, Zhang J, Yuge K, Hino Y, Jimbo O, Fukazawa R, Hayashi RAm J Cardiol. 1996 Jul 15;78(2):175-81. Evaluation of myocardial ischemia and infarction by signal-averaged electrocardiographic late potentials in children with Kawasaki disease. Ogawa S, Nagai Y, Zhang J, Yuge K, Hino Y, Jimbo O, Fukazawa R, Hayashi R

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44508

Study title: Snow RD, Lecklitner ML. Musculoskeletal findings in Klippel-Trenaunay syndrome. Clin Nucl Med. 1991 Dec;16(12):928-30. Snow RD, Lecklitner ML. Musculoskeletal findings in Klippel-Trenaunay syndrome. Clin Nucl Med. 1991 Dec;16(12):928-30.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43721

Study title: Undesirable events with radiopharmaceuticals.Santos-Oliveira R. Tohoku J Exp Med 2009;217:251-7

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48757

Study title: Ianovskaia EM, Torbenko VP, Mironov SP, Riazantseva VI. [A radionuclide method used in post-traumatic stiffness of the elbow joint] Khirurgiia (Mosk). 1988 Dec;(12):117-9. Russian. No abstract available. Ianovskaia EM, Torbenko VP, Mironov SP, Riazantseva VI. [A radionuclide method used in post-traumatic stiffness of the elbow joint] Khirurgiia (Mosk). 1988 Dec;(12):117-9. Russian. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43802

Study title: Strenge-Hesse Postmarkting surveillance study (evaluation of 154 Legalon-SIL-case reports,18 children) 1983-1992 Internal Report; Cesko-Slovenska Pediatrie; VOL: 61 (6); p. 350-356 /2006/Internal Report, Strenge-Hesse, March 1996

Active substance: Silibinine dihydrogen succinate, disodium

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Document reference: 39873

Study title: GM2002/00081/00 A double blind, placebo controlled two way cross over study investigating the efficacy of sumatriptan nasal spray in children's migraine.

Active substance: SUMATRIPTAN

Study summary document link (including results): sumatriptan-SUM40019-ICHE3.pdf

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Document reference: 43074

Study title: A fluoride dose response evaluation in an anticaries clinical trial1992-Marks, J Dent Res(71)6:1286-1291, June 1992

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1992-Marks-a fluoride dose response evaluation in an anticaries clinical trial.pdf

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Document reference: 49086

Study title: Non-corticosteroid treatment for nephrotic syndrome in children (part III).Hodson EM, Willis NS, Craig JC. Cochrane Database Syst Rev. 2010, Issue 4

Active substance: Azathioprine

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Document reference: 49283

Study title: Steroid treatment for severe childhood IgA nephropathy: a randomized, controlled trial.Yoshikawa N, Honda M, Iijima K, Awazu M, Hattori S, Nakanishi K, Ito H; Japanese Pediatric IgA Nephropathy Treatment Study Group. Clin J Am Soc Nephrol. 2006 May;1(3):511-7.

Active substance: Azathioprine

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Document reference: 49280

Study title: Tacrolimus and steroids versus ciclosporin microemulsion, steroids, and azathioprine in children undergoing liver transplantation: randomised European multicentre trial.Kelly D1, Jara P, Rodeck B, Lykavieris P, Burdelski M, Becker M, Gridelli B, Boillot O, Manzanares J, Reding R. Lancet. 2004 Sep 18-24;364(9439):1054-61.

Active substance: Azathioprine

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Document reference: 49265

Study title: The effect of long-term calcineurin inhibitor therapy on renal function in children after liver transplantation.Arora-Gupta N, Davies P, McKiernan P, Kelly DA. Pediatr Transplant. 2004 Apr;8(2):145-50.

Active substance: Azathioprine

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Document reference: 49262

Study title: The replacement of azathioprine by mycophenolate mofetil in pediatric patients with specific risks in renal transplantation.Anguita A, Repetto HA, Rodriguez-Rilo L, Vazquez LA, Iturzaeta A, Morrone G, Deheza R, Maldonado L, Goldberg JL. Transplant Proc. 1999 Sep;31(6):2279.

Active substance: Azathioprine

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Document reference: 49230

Study title: Thiopurine metabolite monitoring in paediatric inflammatory bowel disease.Ooi CY, Bohane TD, Lee D, Naidoo D, Day AS. Aliment Pharmacol Ther. 2007 Apr 15;25(8):941-7.

Active substance: Azathioprine

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Document reference: 49278

Study title: Treatment of small vessel primary CNS vasculitis in children: an open-label cohort study.Hutchinson C, Elbers J, Halliday W, Branson H, Laughlin S, Armstrong D, Hawkins C, Westmacott R, Benseler SM. Lancet Neurol. 2010 Nov;9(11):1078-84

Active substance: Azathioprine

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Document reference: 49295

Study title: Twelve years experience of juvenile dermatomyositis in North India.Singh S, Bansal A. Rheumatol Int. 2006 Apr;26(6):510-5.

Active substance: Azathioprine

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Document reference: 49269

Study title: produits de contraste et principes d'injection en acquisition helicoidale; DEBELLE L; in : scanner helicoidal ; principes et modalites pratique d'utilisation ; BLUM A. REGENT D. ; Masson Paris 1995 ; p.45 52produits de contraste et principes d'injection en acquisition helicoidale; DEBELLE L; in : scanner helicoidal ; principes et modalites pratique d'utilisation ; BLUM A. REGENT D. ; Masson Paris 1995 ; p.45 52

Active substance: BARIUM SULPHATE

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Document reference: 22197

Study title: Ritzel G. Letter: Ascorbic acid and the common cold.JAMA. 1976 Mar 15;235(11):1108.

Active substance: ASCORBIC ACID

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Document reference: 21878

Study title: Valor profilactico de la vitamina C en infecciones respiratorias agudas del escolar. (Prophylactic value of vitamin C in acute respiratory tract infections in schoolchildren.)Bancalari A, Seguel C, Neira F, et al., 1984, Rev Med Chil. 1984;112(9):871-6

Active substance: ASCORBIC ACID

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48908

Study title: Valor profilactico de la vitamina C en infecciones respiratorias agudas del escolar. (Prophylactic value of vitamin C in acute respiratory tract infections in schoolchildren.)Bancalari A, Seguel C, Neira F, et al., 1984, Rev Med Chil. 1984;112(9):871-6

Active substance: ASCORBIC ACID

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48909

Study title: Graf. P. (1996) Long-term use of oxy- and xylometazoline nasal sprays induces rebound swelling, tolerance, and nasal hyperactivity. Rhinology, 34, 9-13.

Active substance: XYLOMETAZOLINE

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Document reference: 45643

Study title: Analyse critique des études cliniques Abbott, contains study 75-030 of Depakene syrup in epileptic children - Canlorbe P. - 03/04/1981

Active substance: VALPROIC ACID

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Document reference: 45447

Study title: A Formulation of Aerosolized Tobramycin (BramitobR) in the Treatment of Patients with Cystic Fibrosis and Pseudomonas aeruginosa Infection A Double-Blind, Placebo-Controlled, Multicenter StudyChuchalinet al, Pediatr Drugs 2007; 9 Suppl. 1: 21-31

Active substance: TOBRAMYCIN

Study summary document link (including results): DM.RS.10000.002.04 publication.pdf

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Document reference: 49196

Study title: Efficacy, Safety, and Local Pharmacokinetics of Highly Concentrated Nebulized Tobramycin in Patients with Cystic Fibrosis Colonized with Pseudomonas aeruginosaLenoir et al, Pediatr Drugs 2007; 9 Suppl. 1: 11-20, 1174-5878/07/0001-0011/

Active substance: TOBRAMYCIN

Study summary document link (including results): DM.PR.10000.001.01 publication.pdf

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Document reference: 49195

Study title: Tobramycin sulfate elimination in premature infants. Arbeter AM, Saccar CL, Eisner S, Sarni E, Yaffe SJ. J Pediatr. 1983 Jul;103(1):131-5.

Active substance: TOBRAMYCIN

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Document reference: 48896

Study title: Schmidt LM. Topical dermatologic therapy for the pediatrician. Pediatr Clin North Am. 1978 May;25(2):191-208. Schmidt LM. Topical dermatologic therapy for the pediatrician. Pediatr Clin North Am. 1978 May;25(2):191-208.

Active substance: TOLNAFTATE

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Document reference: 44831

Study title: Final report on clinical trials of K 75 - Rhi and K 76 - Rhi (Rhinospray drops).

Active substance: TRAMAZOLINE

Study summary document link (including results): Tramazoline Hydrochloride_U68-0083_synopsis.pdf

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Document reference: 46698

Study title:

Active substance: venticoll

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Document reference: 48220

Study title: A double-blind, randomised trial to compare treatment results for trimethoprim treatment in a once a day-dosage regimen with conventional thrice a day pivmecillinam in female patients with cystitis.Örsten et al

Active substance: TRIMETHOPRIM

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Trimetoprim_7.xlsx

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Document reference: 49065

Study title: Compare the effectiveness of trimethoprim alone with both co-trimoxazole and sulphamethizole for the treatment of uncomplicated urinary tract infections in general practice.Keenan et al

Active substance: TRIMETHOPRIM

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Trimetoprim_6.xlsx

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Document reference: 49064

Study title: Evaluate the prophylactic efficacy of trimetoprim in urinary tract infections and its effect on the normal gastrointestinal and periurethral bacterial flora.Lidin-Janson et al

Active substance: TRIMETHOPRIM

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Trimetoprim_3.xlsx

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Document reference: 49061

Study title: Investigate the efficacy of trimethoprim administered once daily for three days.Ahlmén et al

Active substance: TRIMETHOPRIM

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Trimetoprim_4.xlsx

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Document reference: 49062

Study title: Investigate the efficacy of trimethoprim in the long-term treatment of urinary tract infections in children.Helle

Active substance: TRIMETHOPRIM

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Trimetoprim_2.xlsx

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Document reference: 49060

Study title: Phase 1, Multicenter open-label trial to gain additional experience with topiramate among subjects with infantile spasms

Active substance: TOPIRAMATE

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Document reference: 44912

Study title: An open study to compare the clinical efficacy and tolerance of two sustained action corticosteroids in ORL manifestations.Larger (Publication Thérapeutique, No. 3 (Suppl.), Apr. 1979)

Active substance: TRIAMCINOLONE

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Document reference: 48963

Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.

Active substance: TAMOXIFEN

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Document reference: 43110

Study title: Topical stannous fluoride as a caries preventive for preschool children1962-Burgess

Active substance: SODIUM FLUORIDE

Study summary document link (including results): 1962-Burgess-Topical stannous fluoride as a caries preventive for preschool children.pdf

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Document reference: 49142

Study title: Familial juvenile hypertrophy of the breast. Familial juvenile hypertrophy of the breast.

Active substance: TAMOXIFEN

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Document reference: 43262

Study title: Indagine clinica preliminare del trazodone in preanestesia.

Active substance: TRAZODONE

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Document reference: 46728

Study title: Myopia progression in young school children. A prospective study of myopia progression and the effect of a trial with bifocal lenses and beta blocker eye drops. Jensen H. Acta Ophthalmol Suppl. 1991;(200):1-79. Myopia progression in young school children. A prospective study of myopia progression and the effect of a trial with bifocal lenses and beta blocker eye drops. Jensen H. Acta Ophthalmol Suppl. 1991;(200):1-79.

Active substance: TIAGABINE

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Document reference: 38486

Study title: Utilidad de la tizanidina. Seguimiento de un ano en el tratamiento de la espasticidad en la paralysis (The usefulness of tizanidine. A one−year follow−up of the treatment of spasticity in infantile cerebral palsy). Vásquez BA, Arellano SME, León HSR, Morales OMG. Revista de neurologia, Aug 1−15 2006, vol. 43, no. 3, p. 132−6Utilidad de la tizanidina. Seguimiento de un ano en el tratamiento de la espasticidad en la paralysis (The usefulness of tizanidine. A one−year follow−up of the treatment of spasticity in infantile cerebral palsy). Vásquez BA, Arellano SME, León HSR, Morales OMG. Revista de neurologia, Aug 1−15 2006, vol. 43, no. 3, p. 132−6

Active substance: TINZANIDINE

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Document reference: 44790

Study title: 41. Phase 3, double-blind, parallel-group, safety and efficacy study of TPM monotherapy in adults with refractory partial epilepsy.

Active substance: TOPIRAMATE

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Document reference: 44975

Study title: Pharmacokinetics of teicoplanin in children. - Tarral E, Jehl F, Tarral A et al. (1988) - Journal of Antimicrobial Chematherapy 21, Supplement A, 47-51.

Active substance: TEICOPLANIN

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Document reference: 44306

Study title: Levin TL, Berdon WE, Haller JO, Ruzal-Shapiro C, Hurlet-Jenson A. Intrasplenic masses of "preserved" functioning splenic tissue in sickle cell disease: correlation of imaging findings (CT, ultrasound, MRI, and nuclear scintigraphy). Pediatr Radiol. 1996 Sep;26(9):646-9. Levin TL, Berdon WE, Haller JO, Ruzal-Shapiro C, Hurlet-Jenson A. Intrasplenic masses of "preserved" functioning splenic tissue in sickle cell disease: correlation of imaging findings (CT, ultrasound, MRI, and nuclear scintigraphy). Pediatr Radiol. 1996 Sep;26(9):646-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44259

Study title: A double blinded trial to compare once a day dose regimen of trimethoprim with standard dose of two tablets twice daily of co-trimoxazole in the treatment of uncomplicated urinary tract infections in general practice.Cartwright et al

Active substance: TRIMETHOPRIM

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Trimetoprim_5.xlsx

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Document reference: 49063

Study title: Yuen et al. Phenytoin dosage prediction in paediatric patients. Clin Pharmacokinet 1989; 16:254-60Yuen et al. Phenytoin dosage prediction in paediatric patients. Clin Pharmacokinet 1989; 16:254-60

Active substance: PHENYLEPHRINE

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Document reference: 33943

Study title: Effect of bacterial antigen lysate on IgG and IgA levels in children with recurrent infections and hypogamma-globulinemia

Active substance: Bacterial lysate

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Document reference: 41840

Study title: Assessment of Efficacy and Systemic Safety of a New Chlorofluorocarbon-Free Formulation of Inhaled Beclomethasone Dipropionate in Asthmatic ChildrenPEDIATRIC ASTHMA, ALLERGY & IMMUNOLOGY, Volume 15, Number 3, 2002

Active substance: BECLAMETHASONE

Study summary document link (including results): DM-RS-3303-05-00 pubblication.pdf

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Document reference: 49208

Study title: Beclomethasone dipropionate versus budesonide inhalation suspension in children with mild to moderate persistent asthma. Terzano C Allegra L Barkai L , Cremonesi G. Eur Rev Med Pharmacol Sci. 2000, 4:17-24.

Active substance: BECLAMETHASONE

Study summary document link (including results): MC.PR.1400.001.98 publication.pdf

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Document reference: 49203

Study title: Comparison of nebulized beclomethasone dipropionate and nebulized budesonide in asthma of infants and children. Multicentre, randomized, controlled, open-label study versus reference product in 2 parallel groups over 14 weeks including a 2-week run-in, in severe or persistent asthma in infants and young children of the equivalent safety and efficacy of the addition, to the usual maintenance treatment, of 800 mg of nebulized beclomethasone dipropionate or 750mg of nebulized Pulmicort® twice a day.study synopsis. Please see report

Active substance: BECLAMETHASONE

Study summary document link (including results): 14.06.CT.01.91 (Synopsis).doc

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Document reference: 49206

Study title: Double Blind Double Dummy Multicenter Randomized Parallel-Group Design Trial of the Efficacy and Tolerability of Beclomethasone Dipropionate Suspension for Nebulization and Beclomethasone Dipropionate Spray Via a Metered Dose Inhaler Plus Spacer in the 4-Week Treatment of the Exacerbation of Asthma in Pediatric Patients Terzano C Allegra L Barkai L , Cremonesi G. Eur Rev Med Pharmacol Sci. 2000, 4:17-24.

Active substance: BECLAMETHASONE

Study summary document link (including results): DM.RS.1404.001.99 publication.pdf

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Document reference: 49204

Study title: Double-Blind Randomized Parallel Group Design Multicentre Study of the Efficacy and Tolerability of Two Nasal Spray Presentations of Beclomethasone Dipropionate ( Clenil Aqua, Chiesi and Beconase Aqua®, Glaxo) 200 mcg/bid in Patients with Allergic RhinitisMarni Et AL

Active substance: becLAMETHASONE

Study summary document link (including results): R9010291 publication.pdf

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Document reference: 49198

Study title: Double-Blind Randomized Parallel Group Design Multicentre Study of the Efficacy and Tolerability of Two Nasal Spray Presentations of Beclomethasone Dipropionate ( Clenil Aqua, Chiesi and Beconase Aqua®, Glaxo) 200 mcg/bid in Patients with Allergic Rhinitisstudy synopsis

Active substance: BECLAMETHASONE

Study summary document link (including results): 14.06.CT.01.91 (Synopsis).doc

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Document reference: 49199

Study title: Evidence of adequacy of the performance of the Pulvinal by measuring through-device Peak Inspiratory Flow Rate in severe airways obstruction in adults and children.Dal Negro et al, J.Aerosol Med 2001, 14(3) 343-349

Active substance: BECLAMETHASONE

Study summary document link (including results): Published Paper (Dal Negro).pdf

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Document reference: 49200

Study title: Hendriksz-C-J, Preece-M-A, Chakrapani-A. Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Steelhouse Lane, Birmingham, B4 6NH, UK. Successful pregnancy in a treated patient with biotinidase deficiency. Journal of inherited metabolic disease, {J-Inherit-Metab-Dis}, 2005, vol. 28, no. 5, p. 791-2, ISSN: 0141-8955.Hendriksz-C-J, Preece-M-A, Chakrapani-A. Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Steelhouse Lane, Birmingham, B4 6NH, UK. Successful pregnancy in a treated patient with biotinidase deficiency. Journal of inherited metabolic disease, {J-Inherit-Metab-Dis}, 2005, vol. 28, no. 5, p. 791-2, ISSN: 0141-8955.

Active substance: BIOTIN

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Document reference: 22596

Study title: An open study to investigate the clinical efficacy of Triamcinolone hexacetonide in diseases of the ear in children.Larras-Martenot (Les Cahier d´O.R.L. 14(4): 415-416, 1979)

Active substance: TRIAMCINOLONE

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Document reference: 48964

Study title: Clinical trial to investigate the efficacy of Lederspan.Gedda

Active substance: TRIAMCINOLONE

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Document reference: 48961

Study title: Clinical trial to investigate the efficacy of Triamcinolone hexacetonide in patients with chronic articular reumatism.Kodama et al.

Active substance: TRIAMCINOLONE

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Document reference: 48962

Study title: [Injections and local infiltrations of triamcinolone hexacetonide (Lederle) in rheumatology]. [Article in Spanish] De Usobiaga JL. Rev Esp Reum Enferm Osteoartic. 1970 Apr;13(6):349-59.

Active substance: TRIAMCINOLONE

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Document reference: 48960

Study title: To show the effect of trimethoprim alone in patients with difficult urinary tract infections.Parkkulainen et al

Active substance: TRIMETHOPRIM

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Trimetoprim_1.xlsx

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Document reference: 49059

Study title: A multicentre study for open assessment of the efficacy and safety of TILADE (Nedocromil sodium) QID in the management of Asthma in children - H. Eigen et al. - 1990 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 46994

Study title: "A comparison of once-daily and divided doses of modafinil in children with attention-deficit/hyperactivity disorder: a randomized, double-blind, and placebo-controlled study. J Biederman, et al., Journal of Clinical Psychiatry 2006, 67(5): 727-35.

Active substance: MODAFINIL

Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls

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Document reference: 45291

Study title: "Grinschgl G. Die Kombinationsbehandlung zerebraler Krampfanfälle unter besonderer Berücksichtigung der Epilepsie. Wien Klin Wochenschr 1952; 64/20: 362-365 " "Grinschgl G. Die Kombinationsbehandlung zerebraler Krampfanfälle unter besonderer Berücksichtigung der Epilepsie. Wien Klin Wochenschr 1952; 64/20: 362-365 "

Active substance: MEPHENYTOIN

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Document reference: 31604

Study title: Safety and efficacy comparison of two dosing regimens of MetroGel-Vaginal(R) in the treatment of bacterial vaginosis: a multicenter, randomized, single-blind, parallel comparison.Soper DE1, Livengood C, Sheehan KL, Fenner DE, Martens MG, Nelson AL, Ismail M, Thorp JM, Lappin M, Fleury FJ, Long BJ, Blackwelder T, Sweet RL, Sagov S. Prim Care Update Ob Gyns. 1998 Jul 1;5(4):150.

Active substance: METRONIDAZOLE

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Document reference: 48942

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Mezereum-Homaccord (drops) [AWB-AT]

Active substance: Mezereum-Homaccord

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Document reference: 40071

Study title: Submission of result-related information on paediatric studies submitted under Article 45 of the Paediatric Regulation No 1901/2006. Product concerned by this submission: Nasonex and Associated Tradenames (Mometasone Furoate)Merck Sharp & Dohme (Europe), Inc. Clos du Lynx 5 Lynx Binnenhof B-1200 Brussels

Active substance: MOMETAZONE

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Document reference: 48849

Study title: Miser JS et al. Treatment of metastatic Ewing's sarcoma or primitive neuroectodermal tumor of bone: evaluation of combination ifosfamide and etoposide--a Children's Cancer Group and Pediatric Oncology Group study.J Clin Oncol. 2004 Jul 15;22(14):2873-6.Miser JS et al. Treatment of metastatic Ewing's sarcoma or primitive neuroectodermal tumor of bone: evaluation of combination ifosfamide and etoposide--a Children's Cancer Group and Pediatric Oncology Group study.J Clin Oncol. 2004 Jul 15;22(14):2873-6.

Active substance: MITOXANTRONE

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Document reference: 32177

Study title: An open study to investigate the clinical efficacy and grade of pain relief in patients recieving Triamcinolone hexacetonide by intra-articular injections or paravertebral infusions.Bonilla

Active substance: TRIAMCINOLONE

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Document reference: 48959

Study title: Do inhaled steroids change the response to inhaled ß-agonists in children?

Active substance: TERBUTALINE

Study summary document link (including results): 01-3001 Study Synopsis.pdf

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Document reference: 44403

Study title: Holter-monitored cardiac arrhythmias during induction of anaesthesia in children aged 1-3 years. Britisch Journal Anaesthesia 82 (suppl. 1): 147-148, 1999 Holter-monitored cardiac arrhythmias during induction of anaesthesia in children aged 1-3 years. Britisch Journal Anaesthesia 82 (suppl. 1): 147-148, 1999

Active substance: TRAMADOL

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Document reference: 45019

Study title: Neuropathic osteonecrosis of the knee in childhood. Two cases of myelomeningocele. Kjaerulff H, Hejgaard N. Acta Orthop Scand. 1987 Aug;58(4):436-40.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43852

Study title: Lopez Pereira P, Miguelez C, Caffarati J, Estornell F, Anguera A: Trospium chloride for the treatment of detrusor instability in children; J. Urol. 2003; 170(5): 1978-1981Lopez Pereira P, Miguelez C, Caffarati J, Estornell F, Anguera A: Trospium chloride for the treatment of detrusor instability in children; J. Urol. 2003; 170(5): 1978-1981

Active substance: TROSPIUM

Study summary document link (including results): 14532838.pdf

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Document reference: 46886

Study title: Radionuclide imaging of the patellofemoral joint in young adults with anterior knee pain.Dye SF, Boll DA. Orthop Clin North Am 1986 Apr;17(2):249-62.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48478

Study title: Once daily nebulized beclomethasone is effective in maintaining pulmonary function and improving symptoms in asthmatic children.La Grutta S , Nicolini G, Capristo C, Bellodi SC, Rossi GA (Monaldi Arch Chest Dis. 2007 Mar;67:30-8.)

Active substance: BECLAMETHASONE

Study summary document link (including results): MC.PR.1400.003.01 publication.pdf

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Document reference: 49202

Study title: Open Randomized Parallel Group Design Trial Investigating the Efficacy and Tolerability of Beclomethasone Dipropionate (100 mcg qid) Dry Powder Delivered from Two Different Powder Inhalers (Chiesi and Glaxo) in the Treatment of Chronic Asthma in ChildrenJOURNAL OF AEROSOL MEDICINE, Volume 13, Number 1, 2000

Active substance: BECLAMETHASONE

Study summary document link (including results): 15.02-CT-92-Pubblication.pdf

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Document reference: 49201

Study title: Short-term growth and adrenal function in children with asthma treated with inhaled beclomethasone dipropionate hydroflouroalkane-134aPEDIATRIC ALLERGY AND IMMUNOLOGY, Pediatr Allergy Immunol 2006: 17: 613–619

Active substance: BECLAMETHASONE

Study summary document link (including results): DM-PR-3303-004-03-publication.pdf

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Document reference: 49207

Study title: Comparative Evaluation of Cefixime versus Amoxicillin-Clavulate Following Ceftriaxone Therapy of PneumoniaClin Pediatr 1996; 35: 629-633, Amir J., 1996

Active substance: CEFIXIME

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48974

Study title: Comparative Evaluation of Cefpodoxime Versus Cefixime in children with Lower Respiratory Tract InfectionsIndian J Pediatr 2004; 71: 517-521 Sengupta J.

Active substance: CEFIXIME

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48975

Study title:

Active substance: BUSERELIN

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Document reference: 33742

Study title: Safety_FertilitySafety_Fertility

Active substance: BLEOMYCIN

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Document reference: 22812

Study title: Application of S-CMC to otitis media with effusion. - Yukiko Ito et al.- 1992 (Journal reference not readable, 85:5;815-819) ; Publication M90 French validation registration dossier 05/1995

Active substance: CARBOCYSTEINE

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Document reference: 23308

Study title: An open study to examine whether enhanced control of asthma, assessed by peal flow measurements, was associated wth improvments in patients lifestyles

Active substance: BUDESONIDE

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Document reference: 48890

Study title: emploi d'un nouvel opacifiant triiode en cystographie et pour certains examens digestifs chez l'enfant; COUSSEMENT A; J. Radiol.; 1973 vol.54 n.12 p.67-68emploi d'un nouvel opacifiant triiode en cystographie et pour certains examens digestifs chez l'enfant; COUSSEMENT A; J. Radiol.; 1973 vol.54 n.12 p.67-68

Active substance: BISACODYL

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Document reference: 22725

Study title: Küchle H. J., Busse H., Augenerkrankungen im Kindesalter, Thieme Verlag Stuttgart New York 1985

Active substance: CARBOMER

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Document reference: 23350

Study title: Double blind, double dummy, multinational, multicenter, parallel-group design clinical trial of the efficacy and tolerability of budesonide spray aerosol (200 µg unit dose twice daily) administered via pMDI using the HFA-134a or the CFC propellant in a 12-week treatment period of mild to moderate persistent asthma in pediatric patients. Comparison with an open-label control group treated with budesonide HFA-134a (200 µg unit dose twice daily) given with the ‘JET’ spacer device

Active substance: BUDESONIDE

Study summary document link (including results): DM-PR-3307-003-03.doc

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Document reference: 49197

Study title: Effect of budesonide on bronchial hyperresponsiveness and pulmonary function in patients with mild to moderate asthma.Kivity S, Fireman E, Greif J, Schwarz Y, Topilsky M. Ann Allergy. 1994 Apr;72(4):333-6.

Active substance: BUDESONIDE

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Document reference: 48891

Study title: Effect of continuous treatment with topical corticosteroid on episodic viral wheeze in preschool children (ages 8 months to 6 years).

Active substance: BUDESONIDE

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Document reference: 48432

Study title: Efficacy and tolerability of morniflumate in the treatment of acute pharyngotonsillitis in children. Clinica,anno XXIX, 77-84, gennaio-giugno 1990R.Riondino et al, 1990. Clinica Europea 1990, Riondino

Active substance: MORNIFLUMATE

Study summary document link (including results): Clinica Europea 1990, Riondino.pdf

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Document reference: 48878

Study title: Treatment of acute bronchitis in childhood with morniflumate. Clinica,anno XXIX, 77-84, gennaio-giugno 1990L.Longo et al , 1990. Clinica Europea 1990 Longo

Active substance: MORNIFLUMATE

Study summary document link (including results): Clinica Europea 1990 Longo.pdf

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Document reference: 48877

Study title: Clinical pharmacokinetics and pharmacodynamics of opioid analgesics in infants and childrenOlkkola KT, Hamunen K, Maunuksela EL., 1995, Clin Pharmacokinet 1995; 5: 385-404

Active substance: MORPHINE

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Document reference: 48931

Study title: Epidural and intravenous bolus morphine for postoperative analgesia in infantsCan J Anaesth 1996; 12: 1203-10, Haberkern CM, Lynn AM, Geiduschek JM, Nespeca MK, Jacobson LE, Bratton SL, Pomietto M., 1996

Active substance: MORPHINE

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Document reference: 48928

Study title: Recommended use of morphine in neonates, infants and children based on a literature review: Part 2 - Clinical use.Paediatr Anaesth 1997; 2: 93-101, Kart T, Christrup LL, Rasmussen M., 1997

Active substance: MORPHINE

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Document reference: 48929

Study title: Single-dose caudal epidural morphine in children: safe, effective, and easy.J Clin Anesth 1991; 5: 386-90, Serlin S., 1991

Active substance: MORPHINE

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Document reference: 48932

Study title: The maturation of morphine clearance and metabolismMcRorie TI, Lynn AM, Nespeca MK, Opheim KE, Slattery JT., 1992, Am J Dis Child 1992; 8: 972-6

Active substance: MORPHINE

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Document reference: 48930

Study title: Hofmann S, Knoefler R, Lorenz N, et al. Clinical experiences with low molecular weight heparins in pediatric patients. Thrombosis Research 2001;103: 345–53."

Active substance: NADROPARIN

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Document reference: 32450

Study title: Quach et al. Thyroid and hepatic function after high-dose (131) I-metaiodobenzylguanidine ((131 I) -MIBG) therapy for neuroblastoma Pediatr Blood Cancer. 2010 Sep 9

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48326

Study title: Bacigalupo A et al. Increased risk of leukemia relapse with high-dose cyclosporine A after allogeneic marrow transplantation for acute leukemia. Blood. 1991 Apr 1;77(7):1423-8.Bacigalupo A et al. Increased risk of leukemia relapse with high-dose cyclosporine A after allogeneic marrow transplantation for acute leukemia. Blood. 1991 Apr 1;77(7):1423-8.

Active substance: MITOXANTRONE

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Document reference: 32227

Study title: Dissociation of platelet activation and spontaneous myocardial ischemia in unstable angina. Vejar M, Fragasso G, Hackett D, Lipkin DP, Maseri A, Born GV, Ciabattoni G, Patrono C. Thrombosis and haemostasis, 12 Apr 1990, vol. 63, no. 2, p. 163−8Dissociation of platelet activation and spontaneous myocardial ischemia in unstable angina. Vejar M, Fragasso G, Hackett D, Lipkin DP, Maseri A, Born GV, Ciabattoni G, Patrono C. Thrombosis and haemostasis, 12 Apr 1990, vol. 63, no. 2, p. 163−8

Active substance: DILTIAZEM

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Document reference: 26148

Study title: A new bowel preparation for elective colon and rectal surgery. A prospective, randomized clinical trial.Wolff BG, Beart RW Jr, Dozois RR, Pemberton JH, Zinsmeister AR, Ready RL, Farnell MB, Washington JA 2nd, Heppell J. Archives of surgery (Chicago Ill. : 1960), Jul 1988, vol. 123, no. 7, p. 895−900

Active substance: ERYTHROMYCIN

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Document reference: 26507

Study title: Lee WT, Leung SS, Wang SH, Xu YC, Zeng WP, Lau J, Oppenheimer SJ, Cheng JC. Double-blind, controlled calcium supplementation and bone mineral accretion in children accustomed to a low-calcium diet. Am J Clin Nutr. 1994 Nov; 60(5):744-50. Lee WT, Leung SS, Wang SH, Xu YC, Zeng WP, Lau J, Oppenheimer SJ, Cheng JC. Double-blind, controlled calcium supplementation and bone mineral accretion in children accustomed to a low-calcium diet. Am J Clin Nutr. 1994 Nov; 60(5):744-50.

Active substance: CALCIUM CARBONATE

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Document reference: 23155

Study title: Bisoprolol treatment in children with hyperkinetic heart syndromeEur J Echocardiography 1999; Suppl: S66, Jurko A., 1999

Active substance: Bisoprolol

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Document reference: 48905

Study title: β-Blocker/thiazide combination for treatment of hypertensive children: a randomized double-blind, placebo-controlled trial.Pediatr Nephrol 2002; 17: 345-350; Sorof JM., 2002

Active substance: BISOPROLOL AND HYDROCHLOROTHIAZIDE

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48907

Study title:

Active substance: FLUTICASONE

Study summary document link (including results): Synopsis-Fluticasone Propionate-CUTIVATE-FLD40004.pdf

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Document reference: 28434

Study title: AJNR Am J Neuroradiol. 2003 Mar;24(3):373-81. MR ventriculography for the study of CSF flow. Joseph VB, Raghuram L, Korah IP, Chacko AG. AJNR Am J Neuroradiol. 2003 Mar;24(3):373-81. MR ventriculography for the study of CSF flow. Joseph VB, Raghuram L, Korah IP, Chacko AG.

Active substance: GADODIAMIDE

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Document reference: 28803

Study title: Neurology. 1995 Jan;45(1):123-6. FDG-PET and volumetric MRI in the evaluation of patients with partial epilepsy. Gaillard WD, Bhatia S, Bookheimer SY, Fazilat S, Sato S, Theodore WH.

Active substance: FLUDEOXYGLUCOSE

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Document reference: 28201

Study title: Bericht über die klinische Prüfung von 9alpha-Fluorhydrocortison zur Behandlung hypotoner und orthostatischerKreislaufregulationsstörungen, Arzneim Forsch (Drug Research) 1971; 21: 1144-1149, Legeler HJ. , 1971

Active substance: FLUDOCORTISONE

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Document reference: 48904

Study title: Corticosteroids administered by nebulization to children with bronchial asthma.Terzano C, Barkai L, Cremonesi G., Adv Ther. 2001 Nov-Dec;18:253-60.

Active substance: FLUNISOLIDE

Study summary document link (including results): MC-PR-3502-001-99 publication.pdf

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Document reference: 49211

Study title: Double-blind evaluation of effectiveness and safety of flunisolide aerosol for treatment of bronchial asthma in children.Piacentini G.L. et al, Allergy 1990,45, 612-616

Active substance: FLUNISOLIDE

Study summary document link (including results): Published paper (Piacentini).pdf

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Document reference: 49212

Study title: Aspects of pharmacology of Gentamicin in Newborn Infants - Andersen JH. & Al - 1972 ( Acta Paediat. Scand. 61:343-9) - Publication in Gentamicin Registration Dossier - 1978 -Aspects of pharmacology of Gentamicin in Newborn Infants - Andersen JH. & Al - 1972 ( Acta Paediat. Scand. 61:343-9) - Publication in Gentamicin Registration Dossier - 1978 -

Active substance: GENTAMYCIN

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Document reference: 28890

Study title: Gentamicin in the treatment of acute and chronic pyelonephritis in childrenMed Klinik 1970; 65 (12): 552-557, Kienitz M., 1970

Active substance: GENTAMYCIN

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Document reference: 48933

Study title: Doutre MS, Grosshans E, Saiag P. Herpes virus infection in the immunocompetent child and adult. Cutaneous and mucous herpes. Annales de Dermatologie et de Venereologie. 2002; 129(10 Suppl~):2S27-2S35, Octobre.2002.Doutre MS, Grosshans E, Saiag P. Herpes virus infection in the immunocompetent child and adult. Cutaneous and mucous herpes. Annales de Dermatologie et de Venereologie. 2002; 129(10 Suppl~):2S27-2S35, Octobre.2002.

Active substance: Foscarnet

Study summary document link (including results): Doutre MS et al 2002.pdf

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Document reference: 39636

Study title: A randomized, double-blind trial to determine whether 1 g of erythromycin daily for a week is as a effective as the 2 g daily dose but without the adverse gastrointestinal effects associated with the larger dose.Linnemann et al. (Sexually transmitted diseases, Vol 14, No. 2)

Active substance: ERYTHROMYCIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_4.xlsx

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Document reference: 49052

Study title: A single-blind trial to investigate the ethiology of bacterial respiratory tract infections and the efficacy of penicillin V (Kåvepenin) and erythromycin (Ery-Max) in these infections.Hovelius et al. (Clinical practice and Therapy, suppl 1, 1982)

Active substance: ERYTHROMYCIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_1.xlsx

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Document reference: 49049

Study title: A Double blind, placebo-controlled trial for further evaluation of the effect of these preparations in migraine and also of their side-effects.Kallós et al. (Translation of a paper from The Swedish Medical journal (Svenska Läkartidningen) 1958:55:1782 No. 24)

Active substance: ergotamine

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ergotamine_1.xlsx

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Document reference: 49073

Study title: Comparisons of the effect of ergotamine tartrate adminislered intramuscularly, by inhalation (Medihaler ergotamine) or rectally in combination with meprobamate, chlorcyc1izine, and caffeine (Anervan suppositories ):t, in the treatment of migraine attacks.Kallós et al. REPRINTED FROM HEADACHE, October, 1964

Active substance: ergotamine

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ergotamine_2.xlsx

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Document reference: 49074

Study title: Compare the clinical efficacy and tolerance of a new erythromycin formulation, when administered twice or four times daily in acute bronchitis.Pekkanen (Rhinology, 21, 00-00, 1983)

Active substance: ERYTHROMYCIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_2.xlsx

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Document reference: 49050

Study title: Liver transplantation in the therapy of hepatocellular carcinoma: A revision of our series.

Active substance: Ethyl esters of iodized fatty acids of poppy seed oil

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Document reference: 39920

Study title: Double-blinded, randomized trial to evaluate the efficacy of early erythromycin treatment on the duration of fecal excretion and diarrhea associated with Campylobacter jejuni.Salazar-Lindo et al. (The Journal Of Pediatrics, Aug, 1986)

Active substance: ERYTHROMYCIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_6.xlsx

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Document reference: 49054

Study title: Postoperative emesis after pediatric strabismus surgery. the effect of dixyrazine compared to droperidol

Active substance: DIXYRAZINE

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Document reference: 26278

Study title: PHARMACOKINETICS OF VOLTAREN IN CHILDRENPHARMACOKINETICS OF VOLTAREN IN CHILDREN

Active substance: DICLOFENAC

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Document reference: 26072

Study title: Examine the variability in erythromycin pharmacokinetics after single dose intravenous administration, determine the linearity of pharmacokinetic parameters after administration of different doses, evaluate the usefulness of non-invasive sampling techniques in studying erythromycin pharmacokinetics.Klaustin et al. (Br. J. Am. Pharmac. 1980, 273-279)

Active substance: ERYTHROMYCIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_7.xlsx

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Document reference: 49055

Study title: Investigate how compliance among children may be related to form and dosage of the medicine.Norstedt

Active substance: ERYTHROMYCIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_3.xlsx

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Document reference: 49051

Study title: Investigate if Bordetella pertussis bacterias, that disappear after a couple of days of erythromycin treatment, returns after completed treatment.Quiding Boström Läkartidningen 1981

Active substance: ERYTHROMYCIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_10.xlsx

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Document reference: 49058

Study title: Pharmacokinetic and antibacterial activity of daily gentamicinArchives Dis Childhood 1992; 67: 57-61, Skopnik H., 1992.

Active substance: GENTAMYCIN

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48935

Study title: Mitomycin C and 5-fluorouracil antimetabolite therapy for pediatric glaucoma filtration surgery. Snir M et al. Ophthalmic Surg Lasers. January 1, 2000, 31-7

Active substance: FLUOROURACIL

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Document reference: 28277

Study title: Treatment of Neonatal Sepsis with Ceftriaxone/Gentamicin and with Azlocillin/Gentamicin: A Clinical Comparison of Efficacy and Tolerability Chemotherapy1988; 34: 158-163, Wiese G.

Active substance: GENTAMYCIN

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Document reference: 48934

Study title: Fucithalmic, chloramphenicol or no treatment after squint surgery in children. A single blind randomised study.Kearns P.P. 1992, Acta Ophthalmol, 70:132-134

Active substance: FUSIDIC ACID

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Document reference: 48459

Study title: Bassi F, Serio M. Treatment with an LH-RH agonist ('Zoladex' depot) in patients with precocious puberty. (Ita, English translation). Drugs under Experimental and Clinical Research 1990;16(Suppl):33-37 1990;(Suppl):33-37.Bassi F, Serio M. Treatment with an LH-RH agonist ('Zoladex' depot) in patients with precocious puberty. (Ita, English translation). Drugs under Experimental and Clinical Research 1990;16(Suppl):33-37 1990;(Suppl):33-37.

Active substance: GOSERELIN

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Document reference: 29003

Study title: A PROSPECTIVE SURVEY OF OPPORTUNISTIC INFECTIONS IN PATIENTS RECEIVING CHEMOTHERAPY FOR ACUTE LEUKEMIAS.

Active substance: FLUCONAZOLE

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Document reference: 27481

Study title: CLINICAL EVALUATION OF FLUCONAZOLE (UK-49,858) IN IV DRIP ENJECTION FROM EFFICACY AND SAFETY IN PEDIATRIC SYSTEMIC MYCOSIS.

Active substance: FLUCONAZOLE

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Document reference: 27933

Study title: ONCE-WEEKLY ORAL FCA VS. PLACEBO IN THE PREVENTION OF MUCOCUTANEOUS FUNGAL INFECTIONS IN PATIENTS DISCHARGED FROM THE HOSPITAL AFTER BONE MARROW TRANSPLANTATION.

Active substance: FLUCONAZOLE

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Document reference: 27611

Study title: CLINICAL USEFULNESS OF DIFLUCAN FOR SYSTEMIC MYCOSIS IN HOSPITALIZED PATIENTS ON IVH

Active substance: FLUCONAZOLE

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Document reference: 27520

Study title: Quality of life in a double-blind, randomised, placebo-controlled parallel study comparing the efficacy and safety of three dosage strengths of fexofenadine HCl (15, 30 and 60 mg BID) in paediatric patients (ages 6 to 11 years) in the treatment of Seasonal Allergic Rhinitis, 22 April 1998

Active substance: FEXOFENADINE

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Document reference: 27259

Study title: SAFETY AND EFFICACY OF ORAL AND INTRAVENOUS FLUCONAZOLE IN PATIENTS WITH GASTRO-INTESTINAL CANDIDIASIS.

Active substance: FLUCONAZOLE

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Document reference: 27784

Study title: A comparative study of Fucidin H cream and Hydrocortisone cream in children (4-17 years) with a flare-up of atopic dermatitis. A study using non-invasive bioengineering techniques.

Active substance: FRAMYCETIN

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Document reference: 28625

Study title: Once daily aminoglycoside dosing in full term neonatesPediatr Infect Dis J 1995; 14: 71-72, Skopnik H., 1995

Active substance: GENTAMYCIN

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 48936

Study title: An open uncontrolled study to evaluate the effect of treatment and tolerance of a flucloxacillin nsyrup.Price et al Flucloxacillin in the treatment of infectious conditions in children.

Active substance: FLUCLOXACILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Flukloxacillin_1.xlsx

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Document reference: 49076

Study title: Investigate the bioavailability of 2 commercially available pediatric suspensions of erythromycin containing the stearate salt and the ethylsuccinate ester, respectively.Eriksson et al. (Scand J Infcect Dis 13: 211-215, 1981)

Active substance: ERYTHROMYCIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_9.xlsx

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Document reference: 49057

Study title: Lack of effect of erythromycin and ketoconazole on the pharmacokinetics and pharmacodynamics of steady state intranasal levocabastine. Tran J Q, Di Cicco R A, Sheth S B, Tucci M, Peng L, Jorkasky D K, Hursting M J, Benincosa L J. Journal of clinical pharmacology, {May 1999, vol. 39, no. 5, p. 513 9.

Active substance: ERYTHROMYCIN

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Document reference: 26441

Study title: Doxapram dosage regimen in apnea of prematurity based on pharmacokinetic data. Jamali F, Barrington KJ, Finer NN, Coutts RT, Torok-Both GA. Dev Pharmacol Ther. 1988;11(5):253-7.

Active substance: Doxapram

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Document reference: 48895

Study title: The effect of an infusion of doxapram on morphine analgesia. Gupta PK, Dundee JW. Anaesthesia. 1974 Jan;29(1):40-3.

Active substance: Doxapram

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Document reference: 48894

Study title: Role of doxapram in reducing pulmonary complications after major surgery. Gawley TH, Dundee JW, Gupta PK, Jones CJ. Br Med J. 1976 Jan 17;1(6002):122-4.

Active substance: Doxapram

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Document reference: 48893

Study title: Study the effect of erythromycin on diarrheal illnesses in a clinical trial among children at an orphanage in Bangkok, Thailand.Taylor et al. (Antimicrobial agents and chemotherapy, March 1987, p. 438-442)

Active substance: ERYTHROMYCIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_5.xlsx

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Document reference: 49053

Study title: Study the epidemiology, natural history, treatment and prevention of perinatally aquired chlamydial infections.Grossman et al. (Elsevier biomedical press, 1982)

Active substance: ERYTHROMYCIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_8.xlsx

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Document reference: 49056

Study title: To determine the apparent bioavailability of Dicloxacillin in children of ages ranging from 6 days to 11,5 years.Smith et al. (Dev Pharmacol Ther 1990;14:35-44)

Active substance: dicloxacillin

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Dikloxacillin_1.xlsx

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Document reference: 49078

Study title: Noel G 1967Noel G 1967

Active substance: DROPROPIZINE

Study summary document link (including results): Noel G.xls

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Document reference: 47540

Study title: A modified schedule for routine pertussis immunization

Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)

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Document reference: 40996

Study title: A phase II, double blind, randomized, double center, controlled study to evaluate the safety and immunogenicity of four formulations of DTwPHib combined vaccine containing different concentrations of Hib conjugate in healthy infants at 3, 4, 5 months of age.Please see report- sturdy report

Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)

Study summary document link (including results): V45P1.xlsx

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Document reference: 49183

Study title: A phase II, open-label, randomized, single-center, comparative study evaluating safety, tolerability and immunogenicity of three vaccinations of the DTPHib combined vaccine (Chiron Vaccines; now Novartis Vaccines) in comparison to separate vaccinations of DTP (Chiron Behring; now Novartis Vaccines) and Hib/AlPO4 (Chiron Vaccines; now Novartis Vaccines) vaccines, when administered to 2, 3, 4 months old healthy infants.Please see report- sturdy report

Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)

Study summary document link (including results): V38P1.xlsx

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Document reference: 49186

Study title: A phase II, open-label, single-centre, singal-arm, extension study to evaluate the safety and immunogenicity of a booster vaccination of the DTPHib combined vaccine (Chiron Vaccines; now Novartis Vaccines) administered to 18-20 months old healthy infants who had previously received either DTPHib combined vaccine or separate administrations of DTP (Chiron Behring; now Novartis Vaccines) and Hib/AlPO4 (Chiron Vaccines; now Novartis Vaccines) vaccines at 2, 3 and 4 months of age.Please see report- sturdy report

Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)

Study summary document link (including results): V38P1E1.xlsx

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Document reference: 49185

Study title: Vecchi-V, Pileri-S, Burnelli-R, Bontempi-N, Comelli-A, Testi-A-M, Carli-M, Sotti-G, Rosati-D, Di-Tullio-M-T, et al. III Department of Pediatrics, Bologna University, Italy. Treatment of pediatric Hodgkin disease tailored to stage, mediastinal mass, and age. An Italian (AIEOP) multicenter study on 215 patients. Cancer, {Cancer}, 15 Sep 1993, vol. 72, no. 6, p. 2049-57, ISSN: 0008-543X.Vecchi-V, Pileri-S, Burnelli-R, Bontempi-N, Comelli-A, Testi-A-M, Carli-M, Sotti-G, Rosati-D, Di-Tullio-M-T, et al. III Department of Pediatrics, Bologna University, Italy. Treatment of pediatric Hodgkin disease tailored to stage, mediastinal mass, and age. An Italian (AIEOP) multicenter study on 215 patients. Cancer, {Cancer}, 15 Sep 1993, vol. 72, no. 6, p. 2049-57, ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34871

Study title: Vietti-T-J, Coulter-D-M. Edward Mallinckrodt Dept. Ped., Washington Univ. Sch. Med., St Louis, Mo., United States. Anticancer agents used in the treatment of childhood leukemias. Cancer Bulletin {CANCER-BULL}, 1978, Vol/Iss/Pg. 30/5 (148-159).Vietti-T-J, Coulter-D-M. Edward Mallinckrodt Dept. Ped., Washington Univ. Sch. Med., St Louis, Mo., United States. Anticancer agents used in the treatment of childhood leukemias. Cancer Bulletin {CANCER-BULL}, 1978, Vol/Iss/Pg. 30/5 (148-159).

Active substance: PROCARBAZINE

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Document reference: 34872

Study title: Walker-R-W, Rosenblum-M-K. Memorial Sloan-Kettering Cancer Cnt., 1275 York Avenue, New York, NY 10021, United States. Childhood medulloblastoma. Revue Neurologique {REV-NEUROL}, 1992, Vol/Iss/Pg. 148/6-7 (467-476), ISSN: 0035-3787.Walker-R-W, Rosenblum-M-K. Memorial Sloan-Kettering Cancer Cnt., 1275 York Avenue, New York, NY 10021, United States. Childhood medulloblastoma. Revue Neurologique {REV-NEUROL}, 1992, Vol/Iss/Pg. 148/6-7 (467-476), ISSN: 0035-3787.

Active substance: PROCARBAZINE

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Document reference: 34873

Study title: Weiner-M-A, Leventhal-B-G, Marcus-R, Brecher-M, Ternberg-J, Behm-F-G, Cantor-A, Wharam-M, Chauvenet-A. Hackensack Medical Center, NJ. Intensive chemotherapy and low-dose radiotherapy for the treatment of advanced-stage Hodgkin's disease in pediatric patients: a Ped iatric Oncology Group study. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Sep 1991, vol. 9, no. 9, p. 1591-8, ISSN: 0732-183X.Weiner-M-A, Leventhal-B-G, Marcus-R, Brecher-M, Ternberg-J, Behm-F-G, Cantor-A, Wharam-M, Chauvenet-A. Hackensack Medical Center, NJ. Intensive chemotherapy and low-dose radiotherapy for the treatment of advanced-stage Hodgkin's disease in pediatric patients: a Ped iatric Oncology Group study. Journal of clinical oncology ...

Active substance: PROCARBAZINE

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Document reference: 34875

Study title: Corrias A et al. GH/IGF-I axis in Prader-Willi syndrome: evaluation of IGF-I levels and of the somatotroph responsiveness to various provocative stimuli. Genetic Obesity Study. Group of Italian Society of Pediatric Endocrinology and Diabetology. J Endocrinol Invest. 2000 Feb;23(2):84-9Corrias A et al. GH/IGF-I axis in Prader-Willi syndrome: evaluation of IGF-I levels and of the somatotroph responsiveness to various provocative stimuli. Genetic Obesity Study. Group of Italian Society of Pediatric Endocrinology and Diabetology. J Endocrinol Invest. 2000 Feb;23(2):84-9

Active substance: PYRIDOSTIGMINE

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Document reference: 35190

Study title: De Haes A et al. Pharmacokinetic/pharmacodynamic modeling of rocuronium in myasthenic patients is improved by taking into account the number of unbound acetylcholine receptors. Anesth Analg. 2002 Sep;95(3):588-96De Haes A et al. Pharmacokinetic/pharmacodynamic modeling of rocuronium in myasthenic patients is improved by taking into account the number of unbound acetylcholine receptors. Anesth Analg. 2002 Sep;95(3):588-96

Active substance: PYRIDOSTIGMINE

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Document reference: 35187

Study title: DeLuca G et al. GH secretion in thalassemia patients with short stature. Horm Res. 1995;44(4):158-63DeLuca G et al. GH secretion in thalassemia patients with short stature. Horm Res. 1995;44(4):158-63

Active substance: PYRIDOSTIGMINE

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Document reference: 35200

Study title: Janka-G-E, Lau-B-M, Haas-R-J, et-al. Dept. Haematol. Oncol., Child. Hosp., Univ. Munich, Germany. Combination chemotherapy and radiotherapy for Hodgkin's disease in children. European Journal of Pediatrics {EUR-J-PEDIATR}, 1978, Vol/Iss/Pg. 127 /4 (287-292).Janka-G-E, Lau-B-M, Haas-R-J, et-al. Dept. Haematol. Oncol., Child. Hosp., Univ. Munich, Germany. Combination chemotherapy and radiotherapy for Hodgkin's disease in children. European Journal of Pediatrics {EUR-J-PEDIATR}, 1978, Vol/Iss/Pg. 127 /4 (287-292).

Active substance: PROCARBAZINE

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Document reference: 34747

Study title: Sellami-M, Auclerc-G, Weil-M, et-al. Service d'Oncologie Medicale, Hopital de la Salpetriere, F 75661 Paris, France. Malignant melanoma of children and adolescents. A report of 37 cases. Bulletin du Cancer {BULL-CANCER}, 1986, Vol/Iss/Pg. 73/1 (2-7).Sellami-M, Auclerc-G, Weil-M, et-al. Service d'Oncologie Medicale, Hopital de la Salpetriere, F 75661 Paris, France. Malignant melanoma of children and adolescents. A report of 37 cases. Bulletin du Cancer {BULL-CANCER}, 1986, Vol/Iss/Pg. 73/1 (2-7).

Active substance: PROCARBAZINE

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Document reference: 34841

Study title: Shalet-S-M, Whitehead-E, Jones-P-H-M. Christie Hosp., Manchester, United Kingdom. Testicular dysfunction ater combination chemotherapy for Hodgkin's disease in childhood. Pediatric Research {PEDIATR-RES}, 1981, Vol/Iss/Pg. 15/12 (No. 165).Shalet-S-M, Whitehead-E, Jones-P-H-M. Christie Hosp., Manchester, United Kingdom. Testicular dysfunction ater combination chemotherapy for Hodgkin's disease in childhood. Pediatric Research {PEDIATR-RES}, 1981, Vol/Iss/Pg. 15/12 (No. 165).

Active substance: PROCARBAZINE

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Document reference: 34842

Study title: Shalet-S-M. Dep. Endocrinol., Christie Hosp., Manchester M20 9BX, United Kingdom. Abnormalities of growth and gonadal function in children treated for malignant disease: A review. Journal of the Royal Society of Medicine {J-R-SOC-MED}, 1982, Vol/Iss/Pg. 75/8 (641-647).Shalet-S-M. Dep. Endocrinol., Christie Hosp., Manchester M20 9BX, United Kingdom. Abnormalities of growth and gonadal function in children treated for malignant disease: A review. Journal of the Royal Society of Medicine {J-R-SOC-MED}, 1982, Vol/Iss/Pg. 75/8 (641-647).

Active substance: PROCARBAZINE

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Document reference: 34843

Study title: Shapiro-W-R. Chemotherapy of primary malignant brain tumors in children. Cancer, {Cancer}, Mar 1975, vol. 35, no. 3 suppl, p. 965-72, ISSN: 0008-543X.Shapiro-W-R. Chemotherapy of primary malignant brain tumors in children. Cancer, {Cancer}, Mar 1975, vol. 35, no. 3 suppl, p. 965-72, ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34844

Study title: Sherins-R-J, Olweny-C-L, Ziegler-J-L. Gynecomastia and gonadal dysfunction in adolescent boys treated with combination chemotherapy for Hodgkin's disease. The New England journal of medicine, {N-Engl-J-Med}, 6 Jul 1978, vol.299, no. 1, p. 12-6, ISSN: 0028-4793.Sherins-R-J, Olweny-C-L, Ziegler-J-L. Gynecomastia and gonadal dysfunction in adolescent boys treated with combination chemotherapy for Hodgkin's disease. The New England journal of medicine, {N-Engl-J-Med}, 6 Jul 1978, vol.299, no. 1, p. 12-6, ISSN: 0028-4793.

Active substance: PROCARBAZINE

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Document reference: 34845

Study title: Sinniah-D, Lin-H-P. Extrapyramidal tract syndrome following intensive MOPP therapy for stage IV-B Hodgkin's disease in childhood. Cancer, {Cancer}, May 1979, vol. 43, no. 5, p. 1587-9, ISSN: 0008-543X.Sinniah-D, Lin-H-P. Extrapyramidal tract syndrome following intensive MOPP therapy for stage IV-B Hodgkin's disease in childhood. Cancer, {Cancer}, May 1979, vol. 43, no. 5, p. 1587-9, ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34846

Study title: Desjardins R_1981 Desjardins R_1981

Active substance: PROMETHAZINE

Study summary document link (including results): Bayer Pharma_Promethazine_Desjardins R_1981_publication.pdf

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Document reference: 34999

Study title: Ross RJ et al. Growth hormone response to overnight growth hormone-releasing hormone infusion and oral pyridostigmine in children with short stature. Acta Paediatr Scand Suppl. 1989;349:114-6Ross RJ et al. Growth hormone response to overnight growth hormone-releasing hormone infusion and oral pyridostigmine in children with short stature. Acta Paediatr Scand Suppl. 1989;349:114-6

Active substance: PYRIDOSTIGMINE

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Document reference: 35216

Study title: Singer W et al. Acetylcholinesterase inhibition in patients with orthostatic intolerance. J Clin Neurophysiol. 2006 Oct;23(5):476-81Singer W et al. Acetylcholinesterase inhibition in patients with orthostatic intolerance. J Clin Neurophysiol. 2006 Oct;23(5):476-81

Active substance: PYRIDOSTIGMINE

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Document reference: 35182

Study title: Singer W et al. Acetylcholinesterase inhibition: a novel approach in the treatment of neurogenic orthostatic hypotension. J Neurol Neurosurg Psychiatry. 2003 Sep;74(9):1294-8Singer W et al. Acetylcholinesterase inhibition: a novel approach in the treatment of neurogenic orthostatic hypotension. J Neurol Neurosurg Psychiatry. 2003 Sep;74(9):1294-8

Active substance: PYRIDOSTIGMINE

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Document reference: 35186

Study title: Singer W et al. Pyridostigmine treatment trial in neurogenic orthostatic hypotension. Arch Neurol. 2006 Apr;63(4):513-8Singer W et al. Pyridostigmine treatment trial in neurogenic orthostatic hypotension. Arch Neurol. 2006 Apr;63(4):513-8

Active substance: PYRIDOSTIGMINE

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Document reference: 35183

Study title: Somnier FE et al. EMG evidence of myopathy and the occurrence of titin autoantibodies in patients with myasthenia gravis. Eur J Neurol. 1999 Sep;6(5):555-63Somnier FE et al. EMG evidence of myopathy and the occurrence of titin autoantibodies in patients with myasthenia gravis. Eur J Neurol. 1999 Sep;6(5):555-63

Active substance: PYRIDOSTIGMINE

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Document reference: 35191

Study title: Turner GA, Williams JD, Baker DJ. Effect of pretreatment with oral pyridostigmine on subsequent activity of alcuronium in non-anaesthetized subjects. Br J Anaesth. 1991 Mar;66(3):365-9Turner GA, Williams JD, Baker DJ. Effect of pretreatment with oral pyridostigmine on subsequent activity of alcuronium in non-anaesthetized subjects. Br J Anaesth. 1991 Mar;66(3):365-9

Active substance: PYRIDOSTIGMINE

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Document reference: 35208

Study title: Wong BL. Management of the Child With Weakness. Semin Pediatr Neurol. December 1, 2006, 271-8Wong BL. Management of the Child With Weakness. Semin Pediatr Neurol. December 1, 2006, 271-8

Active substance: PYRIDOSTIGMINE

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Document reference: 35177

Study title: Ziv I et al. Prevention of peripheral side-effects of transdermal hyoscine by adjunctive therapy with low dosage of pyridostigmine. Br J Clin Pharmacol. 1992 May;33(5):507-10 Ziv I et al. Prevention of peripheral side-effects of transdermal hyoscine by adjunctive therapy with low dosage of pyridostigmine. Br J Clin Pharmacol. 1992 May;33(5):507-10

Active substance: PYRIDOSTIGMINE

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Document reference: 35203

Study title: A controlled trial of aerosolized ribavirin in infants receiving mechanical ventilation for severe respiratory syncytial virus infectionA controlled trial of aerosolized ribavirin in infants receiving mechanical ventilation for severe respiratory syncytial virus infection

Active substance: PYRITINOL

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Document reference: 35237

Study title: Antiviral therapy in neonatal chronic lung disease.109Antiviral therapy in neonatal chronic lung disease.109

Active substance: PYRITINOL

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Document reference: 35234

Study title: Bozzo TM. The Effect of Encephabol in School Children with States of Mental Exhaustion (Minerva Medicopsicologica 1970; 2 (12): 44-47)Bozzo TM. The Effect of Encephabol in School Children with States of Mental Exhaustion (Minerva Medicopsicologica 1970; 2 (12): 44-47)

Active substance: PYRITINOL

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Document reference: 35240

Study title: Krizsa J, Husz S, Dobozy A. (1989). Szent-Gyrgyi Albert University Medical School, Hungary, Dermatological Department. Expert Clinical Study report. Inosiplex treatment of patients with herpes zosterKrizsa J, Husz S, Dobozy A. (1989). Szent-Gyrgyi Albert University Medical School, Hungary, Dermatological Department. Expert Clinical Study report. Inosiplex treatment of patients with herpes zoster

Active substance: INOSINE

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Document reference: 30134

Study title: Kynclova S, Mydlil S Presented at the Czechoslovakian Symposium on Isoprinosine®; October, 1989; Prague. (Abstract only). First experience with Isoprinosine®/Modimunal® treatment in childrenKynclova S, Mydlil S Presented at the Czechoslovakian Symposium on Isoprinosine®; October, 1989; Prague. (Abstract only). First experience with Isoprinosine®/Modimunal® treatment in children

Active substance: INOSINE

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Document reference: 30135

Study title: Lento FG, Baretti C, Salemo R, Tandurella S.. Vittorio Emanuele III Hospital, Gela, Italy. 1980. Clinical Study Report . Treatment of varicella and measles with methisoprinolLento FG, Baretti C, Salemo R, Tandurella S.. Vittorio Emanuele III Hospital, Gela, Italy. 1980. Clinical Study Report . Treatment of varicella and measles with methisoprinol

Active substance: INOSINE

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Document reference: 30136

Study title: Lento FG, Cannata G, Baretti C, Salemo R, Tandurella S.. Clinica Europea. Nov-Dec 1981;20(6):3-8. Preliminary results obtained with methisoprinol in the treatment of measles and varicellaLento FG, Cannata G, Baretti C, Salemo R, Tandurella S.. Clinica Europea. Nov-Dec 1981;20(6):3-8. Preliminary results obtained with methisoprinol in the treatment of measles and varicella

Active substance: INOSINE

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Document reference: 30137

Study title: Lento FG, Cannata G, Cannata M, et al.. Presented at del Convegno Siculo-Calabro di Malattie Infettive e Parassitarie; February 6-7, 1981, Messina, Italy. Report on 10 cases of herpes zoster treated with methisoprinolLento FG, Cannata G, Cannata M, et al.. Presented at del Convegno Siculo-Calabro di Malattie Infettive e Parassitarie; February 6-7, 1981, Messina, Italy. Report on 10 cases of herpes zoster treated with methisoprinol

Active substance: INOSINE

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Document reference: 30138

Study title: Lento G, Tandurella S, Baretti C, Cannata G, Salerno R. G Ital Potol Sci Affin 1982;28(1):9-15. Patients suffering from herpes zoster treated with methisoprinol.Lento G, Tandurella S, Baretti C, Cannata G, Salerno R. G Ital Potol Sci Affin 1982;28(1):9-15. Patients suffering from herpes zoster treated with methisoprinol.

Active substance: INOSINE

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Document reference: 30139

Study title: Litzman J, et al . 1999 Scripta Medca (BRNO) 72 (4) 115 -124. Isoprinosine in the treatment of children with frequent respiratory tract infections and minor T lymphocyte immunodeficiency. Litzman J, et al . 1999 Scripta Medca (BRNO) 72 (4) 115 -124. Isoprinosine in the treatment of children with frequent respiratory tract infections and minor T lymphocyte immunodeficiency.

Active substance: INOSINE

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Document reference: 30140

Study title: Litzman J, Lokaj J, Krejci M, Pesak S, Morgan G. Eur J Pediatr 1999 Jan;158(1):32-7. Isoprinosine does not protect against frequent respiratory tract infections in childhood.Litzman J, Lokaj J, Krejci M, Pesak S, Morgan G. Eur J Pediatr 1999 Jan;158(1):32-7. Isoprinosine does not protect against frequent respiratory tract infections in childhood.

Active substance: INOSINE

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Document reference: 30141

Study title: A multicentre randomised, parallel group, double-blind phase III comparison between iodixanol (VISIPAQUE) 150 mg I/ml and 320 mg I/ml and iohexol (Omnipaque) 140 mg I/ml and 300 mg I/ml Report DXC060 (date Jun 1999)

Active substance: IODIXANOL

Study summary document link (including results): DXC060 Redacted.pdf

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Document reference: 48210

Study title: A phase III, randomised, blinded comparison of Iodixanol (VISIPAQUE; 320 mgI/mL) and OMNIPAQUE 350 (Iohexol) in pediatric patients requiring angiocardiographyStudy Report 1968 (Date May 1996)

Active substance: IODIXANOL

Study summary document link (including results): Study Report 1968 Redacted.pdf

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Document reference: 48204

Study title: A phase III, randomised, double blind comparison of Iodixanol (VISIPAQUE; 270 mgI/mL and 320 mgI/mL) and OMNIPAQUE 300 (Iohexol) in pediatric patients requiring computed tomography (CT) scanning of the headStudy Report 1966 (Date Jan 1996)

Active substance: IODIXANOL

Study summary document link (including results): Study Report 1966 Redacted.pdf

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Document reference: 48202

Study title: A phase III, randomised, double blind comparison of Iodixanol (VISIPAQUE; 270 mgI/mL and 320 mgI/mL) and OMNIPAQUE 300 (Iohexol) in pediatric patients requiring computed tomography (CT) scanning of the bodyStudy Report 1967 (Date Dec 1995)

Active substance: IODIXANOL

Study summary document link (including results): Study Report 1967 Redacted.pdf

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Document reference: 48203

Study title: Pharmacokinetic study of a single dose of propofol in paediatric burnt patients under 3 years old.

Active substance: PROPOFOL

Study summary document link (including results): 0859FC-0003 Study Synopsis.pdf

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Document reference: 46135

Study title: Propofol in pedriatic patients aged 1 month to 6 years

Active substance: PROPOFOL

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Document reference: 47083

Study title: Study of intravenous Diprivan (propofol) to determine an effective dose when used as an induction agent in pediatric patients undergoing various surgical procedures

Active substance: PROPOFOL

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Document reference: 46122

Study title: Study of intravenous Diprivan (propofol) to determine an effective dose when used as an induction agent in pediatric patients undergoing various surgical procedures under one hour duration

Active substance: PROPOFOL

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Document reference: 46123

Study title: The pharmacokinetics of Diprivan (propofol) in pediatric patients

Active substance: PROPOFOL

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Document reference: 46121

Study title: The safety of Diprivan (propofol) anesthesia versus standard anesthetic techniques in pediatric subjects less than 36 months of age

Active substance: PROPOFOL

Study summary document link (including results): 0859US0046 Study Synopsis.pdf

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Document reference: 46126

Study title: The safety, efficacy and pharmacokinetics of ZD0859#1 vs. Diprivan (propofol) injection when used for maintenance of anaesthesia in children.

Active substance: PROPOFOL

Study summary document link (including results): 0859IL0058 Study Synopsis.pdf

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Document reference: 46136

Study title: Therapeutic equivalence of a deep propofol sedation in children aged 1 month to 8 years undergoing magnet resonance imaging

Active substance: PROPOFOL

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Document reference: 46120

Study title: To determine wether a modified propofol preparation shows any effect on the incidence of injection pain in children undergoing elective surgery under general anesthesia.

Active substance: PROPOFOL

Study summary document link (including results): BBMDE-0312.xls

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Document reference: 47082

Study title: Tolerability of Propofol Braun 1% compared with Disoprivan 1%

Active substance: PROPOFOL

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Document reference: 46119

Study title: Codispoti M, Mankad PS: Management of anticoagulation and its reversal during paediatric cardiopulmonary bypass: a review of current UK practice. Perfusion 2000; 15: 191-201 Codispoti M, Mankad PS: Management of anticoagulation and its reversal during paediatric cardiopulmonary bypass: a review of current UK practice. Perfusion 2000; 15: 191-201

Active substance: PROTAMINE

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Document reference: 35086

Study title: Effect of different doses of protamine in cyanotic and acyonotic children in congenital heart surgery. Bayrak H et al. Gogus-Kalp-Damar Anestezi ve Yogun Bakim Dernegi Dergisi ( Gogus-Kalp-Damar Anestezi Yogun Bakim Dernegi Derg. ) (Turkey) , March 1, 2007 , 13/1 (24-30) Effect of different doses of protamine in cyanotic and acyonotic children in congenital heart surgery. Bayrak H et al. Gogus-Kalp-Damar Anestezi ve Yogun Bakim Dernegi Dergisi ( Gogus-Kalp-Damar Anestezi Yogun Bakim Dernegi Derg. ) (Turkey) , March 1, 2007 , 13/1 (24-30)

Active substance: PROTAMINE

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Document reference: 35084

Study title: Slanina-J, Wannenmacher-M, Spratler-J. Abteilung Strahlentherapie, Universitatsklinikum Freiburg i.Br, D 7800 Freiburg i.Br., Germany. Pregnancy and development of the child after treatment of Hodgkin's disease. Strahlentherapie {STRAHLENTHERAPIE}, 1985, Vol/Iss/Pg. 161/9 (558-564).Slanina-J, Wannenmacher-M, Spratler-J. Abteilung Strahlentherapie, Universitatsklinikum Freiburg i.Br, D 7800 Freiburg i.Br., Germany. Pregnancy and development of the child after treatment of Hodgkin's disease. Strahlentherapie {STRAHLENTHERAPIE}, 1985, Vol/Iss/Pg. 161/9 (558-564).

Active substance: PROCARBAZINE

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Document reference: 34847

Study title: Smith-K-L, Johnson-D, Hustu-O, et-al. St. Jude Child. Res. Hosp., Memphis, Tenn. 381101, United States. Concurrent chemotherapy and radiation therapy in the treatment of childhood and adolescent Hodgkin's disease. Cancer {CANCER}, 1974, Vol/Iss/Pg. 33/1 (38-46).Smith-K-L, Johnson-D, Hustu-O, et-al. St. Jude Child. Res. Hosp., Memphis, Tenn. 381101, United States. Concurrent chemotherapy and radiation therapy in the treatment of childhood and adolescent Hodgkin's disease. Cancer {CANCER}, 1974, Vol/Iss/Pg. 33/1 (38-46).

Active substance: PROCARBAZINE

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Document reference: 34848

Study title: Efficacy of sucrose to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Gal P, Kissling GE, Young WO, Dunaway KK, Marsh VA, Jones SM, Shockley DH, Weaver NL, Carlos RQ, Ransom JL. Ann Pharmacother. 2005 Jun;39(6):1029-33;Epub 2005 Apr 26. 2. Efficacy of sucrose to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Gal P, Kissling GE, Young WO, Dunaway KK, Marsh VA, Jones SM, Shockley DH, Weaver NL, Carlos RQ, Ransom JL. Ann Pharmacother. 2005 Jun;39(6):1029-33;Epub 2005 Apr 26. 2.

Active substance: PROXYMETHACAINE

Study summary document link (including results): Efficacy of sucrose to reduce pain in premature infants.pdf

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Document reference: 46139

Study title: Efficacy of topical anesthetics to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Marsh VA, Young WO, Dunaway KK, Kissling GE, Carlos RQ, Jones SM, Shockley DH, Weaver NL, Ransom JL, Gal P. Ann Pharmacother. 2005 May;39(5):829-33;Epub 2005 Mar 29. Efficacy of topical anesthetics to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Marsh VA, Young WO, Dunaway KK, Kissling GE, Carlos RQ, Jones SM, Shockley DH, Weaver NL, Ransom JL, Gal P. Ann Pharmacother. 2005 May;39(5):829-33;Epub 2005 Mar 29.

Active substance: PROXYMETHACAINE

Study summary document link (including results): Efficacy of topical anesthetics to reduce pain in premature .pdf

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Document reference: 46140

Study title: Paediatric cycloplegia: a new approach. Shah P, Jacks AS, Adams GG. Eye. 1997;11 ( Pt 6):845-6. Paediatric cycloplegia: a new approach. Shah P, Jacks AS, Adams GG. Eye. 1997;11 ( Pt 6):845-6.

Active substance: PROXYMETHACAINE

Study summary document link (including results): Paediatric cycloplegia.pdf

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Document reference: 46142

Study title: Topical anesthesia during infant eye examinations: does it reduce stress? Saunders RA, Miller KW, Hunt HH. Ann Ophthalmol. 1993 Dec;25(12):436-9. Topical anesthesia during infant eye examinations: does it reduce stress? Saunders RA, Miller KW, Hunt HH. Ann Ophthalmol. 1993 Dec;25(12):436-9.

Active substance: PROXYMETHACAINE

Study summary document link (including results): Topical anesthesia during infant eye examinations.pdf

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Document reference: 46143

Study title:

Active substance: PSEUDOEPHEDRINE/ PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 35159

Study title:

Active substance: PSEUDOEPHEDRINE/ PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 35160

Study title:

Active substance: PSEUDOEPHEDRINE/ PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 35161

Study title:

Active substance: PSEUDOEPHEDRINE/ PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 35162

Study title:

Active substance: PSEUDOEPHEDRINE/ PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 35163

Study title: Does ribavirin impact on the hospital course of children with respiratory syncytial virus (RSV) infection? An analysis using the pediatric investigators collaborative network on infections in Canada (PICNIC) RSV database.Does ribavirin impact on the hospital course of children with respiratory syncytial virus (RSV) infection? An analysis using the pediatric investigators collaborative network on infections in Canada (PICNIC) RSV database.

Active substance: PYRITINOL

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Document reference: 35231

Study title: Ekert-H, Waters-K-D, Smith-P-J, Toogood-I, Mauger-D. Department of Clinical Hematology and Oncology, Royal Children's Hospital, Parkville, Australia. Treatment with MOPP or ChlVPP chemotherapy only for all stages of childhood Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Dec 1988, vol. 6, no. 12, p. 1845-50, ISSN: 0732-183X.Ekert-H, Waters-K-D, Smith-P-J, Toogood-I, Mauger-D. Department of Clinical Hematology and Oncology, Royal Children's Hospital, Parkville, Australia. Treatment with MOPP or ChlVPP chemotherapy only for all stages of childhood Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol},...

Active substance: PROCARBAZINE

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Document reference: 34704

Study title: Ekert-H, Waters-K-D. Results of treatment of 18 children with Hodgkin disease with MOPP chemotherapy as the only treatment modality. Medical and pediatric oncology, {Med-Pediatr-Oncol}, 1983, vol. 11, no. 5, p. 322-6, ISSN: 0098-1532.Ekert-H, Waters-K-D. Results of treatment of 18 children with Hodgkin disease with MOPP chemotherapy as the only treatment modality. Medical and pediatric oncology, {Med-Pediatr-Oncol}, 1983, vol. 11, no. 5, p. 322-6, ISSN: 0098-1532.

Active substance: PROCARBAZINE

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Document reference: 34705

Study title: Ekert-H. Dr. H. Ekert, Department Haematology-Oncology, Royal Children's Hospital, Parkville, Vic, 3052, Australia Massive mediastinal Hodgkin's disease in childhood: Results of treatment from four Australian oncology centres 1972-1993. Cancer Research Therapy and Control {CANCER-RES-THER-CONTROL}, 1996, Vol/Iss/Pg. 5/1 (41-47), ISSN: 1064-0525.Ekert-H. Dr. H. Ekert, Department Haematology-Oncology, Royal Children's Hospital, Parkville, Vic, 3052, Australia Massive mediastinal Hodgkin's disease in childhood: Results of treatment from four Australian oncology centres 1972-1993. Cancer Research Therapy and Control {CANCER-RES-THER-CONTROL}, 1996, Vol/Iss/Pg. 5/1 (41-47), ISSN: 1064-0525.

Active substance: PROCARBAZINE

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Document reference: 34706

Study title: Ekert-H. Treatment of childhood Hodgkin's disease with chemotherapy alone. Experiences from the Royal Children's Hospital, Melbourne. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 241-6, ISSN: 0927-3042. Ekert-H. Treatment of childhood Hodgkin's disease with chemotherapy alone. Experiences from the Royal Children's Hospital, Melbourne. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 241-6, ISSN: 0927-3042.

Active substance: PROCARBAZINE

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Document reference: 34707

Study title: Ekert-H. Treatment of childhood Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Mar 1991, vol. 9, no. 3, p. 528-9, ISSN: 0732-183X.Ekert-H. Treatment of childhood Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Mar 1991, vol. 9, no. 3, p. 528-9, ISSN: 0732-183X.

Active substance: PROCARBAZINE

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Document reference: 34708

Study title: A randomised, parallel, double-blind phase III comparison between iodixanol, 270 mg I/ml and 320 mg I/ml and iohexol (Omnipaque) 300 mg I/ml Trial No. DXV039 (date Dec 1995)

Active substance: IODIXANOL

Study summary document link (including results): DXV039 Redacted.pdf

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Document reference: 48206

Study title: A randomised, parallel, double-blind phase III comparison between iodixanol, 270 mg I/ml and 320 mg I/ml and iohexol (Omnipaque) 300 mg I/ml Trial No. DXV038 (date Mar 1996)

Active substance: IODIXANOL

Study summary document link (including results): DXV038 Redacted.pdf

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Document reference: 48207

Study title: Acad Radiol. 1996 Sep;3 Suppl 3:S524-7. Comparison of iodixanol with iohexol in excretory urography. Siegle RL, Gavant ML. Acad Radiol. 1996 Sep;3 Suppl 3:S524-7. Comparison of iodixanol with iohexol in excretory urography. Siegle RL, Gavant ML.

Active substance: IODIXANOL

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Document reference: 30348

Study title: AJR Am J Roentgenol. 2002 Aug;179(2):437-44. Multidetector CT: detection of active hemorrhage in patients with blunt abdominal trauma. Willmann JK, Roos JE, Platz A, Pfammatter T, Hilfiker PR, Marincek B, Weishaupt D. AJR Am J Roentgenol. 2002 Aug;179(2):437-44. Multidetector CT: detection of active hemorrhage in patients with blunt abdominal trauma. Willmann JK, Roos JE, Platz A, Pfammatter T, Hilfiker PR, Marincek B, Weishaupt D.

Active substance: IODIXANOL

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Document reference: 30351

Study title: An open phase II trial with iodixanol 320 mg I/ml and a double-blind, parallel, randomised phase III trial with iodixanol 320 mg I/ml compared to iohexol (Omnipaque) 350 mg I/ml Trial No. DXV036 (date Mar 1996)

Active substance: IODIXANOL

Study summary document link (including results): DXV036 Redacted.pdf

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Document reference: 48209

Study title: An open phase II trial with iodixanol 320 mg I/mL, and a randomised, parallel, double-blind phase III comparison between iodixanol (VISIPAQUE), 270 mg I/ml and 320 mg I/ml, and iohexol (Omnipaque) 300 mg I/ml Trial No. DXV041 (date Dec 1995)

Active substance: IODIXANOL

Study summary document link (including results): DXV041 Redacted.pdf

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Document reference: 48205

Study title: Clin Radiol. 1993 Oct;48(4):268-72. Iodixanol and ioxaglate in cardioangiography: a double-blind randomized phase III study. Andersen PE, Bolstad B, Berg KJ, Justesen P, Thayssen P, Kloster YF. Clin Radiol. 1993 Oct;48(4):268-72. Iodixanol and ioxaglate in cardioangiography: a double-blind randomized phase III study. Andersen PE, Bolstad B, Berg KJ, Justesen P, Thayssen P, Kloster YF.

Active substance: IODIXANOL

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Document reference: 30354

Study title: Complications with Outpatient Angiography and Interventional ProceduresYoung N 2002. Cardiovasc Intervent Radiol (2002) 25:123–126

Active substance: IODIXANOL

Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc

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Document reference: 48199

Study title: A single-blind trial to compare the efficacy, tolerability and safety of levocabastine nasal spray as compared to sodiumcromoglycate nasal spray in children aged 6 months to 5 years with perennial allergic rhinitis. Part I. Clinical Research Report Dated April 1998A single-blind trial to compare the efficacy, tolerability and safety of levocabastine nasal spray as compared to sodiumcromoglycate nasal spray in children aged 6 months to 5 years with perennial allergic rhinitis. Part I. Clinical Research Report Dated April 1998

Active substance: LEVOCABASTINE

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Document reference: 31116

Study title: A single-blind trial to compare the efficacy, tolerability and safety of levocabastine nasal spray as compared to sodiumcromoglycate nasal spray in children aged 6 months to 5 years with perennial allergic rhinitis. Part I. Clinical Research Report Dated April 1998A single-blind trial to compare the efficacy, tolerability and safety of levocabastine nasal spray as compared to sodiumcromoglycate nasal spray in children aged 6 months to 5 years with perennial allergic rhinitis. Part I. Clinical Research Report Dated April 1998

Active substance: LEVOCABASTINE

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Document reference: 31126

Study title: An efficacy and tolerance comparison of emedastine difumarate 0.05% and levocabastine hydrochloride 0.05% reducing chemosis and eyelid swelling in subjects with seasonal allergic conjunctivitis. Acta Ophthalmica Scandinavica 78, p.48-51,2000An efficacy and tolerance comparison of emedastine difumarate 0.05% and levocabastine hydrochloride 0.05% reducing chemosis and eyelid swelling in subjects with seasonal allergic conjunctivitis. Acta Ophthalmica Scandinavica 78, p.48-51,2000

Active substance: LEVOCABASTINE

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Document reference: 31136

Study title: Antihistaminikum als Nasenspray und Augentropfen in der allergologischen Praxis. Allergo Journal 7(5), p.275-277, 1998Antihistaminikum als Nasenspray und Augentropfen in der allergologischen Praxis. Allergo Journal 7(5), p.275-277, 1998

Active substance: LEVOCABASTINE

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Document reference: 31124

Study title: 56. Vazquez, Encarna-cion, Sem Med Mex 1963; 39: 179-181 56. Vazquez, Encarna-cion, Sem Med Mex 1963; 39: 179-181

Active substance: PYRVINIUM

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Document reference: 39585

Study title: 6. Baranski et al., Rev Inst Med trop 1971; 13: 422-427 6. Baranski et al., Rev Inst Med trop 1971; 13: 422-427

Active substance: PYRVINIUM

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Document reference: 39535

Study title: 7. Barrios, An Hosp Milit Centr 1960; 2: 9-12 7. Barrios, An Hosp Milit Centr 1960; 2: 9-12

Active substance: PYRVINIUM

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Document reference: 39536

Study title: 8. Beck et al., Am J Trop Med Hyg 1959; 8: 349-352 8. Beck et al., Am J Trop Med Hyg 1959; 8: 349-352

Active substance: PYRVINIUM

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Document reference: 39537

Study title: 9. Beck, J Am MEd Assoc 1964; 189: 511 9. Beck, J Am MEd Assoc 1964; 189: 511

Active substance: PYRVINIUM

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Document reference: 39538

Study title: Alexander et al., Tijdschr Geneeskd 1970; 26: 333-335 Alexander et al., Tijdschr Geneeskd 1970; 26: 333-335

Active substance: PYRVINIUM

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Document reference: 39532

Study title: A 3-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase IIIb Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL¿) Immediate-release Tablets in Daily Doses of 400 mg and 600 mg Compared with Placebo in the Treatment of Children and Adolescents with Bipolar I Mania

Active substance: QUETIAPINE

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Document reference: 45051

Study title: A Pilot Trial of Quetiapine (SEROQUEL¿) in Adolescents with the Spectrum of Psychotic Disorders (5077US/0018) DRAFT Clinical Study Report Synopsis

Active substance: QUETIAPINE

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Document reference: 45054

Study title: A Study to Characterize the Steady-State Pharmacokinetics, Safety and Tolerability of Quetiapine Fumarate (SEROQUEL¿) in Children and Adolescents with Selected Psychotic Disorders

Active substance: QUETIAPINE

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Document reference: 45055

Study title: Seroquel: "A NON-COMPARATIVE, OPEN-LABEL STUDY TO DEMONSTRATE THE EFFICACY AND TOLERABILITY OF QUETIAPINE IN ADOLESCENT PATIENTS WITH AN ACUTE SCHIZOPHRENIC EPISODE".

Active substance: QUETIAPINE

Study summary document link (including results): D1441C09025 Study Synopsis.pdf

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Document reference: 45052

Study title: Tolerability and Pharmacokinetics of Quetiapine (SEROQUEL¿) in Adolescents with Selected Psychotic Disorders

Active substance: QUETIAPINE

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Document reference: 45053

Study title: A STUDY OF PHARMACOKINETICS OF QUINAPRIL IN PEDIATRIC PATIENTS

Active substance: QUINAPRIL

Study summary document link (including results): 0906-000-434 EMEA Pediatrics Web Synopsis.pdf

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Document reference: 45056

Study title: AN 8-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE SAFETY AND EFFICACY OF QUINAPRIL IN PEDIATRIC PATIENTS WITH HYPERTENSION

Active substance: QUINAPRIL

Study summary document link (including results): 0906-427 EMEA Pediatrics Web Synopsis.pdf

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Document reference: 45057

Study title: Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68)Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68)

Active substance: QUININE

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Document reference: 45059

Study title: 54. Suzuki, Yamauchi, Jpn J Parasitol 1961; 10: 298-301 54. Suzuki, Yamauchi, Jpn J Parasitol 1961; 10: 298-301

Active substance: PYRVINIUM

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Document reference: 39583

Study title: 55. Turner, Johnson, J Pediatr 1962; 60: 243-251 55. Turner, Johnson, J Pediatr 1962; 60: 243-251

Active substance: PYRVINIUM

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Document reference: 39584

Study title:

Active substance: PSEUDOEPHEDRINE/ PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 35167

Study title:

Active substance: PSEUDOEPHEDRINE/ PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 35168

Study title:

Active substance: PSEUDOEPHEDRINE/ PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 35169

Study title: 49. Aquilonius SM, Hartvig P. Clinical pharmacokinetics of cholinesterase inhibitors. Clin Pharmacokinet 1986;11(3):236-49.49. Aquilonius SM, Hartvig P. Clinical pharmacokinetics of cholinesterase inhibitors. Clin Pharmacokinet 1986;11(3):236-49.

Active substance: PSEUDOEPHEDRINE/ PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 35141

Study title: 50. Lindenschmidt Th, Aleksic D. Der paralytische Ileus in der Chirurgie. Internistische Praxis 1970;10(3):447-58.50. Lindenschmidt Th, Aleksic D. Der paralytische Ileus in der Chirurgie. Internistische Praxis 1970;10(3):447-58.

Active substance: PSEUDOEPHEDRINE/ PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 35142

Study title: Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline (GSK) Biologicals’ RIT’s rec-DNA hepatitis B vaccine (10 mg) injected with or without hepatitis B immunoglobulin (HBIg) in newborns of HBeAg+ mothers.

Active substance: r-DNA hepatitis B surface antigen (HBsAg)

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Document reference: 47767

Study title: Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline (GSK) Biologicals’ RIT’s rec-DNA hepatitis B vaccine (10 ıg) injected with orwithout hepatitis B immunoglobulin (HBIg) in newborns of HBeAg+ mothers.

Active substance: r-DNA hepatitis B surface antigen (HBsAg)

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Document reference: 47768

Study title: Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline (GSK) Biologicals rec-DNA hepatitis B vaccine (10 mg) injected with or without hepatitis B immunoglobulin (HBIg) in newborns of HBeAg+ mothers.

Active substance: r-DNA hepatitis B surface antigen (HBsAg)

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Document reference: 47754

Study title: Comparative study of the immunogenicity and safety of two doses of Engerix-B administered to healthy infants at 2, 4 and 6 months of age.

Active substance: r-DNA hepatitis B surface antigen (HBsAg)

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Document reference: 47763

Study title: Comparative study of the immunogenicity and safety of two doses of Engerix-B in healthy adolescents.

Active substance: r-DNA hepatitis B surface antigen (HBsAg)

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Document reference: 47762

Study title:

Active substance: PSEUDOEPHEDRINE/ PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 35166

Study title: Comparative study of the immunogenicity and safety of two dosing schedules in neonates.

Active substance: r-DNA hepatitis B surface antigen (HBsAg)

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Document reference: 47755

Study title: Immunogenicity and protective efficacy of Smith Kline -RIT's rec-DNA hepatitis b vaccine (10mcg) in newborns of HBsAg positive or negative mothers.

Active substance: r-DNA hepatitis B surface antigen (HBsAg)

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Document reference: 47766

Study title: Immunogenicity and protective efficacy of Smith Kline RIT's rec-DNA Hepatitis B vaccine in newborns of HbsAg positive or negative mothers.

Active substance: r-DNA hepatitis B surface antigen (HBsAg)

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Document reference: 47757

Study title: Immunogenicity and protective efficacy of Smith Kline RIT's rec-DNA Hepatitis B vaccine in newborns of HbsAg positive or negative mothers.

Active substance: r-DNA hepatitis B surface antigen (HBsAg)

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Document reference: 47758

Study title: Immunogenicity and protective efficacy of Smith Kline RIT's rec-DNA Hepatitis B vaccine in newborns of HbsAg positive or negative mothers.

Active substance: r-DNA hepatitis B surface antigen (HBsAg)

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Document reference: 47759

Study title: Immunogenicity and protective efficacy of Smith Kline RIT's rec-DNA Hepatitis B vaccine in newborns of HbsAg positive or negative mothers.

Active substance: r-DNA hepatitis B surface antigen (HBsAg)

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Document reference: 47760

Study title: Immunogenicity and protective efficacy of Smith Kline RIT's rec-DNA Hepatitis B vaccine in newborns of HbsAg positive or negative mothers.

Active substance: r-DNA hepatitis B surface antigen (HBsAg)

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Document reference: 47761

Study title: Open, randomized study to evaluate the immunogenicity of Engerix®-B when administered according to a vaccination schedule of 0, 1 and 12 months to healthy adolescents at two different doses (10 µg vs 20 µg).

Active substance: r-DNA hepatitis B surface antigen (HBsAg)

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Document reference: 47753

Study title: Risk of peripartal transmission of hepatitis B in children born to Hepatitis B positive mothers.

Active substance: r-DNA hepatitis B surface antigen (HBsAg)

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Document reference: 47765

Study title: Ettinger-L-J, Sinniah-D, Siegel-S-E, Fishman-L-S, Segall-H-D, Soni-D, Bennetts-G-A, Schultz-D-H, Raphael-D. Combination chemotherapy with cyclophosphamide, vincristine, procarbazine, and prednisone (COPP) in children with brain tumors. Journal of neuro-oncology, {J-Neurooncol}, 1985, vol. 3, no. 3, p. 263-9, ISSN: 0167-594X.Ettinger-L-J, Sinniah-D, Siegel-S-E, Fishman-L-S, Segall-H-D, Soni-D, Bennetts-G-A, Schultz-D-H, Raphael-D. Combination chemotherapy with cyclophosphamide, vincristine, procarbazine, and prednisone (COPP) in children with brain tumors. Journal of neuro-oncology, {J-Neurooncol}, 1985, vol. 3, no. 3, p. 263-9, ISSN: 0167-594X.

Active substance: PROCARBAZINE

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Document reference: 34709

Study title: Pakisch-B, Urban-C, Slavc-I, Poier-E, Stucklschweiger-G, Oberbauer-R, Mokry-M, Poschauko-J, Hammer-J, Leitner-H, Hackl-A. Abteilung fur Strahlentherapie, Radiologische Universitatsklinik, Augenbruggerplatz 9, A-8036 Graz, Austria. Hyperfractionated radiotherapy and polychemotherapy in brain stem tumors in children. Child's Nervous System {CHILD-S-NERV-SYST}, 1992, Vol/Iss/Pg. 8/4 (215-218), ISSN: 0256-7040.Pakisch-B, Urban-C, Slavc-I, Poier-E, Stucklschweiger-G, Oberbauer-R, Mokry-M, Poschauko-J, Hammer-J, Leitner-H, Hackl-A. Abteilung fur Strahlentherapie, Radiologische Universitatsklinik, Augenbruggerplatz 9, A-8036 Graz, Austria. Hyperfractionated radiotherapy and polychemotherapy in brain stem tumors in children. Child's Nervous System {CHILD-S-NERV-SYST}, ...

Active substance: PROCARBAZINE

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Document reference: 34801

Study title: Paolucci-G, Vecchi-V, Rosito-P, Paolucci-P, Burnelli-R, Pession-A, Mancini-A-F, Vivarelli-F. Clinica Pediatrica III, Universita degli Studi, Via Massaren11, 40138 Bologna, Italy. New perspectives in pediatric oncology. Rivista Italiana di Pediatria {RIV-ITAL-PEDIATR}, 1991, Vol/Iss/Pg. 17/4 (475-487), ISSN: 0392-5161.Paolucci-G, Vecchi-V, Rosito-P, Paolucci-P, Burnelli-R, Pession-A, Mancini-A-F, Vivarelli-F. Clinica Pediatrica III, Universita degli Studi, Via Massaren11, 40138 Bologna, Italy. New perspectives in pediatric oncology. Rivista Italiana di Pediatria {RIV-ITAL-PEDIATR}, 1991, Vol/Iss/Pg. 17/4 (475-487), ISSN: 0392-5161.

Active substance: PROCARBAZINE

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Document reference: 34802

Study title: Papadakis-V, Vlachopapadopoulou-E, Van-Syckle-K, Ganshaw-L, Kalmanti- M, Tan-C, Sklar-C. Department of Pediatrics, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. Gonadal function in young patients successfully treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, May 1999, vol. 32, no. 5, p. 366-72, ISSN: 0098-1532.Papadakis-V, Vlachopapadopoulou-E, Van-Syckle-K, Ganshaw-L, Kalmanti- M, Tan-C, Sklar-C. Department of Pediatrics, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. Gonadal function in young patients successfully treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, May 1999, vol. 32, no. 5, p. 366-72, ISSN: 0098-1532.

Active substance: PROCARBAZINE

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Document reference: 34803

Study title: Pendergrass-T-W, Milstein-J-M, Geyer-J-R, Mulne-A-F, Kosnik-E-J, Morris-J-D, Heideman-R-L, Ruymann-F-B, Stuntz-J-T, Bleyer-W-A. Eight drugs in one day chemotherapy for brain tumors: experience in 107 children and rationale for preradiation chemotherapy. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Aug 1987, vol. 5, no. 8, p. 1221-31, ISSN: 0732-183X.Pendergrass-T-W, Milstein-J-M, Geyer-J-R, Mulne-A-F, Kosnik-E-J, Morris-J-D, Heideman-R-L, Ruymann-F-B, Stuntz-J-T, Bleyer-W-A. Eight drugs in one day chemotherapy for brain tumors: experience in 107 children and rationale for preradiation chemotherapy. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J...

Active substance: PROCARBAZINE

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Document reference: 34804

Study title: Azelastine eye drops in the treatment of seasonal allergic conjunctivitis or rhinoconjunctivitis in young children. Current Medical Research and Opinion 14(3), p. 161-170,1998Azelastine eye drops in the treatment of seasonal allergic conjunctivitis or rhinoconjunctivitis in young children. Current Medical Research and Opinion 14(3), p. 161-170,1998

Active substance: LEVOCABASTINE

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Document reference: 31134

Study title: Clinical evaluation of R50547 eye drops on allergic conjunctivitis and vernal conjunctivitis. A sungle masked comparative study with Sodium Cromoglicate eye drops

Active substance: LEVOCABASTINE

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Document reference: 31066

Study title: Clinical laboratory data related to the safety of levocabastine eye drops and nasal spray. An evaluation based on 27 studies in 655 subjects (6-81 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD45257_Interventional_Levocabastine.xls

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Document reference: 31071

Study title: Comparison of levocabastine a new selective H1-receptor antagonist and disodium cromoglycate in a nasal provocation test with allergen (11-44 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62501_Interventional_Levocabastine.xls

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Document reference: 31076

Study title: Comparison of the effects of fluticasone propionate, aqueous nasal spray and levocabastine on inflammatory cells in nasal lavage and clinical activity during the pollen season in seasonal rhinitis. Clinical and Experimental Allergy 29, p. 1367-1 377, 1999Comparison of the effects of fluticasone propionate, aqueous nasal spray and levocabastine on inflammatory cells in nasal lavage and clinical activity during the pollen season in seasonal rhinitis. Clinical and Experimental Allergy 29, p. 1367-1 377, 1999

Active substance: LEVOCABASTINE

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Document reference: 31118

Study title: Sackmann-Muriel-F, Zubizarreta-P, Gallo-G, Scopinaro-M, Alderete-D, Alfaro-E, Casak-S, Chantada-G, Felice-M-S, Quinteros-R. Hematology Department, Hospital de Pediatria Prof. Dr. Juan P Garrahan, Buenos Aires, Argentina. Hodgkin disease in children: results of a prospective randomized trial in a single institution in Argentina. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Dec 1997, vol. 29, no. 6, p. 544-52, ISSN: 0098-1532.Sackmann-Muriel-F, Zubizarreta-P, Gallo-G, Scopinaro-M, Alderete-D, Alfaro-E, Casak-S, Chantada-G, Felice-M-S, Quinteros-R. Hematology Department, Hospital de Pediatria Prof. Dr. Juan P Garrahan, Buenos Aires, Argentina. Hodgkin disease in children: results of a prospective randomized trial in a single institution in Argentina....

Active substance: PROCARBAZINE

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Document reference: 34820

Study title: Sackmann-Muriel-F, Diez-B, Schvartzman-E, et-al. Oncology Department, Hospital de Ninos, 1425 Buenos Aires, Argentina. Comparison of two consecutive trials for treatment of childhood non-Hodgkin's lymphoma. Cancer {CANCER}, 1984, Vol/Iss/Pg. 54/12 (2863-2868).Sackmann-Muriel-F, Diez-B, Schvartzman-E, et-al. Oncology Department, Hospital de Ninos, 1425 Buenos Aires, Argentina. Comparison of two consecutive trials for treatment of childhood non-Hodgkin's lymphoma. Cancer {CANCER}, 1984, Vol/Iss/Pg. 54/12 (2863-2868).

Active substance: PROCARBAZINE

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Document reference: 34821

Study title: Sackmann-Muriel-F, Maschio-M, Santarelli-M-T, Pavlovsky-S. Results of therapy for Hodgkin's disease in childhood. The Argentine Group for Treatment of Acute Leukemia. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 271-5, ISSN: 0927-3042.Sackmann-Muriel-F, Maschio-M, Santarelli-M-T, Pavlovsky-S. Results of therapy for Hodgkin's disease in childhood. The Argentine Group for Treatment of Acute Leukemia. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 271-5, ISSN: 0927-3042.

Active substance: PROCARBAZINE

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Document reference: 34822

Study title: Sackmann-Muriel-F. Unid. Hematol., Hosp. Ninos, Buenos Aires, Argentina. Recent advances in treatment of children with non-Hodgkin lymphoma. Revista del Hospital de Ninos {REV-HOSP-NINOS}, 1978, Vol/Iss/Pg. 20 /80 (156-161).Sackmann-Muriel-F. Unid. Hematol., Hosp. Ninos, Buenos Aires, Argentina. Recent advances in treatment of children with non-Hodgkin lymphoma. Revista del Hospital de Ninos {REV-HOSP-NINOS}, 1978, Vol/Iss/Pg. 20 /80 (156-161).

Active substance: PROCARBAZINE

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Document reference: 34823

Study title: Green-D-M, Brecher-M-L, Lindsay-A-N, et-al. Dept. Ped., Roswell Park Mem. Inst., Buffalo, N.Y. 14263, United States. Gonadal function in pediatric patients following treatment for Hodgkin disease. Medical and Pediatric Oncology {MED-PEDIATR-ONCOL}, 1981, Vol/Iss/Pg.9/3 (235-244).Green-D-M, Brecher-M-L, Lindsay-A-N, et-al. Dept. Ped., Roswell Park Mem. Inst., Buffalo, N.Y. 14263, United States. Gonadal function in pediatric patients following treatment for Hodgkin disease. Medical and Pediatric Oncology {MED-PEDIATR-ONCOL}, 1981, Vol/Iss/Pg.9/3 (235-244).

Active substance: PROCARBAZINE

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Document reference: 34726

Study title: Grill-J, Le-Deley-M-C, Gambarelli-D, Raquin-M-A, Couanet-D, Pierre- Kahn-A, Habrand-J-L, Doz-F, Frappaz-D, Gentet-J-C, Edan-C, Chastagner-P, Kalifa-C. Department of Pediatrics, Institut Gustave Roussy, Villejuif, France. Postoperative chemotherapy without irradiation for ependymoma in children under 5 years of age: a multicenter trial of the French Society of Pediatric Oncology. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, 1 Mar 2001, vol. 19, no. 5, p. 1288-96, ISSN: 0732-183X.Grill-J, Le-Deley-M-C, Gambarelli-D, Raquin-M-A, Couanet-D, Pierre- Kahn-A, Habrand-J-L, Doz-F, Frappaz-D, Gentet-J-C, Edan-C, Chastagner-P, Kalifa-C. Department of Pediatrics, Institut Gustave Roussy, ...

Active substance: PROCARBAZINE

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Document reference: 34727

Study title: Gulati-S-C, Vega-R, Gee-T, et-al. Department of Medicine and Pediatrics, Memorial Sloan-Kettering Cancer Center, Cornell University Medical College, New York, NY 10021, United States. Growth and development of children born to patients after cancer therapy. Cancer Investigation {CANCER-INVEST}, 1986, Vol/Iss/Pg. 4/3 (197-205).Gulati-S-C, Vega-R, Gee-T, et-al. Department of Medicine and Pediatrics, Memorial Sloan-Kettering Cancer Center, Cornell University Medical College, New York, NY 10021, United States. Growth and development of children born to patients after cancer therapy. Cancer Investigation {CANCER-INVEST}, 1986, Vol/Iss/Pg. 4/3 (197-205).

Active substance: PROCARBAZINE

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Document reference: 34728

Study title: Gutjahr-P. Universitats-Kinderklinik, 6500 Mainz 1, Germany. Second neoplasms following tumor and leukaemia therapy in childhood: Report on 64 cases. Deutsche Medizinische Wochenschrift {DTSCH-MED-WOCHENSCHR}, 1985, Vol /Iss/Pg. 110/42 (1599-1606).Gutjahr-P. Universitats-Kinderklinik, 6500 Mainz 1, Germany. Second neoplasms following tumor and leukaemia therapy in childhood: Report on 64 cases. Deutsche Medizinische Wochenschrift {DTSCH-MED-WOCHENSCHR}, 1985, Vol /Iss/Pg. 110/42 (1599-1606).

Active substance: PROCARBAZINE

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Document reference: 34729

Study title: Haddad-S-F, Menezes-A-H, Bell-W-E, Godersky-J-C, Afifi-A-K, Bale-J-F. Division of Neurosurgery, Department of Surgery, The University of Iowa, Iowa City, IA 52242, United States. Brain tumors occurring before 1 year of age: A retrospective review of 22 cases in an 11-year period (1977-1987). Neurosurgery {NEUROSURGERY}, 1991, Vol/Iss/Pg. 29/1 (8-13), ISSN: 0148-396X.Haddad-S-F, Menezes-A-H, Bell-W-E, Godersky-J-C, Afifi-A-K, Bale-J-F. Division of Neurosurgery, Department of Surgery, The University of Iowa, Iowa City, IA 52242, United States. Brain tumors occurring before 1 year of age: A retrospective review of 22 cases in an 11-year period (1977-1987). Neurosurgery {NEUROSURGERY}, 1991, Vol/Iss/Pg. 29/1 (8-13), ISSN: 0148-396X.

Active substance: PROCARBAZINE

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Document reference: 34730

Study title: Haglund-U, Hayder-S, Zech-L. Dept. Med. Cell Genet., Med. Nobel Inst., Karolinska Inst., S-104 01 Stockholm, Sweden. Sister chromatid exchanges and chromosome aberrations in children after treatment for malignant lymphoma. Cancer Research {CANCER-RES}, 1980, Vol/Iss/Pg. 40/12 (4786-4790).Haglund-U, Hayder-S, Zech-L. Dept. Med. Cell Genet., Med. Nobel Inst., Karolinska Inst., S-104 01 Stockholm, Sweden. Sister chromatid exchanges and chromosome aberrations in children after treatment for malignant lymphoma. Cancer Research {CANCER-RES}, 1980, Vol/Iss/Pg. 40/12 (4786-4790).

Active substance: PROCARBAZINE

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Document reference: 34731

Study title: Borowitz SM, et all. Treatment of childhood constipation by primary care physicians: efficacy and predictors of outcome. Pediatrics. 2005 Apr;115(4):873-7.

Active substance: Rabarbar + senna

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Document reference: 40148

Study title: Spiller HA, et all. Skin breakdown and blisters from senna-containing laxatives in young children. Ann Pharmacother. 2003 May;37(5):636-9.

Active substance: Rabarbar + senna

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Document reference: 40149

Study title: Safety and Efficacy of Rabeprazole in the Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Subjects

Active substance: RABEPRAZOLE

Study summary document link (including results): Rabeprazole-E3810-A001-202 (synopsis).pdf

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Document reference: 35258

Study title: Single and Multiple Dose Pharmacokinetics and Safety Study of Rabeprazole Sodium in 12 to 16 Year Old Subjects

Active substance: RABEPRAZOLE

Study summary document link (including results): Rabeprazole-E3810-A001-119 CSR synopsis.pdf

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Document reference: 35257

Study title: A phase III, randomised, controlled, multicenter study in adults, investigating the antibody response to postexposure rabies vaccination combined with Human Rabies Immune Globuline (HRIG) between two types of tissue culture rabies vaccines, Purified vero cell rabies vaccine (PVRV) and Purified chick embryo cell rabies vaccine (PCECV)

Active substance: RABIES VACCINE FOR HUMAN USE PREPARED FROM CELL CULTURE (DIPLOID CELLS)

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Document reference: 48384

Study title: Jenkin-D, Doyle-J, Berry-M, Blanchette-V, Chan-H, Doherty-M, Freedman-M, Greenberg-M, Panzarella-T, Saunders-F, et al. Division of Hematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada. Hodgkin's disease in children: treatment with MOPP and low-dose, extended field irradiation without laparotomy. Late results and toxicity. Medical and pediatric oncology, {Med-Pediatr-Oncol}, 1990, vol. 18, no. 4, p. 265-72, ISSN: 0098-1532.Jenkin-D, Doyle-J, Berry-M, Blanchette-V, Chan-H, Doherty-M, Freedman-M, Greenberg-M, Panzarella-T, Saunders-F, et al. Division of Hematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada. Hodgkin's disease in children: treatment with MOPP and low-dose, extended field irradiation without la...

Active substance: PROCARBAZINE

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Document reference: 34748

Study title: Jenkin-D, Chan-H, Freedman-M, Greenberg-M, Gribbin-M, McClure-P, Saunders-F, Sonley-M. Hodgkin's disease in children: treatment results with MOPP and low-dose, extended-field irradiation. Cancer treatment reports, {Cancer-Treat-Rep}, Apr 1982, vol. 66, no. 4, p. 949-59, ISSN: 0361-5960.Jenkin-D, Chan-H, Freedman-M, Greenberg-M, Gribbin-M, McClure-P, Saunders-F, Sonley-M. Hodgkin's disease in children: treatment results with MOPP and low-dose, extended-field irradiation. Cancer treatment reports, {Cancer-Treat-Rep}, Apr 1982, vol. 66, no. 4, p. 949-59, ISSN: 0361-5960.

Active substance: PROCARBAZINE

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Document reference: 34749

Study title: Jenkin-D, Doyle-J. Pediatric Hodgkin's disease. Later results and toxicity--the Toronto experience. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 247-56, ISSN: 0927-3042.Jenkin-D, Doyle-J. Pediatric Hodgkin's disease. Later results and toxicity--the Toronto experience. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 247-56, ISSN: 0927-3042.

Active substance: PROCARBAZINE

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Document reference: 34750

Study title: Jenkin-D, Freedman-M, McClure-P, Peters-V, Saunders-F, Sonley-M. Hodgkin's disease in children: treatment with low dose radiation and MOPP without staging laparotomy: a preliminary report. Cancer, {Cancer}, Jul 1979, vol. 44, no. 1, p. 80-6, ISSN: 0008-543X.Jenkin-D, Freedman-M, McClure-P, Peters-V, Saunders-F, Sonley-M. Hodgkin's disease in children: treatment with low dose radiation and MOPP without staging laparotomy: a preliminary report. Cancer, {Cancer}, Jul 1979, vol. 44, no. 1, p. 80-6, ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34751

Study title: Perrone-L, Sinisi-A-A, Di-Tullio-M-T, Casale-F, Indolfi-P, Manzo-T, Coppola-G, Bellastella-A, Faggiano-M. Department of Pediatrics, University of Naples, Naples, Italy. Endocrine function in subjects treated for childhood Hodgkin's disease. Journal of Pediatric Endocrinology {J-PEDIATR-ENDOCRINOL}, 1989, Vol /Iss/Pg. 3/3 (175-179), ISSN: 0334-018X.Perrone-L, Sinisi-A-A, Di-Tullio-M-T, Casale-F, Indolfi-P, Manzo-T, Coppola-G, Bellastella-A, Faggiano-M. Department of Pediatrics, University of Naples, Naples, Italy. Endocrine function in subjects treated for childhood Hodgkin's disease. Journal of Pediatric Endocrinology {J-PEDIATR-ENDOCRINOL}, 1989, Vol /Iss/Pg. 3/3 (175-179), ISSN: 0334-018X.

Active substance: PROCARBAZINE

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Document reference: 34805

Study title: Khalil S_1996Khalil S_1996

Active substance: PROMETHAZINE

Study summary document link (including results): Bayer Pharma_Promethazine_Khalil S_1996_publication.pdf

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Document reference: 35002

Study title: Koenig HJ_1990Koenig HJ_1990

Active substance: PROMETHAZINE

Study summary document link (including results): Bayer Pharma_Promethazine_Koenig HJ_1990_publication.pdf

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Document reference: 35004

Study title: Mayzner ZE_1996Mayzner ZE_1996

Active substance: PROMETHAZINE

Study summary document link (including results): Bayer Pharma_Promethazine_Mayzner ZE_1996_publication.pdf

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Document reference: 35007

Study title: McKee K_1991McKee K_1991

Active substance: PROMETHAZINE

Study summary document link (including results): Bayer Pharma_Promethazine_McKee K_1991_publication.pdf

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Document reference: 35008

Study title: Nad R_1975Nad R_1975

Active substance: PROMETHAZINE

Study summary document link (including results): Bayer Pharma_Promethazine_Nad R_1975_publication.pdf

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Document reference: 35009

Study title: New modalities in postoperative nausea and vomiting.

Active substance: PROMETHAZINE

Study summary document link (including results): New modalities in postoperative nausea and vomiting.pdf

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Document reference: 35028

Study title: Pascarella MA_1983Pascarella MA_1983

Active substance: PROMETHAZINE

Study summary document link (including results): Bayer Pharma_Promethazine_Pascarella MA_1983_publication.pdf

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Document reference: 35012

Study title: Paul AK_1984Paul AK_1984

Active substance: PROMETHAZINE

Study summary document link (including results): Bayer Pharma_Promethazine_Paul AK_1984_publication.pdf

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Document reference: 35013

Study title: Pre-anaesthetic medication in paediatric day-care surgery.

Active substance: PROMETHAZINE

Study summary document link (including results): Pre-anaesthetic medication in paediatric day-care surgery.pdf

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Document reference: 35040

Study title: Promethazine in general anaesthesia - Loyn W.G.G.- (Brit. J. Anaesth. 1956, 28, 126.) - Publication in PHENERGAN therapeutic summary 6th edition May & Baker Ltd.1976 -

Active substance: PROMETHAZINE

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Document reference: 35041

Study title: Publication 8 in PHENERGAN 25mg tablet, 0.1% syrup, 2,5% sol for injection. Clinical documentation. June 1988. Anaesthesia in children. -Anglade G.- (Maroc médical (1970), 50, 545-561.)

Active substance: PROMETHAZINE

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Document reference: 35043

Study title: Geist ET_1982Geist ET_1982

Active substance: PROMETHAZINE

Study summary document link (including results): Bayer Pharma_Promethazine_Geist ET_1982_publication.pdf

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Document reference: 35001

Study title: Publication in PROMETHAZINE Safety and efficacy review of medicines following UK authorities review of psychotropic and centrally acting drugs. May&Baker Ltd. Company April 1980.

Active substance: PROMETHAZINE

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Document reference: 35045

Study title: Compassionate use of SR29142 for prevention or treatment of hyperuricemia at multiple centers in Europe, Australasia, and Asia (LTS3256)

Active substance: rasburicase

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Document reference: 47280

Study title: Compassionate use of SR29142 for prevention or treatment of hyperuricemia at multiple centers in the United States and Canada (LTS3257)

Active substance: rasburicase

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Document reference: 47281

Study title: Evaluation of single agent rasburicase in treatment/ prevention of hyperuricemia associated with tumor lysis syndrome in adult and paediatric patients with lymphoma/ leukemia/solid tumor or malignancies at their first relapse or refractory disease

Active substance: rasburicase

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Document reference: 41509

Study title: Non-comparative open label

Active substance: rasburicase

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Document reference: 47284

Study title: Open label, single arm, multicentric Phase IV

Active substance: rasburicase

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Document reference: 47283

Study title: Open-label, multi-center study of SR29142 as uricolytic therapy/prophylaxis for hyperuricemia in pediatric patients with newly diagnosed hematological malignacies at high risk for Tumor Lysis Syndrome

Active substance: rasburicase

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Document reference: 41508

Study title: Phase IV study of Rasburicase for treatment of hyperuricemia in patients with tumoral lysis syndrome (Code: L_9436)

Active substance: rasburicase

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Document reference: 47282

Study title: Phase IV, compassionate use program of rasburicase for treatment of hyperuricemia in children and adolescent patients with tumor lysis syndrome

Active substance: rasburicase

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Document reference: 47278

Study title: Single arm, open label Phase IV

Active substance: rasburicase

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Document reference: 47285

Study title: Lo Iacono F, Agnello D, Malizia R, Balsamo M. Aggiornamento Pediatrico. 1982; 33(1):85-90. Methisoprinol in the treatment of certain diseases of the upper respiratory tract in children .Lo Iacono F, Agnello D, Malizia R, Balsamo M. Aggiornamento Pediatrico. 1982; 33(1):85-90. Methisoprinol in the treatment of certain diseases of the upper respiratory tract in children .

Active substance: INOSINE

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Document reference: 30142

Study title: Lokaj J, Wiedermannov, Litzman J. Presented at the Czechoslovakian Symposium on Isoprinosine®; October, 1989; Prague. (Abstract only). Importance of immunological laboratory examination while indicating and controlling treatment with Isoprinosine®/Modimunal®Lokaj J, Wiedermannov, Litzman J. Presented at the Czechoslovakian Symposium on Isoprinosine®; October, 1989; Prague. (Abstract only). Importance of immunological laboratory examination while indicating and controlling treatment with Isoprinosine®/Modimunal®

Active substance: INOSINE

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Document reference: 30143

Study title: Lowy M, Ledoux-Corbusier M, Achten G, Wybran J. . J Am Acad Dermatol. Jan 1985;12(1 Pt 1):78-84. Clinical and immunologic response to Isoprinosine in alopecia areata and alopecia universalis: association with autoantibodiesLowy M, Ledoux-Corbusier M, Achten G, Wybran J. . J Am Acad Dermatol. Jan 1985;12(1 Pt 1):78-84. Clinical and immunologic response to Isoprinosine in alopecia areata and alopecia universalis: association with autoantibodies

Active substance: INOSINE

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Document reference: 30144

Study title: An open label prospective study to observe the postmarketing safety of Euvax B Inj.

Active substance: Recombinant DNA Hepatitis B Surface Antigen (HBsAg)

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Document reference: 41089

Study title: A randomized double-blind study evaluating the safety, tolerability and efficacy of SMOF 20% compared to Intralipid in premature infants

Active substance: REFINED SOYBEAN OIL; MEDIUM CHAINED TRIGLYCERIDES; REFINED OLIVE OIL; FISH OIL

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Document reference: 40152

Study title: A randomized double-blind study of safety and efficacy of SMOF 20% vs. Intralipid 20% in infants and children requiring long-term parenteral nutrition

Active substance: REFINED SOYBEAN OIL; MEDIUM CHAINED TRIGLYCERIDES; REFINED OLIVE OIL; FISH OIL

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Document reference: 40151

Study title:

Active substance: REMIFENTANIL

Study summary document link (including results): Study PED-USAA3119 Remifentanil Hydrochloride.xls

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Document reference: 47737

Study title: Schaison-G-S. Service d'Hematologie Pediatrique, Hopital Saint Louis, 1, Avenue Claude Vellefaux,75475 Parix Cedex 10, France. Current treatment of Hodgkin's disease in children. Pathologie Biologie {PATHOL-BIOL}, 1994, Vol/Iss/Pg. 42/10 (1026-1027), ISSN: 0369-8114.Schaison-G-S. Service d'Hematologie Pediatrique, Hopital Saint Louis, 1, Avenue Claude Vellefaux,75475 Parix Cedex 10, France. Current treatment of Hodgkin's disease in children. Pathologie Biologie {PATHOL-BIOL}, 1994, Vol/Iss/Pg. 42/10 (1026-1027), ISSN: 0369-8114.

Active substance: PROCARBAZINE

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Document reference: 34824

Study title: Schapira-D-V, Chudley-A-E. Successful pregnancy following continuous treatment with combination chemotherapy before conception and throughout pregnancy. Cancer, {Cancer}, 1 Sep 1984, vol. 54, no. 5, p. 800-3, ISSN: 0008-543X.Schapira-D-V, Chudley-A-E. Successful pregnancy following continuous treatment with combination chemotherapy before conception and throughout pregnancy. Cancer, {Cancer}, 1 Sep 1984, vol. 54, no. 5, p. 800-3, ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34825

Study title: Schellong-G, Braemswig-J, Ludwig-R, Gerein-V, Jobke-A, Juergens-H, Kabisch-H, Stollmann-B, Weinel-P, Gadner-H, et al. (Combined treatment strategy in over 200 children with Hodgkin's disease: graduated chemotherapy, involved field irradiation with low dosage and selective splenectomy. A report of the cooperative therapy study DAL-HD-82). Klinische Paediatrie, {Klin-Padiatr}, May-Jun 1986, vol. 198, no. 3, p. 137-46, ISSN: 0300-8630.Schellong-G, Braemswig-J, Ludwig-R, Gerein-V, Jobke-A, Juergens-H, Kabisch-H, Stollmann-B, Weinel-P, Gadner-H, et al. (Combined treatment strategy in over 200 children with Hodgkin's disease: graduated chemotherapy, involved field irradiation with low dosage and selective splenectomy. A report of the cooperative therapy study DAL-HD-82). Kl...

Active substance: PROCARBAZINE

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Document reference: 34826

Study title: Schellong-G, Bramswig-J-H, Hornig-Franz-I, Schwarze-E-W, Potter-R, Wannenmacher-M. Universitat Kinderklinik, Albert Schweitzer Str. 33, D-48149 Munster, Germany. Hodgkin's disease in children: Combined modality treatment for stages IA, IB, and IIA. Annals of Oncology {ANN-ONCOL}, 1994, Vol/Iss/Pg. 5/SUPPL. 2 (113-115), ISSN: 0923-7534.Schellong-G, Bramswig-J-H, Hornig-Franz-I, Schwarze-E-W, Potter-R, Wannenmacher-M. Universitat Kinderklinik, Albert Schweitzer Str. 33, D-48149 Munster, Germany. Hodgkin's disease in children: Combined modality treatment for stages IA, IB, and IIA. Annals of Oncology {ANN-ONCOL}, 1994, Vol/Iss/Pg. 5/SUPPL. 2 (113-115), ISSN: 0923-7534.

Active substance: PROCARBAZINE

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Document reference: 34827

Study title: Schellong-G, Potter-R, Bramswig-J, Wagner-W, Prott-F-J, Dorffel-W, Korholz-D, Mann-G, Rath-B, Reiter-A, Weissbach-G, Riepenhausen-M, Thiemann-M, Schwarze-E-W. Dr. G. Schellong, Univ.-Kinderklinik, Albert-Schweitzer-Strasse 33, D-48129 Munster, Germany e-mail: schellon@uni-muenster.de. High cure rates and reduced long-term toxicity in pediatric Hodgkin's disease: The German-Austrian multicenter trial DAL-HD-90. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1999, Vol/Iss/Pg. 17/12 (3736-3744), ISSN: 0732-183X.Schellong-G, Potter-R, Bramswig-J, Wagner-W, Prott-F-J, Dorffel-W, Korholz-D, Mann-G, Rath-B, Reiter-A, Weissbach-G, Riepenhausen-M, Thiemann-M, Schwarze-E-W. Dr. G. Schellong, Univ.-Kinderklinik, Albert-Schweitzer-Strasse 33, D-48129 Munster, Germany e-mail: schel...

Active substance: PROCARBAZINE

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Document reference: 34828

Study title: Kwiatkowski JL, Manno CS: Blood transfusion support in pediatric cardiovascular surgey. Transfusion Science 1999; 21: 63-72 Kwiatkowski JL, Manno CS: Blood transfusion support in pediatric cardiovascular surgey. Transfusion Science 1999; 21: 63-72

Active substance: PROTAMINE

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Document reference: 35087

Study title: Pouard P: Review of Efficacy Parameters. Ann Thorac Surg 1998; 65: S40-4 Pouard P: Review of Efficacy Parameters. Ann Thorac Surg 1998; 65: S40-4

Active substance: PROTAMINE

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Document reference: 35085

Study title: Donaubauer J et al. Re-assessment of growth hormone secretion in young adult patients with childhood-onset growth hormone deficiency. Clin Endocrinol. April 1, 2003, 456-63Donaubauer J et al. Re-assessment of growth hormone secretion in young adult patients with childhood-onset growth hormone deficiency. Clin Endocrinol. April 1, 2003, 456-63

Active substance: PYRIDOSTIGMINE

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Document reference: 35179

Study title: Eakman GD et al. The effects of testosterone and dihydrotestosterone on hypothalamic regulation of growth hormone secretion. J Clin Endocrinol Metab. 1996 Mar;81(3):1217-23Eakman GD et al. The effects of testosterone and dihydrotestosterone on hypothalamic regulation of growth hormone secretion. J Clin Endocrinol Metab. 1996 Mar;81(3):1217-23

Active substance: PYRIDOSTIGMINE

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Document reference: 35196

Study title: Eiermann B, Sommer N, Winne D, Schumm F, Maier U, Breyer-Pfaff U. Renal clearance of pyridostigmine in myasthenic patients and volunteers under the influence of ranitidine and pirenzepine. Xenobiotica. 1993 Nov;23(11):1263-75.Eiermann B, Sommer N, Winne D, Schumm F, Maier U, Breyer-Pfaff U. Renal clearance of pyridostigmine in myasthenic patients and volunteers under the influence of ranitidine and pirenzepine. Xenobiotica. 1993 Nov;23(11):1263-75.

Active substance: PYRIDOSTIGMINE

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Document reference: 35222

Study title: Fagan M, Khine H. Pediatric neurologic potpourri: Cases to remember. Clin Pediatr Emerg Med. September 1, 2003, 207-14Fagan M, Khine H. Pediatric neurologic potpourri: Cases to remember. Clin Pediatr Emerg Med. September 1, 2003, 207-14

Active substance: PYRIDOSTIGMINE

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Document reference: 35178

Study title: Ghigo E et al. Arginine but not pyridostigmine, a cholinesterase inhibitor, enhances the GHRH-induced GH rise in patients with anorexia nervosa. Biol Psychiatry. 1994 Nov 15;36(10):689-95Ghigo E et al. Arginine but not pyridostigmine, a cholinesterase inhibitor, enhances the GHRH-induced GH rise in patients with anorexia nervosa. Biol Psychiatry. 1994 Nov 15;36(10):689-95

Active substance: PYRIDOSTIGMINE

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Document reference: 35201

Study title: Ghigo E et al. Arginine potentiates the GHRH- but not the pyridostigmine-induced GH secretion in normal short children. Further evidence for a somatostatin suppressing effect of arginine. Clin Endocrinol (Oxf). 1990 Jun;32(6):763-7Ghigo E et al. Arginine potentiates the GHRH- but not the pyridostigmine-induced GH secretion in normal short children. Further evidence for a somatostatin suppressing effect of arginine. Clin Endocrinol (Oxf). 1990 Jun;32(6):763-7

Active substance: PYRIDOSTIGMINE

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Document reference: 35213

Study title: An open label, multicenter, international pilot study evaluating the efficacy and safety of Pegylated interferon alfa-2a in combination with ribavirin in pediatric and teenage patients with CHC virus infection (CHIPS) [100 children adolescents aged 6 – 18 years with CHC (all genotypes)]

Active substance: RIBAVIRIN

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Document reference: 35302

Study title: Pegylated Interferon with and without ribavirin for children with HCV (PEDS – C) [112 children and adolescents aged 5-18 years with CHC (all genotypes) that are able to swallow tablets]

Active substance: RIBAVIRIN

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Document reference: 35303

Study title: Donati F et al. Neostigmine, pyridostigmine and edrophonium as antagonists of deep pancuronium blockade. Can J Anaesth. 1987 Nov;34(6):589-93 Donati F et al. Neostigmine, pyridostigmine and edrophonium as antagonists of deep pancuronium blockade. Can J Anaesth. 1987 Nov;34(6):589-93

Active substance: PYRIDOSTIGMINE

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Document reference: 35218

Study title: EFFICACY AND SAFETY OF AN INTERMITTENT REGIMEN INCLUDING RIFABUTIN (AMSAMYCIN LM 427) IN THE TREATMENT OF OUT-PATIENTS WITH MYCOBACTERIAL PULMONARY INFECTIONS. FARMITALIA CARLO ERBA INTERNAL REPORT LM 427/713I, OCTOBER 1990

Active substance: RIFABUTIN

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Document reference: 35374

Study title: EFFICACY AND SAFETY OF RIFABUTIN (AMSAMYCIN LM 427) IN PATIENTS WITH NEWLY DIAGNOSED PULMONARY TUBERCULOSIS. FCE REPORT LM 427/714I NOVEMBER 1990 AGE RANGE 14-79 YEARS

Active substance: RIFABUTIN

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Document reference: 35369

Study title: EFFICACY AND SAFETY OF RIFABUTIN (AMSAMYCIN LM 427) IN PATIENTS WITH NEWLY DIAGNOSED PULMONARY TUBERCULOSIS. FCE REPORT LM 427/715I NOVEMBER 1990 AGE RANGE 15 -65 YEARSPuri H C et al. Severe hypertension in children with renal

Active substance: RIFABUTIN

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Document reference: 35370

Study title: Sedation for paediatric computed tomography

Active substance: PROMETHAZINE

Study summary document link (including results): Sedation for paediatric computed tomography.pdf

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Document reference: 35048

Study title: Sedation in children scanned with high-field magnetic resonance; the experience at The Hospital for Sick Children, Great Ormond Street.

Active substance: PROMETHAZINE

Study summary document link (including results): Sedation in children scanned with high-field magnetic resonance; the experience at The Hospital for Sick Children, Great Ormond Street.pdf

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Document reference: 35049

Study title: Early ribavirin aerosol treatment of respiratory syncytial virus infection in high-risk children.Early ribavirin aerosol treatment of respiratory syncytial virus infection in high-risk children.

Active substance: PYRITINOL

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Document reference: 35239

Study title: Early ribavirin treatment of respiratory syncytial viral infection in high-risk children.Early ribavirin treatment of respiratory syncytial viral infection in high-risk children.

Active substance: PYRITINOL

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Document reference: 35238

Study title: Effectiveness of ribavirin in otherwise well infants with respiratory syncytial virus-associated respiratory failure. Pediatric Critical Study Group. Effectiveness of ribavirin in otherwise well infants with respiratory syncytial virus-associated respiratory failure. Pediatric Critical Study Group.

Active substance: PYRITINOL

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Document reference: 35233

Study title: Efficacy and safety of aerosolized ribavirin in young children hospitalized with influenza: a double-blind, multicenter, placebo-controlled trial. Efficacy and safety of aerosolized ribavirin in young children hospitalized with influenza: a double-blind, multicenter, placebo-controlled trial.

Active substance: PYRITINOL

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Document reference: 35235

Study title: Romiti M_1980Romiti M_1980

Active substance: PROMETHAZINE

Study summary document link (including results): Bayer Pharma_Promethazine_Romiti M_1980_publication.pdf

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Document reference: 35014

Study title: Follow-up of children with respiratory syncytial virus bronchiolitis in 1986 and 1987: potential effect of ribavirin on long term pulmonary function. The Bronchiolitis Study Group.Follow-up of children with respiratory syncytial virus bronchiolitis in 1986 and 1987: potential effect of ribavirin on long term pulmonary function. The Bronchiolitis Study Group.

Active substance: PYRITINOL

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Document reference: 35232

Study title: Hanck A: Verhütung und Behandlung der postoperativen Darmatonie und anderer Formen der paralytischen Ileus mit Bepanthen Roche. Therapiewoche 1977; 27 (39): 6878, 6881-4,6887. Hanck A: Verhütung und Behandlung der postoperativen Darmatonie und anderer Formen der paralytischen Ileus mit Bepanthen Roche. Therapiewoche 1977; 27 (39): 6878, 6881-4,6887.

Active substance: PYRITINOL

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Document reference: 35229

Study title: Long term follow-up of children hospitalized with respiratory syncytial virus lower respiratory tract infection and randomly treated with ribavirin or placebo.Long term follow-up of children hospitalized with respiratory syncytial virus lower respiratory tract infection and randomly treated with ribavirin or placebo.

Active substance: PYRITINOL

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Document reference: 35230

Study title: Ribavirin effect on pulmonary function in young infants with respiratory syncytial virus bronchiolitis.Ribavirin effect on pulmonary function in young infants with respiratory syncytial virus bronchiolitis.

Active substance: PYRITINOL

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Document reference: 35236

Study title: Abdallah et al., Egypt Med Assoc 1965; 48: 396-398 Abdallah et al., Egypt Med Assoc 1965; 48: 396-398

Active substance: PYRVINIUM

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Document reference: 39530

Study title: Luna Solano JL, Silva Baeza JC.. Ed Medico [Mexico] April 1973;23(1):57- 58,61 Methisporinol in some common infectious viraliseasesLuna Solano JL, Silva Baeza JC.. Ed Medico [Mexico] April 1973;23(1):57- 58,61 Methisporinol in some common infectious viraliseases

Active substance: INOSINE

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Document reference: 30145

Study title: Malfroot A, Wybran J, Duchateau J, Zissus G. (1981). Pediatric Research. January-December,15:1180. Abstract 11. Successful treatment of a systemic CMV infection with IsoprinosineMalfroot A, Wybran J, Duchateau J, Zissus G. (1981). Pediatric Research. January-December,15:1180. Abstract 11. Successful treatment of a systemic CMV infection with Isoprinosine

Active substance: INOSINE

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Document reference: 30146

Study title: Mechanisms of severe immediate reactions to iodinated contrast material; Laroche D et al; Radiology; 1998 vol.209 p.183 190Mechanisms of severe immediate reactions to iodinated contrast material; Laroche D et al; Radiology; 1998 vol.209 p.183 190

Active substance: INOSINE

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Document reference: 30180

Study title: Mehta PD, Kulczycki J, Patrick BA, Sobczyk W, Wisniewski HM. J Neurol Sci. 1992 May;109(1):64-8. Effect of treatment on oligoclonal IgG bands and intrathecal IgG synthesis in sequential cerebrospinal fluid and serum from patients with subacute sclerosing panencephalitis.Mehta PD, Kulczycki J, Patrick BA, Sobczyk W, Wisniewski HM. J Neurol Sci. 1992 May;109(1):64-8. Effect of treatment on oligoclonal IgG bands and intrathecal IgG synthesis in sequential cerebrospinal fluid and serum from patients with subacute sclerosing panencephalitis.

Active substance: INOSINE

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Document reference: 30147

Study title: Minarro A, Linfante E, et alLa SemanaMedica {Argentina] Aug 91973;80(4379): 362-372 Results obtained using antiviral(NPl13) on diverse pediatric viral infections.Minarro A, Linfante E, et alLa SemanaMedica {Argentina] Aug 91973;80(4379): 362-372 Results obtained using antiviral(NPl13) on diverse pediatric viral infections.

Active substance: INOSINE

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Document reference: 30148

Study title: Moroni M, Lazzarin A, Galli M.. Presented at the 15th National Congress of the Italian Society of Clinical Allergology and Immunology. October 30-November 1, 1981; Rome, Italy; 73-84. Immunoterapia delle infezioni chroniche e recidivanti. Moroni M, Lazzarin A, Galli M.. Presented at the 15th National Congress of the Italian Society of Clinical Allergology and Immunology. October 30-November 1, 1981; Rome, Italy; 73-84. Immunoterapia delle infezioni chroniche e recidivanti.

Active substance: INOSINE

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Document reference: 30149

Study title: Moroni P, Baratta L, Baratta B. Chron Dermatologica 1980;11:3-8. Cytologic effects in herpes zoster.Moroni P, Baratta L, Baratta B. Chron Dermatologica 1980;11:3-8. Cytologic effects in herpes zoster.

Active substance: INOSINE

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Document reference: 30150

Study title: Muscianese V, Koverech A, Simoni R Chron Derm 1980;10(1):3-11. Il metisoprinolo nelle virosi cutanee.Muscianese V, Koverech A, Simoni R Chron Derm 1980;10(1):3-11. Il metisoprinolo nelle virosi cutanee.

Active substance: INOSINE

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Document reference: 30151

Study title: Nunan B, Tonelli E. Jomal de pediatria [Brazil] Nov-Dec 1972;37(11-12):325-328. Therapy of certain acute viral diseases with Isoprinosine Nunan B, Tonelli E. Jomal de pediatria [Brazil] Nov-Dec 1972;37(11-12):325-328. Therapy of certain acute viral diseases with Isoprinosine

Active substance: INOSINE

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Document reference: 30152

Study title: Ochocka M, Chmielewska D, Matysiak M. Folia Haematol Int Mag Klin Morphol Blutforsch. 1984;111(3):343-9 Isoprinosine in the treatment of herpes virus infections in children with leukaemia and malignant lymphoma.Ochocka M, Chmielewska D, Matysiak M. Folia Haematol Int Mag Klin Morphol Blutforsch. 1984;111(3):343-9 Isoprinosine in the treatment of herpes virus infections in children with leukaemia and malignant lymphoma.

Active substance: INOSINE

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Document reference: 30153

Study title: Patel P, Gemmell R, Carruth JASJ Laryngol Otol Dec 1987 101(12):1306-1307. Inosine pranobex in recurrent laryngeal papillomatosis.Patel P, Gemmell R, Carruth JASJ Laryngol Otol Dec 1987 101(12):1306-1307. Inosine pranobex in recurrent laryngeal papillomatosis.

Active substance: INOSINE

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Document reference: 30154

Study title: Cytogenetic analysis of peripheral blood lymphocytes after arteriography (exposure to x-rays and contrast medium)Popova L 2005. Radio/ Oncol 2005; 39(2): 153-8.

Active substance: IODIXANOL

Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc

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Document reference: 48197

Study title: Eur J Radiol. 1993 Nov;17(3):203-9. A double-blind study comparing safety, tolerability and efficacy of iodixanol 320 mgI/ml and ioxaglate 320 mgI/ml in cerebral arteriography. Palmers Y, De Greef D, Grynne BH, Smits J, Put E Eur J Radiol. 1993 Nov;17(3):203-9. A double-blind study comparing safety, tolerability and efficacy of iodixanol 320 mgI/ml and ioxaglate 320 mgI/ml in cerebral arteriography. Palmers Y, De Greef D, Grynne BH, Smits J, Put E

Active substance: IODIXANOL

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Document reference: 30349

Study title: Bartkowski S.B., Krystkowa K.M., Pruszkiewicz W., Zapala J.: Follow-up results of surgical treatment of post-traumatic diplopia. Bartkowski S.B., Krystkowa K.M., Pruszkiewicz W., Zapala J.: Follow-up results of surgical treatment of post-traumatic diplopia.

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35103

Study title: Bedavanija A, Singalavanija A, Kombara M.: Solcoseryl Eye Gel: An Effective Adjunct in the Treatment of Chronic Ulcers of the Cornea. J.med. Assoc. Thailand 68, 415-418 (1985). Bedavanija A, Singalavanija A, Kombara M.: Solcoseryl Eye Gel: An Effective Adjunct in the Treatment of Chronic Ulcers of the Cornea. J.med. Assoc. Thailand 68, 415-418 (1985).

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35104

Study title: Egorova G.B., Avetisov S.E., Churkina M.N., Rybakova E.: A comparative assessment of contact lens tolerance and a study of possibilities for its improvement. Egorova G.B., Avetisov S.E., Churkina M.N., Rybakova E.: A comparative assessment of contact lens tolerance and a study of possibilities for its improvement.

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35099

Study title: Gerkowicz K.; Toczolowski J.; Hamerski W.; Jedrzejewski D.; Gerkowicz M.: Evaluation of the effectiveness of Solcoseryl Eye-Gel in the treatment of some corneal diseases. Klin. Oczna 87: 21-22, 1985. Gerkowicz K.; Toczolowski J.; Hamerski W.; Jedrzejewski D.; Gerkowicz M.: Evaluation of the effectiveness of Solcoseryl Eye-Gel in the treatment of some corneal diseases. Klin. Oczna 87: 21-22, 1985.

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35106

Study title: Joannidis P: Doppelblinde klinische Prüfung von Solcoseryl Dental Adhäsipaste als Wundverband nach oral-chirurgischen Eingriffen. Dissertetion, durchgeführt unter der Leitung von Prof. Dr. A. Schrpeder, Direktor der Klinik für Zahnerhaltung der Univ. Bern, 1983 Joannidis P: Doppelblinde klinische Prüfung von Solcoseryl Dental Adhäsipaste als Wundverband nach oral-chirurgischen Eingriffen. Dissertetion, durchgeführt unter der Leitung von Prof. Dr. A. Schrpeder, Direktor der Klinik für Zahnerhaltung der Univ. Bern, 1983

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35094

Study title: Krasny J.; Krejci L.; Rezek P.: Solcoseryl eye gel in pediatric ophthalmology practice. Ceskol. Oftalm. 42, 1986, No. 6, 448-453. Krasny J.; Krejci L.; Rezek P.: Solcoseryl eye gel in pediatric ophthalmology practice. Ceskol. Oftalm. 42, 1986, No. 6, 448-453.

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35102

Study title: "Krekeler G: Clinical study to assess the effect of Solcoseryl adhesive oinment on wound healing. Unpublished report 1979 Felber P, Gasser F: Double-blind clinical trial of Solcoseryl Dental Adhesive Paste for treating dental sores. Schweiz. Mschr. Zahnheilkunde, 1983, 93, 362-372" "Krekeler G: Clinical study to assess the effect of Solcoseryl adhesive oinment on wound healing. Unpublished report 1979 Felber P, Gasser F: Double-blind clinical trial of Solcoseryl Dental Adhesive Paste for treating dental sores. Schweiz. Mschr. Zahnheilkunde, 1983, 93, 362-372"

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35092

Study title: Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68)Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68)

Active substance: QUININE

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Document reference: 45064

Study title: EFFICACY AND SAFETY OF RIFABUTIN (AMSAMYCIN LM 427) IN PATIENTS WITH NEWLY DIAGNOSED PULMONARY TUBERCULOSIS. FCE REPORT LM 427/706I OCTOBER 1990 D93 AGE RANGE 15- 62 YEARS

Active substance: RIFABUTIN

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Document reference: 35372

Study title: PARTIALLY RANDOMIZED DOSE COMPARSION TRAIL OF COMPASSIONATE USE RIFABUTIN (AMSAMYCIN LM 427) IN AIDS OATIENTS WITH MYCOBACTERIUM AVIUM COMPLEX INFECTION FCE REPORT LM 427/723I FEBRUARY 1991 AGE RANGE 1-62

Active substance: RIFABUTIN

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Document reference: 35376

Study title: PARTIALLY RANDOMIZED, DOSE COMPARISON TRIAL OF COMPASSIONATE USE RIFABUTIN (AMSAMYCIN LM 427) IN NON-AIDS PATIENTS WITH MYCOBACTERIUM AVIUM COMPLEX INFECTION. FCE REPORT: LM 427/719I MARCH, 1991 AGE RANGE: 0-91 YRS

Active substance: RIFABUTIN

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Document reference: 35377

Study title: RIFABUTIN FOR THE TREATMENT OF NEWLY DIAGNOSIED PULMONARYTUBERCULOIS: A MULTINATIONAL, RANDOMIZED COMPARATIVE STUDY VERUS RIFAMPICIN LUIS JULIO GONZALES-MONTANER AGE RANGE 15-67

Active substance: RIFABUTIN

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Document reference: 35375

Study title: SAFETY OF RIFABUTIN (AMSAMYCIN, LM 427) IN PATIENTS WITH NEWLY DIAGNOSED PULMONARY TUBERCULOSIS. FCE REPORT LM 427/708I OCTOBER 1990 AGE RANGE: 15-68 YRS

Active substance: RIFABUTIN

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Document reference: 35371

Study title: THE COMPASSIONATE USE OF RIFABUTIN FOR THE TREATMENT OF MYCOBACTERIU AVIUM COMPLEX DISEASE IN HIV POSITIVE PATIENTS. FCE REPORTS LM 427/720I JANUARY 1991 AGE RANGE 5 -61

Active substance: RIFABUTIN

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Document reference: 35373

Study title: Clinical Expert Statement for MA Renewal in Slovenial - Djebbar F. & Verdoncq B. - 12 July 2007

Active substance: RIFAMPICIN/ISONIAZID

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Document reference: 35378

Study title: Clinical Certificate for MA Renewal in Slovenia - Verdoncq B. - 10 July 2007 (0703-CC-RIF+ISO+PYR-SLOVENIA-BV-10.07.07)

Active substance: RIFAMPICIN/ISONIAZID/PYRAZINAMIDE

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Document reference: 35379

Study title: Referenced in Rifater Registration Dossier - Clinical Documentation - Update April 1998 : The use of fixed-dose combinations in antituberculosis chemotherapy. Rationale for their application in daily, intermittant and pediatric regimens. - Acoccella G. - 1990 (Bulletin of the Int. Union Against Tuberculosis and Lung Disease, 65, 2-3: 77-83)

Active substance: RIFAMPICIN/ISONIAZID/PYRAZINAMIDE

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Document reference: 35380

Study title: Spectrophotofluorometric assay for Isoniazid and Acetyl Isoniazid in Plasma adapted tp pediatric studies - Clin. Chem., 23(4), 745 - Olson W.A. Et al (1977) Spectrophotofluorometric assay for Isoniazid and Acetyl Isoniazid in Plasma adapted tp pediatric studies - Clin. Chem., 23(4), 745 - Olson W.A. Et al (1977)

Active substance: RIFAMPICIN/ISONIAZID/PYRAZINAMIDE

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Document reference: 45141

Study title: Compliance and tolerance of new antitubercular short-term chemopreventive regimens in childhood - a pilot project - Magdorf K, Arizzi-Rusche AF, Geiter LJ, O'Brien RJ et al - 1994 (Pneumologie, 48(10): 761 - 4)Compliance and tolerance of new antitubercular short-term chemopreventive regimens in childhood - a pilot project - Magdorf K, Arizzi-Rusche AF, Geiter LJ, O'Brien RJ et al - 1994 (Pneumologie, 48(10): 761 - 4)

Active substance: RIFAMYCIN

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Document reference: 35381

Study title: Matus-Ridley-M, Nicosia-S-V, Meadows-A-T. Children's Cancer Research Center, Children's Hospital of Philadelphia, Philadelphia, PA 19104, United States. Gonadal effects of cancer therapy in boys. Cancer {CANCER}, 1985, Vol/Iss/Pg. 55/10 (2353-2363).Matus-Ridley-M, Nicosia-S-V, Meadows-A-T. Children's Cancer Research Center, Children's Hospital of Philadelphia, Philadelphia, PA 19104, United States. Gonadal effects of cancer therapy in boys. Cancer {CANCER}, 1985, Vol/Iss/Pg. 55/10 (2353-2363).

Active substance: PROCARBAZINE

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Document reference: 34782

Study title: Mauch-P-M, Weinstein-H, Botnick-L, Belli-J, Cassady-J-R. An evaluation of long-term survival and treatment complications in children with Hodgkin's disease. Cancer, {Cancer}, 1 Mar 1983, vol. 51, no. 5, p. 925-32, ISSN: 0008-543X.Mauch-P-M, Weinstein-H, Botnick-L, Belli-J, Cassady-J-R. An evaluation of long-term survival and treatment complications in children with Hodgkin's disease. Cancer, {Cancer}, 1 Mar 1983, vol. 51, no. 5, p. 925-32, ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34783

Study title: 11. Botero et al., Bol Chil Parasitol 1966; 21: 111-114 11. Botero et al., Bol Chil Parasitol 1966; 21: 111-114

Active substance: PYRVINIUM

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Document reference: 39540

Study title: 12. Bruhn, Padelt, Padiatr Grenzgeb 1968 ; 7 : 331341 12. Bruhn, Padelt, Padiatr Grenzgeb 1968 ; 7 : 331341

Active substance: PYRVINIUM

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Document reference: 39541

Study title: 13. Brus et al., Polski Tygodnik Lekarski 1976; 31: 195-197 13. Brus et al., Polski Tygodnik Lekarski 1976; 31: 195-197

Active substance: PYRVINIUM

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Document reference: 39542

Study title: 14. Bumbalo et al., Am J Trop Med Hyg 1958; 7: 212-214 14. Bumbalo et al., Am J Trop Med Hyg 1958; 7: 212-214

Active substance: PYRVINIUM

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Document reference: 39543

Study title: Farah-R, Golomb-H-M, Hallahan-D-E, Desser-R-K, Griem-M-L, Blough-R, Ultmann-J-E, Weichselbaum-R-R. Pritzker School of Medicine, University of Chicago, Chicago, IL 60637, United States. Radiation therapy for pathologic stage III Hodgkin's disease with and without chemotherapy. International Journal of Radiation Oncology Biology Physics {INT-J- RADIAT-ONCOL-BIOL-PHYS}, 1989, Vol/Iss/Pg. 17/4 (761766), ISSN: 0360-3016.Farah-R, Golomb-H-M, Hallahan-D-E, Desser-R-K, Griem-M-L, Blough-R, Ultmann-J-E, Weichselbaum-R-R. Pritzker School of Medicine, University of Chicago, Chicago, IL 60637, United States. Radiation therapy for pathologic stage III Hodgkin's disease with and without chemotherapy. International Journal of Radiation Oncology Biology Physics {INT-J- RADIAT-...

Active substance: PROCARBAZINE

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Document reference: 34710

Study title: Fernandez-Bouzas-A, Ramirez-Jimenez-H, Vazquez-Zamudio-J, Alonso- Vanegas-M, Mendizabal-Guerra-R. Department of Neuroradiology, Hospital 20 de Noviembre, ISSSTE, Mexico City. Brain calcifications and dementia in children treated with radiotherapy and intrathecal methotrexate. Journal of neurosurgical sciences, {J-Neurosurg-Sci}, Oct-Dec 1992, vol. 36, no. 4, p. 211-4, ISSN: 0390-5616.Fernandez-Bouzas-A, Ramirez-Jimenez-H, Vazquez-Zamudio-J, Alonso- Vanegas-M, Mendizabal-Guerra-R. Department of Neuroradiology, Hospital 20 de Noviembre, ISSSTE, Mexico City. Brain calcifications and dementia in children treated with radiotherapy and intrathecal methotrexate. Journal of neurosurgical sciences, {J-Neurosurg-Sci}, Oct-Dec 1992, vol. 36, no. 4, p...

Active substance: PROCARBAZINE

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Document reference: 34711

Study title: Fink-F-M, Ausserer-B, Dengg-K, Pallua-A-K, Twerdy-K, Frommhold-H, Berger-H. Department of Pediatrics, University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria. Long term remission of intrinsic brainstem gliomas: The case reports of two children. Wiener Klinische Wochenschrift {WIEN-KLIN-WOCHENSCHR}, 1991, Vol/Iss /Pg. 103/13 (392-395), ISSN: 0043-5325.Fink-F-M, Ausserer-B, Dengg-K, Pallua-A-K, Twerdy-K, Frommhold-H, Berger-H. Department of Pediatrics, University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria. Long term remission of intrinsic brainstem gliomas: The case reports of two children. Wiener Klinische Wochenschrift {WIEN-KLIN-WOCHENSCHR}, 1991, Vol/Iss /Pg. 103/13 (392-395), ISSN: 0043-5325.

Active substance: PROCARBAZINE

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Document reference: 34712

Study title: Flamant-F, Rodary-C, Voute-P-A, Otten-J. Pediatric Department, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. Primary chemotherapy in the treatment of rhabdomyosarcoma in children: Trial of the international society of pediatric oncology (SIOP) preliminary results. Radiotherapy and Oncology {RADIOTHER-ONCOL}, 1985, Vol/Iss/Pg. 3/3 (227-236).Flamant-F, Rodary-C, Voute-P-A, Otten-J. Pediatric Department, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. Primary chemotherapy in the treatment of rhabdomyosarcoma in children: Trial of the international society of pediatric oncology (SIOP) preliminary results. Radiotherapy and Oncology {RADIOTHER-ONCOL}, 1985, Vol/Iss/Pg. 3/3 (227-236).

Active substance: PROCARBAZINE

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Document reference: 34713

Study title: 10. Biguet et al., Presse Med 1959; 67: 1739-1740 10. Biguet et al., Presse Med 1959; 67: 1739-1740

Active substance: PYRVINIUM

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Document reference: 39539

Study title: Eur J Radiol. 1993 Nov;17(3):203-9. A double-blind study comparing safety, tolerability and efficacy of iodixanol 320 mgI/ml and ioxaglate 320 mgI/ml in cerebral arteriography. Palmers Y, De Greef D, Grynne BH, Smits J, Put E Eur J Radiol. 1993 Nov;17(3):203-9. A double-blind study comparing safety, tolerability and efficacy of iodixanol 320 mgI/ml and ioxaglate 320 mgI/ml in cerebral arteriography. Palmers Y, De Greef D, Grynne BH, Smits J, Put E

Active substance: IODIXANOL

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Document reference: 30353

Study title: : Eur Radiol. 1997;7 Suppl 4:S123-6 Iopentol (Imagopaque 350) compared with iohexol (Omnipaque 350) in paediatric cardioangiography. A clinical trial assessing adverse events, ECG, blood pressure and diagnostic information. Kunnen M, De Greef D, Skinningsrud K : Eur Radiol. 1997;7 Suppl 4:S123-6 Iopentol (Imagopaque 350) compared with iohexol (Omnipaque 350) in paediatric cardioangiography. A clinical trial assessing adverse events, ECG, blood pressure and diagnostic information. Kunnen M, De Greef D, Skinningsrud K

Active substance: IODIXANOL

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Document reference: 30356

Study title: Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG. Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG.

Active substance: IODIXANOL

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Document reference: 30352

Study title: Evaluation of a coronary-cameral fistula: benefits of coronary dual-source MDCT angiography in childrenLerner CB 2008. Pediatr Radiol (2008) 38:874–878

Active substance: IODIXANOL

Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc

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Document reference: 48201

Study title: Experiences with iohexol and iodixanol during cardioangiography in an unselected patient population.Int J Cardiol. 2001 Sep-Oct;80(2-3):143-51. Flinck A, Gottfridsson B.

Active substance: IODIXANOL

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Document reference: 30347

Study title: Frequency, Management, and Outcome of Extravasation of Nonionic Iodinated Contrast Medium in 69 657 Intravenous InjectionsWang CL 2007. Radiology: Volume 243: Number 1-April 2007

Active substance: IODIXANOL

Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc

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Document reference: 48198

Study title: Iodixanol in paediatric excretory urography: efficiency and safety compared to iohexolDacher JN 1998. Pediatr Radiol (1998) 28: 112-114

Active substance: IODIXANOL

Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc

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Document reference: 48195

Study title: Iodixanol Pharmacokinetics in ChildrenJohnson WH 2001 Pediatr Cardiol 22:223–227, 2001

Active substance: IODIXANOL

Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc

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Document reference: 48196

Study title: J Comput Assist Tomogr. 2000 Mar-Apr;24(2):327-31 Gadolinium-enhanced magnetic resonance dacryocystography in patients with epiphora. Kirchhof K, Hähnel S, Jansen O, Zake S, Sartor K. J Comput Assist Tomogr. 2000 Mar-Apr;24(2):327-31 Gadolinium-enhanced magnetic resonance dacryocystography in patients with epiphora. Kirchhof K, Hähnel S, Jansen O, Zake S, Sartor K.

Active substance: IODIXANOL

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Document reference: 30355

Study title: Lange-B, Littman-P. Div. Oncol., Hosp. Univ. Pennsylvania, Philadelphia, PA 19104, United States. Management of Hodgkin's disease in children and adolescents. Cancer {CANCER}, 1983, Vol/Iss/Pg. 51/8 (1371-1377).Lange-B, Littman-P. Div. Oncol., Hosp. Univ. Pennsylvania, Philadelphia, PA 19104, United States. Management of Hodgkin's disease in children and adolescents. Cancer {CANCER}, 1983, Vol/Iss/Pg. 51/8 (1371-1377).

Active substance: PROCARBAZINE

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Document reference: 34768

Study title: Willoughby CR, Tesh JM, McAnulty PA, Tesh SA, Wilby OK. Teratology study of NY-198 in the rat (segment II). 1986. Internal Report

Active substance: LOMEFLOXACIN

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Document reference: 31400

Study title: Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68)Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68)

Active substance: QUININE

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Document reference: 45069

Study title: Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68)Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68)

Active substance: QUININE

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Document reference: 45074

Study title: Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68)Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68)

Active substance: QUININE

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Document reference: 45079

Study title: Dose-dependant Resoption of quinine after intrarectal administration to children with moderate Plasmodium falciparum Malaria - Eric Pussard et al. - 11/2004 (Antimicrobial agents and Chimiotherapy;vol. 48,No. 11:4422-4426)Dose-dependant Resoption of quinine after intrarectal administration to children with moderate Plasmodium falciparum Malaria - Eric Pussard et al. - 11/2004 (Antimicrobial agents and Chimiotherapy;vol. 48,No. 11:4422-4426)

Active substance: QUININE

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Document reference: 45060

Study title: Dose-dependant Resoption of quinine after intrarectal administration to children with moderate Plasmodium falciparum Malaria - Eric Pussard et al. - 11/2004 (Antimicrobial agents and Chimiotherapy;vol. 48,No. 11:4422-4426)Dose-dependant Resoption of quinine after intrarectal administration to children with moderate Plasmodium falciparum Malaria - Eric Pussard et al. - 11/2004 (Antimicrobial agents and Chimiotherapy;vol. 48,No. 11:4422-4426)

Active substance: QUININE

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Document reference: 45070

Study title: Dose-dependant Resoption of quinine after intrarectal administration to children with moderate Plasmodium falciparum Malaria - Eric Pussard et al. - 11/2004 (Antimicrobial agents and Chimiotherapy;vol. 48,No. 11:4422-4426)Dose-dependant Resoption of quinine after intrarectal administration to children with moderate Plasmodium falciparum Malaria - Eric Pussard et al. - 11/2004 (Antimicrobial agents and Chimiotherapy;vol. 48,No. 11:4422-4426)

Active substance: QUININE

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Document reference: 45075

Study title: McClain-K-L, Heise-R, Day-D-L, Lee-C-K, Woods-W-G, Aeppli-D. Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis. Hodgkin's disease in children: correlation of clinical characteristics, staging procedures, and treatment at the University of Minnesota. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Summer 1990, vol. 12, no. 2, p. 147-54, 29 refs, ISSN: 0192-8562.McClain-K-L, Heise-R, Day-D-L, Lee-C-K, Woods-W-G, Aeppli-D. Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis. Hodgkin's disease in children: correlation of clinical characteristics, staging procedures, and treatment at the University of Minnesota. The American journal of pediatric hematology/o...

Active substance: PROCARBAZINE

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Document reference: 34785

Study title: McClain-K, Heise-R, Day-D-L, Lee-C-K-K, Woods-G, Aeppli-D. Department of Pediatrics, The University of Minnesota School of Medicine, Minneapolis, MN, United States. Hodgekin's disease in children: Correlation of clinical characteristics, staging procedures, and treatment at the university of Minnesota. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR-HEMATOL-ONCOL}, 1990, Vol/Iss/Pg. 12/2 (147-154), ISSN: 0192-8562.McClain-K, Heise-R, Day-D-L, Lee-C-K-K, Woods-G, Aeppli-D. Department of Pediatrics, The University of Minnesota School of Medicine, Minneapolis, MN, United States. Hodgekin's disease in children: Correlation of clinical characteristics, staging procedures, and treatment at the university of Minnesota. American Jo...

Active substance: PROCARBAZINE

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Document reference: 34784

Study title: Meadows-A-T, Silber-J. Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, United States. Delayed consequences of therapy for childhood cancer. Ca-A Cancer Journal for Clinicians {CA-CANCER-J-CLIN}, 1985, Vol/Iss /Pg. 35/5 (271-286).Meadows-A-T, Silber-J. Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, United States. Delayed consequences of therapy for childhood cancer. Ca-A Cancer Journal for Clinicians {CA-CANCER-J-CLIN}, 1985, Vol/Iss /Pg. 35/5 (271-286).

Active substance: PROCARBAZINE

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Document reference: 34786

Study title: Morgenfeld-M-C, Pavlovsky-A, Suarez-A, Somoza-N, Pavlovsky-S, Palau- M, Barros-C-A. Combined cyclophosphamide vincristine, procarbazine, and prednisone (COPP) therapy of malignant lymphoma. Evaluation of 190 patients. Cancer, {Cancer}, Oct 1975, vol. 36, no. 4, p. 1241-9, ISSN: 0008-543X.Morgenfeld-M-C, Pavlovsky-A, Suarez-A, Somoza-N, Pavlovsky-S, Palau- M, Barros-C-A. Combined cyclophosphamide vincristine, procarbazine, and prednisone (COPP) therapy of malignant lymphoma. Evaluation of 190 patients. Cancer, {Cancer}, Oct 1975, vol. 36, no. 4, p. 1241-9, ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34787

Study title: Weiner-M-A, Leventhal-B, Brecher-M-L, Marcus-R-B, Cantor-A, Gieser-P- W, Ternberg-J-L, Behm-F-G, Wharam-M-D-Jr, Chauvenet-A-R. W, Ternberg-J-L, Behm-F-G, Wharam-M-D-Jr, Chauvenet-A-R College of Physicians and Surgeons of Columbia University, New York, USA. Randomized study of intensive MOPP-ABVD with or without low-dose total-nodal radiation therapy in the treatment of stages IIB, IIIA2, IIIB, and IV Hodgkin's disease in pediatric patients: a Pediatric Oncology Group study. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Aug 1997, vol. 15, no. 8, p. 2769-79, ISSN: 0732-183X.Weiner-M-A, Leventhal-B, Brecher-M-L, Marcus-R-B, Cantor-A, Gieser-P- W, Ternberg-J-L, Behm-F-G, Wharam-M-D-Jr, Chauvenet-A-R. W, Ternb...

Active substance: PROCARBAZINE

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Document reference: 34874

Study title: Fryer-C-J, Hutchinson-R-J, Krailo-M, Collins-R-D, Constine-L-S, Hays- D-M, Heller-R-M, Davis-P-C, Nachman-J, O-Brien-R-T, O-Neill-J-A, Pringle-K-C, Trigg-M-E, Hammond-G-D. Childrens Cancer Study Group, Operations Office, 199 North Lake Ave, Pasadena, CA 91101, United States. Efficacy and toxicity of 12 courses of ABVD chemotherapy followed by low-dose regional radiation in advanced Hodgkin's disease in children: A report from the Childrens Cancer Study Group. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1990, Vol/Iss/Pg. 8/12 (1971-1980), ISSN: 0732-183X.Fryer-C-J, Hutchinson-R-J, Krailo-M, Collins-R-D, Constine-L-S, Hays- D-M, Heller-R-M, Davis-P-C, Nachman-J, O-Brien-R-T, O-Neill-J-A, Pringle-K-C, Trigg-M-E, Hammond-G-D. Childrens Cancer Study Group, Operations...

Active substance: PROCARBAZINE

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Document reference: 34714

Study title: Petera-J, Macharova-H, Pohankova-R, Malir-A, Coupek-P, Konecný-M, Patera-J, Pecina-J, Drbal-J, Koukalova-H, Vasova-I. Masaryk Memorial Cancer Institute, Brno, Czech Republic. Petera @fuhk.cz. Radiotherapy of early stages Hodgkin's disease. 10 years experience of the Masaryk Memorial Cancer Institute. Neoplasma, {Neoplasma}, 2000, vol. 47, no. 2, p. 129-32, ISSN: 0028-2685.Petera-J, Macharova-H, Pohankova-R, Malir-A, Coupek-P, Konecný-M, Patera-J, Pecina-J, Drbal-J, Koukalova-H, Vasova-I. Masaryk Memorial Cancer Institute, Brno, Czech Republic. Petera @fuhk.cz. Radiotherapy of early stages Hodgkin's disease. 10 years experience of the Masaryk Memorial Cancer Institute. Neoplasma, {Neoplasma}, 2000, vol. 47, no. 2, p. 129-32, ISSN: 0028-2685.

Active substance: PROCARBAZINE

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Document reference: 34806

Study title: Petronio-J, Edwards-M-S-B, Prados-M, Freyberger-S, Rabbitt-J, Silver- P, Levin-V-A. c/o Editorial Office, 1360 Ninth Avenue, San Francisco, CA 94122, United States. Management of chiasmal and hypothalamic gliomas of infancy and childhood with chemotherapy. Journal of Neurosurgery {J-NEUROSURG}, 1991, Vol/Iss/Pg. 74/5 (701-708), ISSN: 0022-3085.Petronio-J, Edwards-M-S-B, Prados-M, Freyberger-S, Rabbitt-J, Silver- P, Levin-V-A. c/o Editorial Office, 1360 Ninth Avenue, San Francisco, CA 94122, United States. Management of chiasmal and hypothalamic gliomas of infancy and childhood with chemotherapy. Journal of Neurosurgery {J-NEUROSURG}, 1991, Vol/Iss/Pg. 74/5 (701-708), ISSN: 0022-3085.

Active substance: PROCARBAZINE

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Document reference: 34807

Study title: Pezzotta-S, Cordero-Di-Montezemolo-L, Knerich-R, Arrigoni-M, Barbara- A, Besenzon-L, Brach-del-Prever-A, Fidani-P, Locatelli-D, Loiacono-G, Magrassi-L, Perilongo-G, Rigobello-L, Urgesi-A, Madon-E. Dept. of Surg., Neurosurgical Clinic, University of Pavia, IRCCS Policlinico San Matteo, Piazzale Golgi, 2, I-27100 Pavia, Italy. CNS-85 trial: A cooperative pediatric CNS tumor study - results of treatment of medulloblastoma patients. Child's Nervous System {CHILD-S-NERV-SYST}, 1996, Vol/Iss/Pg. 12/2 (87-96), ISSN: 0256-7040.Pezzotta-S, Cordero-Di-Montezemolo-L, Knerich-R, Arrigoni-M, Barbara- A, Besenzon-L, Brach-del-Prever-A, Fidani-P, Locatelli-D, Loiacono-G, Magrassi-L, Perilongo-G, Rigobello-L, Urgesi-A, Madon-E. Dept. of Surg., Neurosurgical Clinic, University of Pavia, ...

Active substance: PROCARBAZINE

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Document reference: 34808

Study title: Pezzotta-S, Knerich-R, Butti-G. ICNG Coord. Cent., Neurosurg. Clin., Univ. Pavia, 27100 Pavia, Italy. Chemotherapy for medulloblastoma in children. Current status and future prospects. Child's Brain {CHILD-S-BRAIN}, 1982, Vol/Iss/Pg. 9/3-4 (294-298).Pezzotta-S, Knerich-R, Butti-G. ICNG Coord. Cent., Neurosurg. Clin., Univ. Pavia, 27100 Pavia, Italy. Chemotherapy for medulloblastoma in children. Current status and future prospects. Child's Brain {CHILD-S-BRAIN}, 1982, Vol/Iss/Pg. 9/3-4 (294-298).

Active substance: PROCARBAZINE

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Document reference: 34809

Study title: Lemerle-J, Bernard-A, Kalifa-C. Serv. Cancerol. Inf., Inst. Gustave Roussy, Villejuif, France. Management and follow up of antitumoral chemotherapy of the child. Revue du Praticien {REV-PRAT}, 1977, Vol/Iss/Pg. 27/5 (237-247).Lemerle-J, Bernard-A, Kalifa-C. Serv. Cancerol. Inf., Inst. Gustave Roussy, Villejuif, France. Management and follow up of antitumoral chemotherapy of the child. Revue du Praticien {REV-PRAT}, 1977, Vol/Iss/Pg. 27/5 (237-247).

Active substance: PROCARBAZINE

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Document reference: 34770

Study title: Leventhal-B-G. Johns Hopkins Oncology Center, Baltimore, MD, United States. Management of stage I-II Hodgkin's disease in children. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1990, Vol/Iss/Pg. 8/7 (1123-1124), ISSN: 0732-183X.Leventhal-B-G. Johns Hopkins Oncology Center, Baltimore, MD, United States. Management of stage I-II Hodgkin's disease in children. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1990, Vol/Iss/Pg. 8/7 (1123-1124), ISSN: 0732-183X.

Active substance: PROCARBAZINE

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Document reference: 34771

Study title: Leverger-G, Oberlin-O, Schaison-G, Lemerle-J. (Treatment of Hodgkin's disease in children with chemotherapy and low-dose radiation). Nouvelle revue francaise d'hematologie, {Nouv-Rev-Fr-Hematol}, 1987,vol. 29, no. 1, p. 83-5.vol. 29, no. 1, p. 83-5.Leverger-G, Oberlin-O, Schaison-G, Lemerle-J. (Treatment of Hodgkin's disease in children with chemotherapy and low-dose radiation). Nouvelle revue francaise d'hematologie, {Nouv-Rev-Fr-Hematol}, 1987,vol. 29, no. 1, p. 83-5.vol. 29, no. 1, p. 83-5.

Active substance: PROCARBAZINE

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Document reference: 34773

Study title: Leverger-G, Oberlin-O, Schaison-G, Lemerle-J. ( Treatment of Hodgkin's disease in children with chemotherapy and low-dose radiation). Nouvelle revue francaise d'hematologie {Nouv-Rev-Fr-Hematol} 1987, VOL: 29 (1), P: 83-5.Leverger-G, Oberlin-O, Schaison-G, Lemerle-J. ( Treatment of Hodgkin's disease in children with chemotherapy and low-dose radiation). Nouvelle revue francaise d'hematologie {Nouv-Rev-Fr-Hematol} 1987, VOL: 29 (1), P: 83-5.

Active substance: PROCARBAZINE

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Document reference: 34772

Study title: Loeuille-G-A. Consultation d'Endocrinologie Pediatrique, Hopital Regional, 59037 Lille Cedex, France. Endocrine surveillance of children after antineoplastic radiotherapy and chemotherapy. LARC Medical {LARC-MED}, 1985, Vol/Iss/Pg. 5/10 (562-566).Loeuille-G-A. Consultation d'Endocrinologie Pediatrique, Hopital Regional, 59037 Lille Cedex, France. Endocrine surveillance of children after antineoplastic radiotherapy and chemotherapy. LARC Medical {LARC-MED}, 1985, Vol/Iss/Pg. 5/10 (562-566).

Active substance: PROCARBAZINE

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Document reference: 34774

Study title: Longo-D-L, Russo-A, Duffey-P-L, Hubbard-S-M, Glatstein-E, Hill-J-B, Division of Cancer Treatment, National Cancer Institute, Bethesda, MD. Treatment of advanced-stage massive mediastinal Hodgkin's disease: the case for combined modality treatment. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Feb 1991, vol. 9, no. 2, p. 227-35, ISSN: 0732-183X.Longo-D-L, Russo-A, Duffey-P-L, Hubbard-S-M, Glatstein-E, Hill-J-B, Division of Cancer Treatment, National Cancer Institute, Bethesda, MD. Treatment of advanced-stage massive mediastinal Hodgkin's disease: the case for combined modality treatment. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol...

Active substance: PROCARBAZINE

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Document reference: 34775

Study title: Lawhorn-T-I, Stone-H-H, Martin-J-D-Jr. Chemotherapy in solid tumors of childhood. Oncology, {Oncology}, 1972, vol. 26, no. 2, p. 250-8, 22 refs, ISSN: 0030-2414.Lawhorn-T-I, Stone-H-H, Martin-J-D-Jr. Chemotherapy in solid tumors of childhood. Oncology, {Oncology}, 1972, vol. 26, no. 2, p. 250-8, 22 refs, ISSN: 0030-2414.

Active substance: PROCARBAZINE

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Document reference: 34769

Study title: Hamilton-V-M, Norris-C, Bunin-N, Goldwein-J-W, Bunin-G-R, Lange-B, Meadows-A-T. Division of Oncology, Children's Hospital of Philadelphia, Pennsylvania 19104, USA. Cyclophosphamide-based, seven-drug hybrid and low-dose involved field radiation for the treatment of childhood and adolescent Hodgkin disease. Journal of pediatric hematology/oncology : official journal of the American Society of Pediatric Hematology/Oncology, {J-Pediatr- Hematol-Oncol}, Feb 2001, vol. 23, no. 2, p. 84-8, ISSN: 1077-4114.Hamilton-V-M, Norris-C, Bunin-N, Goldwein-J-W, Bunin-G-R, Lange-B, Meadows-A-T. Division of Oncology, Children's Hospital of Philadelphia, Pennsylvania 19104, USA. Cyclophosphamide-based, seven-drug hybrid and low-dose involved field radiation for ...

Active substance: PROCARBAZINE

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Document reference: 34732

Study title: Hartmann-O, Oberlin-O, Beaujean-F, Brugieres-L, Valteau-D, Vassal-G, Lemerle-J. Departement de Pediatrie, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. High-dose chemotherapy followed by autologous bone marrow transplantation in children's metastatic Ewing sarcoma. Bulletin du Cancer {BULL-CANCER}, 1990, Vol/Iss/Pg. 77/2 (181-187), ISSN: 0007-4551.Hartmann-O, Oberlin-O, Beaujean-F, Brugieres-L, Valteau-D, Vassal-G, Lemerle-J. Departement de Pediatrie, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. High-dose chemotherapy followed by autologous bone marrow transplantation in children's metastatic Ewing sarcoma. Bulletin du Cancer {BULL-CANCER}, 1990, Vol/Iss/Pg. 77/2 (181-187), ISSN: 0007-4551.

Active substance: PROCARBAZINE

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Document reference: 34733

Study title: Hassel-J-U, Braemswig-J-H, Schlegel-W, Schellong-G. Universitaets-Kinderklinik, Muenster. (Testicular function after OPA/COMP chemotherapy without procarbazine in boys with Hodgkin's disease. Results in 25 patients of the DAL-HD-85 study). Klinische Paediatrie {Klin-Padiatr} 1991 Jul-Aug, VOL: 203 (4), P: 268-72, ISSN: 0300-8630.Hassel-J-U, Braemswig-J-H, Schlegel-W, Schellong-G. Universitaets-Kinderklinik, Muenster. (Testicular function after OPA/COMP chemotherapy without procarbazine in boys with Hodgkin's disease. Results in 25 patients of the DAL-HD-85 study). Klinische Paediatrie {Klin-Padiatr} 1991 Jul-Aug, VOL: 203 (4), P: 268-72, ISSN: 0300-8630.

Active substance: PROCARBAZINE

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Document reference: 34734

Study title: Hayani-A, Mahoney-D-H-Jr, Taylor-L-D. Department of Pediatrics, Baylor College of Medicine, Houston, TX. Therapy-related myelodysplastic syndrome in children with medulloblastoma following MOPP chemotherapy. Journal of neuro-oncology, {J-Neurooncol}, Sep 1992, vol. 14, no. 1, p. 57-62, ISSN: 0167-594X.Hayani-A, Mahoney-D-H-Jr, Taylor-L-D. Department of Pediatrics, Baylor College of Medicine, Houston, TX. Therapy-related myelodysplastic syndrome in children with medulloblastoma following MOPP chemotherapy. Journal of neuro-oncology, {J-Neurooncol}, Sep 1992, vol. 14, no. 1, p. 57-62, ISSN: 0167-594X.

Active substance: PROCARBAZINE

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Document reference: 34735

Study title: Heath-John-A, Turner-Christopher-D, Poussaint-Tina-Young, Scott-R- Michael, Goumnerova-Liliana, Kieran-Mark-W. Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. john.heath@rch.org.au. Chemotherapy for progressive low-grade gliomas in children older than ten years: the Dana-Farber experience. Pediatric hematology and oncology, {Pediatr-Hematol-Oncol}, Oct-Nov 2003, vol. 20, no. 7, p. 497-504, ISSN: 0888-0018.Heath-John-A, Turner-Christopher-D, Poussaint-Tina-Young, Scott-R- Michael, Goumnerova-Liliana, Kieran-Mark-W. Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. john.heath@rch.org.au. Chemotherapy for progressive low-grade gliomas in children older than ten years: the Dana-Farber...

Active substance: PROCARBAZINE

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Document reference: 34737

Study title: Whitehead-E, Shalet-S-M, Jones-P-H, Beardwell-C-G, Deakin-D-P. Gonadal function after combination chemotherapy for Hodgkin's disease in childhood. Archives of disease in childhood, {Arch-Dis-Child}, Apr 1982, vol. 57, no. 4, p. 287-91, ISSN: 1468-2044.Whitehead-E, Shalet-S-M, Jones-P-H, Beardwell-C-G, Deakin-D-P. Gonadal function after combination chemotherapy for Hodgkin's disease in childhood. Archives of disease in childhood, {Arch-Dis-Child}, Apr 1982, vol. 57, no. 4, p. 287-91, ISSN: 1468-2044.

Active substance: PROCARBAZINE

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Document reference: 34876

Study title: Wiedrich-T, Keller-D, Arya-S-A, Gilbert-E. Department of Pathology, University of Wisconsin Center for Health Sciences and Medical School, Madison, WI 53792, United States. Adverse histopathologic effects of chemotherapeutic agents in childhood leukemia and lymphoma. Pediatric Pathology {PEDIATR-PATHOL}, 1984, Vol/Iss/Pg. 2/3 (267-283).Wiedrich-T, Keller-D, Arya-S-A, Gilbert-E. Department of Pathology, University of Wisconsin Center for Health Sciences and Medical School, Madison, WI 53792, United States. Adverse histopathologic effects of chemotherapeutic agents in childhood leukemia and lymphoma. Pediatric Pathology {PEDIATR-PATHOL}, 1984, Vol/Iss/Pg. 2/3 (267-283).

Active substance: PROCARBAZINE

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Document reference: 34877

Study title: Woo-S-Y, Donaldson-S-S, Cox-R-S. Department of Therapeutic Radiology, Stanford University Medical Center, Stanford, CA 94305, United States. Astrocytoma in children: 14 years' experience at Stanford University Medical Center. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1988, Vol/Iss/Pg. 6/6 (1001-1007), ISSN: 0732-183X.Woo-S-Y, Donaldson-S-S, Cox-R-S. Department of Therapeutic Radiology, Stanford University Medical Center, Stanford, CA 94305, United States. Astrocytoma in children: 14 years' experience at Stanford University Medical Center. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1988, Vol/Iss/Pg. 6/6 (1001-1007), ISSN: 0732-183X.

Active substance: PROCARBAZINE

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Document reference: 34879

Study title: Yaniv-I, Saab-A, Cohen-I-J, Goshen-Y, Loven-D, Stark-B, Tamary-H, Zaizov-R. Department of Pediatric Hematology Oncology, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. Hodgkin disease in children: reduced tailored chemotherapy for stage I-II disease. Journal of pediatric hematology/oncology : official journal of the American Society of Pediatric Hematology/Oncology, {J-Pediatr- Hematol-Oncol}, Feb 1996, vol. 18, no. 1, p. 76-80, ISSN: 1077-4114.Yaniv-I, Saab-A, Cohen-I-J, Goshen-Y, Loven-D, Stark-B, Tamary-H, Zaizov-R. Department of Pediatric Hematology Oncology, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. Hodgkin disease in children: reduced tailored chemotherapy for stage I-II disease. Journal of pediatric hem...

Active substance: PROCARBAZINE

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Document reference: 34880

Study title: Ghigo E et al. Growth hormone responses to pyridostigmine in normal adults and in normal and short children. Clin Endocrinol (Oxf). 1987 Dec;27(6):669-73Ghigo E et al. Growth hormone responses to pyridostigmine in normal adults and in normal and short children. Clin Endocrinol (Oxf). 1987 Dec;27(6):669-73

Active substance: PYRIDOSTIGMINE

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Document reference: 35217

Study title: Ghigo E, Mazza E, Imperiale E, Rizzi G, Benso L, Müller EE, Camanni F, Massara F. Enhancement of cholinergic tone by pyridostigmine promotes both basal and growth hormone (GH)-releasing hormone-induced GH secretion in children of short stature. J Clin Endocrinol Metab. 1987 Sep;65(3):452-6.Ghigo E, Mazza E, Imperiale E, Rizzi G, Benso L, Müller EE, Camanni F, Massara F. Enhancement of cholinergic tone by pyridostigmine promotes both basal and growth hormone (GH)-releasing hormone-induced GH secretion in children of short stature. J Clin Endocrinol Metab. 1987 Sep;65(3):452-6.

Active substance: PYRIDOSTIGMINE

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Document reference: 35221

Study title: Phuphanich-S, Edwards-M-S-B, Levin-V-A, et-al. Neuro-Oncology Service, Brain Tumor Research Center, Department of Neurological Surgery, School of Medicine, University of California, San Francisco, CA, United States. Supratentorial malignant gliomas of childhood. Results of treatment with radiation therapy and chemotherapy. Journal of Neurosurgery {J-NEUROSURG}, 1984, Vol/Iss/Pg. 60/3 (495-499).Phuphanich-S, Edwards-M-S-B, Levin-V-A, et-al. Neuro-Oncology Service, Brain Tumor Research Center, Department of Neurological Surgery, School of Medicine, University of California, San Francisco, CA, United States. Supratentorial malignant gliomas of childhood. Results of treatment with radiation therapy and chemotherapy. Journal of Neurosurgery {J-NEUROSURG}, 1984, V...

Active substance: PROCARBAZINE

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Document reference: 34810

Study title: Please refer to the product: SINERTEC Under Licence of MSDPlease refer to the product: SINERTEC Under Licence of MSD

Active substance: PROCARBAZINE

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Document reference: 34811

Study title: Sedation in pediatric neuroimaging: The science and the art.

Active substance: PROMETHAZINE

Study summary document link (including results): Sedation in pediatric neuroimaging The science and the art.pdf

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Document reference: 35050

Study title: Synergistic effect of promethazine with gentamycin in frequently recurring

Active substance: PROMETHAZINE

Study summary document link (including results): Synergistic effect of promethazine with gentamycin in frequently recurring.pdf

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Document reference: 35053

Study title: Wallace G_1963Wallace G_1963

Active substance: PROMETHAZINE

Study summary document link (including results): Bayer Pharma_Promethazine_Wallace G_1963_publication.pdf

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Document reference: 35015

Study title: Banzas

Active substance: PROMETHAZINE AND MAGNESIUM BROMHYDRATE GLUTAMATE

Study summary document link (including results): Banzas_NoPublicado.pdf

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Document reference: 48123

Study title: Berthaud

Active substance: PROMETHAZINE AND MAGNESIUM BROMHYDRATE GLUTAMATE

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Document reference: 48124

Study title: Blumenbach

Active substance: PROMETHAZINE AND MAGNESIUM BROMHYDRATE GLUTAMATE

Study summary document link (including results): Blumenbach_TherapieWoche,Cuaderno36,p.1699-1701,1969_ORIG.pdf

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Document reference: 48125

Study title: Bulgarelli

Active substance: PROMETHAZINE AND MAGNESIUM BROMHYDRATE GLUTAMATE

Study summary document link (including results): Bulgarelli_NoPublicado.pdf

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Document reference: 48135

Study title: Combes-Hamelle

Active substance: PROMETHAZINE AND MAGNESIUM BROMHYDRATE GLUTAMATE

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Document reference: 48126

Study title: Experiencas en clinica pediatrica con psico-soma jarabe

Active substance: PROMETHAZINE AND MAGNESIUM BROMHYDRATE GLUTAMATE

Study summary document link (including results): Arima_NoPublicado.pdf

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Document reference: 48122

Study title: Honda

Active substance: PROMETHAZINE AND MAGNESIUM BROMHYDRATE GLUTAMATE

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Document reference: 48127

Study title: Kishiro_ShinyakuToRinsho

Active substance: PROMETHAZINE AND MAGNESIUM BROMHYDRATE GLUTAMATE

Study summary document link (including results): Kishiro_ShinyakuToRinsho_vol.3,p.44-48,1967_ORIG.pdf

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Document reference: 48128

Study title: KUNIOMI YOKOTA

Active substance: PROMETHAZINE AND MAGNESIUM BROMHYDRATE GLUTAMATE

Study summary document link (including results): KUNIOMI YOKOTA_ORIG.pdf

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Document reference: 48129

Study title: Marques De Carvalho

Active substance: PROMETHAZINE AND MAGNESIUM BROMHYDRATE GLUTAMATE

Study summary document link (including results): MarquesDeCarvalho_Bol.daClin.Psiq.,II,1,p.6-22,1963_ORIG.pdf

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Document reference: 48130

Study title: Mises_RevueNeuropsychiatrieInfantile

Active substance: PROMETHAZINE AND MAGNESIUM BROMHYDRATE GLUTAMATE

Study summary document link (including results): Mises_RevueNeuropsychiatrieInfantile_vol.6,p.483-485,1966_ORIG.pdf

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Document reference: 48131

Study title: Puech_Semaine Des Hopitaux

Active substance: PROMETHAZINE AND MAGNESIUM BROMHYDRATE GLUTAMATE

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Document reference: 48132

Study title: Urgesi-A, Vasario-E, Monetti-U, et-al. Universita di Torino, Istituto di Radiologia, Divisione di Radioterapia, 10126 Torino, Italy. Treatment of childhood brain stem tumors with irradiation and chemotherapy. Preliminary results. Minerva Pediatrica {MINERVA-PEDIATR}, 1985, Vol/Iss/Pg. 37/20 (779-785).Urgesi-A, Vasario-E, Monetti-U, et-al. Universita di Torino, Istituto di Radiologia, Divisione di Radioterapia, 10126 Torino, Italy. Treatment of childhood brain stem tumors with irradiation and chemotherapy. Preliminary results. Minerva Pediatrica {MINERVA-PEDIATR}, 1985, Vol/Iss/Pg. 37/20 (779-785).

Active substance: PROCARBAZINE

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Document reference: 34862

Study title: Vailati-G, Occhiogrosso-M, Belsanti-M, et-al. Catt. Neurochir., Univ. Bari, Bari, Italy. Medulloblastomas and other intracranial brain tumors in infacy and childhood: Late effects of chemio and radiotherapy. Folia Oncologica {FOLIA-ONCOL}, 1982, Vol/Iss/Pg. 5/3 (523-529).Vailati-G, Occhiogrosso-M, Belsanti-M, et-al. Catt. Neurochir., Univ. Bari, Bari, Italy. Medulloblastomas and other intracranial brain tumors in infacy and childhood: Late effects of chemio and radiotherapy. Folia Oncologica {FOLIA-ONCOL}, 1982, Vol/Iss/Pg. 5/3 (523-529).

Active substance: PROCARBAZINE

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Document reference: 34863

Study title: van-den-Berg-H, Furstner-F, van-den-Bos-C, Behrendt-H. Department of Pediatric Oncology, Emma Children Hospital AMC, University of Amsterdam, Amsterdam; The Netherlands. h.vandenberg@amc.uva.nl. Decreasing the number of MOPP courses reduces gonadal damage in survivors of childhood Hodgkin disease. Pediatric blood & cancer, {Pediatr-Blood-Cancer}, Mar 2004, vol. 42, no. 3, p. 210-5, ISSN: 1545-5009.van-den-Berg-H, Furstner-F, van-den-Bos-C, Behrendt-H. Department of Pediatric Oncology, Emma Children Hospital AMC, University of Amsterdam, Amsterdam; The Netherlands. h.vandenberg@amc.uva.nl. Decreasing the number of MOPP courses reduces gonadal damage in survivors of childhood Hodgkin disease. Pediatric blood & cancer, {Pediatr-Blood-Cancer}, Mar 2004,...

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Document reference: 34864

Study title: van-den-Berg-H, Zsiros-J, Behrendt-H. Emma Kinderziekenhuis AMC, University of Amsterdam, The Netherlands. Treatment of childhood Hodgkin's disease without radiotherapy. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Jun 1997, vol. 15, no. 6, p. 2247-53, ISSN: 0732-183X.van-den-Berg-H, Zsiros-J, Behrendt-H. Emma Kinderziekenhuis AMC, University of Amsterdam, The Netherlands. Treatment of childhood Hodgkin's disease without radiotherapy. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Jun 1997, vol. 15, no. 6, p. 2247-53, ISSN: 0732-183X.

Active substance: PROCARBAZINE

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Document reference: 34865

Study title: van-Eys-J, Cangir-A, Coody-D, Smith-B. MOPP regimen as primary chemotherapy for brain tumors in infants. Journal of neuro-oncology, {J-Neurooncol}, 1985, vol. 3, no. 3, p. 237-43, ISSN: 0167-594X.van-Eys-J, Cangir-A, Coody-D, Smith-B. MOPP regimen as primary chemotherapy for brain tumors in infants. Journal of neuro-oncology, {J-Neurooncol}, 1985, vol. 3, no. 3, p. 237-43, ISSN: 0167-594X.

Active substance: PROCARBAZINE

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Document reference: 34866

Study title: Perani V. Riv Patol Clin Sep/Oct 1978;33(5):1-15. . Clinical evaluation of the efficacy of a new antiviral drug, methisoprinol, in pediatric infectionsPerani V. Riv Patol Clin Sep/Oct 1978;33(5):1-15. . Clinical evaluation of the efficacy of a new antiviral drug, methisoprinol, in pediatric infections

Active substance: INOSINE

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Document reference: 30155

Study title: Perani V. Rivista di Patalogia e Clinica Sept-Oct 1978;33(5):361-372. Clinical evaluation of the efficacy of a new antiviral drug, methisoprinol, in pediatric infections.Perani V. Rivista di Patalogia e Clinica Sept-Oct 1978;33(5):361-372. Clinical evaluation of the efficacy of a new antiviral drug, methisoprinol, in pediatric infections.

Active substance: INOSINE

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Document reference: 30156

Study title: Schellong-G, Braemswig-J-H, Hoernig-Franz-I, Schwarze-E-W, Poetter-R, Wannenmacher-M. Children's Hospital, University of Muenster, Germany. Hodgkin's disease in children: combined modality treatment for stages IA, IB, and IIA. Results in 356 patients of the German/Austrian Pediatric Study Group. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}, 1994, vol. 5 Suppl 2, p. 113-5, ISSN: 0923-7534.Schellong-G, Braemswig-J-H, Hoernig-Franz-I, Schwarze-E-W, Poetter-R, Wannenmacher-M. Children's Hospital, University of Muenster, Germany. Hodgkin's disease in children: combined modality treatment for stages IA, IB, and IIA. Results in 356 patients of the German/Austrian Pediatric Study Group. Annals of oncology : official j...

Active substance: PROCARBAZINE

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Document reference: 34829

Study title: Schellong-G, Braemswig-J-H, Hoernig-Franz-I. University Childrens Hospital, Department of Haematology and Oncology, Muenster, Germany. Pediatric Oncology Group. Treatment of children with Hodgkin's disease-results of the German Pediatric Oncology Group. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}, Sep 1992, vol. 3 Suppl 4, p. 73-6, ISSN: 0923-7534.Schellong-G, Braemswig-J-H, Hoernig-Franz-I. University Childrens Hospital, Department of Haematology and Oncology, Muenster, Germany. Pediatric Oncology Group. Treatment of children with Hodgkin's disease-results of the German Pediatric Oncology Group. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}...

Active substance: PROCARBAZINE

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Document reference: 34830

Study title: Schellong-G, Braemswig-J-H, Schwarze-E-W, Wannenmacher-M. Children's Hospital University of Muenster, FRG. An approach to reduce treatment and invasive staging in childhood Hodgkin's disease: the sequence of the German DAL multicenter studies. Bulletin du cancer, {Bull-Cancer}, 1988, vol. 75, no. 1, p. 41-51,Schellong-G, Braemswig-J-H, Schwarze-E-W, Wannenmacher-M. Children's Hospital University of Muenster, FRG. An approach to reduce treatment and invasive staging in childhood Hodgkin's disease: the sequence of the German DAL multicenter studies. Bulletin du cancer, {Bull-Cancer}, 1988, vol. 75, no. 1, p. 41-51,

Active substance: PROCARBAZINE

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Document reference: 34831

Study title: Schellong-G, Bramswig-J-H, Schwarze-E-W, Wannenmacher-M. Children's Hospital University of Munster, D-4400 Munster, Germany. An approach to reduce treatment and invasive staging in childhood Hodgkin's disease: The sequence of the German DAL multicenter studies. Bulletin du Cancer {BULL-CANCER}, 1988, Vol/Iss/Pg. 75/1 (41-51), ISSN: 0007-4551.Schellong-G, Bramswig-J-H, Schwarze-E-W, Wannenmacher-M. Children's Hospital University of Munster, D-4400 Munster, Germany. An approach to reduce treatment and invasive staging in childhood Hodgkin's disease: The sequence of the German DAL multicenter studies. Bulletin du Cancer {BULL-CANCER}, 1988, Vol/Iss/Pg. 75/1 (41-51), ISSN: 0007-4551.

Active substance: PROCARBAZINE

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Document reference: 34832

Study title: Schellong-G, Hoernig-I, Schwarze-E-W, Wannenmacher-M. Kinderklinik, Muenster, FRG. Risk factor adapted treatment of Hodgkin's lymphoma in childhood: strategies and results of three consecutive multicenter studies in the Federal Republic of Germany. Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer, {Recent-Results-Cancer-Res}, 1989, vol. 117, p. 205-13, 7 refs, ISSN: 0080-0015.Schellong-G, Hoernig-I, Schwarze-E-W, Wannenmacher-M. Kinderklinik, Muenster, FRG. Risk factor adapted treatment of Hodgkin's lymphoma in childhood: strategies and results of three consecutive multicenter studies in the Federal Republic of Germany. Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les reche...

Active substance: PROCARBAZINE

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Document reference: 34833

Study title: Giustina A et al. Effects of exogenous growth hormone pretreatment on the pituitary growth hormone response to growth hormone-releasing hormone alone or in combination with pyridostigmine in type I diabetic patients. Acta Endocrinol (Copenh). 1991 Nov;125(5):510-7Giustina A et al. Effects of exogenous growth hormone pretreatment on the pituitary growth hormone response to growth hormone-releasing hormone alone or in combination with pyridostigmine in type I diabetic patients. Acta Endocrinol (Copenh). 1991 Nov;125(5):510-7

Active substance: PYRIDOSTIGMINE

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Document reference: 35205

Study title: Giustina A et al. Effects of pyridostigmine on spontaneous and growth hormone-releasing hormone stimulated growth hormone secretion in children on daily glucocorticoid therapy after liver transplantation. Clin Endocrinol (Oxf). 1991 Dec;35(6):491-8Giustina A et al. Effects of pyridostigmine on spontaneous and growth hormone-releasing hormone stimulated growth hormone secretion in children on daily glucocorticoid therapy after liver transplantation. Clin Endocrinol (Oxf). 1991 Dec;35(6):491-8

Active substance: PYRIDOSTIGMINE

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Document reference: 35204

Study title: Giustina A et al. Impaired growth hormone (GH) response to pyridostigmine in type 1 diabetic patients with exaggerated GH-releasing hormone-stimulated GH secretion. J Clin Endocrinol Metab. 1990 Dec;71(6):1486-90 Giustina A et al. Impaired growth hormone (GH) response to pyridostigmine in type 1 diabetic patients with exaggerated GH-releasing hormone-stimulated GH secretion. J Clin Endocrinol Metab. 1990 Dec;71(6):1486-90

Active substance: PYRIDOSTIGMINE

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Document reference: 35211

Study title: Glikson M et al. The influence of pyridostigmine administration on human neuromuscular functions--studies in healthy human subjects. Fundam Appl Toxicol. 1991 Feb;16(2):288-98Glikson M et al. The influence of pyridostigmine administration on human neuromuscular functions--studies in healthy human subjects. Fundam Appl Toxicol. 1991 Feb;16(2):288-98

Active substance: PYRIDOSTIGMINE

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Document reference: 35209

Study title: Guzzaloni G, Grugni G, Morabito F. Growth hormone response to hexarelin, growth hormone-releasing hormone plus pyridostigmine and arginine plus estrogen in prepubertal and early pubertal short children. Minerva Endocrinol. 1998 Dec;23(4):99-104Guzzaloni G, Grugni G, Morabito F. Growth hormone response to hexarelin, growth hormone-releasing hormone plus pyridostigmine and arginine plus estrogen in prepubertal and early pubertal short children. Minerva Endocrinol. 1998 Dec;23(4):99-104

Active substance: PYRIDOSTIGMINE

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Document reference: 35192

Study title: Gyermek L. Clinical studies on the reversal of the neuromuscular blockade produced by pancuronium bromide. I. The effects of glycopyrrolate and pyridostigmine. Curr Ther Res Clin Exp. 1975 Sep;18(3):377-86Gyermek L. Clinical studies on the reversal of the neuromuscular blockade produced by pancuronium bromide. I. The effects of glycopyrrolate and pyridostigmine. Curr Ther Res Clin Exp. 1975 Sep;18(3):377-86

Active substance: PYRIDOSTIGMINE

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Document reference: 35219

Study title: Hanck A. Verhuetung und Behandlung der postoperativen Daratonie und anderer Formen des paralytischen Ileus mit Bepanthen Roche. Therapiewoche 1977;27:6878, 1881-4, 6887. Hanck A. Verhuetung und Behandlung der postoperativen Daratonie und anderer Formen des paralytischen Ileus mit Bepanthen Roche. Therapiewoche 1977;27:6878, 1881-4, 6887.

Active substance: PYRIDOSTIGMINE

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Document reference: 35227

Study title: Hepatic enzyme abnormalities in children on triple therapy for tuberbulosis - Corrigan D, Paton J. - 1999 (Pediatr Pulmonol. 27(1): 37 - 42) Hepatic enzyme abnormalities in children on triple therapy for tuberbulosis - Corrigan D, Paton J. - 1999 (Pediatr Pulmonol. 27(1): 37 - 42)

Active substance: RIFAMYCIN

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Document reference: 35382

Study title: Intraventricular chemotherapy in neonatal meningitis - E. L. Lee et al - 1977 (J. Pediat., 91. 991 - 995) Intraventricular chemotherapy in neonatal meningitis - E. L. Lee et al - 1977 (J. Pediat., 91. 991 - 995)

Active substance: RIFAMYCIN

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Document reference: 35383

Study title: Wilson

Active substance: PROMETHAZINE AND MAGNESIUM BROMHYDRATE GLUTAMATE

Study summary document link (including results): Wilson_NoPublicado.pdf

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Document reference: 48134

Study title: Wirksamkeit und Vertraeglichkeit von Rytmonorm 10 mg, Dragees, bei Kindern - Ergebnisse einer multizentrischen Studie - (Efficacy and safety of Rytmonorm 10 mg sugar-coated tablets in children - Results of a multicentre study -)

Active substance: PROPAFENONE

Study summary document link (including results): propafenone-m03681.pdf

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Document reference: 35059

Study title: A comparative evaluation of Diprivan (propofol) versus standard anesthetic techniques when administered for the induction and maintenance of general anesthesia in pediatric patients undergoing surgical procedures of one hour or greater duration

Active substance: PROPOFOL

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Document reference: 46124

Study title: 16. Cabrera, Garcia, MD J 1961 ; 10 : 217-220 16. Cabrera, Garcia, MD J 1961 ; 10 : 217-220

Active substance: PYRVINIUM

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Document reference: 39545

Study title: 17. Carlier, Witry, Rev Med Liege 1965; 20: 461-465 17. Carlier, Witry, Rev Med Liege 1965; 20: 461-465

Active substance: PYRVINIUM

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Document reference: 39546

Study title: 18. Cervova, Cs Pediat 1973; 28: 43 18. Cervova, Cs Pediat 1973; 28: 43

Active substance: PYRVINIUM

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Document reference: 39547

Study title: 19. Chavarria, Lizano, Indian Pract 1967; 20: 25-29 19. Chavarria, Lizano, Indian Pract 1967; 20: 25-29

Active substance: PYRVINIUM

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Document reference: 39548

Study title: 2. Adiao et al., J Philipp Med Assoc 1961; 37: 485-488 2. Adiao et al., J Philipp Med Assoc 1961; 37: 485-488

Active substance: PYRVINIUM

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Document reference: 39531

Study title: 20. Cho et al., Korean J of Parasitology 1977; 2: 100-108 20. Cho et al., Korean J of Parasitology 1977; 2: 100-108

Active substance: PYRVINIUM

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Document reference: 39549

Study title: 21. Davis, Am J Dis Child 1966; 112: 49-51 21. Davis, Am J Dis Child 1966; 112: 49-51

Active substance: PYRVINIUM

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Document reference: 39550

Study title: 22. Desai, BMJ 1962; 2: 1583-1585 22. Desai, BMJ 1962; 2: 1583-1585

Active substance: PYRVINIUM

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Document reference: 39551

Study title: 23. Eriksen, Ugeskr Laeg 1964; 126: 801-803 23. Eriksen, Ugeskr Laeg 1964; 126: 801-803

Active substance: PYRVINIUM

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Document reference: 39552

Study title: 24. Fossati, Minerva Med 1964; 55: 3578-3580 24. Fossati, Minerva Med 1964; 55: 3578-3580

Active substance: PYRVINIUM

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Document reference: 39553

Study title: 25. Fritz, Wiener Med Wochenschrift 1965; 115: 122-124 25. Fritz, Wiener Med Wochenschrift 1965; 115: 122-124

Active substance: PYRVINIUM

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Document reference: 39554

Study title: 26. Garin, Pediatrie 1962; 17: 551-559 26. Garin, Pediatrie 1962; 17: 551-559

Active substance: PYRVINIUM

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Document reference: 39555

Study title: Takamuro_ShinyakuToRinsho

Active substance: PROMETHAZINE AND MAGNESIUM BROMHYDRATE GLUTAMATE

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Document reference: 48133

Study title: 27. Giberti, Lenge, Prensa Med Arg 1961; 48: 2096-2097 27. Giberti, Lenge, Prensa Med Arg 1961; 48: 2096-2097

Active substance: PYRVINIUM

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Document reference: 39556

Study title: 15. Bumbalo et al., Am J Dis Child 1960; 99: 617-621 15. Bumbalo et al., Am J Dis Child 1960; 99: 617-621

Active substance: PYRVINIUM

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Document reference: 39544

Study title: 28. Grinenko et al., Med Parazitol 1970; 39: 390-391 28. Grinenko et al., Med Parazitol 1970; 39: 390-391

Active substance: PYRVINIUM

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Document reference: 39557

Study title: 29. Hsieh et al., J Formosan Med Assoc 1963; 62: 373-378 29. Hsieh et al., J Formosan Med Assoc 1963; 62: 373-378

Active substance: PYRVINIUM

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Document reference: 39558

Study title: Poeta G. Rass Dermatol Sifilogr 1980;33:29-34 . Therapeutic use of methisoprinol in the treatment of herpes virus infectionsPoeta G. Rass Dermatol Sifilogr 1980;33:29-34 . Therapeutic use of methisoprinol in the treatment of herpes virus infections

Active substance: INOSINE

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Document reference: 30157

Study title: Precchia et al. Chemioterapia Antimicrobia [Italy] Jan 1981 4 (1): 64 -69 Methisoprinol in the therapy of viral diseases: preliminary data relative to a set of diseasesPrecchia et al. Chemioterapia Antimicrobia [Italy] Jan 1981 4 (1): 64 -69 Methisoprinol in the therapy of viral diseases: preliminary data relative to a set of diseases

Active substance: INOSINE

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Document reference: 30159

Study title: Precchia et al. Methisoprinol in the therapy of viral diseases: preliminary data relative to a set of diseases Chemioterapia Antimicrobia [Italy] Jan 1981 4 (1): 64 -69, 32 patients, 2 months – 10 years, 500 mg tablet Precchia et al. Methisoprinol in the therapy of viral diseases: preliminary data relative to a set of diseases Chemioterapia Antimicrobia [Italy] Jan 1981 4 (1): 64 -69, 32 patients, 2 months – 10 years, 500 mg tablet

Active substance: INOSINE

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Document reference: 30160

Study title: Robert J, Ghipponi J, Guerrier G, Noiret A, Springer G, Carron R. Gazette Medicale [original in French]. 1987; 94(45):60-62. Prevention of recurrent respiratory infections in children with [use of] Isoprinosine®Robert J, Ghipponi J, Guerrier G, Noiret A, Springer G, Carron R. Gazette Medicale [original in French]. 1987; 94(45):60-62. Prevention of recurrent respiratory infections in children with [use of] Isoprinosine®

Active substance: INOSINE

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Document reference: 30161

Study title: Rouis BO, HamzaM, Doumbe P Laboratoires Delande; Paris 1987. Clinical Study Report Double-blind, placebo-controlled study of Isoprinosine for the treatment of severe or complicated measles.Rouis BO, HamzaM, Doumbe P Laboratoires Delande; Paris 1987. Clinical Study Report Double-blind, placebo-controlled study of Isoprinosine for the treatment of severe or complicated measles.

Active substance: INOSINE

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Document reference: 30162

Study title: Salas MA, Rossotti N et al. Orient Med 1972;21:551-555. Treatment of some pediatric viral infections with IsoprinosineSalas MA, Rossotti N et al. Orient Med 1972;21:551-555. Treatment of some pediatric viral infections with Isoprinosine

Active substance: INOSINE

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Document reference: 30163

Study title: Santangelo G, Lombardo S, Randazzo S, Maccarrone N, Amato M. Aggiornamento Pediatrico; 1981; 32:1-24. Viruxan® in the treatment of viral infections in children. Therapeutic prospects for the treatment of recurrent viral infections in infants.Santangelo G, Lombardo S, Randazzo S, Maccarrone N, Amato M. Aggiornamento Pediatrico; 1981; 32:1-24. Viruxan® in the treatment of viral infections in children. Therapeutic prospects for the treatment of recurrent viral infections in infants.

Active substance: INOSINE

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Document reference: 30164

Study title: Schaison, AG. (1977) [in French]. In: Journal Officiel du Hpital Saint-Louis, Paris. May 6. Expert Clinical Report. Isoprinosine in the immunodepressed patient: discussion of the results of a clinical study on the effectiveness conducted in a leukemia treatment centerSchaison, AG. (1977) [in French]. In: Journal Officiel du Hpital Saint-Louis, Paris. May 6. Expert Clinical Report. Isoprinosine in the immunodepressed patient: discussion of the results of a clinical study on the effectiveness conducted in a leukemia treatment center

Active substance: INOSINE

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Document reference: 30165

Study title: Serdaroglu A, Gucuyener K, Dursun I, Aydin K, Okuyaz C, Subasi M, Or M, Ozkan B. Ocul Immunol Inflamm. 2005 Sep-Oct;13(5):405-10. Macular retinitis as a first sign of subacute sclerosing panencephalitis: the importance of early diagnosisSerdaroglu A, Gucuyener K, Dursun I, Aydin K, Okuyaz C, Subasi M, Or M, Ozkan B. Ocul Immunol Inflamm. 2005 Sep-Oct;13(5):405-10. Macular retinitis as a first sign of subacute sclerosing panencephalitis: the importance of early diagnosis

Active substance: INOSINE

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Document reference: 30166

Study title: Sobczyk W, Kulczycki J, Pilkowska E, Iwinska B, Milewska D, Szmigielski S. Neurol Neurochir Pol. 1991 Sep-Oct;25(5):626-33. Comparison of the results of the treatment of patients with SSPE using various immunomodulating preparationsSobczyk W, Kulczycki J, Pilkowska E, Iwinska B, Milewska D, Szmigielski S. Neurol Neurochir Pol. 1991 Sep-Oct;25(5):626-33. Comparison of the results of the treatment of patients with SSPE using various immunomodulating preparations

Active substance: INOSINE

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Document reference: 30167

Study title: Sobczyk W, Pilkowska E, Iwinska-Buksowicz B, Jakubowska T. Neurol Neurochir Pol. 1997 Nov-Dec;31(6):1147-56. Polish. Assessment of early treatment results with antineoplaston AS2-1 in subacute sclerosing PanencephalitisSobczyk W, Pilkowska E, Iwinska-Buksowicz B, Jakubowska T. Neurol Neurochir Pol. 1997 Nov-Dec;31(6):1147-56. Polish. Assessment of early treatment results with antineoplaston AS2-1 in subacute sclerosing Panencephalitis

Active substance: INOSINE

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Document reference: 30168

Study title: J Radiol. 1999 Jul;80(7):727-32. [Comparison of iodixanol (Visipaque) and ioxaglate (Hexabrix) in coronary angiography and ventriculography: a double-blind randomized study] [Article in French] Roriz R, de Gevigney G, Finet G, Nantois-Collet C, Borch KW, Amiel M, Beaune J. J Radiol. 1999 Jul;80(7):727-32. [Comparison of iodixanol (Visipaque) and ioxaglate (Hexabrix) in coronary angiography and ventriculography: a double-blind randomized study] [Article in French] Roriz R, de Gevigney G, Finet G, Nantois-Collet C, Borch KW, Amiel M, Beaune J.

Active substance: IODIXANOL

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Document reference: 30350

Study title: Kryst L, Kowalik S, Barthowski S, Henning g: Multicenter comparative clinical trial of the treatment of alveolitis after tooth extraction with Solcoseryl Dental Adhesive Paste and Apernyl. Czas. Stomat. 1990, 43, 334-341 Kryst L, Kowalik S, Barthowski S, Henning g: Multicenter comparative clinical trial of the treatment of alveolitis after tooth extraction with Solcoseryl Dental Adhesive Paste and Apernyl. Czas. Stomat. 1990, 43, 334-341

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35091

Study title: Krystkowa M. Krystyna; Hydzikowa Marta: Application of Solcoseryl eye-gel in the treatment of certain corneal and conjunctival disease. Transl. from Klin. Ozna (Warszawa) 86, 457-495 (1985) Krystkowa M. Krystyna; Hydzikowa Marta: Application of Solcoseryl eye-gel in the treatment of certain corneal and conjunctival disease. Transl. from Klin. Ozna (Warszawa) 86, 457-495 (1985)

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35101

Study title: "Marichy J. et al: The wound healing efffect of Solcoseyl oinment in the treatment of children with burns. Acta Therap. Brussels 10, 107-117 (1984) " "Marichy J. et al: The wound healing efffect of Solcoseyl oinment in the treatment of children with burns. Acta Therap. Brussels 10, 107-117 (1984) "

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35095

Study title: Menna F., Napolitano F.: The application of Cysteine gel and Solcoseryl eye gel in different corneal diseases. Proceedings of the IVth World Congress of Ergophtalmology, Italy, May, 1985. Editor: Gennaro G, Naples. Menna F., Napolitano F.: The application of Cysteine gel and Solcoseryl eye gel in different corneal diseases. Proceedings of the IVth World Congress of Ergophtalmology, Italy, May, 1985. Editor: Gennaro G, Naples.

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35105

Study title: Metah D: Treatment of lesions of the oral mucosa with Solcoseryl Dental Adhesive Paste. Zahnärztliche Praxis, 1987; 38 (4) 137-139 " Metah D: Treatment of lesions of the oral mucosa with Solcoseryl Dental Adhesive Paste. Zahnärztliche Praxis, 1987; 38 (4) 137-139 "

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35097

Study title: Nakova N, Belazelkaska Z, Bogdanovski I, Glavas E: SDAP for the treatment of chronic recurrent aphthous stomatitis and decubital ulcers in the buccal cavity. Accepted for publication by serbian Dental Journal 1, 1991 Nakova N, Belazelkaska Z, Bogdanovski I, Glavas E: SDAP for the treatment of chronic recurrent aphthous stomatitis and decubital ulcers in the buccal cavity. Accepted for publication by serbian Dental Journal 1, 1991

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35098

Study title: Osamu Maki: Clinical use of Solcoseryl Eeye-gel in anterior ocular diseases. Jap. Rev.clin. Ophtal. 63, 488-489, (1968) Osamu Maki: Clinical use of Solcoseryl Eeye-gel in anterior ocular diseases. Jap. Rev.clin. Ophtal. 63, 488-489, (1968)

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35100

Study title: Popov N: Solcoseryl Dental Adhesive Paste - Results of a clinical investigation and its use with oral implants. Stomatologija 1988, 6, 47-50 Popov N: Solcoseryl Dental Adhesive Paste - Results of a clinical investigation and its use with oral implants. Stomatologija 1988, 6, 47-50

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35088

Study title: La Rifamycine SV dans les infections pulmonaires aigüe en pédiatrie - M. De Vriendt - 1967 (Brux. Méd., 47. 169 - 181) La Rifamycine SV dans les infections pulmonaires aigüe en pédiatrie - M. De Vriendt - 1967 (Brux. Méd., 47. 169 - 181)

Active substance: RIFAMYCIN

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Document reference: 35384

Study title: Valoracion de la Rifamicina SV en la practica pediatrica - O. Turro et al - 1965 (Sem. Med., 127. 239 - 241.) Valoracion de la Rifamicina SV en la practica pediatrica - O. Turro et al - 1965 (Sem. Med., 127. 239 - 241.)

Active substance: RIFAMYCIN

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Document reference: 35385

Study title: Beseghi; Comparison of two non-absorbable antibiotics for treatment of bacterial enteritis in children; European Review for Medical and Pharmacological SciencesBeseghi; Comparison of two non-absorbable antibiotics for treatment of bacterial enteritis in children; European Review for Medical and Pharmacological Sciences

Active substance: RIFAXIMIN

Study summary document link (including results): rifaximin-article-Beseghi.pdf

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Document reference: 47563

Study title: Curr Med Res Opin. 1997;14(1):39-45. An open, controlled study of two non-absorbable antibiotics for the oral treatment of paediatric infectious diarrhoea. Frisari L, Viggiano V, Pelagalli M. Curr Med Res Opin. 1997;14(1):39-45. An open, controlled study of two non-absorbable antibiotics for the oral treatment of paediatric infectious diarrhoea. Frisari L, Viggiano V, Pelagalli M.

Active substance: RIFAXIMIN

Study summary document link (including results): 2011-05-20-Clin Dat Results-Alfa Wassermann.xls

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Document reference: 47566

Study title: De Castro; RIFAXIMIN TREATMENT FOR ACUTE RECURRENT DIARRHEA IN CHILDREN WITH GENITOURINARY DISORDERSDe Castro; RIFAXIMIN TREATMENT FOR ACUTE RECURRENT DIARRHEA IN CHILDREN WITH GENITOURINARY DISORDERS

Active substance: RIFAXIMIN

Study summary document link (including results): rifaximin-article-De Castro.pdf

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Document reference: 47564

Study title: Muniyappa; Use of Rifaximin in Pediatric Patients with Inflammatory Bowel DiseaseMuniyappa; Use of Rifaximin in Pediatric Patients with Inflammatory Bowel Disease

Active substance: RIFAXIMIN

Study summary document link (including results): rifaximin-article-Muniyappa.pdf

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Document reference: 47565

Study title: Ocular-hypertensive and anti-inflammatory response to rimexolone therapy in children. Fan DS, Yu CB, Chiu TY, Wong CY, Ng JS, Pang CP, Lam DS. Arch Ophthalmol. 2003 Dec;121(12):1716-21.Ocular-hypertensive and anti-inflammatory response to rimexolone therapy in children. Fan DS, Yu CB, Chiu TY, Wong CY, Ng JS, Pang CP, Lam DS. Arch Ophthalmol. 2003 Dec;121(12):1716-21.

Active substance: RIMEXOLONE

Study summary document link (including results): Ocular-hypertensive and anti-inflammatory response to rimexo.pdf

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Document reference: 35387

Study title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study of One year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate, in Children ≥ 4 to < 16 Years Old with Osteogenesis Imperfecta

Active substance: RISEDRONIC ACID

Study summary document link (including results): Risedronate sodium - Study 1.pdf

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Document reference: 35389

Study title: Muriel-F-S, Roca-Garcia-C, Schwartz-L, et-al. Grupo Argentino Tratam. Leucem. Aguda, Buenos Aires, Argentina. Comparison of two consecutive trials for treatment of childhood non-Hodgkin lymphoma. Proceedings of the American Association for Cancer Research {PROC-AM-ASSOC-CANCER-RES}, 1981, Vol/Iss/Pg. Vol. 22/- (778).Muriel-F-S, Roca-Garcia-C, Schwartz-L, et-al. Grupo Argentino Tratam. Leucem. Aguda, Buenos Aires, Argentina. Comparison of two consecutive trials for treatment of childhood non-Hodgkin lymphoma. Proceedings of the American Association for Cancer Research {PROC-AM-ASSOC-CANCER-RES}, 1981, Vol/Iss/Pg. Vol. 22/- (778).

Active substance: PROCARBAZINE

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Document reference: 34788

Study title: 30. Kleinschmidt, Med Welt 1963; 14: 377-379 30. Kleinschmidt, Med Welt 1963; 14: 377-379

Active substance: PYRVINIUM

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Document reference: 39559

Study title: 31. Kluska, Tzegota, Wiad Parazytol 1965; 11: 619-620 31. Kluska, Tzegota, Wiad Parazytol 1965; 11: 619-620

Active substance: PYRVINIUM

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Document reference: 39560

Study title: 32. Marzullo, Squadrini, G Mal Infett Parassit 1963; 15: 465-467 32. Marzullo, Squadrini, G Mal Infett Parassit 1963; 15: 465-467

Active substance: PYRVINIUM

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Document reference: 39561

Study title: 33. Milosavljevic, Lambrechts, Rev Med Liege 1964; 19: 449-452 33. Milosavljevic, Lambrechts, Rev Med Liege 1964; 19: 449-452

Active substance: PYRVINIUM

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Document reference: 39562

Study title: 34. Molla, Donald, J Int Med Res 1977; 5: 136-138 34. Molla, Donald, J Int Med Res 1977; 5: 136-138

Active substance: PYRVINIUM

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Document reference: 39563

Study title: Garaventa-A, Haupt-R, Panarello-C, Dodero-P, Gambini-C, Gambaro-M. Department of Pediatric Haematology/Oncology, G. Gaslini Children's Hospital, Genova, Italy. Early occurrence of a secondary thyroid carcinoma in a child treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Mar 2001, vol. 36, no. 3, p. 396-7, ISSN: 0098-1532.Garaventa-A, Haupt-R, Panarello-C, Dodero-P, Gambini-C, Gambaro-M. Department of Pediatric Haematology/Oncology, G. Gaslini Children's Hospital, Genova, Italy. Early occurrence of a secondary thyroid carcinoma in a child treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Mar 2001, vol. 36, no. 3, p. 396-7, ISSN: 0098-1532.

Active substance: PROCARBAZINE

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Document reference: 34715

Study title: Garber-J-E. Dana-Farber Cancer Institute, Boston, MA 02115, United States. Long-term follow-up of children exposed in utero to antineoplastic agents. Seminars in Oncology {SEMIN-ONCOL}, 1989, Vol/Iss/Pg. 16/5 (437-444). ISSN: 0093-7754.Garber-J-E. Dana-Farber Cancer Institute, Boston, MA 02115, United States. Long-term follow-up of children exposed in utero to antineoplastic agents. Seminars in Oncology {SEMIN-ONCOL}, 1989, Vol/Iss/Pg. 16/5 (437-444). ISSN: 0093-7754.

Active substance: PROCARBAZINE

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Document reference: 34716

Study title: Gentet-J-C, Bouffet-E, Doz-F, Tron-P, Roche-H, Thyss-A, Plantaz-D, Stephan-J-L, Mottolese-C, Ponvert-D, Carrie-C, Raybaud-C, Brunat-Mentigny-M, Choux-M, Philip-T, Zucker-J-M, Bernard-J-L. Service d'Oncologie Pediatrique, Hopital d'Enfants de la Timone,13385 Marseille Cedex 5, France. Preirradiation chemotherapy including 'eight drugs in 1 day' regimen and high-dose methotrexate in childhood medulloblastoma: Results of the M7 French Cooperative Study. Journal of Neurosurgery {J-NEUROSURG}, 1995, Vol/Iss/Pg. 82/4 (608-614), ISSN: 0022-3085.Gentet-J-C, Bouffet-E, Doz-F, Tron-P, Roche-H, Thyss-A, Plantaz-D, Stephan-J-L, Mottolese-C, Ponvert-D, Carrie-C, Raybaud-C, Brunat-Mentigny-M, Choux-M, Philip-T, Zucker-J-M, Bernard-J-L. Service d'Oncologie Pediatrique, Hopital...

Active substance: PROCARBAZINE

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Document reference: 34717

Study title: Geyer-J-R, Finlay-J-L, Boyett-J-M, Wisoff-J, Yates-A, Mao-L, Packer-R-J. Publications Office, Childrens Cancer Group, P.O. Box 60012, Arcadia, CA 91066-6012, United States. Survival of infants with malignant astrocytomas: A report from the Childrens Cancer Group. Cancer {CANCER}, 1995, Vol/Iss/Pg. 75/4 (1045-1050), ISSN: 0008-543X.Geyer-J-R, Finlay-J-L, Boyett-J-M, Wisoff-J, Yates-A, Mao-L, Packer-R-J. Publications Office, Childrens Cancer Group, P.O. Box 60012, Arcadia, CA 91066-6012, United States. Survival of infants with malignant astrocytomas: A report from the Childrens Cancer Group. Cancer {CANCER}, 1995, Vol/Iss/Pg. 75/4 (1045-1050), ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34718

Study title: Iodine-supplementation trials;Peter OD Pharoah. Am J Clin Nutr Suppl 1993;57:276S-9S. Iodine-supplementation trials;Peter OD Pharoah. Am J Clin Nutr Suppl 1993;57:276S-9S.

Active substance: IODINE

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Document reference: 30274

Study title: Three Dimensional CT Angiography for Patients with Congenital Heart Disease: Scanning Protocol for Pediatric PatientsJelnin V 2006. Catheterization and Cardiovascular Interventions 67:120-126 (2006)

Active substance: IODIXANOL

Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc

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Document reference: 48200

Study title: J Nucl Med Technol. 2007 Mar;35(1):21-6.Reproducibility of a standardized quantitative analysis using fixed regions of interest to differentiate movement disorders on 123I-FP-CIT SPECT. Stokkel MP, Dibbets-Schneider P, Koestering E, Dragoiescu C, Blokland KA. J Nucl Med Technol. 2007 Mar;35(1):21-6.Reproducibility of a standardized quantitative analysis using fixed regions of interest to differentiate movement disorders on 123I-FP-CIT SPECT. Stokkel MP, Dibbets-Schneider P, Koestering E, Dragoiescu C, Blokland KA.

Active substance: ioflupane (123l)

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Document reference: 41498

Study title: Neurology. 2001 Jan 23;56(2):266-7. SPECT imaging of the dopamine transporter in juvenile-onset dystonia. O'Sullivan JD, Costa DC, Gacinovic S, Lees AJ.Neurology. 2001 Jan 23;56(2):266-7. SPECT imaging of the dopamine transporter in juvenile-onset dystonia. O'Sullivan JD, Costa DC, Gacinovic S, Lees AJ.

Active substance: ioflupane (123l)

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Document reference: 41501

Study title: Neurology. 2004 Dec 14;63(11):2097-103. Imaging of dopaminergic dysfunction with [123I]FP-CIT SPECT in early-onset parkin disease. Varrone A, Pellecchia MT, Amboni M, Sansone V, Salvatore E, Ghezzi D, Garavaglia B, Brice A, Brunetti A, Bonavita V, De Michele G, Salvatore M, Pappatà S, Barone P. Neurology. 2004 Dec 14;63(11):2097-103. Imaging of dopaminergic dysfunction with [123I]FP-CIT SPECT in early-onset parkin disease. Varrone A, Pellecchia MT, Amboni M, Sansone V, Salvatore E, Ghezzi D, Garavaglia B, Brice A, Brunetti A, Bonavita V, De Michele G, Salvatore M, Pappatà S, Barone P.

Active substance: ioflupane (123l)

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Document reference: 41499

Study title: Double-blind comparative study of Ultravist, Solutrast and Omnipaque in excretory urography in children

Active substance: IOHEXOL

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Document reference: 30357

Study title: Transplacental passage in rats and rabbits

Active substance: CICLOSPORIN

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Document reference: 24112

Study title: Acta Radiol Diagn (Stockh). 1984;25(2):155-8 Iohexol and metrizoate in urography in children. Comparison between a non-ionic and an ionic contrast medium. Bolz KD, Skalpe IO, Gutteberg TJ Acta Radiol Diagn (Stockh). 1984;25(2):155-8 Iohexol and metrizoate in urography in children. Comparison between a non-ionic and an ionic contrast medium. Bolz KD, Skalpe IO, Gutteberg TJ

Active substance: IOHEXOL

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Document reference: 30358

Study title: Acta Radiol Suppl. 1983;366:126-33 Non-ionic contrast media in cardioangiography in infants. A comparison of iohexol and metrizamide. Hellström M, Jacobsson B, Eriksson BO, Jagenburg R Acta Radiol Suppl. 1983;366:126-33 Non-ionic contrast media in cardioangiography in infants. A comparison of iohexol and metrizamide. Hellström M, Jacobsson B, Eriksson BO, Jagenburg R

Active substance: IOHEXOL

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Document reference: 30359

Study title: Acta Radiol Suppl. 1983;366:25-9 Iohexol in urography. Survey and present state. Ekelund L. Acta Radiol Suppl. 1983;366:25-9 Iohexol in urography. Survey and present state. Ekelund L.

Active substance: IOHEXOL

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Document reference: 30360

Study title: Acta Radiol. 1989 Nov-Dec;30(6):643-6 Influence of urography on renal function in children. A double blind study with metrizoate and iohexol. Stake G, Monn E, Rootwelt K, Golman K, Monclair T Acta Radiol. 1989 Nov-Dec;30(6):643-6 Influence of urography on renal function in children. A double blind study with metrizoate and iohexol. Stake G, Monn E, Rootwelt K, Golman K, Monclair T

Active substance: IOHEXOL

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Document reference: 30361

Study title: EMLA: an aid to suture removal following cleft lip repair.

Active substance: LIDOCAINE

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Document reference: 31218

Study title: Dose-dependant Resoption of quinine after intrarectal administration to children with moderate Plasmodium falciparum Malaria - Eric Pussard et al. - 11/2004 (Antimicrobial agents and Chimiotherapy;vol. 48,No. 11:4422-4426)Dose-dependant Resoption of quinine after intrarectal administration to children with moderate Plasmodium falciparum Malaria - Eric Pussard et al. - 11/2004 (Antimicrobial agents and Chimiotherapy;vol. 48,No. 11:4422-4426)

Active substance: QUININE

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Document reference: 45080

Study title: Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152)Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152)

Active substance: QUININE

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Document reference: 45061

Study title: Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152)Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152)

Active substance: QUININE

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Document reference: 45066

Study title: Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152)Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152)

Active substance: QUININE

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Document reference: 45071

Study title: Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152)Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152)

Active substance: QUININE

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Document reference: 45076

Study title: Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152)Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152)

Active substance: QUININE

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Document reference: 45081

Study title: Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45)Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45)

Active substance: QUININE

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Document reference: 45062

Study title: Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45)Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45)

Active substance: QUININE

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Document reference: 45067

Study title: Muwakkit-S, Geara-F, Nabbout-B, Farah-R-A, Shabb-N-S, Hajjar-T, Khogali-M. Department of Pediatrics, American University of Beirut Medical Center, Lebanon. Treatment of pediatric Hodgkin's disease with chemotherapy alone or combined modality therapy. Radiation oncology investigations, {Radiat-Oncol-Investig}, 1999, vol. 7, no. 6, p. 365-73, ISSN: 1065-7541.Muwakkit-S, Geara-F, Nabbout-B, Farah-R-A, Shabb-N-S, Hajjar-T, Khogali-M. Department of Pediatrics, American University of Beirut Medical Center, Lebanon. Treatment of pediatric Hodgkin's disease with chemotherapy alone or combined modality therapy. Radiation oncology investigations, {Radiat-Oncol-Investig}, 1999, vol. 7, no. 6, p. 365-73, ISSN: 1065-7541.

Active substance: PROCARBAZINE

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Document reference: 34789

Study title: Neidhardt-M-K. I Kinderklinik, Augsburg, Germany. Treatment of medulloblastoma in children: Results and conclusions. Wiener Medizinische Wochenschrift {WIEN-MED-WOCHENSCHR}, 1983, Vol /Iss/Pg. 133/SUPPL. 78 (39-45).Neidhardt-M-K. I Kinderklinik, Augsburg, Germany. Treatment of medulloblastoma in children: Results and conclusions. Wiener Medizinische Wochenschrift {WIEN-MED-WOCHENSCHR}, 1983, Vol /Iss/Pg. 133/SUPPL. 78 (39-45).

Active substance: PROCARBAZINE

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Document reference: 34792

Study title: Neidhardt-M, Bailey-C-C, Gnekow-A, Kleihues-P, Michaelis-J, Wellek-S. (Medulloblastoma therapy studies MBL 80 and MED 84 of the Society of Pediatric Oncology and the Societe Internationale d'Oncologie Pediatrique (SIOP)). Klinische Paediatrie {Klin-Padiatr} 1987 May-Jun, VOL: 199 (3), P: 188-92, ISSN: 0300-8630.Neidhardt-M, Bailey-C-C, Gnekow-A, Kleihues-P, Michaelis-J, Wellek-S. (Medulloblastoma therapy studies MBL 80 and MED 84 of the Society of Pediatric Oncology and the Societe Internationale d'Oncologie Pediatrique (SIOP)). Klinische Paediatrie {Klin-Padiatr} 1987 May-Jun, VOL: 199 (3), P: 188-92, ISSN: 0300-8630.

Active substance: PROCARBAZINE

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Document reference: 34790

Study title: Neidhardt-M, Habermalz-H-J, Henze-G, Langermann-H-J. (Medulloblastoma study of the German Society for Pediatric Oncology, a first report). Klinische Paediatrie {Klin-Padiatr} 1982 Jul-Aug, VOL: 194 (4), P: 257-61, ISSN: 0300-8630.Neidhardt-M, Habermalz-H-J, Henze-G, Langermann-H-J. (Medulloblastoma study of the German Society for Pediatric Oncology, a first report). Klinische Paediatrie {Klin-Padiatr} 1982 Jul-Aug, VOL: 194 (4), P: 257-61, ISSN: 0300-8630.

Active substance: PROCARBAZINE

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Document reference: 34791

Study title: Oberlin-O, Habrand-J-L, Schaison-G, Leverger-G, Zucker-J-M, Olive-D, Lemerle-J. Departement de pediatrie, Institut Gustave-Roussy, Villejuif, France. (Hodgkin's disease in children. Current therapeutic strategies). Bulletin du cancer {Bull-Cancer} 1988, VOL: 75 (1), P: 53-60, ISSN: 0007-4551.Oberlin-O, Habrand-J-L, Schaison-G, Leverger-G, Zucker-J-M, Olive-D, Lemerle-J. Departement de pediatrie, Institut Gustave-Roussy, Villejuif, France. (Hodgkin's disease in children. Current therapeutic strategies). Bulletin du cancer {Bull-Cancer} 1988, VOL: 75 (1), P: 53-60, ISSN: 0007-4551.

Active substance: PROCARBAZINE

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Document reference: 34793

Study title: Oberlin-O, Bayle-C, Lemerle-J. Service de Pediatrie, Institut Gustave-Roussy, 94800 Villejuif, France. Hodgkin's disease of the child. Clinical and therapeutic peculiarities. Revue du Praticien {REV-PRAT}, 1984, Vol/Iss/Pg. 34/21 (1081-1084)Oberlin-O, Bayle-C, Lemerle-J. Service de Pediatrie, Institut Gustave-Roussy, 94800 Villejuif, France. Hodgkin's disease of the child. Clinical and therapeutic peculiarities. Revue du Praticien {REV-PRAT}, 1984, Vol/Iss/Pg. 34/21 (1081-1084)

Active substance: PROCARBAZINE

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Document reference: 34794

Study title: Geyer-J-R, Pendergrass-T-W, Milstein-J-M, Bleyer-W-A. Department of Pediatrics, University of Washington, Seattle, WA, United States. Eight drugs in one day chemotherapy in children with brain tumors: A critical toxicity appraisal. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1988, Vol/Iss/Pg. 6/6 (996-1000), ISSN: 0732-183X.Geyer-J-R, Pendergrass-T-W, Milstein-J-M, Bleyer-W-A. Department of Pediatrics, University of Washington, Seattle, WA, United States. Eight drugs in one day chemotherapy in children with brain tumors: A critical toxicity appraisal. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1988, Vol/Iss/Pg. 6/6 (996-1000), ISSN: 0732-183X.

Active substance: PROCARBAZINE

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Document reference: 34719

Study title: Prados-M, Levin-V. Department of Neurological Surgery, Brain Tumor Research Center, University of California, San Francisco, CA 94143-0520, United States. Malignant supratentorial gliomas in childhood. Pediatric Neuroscience {PEDIATR-NEUROSCI}, 1987, Vol/Iss/Pg. 13/3 (144-151), ISSN: 0255-7975.Prados-M, Levin-V. Department of Neurological Surgery, Brain Tumor Research Center, University of California, San Francisco, CA 94143-0520, United States. Malignant supratentorial gliomas in childhood. Pediatric Neuroscience {PEDIATR-NEUROSCI}, 1987, Vol/Iss/Pg. 13/3 (144-151), ISSN: 0255-7975.

Active substance: PROCARBAZINE

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Document reference: 34812

Study title: Ramsay-N-K, Coccia-P-F, Krivit-W, Bloomfield-C-D, Nesbit-M-E. Vinblastine, procarbazine, and cytosine arabinoside in combination for reinduction of childhood acute myelocytic leukemia. Cancer treatment reports, {Cancer-Treat-Rep}, Nov 1976, vol. 60, no. 11, p. 1683-5, ISSN: 0361-5960.Ramsay-N-K, Coccia-P-F, Krivit-W, Bloomfield-C-D, Nesbit-M-E. Vinblastine, procarbazine, and cytosine arabinoside in combination for reinduction of childhood acute myelocytic leukemia. Cancer treatment reports, {Cancer-Treat-Rep}, Nov 1976, vol. 60, no. 11, p. 1683-5, ISSN: 0361-5960.

Active substance: PROCARBAZINE

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Document reference: 34813

Study title: Rana-S-R, Haddy-T-B, Ashayeri-E, Goldson-A-L. Intraoperative radiotherapy in childhood malignant astrocytoma. Journal of the National Medical Association, {J-Natl-Med-Assoc}, Apr 1984, vol. 76, no. 4, p. 409-11, ISSN: 0027-9684.Rana-S-R, Haddy-T-B, Ashayeri-E, Goldson-A-L. Intraoperative radiotherapy in childhood malignant astrocytoma. Journal of the National Medical Association, {J-Natl-Med-Assoc}, Apr 1984, vol. 76, no. 4, p. 409-11, ISSN: 0027-9684.

Active substance: PROCARBAZINE

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Document reference: 34814

Study title: Roettinger-E-M. (Survival of children with primitive neuroectodermal tumors and malignant ependymomas of the central nervous system after treatment with 8 cytostatic agents in one day. A report of the Children's Cancer Group). Strahlentherapie und Onkologie : Organ der Deutschen oentgengesellschaft ... (et al), {Strahlenther-Onkol}, May 1995, vol. 171, no. 5, p. 303-4, ISSN: 0179-7158.Roettinger-E-M. (Survival of children with primitive neuroectodermal tumors and malignant ependymomas of the central nervous system after treatment with 8 cytostatic agents in one day. A report of the Children's Cancer Group). Strahlentherapie und Onkologie : Organ der Deutschen oentgengesellschaft ... (et al), {Strahlenther-Onkol}, May ...

Active substance: PROCARBAZINE

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Document reference: 34815

Study title: Rosenberg-S-A, Kaplan-H-S. The evolution and summary results of the Stanford randomized clinical trials of the management of Hodgkin's disease: 1962-1984. International journal of radiation oncology biology physics, {Int-J-Radiat-Oncol-Biol-Phys}, Jan 1985, vol. 11, no. 1, p. 5-22, ISSN: 0360-3016.Rosenberg-S-A, Kaplan-H-S. The evolution and summary results of the Stanford randomized clinical trials of the management of Hodgkin's disease: 1962-1984. International journal of radiation oncology biology physics, {Int-J-Radiat-Oncol-Biol-Phys}, Jan 1985, vol. 11, no. 1, p. 5-22, ISSN: 0360-3016.

Active substance: PROCARBAZINE

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Document reference: 34816

Study title: Cook MR et al. Side effects of low-dose pyridostigmine bromide are not related to cholinesterase inhibition. Aviat Space Environ Med. 2001 Dec;72(12):1102-6Cook MR et al. Side effects of low-dose pyridostigmine bromide are not related to cholinesterase inhibition. Aviat Space Environ Med. 2001 Dec;72(12):1102-6

Active substance: PYRIDOSTIGMINE

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Document reference: 35189

Study title: van-Eys-J, Cangir-A, Pack-R, Baram-T. Department of Pediatrics, University of Texas System Cancer Center, M. D. Anderson Hospital and Tumor Institute, Houston 77030.. Phase I trial of procarbazine as a 5-day continuous infusion in children with central nervous system tumors. Cancer treatment reports, {Cancer-Treat-Rep}, Oct 1987, vol. 71, no. 10, p. 973-4, ISSN: 0361-5960. van-Eys-J, Cangir-A, Pack-R, Baram-T. Department of Pediatrics, University of Texas System Cancer Center, M. D. Anderson Hospital and Tumor Institute, Houston 77030.. Phase I trial of procarbazine as a 5-day continuous infusion in children with central nervous system tumors. Cancer treatment reports, {Cancer-Treat-Rep}, Oct 1987, vol. 71, no. 10, p. 973-4, ISSN: 0361-5960.

Active substance: PROCARBAZINE

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Document reference: 34867

Study title: Andersen M et al. Evaluation of growth hormone assays using ratio plots. Clin Chem. 1998 May;44(5):1032-8 Andersen M et al. Evaluation of growth hormone assays using ratio plots. Clin Chem. 1998 May;44(5):1032-8

Active substance: PYRIDOSTIGMINE

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Document reference: 35193

Study title: Aquilonius SM, Hartvig P. Clinical pharmacokinetics of cholinesterase inhibitors. Clin Pharmacokinet 1986;11(3):236-49.Aquilonius SM, Hartvig P. Clinical pharmacokinetics of cholinesterase inhibitors. Clin Pharmacokinet 1986;11(3):236-49.

Active substance: PYRIDOSTIGMINE

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Document reference: 35225

Study title: Arvat E et al. The enhancing effect of pyridostigmine on the GH response to GHRH undergoes an accelerated age-related reduction in Down syndrome. Dementia. 1996 Sep-Oct;7(5):288-92Arvat E et al. The enhancing effect of pyridostigmine on the GH response to GHRH undergoes an accelerated age-related reduction in Down syndrome. Dementia. 1996 Sep-Oct;7(5):288-92

Active substance: PYRIDOSTIGMINE

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Document reference: 35194

Study title: Burke G et al. Distinct phenotypes of congenital acetylcholine receptor deficiency. Neuromuscul Disord. 2004 Jun;14(6):356-64Burke G et al. Distinct phenotypes of congenital acetylcholine receptor deficiency. Neuromuscul Disord. 2004 Jun;14(6):356-64

Active substance: PYRIDOSTIGMINE

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Document reference: 35185

Study title: Cappa M et al. The growth hormone response to pyridostigmine plus growth hormone releasing hormone is not influenced by pubertal maturation. J Endocrinol Invest. 1991 Jan;14(1):41-5Cappa M et al. The growth hormone response to pyridostigmine plus growth hormone releasing hormone is not influenced by pubertal maturation. J Endocrinol Invest. 1991 Jan;14(1):41-5

Active substance: PYRIDOSTIGMINE

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Document reference: 35210

Study title: Coiro V et al. Age-dependent decrease in the growth hormone response to growth hormone-releasing hormone in normally cycling women. Fertil Steril. 1996 Aug;66(2):230-4Coiro V et al. Age-dependent decrease in the growth hormone response to growth hormone-releasing hormone in normally cycling women. Fertil Steril. 1996 Aug;66(2):230-4

Active substance: PYRIDOSTIGMINE

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Document reference: 35195

Study title: Cook JE, Kolka MA, Wenger CB. Chronic pyridostigmine bromide administration: side effects among soldiers working in a desert environment. Mil Med. 1992 May;157(5):250-4 Cook JE, Kolka MA, Wenger CB. Chronic pyridostigmine bromide administration: side effects among soldiers working in a desert environment. Mil Med. 1992 May;157(5):250-4

Active substance: PYRIDOSTIGMINE

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Document reference: 35202

Study title: Cook MR et al. Physiological and performance effects of pyridostigmine bromide in healthy volunteers: a dose-response study. Psychopharmacology (Berl). 2002 Jul;162(2):186-92Cook MR et al. Physiological and performance effects of pyridostigmine bromide in healthy volunteers: a dose-response study. Psychopharmacology (Berl). 2002 Jul;162(2):186-92

Active substance: PYRIDOSTIGMINE

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Document reference: 35188

Study title: Hegewald-G, Reddemann-H, Barenwald-G, Schwanengel-H. Pathol. Inst., Ernst-Moritz-Arndt-Univ., 2200 Greifswald, Germany. Ultrastructural findings in the liver of children survived a long time after antineoplatic polychemotherapy. Archiv fur Geschwulstforschung {ARCH-GESCHWULSTFORSCH}, 1982, Vol/Iss /Pg. 52/5 (397-405).Hegewald-G, Reddemann-H, Barenwald-G, Schwanengel-H. Pathol. Inst., Ernst-Moritz-Arndt-Univ., 2200 Greifswald, Germany. Ultrastructural findings in the liver of children survived a long time after antineoplatic polychemotherapy. Archiv fur Geschwulstforschung {ARCH-GESCHWULSTFORSCH}, 1982, Vol/Iss /Pg. 52/5 (397-405).

Active substance: PROCARBAZINE

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Document reference: 34738

Study title: Heikens-J, Behrendt-H, Adriaanse-R, Berghout-A. Department of Internal Medicine, University of Amsterdam, The Netherlands. Irreversible gonadal damage in male survivors of pediatric Hodgkin's disease. Cancer, {Cancer}, 1 Nov 1996, vol. 78, no. 9, p. 2020-4, ISSN 0008-543X.Heikens-J, Behrendt-H, Adriaanse-R, Berghout-A. Department of Internal Medicine, University of Amsterdam, The Netherlands. Irreversible gonadal damage in male survivors of pediatric Hodgkin's disease. Cancer, {Cancer}, 1 Nov 1996, vol. 78, no. 9, p. 2020-4, ISSN 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34739

Study title: Horowitz-M-E, Mulhern-R-K, Kun-L-E, Kovnar-E, Sanford-R-A, Simmons-J, Hayes-F-A, Jenkins-III-J-J. Department of Hematology-Oncology, St. Jude Children's Research Hospital, Memphis, TN, United States. Brain tumors in the very young child. Postoperative chemotherapy in combined-modality treatment. Cancer {CANCER}, 1988, Vol/Iss/Pg. 61/3 (428-434), ISSN: 0008-543X.Horowitz-M-E, Mulhern-R-K, Kun-L-E, Kovnar-E, Sanford-R-A, Simmons-J, Hayes-F-A, Jenkins-III-J-J. Department of Hematology-Oncology, St. Jude Children's Research Hospital, Memphis, TN, United States. Brain tumors in the very young child. Postoperative chemotherapy in combined-modality treatment. Cancer {CANCER}, 1988, Vol/Iss/Pg. 61/3 (428-434), ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34740

Study title: Hudson-M-M, Greenwald-C, Thompson-E, Wilimas-J, Marina-N, Fairclough- D, Kauffman-W, Bozeman-P, Mackert-P-W, Abromowitch-M, Jenkins-J, Boulden-T, Kun-L. Department of Hematology-Oncology, St Jude Children's Research Hospital, PO Box 318, Memphis, TN 38101, United States. Efficacy and toxicity of multiagent chemotherapy and low-dose involved- field radiotherapy in children and adolescents with Hodgkin's disease. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1993, Vol/Iss/Pg. 11/1 (100-108), ISSN: 0732-183X.Hudson-M-M, Greenwald-C, Thompson-E, Wilimas-J, Marina-N, Fairclough- D, Kauffman-W, Bozeman-P, Mackert-P-W, Abromowitch-M, Jenkins-J, Boulden-T, Kun-L. Department of Hematology-Oncology, St Jude Children's Research Hospital, PO Box 318, Memphis...

Active substance: PROCARBAZINE

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Document reference: 34741

Study title: Huma-Z, Boulad-F, Black-P, Heller-G, Sklar-C. Department of Pediatrics, Memorial Sloan-Kettering Cancer Ctr., 1275 York Ave, New York, NY 10021, United States. Growth in children after bone marrow transplantation for acute leukemia. Blood {BLOOD}, 1995, Vol/Iss/Pg. 86/2 (819-824), ISSN: 0006-4971.Huma-Z, Boulad-F, Black-P, Heller-G, Sklar-C. Department of Pediatrics, Memorial Sloan-Kettering Cancer Ctr., 1275 York Ave, New York, NY 10021, United States. Growth in children after bone marrow transplantation for acute leukemia. Blood {BLOOD}, 1995, Vol/Iss/Pg. 86/2 (819-824), ISSN: 0006-4971.

Active substance: PROCARBAZINE

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Document reference: 34742

Study title: Zeltzer-L-K, LeBaron-S, Zeltzer-P-M. Department of Pediatrics, The University of Texas Health Science Center, San Antonio, TX 78284, United States. A prospective assessment of chemotherapy-related nausea and vomiting in children with cancer. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR-HEMATOL-ONCOL}, 1984, Vol/Iss/Pg. 6/1 (5-16).Zeltzer-L-K, LeBaron-S, Zeltzer-P-M. Department of Pediatrics, The University of Texas Health Science Center, San Antonio, TX 78284, United States. A prospective assessment of chemotherapy-related nausea and vomiting in children with cancer. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR-HEMATOL-ONCOL}, 1984, Vol/Iss/Pg. 6/1 (5-16).

Active substance: PROCARBAZINE

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Document reference: 34882

Study title: Zeltzer-L, LeBaron-S, Zeltzer-P-M. Division of Adolescent Medicine, Department of Pediatrics, The University of Texas Health Science Center at San Antonio, San Antonio, TX 78284, United States. The effectiveness of behavioral intervention for reduction of nausea and vomiting in children and adolescents receiving chemotherapy. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1984, Vol/Iss/Pg. 2/6 (683-690).Zeltzer-L, LeBaron-S, Zeltzer-P-M. Division of Adolescent Medicine, Department of Pediatrics, The University of Texas Health Science Center at San Antonio, San Antonio, TX 78284, United States. The effectiveness of behavioral intervention for reduction of nausea and vomiting in children and adolescents receiving chemotherapy. Journal of Clinical Oncolo...

Active substance: PROCARBAZINE

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Document reference: 34881

Study title: Zolezzi-P, Rubio-J, Cardemil-B, Born-R, Moraleda-L, Ramos-M-I, Albornoz-C, Amigo-O, Kyling-A, Badilla-V, et al. Instituto de Hematologia, Facultad de Medicina, Universidad Austral de Chile. (Hodgkin's disease in children. Modified COPP combined treatment and radiotherapy in advanced stages). Revista chilena de pediatria {Rev-Chil-Pediatr} 1990 Mar-Apr, VOL: 61 (2), P: 74-6, ISSN: 0370-4106.Zolezzi-P, Rubio-J, Cardemil-B, Born-R, Moraleda-L, Ramos-M-I, Albornoz-C, Amigo-O, Kyling-A, Badilla-V, et al. Instituto de Hematologia, Facultad de Medicina, Universidad Austral de Chile. (Hodgkin's disease in children. Modified COPP combined treatment and radiotherapy in advanced stages). Revista chilena de pediatria {Rev-Chil-Pediatr} 1990 Mar-Apr, VOL: 61 (2), P: 74-6, ISSN: 0...

Active substance: PROCARBAZINE

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Document reference: 34883

Study title: "Publication mentioned in CES made available in 2007 for national renewals: Options for the prevention and management of acute chemotherapy-induced nausea and vomiting in children. L.L. Dupuis, P.C. Nathan, Paediatric drugs 2003; 5(9): 597-613." "Publication mentioned in CES made available in 2007 for national renewals: Options for the prevention and management of acute chemotherapy-induced nausea and vomiting in children. L.L. Dupuis, P.C. Nathan, Paediatric drugs 2003; 5(9): 597-613."

Active substance: PROCHLOPERAZINE

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Document reference: 34969

Study title: Clinical Report - Ph. VERIN - 06.11.1973

Active substance: PROCYANIDOLIC OLIGOMERS

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Document reference: 40140

Study title: Efficacité et tolérance du progabide (SL 76.002) dans les syndromes spastiques d'origine cérébrale chez des enfants, adolescents, jeunes adultes - Ferriere G. - 04/1981

Active substance: PROGABIDE

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Document reference: 34972

Study title: "Quality of life and micronised progesterone (200 mg) in adolescent menstrual cycle disorders"

Active substance: PROGESTERONE

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication_Besins.xls

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Document reference: 34993

Study title: Double-blind randomized comparison of proglumetacin and naproxen sodium in the treatment of patients with ankle sprains [Current Therapeutic Research 1995, 56(7): 639-48].Double-blind randomized comparison of proglumetacin and naproxen sodium in the treatment of patients with ankle sprains [Current Therapeutic Research 1995, 56(7): 639-48].

Active substance: PROGLUMETACIN

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Document reference: 34995

Study title: Rosenthal-J, Arush-M-W-B, Kuten-A, Arie-J-B, Shahar-M-B, Robinson-E. Pediatric Oncology Unit, Rambam Medical Center, Haifa 31096, Israel. Hodgkin's disease in childhood: Treatment modalities, outcome and epidemiological aspects: The Northern Israel Cancer Center experience. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR- HEMATOL-ONCOL}, 1994, Vol/Iss/Pg. 16/2 (138-142), ISSN: 0192-8562.Rosenthal-J, Arush-M-W-B, Kuten-A, Arie-J-B, Shahar-M-B, Robinson-E. Pediatric Oncology Unit, Rambam Medical Center, Haifa 31096, Israel. Hodgkin's disease in childhood: Treatment modalities, outcome and epidemiological aspects: The Northern Israel Cancer Center experience. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR- HEMATOL-ONC...

Active substance: PROCARBAZINE

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Document reference: 34817

Study title: A comparative evaluation of Diprivan /Diprivan N20 versus thiopental/halothane/N20 versus Diprivan/Diprivan when administered for the induction and maintenance of general anesthesia in pedaitric patients undergoing general surgical procedures of one hour or greater duration

Active substance: PROPOFOL

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Document reference: 46125

Study title: A comparison of Diprivan (propofol) and thiopentone for induction of anaesthesia in children.

Active substance: PROPOFOL

Study summary document link (including results): 035868_0208 Study Synopsis.pdf

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Document reference: 46131

Study title: A comparison of the characteristics of propofol and methohexitone for induction and maintenance of anaesthesia in children.

Active substance: PROPOFOL

Study summary document link (including results): 035868_0248 Study Synopsis.pdf

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Document reference: 46134

Study title: A comparison of the characteristics of propofol and thiopentone for induction of general anaesthesia for paediatric surgery.

Active substance: PROPOFOL

Study summary document link (including results): 035868_0186 Study Synopsis.pdf

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Document reference: 46129

Study title: A comparison of venous tolerability and injection pain of Propofol diluted in a lipid emulsion and standard Propofol in the induction of anesthesia in children

Active substance: PROPOFOL

Study summary document link (including results): BBM0201-09_ICH-280306_FINAL-VERSION.pdf

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Document reference: 47084

Study title: A multicenter, comparative, randomized trial to determine the overall safety and efficacy of 1% Diprivan vs 2% Diprivan vs standard agents without disodium edetate for sedation of trauma, postsurgical, or critically ill paediatric subjects.

Active substance: PROPOFOL

Study summary document link (including results): 0859IL0068 Study Synopsis.pdf

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Document reference: 46137

Study title: A preliminary evaluation of the characteristics of propofol (Diprivan) for induction of general anaesthesia for paediatric surgery.

Active substance: PROPOFOL

Study summary document link (including results): 035868_0141 Study Synopsis.pdf

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Document reference: 46128

Study title: A study to assess the pharmacokinetics of propofol in young children after a single dose for induction of anaesthesia.

Active substance: PROPOFOL

Study summary document link (including results): 035868_0243 Study Synopsis.pdf

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Document reference: 46130

Study title: Cordido F, Casanueva FF, Dieguez C. Cholinergic receptor activation by pyridostigmine restores growth hormone (GH) responsiveness to GH-releasing hormone administration in obese subjects: evidence for hypothalamic somatostatinergic participation in the blunted GH release of obesity. J Clin Endocrinol Metab. 1989 Feb;68(2):290-39 Cordido F, Casanueva FF, Dieguez C. Cholinergic receptor activation by pyridostigmine restores growth hormone (GH) responsiveness to GH-releasing hormone administration in obese subjects: evidence for hypothalamic somatostatinergic participation in the blunted GH release of obesity. J Clin Endocrinol Metab. 1989 Feb;68(2):290-39

Active substance: PYRIDOSTIGMINE

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Document reference: 35215

Study title: Corrias A et al. GH/IGF-I axis in Prader-Willi syndrome: Evaluation of IGF-I levels and of the somatotroph responsiveness to various provocative stimuli. J Endocrinol Invest. April 20, 2000, 84-9Corrias A et al. GH/IGF-I axis in Prader-Willi syndrome: Evaluation of IGF-I levels and of the somatotroph responsiveness to various provocative stimuli. J Endocrinol Invest. April 20, 2000, 84-9

Active substance: PYRIDOSTIGMINE

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Document reference: 35181

Study title: Remifentanil/Propofol versus Desflurane/N2O in general surgery, opthalmic surgery and ENT surgery in children

Active substance: REMIFENTANIL

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Document reference: 35286

Study title: Remifentanil/propofol versus remifentanil/sevoflurane in- and outpatient paediatric surgery

Active substance: REMIFENTANIL

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Document reference: 35288

Study title: Remifentanil/Propofol versus Sevofluran/N2O für allgemeinchirurgische und HNO-Eingriffe bei Kindern: Ein Vergleich der Hämodynamik, des Einschlaf- und Aufwachverhaltens sowie der anästhesierelevanten Zeiten

Active substance: REMIFENTANIL

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Document reference: 35287

Study title: Küchle H. J., Busse H., Augenerkrankungen im Kindesalter, Thieme Verlag Stuttgart New York 1985 Küchle H. J., Busse H., Augenerkrankungen im Kindesalter, Thieme Verlag Stuttgart New York 1985

Active substance: RETINOL

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Document reference: 35292

Study title: A randomised controlled trial comparing low molecular weight heparin (reviparin sodium) to standard of practice unfractionated heparin plus a vitamin K antagonist for the treatment of venous thromboembolism in a pediatric patient population.

Active substance: REVIPARIN

Study summary document link (including results): Reviparin-CL052.pdf

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Document reference: 45107

Study title: An open-label dose-finding trial of low molecular weight heparin LU 47311 (Clivarine®) for the prophylaxis of deep vein thrombosis/pulmonary embolism in children with short term placement of central venous catheters.

Active substance: REVIPARIN

Study summary document link (including results): Reviparin-CL057.pdf

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Document reference: 35289

Study title: An open-label, dose-finding trial of low molecular weight heparin (Clivarine®) for the treatment of deep vein thrombosis/pulmonary embolism in a pediatric patient population.

Active substance: REVIPARIN

Study summary document link (including results): Reviparin-CL022.pdf

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Document reference: 35291

Study title: An open-label, multicenter, randomized trial comparing low molecular weight heparin (reviparin) to standard of care for the prophylaxis of deep vein thrombosis/pulmonary embolism in children with short term placement of central venous catheters.

Active substance: REVIPARIN

Study summary document link (including results): Reviparin-CL055.pdf

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Document reference: 35290

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Rheuma-Heel (tablets) [AWB-AT]

Active substance: Rheuma-Heel/ Rhumeel

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Document reference: 40154

Study title: Sobczyk W, Pilkowska E, Iwinska-Buksowicz B. Neurol Neurochir Pol. 1999 Jul-Aug;33(4):797-805. The evaluation of the use of antineoplaston AS2-1 treatment in subacute sclerosing panencephalitisSobczyk W, Pilkowska E, Iwinska-Buksowicz B. Neurol Neurochir Pol. 1999 Jul-Aug;33(4):797-805. The evaluation of the use of antineoplaston AS2-1 treatment in subacute sclerosing panencephalitis

Active substance: INOSINE

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Document reference: 30169

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Rhododendroneel S (drops) [AWB-AT]

Active substance: Rhododendroneel/ Rhododendroneel S

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Document reference: 40153

Study title: Dr Martinez (publication 20-30 years ago in neonates) 15 infants aged from 9 days to 1 year old 1973Dr Martinez (publication 20-30 years ago in neonates) 15 infants aged from 9 days to 1 year old 1973

Active substance: RHUBARB AND SALICYLIC ACID

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Document reference: 35293

Study title: Schellong-G, Poetter-R, Braemswig-J, Wagner-W, Prott-F-J, Doerffel-W, Koerholz-D, Mann-G, Rath-B, Reiter-A, Weissbach-G, Riepenhausen-M, Thiemann-M, Schwarze-E-W. Department of Pediatric Hematology and Oncology, University Children's Hospital, Germany. schellon@uni-muenster.de. High cure rates and reduced long-term toxicity in pediatric Hodgkin's disease: the German-Austrian multicenter trial DAL-HD-90. The German- Austrian Pediatric Hodgkin's Disease Study Group. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Dec 1999, vol. 17, no. 12, p. 3736-44, ISSN: 0732-183X.Schellong-G, Poetter-R, Braemswig-J, Wagner-W, Prott-F-J, Doerffel-W, Koerholz-D, Mann-G, Rath-B, Reiter-A, Weissbach-G, Riepenhausen-M, Thi...

Active substance: PROCARBAZINE

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Document reference: 34834

Study title: Schellong-G. Department of Haematology and Oncology, University Children's Hospital, Muenster, Germany. Treatment of children and adolescents with Hodgkin's disease: the experience of the German-Austrian Paediatric Study Group. Bailliere's clinical haematology, {Baillieres-Clin-Haematol}, Sep 1996, vol. 9, no. 3, p. 619-34, ISSN: 0950-3536.Schellong-G. Department of Haematology and Oncology, University Children's Hospital, Muenster, Germany. Treatment of children and adolescents with Hodgkin's disease: the experience of the German-Austrian Paediatric Study Group. Bailliere's clinical haematology, {Baillieres-Clin-Haematol}, Sep 1996, vol. 9, no. 3, p. 619-34, ISSN: 0950-3536.

Active substance: PROCARBAZINE

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Document reference: 34835

Study title: Schmitt-C, Bordigoni-P, Chastagner-P, Galloy-M-A, Bey-P, Sommelet-D. Service de Medecine Infantile II, Hopital d'Enfants, C.H.U., Nancy, France. Hodgkin's disease in childhood. Annales Medicales de Nancy et de l'Est {ANN-MED-NANCY-EST}, 1992, Vol /Iss/Pg. 31/1 (75-78), ISSN: 0221-3796.Schmitt-C, Bordigoni-P, Chastagner-P, Galloy-M-A, Bey-P, Sommelet-D. Service de Medecine Infantile II, Hopital d'Enfants, C.H.U., Nancy, France. Hodgkin's disease in childhood. Annales Medicales de Nancy et de l'Est {ANN-MED-NANCY-EST}, 1992, Vol /Iss/Pg. 31/1 (75-78), ISSN: 0221-3796.

Active substance: PROCARBAZINE

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Document reference: 34837

Study title: Schut-L, Rosenstock-J-G. Neurosurg. Serv.Child. Hosp.PhiladelphiaPa. 19146, United States. Treatment of intracranial neoplasms in children. Seminars in Oncology {SEMIN-ONCOL}, 1974, Vol/Iss/Pg. 1/1 (9-15).Schut-L, Rosenstock-J-G. Neurosurg. Serv.Child. Hosp.PhiladelphiaPa. 19146, United States. Treatment of intracranial neoplasms in children. Seminars in Oncology {SEMIN-ONCOL}, 1974, Vol/Iss/Pg. 1/1 (9-15).

Active substance: PROCARBAZINE

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Document reference: 34838

Study title: Schwabe-D, Gussetis-E, Jacobi-G, Gerein-V, Kornhuber-B. Klinik. J.W. Goethe Univ., Zentrum der Kinderheilkunde, Theodor- Stern-Kai 7,6000 Frankfurt 70, Germany. High-dose methotrexate combined with '8 in 1' in the treatment of class III/IV brain tumors in children. Klinische Padiatrie {KLIN-PADIATR}, 1992, Vol/Iss/Pg. 204/2 (72-77), ISSN: 0300-8630.Schwabe-D, Gussetis-E, Jacobi-G, Gerein-V, Kornhuber-B. Klinik. J.W. Goethe Univ., Zentrum der Kinderheilkunde, Theodor- Stern-Kai 7,6000 Frankfurt 70, Germany. High-dose methotrexate combined with '8 in 1' in the treatment of class III/IV brain tumors in children. Klinische Padiatrie {KLIN-PADIATR}, 1992, Vol/Iss/Pg. 204/2 (72-77), ISSN: 0300-8630.

Active substance: PROCARBAZINE

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Document reference: 34839

Study title: Seiler-R-W, Bernasconi-S, Berchtold-W, Feldges-A, Imbach-P, Luethi-A, Pluess-H-J, Vassella-F, Wyss-M, Wagner-H-P. Adjuvant chemotherapy with procarbazine, vincristine and prednisone for medulloblastomas. A preliminary report. Helvetica paediatrica acta, {Helv-Paediatr-Acta}, Jul 1981, vol. 36, no. 3, p. 249-54, ISSN: 0018-022X.Seiler-R-W, Bernasconi-S, Berchtold-W, Feldges-A, Imbach-P, Luethi-A, Pluess-H-J, Vassella-F, Wyss-M, Wagner-H-P. Adjuvant chemotherapy with procarbazine, vincristine and prednisone for medulloblastomas. A preliminary report. Helvetica paediatrica acta, {Helv-Paediatr-Acta}, Jul 1981, vol. 36, no. 3, p. 249-54, ISSN: 0018-022X.

Active substance: PROCARBAZINE

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Document reference: 34840

Study title: Henze T. Therapy of myasthenia gravis with cholinesterase inhibitors--principles and pharmacologic monitoring. Fortschr Neurol Psychiatr. 1996 Mar;64(3):110-21. Henze T. Therapy of myasthenia gravis with cholinesterase inhibitors--principles and pharmacologic monitoring. Fortschr Neurol Psychiatr. 1996 Mar;64(3):110-21.

Active substance: PYRIDOSTIGMINE

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Document reference: 35223

Study title: Kirk JM et al. Pyridostigmine fails to increase either spontaneous or GHRH-stimulated GH secretion during day or night in growth hormone-insufficient children. Clin Endocrinol (Oxf). 1991 May;34(5):407-11Kirk JM et al. Pyridostigmine fails to increase either spontaneous or GHRH-stimulated GH secretion during day or night in growth hormone-insufficient children. Clin Endocrinol (Oxf). 1991 May;34(5):407-11

Active substance: PYRIDOSTIGMINE

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Document reference: 35207

Study title: Loche S et al. Evidence for involvement of endogenous somatostatin in the galanin-induced growth hormone secretion in children. Pediatr Res. 1990 Apr;27(4 Pt 1):405-7Loche S et al. Evidence for involvement of endogenous somatostatin in the galanin-induced growth hormone secretion in children. Pediatr Res. 1990 Apr;27(4 Pt 1):405-7

Active substance: PYRIDOSTIGMINE

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Document reference: 35214

Study title: Loche S et al. The effect of galanin on baseline and GHRH-induced growth hormone secretion in obese children. Clin Endocrinol (Oxf). 1990 Aug;33(2):187-92Loche S et al. The effect of galanin on baseline and GHRH-induced growth hormone secretion in obese children. Clin Endocrinol (Oxf). 1990 Aug;33(2):187-92

Active substance: PYRIDOSTIGMINE

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Document reference: 35212

Study title: Morita M, Gabbai AA, Oliveira ASB, Penn AS: Myasthenia gravis in children. Arq Neuropsiquiatr 2001, 59 (3-B): 681-685 Morita M, Gabbai AA, Oliveira ASB, Penn AS: Myasthenia gravis in children. Arq Neuropsiquiatr 2001, 59 (3-B): 681-685

Active substance: PYRIDOSTIGMINE

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Document reference: 35220

Study title: Oh AY, Kim SD, Kim CS. Early and late reversal of rocuronium with pyridostigmine during sevoflurane anaesthesia in children. Anaesth Intensive Care. 2004 Oct;32(5):649-52Oh AY, Kim SD, Kim CS. Early and late reversal of rocuronium with pyridostigmine during sevoflurane anaesthesia in children. Anaesth Intensive Care. 2004 Oct;32(5):649-52

Active substance: PYRIDOSTIGMINE

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Document reference: 35184

Study title: Peino R. Acipimox-mediated plasma free fatty acid depression per se stimulates growth hormone (GH) secretion in normal subjects and potentiates the response to other GH-releasing stimuli. J Clin Endocrinol Metab. 1996 Mar;81(3):909-13Peino R. Acipimox-mediated plasma free fatty acid depression per se stimulates growth hormone (GH) secretion in normal subjects and potentiates the response to other GH-releasing stimuli. J Clin Endocrinol Metab. 1996 Mar;81(3):909-13

Active substance: PYRIDOSTIGMINE

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Document reference: 35197

Study title: Procopio M et al. Effect of arginine and pyridostigmine on the GHRH-induced GH rise in obesity and Cushing's syndrome. Int J Obes Relat Metab Disord. 1995 Feb;19(2):108-12Procopio M et al. Effect of arginine and pyridostigmine on the GHRH-induced GH rise in obesity and Cushing's syndrome. Int J Obes Relat Metab Disord. 1995 Feb;19(2):108-12

Active substance: PYRIDOSTIGMINE

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Document reference: 35199

Study title: Radetti G et al. Pyridostigmine and metoclopramide do not restore the TSH response to TRH inhibited by L-thyroxine treatment in children with goiter. J Endocrinol Invest. December 1, 2000, 744-7Radetti G et al. Pyridostigmine and metoclopramide do not restore the TSH response to TRH inhibited by L-thyroxine treatment in children with goiter. J Endocrinol Invest. December 1, 2000, 744-7

Active substance: PYRIDOSTIGMINE

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Document reference: 35180

Study title: Ram Z et al. The effect of pyridostigmine on respiratory function in healthy and asthmatic volunteers. Isr J Med Sci. 1991 Nov-Dec;27(11-12):664-8 Ram Z et al. The effect of pyridostigmine on respiratory function in healthy and asthmatic volunteers. Isr J Med Sci. 1991 Nov-Dec;27(11-12):664-8

Active substance: PYRIDOSTIGMINE

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Document reference: 35206

Study title: A study to assess the use of propofol for induction and maintenance of anaesthesia by continuous infusion for paediatric procedures.

Active substance: PROPOFOL

Study summary document link (including results): 035868_0238 Study Synopsis.pdf

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Document reference: 46133

Study title: An assessment of the characteristics of propofol for maintenance of anaesthesia by infusion for paediatric surgery.

Active substance: PROPOFOL

Study summary document link (including results): 035868_0187 Study Synopsis.pdf

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Document reference: 46132

Study title: EEG during intravenous anaesthesia with propofol in children

Active substance: PROPOFOL

Study summary document link (including results): 0859FC-0018 Study Synopsis.pdf

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Document reference: 46127

Study title: 35. do Nascimento et al., Hosp Rio de Brasilia 1962; 61: 117-121 35. do Nascimento et al., Hosp Rio de Brasilia 1962; 61: 117-121

Active substance: PYRVINIUM

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Document reference: 39564

Study title: 36. Nassif et al., J Trop Med Hyg 1974 ; 77 : 270-271 36. Nassif et al., J Trop Med Hyg 1974 ; 77 : 270-271

Active substance: PYRVINIUM

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Document reference: 39565

Study title: 38. Padelt, Flentje, childrenärztl Prax 1967; 35: 93-97 38. Padelt, Flentje, childrenärztl Prax 1967; 35: 93-97

Active substance: PYRVINIUM

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Document reference: 39567

Study title: 39. Palicka, Cesk Pediatr 1971; 26: 563-565 39. Palicka, Cesk Pediatr 1971; 26: 563-565

Active substance: PYRVINIUM

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Document reference: 39568

Study title: 4. Asmera et al., Ceskoslovenska pediatrie 1971; 26: 456-458 4. Asmera et al., Ceskoslovenska pediatrie 1971; 26: 456-458

Active substance: PYRVINIUM

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Document reference: 39533

Study title: 40. Pawlowski, Kolo-wrotkiewicz, Wiad Parazytol 1964; 10: 443-446 40. Pawlowski, Kolo-wrotkiewicz, Wiad Parazytol 1964; 10: 443-446

Active substance: PYRVINIUM

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Document reference: 39569

Study title: 41. Pazdziora, Cesk Epidemiol Mikrobiol Immunol 1976; 25: 50-55 41. Pazdziora, Cesk Epidemiol Mikrobiol Immunol 1976; 25: 50-55

Active substance: PYRVINIUM

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Document reference: 39570

Study title: 42. Pistoletti, Igiene Sania Publ 1962; 18: 42-45 42. Pistoletti, Igiene Sania Publ 1962; 18: 42-45

Active substance: PYRVINIUM

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Document reference: 39571

Study title: 43. Plotnikov et al., Med Parazytol 1970; 39: 38: 387-390 43. Plotnikov et al., Med Parazytol 1970; 39: 38: 387-390

Active substance: PYRVINIUM

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Document reference: 39572

Study title: 44. Priebe, Münch Med Wochenschr 1961; 103: 1730-1732 44. Priebe, Münch Med Wochenschr 1961; 103: 1730-1732

Active substance: PYRVINIUM

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Document reference: 39573

Study title: 45. Reitano, Pane, Riv Pediatr Seciliana 1960; 15: 270-288 45. Reitano, Pane, Riv Pediatr Seciliana 1960; 15: 270-288

Active substance: PYRVINIUM

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Document reference: 39574

Study title: 46. Rodriguez et al., J Pediatr 1960; 25: 324-330 46. Rodriguez et al., J Pediatr 1960; 25: 324-330

Active substance: PYRVINIUM

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Document reference: 39575

Study title: 47. Salem et al., J Egypt Pub Health Assoc 1961; 26: 225-233 47. Salem et al., J Egypt Pub Health Assoc 1961; 26: 225-233

Active substance: PYRVINIUM

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Document reference: 39576

Study title: 48. Sandars, Med J Aust 1963; 1: 722-725 48. Sandars, Med J Aust 1963; 1: 722-725

Active substance: PYRVINIUM

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Document reference: 39577

Study title: Spicak V, Polackova M, Tlaskalova H, Kacirek E. Presented at the 8th European Immunology Meeting; August 30 - September 5, 1987; Zagreb, Yugoslavia. (Abstract only). Modimunal®/Isoprinosine® in the treatment of asthmatic children.Spicak V, Polackova M, Tlaskalova H, Kacirek E. Presented at the 8th European Immunology Meeting; August 30 - September 5, 1987; Zagreb, Yugoslavia. (Abstract only). Modimunal®/Isoprinosine® in the treatment of asthmatic children.

Active substance: INOSINE

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Document reference: 30170

Study title: Spicak V, Polackova M, Tlaskalova H, Kaminkova J, Vanecek K. Presented at the 4th International Conference on Immunopharmacology; Kyoto, Japan; 1988. (Abstract only). Immunomodulation by Isoprinosine® in the treatment of asthmatic childrenSpicak V, Polackova M, Tlaskalova H, Kaminkova J, Vanecek K. Presented at the 4th International Conference on Immunopharmacology; Kyoto, Japan; 1988. (Abstract only). Immunomodulation by Isoprinosine® in the treatment of asthmatic children

Active substance: INOSINE

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Document reference: 30171

Study title: Sueri L, Ielasi G, Del Massa M. (1979). Presented at del Convegno Internazionale sulla Isoprinosina; April 28, Rome, Italy; 87-93. Isoprinosine® in the treatment of some acute infectious diseases of viral origin: open and double-blind studySueri L, Ielasi G, Del Massa M. (1979). Presented at del Convegno Internazionale sulla Isoprinosina; April 28, Rome, Italy; 87-93. Isoprinosine® in the treatment of some acute infectious diseases of viral origin: open and double-blind study

Active substance: INOSINE

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Document reference: 30172

Study title: Tekgul H, Tutuncuoglu S, Kutukculer N, Dizdarer G, Huseyinov A. J Child Neurol. 1999 Jul;14(7):418-21. Lymphocyte subsets and inflammatory mediators in patients with subacute sclerosing panencephalitis.Tekgul H, Tutuncuoglu S, Kutukculer N, Dizdarer G, Huseyinov A. J Child Neurol. 1999 Jul;14(7):418-21. Lymphocyte subsets and inflammatory mediators in patients with subacute sclerosing panencephalitis.

Active substance: INOSINE

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Document reference: 30173

Study title: Tepebasili I, Caksen H, Odabas D, Atas B, Akbayram S. J Emerg Med. 2004 Apr;26(3):356-9. Report of two children with subacute sclerosing panencephalitis displaying an atypical clinical course.Tepebasili I, Caksen H, Odabas D, Atas B, Akbayram S. J Emerg Med. 2004 Apr;26(3):356-9. Report of two children with subacute sclerosing panencephalitis displaying an atypical clinical course.

Active substance: INOSINE

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Document reference: 30174

Study title: Therapeutic agent for viral disease: preliminary information Therapeutic agent for viral disease: preliminary information

Active substance: INOSINE

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Document reference: 30175

Study title: Von Frenkell AR.. Laboratoires Delande; Paris 1987. Clinical Study Report. Statistical study concerning the clinical double blind study of Isoprinosine and a placebo for the the treatment of severe or complicated measlesVon Frenkell AR.. Laboratoires Delande; Paris 1987. Clinical Study Report. Statistical study concerning the clinical double blind study of Isoprinosine and a placebo for the the treatment of severe or complicated measles

Active substance: INOSINE

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Document reference: 30176

Study title: Wiedermann D, Widermannova D, Lokaj J. Scripta Medica [Czech edition from Brno]. 1986; 59(7):415-424. Several parameters of cellular and humoral immune function in children with recurrent respiratory infections treated with Isoprinosine®.Wiedermann D, Widermannova D, Lokaj J. Scripta Medica [Czech edition from Brno]. 1986; 59(7):415-424. Several parameters of cellular and humoral immune function in children with recurrent respiratory infections treated with Isoprinosine®.

Active substance: INOSINE

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Document reference: 30177

Study title: Wiedermann D, Wiedermannova D, Lokaj J. International Journal of Immunopharmacology 1987; 9(8):947-949. .Immunorestoration in children with recurrent respiratory infections treated with Isoprinosine®.Wiedermann D, Wiedermannova D, Lokaj J. International Journal of Immunopharmacology 1987; 9(8):947-949. .Immunorestoration in children with recurrent respiratory infections treated with Isoprinosine®.

Active substance: INOSINE

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Document reference: 30178

Study title: Yalaz K, Anlar B, Oktem F, Aysun S, Ustacelebi S, Gurcay O, Gucuyener K, Renda Y. Neurology. 1992 Mar;42(3 Pt 1):488-91. Intraventricular interferon and oral inosiplex in the treatment of subacute sclerosing panencephalitis.Yalaz K, Anlar B, Oktem F, Aysun S, Ustacelebi S, Gurcay O, Gucuyener K, Renda Y. Neurology. 1992 Mar;42(3 Pt 1):488-91. Intraventricular interferon and oral inosiplex in the treatment of subacute sclerosing panencephalitis.

Active substance: INOSINE

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Document reference: 30179

Study title: Insulin Lispro versus Humulin R in Adolescent Patients with Type I Diabetes

Active substance: INSULIN (HUMAN)

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Document reference: 30183

Study title: The Exclusive Use of Neutral Regular Human Insulin (rDNA) in the Treatment of Insulin-Dependent Diabetes Mellitus in Patients Who Have Never Received Insulin

Active substance: INSULIN (HUMAN)

Study summary document link (including results): Human insulin - B5K-MC-IBAI redacted CSR.PDF

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Document reference: 30184

Study title: Acta Radiol. 1992 Nov;33(6):592-5 Comparison of intravenous contrast agents for CT studies in children. Cohen MD, Herman E, Herron D, White SJ, Smith JA Acta Radiol. 1992 Nov;33(6):592-5 Comparison of intravenous contrast agents for CT studies in children. Cohen MD, Herman E, Herron D, White SJ, Smith JA

Active substance: IOHEXOL

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Document reference: 30363

Study title: Porteder H, Henning G: Improvment in wound healing after oral implantation with Solcoseryl Dental Adhesive paste. das deutsche Ärzteblatt, 1996, &, 320-323 Porteder H, Henning G: Improvment in wound healing after oral implantation with Solcoseryl Dental Adhesive paste. das deutsche Ärzteblatt, 1996, &, 320-323

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35090

Study title: Sato Y, Takashima A, Oka S: A double-blind study of the clinical efficacy of Solcoseryl in childblains. Kis to Rinsho,. Clin Rep 1975; 9 2453-2489 Sato Y, Takashima A, Oka S: A double-blind study of the clinical efficacy of Solcoseryl in childblains. Kis to Rinsho,. Clin Rep 1975; 9 2453-2489

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35096

Study title: Trzcinska-Dabrowska Z.; Kanigowska K.: Solcoseryl eye-gel preparation in the treatment of selected corneal diseases. Klin. Oczna 89: 27-28 (1987). Trzcinska-Dabrowska Z.; Kanigowska K.: Solcoseryl eye-gel preparation in the treatment of selected corneal diseases. Klin. Oczna 89: 27-28 (1987).

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35107

Study title: Vamos I, Kövesi G: Experince in use of Solcoseryl Dental adhesive Paste. Különenyomat 1980, 73, 361-363 Vamos I, Kövesi G: Experince in use of Solcoseryl Dental adhesive Paste. Különenyomat 1980, 73, 361-363

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35089

Study title: A study to determine the safety of virus inactivated factor concentrates in Hameophiliacs Naive to Blood Product Admiinistration (International Factor Safety Study) A study to determine the safety of virus inactivated factor concentrates in Hameophiliacs Naive to Blood Product Admiinistration (International Factor Safety Study)

Active substance: PROTHROMBIN

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Document reference: 35112

Study title: "Behandlung einer Hemmkörperhämophilie B mit hochdosierter Factor IX-Substitution. In: Landbeck,G., Marx R. (Hrsg.): 15 Hämophilie-Symposium Hamburg, 1984, Springer-Verlag, Berlin, Heidelberg, New York, Tokyo: 251-254 (1986).(Kraus B et al.) " "Behandlung einer Hemmkörperhämophilie B mit hochdosierter Factor IX-Substitution. In: Landbeck,G., Marx R. (Hrsg.): 15 Hämophilie-Symposium Hamburg, 1984, Springer-Verlag, Berlin, Heidelberg, New York, Tokyo: 251-254 (1986).(Kraus B et al.) "

Active substance: PROTHROMBIN

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Document reference: 35111

Study title: "Erfahrungen mit einem Faktor II-, IX- und X-Konzentrat. Laboratoriumsuntersuchungen, In-Vivo-Recovery und klinische Ergebnisse. Global-Druck und Verlag, Heidelberg, (1980).(Vinazzer H, Bergmann H.) " "Erfahrungen mit einem Faktor II-, IX- und X-Konzentrat. Laboratoriumsuntersuchungen, In-Vivo-Recovery und klinische Ergebnisse. Global-Druck und Verlag, Heidelberg, (1980).(Vinazzer H, Bergmann H.) "

Active substance: PROTHROMBIN

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Document reference: 35109

Study title: "Factor X survival and therapeutic factor X levels in the abnormal factor X (factor X FRIULI) COAGULATION DISORDER. Acta Haematol (1974) 52: 223-231.(Girolami A et al.) " "Factor X survival and therapeutic factor X levels in the abnormal factor X (factor X FRIULI) COAGULATION DISORDER. Acta Haematol (1974) 52: 223-231.(Girolami A et al.) "

Active substance: PROTHROMBIN

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Document reference: 35110

Study title: "Laboratory and clinical evaluation of concentrates for treatment of haemophilia. Acta Clin Belg (1975) 30: 437-448. (Verstraete M, Vermylen J. ) " "Laboratory and clinical evaluation of concentrates for treatment of haemophilia. Acta Clin Belg (1975) 30: 437-448. (Verstraete M, Vermylen J. ) "

Active substance: PROTHROMBIN

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Document reference: 35108

Study title: Donaldson-S-S, Berberich-F-R, Kaplan-H-S. Stanford Univ. Sch. Med., Stanford, Calif. 94305, United States. A program of low dose radiation and MOPP chemotherapy for pediatric Hodgkin's disease. Proceedings of the American Association for Cancer Research {PROC-AM-ASSOC-CANCER-RES}, 1981, Vol/Iss/Pg. Vol. 22/- (C-730).Donaldson-S-S, Berberich-F-R, Kaplan-H-S. Stanford Univ. Sch. Med., Stanford, Calif. 94305, United States. A program of low dose radiation and MOPP chemotherapy for pediatric Hodgkin's disease. Proceedings of the American Association for Cancer Research {PROC-AM-ASSOC-CANCER-RES}, 1981, Vol/Iss/Pg. Vol. 22/- (C-730).

Active substance: PROCARBAZINE

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Document reference: 34698

Study title: Donaldson-S-S, Kaplan-H-S. Div. Radiat. Ther., Dept. Radiol., Stanford Univ. Med. Cent., Stanford, CA 94305, United States. Complications of treatment of Hodgkin's disease in children. Cancer Treatment Reports {CANCER-TREAT-REP}, 1982, Vol/Iss/Pg. 66/4 (977-989).Donaldson-S-S, Kaplan-H-S. Div. Radiat. Ther., Dept. Radiol., Stanford Univ. Med. Cent., Stanford, CA 94305, United States. Complications of treatment of Hodgkin's disease in children. Cancer Treatment Reports {CANCER-TREAT-REP}, 1982, Vol/Iss/Pg. 66/4 (977-989).

Active substance: PROCARBAZINE

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Document reference: 34699

Study title: Donaldson-S-S, Link-M-P, McDougall-I-R, Parker-B-R, Shochat-S-J. Clinical investigations of children with Hodgkin's disease at Stanford University Medical Center. A preliminary overview using low- dose irradiation and alternating ABVD/MOPP chemotherapy. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 307-15, ISSN: 0927-3042.Donaldson-S-S, Link-M-P, McDougall-I-R, Parker-B-R, Shochat-S-J. Clinical investigations of children with Hodgkin's disease at Stanford University Medical Center. A preliminary overview using low- dose irradiation and alternating ABVD/MOPP chemotherapy. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 307-15, ISSN: 0927-3042.

Active substance: PROCARBAZINE

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Document reference: 34700

Study title: Donaldson-S-S, Link-M-P. Combined modality treatment with low-dose radiation and MOPP chemotherapy for children with Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, May 1987, vol. 5, no. 5, p. 742-9, ISSN: 0732-183X.Donaldson-S-S, Link-M-P. Combined modality treatment with low-dose radiation and MOPP chemotherapy for children with Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, May 1987, vol. 5, no. 5, p. 742-9, ISSN: 0732-183X.

Active substance: PROCARBAZINE

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Document reference: 34701

Study title: Duffner-P-K, Cohen-M-E, Anderson-S-W, et-al. Department of Neurology, Buffalo Children's Hospital, Buffalo, NY 14222, United States. Long-term effects of treatment on endocrine function in children with brain tumors. Annals of Neurology {ANN-NEUROL}, 1983, Vol/Iss/Pg. 14/5 (528-532).Duffner-P-K, Cohen-M-E, Anderson-S-W, et-al. Department of Neurology, Buffalo Children's Hospital, Buffalo, NY 14222, United States. Long-term effects of treatment on endocrine function in children with brain tumors. Annals of Neurology {ANN-NEUROL}, 1983, Vol/Iss/Pg. 14/5 (528-532).

Active substance: PROCARBAZINE

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Document reference: 34702

Study title: Duffner-P-K, Cohen-M-E. Department of Neurology, Children's Hospital of Buffalo, 219 Bryant Street, Buffalo, NY 14222, United States. Changes in the approach to central nervous system tumors in childhood. Pediatric Clinics of North America {PEDIATR-CLIN-NORTH-AM}, 1992, Vol /Iss/Pg. 39/4 (859-877), ISSN: 0031-3955.Duffner-P-K, Cohen-M-E. Department of Neurology, Children's Hospital of Buffalo, 219 Bryant Street, Buffalo, NY 14222, United States. Changes in the approach to central nervous system tumors in childhood. Pediatric Clinics of North America {PEDIATR-CLIN-NORTH-AM}, 1992, Vol /Iss/Pg. 39/4 (859-877), ISSN: 0031-3955.

Active substance: PROCARBAZINE

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Document reference: 34703

Study title: 49. Sanders, Hall, J Lab Clin Med 1960; 56: 413-416 49. Sanders, Hall, J Lab Clin Med 1960; 56: 413-416

Active substance: PYRVINIUM

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Document reference: 39578

Study title: 5. Bandyopadhyay, Chowdhury, Bull Calcutta Scool Trop Med 1961; 2: 125 5. Bandyopadhyay, Chowdhury, Bull Calcutta Scool Trop Med 1961; 2: 125

Active substance: PYRVINIUM

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Document reference: 39534

Study title: 50. Seth, J Indian Med Assoc 1962; 38: 528-530 50. Seth, J Indian Med Assoc 1962; 38: 528-530

Active substance: PYRVINIUM

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Document reference: 39579

Study title: 51. Silli, Riv Clin Pediatr 1968; 81: 1331-1334 51. Silli, Riv Clin Pediatr 1968; 81: 1331-1334

Active substance: PYRVINIUM

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Document reference: 39580

Study title: 52. Suarez, Domingo, Rev Esp Pediatr 1961; 17: 557-561 52. Suarez, Domingo, Rev Esp Pediatr 1961; 17: 557-561

Active substance: PYRVINIUM

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Document reference: 39581

Study title: 53. Sudigbia, et al., Paediatr Indon 1970; 10: 125-130 53. Sudigbia, et al., Paediatr Indon 1970; 10: 125-130

Active substance: PYRVINIUM

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Document reference: 39582

Study title: Geyer-J-R, Zeltzer-P-M, Boyett-J-M, Rorke-L-B, Stanley-P, Albright-A- L, Wisoff-J-H, Milstein-J-M, Allen-J-C, Finlay-J-L, et al. Children's Hospital and Medical Center, Seattle, WA. Survival of infants with primitive neuroectodermal tumors or malignant ependymomas of the CNS treated with eight drugs in 1 day: a report from the Childrens Cancer Group. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Aug 1994, vol. 12, no. 8, p. 1607-15, ISSN: 0732-183X.Geyer-J-R, Zeltzer-P-M, Boyett-J-M, Rorke-L-B, Stanley-P, Albright-A- L, Wisoff-J-H, Milstein-J-M, Allen-J-C, Finlay-J-L, et al. Children's Hospital and Medical Center, Seattle, WA. Survival of infants with primitive neuroectodermal tumors or malignan...

Active substance: PROCARBAZINE

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Document reference: 34720

Study title: Geyer-R, Levy-M, Berger-M-S, Milstein-J, Griffin-B, Bleyer-W-A. Depts. Ped./Neuro Surg./Radia., Children's Hos./Medical Care, University of Washington, Seattle, WA, United States. Infants with medulloblastoma: a single institution review of survival. Neurosurgery {NEUROSURGERY}, 1991, Vol/Iss/Pg. 29/5 (707-711), ISSN: 0148-396X.Geyer-R, Levy-M, Berger-M-S, Milstein-J, Griffin-B, Bleyer-W-A. Depts. Ped./Neuro Surg./Radia., Children's Hos./Medical Care, University of Washington, Seattle, WA, United States. Infants with medulloblastoma: a single institution review of survival. Neurosurgery {NEUROSURGERY}, 1991, Vol/Iss/Pg. 29/5 (707-711), ISSN: 0148-396X.

Active substance: PROCARBAZINE

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Document reference: 34721

Study title: Glynne-Jones-R, Whitaker-S-J, Plowman-P-N. Department of Radiotherapy, St Bartholomew's Hospital, London. The 'urn' portal; an alternative to the 'mantle' portal in the chemoradiotherapy management of paediatric Hodgkin's disease. Clinical oncology (Royal College of Radiologists (Great Britain)), {Clin-Oncol-R-Coll-Radiol}, Jul 1990, vol. 2, no. 4, p. 235-40, ISSN: 0936-6555.Glynne-Jones-R, Whitaker-S-J, Plowman-P-N. Department of Radiotherapy, St Bartholomew's Hospital, London. The 'urn' portal; an alternative to the 'mantle' portal in the chemoradiotherapy management of paediatric Hodgkin's disease. Clinical oncology (Royal College of Radiologists (Great Britain)), {Clin-Oncol-R-Coll-Radiol}, Jul 1990, vol. 2, no. 4, p. 235-40, ISSN: 0936-6555.

Active substance: PROCARBAZINE

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Document reference: 34722

Study title: Acta Radiol. 1994 Mar;35(2):186-90 Nonionic contrast media in pediatric CT. A comparative study of intravenous use of iopentol and iohexol. Wiklund LM, Brolin I, Sjöholm K Acta Radiol. 1994 Mar;35(2):186-90 Nonionic contrast media in pediatric CT. A comparative study of intravenous use of iopentol and iohexol. Wiklund LM, Brolin I, Sjöholm K

Active substance: IOHEXOL

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Document reference: 30364

Study title: Br J Radiol. 1987 Feb;60(710):133-5. Comparison of low-osmolar contrast media in paediatric cardiac angiography. Rubin CM, Ogilvie BC, Keeton BR Br J Radiol. 1987 Feb;60(710):133-5. Comparison of low-osmolar contrast media in paediatric cardiac angiography. Rubin CM, Ogilvie BC, Keeton BR

Active substance: IOHEXOL

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Document reference: 30366

Study title: Cent Afr J Med. 1996 Jul;42(7):192-5 Myelography with Omnipaque (Iohexol) using basic radiographic facilities: the main adverse effects. Ndosi BN, Ndosi NK, Kazema RR Cent Afr J Med. 1996 Jul;42(7):192-5 Myelography with Omnipaque (Iohexol) using basic radiographic facilities: the main adverse effects. Ndosi BN, Ndosi NK, Kazema RR

Active substance: IOHEXOL

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Document reference: 30367

Study title: Clin Radiol. 1993 Oct;48(4):268-72. Iodixanol and ioxaglate in cardioangiography: a double-blind randomized phase III study. Andersen PE, Bolstad B, Berg KJ, Justesen P, Thayssen P, Kloster YF. Clin Radiol. 1993 Oct;48(4):268-72. Iodixanol and ioxaglate in cardioangiography: a double-blind randomized phase III study. Andersen PE, Bolstad B, Berg KJ, Justesen P, Thayssen P, Kloster YF.

Active substance: IOHEXOL

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Document reference: 30368

Study title: Contrast quality and tolerability of iotrolan 300 in the diagnostic work-up of the upper gastrointestinal tract of infants and toddlers

Active substance: IOHEXOL

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Document reference: 30384

Study title: Double-blind comparative study of Ultravist, Solutrast and Omnipaque in excretory urography in childrenAJR Am J Roentgenol. 1991 Feb;156(2):345-50 Comparison of iohexol with barium in gastrointestinal studies of infants and children. Cohen MD, Towbin R, Baker S, Davis S, Becker C, Eggleston DE, Kehler M, Smith JA, Cory DA, White SJ.

Active substance: IOHEXOL

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Document reference: 30365

Study title: Double-blind comparative study of Ultravist, Solutrast and Omnipaque in excretory urography in childrenJ Invasive Cardiol. 2003 Mar;15(3):133-8. Early and late reactions following the use of iopamidol 340, iomeprol 350 and iodixanol 320 in cardiac catheterization. Sutton AG, Finn P, Campbell PG, Price DJ, Hall JA, Stewart MJ, Davies A, Linker NJ, De Belder MA.

Active substance: IOHEXOL

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Document reference: 30379

Study title: Eur J Radiol. 1993 Nov;17(3):203-9. A double-blind study comparing safety, tolerability and efficacy of iodixanol 320 mgI/ml and ioxaglate 320 mgI/ml in cerebral arteriography. Palmers Y, De Greef D, Grynne BH, Smits J, Put E Eur J Radiol. 1993 Nov;17(3):203-9. A double-blind study comparing safety, tolerability and efficacy of iodixanol 320 mgI/ml and ioxaglate 320 mgI/ml in cerebral arteriography. Palmers Y, De Greef D, Grynne BH, Smits J, Put E

Active substance: IOHEXOL

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Document reference: 30370

Study title: Eur Radiol. 1997;7 Suppl 4:S120-2 Iopentol (Imagopaque 300) compared with iohexol (Omnipaque 300) and diatrizoate (Urografin 292) in pediatric urography. A clinical trial assessing adverse events and diagnostic information. Lanning P, Brekke O. Eur Radiol. 1997;7 Suppl 4:S120-2 Iopentol (Imagopaque 300) compared with iohexol (Omnipaque 300) and diatrizoate (Urografin 292) in pediatric urography. A clinical trial assessing adverse events and diagnostic information. Lanning P, Brekke O.

Active substance: IOHEXOL

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Document reference: 30371

Study title: Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG. Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG.

Active substance: IOHEXOL

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Document reference: 30372

Study title: Fortschr Geb Rontgenstrahlen Nuklearmed Erganzungsbd. 1989;128:108-10 Clinical experience with iohexol versus iopromide in excretory urography. Bischoff W Fortschr Geb Rontgenstrahlen Nuklearmed Erganzungsbd. 1989;128:108-10 Clinical experience with iohexol versus iopromide in excretory urography. Bischoff W

Active substance: IOHEXOL

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Document reference: 30373

Study title: Int J Cardiol. 2001 Sep-Oct;80(2-3):143-51. Experiences with iohexol and iodixanol during cardioangiography in an unselected patient population. Flinck A, Gottfridsson B. Int J Cardiol. 2001 Sep-Oct;80(2-3):143-51. Experiences with iohexol and iodixanol during cardioangiography in an unselected patient population. Flinck A, Gottfridsson B.

Active substance: IOHEXOL

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Document reference: 30374

Study title: Anesthetic effects from low concentrations of proparacaine and benoxinate. Jauregui MJ, Sanders TJ, Polse KA. J Am Optom Assoc. 1980 Jan;51(1):37-41.Anesthetic effects from low concentrations of proparacaine and benoxinate. Jauregui MJ, Sanders TJ, Polse KA. J Am Optom Assoc. 1980 Jan;51(1):37-41.

Active substance: PROXYMETHACAINE

Study summary document link (including results): Anesthetic effects from low concentrations of proparacaine a.pdf

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Document reference: 46144

Study title: Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45)Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45)

Active substance: QUININE

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Document reference: 45077

Study title: Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45)Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45)

Active substance: QUININE

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Document reference: 45082

Study title: Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059)Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059)

Active substance: QUININE

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Document reference: 45063

Study title: Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059)Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059)

Active substance: QUININE

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Document reference: 45068

Study title: Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059)Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059)

Active substance: QUININE

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Document reference: 45073

Study title: Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059)Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059)

Active substance: QUININE

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Document reference: 45078

Study title: Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45)Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45)

Active substance: QUININE

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Document reference: 45072

Study title: Oberlin-O, Boilletot-A, Leverger-G, et-al. Institut Gustave-Roussy 94800, Villejuif, France. Clinical staging, primary chemotherapy and involved field radiotherapy in childhood Hodgkin's disease. European Paediatric Haematology and Oncology {EUR-PAEDIATR-HAEMATOL-ONCOL}, 1985, Vol/Iss/Pg. 2/2 (65-70).Oberlin-O, Boilletot-A, Leverger-G, et-al. Institut Gustave-Roussy 94800, Villejuif, France. Clinical staging, primary chemotherapy and involved field radiotherapy in childhood Hodgkin's disease. European Paediatric Haematology and Oncology {EUR-PAEDIATR-HAEMATOL-ONCOL}, 1985, Vol/Iss/Pg. 2/2 (65-70).

Active substance: PROCARBAZINE

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Document reference: 34795

Study title: Oberlin-O, Leverger-G, Pacquement-H, Raquin-M-A, Chompret-A, Habrand- J-L, Terrier-Lacombe-M-J, Bey-P, Bertrand-Y, Rubie-H, et al. Pediatrics Department, Institut Gustave Roussy, Villejuif, France. Low-dose radiation therapy and reduced chemotherapy in childhood Hodgkin's disease: the experience of the French Society of Pediatric Oncology. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Oct 1992, vol. 10, no. 10, p. 1602-8, ISSN: 0732-183X.Oberlin-O, Leverger-G, Pacquement-H, Raquin-M-A, Chompret-A, Habrand- J-L, Terrier-Lacombe-M-J, Bey-P, Bertrand-Y, Rubie-H, et al. Pediatrics Department, Institut Gustave Roussy, Villejuif, France. Low-dose radiation therapy and reduced chemotherapy in childhood Hodgkin's...

Active substance: PROCARBAZINE

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Document reference: 34796

Study title: Oberlin-O. Department of Pediatricts, Institut Gustave Roussy,94805 Villejuif Cedex, France. Present and future strategies of treatment in childhood Hodgkin's lymphomas. Annals of Oncology {ANN-ONCOL}, 1996, Vol/Iss/Pg. 7/SUPPL. 4 (S73- S78), ISSN: 0923-7534.Oberlin-O. Department of Pediatricts, Institut Gustave Roussy,94805 Villejuif Cedex, France. Present and future strategies of treatment in childhood Hodgkin's lymphomas. Annals of Oncology {ANN-ONCOL}, 1996, Vol/Iss/Pg. 7/SUPPL. 4 (S73- S78), ISSN: 0923-7534.

Active substance: PROCARBAZINE

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Document reference: 34797

Study title: Olive-D, Philip-T, Zucker-J-M, et-al. Service de Medicine Infantile II, Hopital d'Enfants, 54511 Vandoeuvre Cedex 11, France. Efficacy of '8 drugs in 1 day' regimen in the treatment of poor risk childhood brain tumors. European Paediatric Haematology and Oncology {EUR-PAEDIATR-HAEMATOL-ONCOL}, 1985, Vol/Iss/Pg. 2/1 (57-58).Olive-D, Philip-T, Zucker-J-M, et-al. Service de Medicine Infantile II, Hopital d'Enfants, 54511 Vandoeuvre Cedex 11, France. Efficacy of '8 drugs in 1 day' regimen in the treatment of poor risk childhood brain tumors. European Paediatric Haematology and Oncology {EUR-PAEDIATR-HAEMATOL-ONCOL}, 1985, Vol/Iss/Pg. 2/1 (57-58).

Active substance: PROCARBAZINE

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Document reference: 34798

Study title: Olive-D. Serv. Ped. 'A', CHU, Nancy, France. Advances in the management of chemotherapy in solid tumors in children. Archives Francaises de Pediatrie {ARCH-FR-PEDIATR}, 1976, Vol/Iss/Pg. 33/6 (607-620).Olive-D. Serv. Ped. 'A', CHU, Nancy, France. Advances in the management of chemotherapy in solid tumors in children. Archives Francaises de Pediatrie {ARCH-FR-PEDIATR}, 1976, Vol/Iss/Pg. 33/6 (607-620).

Active substance: PROCARBAZINE

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Document reference: 34799

Study title: Ortin-T-T, Shostak-C-A, Donaldson-S-S. CA 94305. Gonadal status and reproductive function following treatment for Hodgkin's disease in childhood: the Stanford experience. International journal of radiation oncology biology physics, {Int-J- Radiat-Oncol-Biol-Phys}, Oct 1990, vol. 19, no. 4, p. 873-80, ISSN: 0360-3016.Ortin-T-T, Shostak-C-A, Donaldson-S-S. CA 94305. Gonadal status and reproductive function following treatment for Hodgkin's disease in childhood: the Stanford experience. International journal of radiation oncology biology physics, {Int-J- Radiat-Oncol-Biol-Phys}, Oct 1990, vol. 19, no. 4, p. 873-80, ISSN: 0360-3016.

Active substance: PROCARBAZINE

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Document reference: 34800

Study title: A Study to Compare the Efficacy and Safety of 0.25% Levobupivacaine to 0.25% Bupivacaine when Administered as a Caudal Extradural for PostOperative Analgesia in Paediatric In-Patients Undergoing Elective Orthopaedic or Major Urological Surgery

Active substance: LEVOBUVICAINE HCL

Study summary document link (including results): Levobupivacaine-30590.pdf

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Document reference: 47650

Study title: Astudy to assess the efficacy and safety of 0.25% levobupivacaine when administered as a caudal injection in paediatric patients undergoing hernia repair, circumcision or orchidopexy.

Active substance: LEVOBUVICAINE HCL

Study summary document link (including results): Levobupivacaine-30585.pdf

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Document reference: 47649

Study title: Double-Blind Randomized Controlled Trial of05% L.evobupivacaine for Post-Operative Pain Control in Pediatric Patients Foliowing Hernia Repair Surgery

Active substance: LEVOBUVICAINE HCL

Study summary document link (including results): Levobupivacaine-CS007.pdf

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Document reference: 47648

Study title: A comparative study of the treatment of seasonal rhinoconjunctivitis with levocabastine, up-to date and classical H1 inhibitors. 18"' Congress of the European Academy of Allergy and Clinical Immunology, Brussels, Belgium, NO-P292, July 3-7, 1999A comparative study of the treatment of seasonal rhinoconjunctivitis with levocabastine, up-to date and classical H1 inhibitors. 18"' Congress of the European Academy of Allergy and Clinical Immunology, Brussels, Belgium, NO-P292, July 3-7, 1999

Active substance: LEVOCABASTINE

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Document reference: 31132

Study title: A double masked study on the effect of opthlamic levocabastine vs placebo on the signs and symptomsof allergic conjunctivitis

Active substance: LEVOCABASTINE

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Document reference: 31063

Study title: A double-blind placebo-controlled study of levocabastine eye drops and nose spray in patients with hay fever (13-73 yrs)

Active substance: LEVOCABASTINE

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Document reference: 31093

Study title: A double-blind, placebo-controlled comparison of treatment with fluticasone propionate and levocabastine in patients with seasonal allergic rhinitis. Allergy 54, p.1173-1180, 1999A double-blind, placebo-controlled comparison of treatment with fluticasone propionate and levocabastine in patients with seasonal allergic rhinitis. Allergy 54, p.1173-1180, 1999

Active substance: LEVOCABASTINE

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Document reference: 31138

Study title: A placebo-controlled trial of the therapeutic value of levocabastine eye drops used as required in the treatment of seasonal allergic conjunctivitis (13.1-56.7 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62493_Interventional_Levocabastine.xls

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Document reference: 31105

Study title: A single-blind trial to compare the efficacy, tolerability and safety of levocabastine nasal spray as compared to sodiumcromoglycate nasal spray in children aged 6 months to 5 years with perennial allergic rhinitis. Part I. Clinical Research Report Dated April 1998

Active substance: LEVOCABASTINE

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Document reference: 31059

Study title: Gobel-U, Kauther-K, Seibert-H, et-al. Univ. Kinderklin. B, Univ., D-4000 Dusseldorf, Germany. Evaluation of combination chemotherapy with high-dose methotrexate ollowed by citrovorum factor rescue (CFR) and COPP in children with recurrent brain tumours. Acta Neurochirurgica {ACTA-NEUROCHIR}, 1982, Vol/Iss/Pg. 62/1-2 (129-130).Gobel-U, Kauther-K, Seibert-H, et-al. Univ. Kinderklin. B, Univ., D-4000 Dusseldorf, Germany. Evaluation of combination chemotherapy with high-dose methotrexate ollowed by citrovorum factor rescue (CFR) and COPP in children with recurrent brain tumours. Acta Neurochirurgica {ACTA-NEUROCHIR}, 1982, Vol/Iss/Pg. 62/1-2 (129-130).

Active substance: PROCARBAZINE

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Document reference: 34723

Study title: Goldis-Gh. Clin. Pediat. 'Fundeni' IMF, Bucuresti, Romania. Children and the cancerous diseases (present general aspects in pediatric oncology). Pediatrie {PEDIATRIE}, 1982, Vol/Iss/Pg. 31/1 (3-14).Goldis-Gh. Clin. Pediat. 'Fundeni' IMF, Bucuresti, Romania. Children and the cancerous diseases (present general aspects in pediatric oncology). Pediatrie {PEDIATRIE}, 1982, Vol/Iss/Pg. 31/1 (3-14).

Active substance: PROCARBAZINE

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Document reference: 34724

Study title: Micromedex. Diphenhydramine Hydrochloride. Thomson Healthcare. 1974-2005 medizinishes Informationssystem Vol.125 expires 9/2005, 2005Micromedex. Diphenhydramine Hydrochloride. Thomson Healthcare. 1974-2005 medizinishes Informationssystem Vol.125 expires 9/2005, 2005

Active substance: DEXAMETHASONE AND DIPHENHYDRAMINE

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Document reference: 25712

Study title: Scott, M.R.Report of a double-blind trial of Pyralvex against placebo in the relief of pain associated with mouth ulcers. 1987 49 subjects (36 evaluable) 16 m, 20 f, 7-67 y (39.2)Scott, M.R.Report of a double-blind trial of Pyralvex against placebo in the relief of pain associated with mouth ulcers. 1987 49 subjects (36 evaluable) 16 m, 20 f, 7-67 y (39.2)

Active substance: RHUBARB AND SALICYLIC ACID

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Document reference: 35294

Study title: Vorberg, G. Erfolgreiche Behandlung von entzündlichen Veränderungen der Mund- und Rachenschleimhaut sowie des Zahnfleisches mit Pyralves. 1982, 28:2972-2973 aged 15 - 72 years, 60 patientsVorberg, G. Erfolgreiche Behandlung von entzündlichen Veränderungen der Mund- und Rachenschleimhaut sowie des Zahnfleisches mit Pyralves. 1982, 28:2972-2973 aged 15 - 72 years, 60 patients

Active substance: RHUBARB AND SALICYLIC ACID

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Document reference: 35296

Study title: Placebo-controlled comparison of levamisole, pyrantel pamoate, thiabendazole, piperazine citrate, and varlaus dosages of mebendazole in the treatment of ascariasis and trichuriasis in children. 1975

Active substance: MEBENDAZOLE

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Document reference: 31539

Study title: A randomized study of Ultiva versus Halothane in neonates and infants undergoing surgery for pyloric stenosis

Active substance: REMIFENTANIL

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Document reference: 35285

Study title: Longo-D-L, Young-R-C, Wesley-M, Hubbard-S-M, Duffey-P-L, Jaffe-E-S, DeVita-V-T-Jr. Twenty years of MOPP therapy for Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Sep 1986, vol. 4, no. 9, p. 1295-306, ISSN: 0732-183X.Longo-D-L, Young-R-C, Wesley-M, Hubbard-S-M, Duffey-P-L, Jaffe-E-S, DeVita-V-T-Jr. Twenty years of MOPP therapy for Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Sep 1986, vol. 4, no. 9, p. 1295-306, ISSN: 0732-183X.

Active substance: PROCARBAZINE

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Document reference: 34776

Study title: Luker-G-D, Siegel-M-J. Department of Radiology, Mallinckrodt Institute of Radiology, Washington Univ. School of Medicine, 510 S Kingshighway Blvd, St Louis, MO 63110, United States. Mediastinal Hodgkin disease in children: Response to therapy. Radiology {RADIOLOGY}, 1993, Vol/Iss/Pg. 189/3 (737-740), ISSN: 0033-8419.Luker-G-D, Siegel-M-J. Department of Radiology, Mallinckrodt Institute of Radiology, Washington Univ. School of Medicine, 510 S Kingshighway Blvd, St Louis, MO 63110, United States. Mediastinal Hodgkin disease in children: Response to therapy. Radiology {RADIOLOGY}, 1993, Vol/Iss/Pg. 189/3 (737-740), ISSN: 0033-8419.

Active substance: PROCARBAZINE

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Document reference: 34777

Study title: Lipiodol computerized tomography: How sensitive and specific is the technique in the diagnosis of hepatocellular carcinoma?

Active substance: Ethyl esters of iodized fatty acids of poppy seed oil

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Document reference: 39899

Study title: A therapeutic trial of the use of penicillin V or erythromycin with or without rifampin in the treatment of psoriasis. Vincent F, Ross JB, Dalton M, Wort AJ. Journal of the American Academy of Dermatology, Mar 1992, vol. 26, no. 3 Pt 2, p. 458−61.

Active substance: ERYTHROMYCIN

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Document reference: 26479

Study title: Th 1165a metered aerosol: pediatrics / therapeutic observations.

Active substance: FENOTEROL

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Document reference: 27033

Study title: Efficacy and safety of loratadina-betamethasone combination in the initial treatment of severe perennial allergic rhinitis in children

Active substance: LARATADINE

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Document reference: 31016

Study title: The effectiveness of the homeopathic remedy Rhinital in the out-patient treatment of children suffering from perennial and seasonal rhinitis

Active substance: Luffa operculata, Cardiospermum halicacabum, Galphimia glauca

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Document reference: 39743

Study title: Liberal use of antibiotics and its effect in neonatal staphylococcal infection, with particular reference to erythromycin.Forfar J O, Keay A J, Maccabe A F, Gould J C, Bain A D. Lancet, {Lancet}, 6 Aug 1966, vol. 2, no. 7458, p. 295−300, ISSN: 0140−6736.

Active substance: ERYTHROMYCIN

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Document reference: 26564

Study title: Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059)Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059)

Active substance: QUININE

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Document reference: 45083

Study title: A comparative study of two different doses of Smith Kline-RIT rec-DNA Hepatitis B vaccine (10 mcg and 20 mcg).

Active substance: r-DNA hepatitis B surface antigen (HBsAg)

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Document reference: 47756

Study title: A comparative, Single-Blind, Randomised Study of the Immunogenicity and Safety of Engerix-B administered at two different dose levels.

Active substance: r-DNA hepatitis B surface antigen (HBsAg)

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Document reference: 47764

Study title: Hunger-S-P, Link-M-P, Donaldson-S-S. Department of Pediatrics, Stanford University School of Medicine, CA 94305. ABVD/MOPP and low-dose involved-field radiotherapy in pediatric Hodgkin's disease: the Stanford experience. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Oct 1994, vol. 12, no. 10, p. 2160-6, ISSN: 0732-183X.Hunger-S-P, Link-M-P, Donaldson-S-S. Department of Pediatrics, Stanford University School of Medicine, CA 94305. ABVD/MOPP and low-dose involved-field radiotherapy in pediatric Hodgkin's disease: the Stanford experience. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Oct 1994, vol. 12, no. 10, p. 2160-6, ISSN: 0732-183X.

Active substance: PROCARBAZINE

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Document reference: 34743

Study title: Hutchinson-R-J, Fryer-C-J, Davis-P-C, Nachman-J, Krailo-M-D, O-Brien-R-T, Collins-R-D, Whalen-T, Reardon-D, Trigg-M-E, Gilchrist-G-S. C.S. Mott Children's Hospital, Ann Arbor, MI, USA. MOPP or radiation in addition to ABVD in the treatment of pathologically staged advanced Hodgkin's disease in children: results of the Children's Cancer Group Phase III Trial. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Mar 1998, vol. 16, no. 3, p. 897-906, ISSN: 0732-183X.Hutchinson-R-J, Fryer-C-J, Davis-P-C, Nachman-J, Krailo-M-D, O-Brien-R-T, Collins-R-D, Whalen-T, Reardon-D, Trigg-M-E, Gilchrist-G-S. C.S. Mott Children's Hospital, Ann Arbor, MI, USA. MOPP or radiation in addition to ABVD i...

Active substance: PROCARBAZINE

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Document reference: 34744

Study title: Ilveskoski-I, Saarinen-U-M, Wiklund-T, Perkkioe-M, Salmi-T-T, Lanning-M, Maekipernaa-A, Pihko-H. Children's Hospital, University of Helsinki, Finland. Ototoxicity in children with malignant brain tumors treated with the 8 in 1 chemotherapy protocol. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Jul 1996, vol. 27, no. 1, p. 26-31, ISSN: 0098-1532.Ilveskoski-I, Saarinen-U-M, Wiklund-T, Perkkioe-M, Salmi-T-T, Lanning-M, Maekipernaa-A, Pihko-H. Children's Hospital, University of Helsinki, Finland. Ototoxicity in children with malignant brain tumors treated with the 8 in 1 chemotherapy protocol. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Jul 1996, vol. 27, no. 1, p. 26-31, ISSN: 0098-1532.

Active substance: PROCARBAZINE

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Document reference: 34745

Study title: Jacobi-G. Abt. Pad. Neurol., Zent. Kinderheilk., 6000 Frankfurt am M. 70, Germany. Intracranial tumors in children. Aktuelle Neurologie {AKTUEL-NEUROL}, 1982, Vol/Iss/Pg. 9/1 (42-50).Jacobi-G. Abt. Pad. Neurol., Zent. Kinderheilk., 6000 Frankfurt am M. 70, Germany. Intracranial tumors in children. Aktuelle Neurologie {AKTUEL-NEUROL}, 1982, Vol/Iss/Pg. 9/1 (42-50).

Active substance: PROCARBAZINE

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Document reference: 34746

Study title:

Active substance: PROMETHAZINE

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Document reference: 35044

Study title: A controled surgical series treated with promethazine before inducation. - Smith A.H.- (N.Y. State J. Med. 19/03/1959, 1024-9). - Publication in PROMETHAZINE Safety and efficacy review of medicines following UK authorities review of psychotropic and centrally acting drugs. May&Baker Ltd. Company April 1980 -

Active substance: PROMETHAZINE

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Document reference: 34996

Study title: Acute poisoning in a children's hospital A 2-year experience

Active substance: PROMETHAZINE

Study summary document link (including results): Acute poisoning in a children's hospital A 2-year experience.pdf

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Document reference: 35052

Study title: Advanced pediatric joint imaging

Active substance: PROMETHAZINE

Study summary document link (including results): Advanced pediatric joint imaging.pdf

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Document reference: 35046

Study title: Adverse effects of meperidine, promethazine, and chlorpromazine for sedation in pediatric patients.

Active substance: PROMETHAZINE

Study summary document link (including results): Adverse effects of meperidine, promethazine, and chlorpromazine for sedation in pediatric patients.pdf

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Document reference: 35000

Study title: Adverse reactions in children

Active substance: PROMETHAZINE

Study summary document link (including results): Adverse reactions in children.pdf

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Document reference: 35038

Study title: An open-label randomized comparison of olanzapine versus risperidone in the treatment of childhood-onset schizophrenia

Active substance: PROMETHAZINE

Study summary document link (including results): An open-label randomized comparison of olanzapine versus risperidone in the treatment of childhood-onset schizophrenia.pdf

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Document reference: 35030

Study title: Anasthesia for paediatric cardiac catheterization and angiocardiography. - Moffitt E.A. Dawson B. O'Neill N.C.- 1961 (Anaesth. And Analg., 1961, 40, 483.) - Publication in PHENERGAN therapeutic summary 6th edition May & Baker Ltd.1976 -

Active substance: PROMETHAZINE

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Document reference: 35003

Study title: Annotation The use of psychotropic medications in children A British view

Active substance: PROMETHAZINE

Study summary document link (including results): Annotation The use of psychotropic medications in children A British view.pdf

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Document reference: 35029

Study title: Banerjee SR_1977Banerjee SR_1977

Active substance: PROMETHAZINE

Study summary document link (including results): Bayer Pharma_Promethazine_Banerjee SR_1977_publication.pdf

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Document reference: 23338

Study title: Blanc VF_1991; Antiemetic prophylaxis with promethazine or droperidol in paediatric outpatient strabismus surgeryBlanc VF_1991; Antiemetic prophylaxis with promethazine or droperidol in paediatric outpatient strabismus surgery

Active substance: PROMETHAZINE

Study summary document link (including results): Bayer Pharma_Promethazine_Blanc VF_1991_publication.pdf

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Document reference: 34998

Study title: Clinical observations with promethazine hydrochloride (PHERNERGAN ELIXIR), in paediatric practice. - Sarma D.N. Dass C.S.- (Indian Med. J., 1978, 72 (9), 156-157.) - Publication in PHENERGAN Tableelt 25mg, Syrup 1%, Sol inj 2,5%. Syndthesis documentation. French validation dossier 17/06

Active substance: PROMETHAZINE

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Document reference: 35011

Study title: Randomized,double-blind study of the efficacy and tolerability of proglumetacin versus diclofenac in sports trauma [Current Therapeutic Research 1993, 53(6):630-4]. Randomized,double-blind study of the efficacy and tolerability of proglumetacin versus diclofenac in sports trauma [Current Therapeutic Research 1993, 53(6):630-4].

Active substance: PROGLUMETACIN

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Document reference: 34994

Study title: Goldman-A, Pritchard-J. Hospital For Sick Children, London WC1N 3JH, United Kingdom. Current management of children with cancer. Prescribers' Journal {PRESCR-J}, 1985, Vol/Iss/Pg. 25/1 (2-11).Goldman-A, Pritchard-J. Hospital For Sick Children, London WC1N 3JH, United Kingdom. Current management of children with cancer. Prescribers' Journal {PRESCR-J}, 1985, Vol/Iss/Pg. 25/1 (2-11).

Active substance: PROCARBAZINE

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Document reference: 34725

Study title: Rousseau-P, Habrand-J-L, Sarrazin-D, Kalifa-C, Terrier-Lacombe-M-J, Rekacewicz-C, Rey-A. Department of Radiation Oncology, Montreal General Hospital, 1650 Cedar Ave, Montreal, Que. H3G 1A4, Canada. Treatment of intracranial ependymomas of children: Review of a 15- year experience. International Journal of Radiation Oncology Biology Physics {INT-J- RADIAT-ONCOL-BIOL-PHYS}, 1994, Vol/Iss/Pg. 28/2 (381-386), ISSN: 0360-3016.Rousseau-P, Habrand-J-L, Sarrazin-D, Kalifa-C, Terrier-Lacombe-M-J, Rekacewicz-C, Rey-A. Department of Radiation Oncology, Montreal General Hospital, 1650 Cedar Ave, Montreal, Que. H3G 1A4, Canada. Treatment of intracranial ependymomas of children: Review of a 15- year experience. International Journal of Radiation Oncology Biology Physics {...

Active substance: PROCARBAZINE

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Document reference: 34818

Study title: Sackmann-Muriel-F, Bonesana-A-C, Pavlovsky-S, Papendieck-C, Morgenfeld-M, Penchansky-L, Schwartz-L, Kvicala-R, Sica-M, Ojeda-F. Hodgkin's disease in childhood: therapy results in Argentina. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Fall 1981, vol. 3, no. 3, p. 247-54, ISSN: 0192-8562.Sackmann-Muriel-F, Bonesana-A-C, Pavlovsky-S, Papendieck-C, Morgenfeld-M, Penchansky-L, Schwartz-L, Kvicala-R, Sica-M, Ojeda-F. Hodgkin's disease in childhood: therapy results in Argentina. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Fall 1981, vol. 3, no. 3, p. 247-54, ISSN: 0192-8562.

Active substance: PROCARBAZINE

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Document reference: 34819

Study title: Kato Z, Asano T, Kondo N. J Child Neurol. 2006 Feb;21(2):177-8. Inosiplex affects the spectra of proton magnetic resonance spectroscopy in subacute sclerosing panencephalitis.Kato Z, Asano T, Kondo N. J Child Neurol. 2006 Feb;21(2):177-8. Inosiplex affects the spectra of proton magnetic resonance spectroscopy in subacute sclerosing panencephalitis.

Active substance: INOSINE

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Document reference: 30129

Study title: Kho LK, Wulur H, Himawan T.. Abstracts of Scientific Papers: Asian Congress of Pediatrics; May 1-2, 1974; Manila, Philippines: Philippines Pediatric Society; 1974. Abstract 1. Experiences in the management of dengue hemorrhagic feverKho LK, Wulur H, Himawan T.. Abstracts of Scientific Papers: Asian Congress of Pediatrics; May 1-2, 1974; Manila, Philippines: Philippines Pediatric Society; 1974. Abstract 1. Experiences in the management of dengue hemorrhagic fever

Active substance: INOSINE

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Document reference: 30130

Study title: Kho LK. Report to Newport Pharmaceuticals, Inc: September 20, 1973. Isoprinosine in dengue fever, hepatitis, herpes zoster opthalmicus.Kho LK. Report to Newport Pharmaceuticals, Inc: September 20, 1973. Isoprinosine in dengue fever, hepatitis, herpes zoster opthalmicus.

Active substance: INOSINE

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Document reference: 30131

Study title: Kowalik-Mikolajewska B, Barszcz T, Ladyzynska E, Wojnarowski M. Polski Tygodnik Lekarski. 1993; 48(11-13):263-264. Markers of chronic hepatitis B in children after completion of therapy with Isoprinosine Kowalik-Mikolajewska B, Barszcz T, Ladyzynska E, Wojnarowski M. Polski Tygodnik Lekarski. 1993; 48(11-13):263-264. Markers of chronic hepatitis B in children after completion of therapy with Isoprinosine

Active substance: INOSINE

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Document reference: 30132

Study title: Kowalik-Mikolajewska B. Polski Tygodnik Lekarski. 1993; 48(11-13):258-260. The course of chronic hepatitis B in children and attempts at modifying its treatment. Kowalik-Mikolajewska B. Polski Tygodnik Lekarski. 1993; 48(11-13):258-260. The course of chronic hepatitis B in children and attempts at modifying its treatment.

Active substance: INOSINE

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Document reference: 30133

Study title: Maity-A, Goldwein-J-W, Lange-B, D-Angio-G-J. Department of Radiation Oncology, Hospital of the University of Department of Radiation Oncology, Hospital of the University of Pennsylvania, Philadelphia 19104. Mediastinal masses in children with Hodgkin's disease. An analysis of the Children's Hospital of Philadelphia and the Hospital of the University of Pennsylvania experience. University of Pennsylvania experience. Cancer, {Cancer}, 1 Jun 1992, vol. 69, no. 11, p. 2755-60, ISSN: 0008-543X.Maity-A, Goldwein-J-W, Lange-B, D-Angio-G-J. Department of Radiation Oncology, Hospital of the University of Department of Radiation Oncology, Hospital of the University of Pennsylvania, Philadelphia 19104. Mediastinal masses in children with Hodgkin's disease. An ...

Active substance: PROCARBAZINE

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Document reference: 34779

Study title: Makhonova-L-A, Polyakov-V-E, Susuleva-N-A, Ilyashenko-V-V. Detsk. Gematol. Otd., Vsesojuzn. Onkol. Nauch. Tsent., AMN SSSR, Moscow, Russia. Role of polychemotherapy in the program treatment of children with Hodgkin's disease. Pediatriya - Zhurnal im G.N. Speranskogo {PEDIATRIYA}, 1981, Vol/Iss /Pg. 60/8 (36-39).Makhonova-L-A, Polyakov-V-E, Susuleva-N-A, Ilyashenko-V-V. Detsk. Gematol. Otd., Vsesojuzn. Onkol. Nauch. Tsent., AMN SSSR, Moscow, Russia. Role of polychemotherapy in the program treatment of children with Hodgkin's disease. Pediatriya - Zhurnal im G.N. Speranskogo {PEDIATRIYA}, 1981, Vol/Iss /Pg. 60/8 (36-39).

Active substance: PROCARBAZINE

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Document reference: 34780

Study title: Mamelak-A-N, Prados-M-D, Obana-W-G, Cogen-P-H, Edwards-M-S-B. Department of Neurological Surgery, c/o The Editorial Office, 1360 Ninth Avenue, San Francisco, CA 94122, United States. Treatment options and prognosis for multicentric juvenile pilocytic astrocytoma. Journal of Neurosurgery {J-NEUROSURG}, 1994, Vol/Iss/Pg. 81/1 (24-30) , ISSN: 0022-3085. Mamelak-A-N, Prados-M-D, Obana-W-G, Cogen-P-H, Edwards-M-S-B. Department of Neurological Surgery, c/o The Editorial Office, 1360 Ninth Avenue, San Francisco, CA 94122, United States. Treatment options and prognosis for multicentric juvenile pilocytic astrocytoma. Journal of Neurosurgery {J-NEUROSURG}, 1994, Vol/Iss/Pg. 81/1 (24-30) , ISSN: 0022-3085.

Active substance: PROCARBAZINE

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Document reference: 34781

Study title: Van-Eys-J, Cangir-A. Dept. Ped., M.D. Anderson Hosp., Houston, Tex. 77030, United States. Chemotherapy for childhood brain tumors. Journal of Pediatrics {J-PEDIATR}, 1978, Vol/Iss/Pg. 93/3 (544-546).Van-Eys-J, Cangir-A. Dept. Ped., M.D. Anderson Hosp., Houston, Tex. 77030, United States. Chemotherapy for childhood brain tumors. Journal of Pediatrics {J-PEDIATR}, 1978, Vol/Iss/Pg. 93/3 (544-546).

Active substance: PROCARBAZINE

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Document reference: 34868

Study title: Van-Eys-J. Dept. Ped., Univ. Texas Syst. Cancer Cent., M.D. Anderson Hosp. Tum. Inst., Houston, Tex., United States. Chemotherapy for gliomas in children. Cancer Bulletin {CANCER-BULL}, 1975, Vol/Iss/Pg. 27/1 (16-19).Van-Eys-J. Dept. Ped., Univ. Texas Syst. Cancer Cent., M.D. Anderson Hosp. Tum. Inst., Houston, Tex., United States. Chemotherapy for gliomas in children. Cancer Bulletin {CANCER-BULL}, 1975, Vol/Iss/Pg. 27/1 (16-19).

Active substance: PROCARBAZINE

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Document reference: 34869

Study title: Van-Eys-J. Division of Pediatrics, The University of Texas M.D. AndersonHospital and Tumor Institute, Houston, TX, United States. The improved outlook for children with brain tumors. Cancer Bulletin {CANCER-BULL}, 1986, Vol/Iss/Pg. 38/1 (19-23).Van-Eys-J. Division of Pediatrics, The University of Texas M.D. AndersonHospital and Tumor Institute, Houston, TX, United States. The improved outlook for children with brain tumors. Cancer Bulletin {CANCER-BULL}, 1986, Vol/Iss/Pg. 38/1 (19-23).

Active substance: PROCARBAZINE

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Document reference: 34870

Study title: Report in Clinical documentation for Marketing Authorisation Application (June 1987): Clinical study of the efficacy and safety of teicoplanin in the treatment of Gram-positive infections - Schiraldi O., Terragna A., De Rosa F., Olivero S. - 4 March 1987Report in Clinical documentation for Marketing Authorisation Application (June 1987): Clinical study of the efficacy and safety of teicoplanin in the treatment of Gram-positive infections - Schiraldi O., Terragna A., De Rosa F., Olivero S. - 4 March 1987

Active substance: TEICOPLANIN

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Document reference: 44316

Study title: Report in Clinical documentation for Marketing Authorisation Application (June 1987): Drug experience reports on 2 children receiving overdosage of teicoplaninReport in Clinical documentation for Marketing Authorisation Application (June 1987): Drug experience reports on 2 children receiving overdosage of teicoplanin

Active substance: TEICOPLANIN

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Document reference: 44317

Study title: Report in Clinical documentation for Marketing Authorisation Application (June 1987): Efficacy and tolerability of teicoplanin in infections caused by Gram-positive organisms - Del Favero A. - 28 November 1985Report in Clinical documentation for Marketing Authorisation Application (June 1987): Efficacy and tolerability of teicoplanin in infections caused by Gram-positive organisms - Del Favero A. - 28 November 1985

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY Gram positive - Del Favero.xls

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Document reference: 44318

Study title: Report in Clinical documentation for Marketing Authorisation Application (June 1987): Evaluation of therapeutic efficacy and tolerability of teicoplanin in serious infections caused by Gram-positive micro-organisms - Martino - 28 November 1985Report in Clinical documentation for Marketing Authorisation Application (June 1987): Evaluation of therapeutic efficacy and tolerability of teicoplanin in serious infections caused by Gram-positive micro-organisms - Martino - 28 November 1985

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY Serious infections - Martino.xls

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Document reference: 44320

Study title: Report in Clinical documentation for Marketing Authorisation Application (March 1987): European Multicentre open study of teicoplanin in Gram-positive infection ; 1987 sponsor summary - P.J. Lewis - 6 April 1987

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY EG-87-42.xls

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Document reference: 44310

Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Clinical Pharmacology of teicoplanin in children - Milner R.D.G., Whincup G. - 1985Report in Clinical documentation for Marketing Autorisation Application (June 1987): Clinical Pharmacology of teicoplanin in children - Milner R.D.G., Whincup G. - 1985

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY pharmacological.xls

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Document reference: 44315

Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Clinical study of the efficacy and safety of teicoplanin in the treatment of Gram-positive infections - Concia E., Andreoni M., Suter F. - 4 March 1987

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY DRC 357.DLI.1075.xls

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Document reference: 44296

Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Clinical study of the efficacy and safety of teicoplanin in the treatment of Gram-positive infections - Dietrich H.A., Fell J.J., Pugnetti P. - 6 February 1987

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY LP-SM-0025.xls

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Document reference: 44297

Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Clinical study of the efficacy and safety of teicoplanin in the treatment of Gram-positive infections - Schiraldi O., Terragna A., De Rosa F., Olivero S. - 4 March 1987

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY DRC 356.DLI.1074.xls

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Document reference: 44298

Study title: Perindopril preventive treatment on mortality in Duchenne muscular dystrophy: 10 years’ follow-upPerindopril preventive treatment on mortality in Duchenne muscular dystrophy: 10 years’ follow-up

Active substance: PERINDOPRIL

Study summary document link (including results): perindopril_CL3-09490-123-FRA_publication_Duboc_2007.pdf

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Document reference: 47712

Study title: Preventive effect of perindopril on the onset and progression of left ventricular dysfunction in subjects suffering from Duchenne Muscular Dystrophy. Double-blind multicentre, placebo-controlled study of 2 and 4 mg of perindopril in 60 subjects over a period of 3 years.

Active substance: PERINDOPRIL

Study summary document link (including results): perindopril_CL3-09490-123-FRA_publication_Duboc_2005.pdf

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Document reference: 45864

Study title: A multi-center, 6-week, open label study to document the visual treatment characteristics of Elidel (pimecrolimus) cream 1% (twice daily application) by photography in patients >2 years old in the treatment of mild to moderate atopic dermatitis.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2314 Art45 listing 2011.xls

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Document reference: 34089

Study title: A multi-center, 6-week, open label study to document the visual treatment characteristicsof Elidel (pimecrolimus) cream 1% (twice daily application) by photography in patients >2 years old in the treatment of mild to moderate atopic dermatitis.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2435 Art45 listing 2011.xls

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Document reference: 47710

Study title: A multicenter , non-interventional study about pimecrolimus 1 % cream, to measure the drug consumption and cosmetical tolerability in the treatment of mild or moderate atopic dermatitis

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CHU03 Art45 listing 2011.xls

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Document reference: 34113

Study title: A prospective, open label proof of concept study

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CBE01 Art45 listing 2011.xls

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Document reference: 48117

Study title: A randomized, double-blind, multicenter study of the blood concentrations, safety and efficacy of 1% SDZ ASM981 cream administered up to four times daily in adolescents and adults with atopic dermatitis

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CUS01 Art45 listing 2011.xls

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Document reference: 34138

Study title: A randomized, multi-center, parallel-group, double-blind, vehicle-controlled study to evaluate the time of pruritus improvement during the first week of pimecrolimus cream 1% treatment in patients >2 years old with mild to moderate atopic dermatitis.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CUS08 Art45 listing 2011.xls

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Document reference: 34104

Study title: A Retrospective Analysis of Elidel (pimecrolimus cream 1%) for the Treatment of Facial Vitiligo.

Active substance: PIMECROLIMUS

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Document reference: 47708

Study title: AN OPEN, NON-COMPARATIVE STUDY OF SULBACTAM/AMPICILLIN (UNASYN) ADMINISTERED INTRAVENOUSLY FOR THE TREATMENT OF PEDIATRIC INFECTIONS

Active substance: SULBACTAM

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Document reference: 42753

Study title: AN OPEN, NON-COMPARATIVE STUDY OF SULBACTAM/AMPICILLIN (UNASYN) IN THE TREATMENT OF PEDIATRIC INFECTIONS

Active substance: SULBACTAM

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Document reference: 42754

Study title: AN OPEN, NON-COMPARATIVE STUDY OF SULPERAZONE IN THE TREATMENT OF INFECTIONS IN LEUKEMIC CHILDREN.

Active substance: SULBACTAM

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Document reference: 42759

Study title: AN OPEN, NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF CEFOPERAZONE/SULBACTAM (1:1) IN THE EMPIRICAL TREATMENT OF SYSTEMIC INFECTIONS IN ADULT PATIENTS IN HOSPITAL KUALA LUMPUR

Active substance: SULBACTAM

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Document reference: 42847

Study title: AN OPEN, NON-COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IM/IV SBT/CFP IN THE TREATMENT OF URINARY TRACT INFECTIONS

Active substance: SULBACTAM

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Document reference: 42851

Study title: AN OPEN, NON-COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IMIV SBT/CPZ IN THE TREATMENT OF LOWER RESPIRATORY TRACT INFECTION.

Active substance: SULBACTAM

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Document reference: 42854

Study title: AN OPEN, NONCOMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IM/IV SBT/CFP IN THE TREATMENT OF BONE/JOINT INFECTIONS AND OSTEOMYELITIS

Active substance: SULBACTAM

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Document reference: 42857

Study title: AN OPEN, NONCOMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IM/IV SBT/CFP IN THE TREATMENT OF SURGICAL INFECTIONS

Active substance: SULBACTAM

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Document reference: 42849

Study title: AN OPEN, NONCOMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IM/IV SBT/CFP IN THE TREATMENT OF URINARY TRACT INFECTIONS

Active substance: SULBACTAM

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Document reference: 42852

Study title: AN OPEN, PROSPECTIVE STUDY OF SBT/CFP (1:1) IN THE TREATMENT OF NEUTROPENIC PATIENTS WITH FEVER

Active substance: SULBACTAM

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Document reference: 42861

Study title: AN OPEN, PROSPECTIVE, STUDY OF THE EFFICACY AND SAFETY OF SBT/CFP (1:1) IN THE TREATMENT OF NOSOCOMIAL PNEUMONIA, IN ADULT PATIENTS.

Active substance: SULBACTAM

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Document reference: 42869

Study title: CLINICAL EVALUATION IF SULPERAZON (SP) FOR INFECTIONS WITH UNDERLYING DISEASES IN THE FIELD OF UROLOGY

Active substance: SULBACTAM

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Document reference: 42769

Study title: CLINICAL EVALUATION OF SBT/CFP FOR RESPIRATORY TRACT INFECTIONS IN PREMATURE BORN BABIES.

Active substance: SULBACTAM

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Document reference: 42760

Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR HBTI COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES.

Active substance: SULBACTAM

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Document reference: 42791

Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH DIGESTIVE MALIGNANT DISEASE

Active substance: SULBACTAM

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Document reference: 42797

Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASE

Active substance: SULBACTAM

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Document reference: 42798

Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH CEREBROVASCULAR DISEASES.

Active substance: SULBACTAM

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Document reference: 42786

Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH DIGESTIVE MALIGNANT DISEASE

Active substance: SULBACTAM

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Document reference: 42783

Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH GYNECOLOGICAL MALIGNANT DISEASES.

Active substance: SULBACTAM

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Document reference: 42814

Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES.

Active substance: SULBACTAM

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Document reference: 42781

Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASE

Active substance: SULBACTAM

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Document reference: 42820

Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT MALIGNANT DISEASES

Active substance: SULBACTAM

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Document reference: 42782

Study title: A single-centre, randomised, double-blind, placebo-controlled pilot study of cross-over design testing nifedipine in patients with cystic fibrosis.

Active substance: NIFEPIDINE

Study summary document link (including results): Bayer Pharma_Nifedipine_1123_study_synopsis.pdf

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Document reference: 32631

Study title: A study to determine the effect of nifedipine (Adalat Retard) on early renal allograft function and cyclosoprin nephrotoxicity.

Active substance: NIFEPIDINE

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Document reference: 32633

Study title: "DRUCKSENKUNG DER PULMONALEN HYPERTENSION DURCH BAYA1040, SUBLINGUAL, IM RAHMEN VON BRONCHOPULMONALER DYSPLASIE BEI KINDERN UNTER 2 JAHRE"

Active substance: NIFEPIDINE

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Document reference: 32635

Study title: Open, non controlled, non randomised, unicenter pilot study to investigate the long-term efficacy of Adalat® drops and Adalat® retard 10 mg tablets in children with pulmonary hypertension and with peripheral pulmonary stenosis

Active substance: NIFEPIDINE

Study summary document link (including results): Bayer Pharma_Nifedipine_1555_study_synopsis.pdf

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Document reference: 32632

Study title: "PILOTSTUDIE: LANGZEITWIRKUNG VON ADALAT TROPFEN UND ADALAT RETARD BEI KINDERN MIT PULMONALER HYPERTONIE UND PERIPHEREN PULMONALSTENOSEN."

Active substance: NIFEPIDINE

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Document reference: 32636

Study title: Dr. Benezis Essai contrôle en double aveugle etablissant l'efficacité et la tolerance de l'acide niflumique gélule par rapport au placébo et au diclofenac dans les tendinites du membre inférieur.

Active substance: NIFLUMIC ACID

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Document reference: 32637

Study title: Dr. M. Chelly.Essai controle en ouvert evaluant l'efficacitè et la tolèrance du morniflumate suppositoire enfant versus alpha-amylase sirop dans les angines.

Active substance: NIFLUMIC ACID

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Document reference: 32638

Study title: A propos du traitement des diarrhées aiguës du nourrisson.Essai d’un nouvel antiseptique intestinal : le 27.109 R.C - Riedweg M, Herlier M. - 1964 (J. Méd. Lyon, 5 Mai 1964) - Publication in Clinical Expert Report - Lassale C. - July 1998 -

Active substance: NIFUROXAZIDE

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Document reference: 47065

Study title: Clinical Expert Statement - Renewal of the MA for Nifuroxazide Capsules - Guigen S. & Verdoncq B. - 15/11/2007

Active substance: NIFUROXAZIDE

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Document reference: 47067

Study title: Diarrhées infantiles et médicaments antidiarrhétiques en France - No author - 09/1996 (Pimed) - Publication in Clinical Expert Report - Lassale C. - July 1998 -

Active substance: NIFUROXAZIDE

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Document reference: 47069

Study title: Recherche d'une éventuelle absorption digestive du nifuroxazide au cours des gastro-entérites aigues infantiles - Colle M. Battin J. Guinebault P. - 16/07/85

Active substance: NIFUROXAZIDE

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Document reference: 47070

Study title: The management of acute diarrhea in children: oral rehydratation, maintenance, and nutritiaonal therapy - Duggan C. et al. - 1992 (Morb. Mortal. Wkly. Rep., 1992, 41 (RR-16): 1-20)The management of acute diarrhea in children: oral rehydratation, maintenance, and nutritiaonal therapy - Duggan C. et al. - 1992 (Morb. Mortal. Wkly. Rep., 1992, 41 (RR-16): 1-20)

Active substance: NIFUROXAZIDE

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Document reference: 47063

Study title: "Tolerability of Nimesulide and Ketoprofen in Paediatric Patients with Traumatic or Surgical Fractures, Facchini R et al. Drugs 46 (Suppl.1): 238-241, 1993 (only studies with patients 12-17 years are included, as use below 12 is contraindicated)" "Tolerability of Nimesulide and Ketoprofen in Paediatric Patients with Traumatic or Surgical Fractures, Facchini R et al. Drugs 46 (Suppl.1): 238-241, 1993 (only studies with patients 12-17 years are included, as use below 12 is contraindicated)"

Active substance: NIMESULIDE

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Document reference: 32648

Study title: British-Scandinavian co-operative headinjury study (HIT-I)

Active substance: NIMODIPINE

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Document reference: 32649

Study title: Anticonvulsant toxicity in paediatric out-patients.

Active substance: NITRAZEPAM

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Document reference: 32659

Study title: A screening study for potential intestinal absorption of nifuroxazide in infants presenting with acute gastro-enteritis - Battin J. Guinebault P. Colle M. - 18/12/2002

Active substance: NIFUROXAZIDE

Study summary document link (including results): NIFUROXAZIDE 86 00311-EN-00.xls

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Document reference: 47066

Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Efficacy and safety of teicoplanin in the treatment of infections caused by Gram-positive cocci. A summary report of over 298 cases treated in France - Garaud J.J., Tarra -17/02/1987

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY EG-87.03.xls

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Document reference: 44299

Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Efficacy and tolerability of teicoplanin in infections caused by Gram-positive organisms - Martinetto P. - 22 November 1985Report in Clinical documentation for Marketing Autorisation Application (June 1987): Efficacy and tolerability of teicoplanin in infections caused by Gram-positive organisms - Martinetto P. - 22 November 1985

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY Gram positive - Martinetto.xls

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Document reference: 44319

Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): European Multicentre open study of teicoplanin in Gram-positive infection ; 1987 sponsor summary - P.J. Lewis - 6 April 1987

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY EG-87-42.xls

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Document reference: 44300

Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Evaluation of therapeutic efficacy and tolerability of teicoplanin in serious infections caused by Gram-positive micro-organisms - Terragna A. - 28 November 1985Report in Clinical documentation for Marketing Autorisation Application (June 1987): Evaluation of therapeutic efficacy and tolerability of teicoplanin in serious infections caused by Gram-positive micro-organisms - Terragna A. - 28 November 1985

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY Serious infections - Terragna.xls

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Document reference: 44321

Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Pharmacokinetics of teicoplanin in paediatric patients - Rosina R., Bernareggi A., Danese A., Cavenaghi L - 14 November 1986

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY DRC 348.DLI 1039.xls

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Document reference: 44301

Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Teicoplanin in combination therapy for febrile episodes in neutropenic and non-neutropenic paediatric patients - Garaud J.J. - 9 March 1987

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY EG-87-16.xls

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Document reference: 44302

Study title: Summary - Clinical documentation for Marketing Autorisation Application - June 1987Summary - Clinical documentation for Marketing Autorisation Application - June 1987

Active substance: TEICOPLANIN

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Document reference: 44322

Study title: Summary of clinical studies of the efficacy and safety of teicoplanin in the treatment of Gram-positive infections in the UK and Eire- Concia E., Andreoni M., Suter F. - 4 March 1987 ; Report in Clinical documentation for Marketing Autorisation Application - June 1987

Active substance: TEICOPLANIN

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Document reference: 44303

Study title: Teicoplanin in combination therapy for febrile episodes in neutropenic and non-neutropenic paediatric patients. - Lemerle S, De la Roque F, Lamy R, et al. - J Antimicrob Chemother 1988; 21, S.A.: 112-116.Teicoplanin in combination therapy for febrile episodes in neutropenic and non-neutropenic paediatric patients. - Lemerle S, De la Roque F, Lamy R, et al. - J Antimicrob Chemother 1988; 21, S.A.: 112-116.

Active substance: TEICOPLANIN

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Document reference: 44324

Study title: Teicoplanin in gram-positive paediatric infections. (Abstract) In: Abstracts of the 8th mediterranean congress of chemotherapy. - Careddi P, Boccazzi A, Mosconi G. - Athens, 24-29 May 1992: 236.Teicoplanin in gram-positive paediatric infections. (Abstract) In: Abstracts of the 8th mediterranean congress of chemotherapy. - Careddi P, Boccazzi A, Mosconi G. - Athens, 24-29 May 1992: 236.

Active substance: TEICOPLANIN

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Document reference: 44325

Study title: AD on face: A 6-month study with 3 week randomized, multicenter, double blind, vehicle-controlled, parallel phase followed by 23 week open-label phase to study the safety and efficacy of 1% SDS ASM981 cream in pediatric subjects with atopic dermatitis

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CES01 Art45 listing 2011.xls

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Document reference: 34102

Study title: An investigator initiated study to explore the effectiveness of pimecrolimus cream 1% used twice daily (BID) for the treatment of facial vitiligo

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CUS28 Art45 listing 2011.xls

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Document reference: 48121

Study title: Graf et al. Ten days' Use of Oxymetazoline Nasal Spray With or Without Benzalkonium Chloride in Patients With Vasomotor Rhinits. Arch Otolaryngol Head Neck Surg 1999; 125: 1128-1132Graf et al. Ten days' Use of Oxymetazoline Nasal Spray With or Without Benzalkonium Chloride in Patients With Vasomotor Rhinits. Arch Otolaryngol Head Neck Surg 1999; 125: 1128-1132

Active substance: OXYMETAZOLINE

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Document reference: 33042

Study title: Graf, Hallén. Effect on the Nasal Mucosa of Long-Term Treatment With Oxymetazoline, Benzalkonium Chloride, and Placebo Nasal Sprays. Laryngoscope 1996; 106:605-609Graf, Hallén. Effect on the Nasal Mucosa of Long-Term Treatment With Oxymetazoline, Benzalkonium Chloride, and Placebo Nasal Sprays. Laryngoscope 1996; 106:605-609

Active substance: OXYMETAZOLINE

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Document reference: 33041

Study title: Grävinghoff 1972Grävinghoff 1972

Active substance: OXYMETAZOLINE

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Document reference: 47265

Study title: GrossmanGrossman

Active substance: OXYMETAZOLINE

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Document reference: 47267

Study title: Petczelies 1972Petczelies 1972

Active substance: OXYMETAZOLINE

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Document reference: 47264

Study title: Semmelmayer 1972Semmelmayer 1972

Active substance: OXYMETAZOLINE

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Document reference: 33040

Study title: Wolf 1973Wolf 1973

Active substance: OXYMETAZOLINE

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Document reference: 47266

Study title: Treatment of trachoma in the West Bank. Chumbley LC, Viswalingam ND, Thomson IM, Zeidan MA. Eye. 1988;2 ( Pt 5):471-5.Treatment of trachoma in the West Bank. Chumbley LC, Viswalingam ND, Thomson IM, Zeidan MA. Eye. 1988;2 ( Pt 5):471-5.

Active substance: OXYTETRACYCLINE

Study summary document link (including results): Treatment of trachoma in the West Bank. Chumbley LC, Viswalingam ND, Thomson IM, Zeidan MA. Eye. 1988;2 ( Pt 5)471-5.pdf

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Document reference: 33043

Study title: Study of a 3-hour paclitaxel infusion in children with refractory solid tumours: a SFOP study.Doz F; Gentet J C et al. British journal of cancer Mar 2 2001, 84 (5) p604-10 , Study of a 3-hour paclitaxel infusion in children with refractory solid tumours: a SFOP study.Doz F; Gentet J C et al. British journal of cancer Mar 2 2001, 84 (5) p604-10 ,

Active substance: PACLITAXEL

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Document reference: 33044

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Paeonia-Salbe-Heel (ointment) [AWB-AT]

Active substance: Paeonia-Heel - Salbe

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Document reference: 40092

Study title: Study PALIOROS-PSZ-1001 is a multicenter, open-label, single- and multiple-dose study in subjects aged 10 to 17 years, inclusive, diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder to evaluate pharmcokinetics and tolerability.

Active substance: PALIPERIDONE

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Document reference: 45719

Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFLAMMATION OF PELVIC DEAD SPACE POST-OPERATION OF GYNECOLOGICAL MALIGNANT DISEASE.

Active substance: SULBACTAM

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Document reference: 42823

Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR RESPIRATORY TRACT INFECTION (RTI) OR SEPSIS COMPLICATED WITH LUNG CANCER

Active substance: SULBACTAM

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Document reference: 42793

Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR URINARY TRACT INFECTIONS (UTI) WITH UNDERLYING DISEASES IN THE FIELD OF UROLOGY.

Active substance: SULBACTAM

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Document reference: 42803

Study title: CLINICAL EVALUATION OF SULPERAZON AND PIPERACILLIN FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER.

Active substance: SULBACTAM

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Document reference: 42838

Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO-BILIARY TRACT MALIGNANT DISEASES.

Active substance: SULBACTAM

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Document reference: 42822

Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES.

Active substance: SULBACTAM

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Document reference: 42830

Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES.

Active substance: SULBACTAM

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Document reference: 42831

Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES.

Active substance: SULBACTAM

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Document reference: 42832

Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES.

Active substance: SULBACTAM

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Document reference: 42836

Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES.

Active substance: SULBACTAM

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Document reference: 42841

Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES.

Active substance: SULBACTAM

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Document reference: 42842

Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES.

Active substance: SULBACTAM

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Document reference: 42844

Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT MALIGNANT DISEASES.

Active substance: SULBACTAM

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Document reference: 42827

Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT MALIGNANT DISEASES.

Active substance: SULBACTAM

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Document reference: 42845

Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASE

Active substance: SULBACTAM

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Document reference: 42819

Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES

Active substance: SULBACTAM

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Document reference: 42818

Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES.

Active substance: SULBACTAM

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Document reference: 42808

Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT MALIGNANT DISEASES.

Active substance: SULBACTAM

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Document reference: 42816

Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES.

Active substance: SULBACTAM

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Document reference: 42811

Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS WITH TOTAL PARENTAL NUTRITION (T.P.N.) PATIENTS

Active substance: SULBACTAM

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Document reference: 42776

Study title: CLINICAL EVALUATION OF SULPERAZON FOR POST-OPERATIVE INFECTIONS IN THE FIELD OF PLASTIC SURGERY.

Active substance: SULBACTAM

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Document reference: 42771

Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY INFECTIONS (RTI) IN PATIENTS WITH UNDERLYING DISEASES (CHRONIC OBSTRUCTIVE PULMONARY DISEASE ETC.)

Active substance: SULBACTAM

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Document reference: 42772

Study title: Deaths in young children receiving nitrazepam.

Active substance: NITRAZEPAM

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Document reference: 32660

Study title: Human pharmacokinetics of nitrazepam:effect of age and disease.

Active substance: NITRAZEPAM

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Document reference: 32661

Study title: Improvement of mental retardation plus epilepsy in children following management.

Active substance: NITRAZEPAM

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Document reference: 32654

Study title: Incidence of Death in Patients with Intractable Epilepsy during Nitrazepam therapy.

Active substance: NITRAZEPAM

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Document reference: 32662

Study title: Infantile spasms. A retrospective study of 105 cases.

Active substance: NITRAZEPAM

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Document reference: 32658

Study title: Infantile spasms. Comparative trial of nitrazepam and corticotropin.

Active substance: NITRAZEPAM

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Document reference: 32652

Study title: Nitrazepam for refractory infantile spasms and the Lennox-Gastaut syndrome.

Active substance: NITRAZEPAM

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Document reference: 32656

Study title: Nitrazepam for the treatment of Lennox-Gastaut syndrome.

Active substance: NITRAZEPAM

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Document reference: 32655

Study title: Prospective study of first-choice topiramate therapy in newly diagnosed infantile spasms.

Active substance: NITRAZEPAM

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Document reference: 32653

Study title: Seizures with clonazepam: Discontinuation and suggestions for safe discontinuation rates in children.

Active substance: NITRAZEPAM

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Document reference: 32657

Study title: Short-term nonhormonal and nonsteroid treatment in West syndrome. Short-term nonhormonal and nonsteroid treatment in West syndrome.

Active substance: NITRAZEPAM

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Document reference: 32650

Study title: West syndrome: clinical and electroencephalographic follow up of 70 patients and response to its treatment with adrenocorticotropic hormone, prednisone, vigabatrin, nitrazepam and valproate.

Active substance: NITRAZEPAM

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Document reference: 32651

Study title: Nitrix oxide for inhalation, INOMAX® INOT22 1-Year and 3-Year Follow up report: comparison of supplemental Oxygen and nitric oxide for inhalation plus oxygen in the evaluation of the reactivity of the pulmonary vasculature during acute pulmonary vasodilator testing

Active substance: Nitric oxide

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Document reference: 41519

Study title: Bortone L, Picetti E, Mergoni M. Anaesthesia with sevoflurane in children: Nitrous oxide does not increase postoperative vomiting. Paediatric Anaesthesia. 2002; 12(9):775-9. Bortone L, Picetti E, Mergoni M. Anaesthesia with sevoflurane in children: Nitrous oxide does not increase postoperative vomiting. Paediatric Anaesthesia. 2002; 12(9):775-9.

Active substance: NITROUS OXIDE

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Document reference: 32663

Study title: Byhahn C, Strouhal U, Westphal K. The anaesthesiologist's occupational exposure to sevoflurane and nitrous oxide during inhalation mask induction and general anaesthesia in paediatric anaesthesia. Anaesthesiologie und Reanimation. 2000; 25(1):12-6. Byhahn C, Strouhal U, Westphal K. The anaesthesiologist's occupational exposure to sevoflurane and nitrous oxide during inhalation mask induction and general anaesthesia in paediatric anaesthesia. Anaesthesiologie und Reanimation. 2000; 25(1):12-6.

Active substance: NITROUS OXIDE

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Document reference: 32664

Study title: Felmet K, Robins B, Tilford D, Hayflick SJ. Acute neurologic decompensation in an infant with cobalamin deficiency exposed to nitrous oxide. Journal of Pediatrics. 2000; 137(3):427-8. Felmet K, Robins B, Tilford D, Hayflick SJ. Acute neurologic decompensation in an infant with cobalamin deficiency exposed to nitrous oxide. Journal of Pediatrics. 2000; 137(3):427-8.

Active substance: NITROUS OXIDE

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Document reference: 32665

Study title: Goldman LJ. Anesthetic uptake of sevoflurane and nitrous oxide during an inhaled induction in children. Anesthesia and Analgesia. 2003; 96(2):400-6 Goldman LJ. Anesthetic uptake of sevoflurane and nitrous oxide during an inhaled induction in children. Anesthesia and Analgesia. 2003; 96(2):400-6

Active substance: NITROUS OXIDE

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Document reference: 32666

Study title: Teicoplanin in the treatment of gram positive infections in paediatric patients. (Abstract) In: Abstracts of the 7th mediterranean congress of chemotherapy. - Becker L, Fell JJ, Dieterich HA. -Barcelona, 20-25 May 1990: 183.Teicoplanin in the treatment of gram positive infections in paediatric patients. (Abstract) In: Abstracts of the 7th mediterranean congress of chemotherapy. - Becker L, Fell JJ, Dieterich HA. -Barcelona, 20-25 May 1990: 183.

Active substance: TEICOPLANIN

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Document reference: 44326

Study title: A 4-week repeated dose toxicity study of HMR3647 administered orally to young Beagle dogs followed by a 4-weeek recovery period

Active substance: telithromycin

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Document reference: 41545

Study title: A 4-week repeated dose toxicity study of HMR3647 administered to young rats

Active substance: telithromycin

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Document reference: 41544

Study title: Activity of telithromycin against erythromycin susceptible and resistant Streptococcus pyogenes and Streptococcus pneumoniae isolates from paediatric origin

Active substance: telithromycin

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Document reference: 41554

Study title: Activity of telithromycin and comparators against paediatric respiratory tract infection (RTI) isolates collected across Canada over the past 3 years (1997-1998, 1998-1999, and 1999-2000)

Active substance: telithromycin

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Document reference: 41558

Study title: Activity of telithromycin on clinical isolates of Streptococcus pyogenes and Streptococcus pneumoniae from paediatric patients in different regions of Italy

Active substance: telithromycin

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Document reference: 41553

Study title: Determination of the susceptibility of isolates of Streptococcus pneumoniae and Streptococcus pyogenes, from paediatric patients, to telithromycin and comparator compounds and identification of the mechanism of resistance in erythromycin A-resistant strains

Active substance: telithromycin

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Document reference: 41551

Study title: Evaluation of pharmacokinetics, safety, efficacy and acceptability of HMR3647 (20mg/kg and 30mg/kg q.d.) in pediatric patients with infection (a non-blind, randomised, parallel-group comparative study)

Active substance: telithromycin

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Document reference: 41572

Study title: Evaluation of telithromycin on acute otitis media in an experimental animal model (chinchilla)

Active substance: telithromycin

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Document reference: 41563

Study title: Evaluation of the Safety, Efficacy, Pharmacokinetics and Acceptability of HMR 3647 20 mg/kg QD for 5 Days with Acute Otitis Media in Children(Multicenter, open label, non comparative study)

Active substance: telithromycin

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Document reference: 41574

Study title: Evaluation of the Safety, Pharmacokinetics, Efficacy and Acceptability of HMR 3647 20mg/kg QD for 5-7 Days with Community Acquired Pneumonia (CAP) in children. (Multicenter, open label, non comparative study)

Active substance: telithromycin

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Document reference: 41573

Study title: Experimental studies of otitis media due to Streptococcus pneumoniae treated with HMR3647

Active substance: telithromycin

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Document reference: 41562

Study title: HMR3647: Exploratory 7-day oral toxicity study in Sprague Dawley juvenile rats (from postnatal day 5)

Active substance: telithromycin

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Document reference: 41546

Study title: HMR3647: Single-dose toxicokinetic study in neonatal Sprague Dawley rats

Active substance: telithromycin

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Document reference: 41543

Study title: In vitro actibity of telithromycin (HMR3647) against Streptococcus pyogenes and Streptococcus pneumoniae clinical isolates from paediatric patients in Greece

Active substance: telithromycin

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Document reference: 41552

Study title: In vitro activity of antimicrobial agents against Streptococcus pyogenes in paediatrics : a Belgian multicenter study

Active substance: telithromycin

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Document reference: 41560

Study title: In vitro activity of telithromycin (HMR3647) against strains of S.pneumoniae and S. pyogenes isolated in Iceland and comparison with other antimicrobials

Active substance: telithromycin

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Document reference: 41556

Study title: In vitro activity of telithromycin and multiple comparison antibiotics against recent clinical isolates from children

Active substance: telithromycin

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Document reference: 41559

Study title: In vitro activity of telithromycin, including well characterized erythromycin. A - resistant clinical isolates of S. pneumoniae and S.pyogenes in paediatrics

Active substance: telithromycin

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Document reference: 41549

Study title: A Phase 1111 Study of the Safety. Tolerance and Pharmacokinetics ofMEDI-493. a Humanized Monoclonal Antibody to Respiratory Syncytial Virus. Administered Intramuscularly in Children with a History of Prematurity or Bronchopulmonary Dysplasia

Active substance: palivizumab

Study summary document link (including results): palivizumab-mi-cp011.pdf

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Document reference: 48096

Study title: A Phase 1111 Study of the Safety. Tolerance and Pharmacokinetics ofMEDI-493. a Humanized Monoclonal Antibody to Respiratory Syncytial Virus. Administered Intramuscularly in Children with a History of Prematurity or Bronchopulmonary Dysplasia

Active substance: palivizumab

Study summary document link (including results): palivizumab-mi-cp012.pdf

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Document reference: 48097

Study title: A Phase 2, Open-Label, Prospective, Safety and pK Study to Assess the Extended Use of Synagis (Seven Injections) in Infants and Children with or without CLD

Active substance: palivizumab

Study summary document link (including results): palivizumab-w00-350.pdf

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Document reference: 48108

Study title: A phase III combined study of efficacy and side effects profile of extended release acetaminophen pediatric chewable tablets compared to acetaminophen eight-hour extended release pediatric suspension in the treatment of febrile children. Aug 1998.A phase III combined study of efficacy and side effects profile of extended release acetaminophen pediatric chewable tablets compared to acetaminophen eight-hour extended release pediatric suspension in the treatment of febrile children. Aug 1998.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33333

Study title: A phase III double-blind, single dose study of the comparative antipyretic effectiveness and safety of standard and double standard (C-47) doses of acetaminophen in febrile children. Jan 1984.A phase III double-blind, single dose study of the comparative antipyretic effectiveness and safety of standard and double standard (C-47) doses of acetaminophen in febrile children. Jan 1984.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33340

Study title: A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Chewable Tablets Compared to Children's Tylenol Chewable Tablets in the Treatment of Febrile Children. Dec 1994.A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Chewable Tablets Compared to Children's Tylenol Chewable Tablets in the Treatment of Febrile Children. Dec 1994.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33336

Study title: A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Suspension Compared to Children's Tylenol Elixir in the Treatment of Febrile Children.   94-406, Unpublished Report CSR204. May 1997.A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Suspension Compared to Children's Tylenol Elixir in the Treatment of Febrile Children.   94-406, Unpublished Report CSR204. May 1997.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33335

Study title: A phase IV double-blind multicenter study comparing the antipyretic effectiveness of aspirin, acetaminophen, and placebo in febrile children. Aug 1992.A phase IV double-blind multicenter study comparing the antipyretic effectiveness of aspirin, acetaminophen, and placebo in febrile children. Aug 1992.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33342

Study title: A phase IV double-blind multicenter study comparing the antipyretic effectiveness of aspirin, acetaminophen, choline salicylate and placebo in febrile children. Jun 1991.A phase IV double-blind multicenter study comparing the antipyretic effectiveness of aspirin, acetaminophen, choline salicylate and placebo in febrile children. Jun 1991.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33343

Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTION (RTI) WITH UNDERLYING DISEASES (CHRONIC OBSTRUCTIVE PULMONARY DISEASES, ETC.)

Active substance: SULBACTAM

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Document reference: 42768

Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER.

Active substance: SULBACTAM

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Document reference: 42792

Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) IN PATIENTS WITH UNDERLYING DISEASES (COPD).

Active substance: SULBACTAM

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Document reference: 42809

Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) IN PATIENTS WITH UNDERLYING DISEASES (COPD ETC.).

Active substance: SULBACTAM

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Document reference: 42817

Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS COMPLICATED WITH STOMACH CANCER OR COLON CANCER

Active substance: SULBACTAM

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Document reference: 42824

Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH CEREBROVASCULAR DISEASES.

Active substance: SULBACTAM

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Document reference: 42834

Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER

Active substance: SULBACTAM

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Document reference: 42778

Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER

Active substance: SULBACTAM

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Document reference: 42801

Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER.

Active substance: SULBACTAM

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Document reference: 42840

Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER.

Active substance: SULBACTAM

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Document reference: 42843

Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) IN PATIENTS WITH UNDERLYING DISEASES (COPD ETC.)

Active substance: SULBACTAM

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Document reference: 42837

Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) OR SEPSIS COMPLICATED WITH LUNG CANCER.

Active substance: SULBACTAM

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Document reference: 42828

Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) WITH UNDERLYING DISEASE (COPD ETC.)

Active substance: SULBACTAM

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Document reference: 42821

Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) IN PATIENTS WITH UNDERLYING DISEASES (CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ETC.)

Active substance: SULBACTAM

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Document reference: 42835

Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS IN PATIENTS WITH UNDERLYING DISEASES (CHRONIC OBSTRUCTIVE PULMONARY DISEASES, ETC.).

Active substance: SULBACTAM

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Document reference: 42765

Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE INFECTIONS COMPLICATED WITH GYNECOLOGICAL MALIGNANT DISEASE, ETC.

Active substance: SULBACTAM

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Document reference: 42775

Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE INFECTIONS COMPLICATED WITH THE MALIGNANT DISEASES IN THE FIELD OF E.N.T.

Active substance: SULBACTAM

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Document reference: 42800

Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE INFECTIONS IN THE FIELD OF INTENSIVE CARE UNIT.

Active substance: SULBACTAM

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Document reference: 42810

Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS COMPLICATED WITH DIGESTIVE SYSTEM MALIGNANT DISEASE

Active substance: SULBACTAM

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Document reference: 42767

Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS IN THE FIELD OF ENT.

Active substance: SULBACTAM

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Document reference: 42780

Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS IN THE FIELD OF ENT.

Active substance: SULBACTAM

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Document reference: 42784

Study title: McNeely JK, Buczulinski B, Rosner DR. Severe neurological impairment in an infant after nitrous oxide anesthesia. Anesthesiology. 2000; 93(6):1549-50. McNeely JK, Buczulinski B, Rosner DR. Severe neurological impairment in an infant after nitrous oxide anesthesia. Anesthesiology. 2000; 93(6):1549-50.

Active substance: NITROUS OXIDE

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Document reference: 32667

Study title: Ou X, Li B, Du H. Clinical study: The effects of inhaling nitrous oxide for analgesia labor on pregnant women and fetus. Zhonghua Fu Chan Ke Za Zhi 2001 Jul;.36(7):399-401 Ou X, Li B, Du H. Clinical study: The effects of inhaling nitrous oxide for analgesia labor on pregnant women and fetus. Zhonghua Fu Chan Ke Za Zhi 2001 Jul;.36(7):399-401

Active substance: NITROUS OXIDE

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Document reference: 32668

Study title: PA Averley, NM Girdler, S Bond, N Steen, J Steele. A randomised controlled trial of paediatric conscious sedation for dental treatment using intravenous midazolam combined with inhaled nitrous oxide or nitrous oxide⁄sevoflurane. Anaesthesia, 2004, 59, pages 844–852 PA Averley, NM Girdler, S Bond, N Steen, J Steele. A randomised controlled trial of paediatric conscious sedation for dental treatment using intravenous midazolam combined with inhaled nitrous oxide or nitrous oxide⁄sevoflurane. Anaesthesia, 2004, 59, pages 844–852

Active substance: NITROUS OXIDE

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Document reference: 32669

Study title: Puttick N, Rosen M. Propofol induction and maintenance with nitrous oxide in paediatric outpatient dental anaesthesia. A comparison with thioopentone-nitrous oxide-halothane. Anaesthesia. 1988; 43(8):646-9. Puttick N, Rosen M. Propofol induction and maintenance with nitrous oxide in paediatric outpatient dental anaesthesia. A comparison with thioopentone-nitrous oxide-halothane. Anaesthesia. 1988; 43(8):646-9.

Active substance: NITROUS OXIDE

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Document reference: 32670

Study title: Selzer RR, Rosenblatt DS, Laxova R, Hogan K. Adverse effect of nitrous oxide in a child with 5,10-methylenetetrahydrofolate reductase deficiency. New England Journal of Medicine. 2003; 349(1):45-50. Selzer RR, Rosenblatt DS, Laxova R, Hogan K. Adverse effect of nitrous oxide in a child with 5,10-methylenetetrahydrofolate reductase deficiency. New England Journal of Medicine. 2003; 349(1):45-50.

Active substance: NITROUS OXIDE

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Document reference: 32671

Study title: Abdelkefi A, Abdennebi YB, Mellouli F, Othman TB, Torjman L, Ladeb S, Aouf S, Béjaoui M, Abdeladhim AB. Effectiveness of fixed 50% nitrous oxide oxygen mixture and EMLA cream for insertion of central venous catheters in children. Pediatr Blood Cancer 2004;43;777-779

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32673

Study title: Annequin D, Carbajal R, Chauvin P, Gall O, Tourniaire B, Murat I. Fixed 50% nitrous oxide oxygen mixture for painful procedures: A French survey. Pediatrics 2000 Apr;105(4):E47.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32675

Study title: Baskett PJF, Hyland J, Deane M, Wray G. Analgesia for burns dressing in children. A dose-finding study for phenoperidine and droperidol with and without 50 per cent nitrous oxide and oxygen. Br J Anaesth 1969 Aug;41(8):684-8.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32676

Study title: Beh T, Splinter W, Kim J. In children, nitrous oxide decreases pain on injection of propofol mixed with lidocaine.Can J Anesth 2002;49(10);1061-1063

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32677

Study title: Berge TI. Acceptance and side effects of nitrous oxide oxygen sedation for oral surgical procedures. Acta Odontol Scand 1999 Aug;57(4):201-6.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32678

Study title: Braam MJI, Bath AP, Spauwen PHM, Bailie FB. Survey of analgesia regimens in burns centres in the UK. Burns 1994 Aug;20(4):360-2.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32679

Study title: Bryan RA. The success of inhalation sedation for comprehensive dental care within the Community Dental Service. Int J Paediatr Dent 2002 Nov;12(6):410-4.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32680

Study title: Burton JH, Auble TE, Fuchs SM. Effectiveness of 50% nitrous oxide/50% oxygen during laceration repair in children. Acad Emerg Med 1998 Feb;5(2):112-7.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32681

Study title: Investigation of the efficacy, safety and acceptability of HMR 3647 (1-g divided 20% fine granule packets) in paediatric patients with infections ( a multi-center collaborative single-group non blinded study)

Active substance: telithromycin

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Document reference: 41575

Study title: macrolide-resistant streptococci among pediatric patients in Denmark, Luxemburg, The Netherlands and Turkey

Active substance: telithromycin

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Document reference: 41548

Study title: Minimal inhibittory concentrations of telithromycin (Ketek) against Streptococcus pneumoniae, Heamophilus influenzae and Moraxella catarrhalis strains isolated from specimen of young patients (17 years old or less) and from specimen of adults (18 years old and older)

Active substance: telithromycin

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Document reference: 41557

Study title: Multicenter, Phase II, open-label study of the efficacy, safety, acceptability, and pharmacokinetics of telithromycin, after repeated oral administration of either of two doses, once daily, for 5 days or 7 to 10 days, in the treatment of respiratory tracts infections in children of 6 months to 12 years

Active substance: telithromycin

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Document reference: 41569

Study title: Multicenter, Phase II, open-label study of the efficacy, safety, acceptability, and pharmacokinetics of telithromycin, following administration of 20mg/kg once daily, for 5 days in the treatment of acute otitis media in children

Active substance: telithromycin

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Document reference: 41570

Study title: Multicenter, Phase II, open-label study of the efficacy, safety, acceptability, and pharmacokinetics of telithromycin, following administration of 15mg/kg twice daily, for 5 days in the treatment of acute otitis media in children

Active substance: telithromycin

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Document reference: 41571

Study title: Open Study to determine the concentration of telithromycin in middle ear fluid and plasma in infants/children with otitis media with effusion after multiple oral administration of 20mg/kg, once daily for 5 days or 15mg/kg twice daily for 4.5/5 days of telithromycin pediatric suspension

Active substance: telithromycin

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Document reference: 41568

Study title: Open Study to determine the concentration of telithromycin in the extracellular and intracellular compartments of middle ear fluid in children with acute otitis media or otitis media with spontaneous effusion after single oral administration of a telithromycin pediatric suspension

Active substance: telithromycin

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Document reference: 41567

Study title: Pattern of killing of telithromycin and azithromycin against various strains of Streptococcus pneumoniae

Active substance: telithromycin

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Document reference: 41561

Study title: Pharmacokinetics of Telithromycin (HMR3647) in infants and children suffering from bacterial lower respiratory tract infections after single oral administration of 30mg/kg of a telithromyucin suspension (50mg/ml)

Active substance: telithromycin

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Document reference: 41565

Study title: Susceptibility of 1034 Streptococcus pneumoniae and 1039 Streptococcus pyogenes strains from paediatric patients in ten central and eastern European contries to telithromycin, erythromycin A, azithromycin, clarithromycin, clindamycin, levofloxacin, quinupristin/dalfopristin, and penicillin G

Active substance: telithromycin

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Document reference: 41555

Study title: Telithromycin : epidemiological multicenter study on macrolide resistance of S.pneumoniae and S.pyogenes in the pediatric population in Germany, 2000- 2001

Active substance: telithromycin

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Document reference: 41550

Study title: Telithromycin epidemiological survey in Austria isolates from paediatric patients

Active substance: telithromycin

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Document reference: 41547

Study title: U.S Survey of Telithromycin Activity against Streptococcus pyogenes

Active substance: telithromycin

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Document reference: 41564

Study title: Evaluation of Prednisone, Vincristine and Teniposide Combination Therapy for Refractory Childhood Lymphocytic Leukemia

Active substance: TENIPOSIDE

Study summary document link (including results): teniposide 106-020.pdf

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Document reference: 46912

Study title: A double blind, parallel, multicenter comparison of tenoxicam with naproxene in the treatment of children and adolescents suffering from Juvenile Chronic Arthritis (JCA).

Active substance: TENOXICAM

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Document reference: 44339

Study title: Open-label 40 weeks extension of study S-12159 to follow-up the long-term tolerability and efficacy of tenoxicam in children and adolescents suffering from juvenile rheumatoid arthritis (JRA) treated for up to one year.

Active substance: TENOXICAM

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Document reference: 44338

Study title: Open-label short-term study to find the adequate dosage tenoxicam for the treatment of children and adolescents suffering from juvenile rheumatoid arthritis.

Active substance: TENOXICAM

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Document reference: 44337

Study title: A randomized, investigator-blinded, parallel, single dose, multicenter study to compare for eight hours the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets (20-30 mg/kg) compared to regular strength, conventional release acetaminophen pediatric chewable tablets (10-25 mg/kg) in the treatment of febrile children. Jan 1990.A randomized, investigator-blinded, parallel, single dose, multicenter study to compare for eight hours the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets (20-30 mg/kg) compared to regular strength, conventional release acetaminophen pediatric chewable tablets (10-25 mg/kg) in the treatment of febrile children. Jan 1990.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33338

Study title: A single dose study to compare the efficacy of acetaminophen elixir dosed at 10-15 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Feb 1992.A single dose study to compare the efficacy of acetaminophen elixir dosed at 10-15 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Feb 1992.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33325

Study title: Burow et al. Kopflausbefall in Deutschland: Korrelation zwischen Häufigkeit des "Resistenz-Gens" und klinischer Wirksamkeit von 0,5 % Permethrin-Lösung. Kinder- und Jugendarzt 2010;41(3):224-228Burow et al. Kopflausbefall in Deutschland: Korrelation zwischen Häufigkeit des "Resistenz-Gens" und klinischer Wirksamkeit von 0,5 % Permethrin-Lösung. Kinder- und Jugendarzt 2010;41(3):224-228

Active substance: PERMETHRIN

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Document reference: 33897

Study title: Hamm et al. Treatment of scabies with 5 % permethrin cream: results of a German multicenter study. J Dtsch Dermatol Ges 2006;4(5): 407-413Hamm et al. Treatment of scabies with 5 % permethrin cream: results of a German multicenter study. J Dtsch Dermatol Ges 2006;4(5): 407-413

Active substance: PERMETHRIN

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Document reference: 33896

Study title: Fujii Y. Anti-emetic efficacy of prophylactic granisetron compared with perphenazine for the prevention of post-operative vomiting in children (Eur J Anesthesiol 1999; 16: 304-307)Fujii Y. Anti-emetic efficacy of prophylactic granisetron compared with perphenazine for the prevention of post-operative vomiting in children (Eur J Anesthesiol 1999; 16: 304-307)

Active substance: PERPHENAZINE

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Document reference: 33898

Study title: Splinter W. Prophylaxis for vomiting by children after tonsillectomy: dexamethasone versus perphenazine (Anest Analg 19976; 85: 534-537Splinter W. Prophylaxis for vomiting by children after tonsillectomy: dexamethasone versus perphenazine (Anest Analg 19976; 85: 534-537

Active substance: PERPHENAZINE

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Document reference: 33900

Study title: Splinter WM. Perphenazine decreases vomiting by children after tonsillectomy (Can J Anesth 1997; 44 /12): 1308-1310)Splinter WM. Perphenazine decreases vomiting by children after tonsillectomy (Can J Anesth 1997; 44 /12): 1308-1310)

Active substance: PERPHENAZINE

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Document reference: 33899

Study title: Splinter WM. Prophylaxis for vomiting by children after tonsillectomy: ondansetron versus perphenazine (Br J Anesthesia 1998; 80: 155-158)Splinter WM. Prophylaxis for vomiting by children after tonsillectomy: ondansetron versus perphenazine (Br J Anesthesia 1998; 80: 155-158)

Active substance: PERPHENAZINE

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Document reference: 33901

Study title: AWB Petadolex for long term prophylaxis of migraine in children and aldolescents

Active substance: Petasitidis extr. e rad. spiss. (28 – 44 :1); extraction solvent: CO2 (HERB)*

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Document reference: 40124

Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS IN THE FIELD OF PLASTIC SURGERY.

Active substance: SULBACTAM

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Document reference: 42802

Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS IN THE FIELD OR UROLOGY.

Active substance: SULBACTAM

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Document reference: 42787

Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS IN THE FIELD OF UROLOGY.

Active substance: SULBACTAM

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Document reference: 42789

Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42785

Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE PERITONITIS THE FIELD OF GYNECOLOGIA

Active substance: SULBACTAM

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Document reference: 42770

Study title: CLINICAL EVALUATION OF SULPERAZON FOR UTI WITH UNDERLYING DISEASES IN THE FIELD OF UROLOGY

Active substance: SULBACTAM

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Document reference: 42764

Study title: CLINICAL EVALUATION OF SULPERAZONE FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES.

Active substance: SULBACTAM

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Document reference: 42833

Study title: CLINICAL EVALUATION OF SULPERAZONE FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASE

Active substance: SULBACTAM

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Document reference: 42812

Study title: CLINICAL EVALUATION OF SULPERAZONE FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES

Active substance: SULBACTAM

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Document reference: 42807

Study title: CLINICAL EVALUATION OF SULPERAZONE FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT MALIGNANCY DISEASES

Active substance: SULBACTAM

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Document reference: 42804

Study title: CLINICAL EVALUATION OF UNASYN-SIV IN THE TREATMENT OF PERFORATIVE PERITONITIS.

Active substance: SULBACTAM

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Document reference: 42713

Study title: CLINICAL EVALUATION SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH CNS DISEASES SUCH AS CEREBROVASCULAR DISORDERS

Active substance: SULBACTAM

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Document reference: 42774

Study title: CLINICAL STUDY OF SULBACTAM/CEFOPERAZONE IN CHILDREN WITH HEMATOLOGICAL DISORDERS

Active substance: SULBACTAM

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Document reference: 42761

Study title: CLINICAL TRIAL OF SULPERAZON (SP) PLUS FOSFOMYCIN/ARBEKACIN FOR RESPIRATORY TRACT INFECTIONS IN PATIENTS WITH UNDERLYING DISEASE

Active substance: SULBACTAM

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Document reference: 42763

Study title: CLINICAL TRIAL OF SULPERAZON (SP) PLUS FOSFOMYCIN/ARBEKACIN/VANCOMYCIN FOR MRSA AND GRAM NEG RODS INFECTIONS

Active substance: SULBACTAM

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Document reference: 42766

Study title: CLINICAL TRIAL OF SULPERAZON ALONE OR SULPERAZON PLUS DALACIN-S FOR INFECTIONS IN PATIENTS WITH LUNG CANCER.

Active substance: SULBACTAM

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Document reference: 42826

Study title: CLINICAL TRIAL OF SULPERAZON PLUS FOSFOMYCIN FOR SEVERE INFECTIONS ASSOCIATED WITH HEMATOLOGICAL DISORDERS. STUDY COMPARATIVE TO WHETHER PATIENTS RECEIVES SBT/CFP OR FOSFOMYCIN.

Active substance: SULBACTAM

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Document reference: 42825

Study title: COMBINED THERAPY OF SBT/CFP AND CLINDAMYCIN (CLDM) FOR SEVERE INFECTIONS ASSOCIATED WITH HEMATOLOGICAL DISORDERS

Active substance: SULBACTAM

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Document reference: 42773

Study title: COMBINED THERAPY OF SULBACTAM/CEFOPERAZONE AND DOXYCYCLINE FOR MRSA RESPIRATORY TRACT INFECTIONS (RTI)

Active substance: SULBACTAM

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Document reference: 42762

Study title: COMBINED THERAPY OF SULPERAZON AND AMIKACIN (AMK) FOR SEVERE INFECTIONS ASSOCIATED WITH HEMATOLOGICAL DISORDERS OF CHILDREN

Active substance: SULBACTAM

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Document reference: 42779

Study title: COMBINED THERAPY OF SULPERAZON AND FOSFOMYCIN FOR RESPIRATORY TRACT INFECTIONS (RTI) WITH UNDERLYING DISEASES (COPD ETC.).

Active substance: SULBACTAM

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Document reference: 42806

Study title: COMBINED THERAPY OF SULPERAZON AND PIPERACILLIN (OR AMIKACIN) FOR SEVERE INFECTIONS ASSOCIATED WITH HEMATOLOGICAL DISORDERS

Active substance: SULBACTAM

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Document reference: 42777

Study title: Cleary AG, Ramamon AV, Baildam E, Birch A, Sills JA, Davidson JE. Nitrous oxide analgesia during intra-articular injection for juvenile idiopathic arthritis. Arch Dis Child 2002;86:416-418.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32682

Study title: Abdeladhim AB. Effectiveness of fixed 50% nitrous oxide oxygen mixture and EMLA cream for insertion of central venous catheters in children. Pediatr Blood Cancer 2004;43;777-779

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32674

Study title: Constant I, Abbas M, Boucheseiche S, Laude D, Murat I. Non-invasive assessment of cardiovascular autonomic activity induced by brief exposure to 50% nitrous oxide in children. Br J Anaesth 2002;88(5):637-43.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32683

Study title: Dunn-Russell T, Adair SM, Sams DR, Russell CM, Barenie JT. Oxygen saturation and diffusion hypoxia in children following nitrous oxide sedation. Pediatr Dent 1993 Mar-Apr;15(2):88-92.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32684

Study title: Ekbom K, Jakobsson J, Marcus C. Nitrous oxide inhalation is a safe and effective way to facilitate procedures in paediatric outpatient departments. Arch Dis Child 2005;90:1073-1076.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32685

Study title: Erbe RW, Salis RJ. Severe methylenetetrahydrofolate reductase deficiency, methionine synthase, and nitrous oxide – A cautionary tale. N Engl J Med 2003;349(1):5-6.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32686

Study title: Evans JK, Buckley SL, Alexander AH, Gilpin AT. Analgesia for the reduction of fractures in children: A comparison of nitrous oxide with intramuscular sedation. J Pediatr Orthop 1995 Jan-Feb;15(1):73-7.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32687

Study title: Fauroux B, Onody P, Gall O, Tourniaire B, Koscielny S, Clément A. The efficacy of premixed nitrous oxide and oxygen for fiberoptic bronchoscopy in paediatric patients: A randomised, double-blind, controlled study. Chest 2004 Jan;125(1):315-21.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32688

Study title: Felmet K, Robins B, Tilford D, Hayflick SJ. Acute neurologic decompensation in an infant with cobalamin deficiency exposed to nitrous oxide. J Paediatr 2000;137;427-428

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32689

Study title: Fishman G, Botzer E, Marouani N, DeRowe A. Nitrous oxide-oxygen inhalation for outpatient otologic examination and minor procedures performed on the uncooperative child. International Journal of Pediatric Otorhinolaryngology 2005;69:501-504.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32690

Study title: Frampton A, Browne GJ, Lam LT, Cooper MG, Lane LG. Nurse administered relative analgesia using high concentration nitrous oxide to facilitate minor procedures in children in an emergency department. Emerg Med J 2003;20:410-413.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32691

Study title: Gall O, Annequin D, Benoit G, Van Glabeke E, Vrancea F, Murat I. Adverse events of premixed nitrous oxide and oxygen for procedural sedation in children. Lancet 2001;358:1514-15.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32692

Study title: Gamis AS, Knapp JF, Glenski JA. Nitrous oxide analgesia in a pediatric emergency department. Ann Emerg Med 1989 Feb;18:177-181.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32693

Study title: Gregory PR, Sullivan JA. Nitrous oxide compared with intravenous regional anesthesia in pediatric forearm fracture manipulation. J Pediatr Orthop 1996;16:187-191.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32694

Study title: Griffin GC, Campbell VD, Jones R. Nitrous oxide-oxygen sedation for minor surgery. JAMA 1981 June 19;245(23):2411-2413.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32695

Study title: Heafield R, Jackson R. Entonox and its use in the orthopaedic out-patient department. The Pain Network Newsletter 2001 Summer;29:4-6.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32696

Study title: Hee HI, Goy RWL, Ng AS. Effective reduction of anxiety and pain during venous cannulation in children: a comparison of analgesic efficacy conferred by nitrous oxide, EMLA and combination. Paed Anaesth 2003;13:210-216.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32697

Study title: Hennrikus WL, Shin AY, Klingelberger CE. Self-administered nitrous oxide and a haematoma block for analgesia in the Outpatient reduction of fractures in children. J Bone Joint Surg 1995;77A(3);335-339

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32698

Study title: Hennrikus WL, Simpson RB, Klingelberger CE, Reis MT. Self-administered nitrous oxide analgesia for pediatric fracture reductions. J Pediatr Orthoped 1994;14:538-542.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32699

Study title: Single dose pharmacokinetic study of tenoxicam in children and adolescents ruffering from Juvenile Rheumathoid Arthritis (JRA).

Active substance: TENOXICAM

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Document reference: 44340

Study title: A randomized, doble-blind, parallel group study to determine the effective duration (1,2 or 4 weeks) and safety of Lamisil (tablets) given once daily to patients with tinea capitis due to Trichophyton species (mainly T. tonsurans)

Active substance: TERBINAFINE

Study summary document link (including results): SFO327 T201MR.xls

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Document reference: 44355

Study title: A randomized, double-blind, parallel group study to determine the effective duration (6, 8, 10 or 12 weeks) and safety of LamisilÒ (tablets) given once daily to patients with tinea capitis due to Microsporum species (mainly M. canis).

Active substance: TERBINAFINE

Study summary document link (including results): SFO327 T202MR.xls

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Document reference: 44356

Study title: EVALUATIONS OF TOLERABILITY AND EFFICACY OF ORAL SF 86-327 IN CHILDREN TREATED FOR FUNGAL INFECTIONS. A SUMMARY OF DATA FROM EXPERIENCE OTHER THAN SPECIAL CLINICAL TRIALS IN CHILDREN

Active substance: TERBINAFINE

Study summary document link (including results): SFE700MR.xls

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Document reference: 44357

Study title: Gupta et al, 2003 (overview article of studies)

Active substance: TERBINAFINE

Study summary document link (including results):

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Document reference: 44341

Study title: Jones, 1995: overview of six clinical studies, 152 children were evaluated for efficacy, 196 for tolerability.

Active substance: TERBINAFINE

Study summary document link (including results):

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Document reference: 44342

Study title: MULTICENTRIC, RANDOMIZED SINGLE-BLIND STUDY OF EFFICACY, SAFETY AND TOLERABILITY OF TERBINAFINE [LAMISIL(R)] TABLETS, ONCE DAILY, FOR 1, 2 OR 4 WEEKS IN THE TREATMENT OF TINEA CAPITIS IN CHILDREN

Active substance: TERBINAFINE

Study summary document link (including results): LASBR 06-22493MR.xls

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Document reference: 44349

Study title: Nejjam et al, 1996: 12 children 5-11 years old

Active substance: TERBINAFINE

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Document reference: 44343

Study title: OPEN STUDY TO DETERMINE THE EFFICACY OF 62.5 MG/D TERBINAFINE IN THE TREATMENT OF CHILDREN WITH TINEA CAPITIS.

Active substance: TERBINAFINE

Study summary document link (including results): SFE302 E-00 001MR.xls

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Document reference: 44352

Study title: PILOT STUDY OF TERBINAFINE IN CHILDREN SUFFERING FROM TINEA CAPITIS: EVALUATION OF THE EFFICACY, SAFETY AND PHARMACOKINETICS SHORT TITLE: LAMISIL(R) _ EFFICACY, SAFETY, PHARMACOKINETICS IN CHILDREN

Active substance: TERBINAFINE

Study summary document link (including results): SFE 306MR.xls

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Document reference: 44353

Study title: Study 1 - Gupta et al, 2003 (overview aricle of studies).

Active substance: TERBINAFINE

Study summary document link (including results):

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Document reference: 44344

Study title: Study 2 - Jones, 1995: overview of six clinical studies, 152 children were evaluated for efficacy, 196 for tolerability.

Active substance: TERBINAFINE

Study summary document link (including results):

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Document reference: 44345

Study title: Study 3 - Nejjam et al, 1996: 12 children 5-11 years old.

Active substance: TERBINAFINE

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Document reference: 44346

Study title: A comparison in children with chronic asthma, of terbutaline sulphate administered either as a metered aerosol with Nebuhaler(TM) or as a nebulised solution.

Active substance: TERBUTALINE

Study summary document link (including results): 01-2104 Study Synopsis.pdf

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Document reference: 44385

Study title: A comparison of Bricanyl Turbuhaler to Ventolin Inhaler in asthmatic children currently using Ventolin Inhaler.

Active substance: TERBUTALINE

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Document reference: 44429

Study title: A comparison of terbutaline Turbuhaler and salbutamol aerosol inhaler in paediatric asthmatic patients with reversible airways obstruction.

Active substance: TERBUTALINE

Study summary document link (including results): 01-9209 Summary.pdf

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Document reference: 44430

Study title: A comparison of terbutaline Turbuhaler® and salbutamol Rotahaler in asthmatic pre-school children.

Active substance: TERBUTALINE

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Document reference: 44427

Study title: A comparison of the Bricanyl Turbohaler and Ventolin Rotahaler in asthmatic children.

Active substance: TERBUTALINE

Study summary document link (including results): Terbutaline Bricanyl 01-2131 interventional.xls

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Document reference: 44416

Study title: TO DETERMINE THE SAFETY AND EFFICACY OF ORAL SULTAMICILLIN VS. CLAVULANIC ACID/AMOXICILLIN IN PEDIATRIC PATIENTS WITH ACUTE OTITIS MEDIA.

Active substance: SULTAMICILLIN

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Document reference: 43024

Study title: TO DETERMINE THE SAFETY AND EFFICACY OF PARENTERAL SBT/AMP FOLLOWED BY ORAL STM IN THE TREATMENT OF BACTERIAL INFECTIONS.

Active substance: SULTAMICILLIN

Study summary document link (including results):

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Document reference: 42955

Study title: TO DETERMINE THE SAFETY AND EFFICACY OF PARENTERAL SBT/AMP, FOLLOWED BY ORAL SULTAMICILLIN IN THE TREATMENT OF PATIENTS WITH THE ENTERIC FEVER SYNDROME.

Active substance: SULTAMICILLIN

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Document reference: 42954

Study title: TO DETERMINE THE SAFETY AND EFFICACY OF STM BID VS AUGMENTIN TID FOR THE TREATMENT OF RESPIRATORY TRACT OR UNCOMPLICATED URINARY TRACT INFECTIONS

Active substance: SULTAMICILLIN

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Document reference: 43018

Study title: TO DETERMINE THE SAFETY AND EFFICACY OF SULTAMICILLIN FOR THE TREATMENT OF UPPER AND LOWER RESPIRATORY TRACT INFECTION AND UNCOMPLICATED URINARY TRACT INFECTION.

Active substance: SULTAMICILLIN

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Document reference: 43048

Study title: TO EVALUATE THE EFFICACY AND SAFETY OF A SINGLE ORAL DOSE OF 2.25 GM OF STM & PRABENECID 1 GM WITH AND WITHOUT PROBENECIDE IN THE TREATMENT OF GONORRHEA.

Active substance: SULTAMICILLIN

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Document reference: 43062

Study title: TO EVALUATE THE EFFICACY AND SAFETY OF SBT/AMP/STM IN THE TREATMENT OF (RTI) RESPIRATORY TRACT INFECTIONS.

Active substance: SULTAMICILLIN

Study summary document link (including results):

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Document reference: 42951

Study title: TO EVALUATE THE EFFICACY AND SAFETY OF SULTAMICILLIN IN THE TREATMENT OF PATIENTS WITH LOWER RESPIRATORY TRACT INFECTIONS.

Active substance: SULTAMICILLIN

Study summary document link (including results):

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Document reference: 43012

Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF STM (SBT/AMP) GIVEN ORALLY BID IN PEDIATRIC INFECTIONS.

Active substance: SULTAMICILLIN

Study summary document link (including results):

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Document reference: 42982

Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF STM GIVEN ORALLY BID IN PEDIATRIC INFECTIONS.

Active substance: SULTAMICILLIN

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Document reference: 42981

Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF STM IN THE TREATMENT OF PATIENTS WITH DIAGNOSED CASES OF UTI.

Active substance: SULTAMICILLIN

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Document reference: 43060

Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SULTAMICILLIN GIVEN ORALLY TWICE A DAY IN PEDIATRIC INFECTIONS.

Active substance: SULTAMICILLIN

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Document reference: 42983

Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SULTAMICILLIN IN THE TREATMENT OF A VARIETY OF CHILDHOOD INFECTIONS, E.G., OTITIS MEDIA.

Active substance: SULTAMICILLIN

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Document reference: 43061

Study title: TO EVALUATE THE EFFICACY OF STM IN THE TREATMENT OF PATIENTS WITH DIAGNOSED CASES OF BRONCHO-PNEUMONIA.

Active substance: SULTAMICILLIN

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Document reference: 43059

Study title: TO STUDY THE EFFICACY AND SAFETY OF ORAL STM FOR THE TREATMENT OF ACUTE PNEUMOPATHY AND LOWER RESPIRATORY TRACT INFECTION

Active substance: SULTAMICILLIN

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Document reference: 42991

Study title: "Ospolot bei Kindern mit BNS. Prüferinitiierte Studie". Publication: Debus EM, Kurlemann G., Epilepsia 2004; 45/2: 103 - 108

Active substance: SULTIAME

Study summary document link (including results):

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Document reference: 43065

Study title: Experimentation clinique du 1403RD chez l'enfant - Delagrange - 10/08/68

Active substance: SULTOPRIDE

Study summary document link (including results):

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Document reference: 43066

Study title: Sultopiride study in paediatric psychiatry - Delagrange - 02/08/89

Active substance: SULTOPRIDE

Study summary document link (including results):

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Document reference: 43067

Study title: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Cross-Over Study to Investigate the Efficacy, Safety and Tolerability of Sumatriptan Nasal Spray (10mg or 20mg) in the Treatment of Acute Migraine in Patients Aged 12-17.

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-SUM30042-ICHE3.pdf

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Document reference: 43068

Study title: GCV/93/006 A Double-Blind study to compare the efficacy & safety of oral sumatriptan (50mg-100mg)

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-S2CT40-ICHE3.pdf

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Document reference: 43071

Study title: COMBINED THERAPY OF SULPERAZON AND PIPERACILLIN FOR SEVERE INFECTIONS ASSOCIATED WITH HEMATOLOGICAL DISORDERS OF CHILDREN

Active substance: SULBACTAM

Study summary document link (including results):

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Document reference: 42788

Study title: COMPARATIVE STUDY OF SULBACTAM/AMPICILLIN VS METRONIDAZOLE/GENTAMICIN IN COLORECTAL SURGERY PROPHYLAXIS

Active substance: SULBACTAM

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Document reference: 42676

Study title: COMPARATIVE STUDY ON THE PROPHYLAXIS OF ABDOMINAL SURGERIES WITH INJECTABLE SULBACTAM - AMPICILLIN (UNASYN) VERSUS CEPHALOSPORINS.

Active substance: SULBACTAM

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Document reference: 42679

Study title: COMPARISON OF AMPICILLIN PLUS SULBACTAM VS CEFUROXIME IN THE TREATMENT OF PERIORBITAL CELLULITIS AND/OR OTHER FACIAL CELLULITIS AND/OR EPIGLOTTIS OF BACTERIAL ETIOLOGY IN HOSPITALIZED PEDIATRIC PATIENTS

Active substance: SULBACTAM

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Document reference: 42642

Study title: COMPARISON OF AMPICILLIN PLUS SULBACTAM VS CEFUROXIME IN THE TREATMENT OF SKIN AND/OR SKIN STRUCTURE INFECTIONS (E.G., PERIORBI-TAL CELLULITIS) AND/OR OSTEOMYELITIS/SUPPURATIVE ARTHRITIS OF BACTERIAL ETIOLOGY IN HOSPITALIZED PEDIATRIC PATIENTS.

Active substance: SULBACTAM

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Document reference: 42643

Study title: CONTROLLED, BLINDED, RANDOMIZED CLINICAL TRIAL OF THE EFFICACY AND TOXICITY OF AMPICILLIN/SULBACTAM VS AMPICILLIN/GENTAMYCIN/CLINDAMYCIN IN POSTPARTUM ENDOMETRIOSIS

Active substance: SULBACTAM

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Document reference: 42658

Study title: DETERMINATION OF AMPICILLIN/SULBACTAM IN HUMAN MILK

Active substance: SULBACTAM

Study summary document link (including results):

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Document reference: 42633

Study title: DRUG TREATMENT VERSUS EXPECTANT MANAGEMENT OF PRETERM PREMATURE RUPTURE OF MEMBRANES

Active substance: SULBACTAM

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Document reference: 42652

Study title: EFFICACY AND SAFETY OF BID DOSAGE OF PARENTERAL SULBACTAM/AMPICILLIN IN MILD-MODERATE SURGICAL INFECTIONS

Active substance: SULBACTAM

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Document reference: 42733

Study title: EFFICACY AND SAFETY OF SBT/AMP FOLLOWED BY ORAL SULTAMICILLIN IN THE TREATMENT OF OSTEOMYELITIS AND BONE/JOINT INFECTIONS.

Active substance: SULBACTAM

Study summary document link (including results):

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Document reference: 42749

Study title: A multicentre randomised, parallel group, double-blind phase III comparison between iodixanol (VISIPAQUE) 270 mg I/ml and 320 mg I/ml, and iohexol (Omnipaque) 300 mg I/ml Trial No. DXV037 (date Dec 1995)

Active substance: IODIXANOL

Study summary document link (including results): DXV037 Redacted.pdf

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Document reference: 48208

Study title: EFFICACY AND SAFETY OF SBT/AMP IN PATIENTS WITH SKIN AND SOFT TISSUE INFECTIONS.

Active substance: SULBACTAM

Study summary document link (including results):

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Document reference: 42685

Study title: EFFICACY AND SAFETY OF SBT/AMP IN PATIENTS WITH SKIN AND SOFT TISSUE INFECTIONS.

Active substance: SULBACTAM

Study summary document link (including results):

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Document reference: 42695

Study title: EFFICACY AND SAFETY OF SBT/AMP IN THE PERIOPERATIVE PROPHYLAXIS IN MAXILLOFACIAL SURGERY.

Active substance: SULBACTAM

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Document reference: 42704

Study title: EFFICACY AND SAFETY OF SBT/AMP IN THE TREATMENT OF DOCUMENTED COMMUNITY OR NOSOCOMIAL INFECTIONS IN GENERAL SURGERY.

Active substance: SULBACTAM

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Document reference: 42706

Study title: EFFICACY AND SAFETY OF SBT/CFP IN MODERATE TO SEVERE BACTERIAL INFECTIONS IN SURGICAL PATIENTS.

Active substance: SULBACTAM

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Document reference: 42848

Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN (UNASYN) VS. PIPERCILLIN IN PATIENTS WITH EXACERBATION OF CHRONIC AND ACUTE LOWER RESPIRATORY INFECTIONS.

Active substance: SULBACTAM

Study summary document link (including results):

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Document reference: 42703

Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN IN ACUTE ENT INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42692

Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN IN NEWBORN PATIENTS WITH SEVERE INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42701

Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN IN PATIENTS WITH SEVERE ORL INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42702

Study title: Houpt MI, Limb R, Livingston RL. Clinical effects of nitrous oxide conscious sedation in children. Pediatric Dentistry 2004;26(1);29-36

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32700

Study title: Jackson D. A trial of premixed nitrous oxide and oxygen in dental anaesthesia in children. Brit J Anaesth 1975;39;161-164

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32701

Study title: Kanagasundaram SA, Lane LJ, Cavalletto BP, Keneally JP, Cooper MG. Efficacy and safety of nitrous oxide in alleviating pain and anxiety during painful procedures. Arch Dis Child 2001;84:492-495.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32702

Study title: Kennedy TL, Gore LB. Middle ear effusions and the nitrous oxide myth. Laryngoscopy 1982 Feb;92(2):169-72.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32703

Study title: Lassen HCA, Henriksen E, Neukirch F, Kristensen HS. Severe bone marrow depression after prolonged nitrous oxide anaesthesia. Lancet 1956;April;527-530

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32704

Study title: Lembert N, Wodey E, Geslot D, Ecoffey C. Prévention de la douleur à l’injection du propofol chez l’infant: comparaison de l’inhalation de protoxyde d’azote à l’injection de lidocaine. Ann Fr Anesth Réanim 2002;21;263-270

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32705

Study title: Luhmann JD, Kennedy RM, Jaffe DM, McAllister JD. Continuous-flow delivery of nitrous oxide and oxygen: A safe and cost-effective technique for inhalation analgesia and sedation of pediatric patients. Pediatric Emergency Care 1999;15(6):388-392.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32706

Study title: Luhmann JD, Kennedy RM, Porter FL, Miller JP, Jaffe DM. A randomized clinical trial of continuous-flow nitrous oxide and midazolam for sedation of young children during laceration repair. Annals of Emergency Medicine 2001;37(1):20-27.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32707

Study title: McNeely JK, Buczulinski B, Rosner D. Severe neurological impairment in an infant after nitrous oxide anesthesia. Anesthesiology 2000;93(6);1549-1550

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32708

Study title: Selzer RR, Rosenblatt DS, Laxova R, Hogan K. Adverse effect of nitrous oxide in a child with 5,10-methylenetetrahydrofolate reductase deficiency. N Engl J Med 2003;349:45-50.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32709

Study title: Vetter TR. A comparison of EMLA cream versus nitrous oxide for pediatric venous cannulation. J Clin Anesth 1995;7;486-490

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32710

Study title: Wilson KE, Girdler NM, Welbury RR. Randomized, controlled, crossover clinical trial comparing intravenous midazolam sedation with nitrous oxide sedation in children undergoing dental extractions. British Journal of Anaesthesia 2003 Dec;91(6):850-856.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32711

Study title: A Prospective Registry of European Hemophilia B Patients Receiving BeneFIX (Nonacog Alfa, Recombinant Human Factor IX) for Usual Use

Active substance: NONACOG ALFA

Study summary document link (including results):

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Document reference: 41494

Study title: An Open-Label, Single-Arm, Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX®) in Children Less Than 6 Years of Age With Severe Hemophilia B

Active substance: NONACOG ALFA

Study summary document link (including results):

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Document reference: 41493

Study title: In Vitro Evaluation of Allergic Reactions in hemophilia B Subjects who have Exhibited a Systemic Allergic Response after Exposure to BeneFIX (Nonacog Alfa; recombinant Factor IX)

Active substance: NONACOG ALFA

Study summary document link (including results):

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Document reference: 41496

Study title: A. Huber: Which contraceptive for adolescents? Sexualmedizin 9; 154-157 (1980)

Active substance: NONOXINOL-9

Study summary document link (including results):

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Document reference: 32719

Study title: H. Brehm, W. Haase: The alternative to hormonal contraception?, Med. Welt 26 (N.F.; 1610-1617 (1975)

Active substance: NONOXINOL-9

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Document reference: 32717

Study title: J. Dimpfl, W. Salomon, K.-H. Schicketanz: The sperizidal barrier. Sexualmedizin 13; 95-98 (1984) J.Balmer, P.Hartmann, K.-H Schicketanz: Sexual behaviour during intravaginal contraception. Sexualmedizin 15: 244-248 (1986)

Active substance: NONOXINOL-9

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Document reference: 32720

Study title: W. Salomon, W. Haase: Intravaginal contraception. Results of a prospective long-term study of the foam ovoid. Sexualmedizin 6; 198-202(1977)

Active substance: NONOXINOL-9

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Document reference: 32718

Study title: A Multicenter, Open‑Label Study to Compare On‑Demand Treatment With 2 Prophylaxis Regimens of Recombinant Coagulation Factor IX (BeneFIX) Reformulated Drug Product (rFIX‑R) in Subjects With Severe Hemophilia B

Active substance: NONACOG ALFA

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Document reference: 41495

Study title: A comparison of the efficacy of terbutaline delivered via Turbuhaler® and pressurised metered dose inhaler (pMDI) plus Nebuhaler® in the treatment of moderate to severe acute asthmatic children.

Active substance: TERBUTALINE

Study summary document link (including results):

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Document reference: 44428

Study title: A comparison of the efficacy of terbutaline sulphate, inhaled via Turbuhaler and via nebulization, in the management of acute severe asthma in small children.

Active substance: TERBUTALINE

Study summary document link (including results): 01-2200 Summary.pdf

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Document reference: 44412

Study title: A cumulative dose-response study of terbutaline in asthmatic children. A comparison between Turbuhaler and metered dose inhaler (MDI)

Active substance: TERBUTALINE

Study summary document link (including results): Terbutaline Bricanyl 01-2129 interventional.xls

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Document reference: 44408

Study title: A double-blind comparison between terbutaline Turbuhaler and terbutaline metered dose inhaler (MDI).

Active substance: TERBUTALINE

Study summary document link (including results): Terbutaline Bricanyl 01-9032 interventional.xls

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Document reference: 44405

Study title: A double-blind study comparing Bricanyl MDI and Bricanyl Turbuhaler in patients with acute asthmatic attacks.

Active substance: TERBUTALINE

Study summary document link (including results): CSR 01-2214.pdf

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Document reference: 44413

Study title: A comparison of Bricanyl Turbuhaler and Berotec dry powder inhaler in asthmatic children.

Active substance: TERBUTALINE

Study summary document link (including results): CSR 01-2135.pdf

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Document reference: 44417

Study title: A six-week study of Bricanyl Turbuhaler in the treatment of asthmatic adults. A multicentre study to be carried out in Denmark, Finland, Norway, Sweden and the United Kingdom.

Active substance: TERBUTALINE

Study summary document link (including results): 01-2114 Summary.pdf

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Document reference: 44415

Study title: A twelve-week, double-blind, randomized study to assess safety and efficacy of Bricanyl Turbuhaler in asthmatic children.

Active substance: TERBUTALINE

Study summary document link (including results): 01-2212 Summary.pdf

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Document reference: 44404

Study title: An assessment of small children's ability to use Bricanyl Turbuhaler according to age.

Active substance: TERBUTALINE

Study summary document link (including results): CSR 01-2191.pdf

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Document reference: 44425

Study title: An evaluation of the respiratory and cardiovascular effects of oral terbutaline in asthmatic pediatric children.

Active substance: TERBUTALINE

Study summary document link (including results):

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Document reference: 44390

Study title: Assessment of Turbuhaler in patients with severe acute asthma.

Active substance: TERBUTALINE

Study summary document link (including results): CSR 01-2215.pdf

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Document reference: 44411

Study title: Bricanyl Turbuhaler in hyperreactive patients. A comparison with Bricanyl metered dose inhaler (MDI) and placebo MDI.

Active substance: TERBUTALINE

Study summary document link (including results): CSR 01-2201.pdf

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Document reference: 44410

Study title: Bricanyl Turbuhaler in pre-school children with asthma. A comparison with Ventolin Rotahaler.

Active substance: TERBUTALINE

Study summary document link (including results): Terbutaline Bricanyl 01-2159 interventional.xls

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Document reference: 44420

Study title: Clinical investigation of Bricanyl Retard.

Active substance: TERBUTALINE

Study summary document link (including results):

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Document reference: 44397

Study title: Clinical Trial to evaluate the efficacy of terbutaline in preventing exercise induced asthma when administered to children via the spacer aerosol.

Active substance: TERBUTALINE

Study summary document link (including results): CSR 01-6032.pdf

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Document reference: 44435

Study title: Comparison of Bricanyl depot tablets 5 mg and ordinary tablets 2.5 mg in children with bronchial asthma.

Active substance: TERBUTALINE

Study summary document link (including results):

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Document reference: 44395

Study title: GCV/93/008 A Double-Blind study to compare the efficacy & safety of oral Sumartriptan (50mg or 100mg) in the treatment of migraine in adolescents

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-S2CT37-ICHE3.pdf

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Document reference: 43070

Study title: GCV/96/007 A double-blind,randomised,placebo-controlled study to compare the safety & efficacy of oral sumatriptan (25mg,50mg, &100mg) in the acute treatment of migraine in adolescents.

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-SUMB2003-ICHE3.pdf

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Document reference: 43080

Study title: GM1997/00059/00 An open design study to evalute repeat dose oral sumatriptan 100mg in the acute treatment of adolescent migraine during a six month period.

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-SUMB3005-ICHE3.pdf

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Document reference: 43081

Study title: GM2002/00080/00 Single centre, placebo controlled, double blind randomised crossover, single attack study evaluating the efficacy and tolerability of sumatriptan nasal spray 10mg for the acute treatment of migraine in children suffering from refractory migraine

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-SUM30009-ICHE3.pdf

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Document reference: 43072

Study title: RM1998/00017/00 A double blind placebo controlled parallel group study to evaluate three dose levels (5mg, 10mg and 20mg) of sumatripaten nasal spray in the acute treatment of a single migraine attack in adolescent migraineurs (12-17 yrs of age).

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-SUMA3005-ICHE3.pdf

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Document reference: 43078

Study title: RM1998/00018/00 An open label study to evaluate the long term safety, tolerability and efficacy of sumatriptan nasal spray in the acute treatment of mutiple migraine attacks in adolescent migraineurs (12-17 yrs of age).

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-SUMA3006-ICHE3.pdf

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Document reference: 43079

Study title: RM2003/00271/00 A double blind placebo controlled, parallel group study to evaluate two dose levels (5mg and 20mg) of sumatriptan nasal spray in the acute treatment of a single migraine attack in adolescent migraineurs (12-17 yrs).

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-SUM30045-ICHE3.pdf

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Document reference: 43073

Study title: S2CQ30 A multicentre placebo-controlled study on the efficacy and safety of oral sumatriptan (100mg) in the treatment of migraine in adolescents.

Active substance: SUMATRIPTAN

Study summary document link (including results): Study S2CQ30(SUM9291)-Sumatriptan-Imigranxlsx.xls

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Document reference: 43076

Study title: UCR/96/001 A randomised,double-blind,placebo-controlled study of the safety & efficacy of 25mg,50mg, &100mg oral sumatriptan in adolescent migraine subjects.

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-SUMA2002-ICHE3.pdf

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Document reference: 43077

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Syzygium compositum (drops) [AWB-AT]

Active substance: Syzygium compositum-Heel - Tropfen

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Document reference: 40250

Study title: Lecha M, 2005: Tacalcitol in the treatment of psoriasis vulgaris: the Spanish experience. (556 patients aged 6-86 years; 6 % <18 years)

Active substance: TACALCITOL

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Document reference: 43083

Study title: publication : Golnick (1998) German study on 5205 patients including 153 children between 5 and 18 years

Active substance: TACALCITOL

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Document reference: 43082

Study title:

Active substance: Tacrolimus

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Document reference: 47775

Study title: GCV/92/005 An in-clinical pilot study to examine the safety & efficacy of oral GR43175 (50mg or 100mg)

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-S2CP46-ICHE3.pdf

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Document reference: 43069

Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN IN VARIOUS INFECTIONS

Active substance: SULBACTAM

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Document reference: 42742

Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN IN VARIOUS INFECTIONS

Active substance: SULBACTAM

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Document reference: 42743

Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN PARENTERAL IN THE TREATMENT OF GENERAL PEDIATRIC INFECTIONS

Active substance: SULBACTAM

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Document reference: 42739

Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN VS. CEFTAZIDIME IN CHILDREN WITH BACTERIAL INFECTIONS OF LOWER RESPIRATORY TRACT.

Active substance: SULBACTAM

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Document reference: 42705

Study title: EFFICACY AND TOLERANCE OF SULBACTAM/AMPICILLIN FOLLOWED BY ORAL SULTAMICILLIN IN PATIENTS WITH HEAD AND NECK ABSCESSES.

Active substance: SULBACTAM

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Document reference: 42670

Study title: EFFICACY AND TOLERATION OF SBT/AMP IN MILD SEVERE GYN-OB INFECTIONS (PID, ENDOMETRITIS, ETC.).

Active substance: SULBACTAM

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Document reference: 42681

Study title: EFFICACY AND TOLERATION OF SULBACTAM/AMPICILLIN IN PATIENTS WITH NON-SEVERE INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42729

Study title: EFFICACY AND TOLERATION OF SULBACTAM/AMPICILLIN VS. NETILMICIN PLUS METRONIDAZOLE USED IN SHORT TERM PERIOPERATIVE PROPHYLAXIS IN PATIENTS WHO UNDERGO ABDOMINAL SURGERY.

Active substance: SULBACTAM

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Document reference: 42709

Study title: EFFICACY AND TOLERATION OF UNASYN IN TREATMENT OF INFECTIONS OF THE RESPIRATORY TRACT, GASTROINTESTINAL TRACT, SKIN AND SAFE TISSUES AND UROGENITAL TRACT

Active substance: SULBACTAM

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Document reference: 42675

Study title: EFFICACY OF SBT.AMP IN VARIOUS INFECTIONS IN CHILDREN.

Active substance: SULBACTAM

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Document reference: 42741

Study title: EFFICACY OF UNASYN IN PATIENTS WITH ACUTE DISEASE OF THE LUNGS.

Active substance: SULBACTAM

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Document reference: 42691

Study title: MULTICENTER CLINICAL STUDY OF SBT/AMP IN PEDIATRIC PATIENTS.

Active substance: SULBACTAM

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Document reference: 42673

Study title: MULTICENTER OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF SBT/AMP IN BACTERIAL LOWER RESPIRATORY TRACT INFECTIONS IN ADULT PATIENTS

Active substance: SULBACTAM

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Document reference: 42735

Study title: MULTICENTER OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN IN GYNECOLOGICAL AND OBSTETRIC INFECTIONS

Active substance: SULBACTAM

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Document reference: 42669

Study title: MULTICENTRIC OPEN NONCOMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF SBT/AMP IN INTRA-ABDOMINAL SURGICAL INFECTIONS

Active substance: SULBACTAM

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Document reference: 42736

Study title: MULTICENTRIC, OPEN NONCOMPARATIVE STUDY OF EFFICACY AND SAFETY OF SBT/AMP IN BACTERIAL LOWER RESPIRATORY TRACT INFECTIONS IN PEDIATRIC PATIENTS

Active substance: SULBACTAM

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Document reference: 42734

Study title: NONCOMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF PARENTERAL SBT/AMP IN THE TREATMENT OF PATIENTS WITH SKIN AND SOFT TISSUE INFECTIONS

Active substance: SULBACTAM

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Document reference: 42730

Study title: OPEN COMPARATIVE STUDY OF SBT/AMP VS. AMPICILLIN IN THE TREATMENT OF LOWER RESPIRATORY TRACT INFECTIONS IN ADULT PATIENTS.

Active substance: SULBACTAM

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Document reference: 42699

Study title: OPEN COMPARATIVE STUDY OF SULBACTAM/CEFOPERAZONE (1:2) VS. CEFTAZIDIME PLUS AMIKACIN IN THE TREATMENT OF NEUTROPENIC PATIENTS WITH FEVER

Active substance: SULBACTAM

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Document reference: 42865

Study title: OPEN MULTICENTRIC STUDY OF THE EFFICACY AND SAFETY OF THE COMBINATION SBT/CFP (1:2) IN THE TREATMENT OF PATIENTS (ADULTS AND CHILDREN) WITH SEVERE INFECTIONS (VTI)

Active substance: SULBACTAM

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Document reference: 42864

Study title: OPEN NON-COMPARATIVE EVALUATION IN THE PROPHYLAXIS OF SURGICAL WOUND INFECTIONS

Active substance: SULBACTAM

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Document reference: 42684

Study title: OPEN NON-COMPARATIVE SAFETY/EFFICACY STUDY SULBACTAM/AMPICILLIN IM/IV IN THE TREATMENT OF BACTERIOLOGICAL ENT INFECTIONS

Active substance: SULBACTAM

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Document reference: 42745

Study title: Norfloxacin interferes with cyclosporine disposition in pediatric patients undergoing renal transplantation; Clin. Pharmacol. Ther. 1995 Sep. 58(3): 322-327

Active substance: NORFLOXACIN

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Document reference: 32721

Study title: Post-marketing surveillance study 2006-2007 on specific immunotherapy with NHD Mites/Pollen preparations in a Cluster-doseescalationregimen. Age of patients: 4-65 Years

Active substance: NovoHelisenDepot Mites/Pollen

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Document reference: 47787

Study title: A 24-week open – label randomized cross-over study to monitor the plasma phenylalanine concentrations of subjects with phenylketonuria, aged 8 to 30 years, using Aminogran 1g tablets supplement to manage at least 50% of their protein substitute requirements or using standard diet supplement (Aminogran 1g tablets excluded)

Active substance: NUTRIENTS WITHOUT PHENYLALANINE

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Document reference: 32722

Study title: Acid-Base status in dietary treatment of phenylketonuria

Active substance: NUTRIENTS WITHOUT PHENYLALANINE

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Document reference: 32725

Study title: Are tablets a practical source of protein substitute in phenylketonuria?

Active substance: NUTRIENTS WITHOUT PHENYLALANINE

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Document reference: 32726

Study title: Comparison of an amino acid mixture and protein hydrolysates in treatment of infants with phenylketonuria

Active substance: NUTRIENTS WITHOUT PHENYLALANINE

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Document reference: 32724

Study title: Mineral and trace – metal Balances in Children receiving normal and synthetic diets

Active substance: NUTRIENTS WITHOUT PHENYLALANINE

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Document reference: 32723

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Nux vomica-Homaccord (drops) [AWB-006]

Active substance: Nux vomica-Homaccord

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Document reference: 40084

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Nux vomica-Homaccord (drops) [AWB-AT]

Active substance: Nux vomica-Homaccord

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Document reference: 40085

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Nux vomica-Homaccord (injection solution) [AWB-081]

Active substance: Nux vomica-Homaccord

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Document reference: 40086

Study title: Alban J.Current therapeutic research 1972; 14(4):158-161 Efficacy of nystatin topical cream in the management of cutaneous candidiasis in infants PMID: 4623594 http://www.ncbi.nlm.nih.gov/pubmed?term=4623594 Alban J.Current therapeutic research 1972; 14(4):158-161 Efficacy of nystatin topical cream in the management of cutaneous candidiasis in infants PMID: 4623594 http://www.ncbi.nlm.nih.gov/pubmed?term=4623594

Active substance: Nystatin

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Document reference: 45239

Study title: De Wet PM, Rode H, van Dyk A, Millar AJ W: Perianal Canidosis-a comparative study with mupirocin and nystatin. Int J Dermatol 1999;38(8):618-22.De Wet PM, Rode H, van Dyk A, Millar AJ W: Perianal Canidosis-a comparative study with mupirocin and nystatin. Int J Dermatol 1999;38(8):618-22.

Active substance: NYSTATIN

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Document reference: 32728

Study title: Freitag V.; Schumacher G.; Sternowsky H-J. Der Kinderarzt 1983; 14(2):177-178 Soor im Mund- und Windelbereich (Thrush in the mouth and nappy area) Freitag V.; Schumacher G.; Sternowsky H-J. Der Kinderarzt 1983; 14(2):177-178 Soor im Mund- und Windelbereich (Thrush in the mouth and nappy area)

Active substance: NYSTATIN

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Document reference: 45240

Study title: Kozinn PJ. et al.: Treatment of cutaneous candidiasis in infancy and childhood with nystatin and amphotericin B. Antibiotics Annual 1956/57:128-13Kozinn PJ. et al.: Treatment of cutaneous candidiasis in infancy and childhood with nystatin and amphotericin B. Antibiotics Annual 1956/57:128-13

Active substance: NYSTATIN

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Document reference: 32727

Study title: Munz D, Powell KR, Pai CH: Treatment of candidal diaper dermatitis: double blind placebo controlled com¬parison of topical nystatin with topical plus oral nystatin. J Pediatr 101 1022 – 1025 (1982)Munz D, Powell KR, Pai CH: Treatment of candidal diaper dermatitis: double blind placebo controlled com¬parison of topical nystatin with topical plus oral nystatin. J Pediatr 101 1022 – 1025 (1982)

Active substance: NYSTATIN

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Document reference: 32729

Study title: Comparison of Bricanyl depot tablets 5 mg b.i.d. and ordinary tablets 2.5 mg t.i.d. in children with bronchial asthma.

Active substance: TERBUTALINE

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Document reference: 44394

Study title: Comparison of Bricanyl depot tablets 5 mg b.i.d. and ordinary tablets 2.5 mg t.i.d. in children with bronchial asthma.

Active substance: TERBUTALINE

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Document reference: 44432

Study title: Comparison of Bricanyl(R) depot tablets 5 mg b.i.d. with ordinary oral ß-agonist treatment b.i.d. in children with bronchial asthma.

Active substance: TERBUTALINE

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Document reference: 44396

Study title: Comparison of the effects of inhaled and oral terbutaline and their combination on large and small airways's function in patients with chronic bronchial asthma.

Active substance: TERBUTALINE

Study summary document link (including results): CSR 01-2161.pdf

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Document reference: 44422

Study title: Comparison of the effects of inhaled dry powder and aerosol terbutaline on large and small airways' function in patients with chronic bronchial asthma.

Active substance: TERBUTALINE

Study summary document link (including results): CSR 01-2160.pdf

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Document reference: 44421

Study title: Determination of the efficacy of Bricanyl in children using the Turbuhaler (DEBUT).

Active substance: TERBUTALINE

Study summary document link (including results): Terbutaline Bricanyl 01-2110 interventional.xls

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Document reference: 44431

Study title: Bricanyl Turbuhaler in pre-school children with asthma. A comparison with nebuhaler.

Active substance: TERBUTALINE

Study summary document link (including results): 01-2155 Study Synopsis.pdf

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Document reference: 44419

Study title: Dose response study of subcutaneous terbutaline and epinephrine in children with acute asthma. (N B! Study code fictitious: allocated for Clint pusposes)

Active substance: TERBUTALINE

Study summary document link (including results): Terbutaline Bricanyl 01-2550 interventional.xls

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Document reference: 44382

Study title: Effect of controlled-release terbutaline and budesonide alone and in combination in asthmatics. A multi-center study.

Active substance: TERBUTALINE

Study summary document link (including results): 01-2167 Summary.pdf

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Document reference: 44399

Study title: Effect of oral terbutaline on exercise-induced asthma.

Active substance: TERBUTALINE

Study summary document link (including results): Terbutaline Bricanyl 01-2589 interventional.xls

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Document reference: 44391

Study title: Efficacy and safety of Bricanyl Turbuhaler in children. A dose-response study in steady state.

Active substance: TERBUTALINE

Study summary document link (including results): 01-2209 Study Synopsis.pdf

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Document reference: 44402

Study title: Efficacy and safety of Bricanyl Turbuhaler in children. A dose-response study in steady state.

Active substance: TERBUTALINE

Study summary document link (including results): 01-2207 Study Synopsis.pdf

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Document reference: 44434

Study title: Treatment of Pneumocystis carinii pneumonitis. Siegel, S.E., Wolff, L.J., Baehner, R.L. and Hammond D. (1984) American Journal of Disease of Children 138:1051-1054Treatment of Pneumocystis carinii pneumonitis. Siegel, S.E., Wolff, L.J., Baehner, R.L. and Hammond D. (1984) American Journal of Disease of Children 138:1051-1054

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45837

Study title: Unusual complications of pentamidine in the treatment of Pneumocystis cariniii pneumonia. Wang, J.J., Freeman, A.I., Gaeta , J.F., and Sinks, L.F. (1970) Journal of Pediatrics 77:311-314Unusual complications of pentamidine in the treatment of Pneumocystis cariniii pneumonia. Wang, J.J., Freeman, A.I., Gaeta , J.F., and Sinks, L.F. (1970) Journal of Pediatrics 77:311-314

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45838

Study title: A Phase 2, Randomized, Double-Blind Study To Evaluate the Dosing Concentration and Application Frequency of Tacrolimus Gel in the Treatment of Mild to Moderate Psoriasis in Pediatric and Adult subjects

Active substance: Tacrolimus

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Document reference: 41599

Study title: A Phase 3 Long-Term Open Label Study to Evaluate the Safety ofOnce Daily 0.3% Tacrolimus Gel in the Treatment of Psoriasis -

Active substance: Tacrolimus

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Document reference: 41603

Study title: A Phase 3, Randomized, Double-Blind Study Comparing Twice Daily FK506 Cream 0.03% Versus Cream Vehicle in the Treatment of Atopic Dermatitis in Pediatric Subjects

Active substance: Tacrolimus

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Document reference: 47773

Study title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Once Daily 0.3% FK506 Gel Versus Gel Vehicle in the Treatment of Psoriasis -

Active substance: Tacrolimus

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Document reference: 41601

Study title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Once Daily 0.3% Tacrolimus Gel Versus Gel Vehicle in the Treatment of Psoriasis -

Active substance: Tacrolimus

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Document reference: 41600

Study title: An open-label study to evaluate the safety of topically applied tacrolimus ointment for the treatment of atopic dermatitis.

Active substance: Tacrolimus

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Document reference: 47776

Study title: Phase 3, randomized, double-blind, multi-center, vehicle-controlled, parallel, two-treatment group study stratified by baseline PSGA and investigative site to evaluate the efficacy and safety of tacrolimus cream 0.03% applied twice daily (bid) compared to cream vehicle applied bid for the treatment of atopic dermatitis.

Active substance: Tacrolimus

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Document reference: 47772

Study title: PRO-002 Final Statistical Report (18OCT2002)_Synopsis_Tacrolimus

Active substance: Tacrolimus

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Document reference: 47774

Study title: Tacrolimus ointment is effective for facial and intertriginous psoriasis ( J Am Acad Dermatol 2004;51:723-30.) -

Active substance: Tacrolimus

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Document reference: 41602

Study title: Tacrolimus Pharmacokinetics after Topical Administration of Tacrolimus Cream 0.01% and 0.03% to Pediatric Subjects with Atopic Dermatitis

Active substance: Tacrolimus

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Document reference: 41604

Study title: Golnick (1998) German study on 5205 patients including 153 children between 5 and 18 years

Active substance: TALCACITOL MONOHYDRATE (EFALIZUMAB)

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Document reference: 36704

Study title: 6Tamoxifen therapy for cyclical mastalgia: Dose randomized trial. Abriata G, Bahamonde J, Bazzani M, Bernasconi C, Boccalandro S, Biondini L et al. Breast 6(4)()(pp 212-213), 1997 Date of Publication: Aug 1997 1997;(4):212-213.6Tamoxifen therapy for cyclical mastalgia: Dose randomized trial. Abriata G, Bahamonde J, Bazzani M, Bernasconi C, Boccalandro S, Biondini L et al. Breast 6(4)()(pp 212-213), 1997 Date of Publication: Aug 1997 1997;(4):212-213.

Active substance: TAMOXIFEN

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Document reference: 43294

Study title: Abriata G, Bahamonde J, Bazzani M, Bernasconi C, Boccalandro S, Biondini L et al. 6Tamoxifen therapy for cyclical mastalgia: Dose randomized trial. Breast 1997; (4):212-213.Abriata G, Bahamonde J, Bazzani M, Bernasconi C, Boccalandro S, Biondini L et al. 6Tamoxifen therapy for cyclical mastalgia: Dose randomized trial. Breast 1997; (4):212-213.

Active substance: TAMOXIFEN

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Document reference: 43152

Study title: Acker JC, Bossen EH, Halperin EC. The management of desmoid tumors. International Journal of Radiation Oncology Biology Physics 1993; 26(5) 851-858.Acker JC, Bossen EH, Halperin EC. The management of desmoid tumors. International Journal of Radiation Oncology Biology Physics 1993; 26(5) 851-858.

Active substance: TAMOXIFEN

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Document reference: 43158

Study title: Adolescent gynecomastia: Differential diagnosis and management. Mahoney CP. Pediatric Clinics of North America 37(6)()(pp 1389-1404), 1990 Date of Publication: 1990 1990;(6):1389-1404.Adolescent gynecomastia: Differential diagnosis and management. Mahoney CP. Pediatric Clinics of North America 37(6)()(pp 1389-1404), 1990 Date of Publication: 1990 1990;(6):1389-1404.

Active substance: TAMOXIFEN

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Document reference: 43311

Study title: THE TREATMENT OF ACUTE PELVIC INFECTIONS WITH PARENTERAL SBT/AMP.

Active substance: SULBACTAM

Study summary document link (including results):

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Document reference: 42744

Study title: OPEN, NON-COMPARATIVE STUDY OF THE EFFICACY, SAFETY AND TOLERABILITY OF SBT/AMP IMIV IN THE TREATMENT OF PEDIATRICS WITH VARIOUS BACTERIAL INFECTIONS

Active substance: SULBACTAM

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Document reference: 42689

Study title: PROCEDURE FOR THE STUDY OF UNASYN USED IN PROPHYLAXIS IN TREATMENT OF ABDOMINAL WOUND SURGERY

Active substance: SULBACTAM

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Document reference: 42720

Study title: RANDOMIZED CONTROLLED CLINICAL TRIAL COMPARING CEFAZOLIN + METRONIDAZOLE TO AMPICILLIN/SULBACTAM IN MAJOR HEAD & NECK SURGERY.

Active substance: SULBACTAM

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Document reference: 42664

Study title: SAFETY AND EFFICACY OF SBT/AMP IN ADULTS WITH LOWER RESPIRATORY TRACT INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42718

Study title: SBT/AMP - OPEN TRIAL.

Active substance: SULBACTAM

Study summary document link (including results):

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Document reference: 42671

Study title: SBT/AMP NON-COMPARATIVE OPEN TRIAL.

Active substance: SULBACTAM

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Document reference: 42672

Study title: THE COMPARISON OF SULBACTAM/AMPICILLIN (UNASYN) AND AMPICILLIN/GENTAMICIN IN THE TREATMENT OF CHORIOAMNIONITIS

Active substance: SULBACTAM

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Document reference: 42665

Study title: THE EVALUATION OF CLINICAL EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN (UNASYN) IN THE TREATMENT OF COMMUNITY-ACQUIRED INFECTIONS

Active substance: SULBACTAM

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Document reference: 42750

Study title: THE NECESSITY FOR GRAM NEGATIVE ANTIMICROBIAL COVERAGE IN THE PREVENTION OF INFECTION FOLLOWING HEAD AND NECK SURGERY

Active substance: SULBACTAM

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Document reference: 42628

Study title: Observational use study of the tolerability of Octenisept in premature infants with a gestational age of less than 27 weeks, at the Department of Neonatology of the Charite Campus Virchow Clinic.(Director: Prof. Dr. med. Michael Obladen.2002.

Active substance: OCTENIDINE

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Document reference: 32734

Study title: Use of 2% 2-phenoxyethanol and 0.1% octenidine as antiseptic in premature newborn infants of 23-26 weeks gestation. C. Buhrer, S. Bahr, J. Siebert, R. Wettstein, C. Geffers and M. Obladen. Journal of Hospital Infection (2002) 51: 305-307.Use of 2% 2-phenoxyethanol and 0.1% octenidine as antiseptic in premature newborn infants of 23-26 weeks gestation. C. Buhrer, S. Bahr, J. Siebert, R. Wettstein, C. Geffers and M. Obladen. Journal of Hospital Infection (2002) 51: 305-307.

Active substance: OCTENIDINE

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Document reference: 41626

Study title: Use of Octenisept for pre-operative skin and mucous membrane antisepsis and for supportive wound and suture treatment in small children and babies. UNIV-KLINIK FUR CHIRURGIE.1998.

Active substance: OCTENIDINE

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Document reference: 32737

Study title: A randomised, multicenter, double-blind trial of Sandostatin LAR Depot (40 mg) versus saline-control in the treatment of pediatric hypothalamic obesity

Active substance: OCTREOTIDE

Study summary document link (including results): Novartis Octreotide_Sandostatin LAR Study B2403_31Aug2011.xls

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Document reference: 32741

Study title: A randomized, multicenter, double-blind trial of Sandostatin LAR Depot (40 mg) versus saline-control in the treatment of pediatric hypothalamic obesity

Active substance: OCTREOTIDE

Study summary document link (including results): Novartis Octreotide_Sandostatin LAR Study B2403E1_31Aug2011.xls

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Document reference: 32742

Study title: OPEN NON-COMPARATIVE STUDY TO DETERMINE THE CONCENTRATION OF SBT/AMP IN JUVENILE CARTILAGE.

Active substance: SULBACTAM

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Document reference: 42688

Study title: A randomized, multicenter, double-blind trial of Sandostatin LAR Depot (40 mg) versus saline-control in the treatment of pediatric hypothalamic obesity

Active substance: OCTREOTIDE

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Document reference: 32743

Study title: Arrighi, Antonello: Homotoxicological versus conventional treatment regimens in the prophylaxis and treatment of pediatric seasonal allergic rhinitis. Biol Ther 2006 (journal spring):8-10 [IIT-publication]

Active substance: Oculoheel

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Document reference: 40088

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Oculoheel (tablets) [AWB-AT]

Active substance: Oculoheel

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Document reference: 40087

Study title: Oral nystatin profilaxis to prevent invasive candidiasis in neonatal intensive care unit 2006

Active substance: NYSTATIN

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Document reference: 41622

Study title: Mora S. Longitudinal Changes of Bone Density and Bone Resorption in Hyperthyroid Girls During Treatment, J Bone Miner Res 1999; 14: 1971-77Mora S. Longitudinal Changes of Bone Density and Bone Resorption in Hyperthyroid Girls During Treatment, J Bone Miner Res 1999; 14: 1971-77

Active substance: OBIDOXIME

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Document reference: 32731

Study title: Schendekehl TK. Therapie und Verlauf der Juvenilen Hyperthyreose, Schweiz Med Wochenschr 1997; 127 (Suppl 87): Abstract 51 Schendekehl TK. Therapie und Verlauf der Juvenilen Hyperthyreose, Schweiz Med Wochenschr 1997; 127 (Suppl 87): Abstract 51

Active substance: OBIDOXIME

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Document reference: 32733

Study title: Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396 Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396

Active substance: OBIDOXIME

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Document reference: 32732

Study title: "Addendum to the clinical expert report, Local and systemic tolerability in babies and premature infants. Author: Priv. Doz. Dr. med. E. Sebastian Debus.2003. "

Active substance: OCTENIDINE

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Document reference: 32735

Study title: "Experience report of the use of Octenisept in children prior to urological procedures. UNIVERSITY TEACHING HOSPITAL OF THE JOHANNES GUTENBERG UNIVERSITY, MAINZ. 1996. "Experience report of the use of Octenisept in children prior to urological procedures. UNIVERSITY TEACHING HOSPITAL OF THE JOHANNES GUTENBERG UNIVERSITY, MAINZ. 1996.

Active substance: OCTENIDINE

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Document reference: 32740

Study title: Bereston ES: Nystatin in the treatment of Candida albicans infections South Med J 50 547-550. (1957)Bereston ES: Nystatin in the treatment of Candida albicans infections South Med J 50 547-550. (1957)

Active substance: NYSTATIN

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Document reference: 29021

Study title: Observational study of the use of Octenisept on babies and neonates at the Pediatric Clinic of Gera Hospital.1996.

Active substance: OCTENIDINE

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Document reference: 32738

Study title: Long-acting terbutaline administered by mouth to children aged 8 - 14 years with chronic asthma. A comparison with Theo-Dur.

Active substance: TERBUTALINE

Study summary document link (including results): 01-2092 Summary.pdf

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Document reference: 44398

Study title: Multicenter study of the effect of terbutaline in children with whooping cough. (Drs JA Gray, Edinburgh: WC Love, Glasgow: the United Kingdom)

Active substance: TERBUTALINE

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Document reference: 44389

Study title: Optimal inhalation flow rate for Bricanyl(R) Turbuhaler powder inhaler 0.25 mg/dose in asthmatic children.

Active substance: TERBUTALINE

Study summary document link (including results): Terbutaline Bricanyl 01-2110 interventional.xls

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Document reference: 44406

Study title: Optimal inhalation technique for Bricanyl Turbuhaler in children with asthma.

Active substance: TERBUTALINE

Study summary document link (including results): Terbutaline Bricanyl 01-2157 interventional.xls

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Document reference: 44409

Study title: Oral terbutaline in chronic childhood asthma.

Active substance: TERBUTALINE

Study summary document link (including results): Terbutaline Bricanyl 01-2045 interventional.xls

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Document reference: 44393

Study title: Zethionate injection 200 mg and 300 mg abridged application for a product licence. Part IV Clinical documentation - Volume 1.Zethionate injection 200 mg and 300 mg abridged application for a product licence. Part IV Clinical documentation - Volume 1.

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45839

Study title: Anaesthesia et Analgesia Current Researches - Rita L. et al. - 1970 (49 : 377) - Publication in Expert Report on the clinical documentation - Steru D. and BRENOT C. - 01/1990 -

Active substance: PENTAZOCINE

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Document reference: 45840

Study title: Hemoclar-rapport final d'étude : essai pilote del'hémoclar (CB 8061) dans la néphrose de l'enfant.C 327A - Kieffer G. - 23/06/1987

Active substance: PENTOSAN

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Document reference: 45841

Study title: Blood radioactivity profile and whole body autoradiography in infant and adult rats following oral administration of 14C-BL 191 - Wheatley-Brown - 31/05/1985

Active substance: PENTOXYFILLINE

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Document reference: 45842

Study title: Disposition of pentoxifylline in neonatal rats in relation to its pharmacological effect - Tabata - 2/05/1988

Active substance: PENTOXYFILLINE

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Document reference: 45843

Study title: Group B strepto-coccus induces tumor necrosis factor in neonatal piglets: Effect of the tumor necrosis factor inhibitor pentoxifylline on haemodynamics and gas exchange. Am. Rev. Respir. Dis. 143:598-604 - Gibson - 1991 - Publication in pharmacological-toxicological expert reportGroup B strepto-coccus induces tumor necrosis factor in neonatal piglets: Effect of the tumor necrosis factor inhibitor pentoxifylline on haemodynamics and gas exchange. Am. Rev. Respir. Dis. 143:598-604 - Gibson - 1991 - Publication in pharmacological-toxicological expert report

Active substance: PENTOXYFILLINE

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Document reference: 45844

Study title: Pentoxifylline reduces ventilatory disturbances in experimental meconium aspiration. Annual meeting of the pediatric societies, Balimore. Ped Research. 51, n°4 Part 2: 394A - Kohonen - April 2002 - Publication in NDA Annual Report -Pentoxifylline reduces ventilatory disturbances in experimental meconium aspiration. Annual meeting of the pediatric societies, Balimore. Ped Research. 51, n°4 Part 2: 394A - Kohonen - April 2002 - Publication in NDA Annual Report -

Active substance: PENTOXYFILLINE

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Document reference: 45845

Study title: Pharmacokinetic and tolerability assessment of a pediatric oral formulation of pentoxifylline in Kawasaki disease. Current-Ther-research,64;2:96-115 - Best-Brookie - February 2003 - Publication in NDA Annual Report -Pharmacokinetic and tolerability assessment of a pediatric oral formulation of pentoxifylline in Kawasaki disease. Current-Ther-research,64;2:96-115 - Best-Brookie - February 2003 - Publication in NDA Annual Report -

Active substance: PENTOXYFILLINE

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Document reference: 45846

Study title: Progressive hearing loss in hearing impaired children: immediate results of antiphlogistic-rheologic infusion therapy. Michael Streppel, Claus Wittekindt, Hasso von Wedel, Martin Walger, Hans Jakob Schondorf, Olaf Michel, Eberhard Stennert. International Journal of Pediatric Otorhinolaryngology 57 (2001) 129-136

Active substance: PENTOXYFILLINE

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Document reference: 45848

Study title: A 12 week multi-center study consisting of a 6 week double-blind, randomized, vehicle controlled, parallel group phase, followed by a 6 week open label phase, to assess the efficacy and safety of Elidel Cream 1% in mild to moderate head and neck atopic dermatitis patients (2-11 years of age, inclusive) intolerant of topical corticosteroids.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2440 Art45 listing 2011.xls

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Document reference: 34091

Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON (SP) AND FOSFOMYCIN (FOM) FOR INFECTIONS COMPLICATED WITH CNS DISEASES SUCH AS CEREBROVASCULAR DISORDER

Active substance: SULBACTAM

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Document reference: 42794

Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON (SP) AND FOSFOMYCIN (FOM) FOR P. AERUGINOSA RESPIRATORY TRACT INFECTIONS (RTI).

Active substance: SULBACTAM

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Document reference: 42839

Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON (SP) AND FOSFOMYCIN (FOM) FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH UNDERLYING DISEASES (CHRONIC OBSTRUCTIVE PULMONARY DISEASES, ETC.).

Active substance: SULBACTAM

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Document reference: 42790

Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON (SP) AND FOSFOMYCIN (FOM) FOR RESPIRATORY TRACT INFECTIONS (RIP) COMPLICATED WITH MALIGNANT DISEASE.

Active substance: SULBACTAM

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Document reference: 42813

Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON (SP) AND FOSFOMYCIN (FOM) FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER

Active substance: SULBACTAM

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Document reference: 42815

Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON (SP) AND FOSFOMYCIN (FOM) FOR RESPIRATORY TRACT INFECTIONS (RTI) IN COMPLICATED LUNG CANCER

Active substance: SULBACTAM

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Document reference: 42805

Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON (SP) AND FOSFOMYCIN (FOM) TO RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER

Active substance: SULBACTAM

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Document reference: 42799

Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON AND FOSFOMYCIN FOR FOR RESPIRATORY TRACT INFECTIONS COMPLICATED WITH LUNG CANCER.

Active substance: SULBACTAM

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Document reference: 42829

Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON AND FOSFOMYCIN FOR SEVERE INFECTIONS ASSOCIATED WITH HEMATOLOGICAL DISORDERS

Active substance: SULBACTAM

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Document reference: 42795

Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON AND FOSFOMYCIN FOR SEVERE INFECTIONS ASSOCIATED WITH HEMATOLOGICAL DISORDERS OF CHILDREN

Active substance: SULBACTAM

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Document reference: 42796

Study title: TO ASSESS THE EFFICACY AND SAFETY OF A SINGLE DOSE OF STUDY MEDICATION IN TREATMENT OF URINARY TRACT INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42728

Study title: TO ASSESS THE SAFETY AND EFFICACY OF SULBACTAM/AMPICILLIN IN THE TREATMENT OF DOCUMENTED INFECTIONS AFTER SURGICAL OPERATION IN THE ABDOMINAL REGION.

Active substance: SULBACTAM

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Document reference: 42700

Study title: TO COMPARE AND ASSESS THE EFFICACY OF SBT/AMP VS CEFOXITIN IN THE PREVENTION OF INFECTIVE COMPLICATIONS FOLLOWING RECTAL SURGERY.

Active substance: SULBACTAM

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Document reference: 42698

Study title: THE USE OF CEFOPERAZONE PLUS SULBACTAM IN THE TREATMENT OF OSTEOMYELITIS

Active substance: SULBACTAM

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Document reference: 42631

Study title: TO COMPARE THE EFFICACY AND SAFETY OF A SINGLE DOSE IM S/A PLUS PROBENECID AND SINGLE DOSES OF S/A WITHOUT PROBENECID IN TREATMENT OF

Active substance: SULBACTAM

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Document reference: 42756

Study title: TO COMPARE THE EFFICACY AND SAFETY OF A SINGLE DOSE OF SULBACTAM/ AMPICILLIN IM PLUS ORAL PROBENECID IN THE TREATMENT OF GONORRHEA.

Active substance: SULBACTAM

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Document reference: 42721

Study title: TO COMPARE THE EFFICACY AND SAFETY OF SBT/AMP VS GENTAMYCIN/ORNIDAZOLE BY PARENTERAL ROUTE FOR TREATMENT OF ABDOMINAL INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42693

Study title: TO CONTINUE TO COMPARE THE EFFICACY AND SAFETY OF SULBACTAM AND AMPICILLIN CO-ADMINISTERED INTRAVENOUSLY WITH THAT OF CONVENTIONAL THERAPY CHLORAMPHENICOL & AMPICILLIN IN THE TREATMENT OF INFANTS & CHILDREN BACTERIAL MENINGITIS.

Active substance: SULBACTAM

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Document reference: 42644

Study title: TO DETERMINE THE EFFICACY AND SAFETY OF SBT/AMP FOR THE TREATMENT OF PEDIATRIC PATIENTS WITH SKIN AND SOFT TISSUE INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42726

Study title: TO DETERMINE THE EFFICACY AND SAFETY OF SBT/AMP FOR THE TREATMENT OF PEDIATRIC PATIENTS WITH URTI.

Active substance: SULBACTAM

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Document reference: 42727

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Oculoheel (eye drops) [AWB-099]

Active substance: Oculoheel

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Document reference: 40089

Study title: A multi-centre, randomised, double masked, parallel-group study completed in the USA, Mexico and Brazil comparing the safety and efficacy of topical Ofloxacin 0.3% ophthalmix solution against that of topical Trimethoprim sulphate/Polymyxin B sulphate combination ophthalmic solution as a positive control, in infants, from birth to 31 days of age, with bacterial conjunctivitis.

Active substance: OFLOXACIN

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Document reference: 41625

Study title: Etude de l'efficacité et de la tolérance de l'ofloxacine en solution auriculaire dans le traitement des otorrhées purulentes de l'enfant sur aérateur transtympanique, sur cavité d'évidement et sur otite chronique à tympan ouvert. - Dr Narcy - Fev. 1995

Active substance: OFLOXACIN

Study summary document link (including results): Ofloxacin STUDY FD.93.280.04.xls

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Document reference: 32745

Study title: John W.Warren et al., Guidelines fro Antimicrobial Treatment of Uncomplicated Acute Bacterial Cystitis and Acute Pyelonephritis in Women, Clinical Infectious Diseases, 1999; 29:745-58

Active substance: OFLOXACIN

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Document reference: 32757

Study title: John W.Warren et al., Guidelines fro Antimicrobial Treatment of Uncomplicated Acute Bacterial Cystitis and Acute Pyelonephritis in Women, Clinical Infectious Diseases, 1999; 29:745-58

Active substance: Ofloxacin

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Document reference: 32767

Study title: Metabolic fate of DL 8280. Distribution of DL-8280 to articular cartilage in immature dog after multiple administration. - TACHIZAWA - 26 March 1985 (ofloxacin Daiichi Dossier)

Active substance: OFLOXACIN

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Document reference: 32746

Study title: Repeated-dose (30 days) intravenous toxicity study of HOE280 (K 82 9164) in immature sprague dawley rats. - Fuchs - 18 March 1986 (ofloxacin Hoechst Dossier)

Active substance: OFLOXACIN

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Document reference: 32749

Study title: Repeated-dose (30 days) intravenous toxicity study of HOE280 (K 82 9164) in immature wistar rats - No author - 18 March 1986 (ofloxacin Hoechst Dossier)

Active substance: OFLOXACIN

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Document reference: 32750

Study title: Special Toxicity : Effects of orally administered DL-8280 for 7 days on the knee and elbow joints of immature rats. Comparison with structurally relating compounds - ONO - 30 June 1984 (ofloxacin Daiichi Dossier)

Active substance: OFLOXACIN

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Document reference: 32751

Study title: Special Toxicity : Effects of orally administered DL-8280 on diarthric joints of immature dogs (no effect dose level and reversibility of arthropathy). - 0N0 - 6 Apr. 1984 (ofloxacin Daiichi Dossier)

Active substance: OFLOXACIN

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Document reference: 32752

Study title: Special Toxicity : Effects of orally administered DL-8280 on diarthric joints of immature dogs. - ONO - 30 Jan. 1984 (ofloxacin Daiichi Dossier)

Active substance: OFLOXACIN

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Document reference: 32753

Study title: Special Toxicity : Effects of orally administered DL-8280 on the knee and elbow joints of immature rats. - ONO - 26 Jul. 1982 (ofloxacin Daiichi Dossier)

Active substance: OFLOXACIN

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Document reference: 32754

Study title: Special Toxicity : Joint toxicity of DR-3355 in Juvenile Rats: Comparison with DR-3354 and Ofloxacin. - Michiyuki Kato - 1990 (Levofloxacin MAA Initial - MRP Dossier - Vol. 46: 167-183)

Active substance: OFLOXACIN

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Document reference: 32755

Study title: Nasal wash in allergic rhinitis

Active substance: OHER NASAL PREPARATIONS_NATURAL ELMS SALT

Study summary document link (including results):

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Document reference: 32758

Study title: Ofloxacin Auricular Solution : Clinical Expert Report - Dr Ichou - Fev. 1995

Active substance: OFLOXACIN

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Document reference: 32748

Study title: Pharmacokinetics of terbutaline in asthmatic children after intravenous administration. (N B! Study code fictitious: allocated for Clint pusposes)

Active substance: TERBUTALINE

Study summary document link (including results): Terbutaline Bricanyl 01-2611 interventional.xls

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Document reference: 44383

Study title: Pilot study of Bricanyl retard in asthmatic children.

Active substance: TERBUTALINE

Study summary document link (including results): CSR 01-9073.pdf

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Document reference: 44400

Study title: Terbutaline in the acute treatment of children with bronchial asthma. (N B! Study code fictitious: allocated for Clint pusposes)

Active substance: TERBUTALINE

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Document reference: 44384

Study title: Terbutaline in breast milk.

Active substance: TERBUTALINE

Study summary document link (including results): Terbutaline Bricanyl 01-8023 interventional.xls

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Document reference: 44392

Study title: The effect and side effects of terbutaline sustained release tablets in children exhibiting symptoms of nocturnal asthma.

Active substance: TERBUTALINE

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Document reference: 44401

Study title: The effect of Bricanyl Turbuhaler and Bricanyl chlorofluorocarbon (CFC) inhaler on exercise-induced asthma in children.

Active substance: TERBUTALINE

Study summary document link (including results): Terbutaline Bricanyl 01-2178 interventional.xls

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Document reference: 44414

Study title: The effect of Bricanyl Turbuhaler and Ventolin inhalation powder in Rotacaps on exercise induced asthma.

Active substance: TERBUTALINE

Study summary document link (including results): Terbutaline Bricanyl 01-2154 interventional.xls

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Document reference: 44418

Study title: The effect of terbutaline 0.4 mg Turbuhaler (prototype) and salbutamol inhalation powder 0.2 mg in Rotacaps, on acute asthma bronchiale in children.

Active substance: TERBUTALINE

Study summary document link (including results): Terbutaline Bricanyl 01-2102 interventional.xls

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Document reference: 44407

Study title: The effects of inhaled terbutaline sulfate and salbutamol on airway caliber, using the aerosol and dry powder systems of drug delivery.

Active substance: TERBUTALINE

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Document reference: 44426

Study title: The efficacy of terbutaline in children with cough. A double-blind placebo controlled study.

Active substance: TERBUTALINE

Study summary document link (including results): 01-2172 Summary.pdf

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Document reference: 44388

Study title: The use of Nebuhaler(TM) in children with acute asthma.

Active substance: TERBUTALINE

Study summary document link (including results): Terbutaline Bricanyl 01-6063 interventional.xls

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Document reference: 44387

Study title: The use of the Nebuhaler in acute asthma in children.

Active substance: TERBUTALINE

Study summary document link (including results): CSR 01-2638.pdf

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Document reference: 44386

Study title: Treatment of exercise induced asthma in adualts. A comparison between Bricanyl Turbuhaler and Ventolin metered dose inhaler.

Active substance: TERBUTALINE

Study summary document link (including results): 01-2186 Study Synopsis.pdf

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Document reference: 44424

Study title: Use and acceptability of the Bricanyl Turbuhaler in children with bronchial asthma.

Active substance: TERBUTALINE

Study summary document link (including results): 01-2176 Summary.pdf

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Document reference: 44423

Study title: Double-blnd clinical trial with two Terfenadine suspension formulations.

Active substance: TERFENADINE

Study summary document link (including results):

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Document reference: 44436

Study title: Double-blnd clinical trial with two Terfenadine tablet formulations at 60 mg.

Active substance: TERFENADINE

Study summary document link (including results):

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Document reference: 44438

Study title: Terfenadin-Suspension versus Clemastin-Sirup bei Kindern mit akuter Pollenrhinitis

Active substance: TERFENADINE

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Document reference: 44437

Study title: A 12 week multicenter study consisting of a 6 week double blind, randomized, vehicle controlled, parallel group phase, followed by a 6 week open label phase, to assess the safety and efficacy of Elidel® Cream 1% in mild to moderate head and neck atopic dermatitis of patients intolerant of topical corticosteroids

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2442 Art45 listing 2011.xls

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Document reference: 34092

Study title: A 12-week open-label, multicenter, effectiveness and safety study of Elidel (pimecrolimus) cream 1% in subjects with atopic dermatitis.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CEG01 Art45 listing 2011.xls

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Document reference: 34098

Study title: A 20-week study with a 4 week randomized, multi-center, double-blind, vehicle-controlled, parallel-group phase followed by a 12 week open label phase and a 4 week follow-up phase to study the efficacy and safety of 1% SDZ ASM981 cream in pediatric subjects with atopic dermatitis and to collect information about the time and extent of relapse.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CDE04 Art45 listing 2011.xls

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Document reference: 34093

Study title: A 26-week study with a 6-week, randomized, multi-center, investigator-blinded, exploratory comparative trial of the tolerability, safety and efficacy of Elidel® (pimecrolimus, SDZ ASM981) cream 1% with tacrolimus ointment 0.03% in the treatment of pediatric subjects with moderate atopic dermatitis, followed by a 20-week open-label phase to study the safety of Elidel® (pimecrolimus, SDZ ASM981) cream 1%.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2406 Art45 listing 2011.xls

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Document reference: 47707

Study title: A 26-week, randomized, multicenter, parallel-group, double-blind, vehicle-controlled study to evaluate the incidence of atopic dermatitis flares when ASM981 (pimecrolimus) cream 1% is used at the first signs and/or symptoms of atopic dermatitis and its safety and tolerability in children and adolescents 2 - 17 years of age

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2406 Art45 listing 2011.xls

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Document reference: 34132

Study title: A 27 week study, 3 week randomized, multicenter, double blind, parallel group, vehicle control and 24 week open label phase, to evaluate efficacy , tolerability and safety, of ASM 981 (pimecrolimus) cream 1% in pediatric patients with mild to moderate atopic dermatitis in face

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981MX01 Art45 listing 2011.xls

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Document reference: 34099

Study title: Bass JL, Gozal D. Oxygen therapy for bronchiolitis. Pediatrics 2007; 119:611Bass JL, Gozal D. Oxygen therapy for bronchiolitis. Pediatrics 2007; 119:611

Active substance: OXYGEN

Study summary document link (including results):

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Document reference: 45401

Study title: TO DETERMINE THE SAFETY AND EFFICACY OF SBT/AMP FOR THE TREATMENT OF PATIENTS WITH METHICILLIN-RESISTANT STAPH INFECTIONS OF THE SKIN AND SOFT TISSUE.

Active substance: SULBACTAM

Study summary document link (including results):

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Document reference: 42725

Study title: TO DOCUMENT THE EFFICACY AND SAFETY OF SBT/AMP IN MODERATE TO SEVERE PEDIATRIC INFECTIONS.

Active substance: SULBACTAM

Study summary document link (including results):

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Document reference: 42680

Study title: TO EVALUATE THE CLINICAL AND BACTERIOLOGICAL EFFICACY, SAFETY AND TOLERABILITY OF SULBACTAM/AMPICILLIN IN THE TREATMENT OF SKIN/SOFT TISSUE INFECTIONS OF BACTERIAL ETIOLOGY.

Active substance: SULBACTAM

Study summary document link (including results):

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Document reference: 42746

Study title: TO EVALUATE THE CLINICAL AND BACTERIOLOGICAL EFFICACY, SAFETY AND TOLERATION OF UNASYN IM/IV IN VARIOUS INFECTIONS.

Active substance: SULBACTAM

Study summary document link (including results):

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Document reference: 42687

Study title: TO EVALUATE THE CLINICAL EFFICACY OF S/S IN HOSPITALIZED PATIENT WITH URINARY TRACT INFECTIONS

Active substance: SULBACTAM

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Document reference: 42682

Study title: TO EVALUATE THE EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN IN THE TREATMENT OF GYNECOLOGICAL INFECTIONS OF BACTERIAL ETIOLOGY, INCLUDING, BUT NOT NECESSARILY LIMITED TO: PELVIC INFLAMMATORY DISEASE, ENDOMETRITIS, SALPINGITIS, BARTHELINITIS, ETC.

Active substance: SULBACTAM

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Document reference: 42716

Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SBT/AMP GIVEN IM TWICE A DAY IN NON-SEVERE INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42724

Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SULBACTAM/AMPICILLIN GIVEN INTRAMUSCULARLY THREE/FOUR TIMES PER DAY TO PATIENTS WITH VARIOUS INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42715

Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SULBACTAM/AMPICILLIN GIVEN INTRAVENOUSLY EVERY 8 HOURS COMPARED TO NETILMYCIN 100 MG, PLUS METRONIDAZOLE TWO TIMES A DAY IN THE TREATMENT OF PATIENTS WITH INTRA ABDOMINAL INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42708

Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SULBACTAM/AMPICILLIN IM/IV IN THE TREATMENT OF SURGICAL INFECTIONS.

Active substance: SULBACTAM

Study summary document link (including results):

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Document reference: 42714

Study title: TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SBT/AMP IN THE TREATMENT OF MODERATE TO SEVERE SKIN/SOFT TISSUE OR BACTERIAL

Active substance: SULBACTAM

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Document reference: 42748

Study title: TO EVALUATE THE EFFICACY, SAFETY AND TOLERATION OF SBT/AMP IN THE TREATMENT OF BACTERIAL INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42747

Study title: TO EVALUATE THE SAFETY AND EFFICACY OF SULBACTAM/AMPICILLIN COMPARED TO CEFOTETAN IN THE TREATMENT OF BACTERIAL ETIOLOGY INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42697

Study title: TO STUDY THE EFFICACY AND SAFETY OF SBT/AMP IN THE TREATMENT OF INFECTIONS IN NEONATES.

Active substance: SULBACTAM

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Document reference: 42694

Study title: UNASYN IM/IV, OPEN, NON COMPARATIVE EVALUATION IN THE TREATMENT OF ACUTE AND CHRONIC INFECTIONS

Active substance: SULBACTAM

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Document reference: 42683

Study title: Prevention of early otorrhea in ventilation tubes Epstein JS, Beane J, Hubbell R. Otolaryngol Head Neck Surg. 1992 Dec;107(6 Pt 1): 758-62 "This prospective randomized study of 430 children, ages 6 months to 15 years, examined the efficacy of sulfacetamide/prednisolone otic drops used for 3 days postoperatively in reducing the incidence of otorrhea at 1 week after the placement of Donaldson tubes" Prevention of early otorrhea in ventilation tubes Epstein JS, Beane J, Hubbell R. Otolaryngol Head Neck Surg. 1992 Dec;107(6 Pt 1): 758-62 "This prospective randomized study of 430 children, ages 6 months to 15 years, examined the efficacy of sulfacetamide/prednisolone otic drops used for 3 days postoperatively in reducing the incidence of otorrhea at 1 week after the placement of Donaldson t...

Active substance: SULFACETAMIDE

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Document reference: 42875

Study title: TO DETERMINE THE SAFETY AND EFFICACY OF PARENTERAL SULBACTAM/AMPICILLIN FOLLOWED BY ORAL SULTAMICILLIN IN TREATING SEVERE LOWER RESPIRATORY TRACT INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42677

Study title: "Prophylaxis of Bacterial Infections after Bone Msrrow Transplantation - E. Gluckman, C. Roudet, I. Hirsch, A. Devergie, H. Bourdeau, C. Arlet - Chemotherapy 1991; 33 (suppl 1): 33-38"

Active substance: OFLOXACIN

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Document reference: 32756

Study title: Efficacy and Safety of Olanzapine in Patients with Borderline Personality Disorder: A Randomized, Flexible-Dose, Double-Blind Comparison with Placebo

Active substance: OLANZAPINE

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Document reference: 32759

Study title: Long-Term Open-Label Trial of Olanzapine in Children with Childhood Onset of Schizophrenia

Active substance: OLANZAPINE

Study summary document link (including results): Olanzapine - F1D-MC-HGCT Synopsis redacted batch numbers.pdf

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Document reference: 32760

Study title: Open-Label Study of Olanzapine in Children with Pervasive Developmental Disorder

Active substance: OLANZAPINE

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Document reference: 32761

Study title: A Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of a Compounded 4 mg/mL Olmesartan Medoxomil Suspension (Total Dose 40 mg) and 40 mg Olmesartan Medoxomil Tablets (Benicar®) in Healthy Adult Volunteers Under Fasting Conditions

Active substance: OLMESARTAN MEDOXOMIL

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Document reference: 32762

Study title: An Open-Label Study of the Single-Dose Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients with Hypertension

Active substance: OLMESARTAN MEDOXOMIL

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Document reference: 32763

Study title: Dose-Ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents with Hypertension

Active substance: OLMESARTAN MEDOXOMIL

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Document reference: 32764

Study title: Efficacy and comfort of olopatadine versus ketotifen ophthalmic solutions: a double-masked, environmental study of patient preference. Leonardi A, Zafirakis P. Curr Med Res Opin. 2004 Aug;20(8):1167-73. Efficacy and comfort of olopatadine versus ketotifen ophthalmic solutions: a double-masked, environmental study of patient preference. Leonardi A, Zafirakis P. Curr Med Res Opin. 2004 Aug;20(8):1167-73.

Active substance: olopatadine

Study summary document link (including results): Efficacy and comfort of olopatadine versus ketotifen ophthalmic solutions a double-masked, environmental study of patient preference. Leonardi A, Z...

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Document reference: 41584

Study title: Ketotifen fumarate and olopatadine hydrochloride in the treatment of allergic conjunctivitis: a real-world comparison of efficacy and ocular comfort. Ganz M, Koll E, Gausche J, Detjen P, Orfan N. Adv Ther. 2003 Mar-Apr;20(2):79-91. Ketotifen fumarate and olopatadine hydrochloride in the treatment of allergic conjunctivitis: a real-world comparison of efficacy and ocular comfort. Ganz M, Koll E, Gausche J, Detjen P, Orfan N. Adv Ther. 2003 Mar-Apr;20(2):79-91.

Active substance: olopatadine

Study summary document link (including results): Ketotifen fumarate and olopatadine hydrochloride in the treatment of allergic conjunctivitis a real-world comparison of efficacy and ocular comfort...

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Document reference: 41583

Study title: Olsalazine vs sulfalazine in mild to moderate childhood ulcerative colitis: results of the Paediatrici gastroenterology Collaborative Research Group Clinical TrialFerry et al

Active substance: OLSALAZINE

Study summary document link (including results): Ferry et al - Olsalazine sodium.pdf

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Document reference: 32765

Study title: Tolerance of olsalazine in young patients treated for ulcerative colitis

Active substance: OLSALAZINE

Study summary document link (including results): L342G26R1 - Olsalazine sodium.pdf

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Document reference: 32766

Study title: A bioavailability study of omeprazole comparing three different liquid formulations after single dose administration to healthy volunteers, 17 November 1996

Active substance: OMEPRAZOLE

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Document reference: 41623

Study title: A Multi-Center, Open-Label Study to Evaluate Omeprazole for the Treatment of Gastrointestinal Symptoms Associated with Acid-Related Disorders in Pediatric Subjects (Ages 2 through 16 years, Inclusive), 9 August 2000

Active substance: OMEPRAZOLE

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Document reference: 32788

Study title: The Use of Remestyp in the Paediatric Gynecology treating Juvenile MetrorrhagiaJ. Hořejší, Československá gynekologie 1980, 45 (5): 292-294The Use of Remestyp in the Paediatric Gynecology treating Juvenile MetrorrhagiaJ. Hořejší, Československá gynekologie 1980, 45 (5): 292-294

Active substance: TERLIPRESSIN

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Document reference: 44439

Study title: Briet, E et al. The prophylactiv treatment of hemophilia B Leyden with anabolic steroids. Ann. Intern. Med. 1985; 103: 225-226.Ann. Intern. Med. 1985; 103: 225-226Briet, E et al. The prophylactiv treatment of hemophilia B Leyden with anabolic steroids. Ann. Intern. Med. 1985; 103: 225-226.Ann. Intern. Med. 1985; 103: 225-226

Active substance: TESTOSTERONE UNDECANOATE

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Document reference: 44441

Study title: Endres W, et al. Priapism in Fabry's disease during testosterone treatment. Klin Wochenschr 1987;65:925; Klin Wochenschr 1987;65:925Endres W, et al. Priapism in Fabry's disease during testosterone treatment. Klin Wochenschr 1987;65:925; Klin Wochenschr 1987;65:925

Active substance: TESTOSTERONE UNDECANOATE

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Document reference: 44440

Study title: Immuntherapie bei kindern mit hilfe eines multibakteriellen ribosomenpräparates

Active substance: Tetanus Vaccine (Adsorbed)

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Document reference: 41393

Study title: Effect of tetrabenazine on tics and Sleep of Gilles de la Tourette's Syndrome (Neurology 1984). Effect of tetrabenazine on tics and Sleep of Gilles de la Tourette's Syndrome (Neurology 1984).

Active substance: TETRABENAZINE

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Document reference: 44443

Study title: Only case reports/review: - Comparaison of weight gain in treatments for Tourette Syndrome: tetrabenazine versus neuroleptic drug (J.Child Neurol. 2008). - Only case reports/review: - Comparaison of weight gain in treatments for Tourette Syndrome: tetrabenazine versus neuroleptic drug (J.Child Neurol. 2008). -

Active substance: TETRABENAZINE

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Document reference: 44442

Study title: Abeyagunawardena, A. S., Hindmarsh, P., and Trompeter, R. S.Abeyagunawardena, A. S., Hindmarsh, P., and Trompeter, R. S.

Active substance: TETRACOSACTIDE

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Document reference: 44457

Study title: Adrenal function improves in asthmatic children on inhaled steroids: a longitudinal studyAdrenal function improves in asthmatic children on inhaled steroids: a longitudinal study

Active substance: TETRACOSACTIDE

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Document reference: 44463

Study title: Arch.Dis.Child 2007;92:585-588.Arch.Dis.Child 2007;92:585-588.

Active substance: TETRACOSACTIDE

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Document reference: 44460

Study title: Azam, M., Bhatti, N., and Krishin, J.Azam, M., Bhatti, N., and Krishin, J.

Active substance: TETRACOSACTIDE

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Document reference: 44468

Study title: Brain Dev. 1996;18:456-460.Brain Dev. 1996;18:456-460.

Active substance: TETRACOSACTIDE

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Document reference: 44479

Study title: Brain Dev. 1999;21:461-467.Brain Dev. 1999;21:461-467.

Active substance: TETRACOSACTIDE

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Document reference: 44475

Study title: Children's Hospital, Pakistan Institute of Medical Sciences, Islamabad, Pakistan. muneeb@sat.net.pkChildren's Hospital, Pakistan Institute of Medical Sciences, Islamabad, Pakistan. muneeb@sat.net.pk

Active substance: TETRACOSACTIDE

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Document reference: 44469

Study title: Children's Hospital, University of Helsinki, FinlandChildren's Hospital, University of Helsinki, Finland

Active substance: TETRACOSACTIDE

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Document reference: 44477

Study title: Fitzgerald DA, Kilham HA. Croup: Assessment and evidence-based management. Medical Journal of Australia. 2003; 179(7):372-7.Fitzgerald DA, Kilham HA. Croup: Assessment and evidence-based management. Medical Journal of Australia. 2003; 179(7):372-7.

Active substance: OXYGEN

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Document reference: 45402

Study title: Gleeson JG, Green S, Price JF. Air or oxygen as driving gas for nebulised salbutamol. Arch Dis Child 1988; 63:900-4.Gleeson JG, Green S, Price JF. Air or oxygen as driving gas for nebulised salbutamol. Arch Dis Child 1988; 63:900-4.

Active substance: OXYGEN

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Document reference: 45403

Study title: Inwald D, Roland M, Kuitert L, Sheila AM, Petros A. Oxygen treatment of acute severe asthma. BMJ (Indian ed) 2001; 17:732-4.Inwald D, Roland M, Kuitert L, Sheila AM, Petros A. Oxygen treatment of acute severe asthma. BMJ (Indian ed) 2001; 17:732-4.

Active substance: OXYGEN

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Document reference: 45404

Study title: Inwald D, Roland M, Kuitert L, Sheila AM, Petros A. Oxygen treatment of acute severe asthma. BMJ (Indian ed) 2001;17:732-4.Inwald D, Roland M, Kuitert L, Sheila AM, Petros A. Oxygen treatment of acute severe asthma. BMJ (Indian ed) 2001;17:732-4.

Active substance: OXYGEN

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Document reference: 45417

Study title: Kinsey VE. Cooperative study of retrolental fibroplasia and the use of oxygen. Arch Ophthalmol 1956;56:481-543. Kinsey VE. Cooperative study of retrolental fibroplasia and the use of oxygen. Arch Ophthalmol 1956;56:481-543.

Active substance: OXYGEN

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Document reference: 45405

Study title: Macey PM, Woo MA, Harper RM. Hyperoxic brain effects are normalized by addition of CO2. PLoS Med. 2007 May;4(5):e173Macey PM, Woo MA, Harper RM. Hyperoxic brain effects are normalized by addition of CO2. PLoS Med. 2007 May;4(5):e173

Active substance: OXYGEN

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Document reference: 45420

Study title: Neonatal inhaled nitric oxide study group. Inhaled nitric oxide in full term and nearly full term infants with hypoxic respiratory failure. NEJM 1997 Feb 27; 336(9):597-604.Neonatal inhaled nitric oxide study group. Inhaled nitric oxide in full term and nearly full term infants with hypoxic respiratory failure. NEJM 1997 Feb 27; 336(9):597-604.

Active substance: OXYGEN

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Document reference: 45406

Study title: Poets CF. When do infants need additional inspired oxygen? A review of the current literature. Pediatric Pulmonology 1998; 26:424-428Poets CF. When do infants need additional inspired oxygen? A review of the current literature. Pediatric Pulmonology 1998; 26:424-428

Active substance: OXYGEN

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Document reference: 45407

Study title: Saugstad OD, Rootwelt T, Aalen O. Resuscitation of Asphyxiated Newborn Infants With Room Air or Oxygen: An International Controlled Trial: The Resair 2 Study Pediatrics 1998; 102;E1Saugstad OD, Rootwelt T, Aalen O. Resuscitation of Asphyxiated Newborn Infants With Room Air or Oxygen: An International Controlled Trial: The Resair 2 Study Pediatrics 1998; 102;E1

Active substance: OXYGEN

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Document reference: 45408

Study title: Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968; 42:565-589Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968; 42:565-589

Active substance: OXYGEN

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Document reference: 45409

Study title: Chen CC, Lin YT, Yang YH, et al.; J Formos Med Assoc (China (Republic:1949-)), Feb 2002, 101(2) p110-6; Sulfasalazine therapy for juvenile rheumatoid arthritis.Chen CC, Lin YT, Yang YH, et al.; J Formos Med Assoc (China (Republic:1949-)), Feb 2002, 101(2) p110-6; Sulfasalazine therapy for juvenile rheumatoid arthritis.

Active substance: SULFASALAZINE

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Document reference: 42882

Study title: Christensen LA, Fallingborg J, Jacobson BA, " Bioavailability of 5-aminosalicylic acid from slow release 5-aminosalicylic acid drug and sulfasalasine in normal children." Did Dis Sci 38 (1993) 1831-1836Christensen LA, Fallingborg J, Jacobson BA, " Bioavailability of 5-aminosalicylic acid from slow release 5-aminosalicylic acid drug and sulfasalasine in normal children." Did Dis Sci 38 (1993) 1831-1836

Active substance: SULFASALAZINE

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Document reference: 42877

Study title: Emery HM; Curr Opin Rheumatol (United States), Sep 1993, 5(5) p629-33 Treatment of juvenile rheumatoid arthritis.Emery HM; Curr Opin Rheumatol (United States), Sep 1993, 5(5) p629-33 Treatment of juvenile rheumatoid arthritis.

Active substance: SULFASALAZINE

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Document reference: 42883

Study title: Ferry GD, Kirschner BS, Grand RJ, Issemann RM, Griffiths AM et al., Olsalasine versus sulfasalasine in mild to moderate childhood ulcerative colitis: results of the pediatric gastroenterology collaborative research group clinical trial. J Chromatogr 162 (1979) 237-243Ferry GD, Kirschner BS, Grand RJ, Issemann RM, Griffiths AM et al., Olsalasine versus sulfasalasine in mild to moderate childhood ulcerative colitis: results of the pediatric gastroenterology collaborative research group clinical trial. J Chromatogr 162 (1979) 237-243

Active substance: SULFASALAZINE

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Document reference: 42878

Study title: Gedalia A, Barash J, Press J, et al. Clin Rheumatol (Belgium), Dec 1993, 12(4) p511-4; Sulphasalazine in the treatment of pauciarticular-onset juvenile chronic arthritis. Gedalia A, Barash J, Press J, et al. Clin Rheumatol (Belgium), Dec 1993, 12(4) p511-4; Sulphasalazine in the treatment of pauciarticular-onset juvenile chronic arthritis.

Active substance: SULFASALAZINE

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Document reference: 42884

Study title: Hertzberger-ten Cate R, Cats A ; Clin Exp Rheumatol (Italy), Jan-Feb 1991, 9(1) p85-8; Toxicity of sulfasalazine in systemic juvenile chronic arthritis.Hertzberger-ten Cate R, Cats A ; Clin Exp Rheumatol (Italy), Jan-Feb 1991, 9(1) p85-8; Toxicity of sulfasalazine in systemic juvenile chronic arthritis.

Active substance: SULFASALAZINE

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Document reference: 42885

Study title: Huang JL, Chen LC.; Clin Rheumatol 1998;17(5):359-63; Sulphasalazine in the treatment of children with chronic arthritis.Huang JL, Chen LC.; Clin Rheumatol 1998;17(5):359-63; Sulphasalazine in the treatment of children with chronic arthritis.

Active substance: SULFASALAZINE

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Document reference: 42886

Study title: Huang JL, Hung IJ, Hsieh KH.; Asian Pac J Allergy Immunol 1997 Jun;15(2):71-5; Sulphasalazine therapy in chronic uveitis of children with chronic arthritis.Huang JL, Hung IJ, Hsieh KH.; Asian Pac J Allergy Immunol 1997 Jun;15(2):71-5; Sulphasalazine therapy in chronic uveitis of children with chronic arthritis.

Active substance: SULFASALAZINE

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Document reference: 42887

Study title: Ilowite NT; Pediatrics (United States), Jan 2002, 109(1) p109-15. Current treatment of juvenile rheumatoid arthritis.Ilowite NT; Pediatrics (United States), Jan 2002, 109(1) p109-15. Current treatment of juvenile rheumatoid arthritis.

Active substance: SULFASALAZINE

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Document reference: 42888

Study title: A Multicenter, Randomized Open-Label, Pharmacokinetics and pH Assessment Study to Evaluate a Single Dose of Omeprazole in a Pediatric Population Ages 0 Months – 24 Months, Inclusive, 3 January 2001

Active substance: OMEPRAZOLE

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Document reference: 32790

Study title: A Multicenter, Randomized, Single-Blind Study to Evaluate Omeprazole for the Treatment of Clinically Diagnosed GERD in Pediatric Patients Ages 0 months through 24 months, Inclusive, 18 October 2000

Active substance: OMEPRAZOLE

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Document reference: 32791

Study title: A Multicenter, Retrospective Study to Evaluate the Effect of Multiple Doses of Omeprazole on Gastric or Esophageal pH in a Pediatric Population, 17 November 2000

Active substance: OMEPRAZOLE

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Document reference: 32792

Study title: A prospective study of a one-week nonbismuth quadruple therapy for childhood Helicobacter pylori infection.

Active substance: OMEPRAZOLE

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Document reference: 32784

Study title: A Randomized, Single-Center, Open-label, Two-period Crossover, Pharmacokinetic Study to Evaluate the Bioequivalence of a Single 20 mg Omeprazole Dose Administered as an Intact Capsule and as an Open Capsule in Healthy Male and Female Volunteers, 30 September 1999

Active substance: OMEPRAZOLE

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Document reference: 32787

Study title: An Open-label, Multicenter, Pharmacokinetic Study to Evaluate the Bioavailability of a Single Dose of Omeprazole in a Pediatric Population, 7 March 2000

Active substance: OMEPRAZOLE

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Document reference: 32786

Study title: An Open-label, Multicenter, Pharmacokinetic Study to Evaluate the Bioavailability of Single and Multiple Doses of Omeprazole in a Pediatric Population, 23 May 2000

Active substance: OMEPRAZOLE

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Document reference: 32789

Study title: Dose finding study of omeprazole given orally to young rats for up to 8 days. Astra Safety Assessment, Södertälje, Sweden. 12 January 1994.

Active substance: OMEPRAZOLE

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Document reference: 32769

Study title: Effect of omeprazole in the treatment of refractory acid-related diseases in childhood: endoscopic healing and twenty-four-hour intragastric acidity

Active substance: OMEPRAZOLE

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Document reference: 32785

Study title: Effect of omeprazole on the efficacy of amoxicillin and clarithromycin for the treatment of Helicobacter pylori associated gastritis in children, 22 February 2001

Active substance: OMEPRAZOLE

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Document reference: 32793

Study title: Evaluation of the role of acidic and non-acidic reflux in recurrent respiratory and chronic ear, nose,and throat (ENT) diseases in children by using multichannel intraluminal impedance (MII) apparatus

Active substance: OMEPRAZOLE

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Document reference: 32778

Study title: General toxicity of omeprazole given orally to young rats for 1 month. AstraZeneca R&D Södertälje, Safety Assessment, Sweden

Active substance: OMEPRAZOLE

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Document reference: 32783

Study title: Histologic findings in children treated with long-term proton pump inhibitors (PPIs)

Active substance: OMEPRAZOLE

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Document reference: 32782

Study title: Omeprazole in children with reflux esophagitis-an open dose finding study and an evaluation of the safety and efficacy during maintenance treatment. Interim report 1996

Active substance: OMEPRAZOLE

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Document reference: 32794

Study title: Pharmacokinetics and pharmacodynamics of the infusion formulation of omeprazole in children when treatment is not possible

Active substance: OMEPRAZOLE

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Document reference: 32780

Study title: PK/PD study on omeprazole in children with gastro-esophageal reflux

Active substance: OMEPRAZOLE

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Document reference: 32771

Study title: Characteristics of Children Receiving Proton Pump Inhibitors Continously for up to 11 years duration

Active substance: OMEPRAZOLE

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Document reference: 32781

Study title: Plasma concentrations of omeprazole in young rats after oral administration. Astra Safety Assessment, Södertälje, Sweden. 13 January 1994.

Active substance: OMEPRAZOLE

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Document reference: 32770

Study title: Department of Allergy and Pneumonology, P. Penteli Children's Hospital, Penteli, Greece. kpriftis@otenet.grDepartment of Allergy and Pneumonology, P. Penteli Children's Hospital, Penteli, Greece. kpriftis@otenet.gr

Active substance: TETRACOSACTIDE

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Document reference: 44462

Study title: Department of Paediatrics, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka. asiri26@hotmail.comDepartment of Paediatrics, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka. asiri26@hotmail.com

Active substance: TETRACOSACTIDE

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Document reference: 44458

Study title: Department of Pediatrics, Shiga Medical Center for Children, Moriyama, Japan. ito-mccs@mx.biwa.ne.jpDepartment of Pediatrics, Shiga Medical Center for Children, Moriyama, Japan. ito-mccs@mx.biwa.ne.jp

Active substance: TETRACOSACTIDE

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Document reference: 44454

Study title: Department of Pediatrics, Tokyo Women's Medical University, JapanDepartment of Pediatrics, Tokyo Women's Medical University, Japan

Active substance: TETRACOSACTIDE

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Document reference: 44473

Study title: Dermatologica 1980;160:261-269.Dermatologica 1980;160:261-269.

Active substance: TETRACOSACTIDE

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Document reference: 44467

Study title: Heiskala, H., Riikonen, R., Santavuori, P., Simell, O., Airaksinen, E., Nuutila, A., and Perheentupa, J.Heiskala, H., Riikonen, R., Santavuori, P., Simell, O., Airaksinen, E., Nuutila, A., and Perheentupa, J.

Active substance: TETRACOSACTIDE

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Document reference: 44476

Study title: Low-dose ACTH therapy for West syndrome: initial effects and long-term outcomeLow-dose ACTH therapy for West syndrome: initial effects and long-term outcome

Active substance: TETRACOSACTIDE

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Document reference: 44455

Study title: Marten, R. H., Byrne, J. P., Peiris, S., Butler, J., and Keenan, J.Marten, R. H., Byrne, J. P., Peiris, S., Butler, J., and Keenan, J.

Active substance: TETRACOSACTIDE

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Document reference: 44465

Study title: Neuroimmunomodulation. 2006;13:56-62.Neuroimmunomodulation. 2006;13:56-62.

Active substance: TETRACOSACTIDE

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Document reference: 44464

Study title: Adjunctive intra-operative local anaesthesia in paediatric strabismus surgery: a randomized controlled trial. Carden SM, Colville DJ, Davidson AJ, McKenzie IM, Mackey DA, McKenzie J, Elder JE. Aust N Z J Ophthalmol. 1998 Nov;26(4):289-97. Adjunctive intra-operative local anaesthesia in paediatric strabismus surgery: a randomized controlled trial. Carden SM, Colville DJ, Davidson AJ, McKenzie IM, Mackey DA, McKenzie J, Elder JE. Aust N Z J Ophthalmol. 1998 Nov;26(4):289-97.

Active substance: TETRACAINE

Study summary document link (including results): Adjunctive intra-operative local anaesthesia in paediatric strabismus surgery a randomized controlled trial. Carden SM, Colville DJ, Davids.pdf

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Document reference: 44446

Study title: Open study on pain free cutting of split skin grafts using local anaesthetic cream1988

Active substance: TETRACAINE

Study summary document link (including results): Tetracaine_1988.xls

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Document reference: 48143

Study title: Open study to assess efficacy and safety of Tetracaine in children undergoing venepuncture or cannulation1992

Active substance: TETRACAINE

Study summary document link (including results): Tetracaine_Amegel199201.xls

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Document reference: 48144

Study title: Open study to collect clinical results, particularly in children with a preparation of Tetracaine gel 4% w/w1990

Active substance: TETRACAINE

Study summary document link (including results): Tetracaine_1990.xls

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Document reference: 48142

Study title: A comparative study of high-dose and low-dose ACTH therapy for West syndromeA comparative study of high-dose and low-dose ACTH therapy for West syndrome

Active substance: TETRACOSACTIDE

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Document reference: 44474

Study title: Wong−A et al. Antipyretic effects of dipyrone versus ibuprofen versus acetaminophen in children: Results of a multinational, randomized, modified double− blind study. {CLIN−PEDIATR}, 2001, Vol/Iss/Pg. 40/6 (313−324)Wong−A et al. Antipyretic effects of dipyrone versus ibuprofen versus acetaminophen in children: Results of a multinational, randomized, modified double− blind study. {CLIN−PEDIATR}, 2001, Vol/Iss/Pg. 40/6 (313−324)

Active substance: PARACETAMOL

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Document reference: 45770

Study title: Yaffe−S−J. Comparative efficacy of aspirin and acetaminophen in the reduction of fever in children. {Arch−Intern−Med}, 23 Feb 1981, vol. 141, no. 3 Spec No, p. 286−92Yaffe−S−J. Comparative efficacy of aspirin and acetaminophen in the reduction of fever in children. {Arch−Intern−Med}, 23 Feb 1981, vol. 141, no. 3 Spec No, p. 286−92

Active substance: PARACETAMOL

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Document reference: 45771

Study title:

Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID

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Document reference: 33260

Study title:

Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID

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Document reference: 33261

Study title:

Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID

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Document reference: 33262

Study title: Agbolosu−N−B et al. Efficacy of tepid sponging versus paracetamol in reducing temperature in febrile children. {ANN−TROP−PAEDIATR}, 1997, Vol/Iss/Pg. 17/3 (283−288)Agbolosu−N−B et al. Efficacy of tepid sponging versus paracetamol in reducing temperature in febrile children. {ANN−TROP−PAEDIATR}, 1997, Vol/Iss/Pg. 17/3 (283−288)

Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID

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Document reference: 33291

Study title: Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6

Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID

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Document reference: 33249

Study title: Friedman−A−D, Barton−L−L. Efficacy of sponging vs acetaminophen for reduction of fever. Sponging Study Group. {Pediatr−Emerg−Care}, Mar 1990, vol. 6, no. 1, p. 6−7Friedman−A−D, Barton−L−L. Efficacy of sponging vs acetaminophen for reduction of fever. Sponging Study Group. {Pediatr−Emerg−Care}, Mar 1990, vol. 6, no. 1, p. 6−7

Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID

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Document reference: 33252

Study title: Gehri−Mario et al. When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm−World−Sci}, Jun 2005, vol. 27, no. 3, p. 254−7Gehri−Mario et al. When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm−World−Sci}, Jun 2005, vol. 27, no. 3, p. 254−7

Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID

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Document reference: 33270

Study title: Imundo LF, Jacobs JC J Rheumatol (Canada), Feb 1996, 23(2) p360-6. Sulfasalazine therapy for juvenile rheumatoid arthritis.Imundo LF, Jacobs JC J Rheumatol (Canada), Feb 1996, 23(2) p360-6. Sulfasalazine therapy for juvenile rheumatoid arthritis.

Active substance: SULFASALAZINE

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Document reference: 42889

Study title: Braunsteiner A*,Habermacher B: Clinical acceptability, tolerability and efficacy of BACTRIM syrup (Ro 06-2580/103) in children. An open uncontrolled study. Final study report. Dr. Eggenberger, Yverdon, Switzerland. 16.04.1985

Active substance: Sulfamethoxazole trimethoprim

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Document reference: 45243

Study title: Braunsteiner A*,Habermacher B: Clinical acceptability, tolerability and efficacy of BACTRIM syrup (Ro 06-2580/103) in children. An open uncontrolled study. Final study report. Dr. Salzberg, Birsfelden/ Switzerland. 26.04.1985

Active substance: Sulfamethoxazole trimethoprim

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Document reference: 45244

Study title: Braunsteiner A*,Habermacher B: Clinical acceptability, tolerability and efficacy of BACTRIM syrup (Ro 06-2580/103) in children. An open uncontrolled study. Final study report. Dr. Herz, Basel/Switzerland. 01.05.1985

Active substance: Sulfamethoxazole trimethoprim

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Document reference: 45245

Study title: Braunsteiner A*,Habermacher B: Clinical acceptability, tolerability and efficacy of BACTRIM syrup (Ro 06-2580/103) in children. An open uncontrolled study. Final study report. Dr. Vich, Winterthur/ Switzerland. 01.05.1985

Active substance: Sulfamethoxazole trimethoprim

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Document reference: 45246

Study title: Braunsteiner A*,Habermacher B: Clinical acceptability, tolerability and efficacy of BACTRIM syrup (Ro 06-2580/103) in children. An open uncontrolled study. Final study report by Dr. D'Aruzzo, Mendrisio/Switzerland. 10.05.1985

Active substance: Sulfamethoxazole trimethoprim

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Document reference: 45247

Study title: Cunningham M*,Barsanti F,Merrell R,Lentz E: Final Study Report: A Comparative Study of Single-Dose Intramuscular (IM) Ceftriaxone Versus Single-Dose IM Bicillin CR plus Oral Trimethoprim-Sulfamethoxazole for the Treatment of Uncomplicated Acute Otitis Media in Infants and Children (Howie Protocol)

Active substance: Sulfamethoxazole trimethoprim

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Document reference: 45248

Study title: Cunningham M*,Barsanti F,Merrell R,Lentz E: Final Study Report: A Comparative Study of Single-Dose Intramuscular (IM) Ceftriaxone and a 10-Day Oral (PO) Course of Trimethorprim-sulfamethoxazole for the Treatment of Acute Otitis Media in Infants and Children (Klein Protocol)

Active substance: Sulfamethoxazole trimethoprim

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Document reference: 45249

Study title: Havas L: DOSAGE OF PHARMACEUTICALS IN CHILDREN B-0054340

Active substance: Sulfamethoxazole trimethoprim

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Document reference: 45251

Study title: M. Sieniawska ,,Clinical evaluation of the prep. Biseptol 480 for i.v. use in children with bacterial infections"

Active substance: Sulfamethoxazole trimethoprim

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Document reference: 45242

Study title: Reggiani G: PHARMACOKINETIC STUDIES OF TRIMETHOPRIM-SULFAMETHOXAZOLE IN CHILDREN WITH GASTROENTERITIS (MANUSCRIPT BY M.I. MARKS, M. KAZEMI, B. HALES AND A.H. NEIMS, ROCHE DEVELOPMENTAL PHARMACOLOGY UNIT, MCGILL UNIVERSITY, MONTREAL)

Active substance: Sulfamethoxazole trimethoprim

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Document reference: 45250

Study title: Bondesen S, Nielsen OH, Schou JB, Jensen PH, Lassen LB, Binder V, Krasilnikoff PA, Dano P, Honore Hansen S, Norby Rasmussen S, Hvidberg EF. Steady-state kinetics of 5-aminosalicylic acid and sulphapyridine during sulfasalazine prophylaxis in ulcerative colitis. Scan J Gastroent 21 (1986) 693-700.Bondesen S, Nielsen OH, Schou JB, Jensen PH, Lassen LB, Binder V, Krasilnikoff PA, Dano P, Honore Hansen S, Norby Rasmussen S, Hvidberg EF. Steady-state kinetics of 5-aminosalicylic acid and sulphapyridine during sulfasalazine prophylaxis in ulcerative colitis. Scan J Gastroent 21 (1986) 693-700.

Active substance: SULFASALAZINE

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Document reference: 42897

Study title: Single dose toxicity of omeprazole in young rats after oral administration. Astra Safety Assessment, Södertälje, Sweden. 13 January 1994

Active substance: OMEPRAZOLE

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Document reference: 32768

Study title: Study about relationship between asthma and GERD in children (NO)

Active substance: OMEPRAZOLE

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Document reference: 32772

Study title: The impact of omeprazole on children with cystic fibrosis who require high dose pancreatic enzymes.

Active substance: OMEPRAZOLE

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Document reference: 32777

Study title: Therapy control in children <1 year of age treated with omeprazole (SE)

Active substance: OMEPRAZOLE

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Document reference: 32779

Study title: Treatment of Helicobacter pylori gastritis in paediatrics: improvement of the eradication rate by adjunction of omeprazole to dual antibiotheraphy (BE)

Active substance: OMEPRAZOLE

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Document reference: 32774

Study title: Treatment of Helicobacter pylori infection in children with recurrent abdominal pain (EE and FI)

Active substance: OMEPRAZOLE

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Document reference: 32773

Study title: Treatment of irritable infants with omeprazole. A double bind placebo controlled prospective study (Australia)

Active substance: OMEPRAZOLE

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Document reference: 32776

Study title: Use of magnesium omeprazole (MOPRAL) for treating pathological gastroesophagael reflux in children (Mexico)

Active substance: OMEPRAZOLE

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Document reference: 32775

Study title:

Active substance: ONDASETRON

Study summary document link (including results): Study S3AM45 Ondansetron.xlsx

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Document reference: 47087

Study title: Cough,wheeze and astma diagnosis in children - KP. Jones - 1993 (Clin Exp Allergy) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47002

Study title: Cough,wheeze and astma diagnosis in children - KP. Jones - 1993 (Clin Exp Allergy) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47027

Study title: Cromolyn sodium in the treatment of children with severe, perennial asthma - BA. Berman et al. - 1975 (Pediatrics vol 55) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47028

Study title: Effects of nedocromil sodium on exercise induced bronchoconstriction exacerbated by inhalation of cold air - S. Oseid et al. - 1995 (Scand J Med Sci Sports vol 5) - Publication in Nedocromil sodium HFA- 227- metered dose inhaler-Part IV clinical Documentation - no author- 26/03/1998 -

Active substance: NEDOCROMIL

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Document reference: 47003

Study title: Estudio comparativo del effecto protector del cromoglicato y el nedocromil en ninos con asma de esfuerzo - A. Rabameda et al. - 1993 ( Rev Esp Alergol Immnunol Clin vol 8) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47029

Study title: Exercise induced asthma in children-protection with nedocromil sodium -In inflammation : Its clinical revelance in airways disease - JM. Henricksen - 1986 (RAI International Congress - Publication in Tilade CFC-Free metered dose inhaler nedocromil sodium-vol2 response to CSM questions references - no author - 09/ 1999 -

Active substance: NEDOCROMIL

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Document reference: 47030

Study title: Il Nedocromil sodium nel trattamento dell'asma cronico infantile. Studio in doppio cieco vs placebo - A. Corrias et al. - 1990 (Ped Med Chir (Med Surg Ped) vol 12) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47031

Study title: Inhibition of exercise -induced asthma (EIA) by nedocromil sodium and sodium cromoglycate in children - E. Novembre et al. - 1993 ( J Allergy Clin Immunol vol 91) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47032

Study title: Randomised prospective masked study comparing patient comfort following the instillation of topical proxymetacaine and amethocaine. Shafi T, Koay P. Br J Ophthalmol. 1998 Nov;82(11):1285-7. Randomised prospective masked study comparing patient comfort following the instillation of topical proxymetacaine and amethocaine. Shafi T, Koay P. Br J Ophthalmol. 1998 Nov;82(11):1285-7.

Active substance: TETRACAINE

Study summary document link (including results): Randomised prospective masked study comparing patient comfort following the instillation of topical proxymetacaine and amethocaine. Shafi T.pdf

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Document reference: 44445

Study title: Single-blinded, reference drug controlled to assess the comparative efficacy and safety of Tetracaine gel versus EMLA cream prior to venepuncture or venous cannulation 1993

Active substance: TETRACAINE

Study summary document link (including results): Tetracaine_Amegel199302.xls

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Document reference: 48145

Study title: Subconjunctival bupivacaine versus topical amethocaine in strabismus surgery. Habib NE, el-Kasaby HT, Marczak AM, Hsuan J. Eye. 1993;7 ( Pt 6):757-9. Subconjunctival bupivacaine versus topical amethocaine in strabismus surgery. Habib NE, el-Kasaby HT, Marczak AM, Hsuan J. Eye. 1993;7 ( Pt 6):757-9.

Active substance: TETRACAINE

Study summary document link (including results): Subconjunctival bupivacaine versus topical amethocaine in strabismus surgery. Habib NE, el-Kasaby HT, Marczak AM, Hsuan J. Eye. 1993;7.pdf

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Document reference: 44447

Study title: The effect of topical tetracaine eye drops on emergence behavior and pain relief after strabismus surgery. Anninger W, Forbes B, Quinn G, Schreiner MS. J AAPOS. 2007 Jun;11(3):273-6;Epub 2007 Mar 26.The effect of topical tetracaine eye drops on emergence behavior and pain relief after strabismus surgery. Anninger W, Forbes B, Quinn G, Schreiner MS. J AAPOS. 2007 Jun;11(3):273-6;Epub 2007 Mar 26.

Active substance: TETRACAINE

Study summary document link (including results): The effect of topical tetracaine eye drops on emergence behavior and pain relief after strabismus surgery. Anninger W, Forbes B, Quinn G, S.pdf

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Document reference: 44444

Study title: Topical amethocaine in strabismus surgery. Watson DM. Anaesthesia. 1991 May;46(5):368-70.Topical amethocaine in strabismus surgery. Watson DM. Anaesthesia. 1991 May;46(5):368-70.

Active substance: TETRACAINE

Study summary document link (including results): Topical amethocaine in strabismus surgery. Watson DM. Anaesthesia. 1991 May;46(5)368-70.pdf

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Document reference: 44448

Study title: Yeo E, Miller JH. Pulmonary gallium-67 uptake in diffuse pulmonary calcinosis. Pediatr Radiol. 1996 Nov;26(11):825-6. Yeo E, Miller JH. Pulmonary gallium-67 uptake in diffuse pulmonary calcinosis. Pediatr Radiol. 1996 Nov;26(11):825-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43557

Study title: Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43391

Study title: Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44148

Study title: Publication in NDA Annual Report: Inhibition of meconium induced activation of granulocytes from neonates and adults by pentoxifylline. - Klin -Padiatr. 214(6): 347-52 - Tegtmeyer - Nov-Dec 2002Publication in NDA Annual Report: Inhibition of meconium induced activation of granulocytes from neonates and adults by pentoxifylline. - Klin -Padiatr. 214(6): 347-52 - Tegtmeyer - Nov-Dec 2002

Active substance: PENTOXYFILLINE

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Document reference: 45847

Study title: Antitussive effect of carbetapentane (toclase) to infantile respiratory tract disturbances.

Active substance: PENTOXYVERINE

Study summary document link (including results): ARCE92G0601 - Pentoxyverine.pdf

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Document reference: 45854

Study title: Antitussive wirkung von pentoxyverin. eine randomisierte kontrollierte doppelblindstudie.

Active substance: PENTOXYVERINE

Study summary document link (including results): ARCD94F2701 - Pentoxyverine.pdf

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Document reference: 45850

Study title: Anwendung von Sedotussin Suppositorien (8 mg) bei Sauglingen und Kleinkindern mit Husten verschiedener genese. integrieter Abschlussbericht.

Active substance: PENTOXYVERINE

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Document reference: 45855

Study title: Clinical study;Administration of Sedotussin to infants and young children. Final evaluation and expert report involving 5,024 patients.

Active substance: PENTOXYVERINE

Study summary document link (including results): ARCE94C1701(2) - Pentoxyverine.pdf

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Document reference: 47360

Study title: Experimentation du sirop ucb 2543 expectorant chez l'enfant.

Active substance: PENTOXYVERINE

Study summary document link (including results): DF68B006 - Pentoxyverine.pdf

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Document reference: 45856

Study title: Expertise clinique du sirop "uc 2543" des laboratoire ucepha.

Active substance: PENTOXYVERINE

Study summary document link (including results): ARCF92G0616 - Pentoxyverine.pdf

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Document reference: 45851

Study title: Expertise clinique du sirop "uc-2543 - expectorant" des laboratoires UCEPHA.

Active substance: PENTOXYVERINE

Study summary document link (including results): ARCF99D1205 - Pentoxyverine.pdf

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Document reference: 45849

Study title: Final report of the study of the possible relation between pentoxyverin dispensing and respiratory depression in children.

Active substance: PENTOXYVERINE

Study summary document link (including results): DE85C261 - Pentoxyverine.pdf

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Document reference: 45852

Study title: Hustenbehandlung bei akuten und chronisch entzundlichen Erkrankungen der Atemwege im sauglings- und kindesalter mit Sedotussin Expectorans Sauglingszapfchen.

Active substance: PENTOXYVERINE

Study summary document link (including results): DID88H112.pdf

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Document reference: 45858

Study title: Open, single-dose, phase i study to evaluate the pharmacokinetic parameters of pentoxyverine and its major metabolites in plasma and urine of children with upper respiratory tract infection.

Active substance: PENTOXYVERINE

Study summary document link (including results): 9738 - Pentoxyverine - MRCE99K0801.pdf

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Document reference: 45861

Study title: Pentoxyverine effectively controls irritating cough in preschool children.

Active substance: PENTOXYVERINE

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Document reference: 45853

Study title: Tableau synoptique des essais avec le produit : "sirop expectoclase".

Active substance: PENTOXYVERINE

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Document reference: 45857

Study title: Besedovsky A, Li BUK. Across the developmental continuum of irritable bowel syndrome: Clinical and pathophysiologic considerations. CURR GASTROENTEROL REP 2004; 6(3): 247−253

Active substance: Peppermint Oil 0.200 ml

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Document reference: 40115

Study title: Brooks CD; J Rheumatol (Canada), Apr 2001, 28(4) p845-53; Sulfasalazine for the management of juvenile rheumatoid arthritis.Brooks CD; J Rheumatol (Canada), Apr 2001, 28(4) p845-53; Sulfasalazine for the management of juvenile rheumatoid arthritis.

Active substance: SULFASALAZINE

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Document reference: 42880

Study title: Treatment of metastatic bone pain with strontium-89. Robinson RG 1987 Int J Rad Appl Instrum B. 1987; 14(3):219-22 R G Robinson et al.

Active substance: STRONTIUM 89

Study summary document link (including results): 2011-09 GE Metastron response List of published articles.doc

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Document reference: 48215

Study title: Arguelles-Martin F. Sucralfate versus cimetidine in the treatment of reflux oesophagitis in children. Am J Med 1989; 86 (suppl 6A): 73-76. Arguelles-Martin F. Sucralfate versus cimetidine in the treatment of reflux oesophagitis in children. Am J Med 1989; 86 (suppl 6A): 73-76.

Active substance: SUCRALFATE

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Document reference: 42602

Study title: Chiang. Chronic duodenal ulcer in children: clinical observation and response to treatment. J Pediatr Gastroenterol Nutr 1989; 8: 161-165. Chiang. Chronic duodenal ulcer in children: clinical observation and response to treatment. J Pediatr Gastroenterol Nutr 1989; 8: 161-165.

Active substance: SUCRALFATE

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Document reference: 42607

Study title: Dr. Kuwabara's study reported in 1987 13 Children (11 boys and 2 girls, from 1-year-old to 14-year-old) Gastric ulcer or duodenal ulcer treated by Ulcerlmin (Sucralfate) and/or Gastrozepin (Pirenzepine)Dr. Kuwabara's study reported in 1987 13 Children (11 boys and 2 girls, from 1-year-old to 14-year-old) Gastric ulcer or duodenal ulcer treated by Ulcerlmin (Sucralfate) and/or Gastrozepin (Pirenzepine)

Active substance: SUCRALFATE

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Document reference: 42610

Study title: Dr. Nagita's study reported in 1986 14 Children (9 boys and 5 girls, from 1-year-old to 13-year-old) Gastric ulcer or duodenal ulcer treated by Ulcerlmin (Sucralfate)Dr. Nagita's study reported in 1986 14 Children (9 boys and 5 girls, from 1-year-old to 13-year-old) Gastric ulcer or duodenal ulcer treated by Ulcerlmin (Sucralfate)

Active substance: SUCRALFATE

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Document reference: 42611

Study title: Esteban F, Soldado L, Delgado M, Barrueco JC, Solanellas J. The usefulness of sucralfate in postoperative improvement of children's tonsillectomy. Anales O.R.L. Iber-Amer 2000, XXVII, 4, 393-404.Esteban F, Soldado L, Delgado M, Barrueco JC, Solanellas J. The usefulness of sucralfate in postoperative improvement of children's tonsillectomy. Anales O.R.L. Iber-Amer 2000, XXVII, 4, 393-404.

Active substance: SUCRALFATE

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Document reference: 42609

Study title: Hermans . Primary duodenogastric reflux in children and adolescents. Eur J Pediatr 2003; 162: 598-602. Hermans . Primary duodenogastric reflux in children and adolescents. Eur J Pediatr 2003; 162: 598-602.

Active substance: SUCRALFATE

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Document reference: 42604

Study title: Lopez-Herce J. Frequency and prophylaxis of upper gastrointestinal hemorrhage in critically ill children: a prospective study comparing the efficacy of almagate, ranitidine, and Sucralfate. Crit Care Med 1992; 20: 1082-1089. Lopez-Herce J. Frequency and prophylaxis of upper gastrointestinal hemorrhage in critically ill children: a prospective study comparing the efficacy of almagate, ranitidine, and Sucralfate. Crit Care Med 1992; 20: 1082-1089.

Active substance: SUCRALFATE

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Document reference: 42608

Study title: Lopriore. Ventilator-associated pneumonia and upper airway colonization with Gram negative bacilli: the role of stress ulcer prophylaxis in children. Intensice Care Med 2002; 28: 763-767. Lopriore. Ventilator-associated pneumonia and upper airway colonization with Gram negative bacilli: the role of stress ulcer prophylaxis in children. Intensice Care Med 2002; 28: 763-767.

Active substance: SUCRALFATE

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Document reference: 42605

Study title: Shenep JL. Efficacy of oral sucralfate suspension in prevention and treatment of chemotherapy-induced mycositis. J Pediatr 1988; 113: 758-763. Shenep JL. Efficacy of oral sucralfate suspension in prevention and treatment of chemotherapy-induced mycositis. J Pediatr 1988; 113: 758-763.

Active substance: SUCRALFATE

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Document reference: 42603

Study title: Long -term effects of budesonide or nedocromil in children with asthma. The Childhood Asthma Management Program Research Group - no author -2000 ( N-Engl-J-Med)

Active substance: NEDOCROMIL

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Document reference: 47033

Study title: Long -term effects of budesonide or nedocromil in children with asthma. The Childhood Asthma Management Program Research Group - no author -2000 ( N-Engl-J-Med) - Publication in Clinical Expert Statement - Renewal application for : Nedocromil-Sodium (all formulations) - DR. Rolf Ohlrogge - 08/12/2005 -

Active substance: NEDOCROMIL

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Document reference: 47034

Study title: Comparison of the protective effects of cromolyn sodium in the treatment of exercice-induced asthma in children - FM. De Benedictis et al. - 1994 (J Allergy Clin Immunol vol 94) - Publication dans le Rapport d'expert clinique sur la compatibilité sur Tiliade et des chambres de mélanges -Tilade 2 mg/ dose, suspension pour inhalation buccale pour flacon pressurisé - Clotilde Bremard-Oury - 07/1996 -

Active substance: NEDOCROMIL

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Document reference: 47001

Study title: Multicentre double-bind crossover study comparing flavoured nedocromil sodium (Tilade mint) 16 mg daily and matching placebo, both delivered via a large volume spacer in the management of paediatric asthma - Dr A R Harndern et al. - 30/03/1994

Active substance: NEDOCROMIL

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Document reference: 47004

Study title: Multicentre double-blind group comparative study assess the efficacy of substituting nedocromil sodium (Tilade) 8 mg daily and sodium cromoglycate (Intal) 20 mg daily in paediatric patients currently maintained on sodium cromoglycate 20 mg daily - D. Hilde et al. - 1993 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47005

Study title: Nedocromil sodium (TILADE) in the treatment of the severe forms of asthma in children - V. Petru et al. - 1991 (Cesk Pediatr vol 46) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47035

Study title: Nedocromil sodium - A preliminary review of its pharmacodynamic and pharmakocinetic properties, and therapeutic efficacy in the treatment of reversible obstructive airways disease -John P. Gonzalez et al.- 1987 (Drugs vol 34) - Publication in Tilade CFC-Free metered dose inhaler nedocromil sodium-vol2 response to CSM questions references - no author - 09/ 1999 -

Active substance: NEDOCROMIL

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Document reference: 47036

Study title: Nedocromil sodium (FPL 59002KP) Safety evaluation - Summary of safety evaluation studies SE 5660/7, January 1987

Active substance: NEDOCROMIL

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Document reference: 47020

Study title: Nedocromil sodium (TILADE) in the treatment of the severe forms of asthma in children - V. Petru et al. - 1991 (Cesk Pediatr vol 46) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47038

Study title: Nedocromil sodium for chronic asthma in children. - A-V. Sridhar et al. - 2006 (Cochrane database of systematics review vol 3) - Publication in Nedocromil Sodium CFC-free Inhaler Corporate Data Sheet - no author - 25/06/2003 -

Active substance: NEDOCROMIL

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Document reference: 47039

Study title: Nedocromil sodium in adults with asthma dependent on inhaled corticosteroids - MF. Bone et al. - 1989 ( Thorax vol 44) - Publication in Product licence application TILADE MINT AEROSOL (nedocromil sodium) -Clinical documentation -29/08/1995 -

Active substance: NEDOCROMIL

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Document reference: 47040

Study title: Nedocromil sodium Safety evaluation- Summary of safety evaluation studies- B. Clark- 01/ 1987 - Publication in Product licence application TILADE MINT AEROSOL (nedocromil sodium) - Pre Clinical documentation -29/08/1995 -

Active substance: NEDOCROMIL

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Document reference: 47007

Study title: Nedocromil sodium vs sodium cromoglycate pressurised aerosol in the prevention of bronconstriction induced by ultrasonic nebulized distilled water in asthmatic children - E. Spezia et al. - 1993 -Pediatr Pulmonol vol 16) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47041

Study title: Prevalence of asthma in Melbourne schoolchildren : changes over 26 years - CF. Robertson et al. - 1991 (BMJ vo l 302) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47024

Study title: Protective effect of nedocromil sodium (4 mg) given by metered dose inhaler, with or whithout an extension tube (Autry-Altounyan Spacer Device), Against exercise-induced bronchoconstriction in children with asthma : A placebo-controlled double-blind crossover trial - A. Boner - 1986 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47008

Study title: Nedocromil Sodium (Eye drops) Corporate Data Sheet - no author - 11/10/2000

Active substance: NEDOCROMIL

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Document reference: 47037

Study title: Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44195

Study title: Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44242

Study title: Yilmaz M, Yilmaz K, Celen Z, Sirikci A, Ozkiliç S, Zincirkeser S. Bilateral symmetrically increased Tc-99m MDP cranial uptake in Hurler syndrome. Clin Nucl Med. 2002 Dec;27(12):915. No abstract available. Yilmaz M, Yilmaz K, Celen Z, Sirikci A, Ozkiliç S, Zincirkeser S. Bilateral symmetrically increased Tc-99m MDP cranial uptake in Hurler syndrome. Clin Nucl Med. 2002 Dec;27(12):915. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43427

Study title: Yoffe N, Besser MI, Sobel JD, Front D. [Early diagnosis of pyogenic sacroiliac infection using 67-gallium scintigram] Harefuah. 1983 Jan 16;104(2):55-6. Hebrew. No abstract available. Yoffe N, Besser MI, Sobel JD, Front D. [Early diagnosis of pyogenic sacroiliac infection using 67-gallium scintigram] Harefuah. 1983 Jan 16;104(2):55-6. Hebrew. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44052

Study title: Two cases of pediatric bone disease (eosinophilic granuloma and Brodie's abscess) showing similar scintigraphic and radiographic findings. Yoshikawa M, Sugawara Y, Kikuchi T, Nakata S, Mochizuki T, Ikezoe J, Sakayama K. Clin Nucl Med. 2000 Dec;25(12):986-90.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43466

Study title: A 3 week randomized, multicenter, double blind, vehicle-controlled, parallel-group study to evaluate the efficacy and safety of Pimecrolimus cream 1% in children between 2-12 years with mild to moderate atopic dermatitis (Speed Study)

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CES02 Art45 listing 2011.xls

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Document reference: 34103

Study title: A 3-month open label study assessing the efficacy and tolerability of Elidel (pimecrolimus) cream 1% in patients with mild or moderate atopic dermatitis

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CSA01 Art45 listing 2011.xls

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Document reference: 34116

Study title: A 3-month open label, national, Quality of Life and safety study with Elidel (pimecrolimus) cream 1% in children (2-12 years) with atopic dermatitis

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CZA01 Art45 listing 2011.xls

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Document reference: 34119

Study title: A 6-month open label, multi-national, effectiveness, and safety study of Elidel® (pimecrolimus) Cream, 1% in subjects with atopic dermatitis

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2405 Art45 listing 2011.xls

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Document reference: 34133

Study title: A 6-month open label, multi-national, effectiveness, and safety study of Elidel® (pimecrolimus) Cream, 1% in subjects with atopic dermatitis

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2405 Art45 listing 2011.xls

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Document reference: 34134

Study title: A 6-month study of the utility of Elidel cream 1% in the long-term management of pediatric patients with severe AD

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CDE10 Art45 listing 2011.xls

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Document reference: 34095

Study title: A 6-month, randomized, multi-center, parallelgroup, double-blind, vehicle controlled study to evaluate the efficacy and safety of ASM981 (pimecrolimus) cream 1% BID vs. standard of care in the management of mild to moderate atopic dermatitis in children 3 months to 11 years.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CUS04 Art45 listing 2011.xls

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Document reference: 47706

Study title: A 6-week open label, national, post-marketing surveillance program to obtain photographic documentation of mild to moderate atopic eczema lesions before and after treatment with Elidel (pimecrolimus) cream 1% in children from 2 years and above and adults with atopic ezcema

Active substance: PIMECROLIMUS

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Document reference: 34120

Study title: Yildizdas D. Occurrence of ventilator-associated pneumonia in mechanically ventilated pediatric intensive care patients during stress ulcer prophylaxis with Sucralfate, ranitidine, and omeprazole. J Crit Care 2002; 17: 240-245. Yildizdas D. Occurrence of ventilator-associated pneumonia in mechanically ventilated pediatric intensive care patients during stress ulcer prophylaxis with Sucralfate, ranitidine, and omeprazole. J Crit Care 2002; 17: 240-245.

Active substance: SUCRALFATE

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Document reference: 42606

Study title: Comparison of intranasal midazolam and sufentanil premedication pediatric outpatients. Clinical Pharmacology and Therapeutics 59, p. 314-348, 1996Comparison of intranasal midazolam and sufentanil premedication pediatric outpatients. Clinical Pharmacology and Therapeutics 59, p. 314-348, 1996

Active substance: SUFENTANYL

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Document reference: 42622

Study title: Fentanly versus sufentanil: plasma concentrations during continuous epidural postoerative infusion in children. British Journal of Anaethesia 85, p.615-617, 2000Fentanly versus sufentanil: plasma concentrations during continuous epidural postoerative infusion in children. British Journal of Anaethesia 85, p.615-617, 2000

Active substance: SUFENTANYL

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Document reference: 42621

Study title: The combination sufentanil-bupivascaine in post-operative patient controlled epidural analgesia. Von H. LuewenThe combination sufentanil-bupivascaine in post-operative patient controlled epidural analgesia. Von H. Luewen

Active substance: SUFENTANYL

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Document reference: 42623

Study title: A COMPARATIVE STUDY OF PARENTERAL AMPICILLIN/SULBACTAM VERSUS CEFTRIAXONE IN THE TREATMENT OF ACUTE BACTERIAL MENINGITIS IN INFANTS AND CHILDREN.

Active substance: SULBACTAM

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Document reference: 42629

Study title: A COMPARATIVE STUDY OF PARENTERAL AMPICILLIN/SULBACTAM VERSUS CEFOTAXIME IN THE TREATMENT OF ACUTE BACTERIAL MENINGITIS IN INFANTS AND CHILDREN

Active substance: SULBACTAM

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Document reference: 42649

Study title: A COMPARATIVE STUDY OF PARENTERAL AMPICILLIN/SULBACTAM VERSUS CEFUROXIME IN THE TREATMENT OF ACUTE BACTERIAL MENINGITIS IN INFANTS AND CHILDREN

Active substance: SULBACTAM

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Document reference: 42645

Study title: A COMPARATIVE STUDY OF PARENTERAL AMPICILLIN/SULBACTAM VS AMPICILLIN AND CHLORAMPHENICOL IN THE TREATMENT OF ACUTE BACTERIAL MENINGITIS IN INFANTS AND CHILDREN

Active substance: SULBACTAM

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Document reference: 42640

Study title: A COMPARATIVE STUDY OF SBT/AMP IN COMPLICATED URINARY TRACT INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42674

Study title: A COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF PARENTERAL SBT/AMP VS CEFUROXIME IN THE TREATMENT OF GENERAL PEDIATRIC INFECTIONS

Active substance: SULBACTAM

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Document reference: 42717

Study title: A COMPARISON OF AMPICILLIN PLUS SULBACTAM VERSUS METRONIDAZOLE/GENTAMYCIN IN THE TREATMENT OF GYNECOLOGICAL OR OBSTETRICAL INFECTIONS OF BACTERIAL ETIOLOGY

Active substance: SULBACTAM

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Document reference: 42635

Study title: A COMPARISON OF AMPICILLIN PLUS SULBACTAM VERSUS CEFOXITIN IN THE TREATMENT OF GYNECOLOGICAL OR OBSTETRICAL INFECTIONS OF BACTERIAL

Active substance: SULBACTAM

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Document reference: 42632

Study title: A COMPARISON OF AMPICILLIN PLUS SULBACTAM VERSUS CEFOXITIN/DOXYCYCLINE OR CLINDAMYCIN/GENTAMICIN IN THE TREATMENT OF GYNECOLOGICAL OR OBSTETRICAL INFECTIONS OF BACTERIAL ETIOLOGY

Active substance: SULBACTAM

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Document reference: 42630

Study title: A COMPARISON OF AMPICILLIN PLUS SULBACTAM VERSUS CEFTRIAXONE IN`THE TREATMENT OF SKIN AND/OR SKIN STRUCTURE INFECTIONS (E.G. PERIORBITAL CELLULITIS) AND/OR OSTEOMYELITIS/SUPPURATIVE ARTHRITIS OF BACTERIAL ETIOLOGY IN HOSPITALIZED PEDIATRIC PATS

Active substance: SULBACTAM

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Document reference: 42641

Study title: A COMPARISON OF AMPICILLIN PLUS SULBACTAM VERSUS CLINDAMYCIN PLUS GENTAMICIN VERSUS CEFOXITIN IN THE TREATMENT OF POST PARTUM ENDOMETRITIS

Active substance: SULBACTAM

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Document reference: 42651

Study title: A COMPARISON OF AMPICILLIN PLUS SULBACTAM VERSUS CLINDAMYCIN/GENTAMICIN IN THE TREATMENT OF POST CESAREAN SECTION ENDOMETRITIS INFECTIONS OF BACTERIAL ETIOLOGY

Active substance: SULBACTAM

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Document reference: 42636

Study title: Publication in Nedocromil sodium HFA-227-metered dose inhaler -Expert report on clinical documentation -Critical evaluation - H. Staudinger - 09/04/1998

Active substance: NEDOCROMIL

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Document reference: 47042

Study title: Report of a double-blind group comparative trial comparing nedocromil sodium (2 mg four times a day) and placebo in the management of bronchial asthma in children - R. Ronchetti - 1986 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47009

Study title: Report of an open assessment of nedocromil sodium (4 mg given four times a day) in the management of bronchial asthma in children - L. Businco - 1986 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47010

Study title: Report on a double-blind crossover study to compare the efficacy and duration of action of nedocromil sodium (4 mg) and placebo, Given by pressurised aerosol exercise-induced asthma in children, carried out - M. Silvermann - 1986 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47011

Study title: Report on a matched-pairs double-blind comparative study on the effects of nedocromil sodium (4mg * 4) with placebo on non-specific bronchial reactivity changes in asthmatic children when re-exposed to allergen (House Dust Mite) in a natural environment - Prof. Boner - 1987 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47012

Study title: Report on a Multicentre Blinded Group Comparative Study Comparative Nedocromil Sodium (Tilade), Beclomethasone Dipropionate (Becotide) and Placebo in the Management of Asthma

Active substance: NEDOCROMIL

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Document reference: 47021

Study title: Safety evaluation - Dentomint : Summary of toxicité - Publication in Product licence application TILADE MINT AEROSOL (nedocromil sodium) - Pre Clinical documentation -29/08/1995 -

Active substance: NEDOCROMIL

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Document reference: 47013

Study title: Sodium nedocromil modifies bronchial hyperreactivity in asthmatic children - BM. Ricci et al. - 1993 (Eur Respi J vol 6 suppl 17) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47043

Study title: Spacing devices and metered-dose inhalers in childhood asthma - H. Levinson et al. - 1983 (J Pediatrics vol 46) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47044

Study title: Summary of the Pharmacokinetics of Nedocromil Sodium in children - MG. Neale - 1994 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47014

Study title: The addition of nedocromil sodium to maintenance therapy in the management of patients with bronchial ashma - AJ. Williams et al. - 1986 (Eur J Resp Dis vol 69) - Publication in Product licence application TILADE MINT AEROSOL (nedocromil sodium) -Clinical documentation -29/08/1995 -

Active substance: NEDOCROMIL

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Document reference: 47045

Study title: The protective effect of nedocromil sodium exercise-induced asthma - CP Bauer et al. - 1986 (European Journal of Respiratory disease vol 69) - Publication in Tilade CFC-Free metered dose inhaler nedocromil sodium-vol2 response to CSM questions references - no author - 09/ 1999 -

Active substance: NEDOCROMIL

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Document reference: 47046

Study title: Tilad mint aerosole - Clinical documentation PART IV

Active substance: NEDOCROMIL

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Document reference: 47022

Study title: Tratamiento con nedocromil sodico en ninos con asma cronica grave. Estudio preliminar - JL. Madrazo et al. - 1991 ( Rev Esp Alergol Immunol Clin suppl 2 vol 6) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47047

Study title: Twelve month open assessment study of the safety and acceptability of flavoured nedocromil sodium (4 mg, QID) in the management of paediatric asthma - J. Cater et al. - 1993 - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47015

Study title: Caudal ropivacaine and neostigmine in pediatric surgeryCaudal ropivacaine and neostigmine in pediatric surgery

Active substance: NEOSTIGMINE

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Document reference: 47048

Study title: Young MR, Lowry JH, Laird JD, Ferguson WR. 99Tcm-MDP bone scanning of injuries of the carpal scaphoid. Injury. 1988 Jan;19(1):14-7. Young MR, Lowry JH, Laird JD, Ferguson WR. 99Tcm-MDP bone scanning of injuries of the carpal scaphoid. Injury. 1988 Jan;19(1):14-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43836

Study title: Yu JQ, Zhuang H, Posteraro A, Reddy S, Alavi A. Transiently increased MDP activity in the soft tissue of lower extremity caused by iliofemoral venous thrombosis. Clin Nucl Med. 2005 Nov;30(11):742-3. No abstract available. Yu JQ, Zhuang H, Posteraro A, Reddy S, Alavi A. Transiently increased MDP activity in the soft tissue of lower extremity caused by iliofemoral venous thrombosis. Clin Nucl Med. 2005 Nov;30(11):742-3. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43383

Study title: Yui N, Kinoshita F, Akiyama Y, Koakutsu M, Umeda T. [Clinical evaluation of transaxial bone imaging with 99mTc-phosphate compounds] Radioisotopes. 1982 Oct;31(10):521-8. Japanese. Yui N, Kinoshita F, Akiyama Y, Koakutsu M, Umeda T. [Clinical evaluation of transaxial bone imaging with 99mTc-phosphate compounds] Radioisotopes. 1982 Oct;31(10):521-8. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44069

Study title: Yunus MB, Berg BC, Masi AT. Multiphase skeletal scintigraphy in primary fibromyalgia syndrome: a blinded study. J Rheumatol. 1989 Nov;16(11):1466-8. Yunus MB, Berg BC, Masi AT. Multiphase skeletal scintigraphy in primary fibromyalgia syndrome: a blinded study. J Rheumatol. 1989 Nov;16(11):1466-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43779

Study title: Unusual bone scan of a child with osteogenesis imperfecta. Yurekli Y, Erdogan S, Cullu E. Clin Nucl Med. 2003 Feb;28(2):156. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43429

Study title: Yurtkuran M, Yurtkuran M, Alp A, Sivrioglu K, Dilek K, Tamgaç F, Alper E, Tunali S, Saricaoğlu H, Nasircilar A. Hand involvement in Behçet's disease. Joint Bone Spine. 2006 Dec;73(6):679-83. Epub 2006 Mar 15. Yurtkuran M, Yurtkuran M, Alp A, Sivrioglu K, Dilek K, Tamgaç F, Alper E, Tunali S, Saricaoğlu H, Nasircilar A. Hand involvement in Behçet's disease. Joint Bone Spine. 2006 Dec;73(6):679-83. Epub 2006 Mar 15.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43377

Study title: Zebedin D, Fotter R, Reittner P, Preidler KW, Mache C, Szolar DH. [Chronic recurrent multifocal osteomyelitis of the lower jaw] Rofo. 1998 Nov;169(5):551-4. German. No abstract available. Zebedin D, Fotter R, Reittner P, Preidler KW, Mache C, Szolar DH. [Chronic recurrent multifocal osteomyelitis of the lower jaw] Rofo. 1998 Nov;169(5):551-4. German. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43521

Study title: Zhibin Y, Quanyong L, Libo C, Jun Z, Hankui L, Jifang Z, Ruisen Z. The role of radionuclide bone scintigraphy in fibrous dysplasia of bone. Clin Nucl Med. 2004 Mar;29(3):177-80. Zhibin Y, Quanyong L, Libo C, Jun Z, Hankui L, Jifang Z, Ruisen Z. The role of radionuclide bone scintigraphy in fibrous dysplasia of bone. Clin Nucl Med. 2004 Mar;29(3):177-80.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43403

Study title: A dermal embryo-fetal development study in rats

Active substance: PIMECROLIMUS

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Document reference: 34126

Study title: A double-blind, randomized, placebo-controlled, paired study to evaluate the efficacy and safety of combined use of Elidel and Cutivate in children with severe atopic dermatitis.

Active substance: PIMECROLIMUS

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Document reference: 47709

Study title: Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968;42:565-589Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968;42:565-589

Active substance: OXYGEN

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Document reference: 45415

Study title: Subcommittee on diagnosis and management of bronchiolitis (American Academy of Pediatrics). Diagnosis and management of bronchiolitis. Pediatrics 2006; 118(4):1774-1793Subcommittee on diagnosis and management of bronchiolitis (American Academy of Pediatrics). Diagnosis and management of bronchiolitis. Pediatrics 2006; 118(4):1774-1793

Active substance: OXYGEN

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Document reference: 45410

Study title: Tay-Uyboco JS, Kwiatkowski K, Cates DB, Kavanagh L, Rigatto H. Hypoxic airway constriction in infants of very low birth weight recovering from moderate to severe bronchopulmonary dysplasia. J Pediatr. 1989; 115:456–459.Tay-Uyboco JS, Kwiatkowski K, Cates DB, Kavanagh L, Rigatto H. Hypoxic airway constriction in infants of very low birth weight recovering from moderate to severe bronchopulmonary dysplasia. J Pediatr. 1989; 115:456–459.

Active substance: OXYGEN

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Document reference: 45411

Study title: The British guidelines on management of asthma. Thorax 2003; 58(suppl)S1:1-83The British guidelines on management of asthma. Thorax 2003; 58(suppl)S1:1-83

Active substance: OXYGEN

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Document reference: 45416

Study title: The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000; 105;295-310The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000; 105;295-310

Active substance: OXYGEN

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Document reference: 45412

Study title: The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000;105;295-310The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000;105;295-310

Active substance: OXYGEN

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Document reference: 45418

Study title: UK Collaborative ECMO Trial Group. UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation. Lancet 1996; 348: 75-82UK Collaborative ECMO Trial Group. UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation. Lancet 1996; 348: 75-82

Active substance: OXYGEN

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Document reference: 45413

Study title: A COMPARISON OF AMPICILLIN/SULBACTAM PLUS DOXYCYCLINE VERSUS CEFOXITIN/DOXYCYCLINE IN THE TREATMENT OF PELVIC INFLAMMATORY DISEASE OF BACTERIAL ETIOLOGY

Active substance: SULBACTAM

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Document reference: 42660

Study title: A COMPARISON OF AMPICILLIN/SULBACTAM VERSUS CEFOTETAN FOR THE PREVENTION OF INFECTION FOLLOWING CESAREAN SECTION IN HIGH RISK PATIENTS

Active substance: SULBACTAM

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Document reference: 42656

Study title: A COMPARISON OF AMPICILLIN/SULBACTAM VERSUS CEFOXITIN AS EARLY EMPIRIC THERAPY FOLLOWING PENETRATING AND BLUNT TRAUMA TO THE ABDOMEN

Active substance: SULBACTAM

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Document reference: 42662

Study title: A COMPARISON OF AMPICILLIN/SULBACTAM VERSUS CEFOXITIN FOR THE PREVENTION OF INFECTION FOLLOWING CESAREAN SECTION IN HIGH RISK PATIENTS

Active substance: SULBACTAM

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Document reference: 42634

Study title: A COMPARISON OF AMPICILLIN/SULBACTAM VERSUS CEFOXITIN IN THE TREATMENT OF PELVIC INFLAMMATORY DISEASE

Active substance: SULBACTAM

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Document reference: 42653

Study title: A COMPARISON OF AMPICILLIN/SULBACTAM VERSUS CLINDAMYCIN/GENTAMICIN IN THE TREATMENT OF POST-CAESAREAN SECTION ENDOMETRITIS INFECTIONS

Active substance: SULBACTAM

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Document reference: 42667

Study title: A COMPARISON OF AMPICILLIN/SULBACTAM VS CEFAZOLIN OR CEFOTETAN FOR THE PREVENTION OF INFECTION FOLLOWING CESAREAN SECTION IN HIGH RISK PATIENTS

Active substance: SULBACTAM

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Document reference: 42659

Study title: A COMPARISON OF CEFOBID (CEFOPERAZONE) PLUS SULBACTAM VERSUS PRIMAXIN (IMIPENEN-CILASTATIN) IN THE THERAPY OF FEBRILE NEUTROPENIC PATIENTS

Active substance: SULBACTAM

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Document reference: 42661

Study title: A COMPARISON OF CEFOPERAZONE PLUS SULBACTAM VERSUS AMIKACIN OR GENTAMICIN PLUS AMPICILLIN AND METRONIDAZOLE IN THE TREATMENT OFPATIENTS WITH AN INTRA-ABDOMINAL INFECTION

Active substance: SULBACTAM

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Document reference: 42637

Study title: A COMPARISON OF CEFOPERAZONE PLUS SULBACTAM VERSUS AMPICILLIN PLUS TOBRAMYCIN IN THE TREATMENT OF PATIENTS WITH BILIARY TRACT INFECTIONS

Active substance: SULBACTAM

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Document reference: 42655

Study title: A COMPARISON OF AMPICILLIN PLUS SULBACTAM VS CLINDAMYCIN PLUS GENTAMICIN VS CEFOXITIN IN THE TREATMENT OF POSTPARTUM ENDOMETRITIS

Active substance: SULBACTAM

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Document reference: 42627

Study title: A COMPARISON OF CEFOPERAZONE PLUS SULBACTAM VERSUS CEFOTAXIME IN THE TREATMENT OF RECURRENT OR COMPLICATED URINARY TRACT INFECTIONS OF BACTERIAL ETIOLOGY

Active substance: SULBACTAM

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Document reference: 42639

Study title: A COMPARISON OF CEFOPERAZONE PLUS SULBACTAM VERSUS PRIMAXIN (IMIPENEM-CILASTATIN) IN THE THERAPY OF FEBRILE NEUTROPENIC PATIENTS

Active substance: SULBACTAM

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Document reference: 42666

Study title: A COMPARISON OF SULPERAZONE (SULBACTAM/CEFOPERAZONE) VERSUS CEFOBID (CEFOPERAZONE) IN THE TREATMENT OF INTRA ABDOMINAL INFECTIONS OF BACTERIAL ETIOLOGY.

Active substance: SULBACTAM

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Document reference: 42846

Study title: A DOUBLE-BLIND COMPARATIVE STUDY OF ONCE VS TWICE ADMINISTRATION OF SBT/AMP IV IN THE PROPHYLAXIS OF POST-HYSTERECTOMY GYNECOLOGICAL

Active substance: SULBACTAM

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Document reference: 42712

Study title: A MULTICENTER COMPARISON OF 2:1 AMPICILLIN/SULBACTAM (UNASYN) VSCEFUROXIME IN THE TREATMENT OF SKIN AND/OR SKIN STRUCTURE INFEC-TIONS OF BACTERIAL ETIOLOGY IN HOSPITALIZED PEDIATRIC PATIENTS

Active substance: SULBACTAM

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Document reference: 42646

Study title: A MULTICENTER COMPARISON OF 2:1 AMPICILLIN/SULBACTAM (UNASYN) + OPTIONAL AMINOGLYCOSIDE VS AMPICILLIN AMINOGLYCOSIDE IN THE TREATMENT OF INTRA-ABDOMINAL INFECTIONS OF BACTERIAL ETIOLOGY IN OSPITALIZED PEDIATRIC PATIENTS

Active substance: SULBACTAM

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Document reference: 42647

Study title: A MULTICENTER STUDY OF 2:1 AMPICILLIN/SULBACTAM (UNASYN) IN THE TREATMENT OF PERIORBITAL/PRESEPTAL AND FACIAL CELLULITIS OF BACTERIAL ETIOLOGY IN HOSPITALIZED PEDIATRIC PATIENTS

Active substance: SULBACTAM

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Document reference: 42648

Study title: A NON-COMPARATIVE STUDY OF UNASYN IM/IV (SULBACTAM/AMPICILLIN) ADMINISTERED INTRAVENOUSLY FOR THE TREATMENT OF COMMUNITY ACQUIRED INFECTIONS. A MULTICENTER TRIAL.

Active substance: SULBACTAM

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Document reference: 42737

Study title: A NON-COMPARATIVE STUDY TO ASSESS THE EFFICACY AND SAFETY OF SULBACTAM/ AMPICILLIN IN PEDIATRIC PATIENTS IN BACTERIAL INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42723

Study title: Dose response study of caudal neostigmine for postoperative analgesia in paediatric patients undergoing genitourinary surgery.Dose response study of caudal neostigmine for postoperative analgesia in paediatric patients undergoing genitourinary surgery.

Active substance: NEOSTIGMINE

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Document reference: 47049

Study title: Dose responses for neostigmine and edrophonium as antagonists of mivacurium in adults and children.Dose responses for neostigmine and edrophonium as antagonists of mivacurium in adults and children.

Active substance: NEOSTIGMINE

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Document reference: 47050

Study title: Dose-response relationships for neostigmine antagonism of rocuronium-induced neuromuscular block in children and adults.Dose-response relationships for neostigmine antagonism of rocuronium-induced neuromuscular block in children and adults.

Active substance: NEOSTIGMINE

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Document reference: 47051

Study title: Ghigo E et al.: Intranasal administration of neostigmine potentiates both intravenous and intranasal growth hormone (GH)-releasing hormone-induced GH release in short children. Journal of Clinical Endocrinology and Metabolism (J. CLIN. ENDOCRINOL. METAB. ) (United States) , May 24, 1991, 72/2 (467-470) Ghigo E et al.: Intranasal administration of neostigmine potentiates both intravenous and intranasal growth hormone (GH)-releasing hormone-induced GH release in short children. Journal of Clinical Endocrinology and Metabolism (J. CLIN. ENDOCRINOL. METAB. ) (United States) , May 24, 1991, 72/2 (467-470)

Active substance: NEOSTIGMINE

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Document reference: 47052

Study title: Gwinnutt CL, Walker RW, Meakin G.: Antagonism of intense atracurium-induced neuromuscular block in children. Br J Anaesth. 1991 Jul;67(1):13-6.Gwinnutt CL, Walker RW, Meakin G.: Antagonism of intense atracurium-induced neuromuscular block in children. Br J Anaesth. 1991 Jul;67(1):13-6.

Active substance: NEOSTIGMINE

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Document reference: 47053

Study title: Intranasal administration of neostigmine potentiates both intravenous and intranasal growth hormone (GH)-releasing hormone-induced GH release in short children.Intranasal administration of neostigmine potentiates both intravenous and intranasal growth hormone (GH)-releasing hormone-induced GH release in short children.

Active substance: NEOSTIGMINE

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Document reference: 47054

Study title: Kumar P et al.: Caudal additives in pediatrics: A comparison among midazolam, ketamine, and neostigmine coadministered with bupivacaine. Anesthesia and Analgesia ( Anesth. Analg. ) (United States) , July 1, 2005 , 101/1 (69-73) Kumar P et al.: Caudal additives in pediatrics: A comparison among midazolam, ketamine, and neostigmine coadministered with bupivacaine. Anesthesia and Analgesia ( Anesth. Analg. ) (United States) , July 1, 2005 , 101/1 (69-73)

Active substance: NEOSTIGMINE

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Document reference: 47055

Study title: Mahajan R.; Grover V.K.; Chari P.: Caudal neostigmine with bupivacaine produces a dose-independent analgesic effect in children. Canadian Journal of Anesthesia ( Can. J. Anesth. ) (Canada), August 1, 2004 , 51/7 (702-706) Mahajan R.; Grover V.K.; Chari P.: Caudal neostigmine with bupivacaine produces a dose-independent analgesic effect in children. Canadian Journal of Anesthesia ( Can. J. Anesth. ) (Canada), August 1, 2004 , 51/7 (702-706)

Active substance: NEOSTIGMINE

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Document reference: 47056

Study title: Reversal of doxacurium and pancuronium neuromuscular blockade with neostigmine in children.Reversal of doxacurium and pancuronium neuromuscular blockade with neostigmine in children.

Active substance: NEOSTIGMINE

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Document reference: 47057

Study title: Turan A, Memiş D, Başaran UN, Karamanlioğlu B, Süt N.: Caudal ropivacaine and neostigmine in pediatric surgery. Anesthesiology. 2003 Mar;98(3):719-22.Turan A, Memiş D, Başaran UN, Karamanlioğlu B, Süt N.: Caudal ropivacaine and neostigmine in pediatric surgery. Anesthesiology. 2003 Mar;98(3):719-22.

Active substance: NEOSTIGMINE

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Document reference: 47058

Study title: Early bisphosphonate treatment in infants with severe osteogenesis imperfecta.(study published in 2006)

Active substance: NERIDRONIC ACID

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Document reference: 47061

Study title: [A case of Maffucci's syndrome] German. Zöller A, Hör G, Köbrich U. Nuklearmedizin. 1993 Jun;32(3):156-8. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43663

Study title: Zompatori M, Gavelli G, Bernasconi A, Fabbri M, Sturani C, Galavotti V. [Pulmonary eosinophilic granuloma in adults. Case histories and a review of the literature] Radiol Med (Torino). 1989 Apr;77(4):347-53. Review. Italian. Zompatori M, Gavelli G, Bernasconi A, Fabbri M, Sturani C, Galavotti V. [Pulmonary eosinophilic granuloma in adults. Case histories and a review of the literature] Radiol Med (Torino). 1989 Apr;77(4):347-53. Review. Italian.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43791

Study title: [Whole-body retention of 99mTc-methylene diphosphonate in skeletal diseases] German. Zorn-Bopp E, Büll U, Münzing W, Lang P, Moser EA. Nuklearmedizin. 1983 Feb;22(1):24-30. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44048

Study title: Zwillich SH, Comer SS, Lee E, Erdman WA, Lipsky PE. Treatment of the seronegative spondyloarthropathies with sulfasalazine. J Rheumatol Suppl. 1988 Sep;16:33-9. Review. Zwillich SH, Comer SS, Lee E, Erdman WA, Lipsky PE. Treatment of the seronegative spondyloarthropathies with sulfasalazine. J Rheumatol Suppl. 1988 Sep;16:33-9. Review.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43812

Study title: Mora S. Longitudinal Changes of Bone Density and Bone Resorption in Hyperthyroid Girls During Treatment, J Bone Miner Res 1999; 14: 1971-77Mora S. Longitudinal Changes of Bone Density and Bone Resorption in Hyperthyroid Girls During Treatment, J Bone Miner Res 1999; 14: 1971-77

Active substance: TEGAFUR/URACIL

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Document reference: 44287

Study title: Schendekehl TK. Therapie und Verlauf der Juvenilen Hyperthyreose, Schweiz Med Wochenschr 1997; 127 (Suppl 87): Abstract 51Schendekehl TK. Therapie und Verlauf der Juvenilen Hyperthyreose, Schweiz Med Wochenschr 1997; 127 (Suppl 87): Abstract 51

Active substance: TEGAFUR/URACIL

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Document reference: 44289

Study title: Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396

Active substance: TEGAFUR/URACIL

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Document reference: 44288

Study title: A once a day antimicrobial therapy. Teicoplanin and ceftriaxone in the treatment of febrile neutropenic children with acute leukaemia. - Schaison, G ., Leverger, G ., Artel, G ., Pecking, D. -28th Interscience Conference on Antimicrobial Agents and Chemotherapy, Los Angeles 1988 ; 23-26 October : 33.A once a day antimicrobial therapy. Teicoplanin and ceftriaxone in the treatment of febrile neutropenic children with acute leukaemia. - Schaison, G ., Leverger, G ., Artel, G ., Pecking, D. -28th Interscience Conference on Antimicrobial Agents and Chemotherapy, Los Angeles 1988 ; 23-26 October : 33.

Active substance: TEICOPLANIN

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Document reference: 44323

Study title: CES for MA renewal in Austria - Bruno Verdoncq - 28 February 2007

Active substance: TEICOPLANIN

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Document reference: 44290

Study title: Clinical and pharmacokinetic study of teicoplanin in children. - Kafetsis DA, Tspra H, Gianacopoulou C, Karamitsos S. -(Abstract) In: Abstract book of the 15th international congress of chemotherapy. Istanbul, 19-24 July 1987:322.

Active substance: TEICOPLANIN

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Document reference: 44304

Study title: Dagan R, Einhorm M, Howard CB, Williams AH. Outpatient and inpatient teicoplanin treatment for serious grm-positive infections in children. Pediatr Infedt Dis J 1993; 12 (6/2): S 17-S 20.

Active substance: TEICOPLANIN

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Document reference: 44311

Study title: Vento M, Asensi M, Sastre J, García-Sala F, Lloret A, Viña J. Oxidative stress in asphyxiated term infants resuscitated with 100% oxygen. Journal of Pediatrics 2003; 142:240-246Vento M, Asensi M, Sastre J, García-Sala F, Lloret A, Viña J. Oxidative stress in asphyxiated term infants resuscitated with 100% oxygen. Journal of Pediatrics 2003; 142:240-246

Active substance: OXYGEN

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Document reference: 45414

Study title: Vento M, Asensi M, Sastre J, García-Sala F, Pallardó FV, Viña J. Resuscitation With Room Air Instead of 100% Oxygen Prevents Oxidative Stress in Moderately Asphyxiated Term Neonates. Pediatrics 2001;107;642-647Vento M, Asensi M, Sastre J, García-Sala F, Pallardó FV, Viña J. Resuscitation With Room Air Instead of 100% Oxygen Prevents Oxidative Stress in Moderately Asphyxiated Term Neonates. Pediatrics 2001;107;642-647

Active substance: OXYGEN

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Document reference: 45419

Study title: Götte−R, Liedtke−R. (On the antipyretic effect of paracetamol. Clinical investigation with two different forms of application (author's transl)). {Med−Klin}, 6 Jan 1978, vol. 73, no. 1, p. 28−33Götte−R, Liedtke−R. (On the antipyretic effect of paracetamol. Clinical investigation with two different forms of application (author's transl)). {Med−Klin}, 6 Jan 1978, vol. 73, no. 1, p. 28−33

Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID

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Document reference: 33266

Study title: Lal−A et al. Antipyretic effects of nimesulide, paracetamol and ibuprofen− paracetamol. {INDIAN−J−PEDIATR}, 2000, Vol/Iss/Pg. 67 /12 (865−870)Lal−A et al. Antipyretic effects of nimesulide, paracetamol and ibuprofen− paracetamol. {INDIAN−J−PEDIATR}, 2000, Vol/Iss/Pg. 67 /12 (865−870)

Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID

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Document reference: 33283

Study title: Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369)Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369)

Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID

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Document reference: 33285

Study title: A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. Jan 1988.A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. Jan 1988.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33331

Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992.A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33317

Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with sore throat pain. Dec 1992.A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with sore throat pain. Dec 1992.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33332

Study title: A NONCOMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF PARENTERAL SBT/AMP IN THE TREATMENT OF PATIENTS WITH SKIN AND SOFT TISSUE INFECTIONS

Active substance: SULBACTAM

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Document reference: 42686

Study title: A PLACEBO-CONTROLLED DOUBLE-BLIND PROSPECTIVE STUDY OF THE EFFICACY OF UNASYN IN MANAGING PRETERM PREMATURE RUPTURE OF THE MEMBRANES

Active substance: SULBACTAM

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Document reference: 42663

Study title: A PROSPECTIVE, RANDOMIZED, EVALUATION OF AMPICILLIN/SULBACTAM VS CLINDAMYCIN/GENTAMICIN FOR TREATMENT OF CHORIOAMNIONITIS

Active substance: SULBACTAM

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Document reference: 42668

Study title: A RANDOMIZED, COMPARATIVE TRIAL OF CEFOPERAZONE/SULBACTAM VS. CEFTAZIDIME VS. PRIMAXIN FOR THE TREATMENT OF INSTITUTIONALLY ACQUIRED DISEASES

Active substance: SULBACTAM

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Document reference: 42654

Study title: AMPICILLIN/SULBACTAM VERSUS PLACEBO FOR THE INHIBITION OF PREMATURE LABOR OF PATIENTS ON TOCOLYSIS AND IN THE PROLONGATION OF THE LATENT PERIOD AFTER PREMATURE RUPTURE OF THE FETAL MEMBRANES

Active substance: SULBACTAM

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Document reference: 42650

Study title: AN OPEN COMPARATIVE PERIOPERATIVE PROPHYLAXIS STUDY OF SULBACTAM/ AMPICILLIN IN SINGLE DOSE VS. PROCAINE PENICILLIN PLUS CHLORAMPHENICOL IN PATIENTS WHO UNDERGO CAESAREAN SECTION

Active substance: SULBACTAM

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Document reference: 42711

Study title: AN OPEN COMPARATIVE STUDY OF SBT/CFP VS. CEFTAZIDIME PLUS AMIKACIN IN THE TREATMENT OF NEUTROPENIC PATIENTS WITH FEVER.

Active substance: SULBACTAM

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Document reference: 42867

Study title: AN OPEN COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF PARENTERAL SBT/AMP VS CEFOTAXIME IN THE TREATMENT OF GENERAL PEDIATRIC INFECTIONS

Active substance: SULBACTAM

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Document reference: 42690

Study title: AN OPEN EVALUATION OF SULBACTAM/AMPICILLIN IN THE MANAGEMENT OF CEREBRO-SPINAL MENINGITIS EMPIDERMICA.

Active substance: SULBACTAM

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Document reference: 42757

Study title: AN OPEN MULTICENTER STUDY OF SBT/CFP (1:2) IN THE TREATMENT OF PATIENTS WITH MODERATE TO SEVERE ABDOMINAL INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42871

Study title: AN OPEN MULTICENTER STUDY OF SULBACTAM/CEFOPERAZONE (1:2) IN THE TREATMENT OF PEDIATRIC PATIENTS WITH MODERATE OR SEVERE BACTERIAL INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42870

Study title: AN OPEN MULTICENTRIC STUDY OF SULBACTAM/CEFOPERAZONE (1:2) IN THE TREATMENT OF PATIENTS WITH INTRAHOSPITALARY PNEUMONIA.

Active substance: SULBACTAM

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Document reference: 42862

Study title: AN OPEN MULTICENTRIC STUDY OF SULPERAZONE (SULBACTAM/CEFOPERAZONE 1:2) IN THE TREATMENT OF PATIENTS WITH INTRAHOSPITALARY PNEUMONIA.

Active substance: SULBACTAM

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Document reference: 42872

Study title: AN OPEN NON COMPARATIVE STUDY OF PARENTERAL SULBACTAM/AMPICILLIN IN THE TREATMENT OF MIXED AEROBIC/ANAEROBIC INFECTIONS

Active substance: SULBACTAM

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Document reference: 42722

Study title: AN OPEN NON-COMPARATIVE STUDY OF EFFICACY AND SAFETY OF SBT/AMP PARENTERAL IN THE TREATMENT OF GENERAL PEDIATRIC INFECTIONS

Active substance: SULBACTAM

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Document reference: 42731

Study title: An open non-comparative study of Sulbactam plus Ampicillin in Serious Infections in Paediatric Patients

Active substance: SULBACTAM

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Document reference: 42874

Study title: AN OPEN NON-COMPARATIVE STUDY OF SULBACTAM/AMPICILLIN I.V. IN THE TREATMENT OF HOSPITALIZED INFECTION PATIENTS.

Active substance: SULBACTAM

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Document reference: 42707

Study title: AN OPEN NON-COMPARATIVE STUDY OF SULBACTAM/AMPICILLIN I.V. IN THE TREATMENT OF INTRA ABDOMINAL INFECTION

Active substance: SULBACTAM

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Document reference: 42710

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF SULBACTAM/CEFOPERAZONE (1:1) IN THE EMPIRICAL TREATMENT OF MODERATE TO SEVERE SYSTEMIC INFECTION IN ADULT PATIENTS IN HOSPITAL

Active substance: SULBACTAM

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Document reference: 42866

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IM/IV SBT/CFP IN THE TREATMENT OF URINARY TRACT INFECTIONS

Active substance: SULBACTAM

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Document reference: 42850

Study title: Intravenous neridronate in children with osteogenesis imperfecta: a randomized controlled study. (study published in 2005)

Active substance: NERIDRONIC ACID

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Document reference: 47062

Study title: Reduction of plasma taurine level in children affected by osteogenesis imperfecta during bisphosphonate therapy. (study published in 2007)

Active substance: NERIDRONIC ACID

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Document reference: 47060

Study title: Holoshina T.V., Opatsa I.A.:Alternative approaches to treat children suffering from nocturnal enuresis. Biological Therapy (Ukraine), 2003, 3: 21-26 [IIT-publication]

Active substance: Nervoheel - Tabletten

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Document reference: 40081

Study title: Retrospective survey for documentation of appllication and dosage of Nervoheel N (tablets) in children < 12 years of age [Bef-019]

Active substance: Nervoheel N

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Document reference: 40082

Study title: Bacopoulou, 2009;Netilmicin in the neonate: pharmacokinetic analysis and influence of parenteral nutrition Pharm World Sci (2009) 31:365–368 DOI 10.1007/s11096-009-9278-z

Active substance: NETILMICIN

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Document reference: 32622

Study title: Bouissou, 2008; PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).Prospective, Randomized Trial Comparing Short and Long Intravenous Antibiotic Treatment of Acute Pyelonephritis in Children: Dimercaptosuccinic Acid Scintigraphic Evaluation at 9 Months

Active substance: NETILMICIN

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Document reference: 32619

Study title: Comparison of 5 milligrams of netilmicin per kilogram of body weight once daily versus 2 milligrams per kilogram thrice daily for treatment of gram-negative pyelonephritis in children; publication from american society for microbiology "antimicrobial agents and chemotherapy, july 1992, p 1499-1503, vol 36, No 7.

Active substance: NETILMICIN

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Document reference: 32618

Study title: Contopoulos-Ioannidis et. Al ; PEDIATRICS Vol. 114 No. 1 July 2004 Extended-Interval Aminoglycoside Administration for Children: A Meta-analysis

Active substance: NETILMICIN

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Document reference: 32623

Study title: Optimalisation of Netilmicin dosage based on therapeutic drug monitoring during the first days of life in very pre-term neonates (gestational age 23-32 weeks); MED.WIEKU ROZWOJ.,2009, XIII,4,252-259

Active substance: NETILMICIN

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Document reference: 32621

Study title: Sherwin, 2008;Individualising netilmicin dosing in neonates. Eur J Clin Pharmacol (2008) 64:1201–1208 DOI 10.1007/s00228-008-0536-0

Active substance: NETILMICIN

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Document reference: 32620

Study title: High levels of serum prostaglandin e2 in children with osteogenesis imperfecta are reduced by neridronate treatment. Not Available (study published in 2008)

Active substance: NERIDRONIC ACID

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Document reference: 47059

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Neuro-Injeel Ampullen (ampoules) [AWB-AT]

Active substance: Neuro-Injeel Ampullen

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Document reference: 40083

Study title: Post-marketing study 2001-2005 with NHD Pollen in patients with saisonal allergic rhinitis, conjunctivitis and possibly asthmatic disorders, so far only statistical analysis. Age of patients: 5-67 Years

Active substance: NHD POLLEN

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Document reference: 47786

Study title: "The effect of continuous epidural analgesia with sufentanil and bupivacaine during and after thoracic surgery on the plasma cortisol concentration and pain relief"

Active substance: NICOMORPHINE

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Document reference: 32624

Study title: Hurt RD et al. Nicotine patch therapy in 101 adolescent smokers: efficacy, withdrawal symptom relief, and carbon monoxide and plasma cotinine levels. Arch Pediatr Adolesc med 2000; 154: 31-37

Active substance: NICOTINE

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Document reference: 32628

Study title: Killen JD et al. Randomised clinical trial of the effiacy of bupropion combined with nicotine patch in the treatment of adolescent smokers. J Consult Clin Psychol 2004; 72: 729-735

Active substance: NICOTINE

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Document reference: 32627

Study title: Kleges LM et al. Use in nicotine replacement therapy in adolescent smokers and nonsmokers. Arch Pediatr Adolesc Med 2003; 157: 517-522

Active substance: NICOTINE

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Document reference: 32630

Study title: Moolchan ET et al. Safety and efficacy of the nicotine patch and gum for the treatment of adolescent tobacco addiction.Pediatrics 2005; 115: 407-414

Active substance: NICOTINE

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Document reference: 32625

Study title: Prochazka AV et al. A randomsied trial of nortriptyline combined with transdermal nicotine for smoking cessation. Arch Intern Med 2004; 164: 2229-2233

Active substance: NICOTINE

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Document reference: 32626

Study title: Smith TA et al. Nicotine patch therapy in adolescent smokers. Pediatrics 1996; 98: 659-667

Active substance: NICOTINE

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Document reference: 32629

Study title: Efficacy and tolerability of teicoplanin in treatment of Gram-positive infections in children - Kafetzis D.A., Romeo B. - 20 February 1987 ; Report in Clinical documentation for Marketing Autorisation Application (June 1987)

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY DRC 359.DLI.1077.xls

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Document reference: 44291

Study title: Expert Report in Clinical documentation for Marketing Autorisation Application (June 1987): Pharmacokinetic study of teicoplanin in paediatrics after a single dose of 6 mg/kg - Tarral A., Thomson G., Geisert J., Willard D., Monteil H. - 9 February 1987

Active substance: TEICOPLANIN

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Document reference: 44292

Study title: Expert Report on the Clinical documentation for Marketing Authorisation Application - Peter J Lewis - 18 March 1986

Active substance: TEICOPLANIN

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Document reference: 44293

Study title: Expert Report on the Clinical documentation for Marketing Authorisation Application - Peter J Lewis - 9 March 1987

Active substance: TEICOPLANIN

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Document reference: 44309

Study title: Expert Report on the Clinical documentation for Marketing Autorisation Application - Peter J Lewis - 20 November 1989

Active substance: TEICOPLANIN

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Document reference: 44308

Study title: Expert Report on the Clinical documentation for Marketing Autorisation Application - Peter J Lewis - 20 November 1989Expert Report on the Clinical documentation for Marketing Autorisation Application - Peter J Lewis - 20 November 1989

Active substance: TEICOPLANIN

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Document reference: 44314

Study title: Expert Report to amend therapeutic indications: Treatment of neonates - Haydn Clifford Cash - April 1992 amended July 1992

Active substance: TEICOPLANIN

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Document reference: 44294

Study title: Expert Report to amend therapeutic indications: Treatment of paediatric patients - Roscigno G. - 28 June 1991

Active substance: TEICOPLANIN

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Document reference: 44295

Study title: Open Study on teicoplanin efficacy and tolerability for the treatment of gram-positive infection in children. (Abstract) In: Abstracts of the 17th international congress of chemotherapy.- Careddu P, Boccazzi A, Mosconi G. - Berlin, 23-28 June 1991; Abstract: No. 1259.Open Study on teicoplanin efficacy and tolerability for the treatment of gram-positive infection in children. (Abstract) In: Abstracts of the 17th international congress of chemotherapy.- Careddu P, Boccazzi A, Mosconi G. - Berlin, 23-28 June 1991; Abstract: No. 1259.

Active substance: TEICOPLANIN

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Document reference: 44327

Study title: Efficacy and safety of teicoplanin in the treatment of infections caused by gram-positive cocci. A summary of over 298 cases in France.Efficacy and safety of teicoplanin in the treatment of infections caused by gram-positive cocci. A summary of over 298 cases in France.

Active substance: TEICOPLANIN

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Document reference: 44312

Study title: Open study on the efficacy and tolerability of teicoplanin in the treatment of Gram positive infection in children.Open study on the efficacy and tolerability of teicoplanin in the treatment of Gram positive infection in children.

Active substance: TEICOPLANIN

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Document reference: 44313

Study title: Outpatient and inpatient teicoplanin treatment for serious grm-positive infections in children. - Dagan R, Einhorm M, Howard CB, Williams AH. -Pediatr Infedt Dis J 1993; 12 (6/2): S 17-S 20.

Active substance: TEICOPLANIN

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Document reference: 44305

Study title: Pharmacokinetics of teicoplanin in pediatric patients. - Terragna A, Ferrea G, Loy A et al. (1988). - Antimicrobial Agents and Chemotherapy 32, 1223-1226.

Active substance: TEICOPLANIN

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Document reference: 44307

Study title: A double-blind multiple dose study of the comparative antipyretic effectiveness and safety of standard and double standard doses of acetaminophen in febrile children. Jun 1986.A double-blind multiple dose study of the comparative antipyretic effectiveness and safety of standard and double standard doses of acetaminophen in febrile children. Jun 1986.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33339

Study title: A phase II study comparing the efficacy and pharmacokinetic/pharmacodynamic profile of acetaminophen extended release suspension, acetaminophen extended release chewable tablets, and acetaminophen elixir in febrile children. Jun 1997.A phase II study comparing the efficacy and pharmacokinetic/pharmacodynamic profile of acetaminophen extended release suspension, acetaminophen extended release chewable tablets, and acetaminophen elixir in febrile children. Jun 1997.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33334

Study title: Kline RM et al. Enteric−coated, pH−dependent peppermint oil capsules for the treatment of irritable bowel syndrome in children. J PEDIATR 2001; 138(1): 125−128

Active substance: Peppermint Oil 0.200 ml

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Document reference: 40117

Study title: Liu JH et al. Enteric−coated peppermint−oil capsules in the treatment of irritable bowel syndrome: a prospective, randomized trial. J Gastroenterol 1997; 32(6): 765−8

Active substance: Peppermint Oil 0.200 ml

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Document reference: 40116

Study title: Miranda A, Sood M. Treatment options for chronic abdominal pain in children and adolescents. CURR TREAT OPTIONS GASTROENTEROL 2006; 9(5): 409−415

Active substance: Peppermint Oil 0.200 ml

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Document reference: 21225

Study title: Miranda A, Sood M. Treatment options for chronic abdominal pain in children and adolescents. CURR TREAT OPTIONS GASTROENTEROL 2006; 9(5): 409−415

Active substance: Peppermint Oil 0.200 ml

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Document reference: 40113

Study title: Verträglichkeit und Wirksamkeit von Pinimenthol® Erkältungssalbe bei Patienten mit Erkältungskrankheiten der Luftwege.

Active substance: per 100g: Kampfer (raz.) 7g Eukalyptusöl 11g Kiefernnadelöl 9,5g Latschenkiefernöl 1,5g Terpentinöl ger. 1g Guajazulen 0,005g/ per 100g: Kampfer (raz.) 7g Eukalyptusöl 11g Kiefernnadelöl 9,5g Latschenkiefernöl 1,5g Terpentinöl ger. 1g Guajazulen 0,005g

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Document reference: 40118

Study title: Efficacy of Tonsiotren for acute angina catarrhalis.

Active substance: Per tablet: Atropinum sulfuricum D5 12,5 mg Hepar sulfuris D3 10,0 mg Kalium bichromicum D4 50,0 mg Silicea D2 5,0 mg Mercurius bijodatus D8 25,0 mg

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Document reference: 39744

Study title: Clinical Expertise - Study N° ERI 175 - Pr. Bouletreau - Nov 83

Active substance: PERFLOXACIN

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Document reference: 45862

Study title: Clinical Expertise - Study N° ERI 177 - Pefloxacin for infections intensive care - Pr Lhoste - Nov 84

Active substance: PERFLOXACIN

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Document reference: 45863

Study title: Campo JV. Coping with ignorance: Exploring pharmacologic management for pediatric functional abdominal pain. J PEDIATR GASTROENTEROL NUTR 2005; 41(5): 569−574

Active substance: Peppermint Oil 0.200 ml

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Document reference: 40114

Study title: Study of high doses in infant psychiatry: neuroses, psychoses, evolving dysharmony, behaviour disorders. Dr R. Mises, fondation Vallee (Gentilly), 01/1970 - Study mentioned in the summary report - Doc. 000632

Active substance: PERICIAZINE

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Document reference: 33893

Study title: Study of the efficacy of the oral drop formulation in children and adolescents. Dr F. Larbre, Hopital Debrousse (Lyon), 05/1964 - Study mentioned in the summary report -

Active substance: PERICIAZINE

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Document reference: 33894

Study title: 10 weeks toxicity study by oral route (gavage) in juvenile rats followed by a 3-week recovery period.

Active substance: PERINDOPRIL

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Document reference: 45866

Study title: 2 weeks toxicity study by oral route (gavage) in juvenile rats. Ongoing

Active substance: PERINDOPRIL

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Document reference: 45865

Study title: Acceptability, safety, pharmacokinetics and effects on blood pressure of a paediatric formulation of perindopril S 90652 (daily dose 0.025 to 0.135 mg/kg) in hypertensive children -an open, non comparative, 3-month then at least 24-months duration multicentre study.

Active substance: PERINDOPRIL

Study summary document link (including results): perindopril_CL2-90652-002_synopsis.pdf

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Document reference: 45867

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IMIV SBT/CPZ IN THE TREATMENT OF LOWER RESPIRATORY TRACT INFECTION.

Active substance: SULBACTAM

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Document reference: 42853

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IMIV SBT/CPZ IN THE TREATMENT OF LOWER RESPIRATORY TRACT INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42855

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IMIV SBT/CPZ IN THE TREATMENT OF LOWER RESPIRATORY TRACT INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42856

Study title: AN OPEN NON-COMPARATIVE STUDY OF UNASYN IMIV IN VARIOUS INFECTIONS

Active substance: SULBACTAM

Study summary document link (including results):

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Document reference: 42696

Study title: AN OPEN NON-COMPARATIVE STUDY OF UNASYN IMIV IN VARIOUS INFECTIONS

Active substance: SULBACTAM

Study summary document link (including results):

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Document reference: 42738

Study title: AN OPEN NON-COMPARATIVE STUDY OF UNASYN IMIV IN VARIOUS INFECTIONS

Active substance: SULBACTAM

Study summary document link (including results):

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Document reference: 42740

Study title: AN OPEN NON-COMPARATIVE STUDY OF UNASYN IMIV IN VARIOUS INFECTIONS

Active substance: SULBACTAM

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Document reference: 42758

Study title: An Open Non-Comparative Study using a combination of Sulbactam plus Ampicillin or Penicillin G in serious but not life threatening infections in Paediatric Patients

Active substance: SULBACTAM

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Document reference: 42873

Study title: AN OPEN NON-COMPARATIVE STUDY, Q COMBINATION OF SULBACTAM SODIUM WITH AMPICILLIN IN SERIOUS INFECTIONS.

Active substance: SULBACTAM

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Document reference: 42625

Study title: AN OPEN NONCOMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IM/IV SULBACTAM/CFP IN THE TREATMENT OF INTRAABDOMINAL INFECTIONS

Active substance: SULBACTAM

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Document reference: 42860

Study title: AN OPEN NONCOMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF SBT/AMP PARENTERAL FOLLOWED OF ORAL STM FOR THE TREATMENT OF PATIENTS WITH LOWER RESPIRATORY TRACT INFECTIONS INCLUDING BRONCHO-PNEUMONIA AND ASPIRATION PNEUMONIA

Active substance: SULBACTAM

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Document reference: 42755

Study title: AN OPEN PLACEBO COMPARATIVE STUDY OF SBT/AMP-IV IN THE PROPHYLAXIS OF POST SURGICAL OBSTETRIC AND GYNECOLOGICAL INFECTIONS. A MULTICENTRIC TRIAL DURATION OF STUDY APP. ONE POST-SURGERY WEEK.

Active substance: SULBACTAM

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Document reference: 42719

Study title: AN OPEN STUDY OF PARENTERAL SULBACTAM SODIUM/AMPICILLIN.

Active substance: SULBACTAM

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Document reference: 42624

Study title: AN OPEN, COMPARATIVE STUDY OF SBT/CFP VS. PIPERACILLIN PLUS AMIKACIN IN THE TREATMENT OF NEUTROPENIC PATIENTS WITH FEVER.

Active substance: SULBACTAM

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Document reference: 42868

Study title: AN OPEN, COMPARATIVE STUDY OF SULBACTAM/CEFOPERAZONE PLUS AMIKACIN VS. CEFTAZIDIME PLUS AMIKACIN (1:2) IN THE TREATMENT OF NEUTROPENIC PATIENTS WITH FEVER.

Active substance: SULBACTAM

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Document reference: 42863

Study title: AN OPEN, COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF SBT/CPZ (1:1) PLUS AMIKACIN VS CEFTAZIDIME PLUS AMIKACIN IN THE EMPIRIC TREATMENT OF NEUTROPENIC PATIENTS WITH FEVER

Active substance: SULBACTAM

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Document reference: 42858

Study title: AN OPEN, NON-COMPARATIVE MULTICENTER STUDY OF SULBACTAM/AMPICILLIN (UNASYN) ADMINISTERED INTRAVENOUSLY FOR THE TREATMENT OF PEDIATRIC INFECTIONS

Active substance: SULBACTAM

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Document reference: 42751

Study title: AN OPEN, NON-COMPARATIVE MULTICENTER STUDY ON THE EFFICACY AND TOLERABILITY OF SULTAMICILLIN (SULBACTAM/AMPICILLIN) IN THE TREATMENT OF CHILDREN PATIENTS WITH SKIN AND SUBCUTANEOUS TISSUE INFECTIONS

Active substance: SULBACTAM

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Document reference: 42678

Study title: AN OPEN, NON-COMPARATIVE STUDY IN PARENTERAL SULBACTAM/AMPICILLIN IN CASES OF MIXED AEROBIC/ANAEROB INFECTIONS

Active substance: SULBACTAM

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Document reference: 42732

Study title: AN OPEN, NON-COMPARATIVE STUDY OF SULBACTAM/AMPICILLIN (UNASYN) ADMINISTERED INTRAVENOUSLY FOR THE TREATMENT OF PEDIATRIC INFECTIONS

Active substance: SULBACTAM

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Document reference: 42752

Study title: Jürgens H et al The German Society of Pediatric Oncology Cooperative Ewing Sarcoma Studies CESS 81/86: report after 6 1/2 years Klin Padiatr. 1988 May-Jun;200(3):243-52. GermanJürgens H et al The German Society of Pediatric Oncology Cooperative Ewing Sarcoma Studies CESS 81/86: report after 6 1/2 years Klin Padiatr. 1988 May-Jun;200(3):243-52. German

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 24944

Study title: Final Summary of Japanese Retrospective Surveillance and Prospective Studies in Children Less than 1 Year of Age.

Active substance: oseltamivir

Study summary document link (including results):

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Document reference: 47896

Study title: - The Completed NIH Chart Review - CASG 113 FSR

Active substance: oseltamivir

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Document reference: 47898

Study title: "Contribution to recalcification therapy in pediatric medicine", Talavera R., Acta Pediatrica Espanola, 1962, 1-25 "Contribution to recalcification therapy in pediatric medicine", Talavera R., Acta Pediatrica Espanola, 1962, 1-25

Active substance: OSSEIN HYDROXYAPATITE COMPOUND

Study summary document link (including results): Ossopan nr5.xls

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Document reference: 47718

Study title: "Monitoring the whole bone-recalciferous therapy", Martin-Santana J., Archivos de Pediatria, 1966, 31(94): 33-44"Monitoring the whole bone-recalciferous therapy", Martin-Santana J., Archivos de Pediatria, 1966, 31(94): 33-44

Active substance: OSSEIN HYDROXYAPATITE COMPOUND

Study summary document link (including results): Ossopan nr4.xls

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Document reference: 47717

Study title: Open-label, cross-over, randomized, reference-controlled, multicenter study to investigate the parents’ preference for Creon for children over Creon 12000 U in infants with pancreatic exocrine insufficiency due to cystic fibrosis

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-S245-3118.pdf

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Document reference: 47669

Study title: "OPEN-LABEL, MULTICENTRE, RANDOMISED CROSSOVER STUDY TO lNVESTlGATE THE PATIENT'S PREFERENCE OF CREON to 000 MINIMICROSPHERES OVER CREON 12000 IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY CAUSED BY CYSTIC FIBROSIS".

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-K245-5002.pdf

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Document reference: 47655

Study title: Open-label, randomized, three-way, cross-over single-center study to Prove the equivalence of a single dose of Creon® 10,000 Minimicrospheres™ and Pancrease by using the 13C-mixed triglyceride breath test in patients with pancreatic exocrine insufficiency due to cystic fibrosis

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-S245-3111.pdf

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Document reference: 47667

Study title: Open. randomized. crossover, multicenter study to investigate relative patient preference for Creane 10 000 Minimicrospheres1M versus Creone 8 000 microspheres in patients with pancreatic exocrine insufficiency caused by cystic fibrosis.

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-S245-3105.pdf

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Document reference: 47666

Study title: Randomized, open-label, cross-over study comparing the efficacy and tolerance of Creon® Forte and Cotazym S Forte® in children and young adults with cystic fibrosis

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-K224-5010.pdf

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Document reference: 45111

Study title: 10.) Oral enzyme therapy in the treat- ment of recurrent respiratory inflamma- tions in patients with indication of immunological in- vestigation before start of treatment

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40102

Study title: 11.) Systemic en- zyme therapy in the treatement of supra- condylar fractures of the humerus in Children

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40103

Study title: 12.) Influence of Wobenzym treat- ment in children with increased sickness rate

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40104

Study title: 14.) Oral Enzyme Therapy of Re- current Respiratory Inflammations in Children

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40105

Study title: Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9.Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9.

Active substance: TOBRAMYCIN

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Document reference: 25751

Study title: Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9.Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9.

Active substance: TOBRAMYCIN

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Document reference: 44821

Study title: Appendix I to Ephynal (dl-α-tocopherol) NDA pharmacokinetic profile (for Vitamin E) in premature neonated following intramuscular administration

Active substance: TOCOPHEROL

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Document reference: 47788

Study title: Kalra V. Vitamin E Administration and Reversal of Neurological Deficits in Protein-Energy Malnutrition. Journal of Tropical Pediatrics 2001; 47: 39-48. Kalra V. Vitamin E Administration and Reversal of Neurological Deficits in Protein-Energy Malnutrition. Journal of Tropical Pediatrics 2001; 47: 39-48.

Active substance: TOCOPHEROL

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Document reference: 44822

Study title: Pharmacokinetic profile for vitamin E in premature neonated following intramuscular administration

Active substance: TOCOPHEROL

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Document reference: 44823

Study title: Tolerability and acceptability of Ro 01-4065/342, EPHYNAL effervescent tablets

Active substance: TOCOPHEROL

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Document reference: 47790

Study title: 3. Numbers LC. Clinical experiences with tolnaftate. J Am Podiatry Assoc. 1967 . 3. Numbers LC. Clinical experiences with tolnaftate. J Am Podiatry Assoc. 1967 .

Active substance: TOLNAFTATE

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Document reference: 44826

Study title: 4. Robinson HM, Jr., Raskin J. Tolnaftate, a potent topical antifungal agent. Arch Dermatol. 1965 Apr;91(4):372-6. 4. Robinson HM, Jr., Raskin J. Tolnaftate, a potent topical antifungal agent. Arch Dermatol. 1965 Apr;91(4):372-6.

Active substance: TOLNAFTATE

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Document reference: 44827

Study title: A comparison of 0.3% Tobramycin Ophthalmic Solution (TOBREX New) vs TOBREX Ophthalmic Solution (TOBREX) for Treatment of Bacterial Conjunctivitis (C9998).

Active substance: TOBRAMYCIN

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Document reference: 44819

Study title: Carpenter WE. Tolnaftate, its effectiveness in pedal mycosis. A preliminary report. J Am Podiatry Assoc. 1966 Dec;56(12):541-6.Jun;57(6):275 Carpenter WE. Tolnaftate, its effectiveness in pedal mycosis. A preliminary report. J Am Podiatry Assoc. 1966 Dec;56(12):541-6.Jun;57(6):275

Active substance: TOLNAFTATE

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Document reference: 44824

Study title: Jacobs PH. Fungal infections in childhood. Pediatr Clin North Am. 1978 May;25(2):357-70. Jacobs PH. Fungal infections in childhood. Pediatr Clin North Am. 1978 May;25(2):357-70.

Active substance: TOLNAFTATE

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Document reference: 44829

Study title: 38. TOPAMAX in der Behandlung des WEST Syndrom (TOPAMAX in the treatment of West Syndrom (patients < 2 years)).

Active substance: TOPIRAMATE

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Document reference: 44972

Study title: 38. Topamax in der Therapie kindlicher Epilepsien (Topamax in the Therapy of Childlike Epilepsy)

Active substance: TOPIRAMATE

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Document reference: 44881

Study title: Clinical evaluation of TOBRADEX Ophthalmic Suspension versus Tobramycin Ophthalmic Solution (TOBREX) (C9192),

Active substance: TOBRAMYCIN

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Document reference: 44818

Study title: Efficacy and safety of Ciprofloxacin Ophthalmic Ointment versus TOBREX Ophthalmic Ointment for treating bacterial conjunctivitis in children (C9129),

Active substance: TOBRAMYCIN

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Document reference: 44816

Study title: A study comparing the efficacy and safety of acetaminophen sustained release 1300 mg to acetaminophen regular release 650 mg in the treatment of post-operative dental pain.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol 88-856.pdf

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Document reference: 47509

Study title: A Study Comparing the Efficacy and Safety of Acetaminophen Sustained Release 1300 mg to Acetaminophen Regular Release 650 mg in the Treatment of Post-Operative Episiotomy Pain.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol 88-857.pdf

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Document reference: 47510

Study title: An evaluation of the efficacy and safety of C-14 elixir in pediatric patients with symptomatology requiring an analgesic and/or antipyretic.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol 0-206.pdf

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Document reference: 47503

Study title: An open trial to assess the acceptability and tolerance of Lonarid mono syrup in children.

Active substance: PARACETAMOL

Study summary document link (including results): Paracetamol_U96-0101_synopsis.pdf

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Document reference: 45778

Study title: An open trial to investigate pharmacokinetics as well as efficacy and safety of 0.25 mg/kg meloxicam suspension administered once daily in children with juvenile rheumatoid arthritis over a treatment period of up to 52 weeks (3 months results).

Active substance: PARACETAMOL

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Document reference: 45776

Study title: An open trial to investigate pharmacokinetics as well as efficacy and safety of 0.25 mg/kg meloxicam suspension administered once daily in children with juvenile rheumatoid arthritis over a treatment period of up to 52 weeks - 12 months results.

Active substance: PARACETAMOL

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Document reference: 45777

Study title: Clinical trial comparing the safety and efficacy of acetaminophen with that of ibuprofen in the treatment of acute musculo-skeletal injury

Active substance: PARACETAMOL

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Document reference: 45788

Study title: Clinical trial comparing the safety and efficacy of acetaminophen with that of ibuprofen in the treatment of acute musculo-skeletal injury

Active substance: PARACETAMOL

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Document reference: 45795

Study title: Comparison of the antipyretic activity of ibuprofen and paracetamol in children with pyrexia.

Active substance: PARACETAMOL

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Document reference: 45802

Study title: Management of middle-ear effusions in children. Hughes KB. J Laryngol Otol. 1984 Jul;98(7):677-84.Management of middle-ear effusions in children. Hughes KB. J Laryngol Otol. 1984 Jul;98(7):677-84.

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33642

Study title: Nasal decongestant activity of pseudoephedrine. Ann Otol Rhinol Laryngol 1977; 86(2 pt. 1):235-42Nasal decongestant activity of pseudoephedrine. Ann Otol Rhinol Laryngol 1977; 86(2 pt. 1):235-42

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33639

Study title: Sperber SJ et al. Effectiveness of pseudoephedrine plus acetaminophen for treatment of symptoms attributed to the paranasal sinuses associated with the common cold. Arch Fam Med 2000; 9(10):979-85 Sperber SJ et al. Effectiveness of pseudoephedrine plus acetaminophen for treatment of symptoms attributed to the paranasal sinuses associated with the common cold. Arch Fam Med 2000; 9(10):979-85

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 25781

Study title: Treatment of the common cold. Supiyaphun P, Kerekhanjananarong V, Saengpanich S, Cutchavaree A. J Med Assoc Thai. 2003 Jun;86 Suppl 2:S362-72.Treatment of the common cold. Supiyaphun P, Kerekhanjananarong V, Saengpanich S, Cutchavaree A. J Med Assoc Thai. 2003 Jun;86 Suppl 2:S362-72.

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33640

Study title: Steele R.W., Tanaka P.T., Lara R.P., Bass J.W. : Evaluation of sponging and of oral antipyretic therapy to reduce fever. J. Pediatr. 1970Steele R.W., Tanaka P.T., Lara R.P., Bass J.W. : Evaluation of sponging and of oral antipyretic therapy to reduce fever. J. Pediatr. 1970

Active substance: PARACETAMOL

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Document reference: 45751

Study title: Study of the pharmacokinetic linearity of three paediatric doses of paracetamol (50, 125, and 250mg) administered as a new Synthelabo formulation, and their bioequivlence with a standard formulation of DOLIPRANE dosed at 16mg healthy male young volunteers. Open, randomised, cross-over and single-center study.

Active substance: PARACETAMOL

Study summary document link (including results): 2890 98 FR 001.pdf

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Document reference: 47077

Study title: Tarlin−L et al. A comparison of the antipyretic effect of acetaminophen and aspirin. Another approach to poison prevention. {Am−J−Dis−Child}, Dec 1972, vol. 124, no. 6, p. 880−2Tarlin−L et al. A comparison of the antipyretic effect of acetaminophen and aspirin. Another approach to poison prevention. {Am−J−Dis−Child}, Dec 1972, vol. 124, no. 6, p. 880−2

Active substance: PARACETAMOL

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Document reference: 45752

Study title: Tepid sponging and paracetamol for reduction of body temperature in febrile children. {MED J AUST}, 04 FEB 2002, Vol/Iss/Pg. 176/3 (130) Tepid sponging and paracetamol for reduction of body temperature in febrile children. {MED J AUST}, 04 FEB 2002, Vol/Iss/Pg. 176/3 (130)

Active substance: PARACETAMOL

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Document reference: 45753

Study title: The antipyretic use of acetaminophen versus ibuprofen in a pediatric care setting. {P T}, 2000, Vol/Iss/Pg. 25/8 (395 397) The antipyretic use of acetaminophen versus ibuprofen in a pediatric care setting. {P T}, 2000, Vol/Iss/Pg. 25/8 (395 397)

Active substance: PARACETAMOL

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Document reference: 45754

Study title: Tramadol hydrochloride: analgesic pharmacodynamics-pharmacokinetics in dental-extraction pain

Active substance: PARACETAMOL

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Document reference: 45727

Study title: Trial of oral paracetamol solution in febrile children. Ann Pediatr Paris, Feb 1983, vol. 30, no. 2, p. 131-3 Trial of oral paracetamol solution in febrile children. Ann Pediatr Paris, Feb 1983, vol. 30, no. 2, p. 131-3

Active substance: PARACETAMOL

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Document reference: 45756

Study title: ULTRAM® tramadol HCl: Safety and efficacy in dental-extraction pain

Active substance: PARACETAMOL

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Document reference: 45728

Study title: Ulukol−B et al. Assessment of the efficacy and safety of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections. {EUR−J−CLIN−PHARMACOL}, 1999, Vol/Iss/Pg. 55/9 (615−618Ulukol−B et al. Assessment of the efficacy and safety of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections. {EUR−J−CLIN−PHARMACOL}, 1999, Vol/Iss/Pg. 55/9 (615−618

Active substance: PARACETAMOL

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Document reference: 45757

Study title: Shannon, M. W. and Townsend, M. K. The Pediatric Environmental Health Center, Children's Hospital, Harvard Medical School, Boston, MA 02115, USA. Adverse effects of reduced-dose d-penicillamine in children with mild-to-moderate lead poisoning Ann.Pharmacother. 2000;34:15-18. Shannon, M. W. and Townsend, M. K. The Pediatric Environmental Health Center, Children's Hospital, Harvard Medical School, Boston, MA 02115, USA. Adverse effects of reduced-dose d-penicillamine in children with mild-to-moderate lead poisoning Ann.Pharmacother. 2000;34:15-18.

Active substance: PENICILLAMINE

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Document reference: 33838

Study title: "Medical Treatment of Essential Enuresis with Oxybutynin Hydrochloride and Imipramine - Laurenti C et al. - Min Urol Nefr - 1987 (39: 195-200) - Publication in UK registration file - " "Medical Treatment of Essential Enuresis with Oxybutynin Hydrochloride and Imipramine - Laurenti C et al. - Min Urol Nefr - 1987 (39: 195-200) - Publication in UK registration file - "

Active substance: OXYBUTYNIN

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Document reference: 32984

Study title: "Oxybutynin Chloride in enuresis/Randomized clinical study - Marconi A M et al - Urologia - 1984 (51(2): 262-263) - Publication in UK registration file -" "Oxybutynin Chloride in enuresis/Randomized clinical study - Marconi A M et al - Urologia - 1984 (51(2): 262-263) - Publication in UK registration file -"

Active substance: OXYBUTYNIN

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Document reference: 32985

Study title: "Oxybutynin and the Prevention of Urinary Incontinence in Spina bifida - M. Hehir, J.M. Fitzpatrick - Eur. Urol. - 1985 (11: 254-256) - Publication in UK registration file - " "Oxybutynin and the Prevention of Urinary Incontinence in Spina bifida - M. Hehir, J.M. Fitzpatrick - Eur. Urol. - 1985 (11: 254-256) - Publication in UK registration file - "

Active substance: OXYBUTYNIN

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Document reference: 32986

Study title: "Oxybutynin Chloride (Ditropan) in Enuresis - Buttarazzi P J. - The Journal of Urology - 1977 (118: 46) - Publication in UK registration file -" "Oxybutynin Chloride (Ditropan) in Enuresis - Buttarazzi P J. - The Journal of Urology - 1977 (118: 46) - Publication in UK registration file -"

Active substance: OXYBUTYNIN

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Document reference: 32988

Study title: "Oxybutynin Chloride on the Pure Unstable Bladder. Preliminary Controlled Study versus Placebo - Bono A V et al. - Urologia - 1982 (49: 764-768) - Publication in UK registration file -" "Oxybutynin Chloride on the Pure Unstable Bladder. Preliminary Controlled Study versus Placebo - Bono A V et al. - Urologia - 1982 (49: 764-768) - Publication in UK registration file -"

Active substance: OXYBUTYNIN

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Document reference: 32989

Study title: Oxybutynin does not affect cyclosporin blood levels - Springate JE - J Drug Monit - 2001; 23(2):155-156 Oxybutynin does not affect cyclosporin blood levels - Springate JE - J Drug Monit - 2001; 23(2):155-156

Active substance: OXYBUTYNIN

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Document reference: 32995

Study title: "Oxybutynin Efficacy in the Treatment of Primary Enuresis - Lovering J S et al. - Pediatrics - 1988 (82(1): 104-106) - Publication in UK registration file - " "Oxybutynin Efficacy in the Treatment of Primary Enuresis - Lovering J S et al. - Pediatrics - 1988 (82(1): 104-106) - Publication in UK registration file - "

Active substance: OXYBUTYNIN

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Document reference: 32990

Study title: "Oxybutynin in Bladder Spasm, Neurogenic Bladder and Enuresis - Thompson I M and Lauvetz R. - Urology - 1976 (8: 452-454) - Publication in UK registration file - " "Oxybutynin in Bladder Spasm, Neurogenic Bladder and Enuresis - Thompson I M and Lauvetz R. - Urology - 1976 (8: 452-454) - Publication in UK registration file - "

Active substance: OXYBUTYNIN

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Document reference: 32991

Study title: Plasma levels of Oxybutynin chloride in children - Autret E, Jonville AP, Dutertre JP, Bertiere MC, Robert M, Averous M. Couet W - Eur J Clin Pharmacol - 1994; 46:83-85 Plasma levels of Oxybutynin chloride in children - Autret E, Jonville AP, Dutertre JP, Bertiere MC, Robert M, Averous M. Couet W - Eur J Clin Pharmacol - 1994; 46:83-85

Active substance: OXYBUTYNIN

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Document reference: 32996

Study title: Valutazione dell’effetto antalgico e della tollerabilità di un nuovo dosaggio di paracetamolo sciroppo nelle faringotonsilliti in pediatria. Studio in doppio cieco verso placebo, controllato verso ketoprofene sale di lisina.

Active substance: PARACETAMOL

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Document reference: 45774

Study title: 39. TOPAMAX in Patienten mit fokalen und generalisierten tonisch klonischen Anfällen (TOPAMAX in Patients with Focally and Generalised Tonic Clonic Seizures) TOP-GER-3 (patients > 12)

Active substance: TOPIRAMATE

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Document reference: 44882

Study title: 4. A pilot study of topiramate in childhood absence epilepsy.

Active substance: TOPIRAMATE

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Document reference: 44938

Study title: 37. Topamax 1st line add on (patients >12 years)

Active substance: TOPIRAMATE

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Document reference: 44902

Study title: 37. TOPAMAX in Patienten mit fokalen und generalisierten tonisch klonischen Anfällen (TOPAMAX in Patients with Focally and Generalised Tonic Clonic Seizures (patients > 12 years)).

Active substance: TOPIRAMATE

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Document reference: 44971

Study title: 4. Phase 3, randomized, double-blind, PBO-controlled, parallel group, multicenter, dose-response study to evaluate the efficacy and safety of TPM vs. PBO in migraine prophylaxis (plus OL Ext)

Active substance: TOPIRAMATE

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Document reference: 44837

Study title: 40. Phase 3, open-label, safety and efficacy, adjunctive or monotherapy study in adults with refractory partial epilepsy originally entered in Studies Y1/Y2/Y3, and who received PBO in the original study.

Active substance: TOPIRAMATE

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Document reference: 44974

Study title: 41. TOPAMAX in der Behandlung des WEST Syndrom (TOPAMAX in the treatment of West Syndrom) (patients < 2 years)

Active substance: TOPIRAMATE

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Document reference: 44903

Study title: 5. Phase 3, randomized, double-blind, parallel group, multicenter, PBO- and active-controlled, dose-response study to evaluate the efficacy and safety of 2 doses of TPM vs. PBO and PROP in migraine prophylaxis (plus blinded Ext)

Active substance: TOPIRAMATE

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Document reference: 44838

Study title: 39. Open-label, safety and efficacy, adjunctive or monotherapy study in asubjects ? 14 years of age with any seizure type.

Active substance: TOPIRAMATE

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Document reference: 44973

Study title: 5. Topiramate clinical trial in primary generalized tonic-clonic seizures (long-term extension).

Active substance: TOPIRAMATE

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Document reference: 44939

Study title: 6. Open study of topamax as adjunct treatment in patients with partial onset seizures : assessing the low and slow titration regimen.

Active substance: TOPIRAMATE

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Document reference: 44940

Study title: 6. Phase 3, randomized, double-blind, parallel group, multicenter, PBO- and active-controlled, dose-response study to evaluate the efficacy and safety of 2 doses of TPM vs. PBO and PROP in migraine prophylaxis (plus blinded Ext)

Active substance: TOPIRAMATE

Study summary document link (including results):

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Document reference: 44839

Study title: 7. Open naturalistic individual dose optimisation trial assessing tolerability and efficacy of topiramate

Active substance: TOPIRAMATE

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Document reference: 44874

Study title: 7. Open naturalistic individual dose optimisation trial assessing tolerability and efficacy of topiramate.

Active substance: TOPIRAMATE

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Document reference: 44941

Study title: 7. Single centre topiramate monotherapy trial

Active substance: TOPIRAMATE

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Document reference: 44840

Study title: 8. Phase 3, open-label, PK, safety, and tolerability study of TPM adjunctive therapy in pediatric subjects with Lennox-Gastaut syndrome

Active substance: TOPIRAMATE

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Document reference: 44841

Study title: 9. Long-term, open-label study of topamax (topiramate) used as adjunctive therapy in patients with partial onset seizures with or without secondary generalization.

Active substance: TOPIRAMATE

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Document reference: 44943

Study title: 9. Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in subjects with Lennox-Gastaut syndrome

Active substance: TOPIRAMATE

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Document reference: 44842

Study title: Publication in CES0506 - Lavin B - 30/06/2006 Comparative efficacy, safety, and effect on quality of life of triamcinolone acetonide and fluticasone propionate aqueous nasal sprays in patients with fall seeasonal allergic rhinitis - Gross - 2002 (Annals of allergy asthma & immunology 89; 1: 56-62, 2002)

Active substance: TRIAMCINOLONE

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Document reference: 46833

Study title: Yoder−K−E, Shaffer−M−L, La−Tournous−S−J, Paul−I−M. Child assessment of dextromethorphan, diphenhydramine, and placebo for nocturnal cough due to upper respiratory infection. Clinical Pediatrics {CLIN−PEDIATR}, 2006, Vol/Iss/Pg. 45/7 (633−640).Yoder−K−E, Shaffer−M−L, La−Tournous−S−J, Paul−I−M. Child assessment of dextromethorphan, diphenhydramine, and placebo for nocturnal cough due to upper respiratory infection. Clinical Pediatrics {CLIN−PEDIATR}, 2006, Vol/Iss/Pg. 45/7 (633−640).

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33624

Study title: Effects of semprex-D and diphenhydramine on learning in young adults with seasonal allergic rhinitis. Vuurman EF, van Veggel LM, Sanders RL, Muntjewerff ND, O'Hanlon, JF. Ann Allergy Asthma Immunol. 1996 Mar;76(3):247-52.

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 33725

Study title: Management of middle-ear effusions in children. Hughes KB. J Laryngol Otol. 1984 Jul;98(7):677-84.

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE AND TRIPTOLIDINE

Study summary document link (including results):

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Document reference: 33723

Study title: Treatment of the common cold. Supiyaphun P, Kerekhanjananarong V, Saengpanich S, Cutchavaree A. J Med Assoc Thai. 2003 Jun;86 Suppl 2:S362-72.

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE AND TRIPTOLIDINE

Study summary document link (including results):

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Document reference: 33724

Study title:

Active substance: PARACETAMOL AND TRAMADOL

Study summary document link (including results): paracetamol 95-530 TRAMAP-ANAG-007.pdf

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Document reference: 47513

Study title: A multinational, multicentre, prospective, Zaldiar post marketing surveillance observation to assess the safety of Zaldiar (tramadol/paracetamol 37.5 mg/325 mg) and patient satisfaction in the routine Latin American clinical setting

Active substance: PARACETAMOL AND TRAMADOL

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Document reference: 44977

Study title: Evaluation of the efficacy and safety of tramadol with acetaminophen (RWJ-26898-002-AQ-22) in oral surgical pain

Active substance: PARACETAMOL AND TRAMADOL

Study summary document link (including results): paracetamol TRAMAP-ANAG-002.pdf

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Document reference: 47519

Study title: Evaluation of the efficacy and safety of tramadol with acetaminophen (RWJ-26898-002-AQ-22) in oral surgical pain

Active substance: PARACETAMOL AND TRAMADOL

Study summary document link (including results): paracetamol TRAMAP-ANAG-003.pdf

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Document reference: 47520

Study title: Evaluation of the efficacy and safety of tramadol/apap in oral surgical pain

Active substance: PARACETAMOL AND TRAMADOL

Study summary document link (including results): paracetamol TRAMAP-ANAG-010.pdf

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Document reference: 47521

Study title: Respilene: expertise clinique en pédiatrie. Clinical study report in paediatrics - Lajouanine P. - 06/04/72Respilene: expertise clinique en pédiatrie. Clinical study report in paediatrics - Lajouanine P. - 06/04/72

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33958

Study title: Albani M. An effective dose schedule for phentoin treatment of status epilepticus in infancy and childhood. Neuropädiatrie 1977; 8: 286-292Albani M. An effective dose schedule for phentoin treatment of status epilepticus in infancy and childhood. Neuropädiatrie 1977; 8: 286-292

Active substance: PHENYTOIN

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Document reference: 33969

Study title: Fritsch G. Bioverfügbarkeit von Diphenylhydantoin - Freie Säure - Serumspiegeluntersuchungen eines Präparates mit Laktose als Tablettenbasis. Monatsschr. Kinderheilkd. 1980; 128: 648-650Fritsch G. Bioverfügbarkeit von Diphenylhydantoin - Freie Säure - Serumspiegeluntersuchungen eines Präparates mit Laktose als Tablettenbasis. Monatsschr. Kinderheilkd. 1980; 128: 648-650

Active substance: PHENYTOIN

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Document reference: 33968

Study title: Grinschgl G. Die Kombinationsbehandlung zerebraler Krampfanfälle unter besonderer Berücksichtigung der Epilepsie. Wien Klin Wochenschr 1952; 64/20: 362-365Grinschgl G. Die Kombinationsbehandlung zerebraler Krampfanfälle unter besonderer Berücksichtigung der Epilepsie. Wien Klin Wochenschr 1952; 64/20: 362-365

Active substance: PHENYTOIN

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Document reference: 33967

Study title: Tanner, M. S., Bhave, S. A., Pradhan, A. M., and Pandit, A. N. Department of Child Health, University of Leicester Clinical trials of penicillamine in Indian childhood cirrhosis Arch.Dis.Child 1987;62:1118-1124. Tanner, M. S., Bhave, S. A., Pradhan, A. M., and Pandit, A. N. Department of Child Health, University of Leicester Clinical trials of penicillamine in Indian childhood cirrhosis Arch.Dis.Child 1987;62:1118-1124.

Active substance: PENICILLAMINE

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Document reference: 33848

Study title: Canadian experience with Pneumodine ( Pentamidine isethionate) in the treatment of Pneumocystis carinii Pneumonia : A retrospective analysis of the results of patients receiving Pneumodine as emergency treatment during 1986, 1987 and the first half of 1988.Canadian experience with Pneumodine ( Pentamidine isethionate) in the treatment of Pneumocystis carinii Pneumonia : A retrospective analysis of the results of patients receiving Pneumodine as emergency treatment during 1986, 1987 and the first half of 1988.

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45821

Study title: Cardiac arrest after intravenous pentamidine in an infant. Miller H.C. The pediatric infectious disease journal 1993 Aug, Vol :12 (8), p:694-6; ISSN : 0891-3668Cardiac arrest after intravenous pentamidine in an infant. Miller H.C. The pediatric infectious disease journal 1993 Aug, Vol :12 (8), p:694-6; ISSN : 0891-3668

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45822

Study title: Comparison of pentamdine isethionate abd trimethoprim-sulfametoxazole in the treatment of Pneumocystis carinii pneumonia. Walter T. Hughes M.D., Sandor Feldman M.D, Subhash C. Chaudary M.D., Michael J. Ossi M.D., Frederick Cox M.D. and S.K. Sanyal MBBS, Memphis-Tenn. The Journal of Pediatrics Vol 92 N° 2 p. 285-291Comparison of pentamdine isethionate abd trimethoprim-sulfametoxazole in the treatment of Pneumocystis carinii pneumonia. Walter T. Hughes M.D., Sandor Feldman M.D, Subhash C. Chaudary M.D., Michael J. Ossi M.D., Frederick Cox M.D. and S.K. Sanyal MBBS, Memphis-Tenn. The Journal of Pediatrics Vol 92 N° 2 p. 285-291

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45823

Study title: Isethionate de pentamidine Poudre pour usage parentéral dosée à 200 et 300 mg - Documentation clinique - Synthèse bibliographique - Aout 1987.Isethionate de pentamidine Poudre pour usage parentéral dosée à 200 et 300 mg - Documentation clinique - Synthèse bibliographique - Aout 1987.

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45824

Study title: Iséthionate de pentamidine Poudre pour usage parentéral dosée à 200 et 300 mg - Rapport d'expert concernant la documentation clinique - R. Woehrle - 20 Mai 1988Iséthionate de pentamidine Poudre pour usage parentéral dosée à 200 et 300 mg - Rapport d'expert concernant la documentation clinique - R. Woehrle - 20 Mai 1988

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45825

Study title: Pentamidine isethionate in the treatment of Pneumocystis carinii pneumonia. Karl A. Western, M.D., David R., Perera, M.D. and Myrong G. Schultz, D.V.M, M.D. Annals of Internal Medicine 73 : 695-702, 1970Pentamidine isethionate in the treatment of Pneumocystis carinii pneumonia. Karl A. Western, M.D., David R., Perera, M.D. and Myrong G. Schultz, D.V.M, M.D. Annals of Internal Medicine 73 : 695-702, 1970

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45826

Study title: J Asthma. 2004;41(3):285-7. Immune modulator pidotimod decreases the in vitro expression of CD30 in peripheral blood mononuclear cells of atopic asthmatic and normal children. Gourgiotis D, Papadopoulos NG, Bossios A, Zamanis P, Saxoni-Papageorgiou PJ Asthma. 2004;41(3):285-7. Immune modulator pidotimod decreases the in vitro expression of CD30 in peripheral blood mononuclear cells of atopic asthmatic and normal children. Gourgiotis D, Papadopoulos NG, Bossios A, Zamanis P, Saxoni-Papageorgiou P

Active substance: PIDOTIMOD

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Document reference: 34074

Study title: Viitanen H, et all. Analgesic efficacy of rectal acetaminophen and ibuprofen alone or in combination for paediatric day-case adenoidectomy. Br J Anaesth. 2003 Sep;91(3):363-7.Viitanen H, et all. Analgesic efficacy of rectal acetaminophen and ibuprofen alone or in combination for paediatric day-case adenoidectomy. Br J Anaesth. 2003 Sep;91(3):363-7.

Active substance: PARACETAMOL

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Document reference: 45760

Study title: Walson−P−D et al. Comparison of multidose ibuprofen and acetaminophen therapy in febrile children. {AM−J−DIS−CHILD}, 1992, Vol /Iss/Pg. 146/5 (626−632)Walson−P−D et al. Comparison of multidose ibuprofen and acetaminophen therapy in febrile children. {AM−J−DIS−CHILD}, 1992, Vol /Iss/Pg. 146/5 (626−632)

Active substance: PARACETAMOL

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Document reference: 45762

Study title: Walson−P−D et al. Ibuprofen, acetaminophen, and placebo treatment of febrile children. {Clin−Pharmacol−Ther}, Jul 1989, vol. 46, no. 1, p. 9−17Walson−P−D et al. Ibuprofen, acetaminophen, and placebo treatment of febrile children. {Clin−Pharmacol−Ther}, Jul 1989, vol. 46, no. 1, p. 9−17

Active substance: PARACETAMOL

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Document reference: 45763

Study title: Walson−P−D. Ibuprofen versus paracetamol for the treatment of fever in children. {BR−J−CLIN−PRACT}, 1990, Vol/Iss /Pg. 44/8 SUPPL. 70 (19−21)Walson−P−D. Ibuprofen versus paracetamol for the treatment of fever in children. {BR−J−CLIN−PRACT}, 1990, Vol/Iss /Pg. 44/8 SUPPL. 70 (19−21)

Active substance: PARACETAMOL

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Document reference: 45764

Study title: Weisse−M−E et al. Fever response to acetaminophen in viral vs. bacterial infections. {Pediatr−Infect−Dis−J}, Dec 1987, vol. 6, no. 12, p. 1091−4Weisse−M−E et al. Fever response to acetaminophen in viral vs. bacterial infections. {Pediatr−Infect−Dis−J}, Dec 1987, vol. 6, no. 12, p. 1091−4

Active substance: PARACETAMOL

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Document reference: 45765

Study title: When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm World Sci}, Jun 2005, vol. 27, no. 3, p. 254-7 When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm World Sci}, Jun 2005, vol. 27, no. 3, p. 254-7

Active substance: PARACETAMOL

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Document reference: 45766

Study title: Wilson, Brown, Bocchini, Kearno; Ther Drug Monitoring 1982Wilson, Brown, Bocchini, Kearno; Ther Drug Monitoring 1982

Active substance: PARACETAMOL

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Document reference: 45767

Study title: Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369)Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369)

Active substance: PARACETAMOL

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Document reference: 45768

Study title: Pentamidine-induced hypoglycemia in patients with the acquired immune deficiency syndrome. Celijne M. Stahl-Baylis, M.D. Concetta M.Kalman, R.N., and Oscar L. Laskin, M.D. NY. Clin. Pharmacol. Ther. March 1986Pentamidine-induced hypoglycemia in patients with the acquired immune deficiency syndrome. Celijne M. Stahl-Baylis, M.D. Concetta M.Kalman, R.N., and Oscar L. Laskin, M.D. NY. Clin. Pharmacol. Ther. March 1986

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45827

Study title: Van Esch, Van Steensel-Moll, Steyerberg, Offringa, Habbema, Derksen-Lubsen; Arch Pediatr Adolesc Med Van Esch, Van Steensel-Moll, Steyerberg, Offringa, Habbema, Derksen-Lubsen; Arch Pediatr Adolesc Med

Active substance: PARACETAMOL

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Document reference: 45758

Study title: Publication in Expert Report - Critical Evaluation - Banerji DD - 06/12/1999 An evaluation of the effects of beclomethasone dipropionate aqueous nasal spray on long-term groqth in children - Rachelefsky GS - 1998 (J. Allergy Clin. Immunol. 101: S236)

Active substance: TRIAMCINOLONE

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Document reference: 46834

Study title: Publication in PSUR Long term safety and efficacy of triamcinolone acetonide aqueous nasal spray for the treatment of perennial allergic rhinitis - Koepke JW - 1997 (Allergy and Asthma Proc. 18: 33-37)

Active substance: TRIAMCINOLONE

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Document reference: 46835

Study title: Publication in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 Short-term growth in children with allergic rhinitis treated with oral antihistamine, depot and intranasal glucocorticoids - Wolthers OD - 1993 (Acta Paediatr 82:635-640)

Active substance: TRIAMCINOLONE

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Document reference: 46836

Study title: Publication in Rapport d'Expert sur la documentation clinique - Staudinger H - Update Dossier 24/03/1997 International Rhinitis Management Working Group. International Consensus Report on the Diagnosis and Management of Rhinitis - No Author - 1994 (Allergy 19:5-34)

Active substance: TRIAMCINOLONE

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Document reference: 46837

Study title: Publication in Rapport d'Expert sur la documentation pharmaco-toxicologique - Roquet F - 15/08/1995 A thirty day comparison of the oral toxicity of CL 30,980 : 1,4-Pregnadiene-3,20-dione, 9a-fluoro-11b-hydroxy-16a,17a-(isopropylidenedioxy)-21-(tetrahydropyran-2-yloxy)- and CL 22,353 : 1,4-Pregnadiene-3,20-dione, 9a-fluoro-11b,21-dihydroxy-16a,17a-(isopropylidenedioxy)- in rats - Kanegis LA - 26/09/1960 (Safety Evaluation.studies. PR Volume 6, 2694-2726)

Active substance: TRIAMCINOLONE

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Document reference: 46838

Study title: Publication in Response Document of MRP type II variation - Banerji D - 16/05/2000 A long-term (1 year) safety study of triamcinolone acetonide (TAA) HFA oral inhaler in asthmatic children - Weinberg EG - 1999 (European Respiratory Journal 14 (S30) abstract P361, p42s)

Active substance: TRIAMCINOLONE

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Document reference: 46839

Study title: Report in Expert Report - Critical Evaluation - Banerji DD - 06/12/1999 A phase III, single center, randomised, cross-over paediatric trial with Nasacort AQ nasal spray assessing short term growth in patients with allergic rhinitis - Kane R- 15/08/2007

Active substance: TRIAMCINOLONE

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Document reference: 46840

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in patients with perennial allergic rhinitis - No Author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46841

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in patients with seasonal (ragweed) allergic rhinitis - No Author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46842

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in patients with seasonal allergic rhinitis - No Author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46843

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in patients with seasonal ragweed allergic rhinitis - No Author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46844

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in pediatric patients with perennial allergic rhinitis - No Author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46845

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in pediatric patients with perennial allergic rhinitis - No Author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46846

Study title: Strotzka H. Die Kombinationsbehandlung der behandlungsresistenten Epilepsie. Wien Med Wochenschr 1951; 101/24-25: 465-468Strotzka H. Die Kombinationsbehandlung der behandlungsresistenten Epilepsie. Wien Med Wochenschr 1951; 101/24-25: 465-468

Active substance: PHENYTOIN

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Document reference: 33966

Study title: A randomised, double-blind, placebo-controlled, multi-centre, Phase I trial investigating the safety of Grazax® in children aged 5-12 years with grass pollen induced rhinoconjunctivitis (with/without asthma)

Active substance: Phleum pratense

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Document reference: 40130

Study title: Five-year follow-up on the PAT study: specific immunotherapy and long-term prevention of asthma in children

Active substance: PHLEUM PRATENSE

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Document reference: 34030

Study title: Five-year follow-up on the PAT study: specific immunotherapy and long-term prevention of asthma in children

Active substance: Phleum pratense

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Document reference: 40128

Study title: Immunotherapy in children with allergic asthma: Effect on bronchial hyperreactivity and pharmacotherapy

Active substance: PHLEUM PRATENSE

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Document reference: 34028

Study title: Immunotherapy in children with allergic asthma: Effect on bronchial hyperreactivity and pharmacotherapy

Active substance: Phleum pratense

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Document reference: 40126

Study title: Respilene: expertise clinique en pédiatrie. Clinical study report in paediatrics - Lafargues G. - 23/03/72Respilene: expertise clinique en pédiatrie. Clinical study report in paediatrics - Lafargues G. - 23/03/72

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33957

Study title: Poets CF. When do infants need additional inspired oxygen? A review of the current literature. Pediatric Pulmonology 1998; 26:424-428Poets CF. When do infants need additional inspired oxygen? A review of the current literature. Pediatric Pulmonology 1998; 26:424-428

Active substance: OXITRIPTAN

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Document reference: 32944

Study title: Saugstad OD, Rootwelt T, Aalen O. Resuscitation of Asphyxiated Newborn Infants With Room Air or Oxygen: An International Controlled Trial: The Resair 2 Study Pediatrics 1998; 102;E1Saugstad OD, Rootwelt T, Aalen O. Resuscitation of Asphyxiated Newborn Infants With Room Air or Oxygen: An International Controlled Trial: The Resair 2 Study Pediatrics 1998; 102;E1

Active substance: OXITRIPTAN

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Document reference: 32945

Study title: Side-effects of oral or intravesical oxybutynin chloride in children with spina bifida - Ferrara P, D'Aleo CM, Tarquini E, Salvatore S, Salvaggio E - BJU International - 2001; 87:674-677Side-effects of oral or intravesical oxybutynin chloride in children with spina bifida - Ferrara P, D'Aleo CM, Tarquini E, Salvatore S, Salvaggio E - BJU International - 2001; 87:674-677

Active substance: OXITRIPTAN

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Document reference: 32924

Study title: Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968; 42:565-589Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968; 42:565-589

Active substance: OXITRIPTAN

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Document reference: 32946

Study title: J Chemother. 1999 Apr;11(2):126-30. Prophylaxis with the novel immunomodulator pidotimod reduces the frequency and severity of upper respiratory tract infections in children with Down's syndrome. La Mantia I, Grillo C, Mattina T, Zaccone P, Xiang M, Di Mauro M, Meroni PL, Nicoletti F.J Chemother. 1999 Apr;11(2):126-30. Prophylaxis with the novel immunomodulator pidotimod reduces the frequency and severity of upper respiratory tract infections in children with Down's syndrome. La Mantia I, Grillo C, Mattina T, Zaccone P, Xiang M, Di Mauro M, Meroni PL, Nicoletti F.

Active substance: PIDOTIMOD

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Document reference: 34075

Study title: Namazova Baranova, Kharit, Tuzankina et al 2010; Results of a multicentre study of pidotimod therapy in the prevention of acute respiratory infections in ailing children.Namazova Baranova, Kharit, Tuzankina et al 2010; Results of a multicentre study of pidotimod therapy in the prevention of acute respiratory infections in ailing children.

Active substance: PIDOTIMOD

Study summary document link (including results): Namazova_VSP_2-2010_pidotimod+ENG transl.pdf

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Document reference: 34071

Study title: Rev Alerg Mex. 2005 Jan-Feb;52(1):25-38. Comparative meta-analysis of immunoestimulant agents used in pediatric patients in Mexico. de la Torre González C, Pacheco Ríos A, Escalante Domínguez AJ, del Río Navarro BE.Rev Alerg Mex. 2005 Jan-Feb;52(1):25-38. Comparative meta-analysis of immunoestimulant agents used in pediatric patients in Mexico. de la Torre González C, Pacheco Ríos A, Escalante Domínguez AJ, del Río Navarro BE.

Active substance: PIDOTIMOD

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Document reference: 34069

Study title: Vargas Correa JB, Espinosa Morales S, Bolanos Ancona JC, Farfan Ale JA. “Pidotimod in recurring respiratory infection in children with allergic rhinitis, asthma, or both conditions.” Publication: Rev Alerg Mex 2002; 49: 27-32, (Polichem Ref. N. 0680).Vargas Correa JB, Espinosa Morales S, Bolanos Ancona JC, Farfan Ale JA. “Pidotimod in recurring respiratory infection in children with allergic rhinitis, asthma, or both conditions.” Publication: Rev Alerg Mex 2002; 49: 27-32, (Polichem Ref. N. 0680).

Active substance: PIDOTIMOD

Study summary document link (including results): Vargas Correa_2002_pidotimod.pdf

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Document reference: 34078

Study title: Eyedrop instillation for reluctant children. Smith SE. Br J Ophthalmol. 1991 Aug;75(8):480-1.Eyedrop instillation for reluctant children. Smith SE. Br J Ophthalmol. 1991 Aug;75(8):480-1.

Active substance: PILOCARPINE

Study summary document link (including results): Eyedrop instillation for reluctant children.pdf

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Document reference: 34079

Study title: Kwitko M. L., Curr Opin Ophthalmology 1990; 1: 127-132Kwitko M. L., Curr Opin Ophthalmology 1990; 1: 127-132

Active substance: PILOCARPINE

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Document reference: 34080

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981 0301-0301E1 Art45 listing 2011.xls

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Document reference: 34081

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981 0315E1 Art45 listing 2011.xls

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Document reference: 34082

Study title: Long term double blind controlled studies in children

Active substance: OXYBUTYNIN

Study summary document link (including results): Oxybutynin STUDY Marion 012-059.xls

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Document reference: 33002

Study title: Pneumocystis carinii pneumonia and altered host resistance : treatement of one patient with pentamidine isethionate. Patterson, J.H. , Lindsey, I.L., Edwards, E.S. and Logan Jr., W.D. (1966) Pediatrics 38:388-397Pneumocystis carinii pneumonia and altered host resistance : treatement of one patient with pentamidine isethionate. Patterson, J.H. , Lindsey, I.L., Edwards, E.S. and Logan Jr., W.D. (1966) Pediatrics 38:388-397

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45828

Study title: Pneumocystis carinii pneumonia and congenital hypogammaglobulinaemia. W.C. Marshall, H.J. Weston and Martin Bodian. Archives of Disease in Childhood, 1964, 39, 18.Pneumocystis carinii pneumonia and congenital hypogammaglobulinaemia. W.C. Marshall, H.J. Weston and Martin Bodian. Archives of Disease in Childhood, 1964, 39, 18.

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45829

Study title: Pneumocystis carinii pneumonia associated with hypogammaglobulinaemia responding to pentamidine. Rodgers T.S., Haggie M.H.K. The Lancet, May 9, 1964, p.1042Pneumocystis carinii pneumonia associated with hypogammaglobulinaemia responding to pentamidine. Rodgers T.S., Haggie M.H.K. The Lancet, May 9, 1964, p.1042

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45830

Study title: Pneumocystis carinii pneumonia in an adopted vietnamese infant. Redman, J.C. (1974) Journal of the American Medical association 230 : 1561-1563Pneumocystis carinii pneumonia in an adopted vietnamese infant. Redman, J.C. (1974) Journal of the American Medical association 230 : 1561-1563

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45831

Study title: Pneumocystis carinii pneumonia in children with cancer. Diagnosis and treatment. Johnson, H.D. and Johnson, W.W. (1970). Journal of the American Medical Association 214 : 1067-1073Pneumocystis carinii pneumonia in children with cancer. Diagnosis and treatment. Johnson, H.D. and Johnson, W.W. (1970). Journal of the American Medical Association 214 : 1067-1073

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45832

Study title: Rapport d'expert sur la documentation pharmacologie humaine et clinique : Dr. F. Pichon - Juin 1989Rapport d'expert sur la documentation pharmacologie humaine et clinique : Dr. F. Pichon - Juin 1989

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45833

Study title: Successful treatment of Pneumocystis carinii pneumonitis in a patient with congenital hypogammaglobulinaemia. Robbins, J.B., Miller, R.H.; Arean, V.M. and Pearson , H.A. (1965). New England Journal of Medicine 272:708-713Successful treatment of Pneumocystis carinii pneumonitis in a patient with congenital hypogammaglobulinaemia. Robbins, J.B., Miller, R.H.; Arean, V.M. and Pearson , H.A. (1965). New England Journal of Medicine 272:708-713

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45834

Study title: Treatment of Pneumocystis carinii in children. Lipson, A., Marshall, W.C., and Hayward, A.R. (1977) Archives of disease in childhood 52 : 314-319Treatment of Pneumocystis carinii in children. Lipson, A., Marshall, W.C., and Hayward, A.R. (1977) Archives of disease in childhood 52 : 314-319

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45835

Study title: Treatment of Pneumocystis carinii pneumonia in infancy Ivady, G. and Paldy, L. (1976). National Cancer Institute Monograph 43:201-208Treatment of Pneumocystis carinii pneumonia in infancy Ivady, G. and Paldy, L. (1976). National Cancer Institute Monograph 43:201-208

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45836

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C1301 Art45 listing 2011.xls

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Document reference: 34083

Study title: 271/87: Steady-state pharmcokinetics and phamacodynamics of theophylline, in asthmatic children of 9 - 13 years, after unequal twice-daily dosing of the oral sustained-release formulation BY158K

Active substance: THEOPHYLLINE

Study summary document link (including results): Study report 271-87 Theopyhlline -synopsis.pdf

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Document reference: 44730

Study title: 84/83: Theophylline retard (250 mg): Clinical efficacy / tolerability and pharmacokinetics

Active substance: THEOPHYLLINE

Study summary document link (including results): Study report 84-83 Theophylline - synopsis English.pdf

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Document reference: 44728

Study title: Dose-dependent kinetics for theophylline obersvations among ambulatory asthmatic children Sarrazin J Pediatr 19801 97(5) 825-8 in Annual Report 02Dose-dependent kinetics for theophylline obersvations among ambulatory asthmatic children Sarrazin J Pediatr 19801 97(5) 825-8 in Annual Report 02

Active substance: THEOPHYLLINE

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Document reference: 44722

Study title: Effect of age on patients of theophylline metabolism Grygiel - No author - 1980 (Clin Pharmacol Therp 1980 28(4) 456-62 in Annual report 02)Effect of age on patients of theophylline metabolism Grygiel - No author - 1980 (Clin Pharmacol Therp 1980 28(4) 456-62 in Annual report 02)

Active substance: THEOPHYLLINE

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Document reference: 44727

Study title: Efficacy of a 12 hour sustained release preparations in maintaining therapeutic serum theophylline levels in asthmatic children Kelly Pediatrics 1980, 66(1): 97-102 in Annual Report 02Efficacy of a 12 hour sustained release preparations in maintaining therapeutic serum theophylline levels in asthmatic children Kelly Pediatrics 1980, 66(1): 97-102 in Annual Report 02

Active substance: THEOPHYLLINE

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Document reference: 44723

Study title: Eriksson et al. Combined theofylline/beta-agonists maintenance therapy in chronic asthma. Eur J Respir Dis 1983; 64:172-177Eriksson et al. Combined theofylline/beta-agonists maintenance therapy in chronic asthma. Eur J Respir Dis 1983; 64:172-177

Active substance: THEOPHYLLINE

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Document reference: 44718

Study title: Kjellman et al. Theofylline Pharmacokinetics in Children, Comparing Sustained Release Spheres (Theo-Dur sprinkle) with Elixir. Eur J Pediatr 1988; 148:278-280Kjellman et al. Theofylline Pharmacokinetics in Children, Comparing Sustained Release Spheres (Theo-Dur sprinkle) with Elixir. Eur J Pediatr 1988; 148:278-280

Active substance: THEOPHYLLINE

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Document reference: 44719

Study title: Laursen et al. Effects of Enprofylline and Theofylline on Exercise-Induced Asthma. Allergy 1985; 40: 506-509Laursen et al. Effects of Enprofylline and Theofylline on Exercise-Induced Asthma. Allergy 1985; 40: 506-509

Active substance: THEOPHYLLINE

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Document reference: 44716

Study title: Laursen et al. Long-term oral therapy of asthma with terbutaline and theofyllin, alone and combined. Eur J Respir Dis 1985; 66: 82-90Laursen et al. Long-term oral therapy of asthma with terbutaline and theofyllin, alone and combined. Eur J Respir Dis 1985; 66: 82-90

Active substance: THEOPHYLLINE

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Document reference: 44717

Study title: Lönnerholm et al. Combined Treatment With Sustained-Release Theopylline and Beta2-adrenoreceotor-stimulatin Agents in Chronoc Childhood Asthma. Br. Med J. 1981; 282: 1029-1031.Lönnerholm et al. Combined Treatment With Sustained-Release Theopylline and Beta2-adrenoreceotor-stimulatin Agents in Chronoc Childhood Asthma. Br. Med J. 1981; 282: 1029-1031.

Active substance: THEOPHYLLINE

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Document reference: 44715

Study title: Metaproterenol and theophylline in asthmatic children Rachelefsky Ann Allergy 1980, 45(4) 207-12 in Annual Report 02Metaproterenol and theophylline in asthmatic children Rachelefsky Ann Allergy 1980, 45(4) 207-12 in Annual Report 02

Active substance: THEOPHYLLINE

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Document reference: 44724

Study title: Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968;42:565-589Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968;42:565-589

Active substance: OXITRIPTAN

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Document reference: 32952

Study title: Study of a 3-hour paclitaxel infusion in children with refractory solid tumours: a SFOP study.Doz F; Gentet J C et al. British journal of cancer Mar 2 2001, 84 (5) p604-10 ,Study of a 3-hour paclitaxel infusion in children with refractory solid tumours: a SFOP study.Doz F; Gentet J C et al. British journal of cancer Mar 2 2001, 84 (5) p604-10 ,

Active substance: OXITRIPTAN

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Document reference: 32962

Study title: Subcommittee on diagnosis and management of bronchiolitis (American Academy of Pediatrics). Diagnosis and management of bronchiolitis. Pediatrics 2006; 118(4):1774-1793Subcommittee on diagnosis and management of bronchiolitis (American Academy of Pediatrics). Diagnosis and management of bronchiolitis. Pediatrics 2006; 118(4):1774-1793

Active substance: OXITRIPTAN

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Document reference: 32947

Study title: Successful Treatment of Nocturnal Enuresis: A Practical Approach - Maizels M and Rosenbaum D. - Primary Care - 1985 (12(4): 621-635) - Publication in UK registration file - Successful Treatment of Nocturnal Enuresis: A Practical Approach - Maizels M and Rosenbaum D. - Primary Care - 1985 (12(4): 621-635) - Publication in UK registration file -

Active substance: OXITRIPTAN

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Document reference: 32916

Study title: Tay-Uyboco JS, Kwiatkowski K, Cates DB, Kavanagh L, Rigatto H. Hypoxic airway constriction in infants of very low birth weight recovering from moderate to severe bronchopulmonary dysplasia. J Pediatr. 1989; 115:456–459.Tay-Uyboco JS, Kwiatkowski K, Cates DB, Kavanagh L, Rigatto H. Hypoxic airway constriction in infants of very low birth weight recovering from moderate to severe bronchopulmonary dysplasia. J Pediatr. 1989; 115:456–459.

Active substance: OXITRIPTAN

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Document reference: 32948

Study title: The British guidelines on management of asthma. Thorax 2003; 58(suppl)S1:1-83The British guidelines on management of asthma. Thorax 2003; 58(suppl)S1:1-83

Active substance: OXITRIPTAN

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Document reference: 32953

Study title: Demonstration of the Analgesic Efficacy and Safety of Liquid Formulations of Ibuprofen (10mg/kg), Acetaminophen (15mg/kg), and Placebo in the relief of Orthodontic Pain in Children

Active substance: PARACETAMOL

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Document reference: 45792

Study title: Demonstration of the Analgesic Efficacy and Safety of Liquid Formulations of Ibuprofen (10mg/kg), Acetaminophen (15mg/kg), and Placebo in the relief of Orthodontic Pain in Children

Active substance: PARACETAMOL

Study summary document link (including results): Paracetamol Clinical Trial Summaries.pdf

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Document reference: 45798

Study title: Double-blind comparison of the taste of children's anacin-3 liquid vs. children tylenol liquid in normal children

Active substance: PARACETAMOL

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Document reference: 45786

Study title: Double-blind, single-dose study of the safety and analgesic efficacy of ibuprofen liquid, acetaminophen liquid, and placebo (liquid vehicle) following orthodontic treatmen

Active substance: PARACETAMOL

Study summary document link (including results): Paracetamol Clinical Trial Summaries.pdf

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Document reference: 45799

Study title: Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial

Active substance: PARACETAMOL

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Document reference: 45800

Study title: Essai comparatif en double aveugle évaluant l’efficacité et la tolérance d’une dose de charge de 30 mg/kg de paracétamol versus 15 mg/kg dans la fièvre de l’enfant pesant entre 4 et 26 kg. Essai en double aveugle, comparatif sur deux groupes parallèles, multicentrique, phase III.Publication = Treluyer JM. Et al : Antipyretic efficacy of an initial 30 mg/kg loading dose of acetaminophen versus a 15 mg/kg maintenance dose.

Active substance: PARACETAMOL

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Document reference: 45780

Study title: AWB Petadolex for the treatment of asthma

Active substance: Petasitidis extr. e rad. spiss. (28 – 44 :1); extraction solvent: CO2 (HERB)*

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Document reference: 40123

Study title: Comparison of IM pethidine, diazepam and flunitrazepam as premedicants in children undergoing otolaryngological surgery - L Lindgren Br J. - 1979 (Anaesth 1979, 51 321-327) - Publication in expert report DOL01VOL2 -

Active substance: PETHIDINE

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Document reference: 45868

Study title: Side effects of opiods during short-term administration:effect of age, gender and race. M. Soledad Clinical Pharmacology & Therapeutics Volu 74, (2), 102-112 including in the ex-ante documentationSide effects of opiods during short-term administration:effect of age, gender and race. M. Soledad Clinical Pharmacology & Therapeutics Volu 74, (2), 102-112 including in the ex-ante documentation

Active substance: PETHIDINE

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Document reference: 45869

Study title: Urinary excretion and metabolism of pethidine and norpethidine in the newborn - M Hogg Br - 1977 ( J. Anaesth 1977, 45:891-898) - Publication in expert report DOL01VOL2 -Urinary excretion and metabolism of pethidine and norpethidine in the newborn - M Hogg Br - 1977 ( J. Anaesth 1977, 45:891-898) - Publication in expert report DOL01VOL2 -

Active substance: PETHIDINE

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Document reference: 45870

Study title: An observational study collecting data on the efficacy and tolerability of Elidel® (pimecrolimus) cream 1% in patients with mild or moderate atopic dermatitis after one and six weeks in real life practice.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CSA02 Art45 listing 2011.xls

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Document reference: 34117

Study title: An open-label, single-arm study to determine the efficacy of 1% Elidel (pimecrolimus) cream in the treatment of pityriasis alba.

Active substance: PIMECROLIMUS

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Document reference: 34105

Study title: An oral fertility and early embryonic development study in rats

Active substance: PIMECROLIMUS

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Document reference: 34124

Study title: EFFECTIVE ELI – Evaluation of EFFECTIVEness of ELIdel in prevention of flares

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CSI01 Art45 listing 2011.xls

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Document reference: 34118

Study title: Efficacy of Elidel in vitiligo vulgaris

Active substance: PIMECROLIMUS

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Document reference: 34108

Study title: Elidel (pimecrolimus) cream 1% on drug consumption and drug utilization in subjects >2 years of age with mild to moderate atopic dermatitis using Elidel cream 1% in routine daily treatment practice

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CBE03 Art45 listing 2011.xls

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Document reference: 34110

Study title: Elidel PMS trial with Elidel in patients with AD.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CDE07 Art45 listing 2011.xls

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Document reference: 34094

Study title: Elidel Tolerability, Safety and Efficacy in Dermatitis Atopic Patients (El-Tosca)

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CID01 Art45 listing 2011.xls

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Document reference: 34114

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C1302 Art45 listing 2011.xls

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Document reference: 34085

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C1303 Art45 listing 2011.xls

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Document reference: 34086

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C1304 Art45 listing 2011.xls

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Document reference: 34087

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2313 Art45 listing 2011.xls

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Document reference: 34088

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2314 Art45 listing 2011.xls

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Document reference: 34121

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981W206-W206E1 Art45 listing 2011.xls

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Document reference: 47701

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981W202 Art45 listing 2011.xls

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Document reference: 47702

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981MX01 Art45 listing 2011.xls

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Document reference: 47703

Study title: 12-week, open-label, uncontrolled, non blinded, non randomized, single-arm, single-center, investigator-initiated study

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CUS11 Art45 listing 2011.xls

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Document reference: 48119

Study title: A 12 month open label non-controlled extension to a randomized multicenter, parallel-group, double-blind, vehicle controlled study to evaluate the efficacy and safety of 1% SDZ ASM981 cream in the long-term management of atopic dermatitis in children from 3 months to 23 months

Active substance: PIMECROLIMUS

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Document reference: 34129

Study title: Side-effects of oral or intravesical oxybutynin chloride in children with spina bifida - Ferrara P, D'Aleo CM, Tarquini E, Salvatore S, Salvaggio E - BJU International - 2001; 87:674-677 Side-effects of oral or intravesical oxybutynin chloride in children with spina bifida - Ferrara P, D'Aleo CM, Tarquini E, Salvatore S, Salvaggio E - BJU International - 2001; 87:674-677

Active substance: OXYBUTYNIN

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Document reference: 32997

Study title: 16.) Evaluation of effectivness of Wobenzym Therapy in children with recurrent obstructive bronchitis

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40106

Study title: 18.) Prophylaxis and treatment chronic hepatitis in children

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40107

Study title: 19.) Efficacy of oral enzyme therapy in the complex treat- ment of atopic dermatitis in children

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40108

Study title: 20.) Efficacy of oral enzyme therapy in children with atopic dermatitis

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40109

Study title: 22.) Enzyme prepa- rations in abdominal surgery

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40110

Study title: 23.) Use of Woben- zym for pseudo- tuberculosis and yersiniosis of children

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40111

Study title: A randomized, investigator-blinded, parallel, single dose, multicenter study to compare for eight hours the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets (20-30 mg/kg) compared to regular strength, conventional release acetaminophen pediatric chewable tablets (10-25 mg/kg) in the treatment of febrile children. Jan 1990.A randomized, investigator-blinded, parallel, single dose, multicenter study to compare for eight hours the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets (20-30 mg/kg) compared to regular strength, conventional release acetaminophen pediatric chewable tablets (10-25 mg/kg) in the treatment of febrile children. Jan 1990.

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33612

Study title: A single dose double-blind study comparing the efficacy of ibuprofen and children's Tylenol elixir. Feb 1988.A single dose double-blind study comparing the efficacy of ibuprofen and children's Tylenol elixir. Feb 1988.

Active substance: PARACETAMOL AND PHENYLEPHRINE

Study summary document link (including results):

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Document reference: 33604

Study title: A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991.A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991.

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33600

Study title: A study of the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets compared to Children's Tylenol chewable tablets in the treatment of febrile children. Mar 1990.A study of the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets compared to Children's Tylenol chewable tablets in the treatment of febrile children. Mar 1990.

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33611

Study title: Amdekar−Y−K, Desai−R−Z. Antipyretic activity of ibuprofen and paracetamol in children with pyrexia. {Br−J−Clin−Pract}, Apr 1985, vol. 39, no. 4, p. 140−3Amdekar−Y−K, Desai−R−Z. Antipyretic activity of ibuprofen and paracetamol in children with pyrexia. {Br−J−Clin−Pract}, Apr 1985, vol. 39, no. 4, p. 140−3

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33577

Study title: Essai comparative en double aveugle évaluant l’efficacité et la tolérance d’une dose de charge 30 mg/kg de paracétamol versus 15 mg/kg dans la fièvre de l’entant pesant entre 4 et 26 kg

Active substance: PARACETAMOL

Study summary document link (including results): DO 428.pdf

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Document reference: 47080

Study title: Etude multicentrique, ouverte, non comparative, de l'acceptabilite et de la tolerance du paracetamol suspension buvable pediatrique a 4,8% - J. Lalau Keraky, C. Leblond-Joly, V. Dubourg, M. Kabir-Ahmadi, C. Kempf - May 25th, 2007.

Active substance: PARACETAMOL

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Document reference: 45779

Study title: Etude multicentrique, randomisée en 2 groupes parallèles, en double aveugle, comparant l’effet antalgique du paracétamol oral en doses répétées, après une dose initiale de 30 mg/kg ou de 15 mg/kg, chez l’enfant âgé de 1 à 6 ans.

Active substance: PARACETAMOL

Study summary document link (including results):

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Document reference: 45782

Study title: Etude multicentrique, randomisée en 2 groupes parallèles, en double aveugle, comparant l’effet antalgique du paracétamol oral en doses répétées, après une dose initiale de 30mg/kg ou de 15mg/kg, chez l’enfant âgé de 1 à 6 ans

Active substance: PARACETAMOL

Study summary document link (including results): DO466.pdf

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Document reference: 47079

Study title: ETUDE MULTICENTRIQUE, RANDOMISEE, EN DOUBLE AVEUGLE, COMPARANT L EFFET ANTIPYRETIQUE DU PARACETAMOL EN DOSES REPETEES, APRES UNE DOSE INITIALE DE 15 MG/KG OU DE 30 MG/KG CHEZ L ENFANT PESANT ENTRE 4 ET 26 KG ET AGE D AU MOINS 1 MOIS

Active substance: PARACETAMOL

Study summary document link (including results): DO465.pdf

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Document reference: 47078

Study title: Etude multicentrique, randomisée, en double aveugle, comparant l’effet antipyrétique du paracétamol en doses répétées, après une dose initiale de 15 mg/kg ou de 30 mg/kg, chez l’enfant pesant entre 4 et 26 kg et âgé d’au moins 1 mois.

Active substance: PARACETAMOL

Study summary document link (including results):

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Document reference: 45781

Study title: Confronto in doppio cieco controllato tra placebo e paracetamolo

Active substance: PARACETAMOL

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Document reference: 45773

Study title: Gehri M, Guignard E, et al. (2005) When fever, paracetamol ? Theory and practice in a paediatric outpatient clinic. Pharmacy World &Science 27: 254-7Gehri M, Guignard E, et al. (2005) When fever, paracetamol ? Theory and practice in a paediatric outpatient clinic. Pharmacy World &Science 27: 254-7

Active substance: PARACETAMOL

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Document reference: 45772

Study title: Evaluation of the efficacy and safety of tramadol/apap in oral surgical pain

Active substance: PARACETAMOL AND TRAMADOL

Study summary document link (including results): paracetamol TRAMAP-ANAG-012.pdf

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Document reference: 47522

Study title: Evaluation of the efficacy and safety of tramadol/apap in oral surgical pain

Active substance: PARACETAMOL AND TRAMADOL

Study summary document link (including results): paracetamol TRAMAP-ANAG-013.pdf

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Document reference: 47523

Study title: Evaluation of the multiple-dose steady-state pharmacokinetic profile of oral tramadol hydrochloride in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-007; Phase 2)

Active substance: PARACETAMOL AND TRAMADOL

Study summary document link (including results):

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Document reference: 45808

Study title: Evaluation of the safety profile and clinical effectiveness of oral tramadol hydrochloride tablets for the treatment of postsurgical pain in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-005; Phase 2)

Active substance: PARACETAMOL AND TRAMADOL

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Document reference: 45806

Study title: Evaluation of the safety profile of oral tramadol for the treatment of painful conditions in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-008; Phase 2)

Active substance: PARACETAMOL AND TRAMADOL

Study summary document link (including results):

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Document reference: 45809

Study title: Open-label evaluation of the pharmacokinetic profile of oral tramadol hydrochloride tablets in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-001 and TRAM-PEDS-006; Phase 2)

Active substance: PARACETAMOL AND TRAMADOL

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Document reference: 45805

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine sulfate and placebo in pain following cesarean section

Active substance: PARACETAMOL AND TRAMADOL

Study summary document link (including results):

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Document reference: 45810

Study title: ELPASO-Elidel Patient Self-observation

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CDE11 Art45 listing 2011.xls

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Document reference: 34096

Study title: An observation post-marketing surveillance (PMS) study evaluating efficacy and safety of Elidel (pimecrolimus) cream 1% in patients >=3 months of age with mild to moderate dermatitis.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CPH01 Art45 listing 2011.xls

View full study record

Document reference: 34100

Study title: Exploratory, 2-week, double-blind, randomized

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CUS22 Art45 listing 2011.xls

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Document reference: 48120

Study title: A Phase 2, Open-Label, Prospective, Safety and pK Study to Assess the Extended Use of Synagis (Seven Injections) in Infants and Children with or without CLD

Active substance: palivizumab

Study summary document link (including results): palivizumab-w00-350.pdf

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Document reference: 48109

Study title: A Phase 4, Prospective, Open-Label, Multi-Center Study to Assess the Use of Synagis® in Preterm Infants Born 29-32 Weeks Gestation Less Than or Equal to 6 Months of Age without Chronic Lung Disease

Active substance: palivizumab

Study summary document link (including results):

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Document reference: 41609

Study title: A Phase I Pilot Safety and Phannacokinetics Study ofMEDI-493, a Respiratory Syncytial Virus (RSV) Humanized Monoclonal Antibody, Administered Intravenously in Bone Marrow or Stem Cell Transplant Recipients with RSV Infection

Active substance: palivizumab

Study summary document link (including results): palivizumab-mi-cp034.pdf

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Document reference: 48101

Study title: A Phase I Safety, Tolerance and Pharmacokinetics Study ofMEDI-493. a Respiratory Syncytial Virus Humanized Monoclonal Antibody, Administered Intravenously in Bone Marrow or Stem-Cell Transplant Recipient Patients

Active substance: palivizumab

Study summary document link (including results): palivizumab-mi-cp004.pdf

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Document reference: 48092

Study title: A Phase I Study of the Safety, Tolerance and Phannacokinetics of Reconstituted Lyophilized MEDI-493, a Humanized Monoclonal Antibody to Respiratory Syncytial Virus, Administered Intravenously at 15 mg/kg and 30 mg/kg in Children with a History of Prematurity or Bronchopulmonary Dysplasia

Active substance: palivizumab

Study summary document link (including results): palivizumab-mi-cp045.pdf

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Document reference: 48104

Study title: A Phase I/II study of the safety, tolerance and pharmacokinetics of MED 493 conducted in otherwise healthy hospitalised children with Respiratory Syncytial Virus Infection

Active substance: palivizumab

Study summary document link (including results): palivizumab-mi-cp009.pdf

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Document reference: 48094

Study title: A Phase I/II study of the safety, tolerance and pharmacokinetics of MED 493 conducted in otherwise healthy hospitalised children with Respiratory Syncytial Virus Infection

Active substance: palivizumab

Study summary document link (including results): palivizumab-mi-cp009.pdf

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Document reference: 48095

Study title: A Phase II Study ofthe Safety, Tolerance,Phannacokinetics,and Effect on Viral Load in Tracheal Aspirates of MEDI-493, a Humanized Monoclonal Antibody to Respiratory Syncytial Virus, in Children on Mechanical Ventilation for Respiratory Syncytial Virus Infection

Active substance: palivizumab

Study summary document link (including results): palivizumab-mi-cp026.pdf

View full study record

Document reference: 48100

Study title: A Phase II, Randomized, Double-Blind, Two-Period, Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palivizumab (MEDI-493, Synagis®), a Humanized Respiratory Syncytial Virus Monoclonal Antibody, in Children with a History of Prematurity

Active substance: palivizumab

Study summary document link (including results): palivizumab-mi-cp097.pdf

View full study record

Document reference: 48106

Study title: "Successful Treatment of Nocturnal Enuresis: A Practical Approach - Maizels M and Rosenbaum D. - Primary Care - 1985 (12(4): 621-635) - Publication in UK registration file - " "Successful Treatment of Nocturnal Enuresis: A Practical Approach - Maizels M and Rosenbaum D. - Primary Care - 1985 (12(4): 621-635) - Publication in UK registration file - "

Active substance: OXYBUTYNIN

Study summary document link (including results):

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Document reference: 32992

Study title: The effect of oxyphenonium bromide and oxybutynin hydrochloride on detrusor contractility and reflux in children with vesicoureteral reflux and detrusor instability. - Scholtmeijer RJ, Van Mastrigt R - J Urol - 1991; 146(2):660-662 The effect of oxyphenonium bromide and oxybutynin hydrochloride on detrusor contractility and reflux in children with vesicoureteral reflux and detrusor instability. - Scholtmeijer RJ, Van Mastrigt R - J Urol - 1991; 146(2):660-662

Active substance: OXYBUTYNIN

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Document reference: 32998

Study title: "Use of Oxybutynin Chloride (Ditropan) in Treatment of Enuresis - R. De Castro, E. Casolari, and S. Ricci - Riv Ital Ped - 1985 (11: 208-211) - Publication in UK registration file - " "Use of Oxybutynin Chloride (Ditropan) in Treatment of Enuresis - R. De Castro, E. Casolari, and S. Ricci - Riv Ital Ped - 1985 (11: 208-211) - Publication in UK registration file - "

Active substance: OXYBUTYNIN

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Document reference: 32993

Study title: A Multi-center, Inpatient, Open-Label, Dose-Ranging Study to Characterize the Pharmacokinetics and Safety of an Oral Liquid Formulation of Oxycodone in Patients from Birth to 4 Years of Age, Who Require Opioid Analgesia

Active substance: OXYCODONE

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Document reference: 45393

Study title: MF-OXY-010898 Oxycodone in post-operative pain

Active substance: OXYCODONE

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Document reference: 45396

Study title: Multi-center, double-blind, randomised, dose ranging study, in pediatric patients 5 to ≤ 16 years of age receiving morphine as standard supplementary pain medication to evaluate pharmacokinetics, efficacy and safety of oxy pediatric liquid (1 mg/ml) versus placebo in the treatment of acute moderate to severe pain. (USA & EU)

Active substance: OXYCODONE

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Document reference: 45394

Study title: Multiple dose, open-label, multicentric study for the conversion of immediate release Oxycodone (OxyIR) dose to controlled release Oxycodone (OxyContin) in order to assess the pharmacokinetics and characterize the efficacy and safety in pediatric patients from 6 to 16 years old. (USA & EU)

Active substance: OXYCODONE

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Document reference: 45395

Study title: OXN9002 safety and efficacy of Targin in patients with pain

Active substance: OXYCODONE

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Document reference: 45398

Study title: OXY4407 Pain controlling with Oxygesic

Active substance: OXYCODONE

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Document reference: 45397

Study title: Oxycodone in post-operative pain

Active substance: OXYCODONE

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Document reference: 45390

Study title: Pain controlling with Oxygesic

Active substance: OXYCODONE

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Document reference: 45391

Study title: safety and efficacy of Targin in patients with pain

Active substance: OXYCODONE

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Document reference: 45392

Study title: Askie LM, Henderson-Smart DJ, Lirwig L, Simpson JM. Oxygen-saturation targets and outcomes in extremely preterm infants. N Engl J Med 2003; 349:959-67Askie LM, Henderson-Smart DJ, Lirwig L, Simpson JM. Oxygen-saturation targets and outcomes in extremely preterm infants. N Engl J Med 2003; 349:959-67

Active substance: OXYGEN

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Document reference: 45399

Study title: Bakwin H. Oxygen therapy in premature babies with anoxemia. Am J Dis Child. 1923; 25:157–192.Bakwin H. Oxygen therapy in premature babies with anoxemia. Am J Dis Child. 1923; 25:157–192.

Active substance: OXYGEN

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Document reference: 45400

Study title: An evaluation of the efficacy and safety of C-14 elixir in pediatric patients with symptomatology requiring an analgesic and/or antipyretic. Jun 1981.An evaluation of the efficacy and safety of C-14 elixir in pediatric patients with symptomatology requiring an analgesic and/or antipyretic. Jun 1981.

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33615

Study title: Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33570

Study title: Fusi−G et al. A double blind clinical trial of the effectiveness and safety of an association of paracetamol−sobrerol vs paracetamol in pediatrics. {G−ITAL−RIC− CLIN−TER}, 1991, Vol/Iss/Pg. 12/1 (17−23)Fusi−G et al. A double blind clinical trial of the effectiveness and safety of an association of paracetamol−sobrerol vs paracetamol in pediatrics. {G−ITAL−RIC− CLIN−TER}, 1991, Vol/Iss/Pg. 12/1 (17−23)

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33568

Study title: Bartoszek M, Brenner AM, Szefler SJ. Prednisolone and methylprednisolone kinetics in children receiving anticonvulsant therapy. Clin Pharmacol Ther. 1987 Oct;42(4):424-32.Bartoszek M, Brenner AM, Szefler SJ. Prednisolone and methylprednisolone kinetics in children receiving anticonvulsant therapy. Clin Pharmacol Ther. 1987 Oct;42(4):424-32.

Active substance: PHENYLEPHRINE

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Document reference: 33931

Study title: Blennow G, Heijbel J, Sandstedt P, Tonnby B. Discontinuation of antiepileptic drugs in children who have outgrown epilepsy: effects on cognitive function. Epilepsia. 1990;31 Suppl 4:S50-3Blennow G, Heijbel J, Sandstedt P, Tonnby B. Discontinuation of antiepileptic drugs in children who have outgrown epilepsy: effects on cognitive function. Epilepsia. 1990;31 Suppl 4:S50-3

Active substance: PHENYLEPHRINE

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Document reference: 33930

Study title: Bowe JC, Cornish EJ,Dawson M. Evaluation of folic acid supplements in children taking phenytoin. Dev Med Child Neurol. 1971 Jun;13(3):343-54.Bowe JC, Cornish EJ,Dawson M. Evaluation of folic acid supplements in children taking phenytoin. Dev Med Child Neurol. 1971 Jun;13(3):343-54.

Active substance: PHENYLEPHRINE

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Document reference: 33940

Study title: Connell JT. Effectiveness of topical nasal decongestants. Ann Allergy 1969; 27(11):541-6 Connell JT. Effectiveness of topical nasal decongestants. Ann Allergy 1969; 27(11):541-6

Active substance: PHENYLEPHRINE

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Document reference: 45103

Study title: Conners CK, Kramer R, Rothschild GH, Schwartz L, Stone A. Treatment of young delinquent boys with diphenylhydantoin sodium and methyphenidate. A controlled comparison. Arch Gen Psychiatry. 1971 Feb;24(2):156- 60.Conners CK, Kramer R, Rothschild GH, Schwartz L, Stone A. Treatment of young delinquent boys with diphenylhydantoin sodium and methyphenidate. A controlled comparison. Arch Gen Psychiatry. 1971 Feb;24(2):156- 60.

Active substance: PHENYLEPHRINE

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Document reference: 33941

Study title: de Wolff FA, Peters AC, van Kempen GM. Serum concentrations and enzyme induction in epileptic children treated with phenytoin and valproate. Neuropediatrics. 1982 Feb;13(1):10-3.de Wolff FA, Peters AC, van Kempen GM. Serum concentrations and enzyme induction in epileptic children treated with phenytoin and valproate. Neuropediatrics. 1982 Feb;13(1):10-3.

Active substance: PHENYLEPHRINE

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Document reference: 33933

Study title: An Assessment of the Safety of Pediatric Ibuprofen ("Boston University Fever Study"). Dec 1993.An Assessment of the Safety of Pediatric Ibuprofen ("Boston University Fever Study"). Dec 1993.

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33594

Study title: A Phase IV Double-Blind Single Dose Study of the Relative Efficacy and Safety of Acetaminophen 650 mg, Acetaminophen 650 mg With Phenyltoloxamine Citrate 60 mg, Phenyltoloxamine Citrate 60 mg, and Placebo in the Treatment of Postoperative Pain Following Oral Surgery.

Active substance: PARACETAMOL PHENYLTOXOLAMINE

Study summary document link (including results): paracetamol 0-235.pdf

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Document reference: 47506

Study title: A Phase IV, Double-Blind, Placebo-Controlled, Multi-Center Study to Determine the Safety and Effectiveness of Zemplar in Decreasing Serum Intact Parathyroid Hormone Levels in Pediatric End Stage Renal Disease Subjects on Hemodialysis

Active substance: PARICALCITOL

Study summary document link (including results): Paricalcitol-2001022.pdf

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Document reference: 45819

Study title: A 16 Week Double-Blind, Placebo Controlled Study to Investigate the Efficacy and Tolerability of Paroxetine in the Treatment of Children and Adolescents with Social Anxiety Disorder/Social Phobia

Active substance: PAROXETINE

Study summary document link (including results): Paroxetine-29060-676-fullCSR.pdf

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Document reference: 48342

Study title: A 38-Week, Two Phase, Multicenter Study to Investigate the Safety and Effectiveness of Paroxetine (10-60 mg/day) in the Treatment of Children and Adolescent Outpatients with Obsessive-Compulsive Disorder

Active substance: PAROXETINE

Study summary document link (including results): Paroxetine-29060-453-fullCSR.pdf

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Document reference: 48341

Study title: A Double-blind, Multicentre Placebo Controlled Study of Paroxetine in Adolescents with Unipolar Major Depression

Active substance: PAROXETINE

Study summary document link (including results): Paroxetine-29060-377-fullCSR.pdf

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Document reference: 48339

Study title: A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression- Acute Phase

Active substance: PAROXETINE

Study summary document link (including results): Paroxetine-29060-329-acute-fullCSR.pdf

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Document reference: 48337

Study title: A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression–Continuation Phase

Active substance: PAROXETINE

Study summary document link (including results): Paroxetine-29060-329-continuation-fullCSR.pdf

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Document reference: 48338

Study title: A Multicenter Study to Assess the Pharmacokinetics of Paroxetine Following Repeat Dose Administration in Children and Adolescents with Obsessive- Compulsive Disorder (OCD) and/or Depression

Active substance: PAROXETINE

Study summary document link (including results): Paroxetine-29060-715-fullCSR.pdf

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Document reference: 48345

Study title: Open label safety evaluation of specific immunotherapy in subjects aged 5-17 years suffering from seasonal allergic rhinoconjunctivitis due to grass pollen not responding to pharmacotherapy

Active substance: PHLEUM PRATENSE

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Document reference: 34027

Study title: Open label safety evaluation of specific immunotherapy in subjects aged 5-17 years suffering from seasonal allergic rhinoconjunctivitis due to grass pollen not responding to pharmacotherapy

Active substance: Phleum pratense

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Document reference: 40125

Study title: Pollen immunotherapy reduces the development of asthma in children with seasonal rhinoconjunctivitis (the PAT-Study)

Active substance: PHLEUM PRATENSE

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Document reference: 34029

Study title: Pollen immunotherapy reduces the development of asthma in children with seasonal rhinoconjunctivitis (the PAT-Study)

Active substance: Phleum pratense

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Document reference: 40127

Study title: A Phase III/IV Multicenter Evaluation ofthe Immunogenicity ofPalivizumab (Synagis®) in Children who Previously Received Palivizumab (Synagis®) Prophylaxis and Children Receiving the Drug for the First Time

Active substance: palivizumab

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Document reference: 47445

Study title: A Phase IIII, Rising, Repeated Dose, Safety, Tolerance and Pharmacokinetics Study of MEDI-493, a Humanized Monoclonal Antibody to Respiratory Syncytial Virus, Conducted in Premature Infants and Infants with Bronchopulmonary Dysplasia

Active substance: palivizumab

Study summary document link (including results): palivizumab-mi-cp005.pdf

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Document reference: 48093

Study title: A Phase IJII Study of the Safety. Tolerance and Phannacokinetics ofMEDI-493. a Humanized Monoclonal Antibody to Respiratory Syncytial Virus. Conducted in Otherwise Healthy Children Hospitalized with Respiratory Syncytial Virus Infection

Active substance: palivizumab

Study summary document link (including results): palivizumab-mi-cp013.pdf

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Document reference: 48098

Study title: A Phase IV study of fie safety of Synagis (Palivizumabib) for Prophylaxis of Respiratory Syncytial Virus Disease in Children with Cystic Fibrosis

Active substance: palivizumab

Study summary document link (including results): palivizumab-mi-ma001.pdf

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Document reference: 48107

Study title: A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991.A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33326

Study title: A single-dose, randomized, investigator-blinded trial to compare the efficacy and safety of ibuprofen suspension 7.5 mg/kg with acetaminophen suspension 12.5 mg/kg for the treatment of febrile patients. Aug 1996.A single-dose, randomized, investigator-blinded trial to compare the efficacy and safety of ibuprofen suspension 7.5 mg/kg with acetaminophen suspension 12.5 mg/kg for the treatment of febrile patients. Aug 1996.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33323

Study title: A study of the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets compared to Children's Tylenol chewable tablets in the treatment of febrile children. Mar 1990.A study of the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets compared to Children's Tylenol chewable tablets in the treatment of febrile children. Mar 1990.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33337

Study title: An Assessment of the Safety of Pediatric Ibuprofen ("Boston University Fever Study"). Dec 1993.An Assessment of the Safety of Pediatric Ibuprofen ("Boston University Fever Study"). Dec 1993.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33320

Study title: An evaluation of the efficacy and safety of C-14 elixir in pediatric patients with symptomatology requiring an analgesic and/or antipyretic. Jun 1981.An evaluation of the efficacy and safety of C-14 elixir in pediatric patients with symptomatology requiring an analgesic and/or antipyretic. Jun 1981.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33341

Study title: Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33300

Study title: Diagnostik und Therapie der Sensibilierung gegen Derm. pter. und Derm. farinae bei Kindern.Allergologie 1988, 11, 12, S503 - 508

Active substance: HOUSE DUST

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Document reference: 29124

Study title: A single blind study to compare the efficacy and safety of intravenous Granisetron with Chlorpromazine combined with Dexamethasone for the prophylaxis of cytotoxic induced emesis in paediatric patients with malignant disease

Active substance: GRANISETRON

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Document reference: 29024

Study title: Advil liquigel Migraine headache study II

Active substance: IBUPROFEN

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Document reference: 29536

Study title: An open-label, multicentre, 8-12 week open-label study in children aged 1-11 years with erosive oesophagitis and / or intra-oesophageal pH<4 greater than 4.2% of the time.

Active substance: LANSOPRAZOLE

Study summary document link (including results): Lansoprazole_M97-808-Synopsis.pdf

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Document reference: 47611

Study title: Intravenous amnesia for total dentistry in one sitting.

Active substance: HYDROXYZINE

Study summary document link (including results): ADPE95A2513.pdf

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Document reference: 29336

Study title: Double-blind comparative clinical study of iopromide (SHL414A) versus amidotrizoate (Visotrast-370Ò) in angiocardiography in 50 newborns and infants

Active substance: IOPROMIDE

Study summary document link (including results): Bayer Pharma_Iopromide_86058_study_synopsis.pdf

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Document reference: 46901

Study title: A double blind, multiple dose study of the antipyretic activity and tolerability of ibuprofen and paracetamol in burns pyrexia in children.

Active substance: IBUPROFEN

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Document reference: 29457

Study title: Gurer YK, Kukner S, Sarica B. Pediatr Neurol. 1996 Jan;14(1):72-4. Intravenous g-globulin treatment in a patient with subacute sclerosing panencephalitis.Gurer YK, Kukner S, Sarica B. Pediatr Neurol. 1996 Jan;14(1):72-4. Intravenous g-globulin treatment in a patient with subacute sclerosing panencephalitis.

Active substance: INOSINE

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Document reference: 30116

Study title: An Open-Label Study of the Safety of an Ibuprofen-Pseudoephedrine HCl Suspension in Children. Sep 1999.An Open-Label Study of the Safety of an Ibuprofen-Pseudoephedrine HCl Suspension in Children. Sep 1999.

Active substance: IBUPROFEN AND PSEUDOEPHEDRINE

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Document reference: 46244

Study title: Post-operative therapeutic decision making in a new Japanese protocol (JPLT-2) for pediatric hepatic malignancies with pulmonary metastasis. ;Ohno-Y. Asian Journal of Surgery, 2001, Vol/Iss/Pg. 24/4 (341-346)Post-operative therapeutic decision making in a new Japanese protocol (JPLT-2) for pediatric hepatic malignancies with pulmonary metastasis. ;Ohno-Y. Asian Journal of Surgery, 2001, Vol/Iss/Pg. 24/4 (341-346)

Active substance: IODINE

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Document reference: 30305

Study title: Indomethacin prophylaxis for patent ductus arteriosus (PDA) in infants with a birth weight of less than 1250 grams.

Active substance: INDOMETHACIN

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Document reference: 29934

Study title: Report on ibuprofen in thetretament of juvenile rheumatoid arthritis - initial observation by Dr G Husby ( Norway )

Active substance: IBUPROFEN

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Document reference: 29442

Study title: The refief of primary dysmenorrhea by ketoprofen and indomethacin.

Active substance: INDOMETHACIN

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Document reference: 30034

Study title:

Active substance: Inactivated hepatitis A virus

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Document reference: 47326

Study title: To study the effect duration of two different doses of IFN-gamma in patients with chronic granulomatous disease (CGD) on functional responses of neutrophils (PMN).

Active substance: INTERFERON GAMMA (1B)

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Document reference: 30203

Study title: Clinical experimentation of calcium bucloxate (804 CB) in rheumatologya

Active substance: INDOMETHACIN

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Document reference: 29834

Study title: Hydroxyurea in the treatment of major beta thalassemia and importance of genetic screening2004

Active substance: HYDROXYUREA

Study summary document link (including results): 14722738.pdf

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Document reference: 48358

Study title: Elibol O., Alcelik T., Yüksel N., Caglar Y., Acta Ophthalmol Scand 1997, 75: 178-180; Rosales T., Isenberg S., Leake R., Everett S., J Ped Opht & Strab 1981; 18, 6: 42-44 Elibol O., Alcelik T., Yüksel N., Caglar Y., Acta Ophthalmol Scand 1997, 75: 178-180; Rosales T., Isenberg S., Leake R., Everett S., J Ped Opht & Strab 1981; 18, 6: 42-44

Active substance: PHENYLEPHRINE

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Document reference: 26156

Study title: Green M. Double-blind study of nasal decongestion with oxymetazoline and phenylephrine in asthmatic children with rhinitis. Rev Allergy 1966; 20(9):863-8 Green M. Double-blind study of nasal decongestion with oxymetazoline and phenylephrine in asthmatic children with rhinitis. Rev Allergy 1966; 20(9):863-8

Active substance: PHENYLEPHRINE

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Document reference: 45104

Study title: Loughnan PM, Greenwald A et al. Pharmacokinetic observations of phenytoin disposition in the newborn and young infant. Archives of Disease in Childhood, 1977, 52: 302-209Loughnan PM, Greenwald A et al. Pharmacokinetic observations of phenytoin disposition in the newborn and young infant. Archives of Disease in Childhood, 1977, 52: 302-209

Active substance: PHENYLEPHRINE

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Document reference: 33937

Study title: Shope JT. Intervention to improve compliance with pediatric anticonvulsant therapy. Patient Couns Health Educ. 1980 3d Quart;2(3):135-41.Shope JT. Intervention to improve compliance with pediatric anticonvulsant therapy. Patient Couns Health Educ. 1980 3d Quart;2(3):135-41.

Active substance: PHENYLEPHRINE

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Document reference: 33936

Study title: "Pediatric use of a whole-bone preparation", D'Oelsnitz M. & Embriaco J.P., Gazette Medicale de France, 1966, 73 : 603-605"Pediatric use of a whole-bone preparation", D'Oelsnitz M. & Embriaco J.P., Gazette Medicale de France, 1966, 73 : 603-605

Active substance: OSSEIN HYDROXYAPATITE COMPOUND

Study summary document link (including results): Ossopan nr2..xls

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Document reference: 47715

Study title: "Symmetrical Transformation zones in infant rickets (Milkman syndrome?)", Kosenow W., Zeitschrift fur kinderheilkunde, 1951, 69 : 191-206"Symmetrical Transformation zones in infant rickets (Milkman syndrome?)", Kosenow W., Zeitschrift fur kinderheilkunde, 1951, 69 : 191-206

Active substance: OSSEIN HYDROXYAPATITE COMPOUND

Study summary document link (including results): Ossopan nr8.xls

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Document reference: 47721

Study title: "The influence of a whole-bone preparation on the growth of dystrophic children", Gotti D. & Nicolaj P., La clinica Pediatrica, 1951, N°5, 33 "The influence of a whole-bone preparation on the growth of dystrophic children", Gotti D. & Nicolaj P., La clinica Pediatrica, 1951, N°5, 33

Active substance: OSSEIN HYDROXYAPATITE COMPOUND

Study summary document link (including results): Ossopan nr7.xls

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Document reference: 47720

Study title: "The use of powdered raw bone of young animals in children", Cornet-Jacquemoud C., Moderne Probleme der Pediatrie, 1954, 1 : 245-251"The use of powdered raw bone of young animals in children", Cornet-Jacquemoud C., Moderne Probleme der Pediatrie, 1954, 1 : 245-251

Active substance: OSSEIN HYDROXYAPATITE COMPOUND

Study summary document link (including results): Ossopan nr6.xls

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Document reference: 47719

Study title: "The value of whole-bone preparations in pediatrics", Dupuis C., Mouvement thérapeutique, 1966, 11(4):137-139"The value of whole-bone preparations in pediatrics", Dupuis C., Mouvement thérapeutique, 1966, 11(4):137-139

Active substance: OSSEIN HYDROXYAPATITE COMPOUND

Study summary document link (including results): Ossopan nr3..xls

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Document reference: 47716

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Osteoheel S (tablets) [AWB-AT]

Active substance: Osteoheel

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Document reference: 40090

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Ovarium compositum (ampoules) [AWB-AT]

Active substance: Ovarium compositum

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Document reference: 40091

Study title: Specific immunotherapy has long-term preventive effect of seasonal and perennial asthma: 10-year follow-up on the PAT study

Active substance: PHLEUM PRATENSE

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Document reference: 34031

Study title: Specific immunotherapy has long-term preventive effect of seasonal and perennial asthma: 10-year follow-up on the PAT study

Active substance: Phleum pratense

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Document reference: 40129

Study title: Efficacy and safety of phloroglucinol versus hyoscine-n-butylbromide for the treatment of dysmenorrheic pain. a clinical trial. Deligeoroglou E. et col. XI worl congress paediatric & adolescent gynaecology 1995. book of abstract Efficacy and safety of phloroglucinol versus hyoscine-n-butylbromide for the treatment of dysmenorrheic pain. a clinical trial. Deligeoroglou E. et col. XI worl congress paediatric & adolescent gynaecology 1995. book of abstract

Active substance: PHLOROGLUCINOL

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Document reference: 34032

Study title: Clinical evaluation in pediatrics

Active substance: PHOLCODINE

Study summary document link (including results): Pholcodine_STUDY_640.6.002_Lafargues.xls

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Document reference: 34033

Study title: Clinical evaluation in pediatrics.

Active substance: PHOLCODINE

Study summary document link (including results): Pholcodine_STUDY__640.6.005_Polonovski.xls

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Document reference: 34035

Study title: Agnese L, Tarello M, Grazioli I. Efficacy of creatine phosphate in treating hypotonotrophy due to non-use of skeletal muscle. Ortop Traumatol Oggi 1992; 12(4):107-113

Active substance: PHOSPHOCREATINE

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Document reference: 34039

Study title: Dal Monte A, Leonardi LM, Figura F, Cappozzo A, Marchetti M, De Santis AM. Effects of phosphocreatine administration on muscle strength in man. Gazz. Med. Ital. 1976; 135 (9): 439-448

Active substance: PHOSPHOCREATINE

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Document reference: 34037

Study title: Radu H, Keresztes L, Stenzel K. Effects of administration of phosphocreatine on the clinical, biochemical and electromyographic evolution of Duchenne's progressive muscular dystrophy. Minerva Med. 1968; 59 (99): 5524-29

Active substance: PHOSPHOCREATINE

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Document reference: 34038

Study title: Simonazzi-P, Tedeschi-C, Lombardi-F, Camurri-G-B. Valutazione isocinetica dell'efficacia della creatina fosfato nel trattamento dell'ipotrofia muscolare da non uso. Il ruolo di farmaci nella medicina riabilitativa 1992; Vol. 2: 262-265

Active substance: PHOSPHOCREATINE

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Document reference: 34036

Study title: The clinical efficacy of oxybutynin - Malone-Lee J - Rev. Contemp. Pharmacother. - 1994; 5:195-202The clinical efficacy of oxybutynin - Malone-Lee J - Rev. Contemp. Pharmacother. - 1994; 5:195-202

Active substance: OXITRIPTAN

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Document reference: 32925

Study title: The effect of oxyphenonium bromide and oxybutynin hydrochloride on detrusor contractility and reflux in children with vesicoureteral reflux and detrusor instability. - Scholtmeijer RJ, Van Mastrigt R - J Urol - 1991; 146(2):660-662The effect of oxyphenonium bromide and oxybutynin hydrochloride on detrusor contractility and reflux in children with vesicoureteral reflux and detrusor instability. - Scholtmeijer RJ, Van Mastrigt R - J Urol - 1991; 146(2):660-662

Active substance: OXITRIPTAN

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Document reference: 32926

Study title: The role of Oxybutynin Chloride as adjuctive therapy for Intermittent Catheterization in children with neurogenic bladder: results on continence - De Castro R., Casolari E, Ricci S. - Ped. Med. Chir. (Med. Surg. Ped.) - 1984 (6: 795-804) - Publication in UK registration file - The role of Oxybutynin Chloride as adjuctive therapy for Intermittent Catheterization in children with neurogenic bladder: results on continence - De Castro R., Casolari E, Ricci S. - Ped. Med. Chir. (Med. Surg. Ped.) - 1984 (6: 795-804) - Publication in UK registration file -

Active substance: OXITRIPTAN

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Document reference: 32917

Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992.A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992.

Active substance: PARACETAMOL AND DIPHENHYDRAMINE

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Document reference: 33430

Study title: A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991.A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991.

Active substance: PARACETAMOL AND DIPHENHYDRAMINE

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Document reference: 33439

Study title: Bernath−V−F et al. Tepid sponging and paracetamol for reduction of body temperature in febrile children. {MED−J−AUST}, 04 FEB 2002, Vol/Iss/Pg. 176/3 (130)Bernath−V−F et al. Tepid sponging and paracetamol for reduction of body temperature in febrile children. {MED−J−AUST}, 04 FEB 2002, Vol/Iss/Pg. 176/3 (130)

Active substance: PARACETAMOL AND DIPHENHYDRAMINE

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Document reference: 33386

Study title: Phase IV study to evaluate the safety and efficacy of Phenobarbitone in children

Active substance: PHENOBARBITAL

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Document reference: 45871

Study title: Antibiotherapie prophylactique de l'enfant - Herrault A. - 1966 (Ann. Pédiatr., 13 (5) 368 - 371)Antibiotherapie prophylactique de l'enfant - Herrault A. - 1966 (Ann. Pédiatr., 13 (5) 368 - 371)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45873

Study title: Comment je traite un R.A.A. de l'enfant - 1973 (Gaz. Méd., 80, (3), 345 - 352)Comment je traite un R.A.A. de l'enfant - 1973 (Gaz. Méd., 80, (3), 345 - 352)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45874

Study title: En présence des angines de l'enfant - Carrier A. - 1976 (Méd. Gén. 2 (4) 33-36)En présence des angines de l'enfant - Carrier A. - 1976 (Méd. Gén. 2 (4) 33-36)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45875

Study title: Essai clinique en pédiatrie d'une forme sirop de pénicilline: l'Oracilline sirop - Verger P. & Guillard J. M. - 1967 (J. Méd. Bordeaux, (12) 1903 - 1908)Essai clinique en pédiatrie d'une forme sirop de pénicilline: l'Oracilline sirop - Verger P. & Guillard J. M. - 1967 (J. Méd. Bordeaux, (12) 1903 - 1908)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45876

Study title: Evaluer l'acceptabilité et la tolérance clinique de la nouvelle formule d'Oracilline suspension buvable, dosée à 250.000 Unités par cuillère-doseuse de 5 ml, auprès d'une population de nourrissons et de jeunes enfants - Pr Y. Castel, Dr Y. Fryda - 1985 à 1986 (résumé du compte-rendu d'essai clinique)Evaluer l'acceptabilité et la tolérance clinique de la nouvelle formule d'Oracilline suspension buvable, dosée à 250.000 Unités par cuillère-doseuse de 5 ml, auprès d'une population de nourrissons et de jeunes enfants - Pr Y. Castel, Dr Y. Fryda - 1985 à 1986 (résumé du compte-rendu d'essai clinique)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45877

Study title: Evaluer l'acceptabilité et la tolérance clinique de la nouvelle formule d'Oracilline suspension buvable, dosée à 250.000 Unités par cuillère-doseuse de 5 ml, auprès d'une population de nourrissons et de jeunes enfants - Pr Y. Castel, Dr Y. Fryda - 1985 à 1986 (résumé du compte-rendu d'essai clinique)Evaluer l'acceptabilité et la tolérance clinique de la nouvelle formule d'Oracilline suspension buvable, dosée à 250.000 Unités par cuillère-doseuse de 5 ml, auprès d'une population de nourrissons et de jeunes enfants - Pr Y. Castel, Dr Y. Fryda - 1985 à 1986 (résumé du compte-rendu d'essai clinique)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45889

Study title: [A multicenter randomized study of fusidic acid ophthalmic gel and rifamycine eyedrops in acute conjunctivitis]. [Article in French]. Adenis J P, Arrata M, Gastaud P, Limon S, Massin M. J. Fr Ophtalmol 1989; 12(4): 317-322

Active substance: FUSIDIC ACID

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Document reference: 48449

Study title: A multicentre, randomised, investigator-blind, parallel group study to compare efficacy and safety of Fucithalmic® with chloramphenicol.

Active substance: FUSIDIC ACID

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Document reference: 48445

Study title: A multicentre, randomised, investigator-blind, parallel group study to compare efficacy and safety of Fucithalmic® with chloramphenicol.

Active substance: FUSIDIC ACID

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Document reference: 48446

Study title: A multicentre, randomised, investigator-blind, parallel group study to compare Efficacy and safety of Fucithalmic® with norfloxacin 0.3%

Active substance: FUSIDIC ACID

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Document reference: 48447

Study title: A multicentre, randomised, investigator-blind, parallel group study to compare efficacy and safety of Fucithalmic® with rifamycin 1%Arrata et al

Active substance: FUSIDIC ACID

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Document reference: 48453

Study title: A multicentre, randomised, open, parallel group study to compare clinical and bacteriological effect as well as safety and acceptability of Fucithalmic® with Minims® eye drops in neonates with a clinical diagnosis of acute conjonctivitis.

Active substance: FUSIDIC ACID

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Document reference: 48442

Study title: A multicentre,randomised, controlled, parallel group study to compare efficacy and safety of Fucithalmic® with ofloxacin 0.3%.

Active substance: FUSIDIC ACID

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Document reference: 48444

Study title: A multicentre,randomised, open-label, parallel group study to compare efficacy and safety of Fucithalmic® with tobramycin 0.3%.

Active substance: FUSIDIC ACID

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Document reference: 48443

Study title: A single centre, randomised, single-blind, parallel group study to compare efficacy and safety of Fucithalmic® compared with chloramphenicol

Active substance: FUSIDIC ACID

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Document reference: 48448

Study title: An open label study to compare efficacy and safety of Fucithalmic® with chloramphenicol.

Active substance: FUSIDIC ACID

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Document reference: 48455

Study title: An open label study to compare efficacy and safety of Fucithalmic® with Fucidin® eye drop.J. Hvidberg

Active substance: FUSIDIC ACID

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Document reference: 48451

Study title: An open label, randomised study to compare efficacy and safety of Fucithalmic® with neosporin.Yacinto U Dy, Llacco, Int. J. of clinical practices, Vol 7., No. 3., 1991

Active substance: FUSIDIC ACID

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Document reference: 48450

Study title: An open randomised study to compare efficacy and safety of Fucithalmic® with chloramphenicolPetounis AD. 4th Mediterranean congress of chemotherapy 1984

Active substance: FUSIDIC ACID

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Document reference: 48458

Study title: An open randomised study to compare efficacy and safety of Fucithalmic® with neosporin.Yacinto U Dy, Llacco Int. J. of clinical practices, Vol 7., No. 3., 1991 82 pts (4-75)

Active substance: FUSIDIC ACID

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Document reference: 48461

Study title: Effects of fusidic acid on staphylococcal keratitis. Tabbara. British jounal Ophthalmology, Vol 73, issue 2 1989

Active substance: FUSIDIC ACID

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Document reference: 48462

Study title: Efficacy and safety of Fucithalmic® compared with chloramphenicolHørven I

Active substance: FUSIDIC ACID

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Document reference: 48460

Study title: Efficacy and tolerability of Fucidin® eye dropThanpaichitra

Active substance: FUSIDIC ACID

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Document reference: 48454

Study title: Efficacy and tolerability of Fucithalmic®P. M. Møller

Active substance: FUSIDIC ACID

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Document reference: 48452

Study title: Gentamicin in paediatrics - McAllister TA. - 1974 (Postgraduate Med. J., 50, Suppl 7: 45-52) - Publication in Gentamicin Registration Dossier - 1978 -

Active substance: GENTAMYCIN

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Document reference: 28912

Study title: Double-blind, randomized, multi-centre, crossover, placebo-controlled pilot study OXC is indicated for use in treatment of partial seizures in adults and pediatric patients ≥6 years of age. This is a pilot study to assess its efficacy in outpatient children and adoloscents with behavioural disorders

Active substance: OXACARBAZEPINE

Study summary document link (including results): oxacarbazepine-TRI476BES04 Art45 Listing 2011.xls

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Document reference: 45121

Study title: A pharmacokinetic study of oxatomide in paediatrics patients

Active substance: OXATOMIDE

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Document reference: 45384

Study title: Cetirizine vs oxatomide in the treatment of children suffering from seasonal allergic rhinitis.

Active substance: OXATOMIDE

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Document reference: 45381

Study title: Comparison of cetirizine and oxatomide in preschool children with perennial allergic rhinitis. A multicenter study.

Active substance: OXATOMIDE

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Document reference: 45380

Study title: Double-blind multicenter study on the efficacy and tolerability of cetirizine compared with oxatomide in chronic idiopathic urticaria in preschool children

Active substance: OXATOMIDE

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Document reference: 45382

Study title: Double-blind placebo-controlled study of oxatomide in the treatment of childhood asthma.

Active substance: OXATOMIDE

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Document reference: 45385

Study title: Drug surveillance on oxatomide in the treatment of various allergic disorders in specialist center (in Italian)

Active substance: OXATOMIDE

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Document reference: 45383

Study title: Efficacy and safety of cetirizine and oxatomide in young children with perennial allergic rhinitis : a 10-day, multicenter, double-blinded, randomised, parallel-group study.

Active substance: OXATOMIDE

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Document reference: 45379

Study title: Oggiano N, Nicora M L'oxatomide nell'asma bronchiale. Rassegna dei principali dati farmacologici e clinici.

Active substance: OXATOMIDE

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Document reference: 45377

Study title: 8.) An open pilot clinical trial Woben- zym for imporvement of treatment results in resistant and complicated case of pulmonary tuberculo- sis

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40100

Study title: 9.) Clinical efficacy of orally applied enzyme medicine Wobenzym in pa- tients with first time diagnosed diabetes mellitus

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40101

Study title: Efficacy and Safety of Woben- zym as Antidema- tous Therapy in Dentosurgical Operations

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40096

Study title: Efficacy and Safety of Woben- zym as Antidema- tous Therapy in Meniscectomies

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40097

Study title: Efficacy and Safety of Woben- zym/Wobenzym N in the post trau- matic treatment after sport injuries and surgery

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40099

Study title: Efficacy and Safety of Woben- zym/Wobenzym N in Patients with inflammatory diseases of the respiratory tract and Sinusitis

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40098

Study title: Influence of therapy by Woben-zym on immune and metabolic parametrs at children with chronic hepatitis B

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40112

Study title: Oral Enzyme Therapy of Re- current Respiratory Infections in Children

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40093

Study title: The role of Oxybutynin Chloride as adjuctive therapy for Intermittent Catheterization in children with neurogenic bladder: results on continence - De Castro R., Casolari E, Ricci S. - Ped. Med. Chir. (Med. Surg. Ped.) - 1984 (6: 795-804) - Publication in UK registration file - The role of Oxybutynin Chloride as adjuctive therapy for Intermittent Catheterization in children with neurogenic bladder: results on continence - De Castro R., Casolari E, Ricci S. - Ped. Med. Chir. (Med. Surg. Ped.) - 1984 (6: 795-804) - Publication in UK registration file -

Active substance: OXITRIPTAN

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Document reference: 32928

Study title: The role of Oxybutynin Chloride as adjuctive therapy for Intermittent Catheterization in children with neurogenic bladder: results on continence - De Castro R., Casolari E, Ricci S. - Ped. Med. Chir. (Med. Surg. Ped.) - 1984 (6: 795-804) - Publication in UK registration file - The role of Oxybutynin Chloride as adjuctive therapy for Intermittent Catheterization in children with neurogenic bladder: results on continence - De Castro R., Casolari E, Ricci S. - Ped. Med. Chir. (Med. Surg. Ped.) - 1984 (6: 795-804) - Publication in UK registration file -

Active substance: OXITRIPTAN

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Document reference: 32930

Study title: The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000; 105;295-310The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000; 105;295-310

Active substance: OXITRIPTAN

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Document reference: 32949

Study title: The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000;105;295-310The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000;105;295-310

Active substance: OXITRIPTAN

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Document reference: 32955

Study title: The Uninhibited Bladder in Children : Effect of Treatment on Recurrence of Urinary Infection and on Vesicoureteral Reflux Resolution - Koff A S and Murtagh D S. - J of Urology - 1983 ; (130: 1138-1141) - Publication in UK registration file - The Uninhibited Bladder in Children : Effect of Treatment on Recurrence of Urinary Infection and on Vesicoureteral Reflux Resolution - Koff A S and Murtagh D S. - J of Urology - 1983 ; (130: 1138-1141) - Publication in UK registration file -

Active substance: OXITRIPTAN

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Document reference: 32918

Study title: Interim statistical analysis of the study of the bioavailability and antipyretic effectiveness of acetaminophen in children.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol 102.pdf

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Document reference: 47515

Study title: K.L.I.P.S. (ketoprofen lysine salt: an Italian pediatric study). Multicentre, randomised, double-blind clinical study aimed at assessing antiphlogistic, antipyretic and pain-killing efficacy of ketoprofen lysine salt suppositories in children suffering...

Active substance: PARACETAMOL

Study summary document link (including results): Paracetamol_U97-0250_synopsis.pdf

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Document reference: 45775

Study title: Leary−P−M et al. Antipyretic effect of oral v. rectal paracetamol. {S−Afr−Med−J}, Dec 1997, vol. 87, no. 12, p. 1708Leary−P−M et al. Antipyretic effect of oral v. rectal paracetamol. {S−Afr−Med−J}, Dec 1997, vol. 87, no. 12, p. 1708

Active substance: PARACETAMOL

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Document reference: 33354

Study title: Meremikwu−M, Oyo−Ita−A. Paracetamol for treating fever in children. {Cochrane−Database− Syst−Rev}, 2002, no. 2, p.CD003676Meremikwu−M, Oyo−Ita−A. Paracetamol for treating fever in children. {Cochrane−Database− Syst−Rev}, 2002, no. 2, p.CD003676

Active substance: PARACETAMOL

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Document reference: 45729

Study title: L'angine aiguë de l'enfant. Son traitement curatif et préventif. Boissiere H. - 1976 (Concours méd., 98 (46) 7437 - 7441)L'angine aiguë de l'enfant. Son traitement curatif et préventif. Boissiere H. - 1976 (Concours méd., 98 (46) 7437 - 7441)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45879

Study title: L'antibiotherapie dans le rhumatisme de l'enfant. 4ème Conférence internationale des maladies rhumatismales - Mozziconacci P. & Gautier M. - 1964 (Les Thérapeutiques médicales des affections rhumatismales. Grenoble, Edit. Imprimerie générale pp. 157 - 176)L'antibiotherapie dans le rhumatisme de l'enfant. 4ème Conférence internationale des maladies rhumatismales - Mozziconacci P. & Gautier M. - 1964 (Les Thérapeutiques médicales des affections rhumatismales. Grenoble, Edit. Imprimerie générale pp. 157 - 176)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45880

Study title: A comparison of oral ondansetron syrup or intravenous ondansetron loading dose regimens given in combination with dexamethasone for the prevention of nausea and emesis in pediatric and adolescent patients receiving moderately/highly emetogenic chemotherapy. White L, Daly SA, McKenna CJ, Zhestkova N, Leal C, Breatnach F, Smelhaus V, Hung IJ, Kowalczyk J, Ninane J, Mitchell T, Haigh C. Pediatr Hematol Oncol. 2000 Sep; 17(6):445-55.A comparison of oral ondansetron syrup or intravenous ondansetron loading dose regimens given in combination with dexamethasone for the prevention of nausea and emesis in pediatric and adolescent patients receiving moderately/highly emetogenic chemotherapy. White L, Daly SA, McKenna CJ, Zhestkova N, Leal C, Breatnach F, Smelhaus V, Hung IJ, Kowalczyk J, Ninane J...

Active substance: ONDASETRON

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Document reference: 32804

Study title: Assessment of chemotherapy-induced emesis and evaluation of a reduced-dose intravenous ondansetron regimen in pediatric outpatients with leukemia.Holdsworth MT, Raisch DW, Duncan MH, Chavez CM, Leasure MM.Ann Pharmacother. 1995 Jan; 29(1):16-21. Assessment of chemotherapy-induced emesis and evaluation of a reduced-dose intravenous ondansetron regimen in pediatric outpatients with leukemia.Holdsworth MT, Raisch DW, Duncan MH, Chavez CM, Leasure MM.Ann Pharmacother. 1995 Jan; 29(1):16-21.

Active substance: ONDASETRON

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Document reference: 32807

Study title: Bolton, C.M., et al., Randomized, double-blind study comparing the efficacy of moderate-dose metoclopramide and ondansetron for the prophylactic control of postoperative vomiting in children after tonsillectomy. Br J Anaesth, 2007. 99(5): p. 699-703.Bolton, C.M., et al., Randomized, double-blind study comparing the efficacy of moderate-dose metoclopramide and ondansetron for the prophylactic control of postoperative vomiting in children after tonsillectomy. Br J Anaesth, 2007. 99(5): p. 699-703.

Active substance: ONDASETRON

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Document reference: 32805

Study title: Ondansetron: a review of its use as an antiemetic in children.Culy CR, Bhana N, Plosker GL Paediatr Drugs. 2001; 3(6):441-79Ondansetron: a review of its use as an antiemetic in children.Culy CR, Bhana N, Plosker GL Paediatr Drugs. 2001; 3(6):441-79

Active substance: ONDASETRON

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Document reference: 32806

Study title: Safety of ondansetron loading doses in children with cancer.Hasler SB, Hirt A, Ridolfi Luethy A, Leibundgut KK, Ammann RA.Support Care Cancer. 2007 Oct 17Safety of ondansetron loading doses in children with cancer.Hasler SB, Hirt A, Ridolfi Luethy A, Leibundgut KK, Ammann RA.Support Care Cancer. 2007 Oct 17

Active substance: ONDASETRON

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Document reference: 32808

Study title: Fucithalmic in acute conjunctivitis. Open, randomized comparison of fusidic acid, chloramphenicol and framycetin eye drops.Dirdal M. Acta Ophthalmol 1987; 65: 129-133.

Active substance: FUSIDIC ACID

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Document reference: 48456

Study title: Fusidic acid in infections of the external eye.Bijsterveld O.P. van 1987, Infection, 15: 16-19

Active substance: FUSIDIC ACID

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Document reference: 48457

Study title: The document describes a West German trial. 337 patients . 90 patients were under the age of 10, 63 patients aged 11-20.

Active substance: FUSIDIC ACID

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Document reference: 28676

Study title: Kudukis TM, Manthous CA, Schmidt GA, Hall JB, Wylam ME. Inhaled helium-oxygen revisited: Effect of inhaled helium-oxygen during the treatment of status asthmaticus in children. J Pediatrics 1997;130:217-224.Kudukis TM, Manthous CA, Schmidt GA, Hall JB, Wylam ME. Inhaled helium-oxygen revisited: Effect of inhaled helium-oxygen during the treatment of status asthmaticus in children. J Pediatrics 1997;130:217-224.

Active substance: HELIUM AND OXYGEN

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Document reference: 29088

Study title: Open clinical study in MRI of intracranial and spinal tumors and other lesion of the CNSAJR Am J Roentgenol. 1998 Feb;170(2):478-80. Non-breath-hold gadolinium-enhanced MR angiography of the thoracoabdominal aorta: experience in 18 children. Lam WW, Chan JH, Hui Y, Chan F.

Active substance: GADODIAMIDE

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Document reference: 28811

Study title: The bronchodilator efficacy of Berotec tablets as measured after single doses (day 1) by comparison with the standard therapeutic agent (ephedrine) with particular emphasis on onset of action and duration of action. 2. The persistence of bronchodila...

Active substance: IPRATROPIUM

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Document reference: 30546

Study title: Non-interventional study on the use of Kanamycin-POS® in children; Küchle H. J., Busse H., Augenerkrankungen im Kindesalter, Thieme Verlag Stuttgart New York 1985Non-interventional study on the use of Kanamycin-POS® in children; Küchle H. J., Busse H., Augenerkrankungen im Kindesalter, Thieme Verlag Stuttgart New York 1985

Active substance: KETOPROFEN AND SUCRALFATE

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Document reference: 30892

Study title: Levron JC, Chwetzoff E, Stephan P, Gluckman DR. Etude des concentrations plasmatiques de L'itraconazole en traitement prophylactique des greffes de moelle, pendant 5 semaines.Rapport de recherche clinique, May 1986. (12-42 years, LMD51161)Levron JC, Chwetzoff E, Stephan P, Gluckman DR. Etude des concentrations plasmatiques de L'itraconazole en traitement prophylactique des greffes de moelle, pendant 5 semaines.Rapport de recherche clinique, May 1986. (12-42 years, LMD51161)

Active substance: ITRACONAZOLE

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Document reference: 30810

Study title: Clinical and spirometric evaluation of ipratropium bromide and salbutamol in children with bronchitis and preceding asthma.

Active substance: IPRATROPIUM

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Document reference: 30548

Study title: Intensive Care Med. 2004 Mar;30(3):461-7. Epub 2003 Dec 12. Evidence of myocardial ischaemia in severe scorpion envenomation. Myocardial perfusion scintigraphy study. Bahloul M, Ben Hamida C, Chtourou K, Ksibi H, Dammak H, Kallel H, Chaari A, Chelly H, Intensive Care Med. 2004 Mar;30(3):461-7. Epub 2003 Dec 12. Evidence of myocardial ischaemia in severe scorpion envenomation. Myocardial perfusion scintigraphy study. Bahloul M, Ben Hamida C, Chtourou K, Ksibi H, Dammak H, Kallel H, Chaari A, Chelly H,

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44586

Study title: J Am Acad Dermatol. 1981 Dec;5(6):670-2. A new noninvasive evaluation of muscular lesions in dermatomyositis: thallium 201 muscle scans. Guillet GY, Guillet JA, Blanquet P, Maleville J. J Am Acad Dermatol. 1981 Dec;5(6):670-2. A new noninvasive evaluation of muscular lesions in dermatomyositis: thallium 201 muscle scans. Guillet GY, Guillet JA, Blanquet P, Maleville J.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44587

Study title: Wobenzym in the Treatment of Patients with Juvenile chronic Arthritis

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40094

Study title: Clinical outcomes of treatment with oral pantoprazole in patients aged 5 to 11 years with symptomatic GERD ; safety and tolerability. Out patient,randomized, double-blind, parallel-group.

Active substance: PANTOPRAZOLE

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Document reference: 45720

Study title: Efficacy and tolerabilty in items of pHmetry of pantoprazole 20 mg (0,5-1,0 mg/kg/day) in pediatrics patients aged 6 to 16 years.

Active substance: PANTOPRAZOLE

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Document reference: 45721

Study title: Pharmacokinetics of a sigle oral dose of pantoprazole 20 mg or 40 mg in pediatric patients aged 5 to 16 years ; safety an tolarability. Open label, randomized, age-stratified, parallel-group study.

Active substance: PANTOPRAZOLE

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Document reference: 45722

Study title: PK of a single dose of intravenous pantoprazole in pediatric patients aged 2 to 16 years ; PD; safety and tolerability. Open label, randomized, age-stratified, parallel-groupe study.

Active substance: PANTOPRAZOLE

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Document reference: 45723

Study title: PK of pantoprazole in pediatrics patients at least 1 year but less than 2 yers of age ; safety and tolerabilty. Open-label, randomized, inpatient study.

Active substance: PANTOPRAZOLE

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Document reference: 45724

Study title: Safety and tolerabilty or oral pantoprazole in subjects aged 12 to 16 years with symptomatic GERD ; efficacy (treatment outcome). Outpatient, randomized; double-blind, parallel-treatment group study.

Active substance: PANTOPRAZOLE

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Document reference: 45725

Study title: A Blinded, Single-Dose, Parallel Study Comparing the Anitpyretic Efficacy and Safety of Ibuprofen Pediatric Suspension and Acetaminophen Suspension in Children with Fever

Active substance: PARACETAMOL

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Document reference: 45783

Study title: Kapoor−S−K et al. Comparison of antipyretic effect of nimesulide and paracetamol in children attending a secondary level hospital. {INDIAN−PEDIATR}, 2002, Vol/Iss/Pg. 39/5 (473−477)Kapoor−S−K et al. Comparison of antipyretic effect of nimesulide and paracetamol in children attending a secondary level hospital. {INDIAN−PEDIATR}, 2002, Vol/Iss/Pg. 39/5 (473−477)

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33546

Study title: Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369)Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369)

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33555

Study title: The use of an antihistamine-decongestant in conjunction with an anti-infective drug in the treatment of acute otitis media. Moran DM, Mutchie KD, Higbee MD, Paul LD. J Pediatr. 1982 Jul;101(1):132-6.The use of an antihistamine-decongestant in conjunction with an anti-infective drug in the treatment of acute otitis media. Moran DM, Mutchie KD, Higbee MD, Paul LD. J Pediatr. 1982 Jul;101(1):132-6.

Active substance: PARACETAMOL AND PHENYLPROPANOLAMINE AND PHENYLTOLOXAMINE

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Document reference: 33616

Study title:

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33645

Study title:

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33647

Study title:

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33649

Study title:

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33650

Study title: Prophylactic Treatment with Wobenzym after Sport Injuries in Karate Fighters

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40095

Study title: Nabulsi−M et al. Equal antipyretic effectiveness of oral and rectal acetaminophen: A randomized controlled trial (ISRCTNI 1886401). {BMC−PEDIATR}, 06 SEP 2005, Vol/Iss/Pg. 5/− (7p)Nabulsi−M et al. Equal antipyretic effectiveness of oral and rectal acetaminophen: A randomized controlled trial (ISRCTNI 1886401). {BMC−PEDIATR}, 06 SEP 2005, Vol/Iss/Pg. 5/− (7p)

Active substance: PARACETAMOL

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Document reference: 45730

Study title: Nabulsi−Mona et al. Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial (ISRCTN11886401). {BMC−Pediatr}, 2005 (epub), vol. 5, p. 35Nabulsi−Mona et al. Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial (ISRCTN11886401). {BMC−Pediatr}, 2005 (epub), vol. 5, p. 35

Active substance: PARACETAMOL

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Document reference: 45731

Study title: Non-comparative, open-label, multicentre study of the acceptability and tolerability of 4.8% paediatric paracetamol oral suspension

Active substance: PARACETAMOL

Study summary document link (including results): PARACL00859.pdf

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Document reference: 47081

Study title: Nwanyanwu−O−C et al. Paracetamol and ibuprofen for treatment of fever in Malawian children aged less than five years. {TRANS−R−SOC−TROP−MED−HYG}, 1999, Vol/Iss/Pg. 93/1 (84)Nwanyanwu−O−C et al. Paracetamol and ibuprofen for treatment of fever in Malawian children aged less than five years. {TRANS−R−SOC−TROP−MED−HYG}, 1999, Vol/Iss/Pg. 93/1 (84)

Active substance: PARACETAMOL

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Document reference: 45733

Study title: Obata H et al Clinical outcome of patients with Ewing sarcoma family of tumors of bone in Japan: the Japanese Musculoskeletal Oncology Group cooperative study Cancer. 2007 Feb 15;109(4):767-75Obata H et al Clinical outcome of patients with Ewing sarcoma family of tumors of bone in Japan: the Japanese Musculoskeletal Oncology Group cooperative study Cancer. 2007 Feb 15;109(4):767-75

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 25043

Study title: Paracetamol and ibuprofen for treatment of fever in Malawian children aged less than five years. {TRANS R SOC TROP MED HYG}, 1999, Vol/Iss/Pg. 93/1 (84)Paracetamol and ibuprofen for treatment of fever in Malawian children aged less than five years. {TRANS R SOC TROP MED HYG}, 1999, Vol/Iss/Pg. 93/1 (84)

Active substance: PARACETAMOL

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Document reference: 45735

Study title: Paracetamol for treating fever in children. {Cochrane Database Syst Rev}, 2002, no. 2

Active substance: PARACETAMOL

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Document reference: 45801

Study title: A Multicenter, Open-label, Six-Month Extension Study to Assess the Longterm Safety of Paroxetine in Children and Adolescents with Major Depressive Disorder (MDD) or Obsessive-Compulsive Disorder (OCD)

Active substance: PAROXETINE

Study summary document link (including results): Paroxetine-29060-716-fullCSR.pdf

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Document reference: 48346

Study title: A Randomized, Multicenter, 10-Week, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Evaluate the Efficacy and Safety of Paroxetine in Children and Adolescents with Obsessive-Compulsive Disorder (OCD)

Active substance: PAROXETINE

Study summary document link (including results): Paroxetine-29060-704-fullCSR.pdf

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Document reference: 48344

Study title: A Randomized, Multicenter, 8-Week, Double-blind, Placebo-Controlled Flexible-Dose Study to Evaluate the Efficacy and Safety of Paroxetine in Children and Adolescents with Major Depressive Disorder

Active substance: PAROXETINE

Study summary document link (including results): Paroxetine-29060-701-fullCSR.pdf

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Document reference: 48343

Study title: PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trialW Voskuijl BMJ Gut 2004

Active substance: PEG 3350

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Document reference: 48370

Study title: Once-per-cycle pegfilgrastim versus daily filgrastim in pediatric patients with Ewing sarcoma. Wendelin, G. et al. Journal of Pediatric Hematology/Oncology 27(8): 449-51.Once-per-cycle pegfilgrastim versus daily filgrastim in pediatric patients with Ewing sarcoma. Wendelin, G. et al. Journal of Pediatric Hematology/Oncology 27(8): 449-51.

Active substance: pegfilgrastim

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Document reference: 41579

Study title: The effects of ondansetron and granisetron on electrocardiography in children receiving chemotherapy for acute leukemia. Buyukavci M, Olgun H, Ceviz N. Am J Clin Oncol. 2005 Apr; 28(2):201-4.The effects of ondansetron and granisetron on electrocardiography in children receiving chemotherapy for acute leukemia. Buyukavci M, Olgun H, Ceviz N. Am J Clin Oncol. 2005 Apr; 28(2):201-4.

Active substance: ONDASETRON

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Document reference: 32809

Study title: Effectiveness of Mass Oral Cholera Vaccination in Beira, Mozambique, published in New England Journal Med in Feb 2005

Active substance: oral cholera vaccine

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Document reference: 41502

Study title: A phase II, randomised, double-blind, placebo-controlled study to evaluate the immunogenicity, reactogenicity and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine when given concomitantly with OPV versus when given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh.

Active substance: oral live attenuated human rotavirus

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Document reference: 45712

Study title: A Phase IV, Case-Matched, Cohort Surveillance Study in Preterm Children Who Receive SYNAGIS@ Prophylaxis in the First Year of Life Versus Preterm Children Without RSV Prophylaxis: Incidence of RSV Hospitalization and Assessment of Disease Severity in the Season Following Prophylaxis

Active substance: palivizumab

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Document reference: 41608

Study title: A pivotal Phase III study of MED-493, for the prophylaxis of severe RSV disease in premature infantsand infants with BPD

Active substance: palivizumab

Study summary document link (including results): palivizumab-mi-cp018.pdf

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Document reference: 48099

Study title: A Study of the Safety, Tolerance, and Efficacy of Palivizumab (MEDI-493, Synagis®) for Prophylaxis of Respiratory Syncytial Virus in Children with Congenital Heart Disease

Active substance: palivizumab

Study summary document link (including results): palivizumab-mi-cp048.pdf

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Document reference: 48105

Study title: An Expanded Access Program Of Palivinumab in Premature Children With or Without Bronchopulmonary Dysplasia (BPD) - Northern Hemisphere

Active substance: palivizumab

Study summary document link (including results): palivizumab-w98-271-northern-hemisphere.pdf

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Document reference: 48110

Study title: An Expanded Access Program Of Palivinumab in Premature Children With or Without Bronchopulmonary Dysplasia (BPD) - Southern Hemisphere

Active substance: palivizumab

Study summary document link (including results): palivizumab-w98-271-southern-hemisphere.pdf

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Document reference: 48111

Study title: Compassionate Use of MEDI-493, a Humanized Respiratory Syncytial Virus (RSV) Monoclonal Antibody, for the Prophylaxis of Severe RSV Disease in Children With Lung Disease Who Are Intolerant to RespiGam® Infusions

Active substance: palivizumab

Study summary document link (including results): palivizumab-mi-cp041.pdf

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Document reference: 48103

Study title: Evaluation of immunogenicity of IM MED-493 in children who previously received IM MED-493 prophylaxis and children receiving IM MED-493 for the first time

Active substance: palivizumab

Study summary document link (including results): palivizumab-mi-cp036.pdf

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Document reference: 48102

Study title: Phase I/II Clinical Trials Investigation of Safety and Pharmacokinetics after Administration of MEDI-493 (Palivizumab) in Premature Infants and Pediatric Chronic Pulmonary Disease Patients

Active substance: palivizumab

Study summary document link (including results): palivizumab-j-med-99-002.pdf

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Document reference: 48090

Study title: Safety and Efficacy Study of Palivizumab in Children with Congenital Heart Disease (Phase III Clinical Trial)

Active substance: palivizumab

Study summary document link (including results): palivizumab-m03-637.pdf

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Document reference: 48091

Study title: Double-blind Pediatric Study to Assess the Safety, Pharmacokinetics and Efficacy of Single IV Doses of Palonosetron, 3.0 μg/kg or 10.0 μg/kg, in the Prevention of Chemotherapy- Induced Nausea and Vomiting

Active substance: PALONOSETRON HYDROCHLORIDE

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Document reference: 47743

Study title: J Am Coll Cardiol. 1983 Mar;1(3):797-803. Variability in coronary hemodynamics in response to ergonovine in patients with normal coronary arteries and atypical chest pain. Schwartz AB, Donmichael TA, Botvinick EH, Ishimori T, Parmley WW, Chatterjee K. J Am Coll Cardiol. 1983 Mar;1(3):797-803. Variability in coronary hemodynamics in response to ergonovine in patients with normal coronary arteries and atypical chest pain. Schwartz AB, Donmichael TA, Botvinick EH, Ishimori T, Parmley WW, Chatterjee K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44588

Study title: J Am Coll Cardiol. 1985 Jan;5(1 Suppl):128S-139S. Thallium-201 myocardial imaging in children. Sty JR, Starshak RJ. J Am Coll Cardiol. 1985 Jan;5(1 Suppl):128S-139S. Thallium-201 myocardial imaging in children. Sty JR, Starshak RJ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44589

Study title: J Am Coll Cardiol. 1998 Aug;32(2):413-9. Efficacy of augmented immunosuppressive therapy for early vasculopathy in heart transplantation. Lamich R, Ballester M, Martí V, Brossa V, Aymat R, Carrió I, Bernà L, Campreciós M, Puig M, Estorch M, FlotatsJ Am Coll Cardiol. 1998 Aug;32(2):413-9. Efficacy of augmented immunosuppressive therapy for early vasculopathy in heart transplantation. Lamich R, Ballester M, Martí V, Brossa V, Aymat R, Carrió I, Bernà L, Campreciós M, Puig M, Estorch M, Flotats

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44590

Study title: J Am Coll Cardiol. 1998 Dec;32(7):1938-42. Exercise-induced abnormal blood pressure responses are related to subendocardial ischemia in hypertrophic cardiomyopathy. Yoshida N, Ikeda H, Wada T, Matsumoto A, Maki S, Muro A, Shibata A, Imaizumi T. J Am Coll Cardiol. 1998 Dec;32(7):1938-42. Exercise-induced abnormal blood pressure responses are related to subendocardial ischemia in hypertrophic cardiomyopathy. Yoshida N, Ikeda H, Wada T, Matsumoto A, Maki S, Muro A, Shibata A, Imaizumi T.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44591

Study title: J Bone Joint Surg Am. 1993 Apr;75(4):526-31. Comment in: J Bone Joint Surg Am. 1993 Dec;75(12):1880-1. Thallium-201 scanning for the evaluation of osteosarcoma and soft-tissue sarcoma. A study of the evaluation and predictability of the histologicalJ Bone Joint Surg Am. 1993 Apr;75(4):526-31. Comment in: J Bone Joint Surg Am. 1993 Dec;75(12):1880-1. Thallium-201 scanning for the evaluation of osteosarcoma and soft-tissue sarcoma. A study of the evaluation and predictability of the histological

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44592

Study title: J Cardiogr. 1981 Mar;11(1):105-14. [Myocardial imaging with thallium -201 in the patients with coronary involvement after Kawasaki disease (author's transl)] [Article in Japanese] J Cardiogr. 1981 Mar;11(1):105-14. [Myocardial imaging with thallium -201 in the patients with coronary involvement after Kawasaki disease (author's transl)] [Article in Japanese]

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44593

Study title:

Active substance: TREOSULFAN

Study summary document link (including results): 21297673.pdf

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Document reference: 47629

Study title:

Active substance: TREOSULFAN

Study summary document link (including results): 20685259.pdf

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Document reference: 47630

Study title:

Active substance: TREOSULFAN

Study summary document link (including results): 19866337.pdf

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Document reference: 47631

Study title:

Active substance: TREOSULFAN

Study summary document link (including results): 19036020.pdf

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Document reference: 47632

Study title:

Active substance: TREOSULFAN

Study summary document link (including results): 18986389.pdf

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Document reference: 47633

Study title:

Active substance: TREOSULFAN

Study summary document link (including results): 18978748.pdf

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Document reference: 47634

Study title:

Active substance: TREOSULFAN

Study summary document link (including results): 18492115.pdf

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Document reference: 47635

Study title:

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

Study summary document link (including results):

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Document reference: 33653

Study title:

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

Study summary document link (including results):

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Document reference: 33654

Study title:

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

Study summary document link (including results):

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Document reference: 33655

Study title:

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33656

Study title: A comparative study using a single dose of acetaminophen, acetaminophen/pseudoephedrine, pseudoephedrine alone, and placebo in dental pain. CSR 163. Protocol 91-123, Unpublished Report 289

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

Study summary document link (including results): paracetamol_pseudoephedrine 91-123.pdf

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Document reference: 47415

Study title: Gehri−Mario et al. When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm−World−Sci}, Jun 2005, vol. 27, no. 3, p. 254−7Gehri−Mario et al. When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm−World−Sci}, Jun 2005, vol. 27, no. 3, p. 254−7

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33540

Study title: A randomized, double-blind, placebo-controlled trial of pseudoephedrine in coryza. Clin Exp Pharmacol Physiol 2004; 31(7): 429-32 A randomized, double-blind, placebo-controlled trial of pseudoephedrine in coryza. Clin Exp Pharmacol Physiol 2004; 31(7): 429-32

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33632

Study title: Wilson JT, Höjer B, Tomson G, Rane A, Sjöqvist F High incidence of contration-dependent skin reaction in children treated with phenytoin B M J, 1978, 1: 1583- 1586Wilson JT, Höjer B, Tomson G, Rane A, Sjöqvist F High incidence of contration-dependent skin reaction in children treated with phenytoin B M J, 1978, 1: 1583- 1586

Active substance: PHENYLEPHRINE

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Document reference: 33938

Study title: Young B, Rapp RP, Norton JA, Haack D, Walsh JW. Failure of prophylactically administered phenytoin to prevent posttraumatic seizures in children. Childs Brain. 1983;10(3):185-92.Young B, Rapp RP, Norton JA, Haack D, Walsh JW. Failure of prophylactically administered phenytoin to prevent posttraumatic seizures in children. Childs Brain. 1983;10(3):185-92.

Active substance: PHENYLEPHRINE

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Document reference: 33932

Study title: Zumpft CW. Double-blind comparison of metizoline hydrochloride (Ellsyl) and phenylephrine in allergic and vasomotor rhinitis. Curr Ther Res Clin Exp 1975; 17(1):40-6 Zumpft CW. Double-blind comparison of metizoline hydrochloride (Ellsyl) and phenylephrine in allergic and vasomotor rhinitis. Curr Ther Res Clin Exp 1975; 17(1):40-6

Active substance: PHENYLEPHRINE

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Document reference: 45102

Study title: Efficacy and safety of intranasally applied dimetindene maleate solution. Multicenter study in children under 14 years suffering from seasonal allergic rhinitisBauer 2001

Active substance: PHENYLEPHRINE AND DEMETHINDENE MALEATE

Study summary document link (including results): 2011-EMA spreadsheet - Vibrocil - Bauer_2001.xls

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Document reference: 48026

Study title: Randomized, double-blind, multicentre, comparative study of the efficacy and safety of VIBROCIL (without neomycin) gel vs. TRIOFAN gel in patients with acute rhinitis)Meran 1993

Active substance: PHENYLEPHRINE AND DEMETHINDENE MALEATE

Study summary document link (including results): 2011-EMA spreadsheet - Vibrocil - Meran_1993.xls

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Document reference: 48028

Study title:

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

Study summary document link (including results):

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Document reference: 33651

Study title:

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33652

Study title: A multi-centre, open label study to assess the safety of 1% penciclovir cream in adolescent patients with recurrent herpes simplex labialis infection

Active substance: PENCICLOVIR

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Document reference: 45820

Study title: Bavdekar, A. R., Bhave, S. A., Pradhan, A. M., Pandit, A. N., and Tanner, M. S. Department of Paediatrics, King Edward Memorial Hospital, Pune, India Long term survival in Indian childhood cirrhosis treated with D-penicillamine Arch.Dis.Child 1996;74:32-35. Bavdekar, A. R., Bhave, S. A., Pradhan, A. M., Pandit, A. N., and Tanner, M. S. Department of Paediatrics, King Edward Memorial Hospital, Pune, India Long term survival in Indian childhood cirrhosis treated with D-penicillamine Arch.Dis.Child 1996;74:32-35.

Active substance: PENICILLAMINE

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Document reference: 33839

Study title: Bhave, S. and Pandit, A. D-penicillamine in the therapy of Indian childhood cirrhosis Indian J.Pediatr. 1987;54:587-590. Bhave, S. and Pandit, A. D-penicillamine in the therapy of Indian childhood cirrhosis Indian J.Pediatr. 1987;54:587-590.

Active substance: PENICILLAMINE

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Document reference: 33847

Study title: Comparison of cefuroxime axetil and phenoxymethyl penicillin for the treatment of children with solitary erythema migrans. Arnez M, Radsel-Medvescek A, Pleterski-Rigler D, Fuzic-Sablijic E, Strle F.Wien Klin Wochenschr (1999) 111/22-23: 916-922.Comparison of cefuroxime axetil and phenoxymethyl penicillin for the treatment of children with solitary erythema migrans. Arnez M, Radsel-Medvescek A, Pleterski-Rigler D, Fuzic-Sablijic E, Strle F.Wien Klin Wochenschr (1999) 111/22-23: 916-922.

Active substance: PENICILLAMINE

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Document reference: 33841

Study title: Giannini, E. H., Brewer, E. J., Kuzmina, N., Alekseev, L., and Shokh, B. P. Baylor College of Medicine, Houston, Texas Characteristics of responders and nonresponders to slow-acting antirheumatic drugs in juvenile rheumatoid arthritis Arthritis Rheum. 1988;31:15-20. Giannini, E. H., Brewer, E. J., Kuzmina, N., Alekseev, L., and Shokh, B. P. Baylor College of Medicine, Houston, Texas Characteristics of responders and nonresponders to slow-acting antirheumatic drugs in juvenile rheumatoid arthritis Arthritis Rheum. 1988;31:15-20.

Active substance: PENICILLAMINE

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Document reference: 33850

Study title: A randomised,multicenter comparison of Curosurf and Survanta in the treatment of established neonatal rerspiratory distress syndrome

Active substance: PHOSPHOLIPIDS

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Document reference: 34043

Study title: Clinical sudy on the use of Curosurf in meconium aspiration syndrome. Chinese multicenter study

Active substance: PHOSPHOLIPIDS

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Document reference: 34044

Study title: Vashev EA. Some aspects of virus hepatitis B treatment in children. Mikrobiol epidemiol i klinika infeksionnykh boleznei 1988, 46-8 (currently only summary available) Vashev EA. Some aspects of virus hepatitis B treatment in children. Mikrobiol epidemiol i klinika infeksionnykh boleznei 1988, 46-8 (currently only summary available)

Active substance: PHOSPHOLIPIDS AND VITAMINS

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Document reference: 34045

Study title: Specific immunotherapy has long-term preventive effect of seasonal and perennial asthma: 10-year follow-up on the PAT study

Active substance: Phosphor-Homaccord

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Document reference: 40135

Study title: A comparison of the effect of a single intramuscular injection of Konakion MM pediatric formulation (Ro 016722-139 or Konakion Cremophor (castor oil) formulation (Ro 016722-119) administered at birth on plasma Vitman K levels in healthy breastfed neonates at day 1 and 14 days after birth (protocol no. BP16063)

Active substance: PHYTOMENADION

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Document reference: 34046

Study title: A comparison of the effect of a single intramuscular injection of Konakion MM pediatric formulation (Ro 016722-139 or Konakion Cremophor (castor oil) formulation (Ro 016722-119) administered at birth on plasma Vitman K levels in healthy breastfed neonates at day 1 and 14 days after birth (protocol no. BP16063)

Active substance: PHYTOMENADION

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Document reference: 34053

Study title: 13C02 breath test with 13C-labelled hiolein for the non-invasive determination of exocrine pancreatic function in healthy subjects and in patients with cystiC fibrosis: Efficacy assessment of pancreatic enzyme replacement in children with cystic fibrosis

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-KREO-629.pdf

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Document reference: 47658

Study title: A Phase III Long-term Administration Study of SA-001 in the Treatment of Cystic Fibrosis

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-S245-3117.pdf

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Document reference: 47668

Study title: A prospectively randomized, cross-over study to evaluate the acceptability of Creon® granules in sachets with Creon® 8000 capsules in the treatment of pancreatic insufficiency in cystic fibrosis patients

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-KREO-592.pdf

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Document reference: 47657

Study title: Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6

Active substance: PARACETAMOL AND DIPHENHYDRAMINE

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Document reference: 33406

Study title: Figueras−Nadal−C et al. Effectiveness and tolerability of ibuprofen−arginine versus paracetamol in children with fever of likely infectious origin. {ACTA−PAEDIATR− INT−J−PAEDIATR}, 2002, Vol/Iss/Pg. 91/4 (383−390)Figueras−Nadal−C et al. Effectiveness and tolerability of ibuprofen−arginine versus paracetamol in children with fever of likely infectious origin. {ACTA−PAEDIATR− INT−J−PAEDIATR}, 2002, Vol/Iss/Pg. 91/4 (383−390)

Active substance: PARACETAMOL AND DIPHENHYDRAMINE

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Document reference: 33383

Study title: Gehri−Mario et al. When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm−World−Sci}, Jun 2005, vol. 27, no. 3, p. 254−7Gehri−Mario et al. When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm−World−Sci}, Jun 2005, vol. 27, no. 3, p. 254−7

Active substance: PARACETAMOL AND DIPHENHYDRAMINE

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Document reference: 33375

Study title: Goyal−P−K et al. Double blind randomized comparative evaluation of nimesulide and paracetamol as antipyretics. {Indian−Pediatr}, Jun 1998, vol. 35, no. 6, p. 519−22Goyal−P−K et al. Double blind randomized comparative evaluation of nimesulide and paracetamol as antipyretics. {Indian−Pediatr}, Jun 1998, vol. 35, no. 6, p. 519−22

Active substance: PARACETAMOL AND DIPHENHYDRAMINE

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Document reference: 33385

Study title: Greene−S−L, Reed−C−E, Schroeter−A−L. Double−blind crossover study comparing doxepin with diphenhydramine for the treatment of chronic urticaria. Journal of the American Academy of Dermatology, {J−Am−Acad−Dermatol}, Apr 1985, vol. 12, no. 4, p. 669−75.Greene−S−L, Reed−C−E, Schroeter−A−L. Double−blind crossover study comparing doxepin with diphenhydramine for the treatment of chronic urticaria. Journal of the American Academy of Dermatology, {J−Am−Acad−Dermatol}, Apr 1985, vol. 12, no. 4, p. 669−75.

Active substance: PARACETAMOL AND DIPHENHYDRAMINE

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Document reference: 33628

Study title: Kramer−M−S et al. Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. {Lancet}, 9 Mar 1991, vol. 337, no. 8741, p. 591−4Kramer−M−S et al. Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. {Lancet}, 9 Mar 1991, vol. 337, no. 8741, p. 591−4

Active substance: PARACETAMOL AND DIPHENHYDRAMINE

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Document reference: 33361

Study title:

Active substance: TREOSULFAN

Study summary document link (including results): 17211437.pdf

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Document reference: 47636

Study title: Treosulfan-based conditioning regimens for hematopoietic stem cell transplantation in children with primary immunodeficiency: United Kingdom experience Treosulfan-based conditioning regimens for hematopoietic stem cell transplantation in children with primary immunodeficiency: United Kingdom experience

Active substance: TREOSULFAN

Study summary document link (including results): 21325599.pdf

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Document reference: 47628

Study title: Efficacy and Safety by Children and Adolescents (5-17 yrs and 2 months) with Autictic Disorders

Active substance: TRETINOIN

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Document reference: 46730

Study title: Etude clinique de Plewig et coll. 1971

Active substance: TRETINOIN

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Document reference: 46729

Study title: Etude d'efficacité et tolérance biologique ouverte multicentrique 320 patients dont 31 de 15 ans et moins

Active substance: TRETINOIN

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Document reference: 46731

Study title: Topical isotretinoin vs. topical retinoic acid in the treatment of acne vulgaris Dominguez J, Hojyo MT, Celayo JL, Dominguez-Soto L, Teixeira F. Int J Dermatol. 1998 Jan;37 (1) : 54-5 "This is a clinical, prospective, and longitudinal study comparing the efficacy and incidence of averse effects of topical isotretinoin against those of topical retinoic acid in the treatment of acne vulgaris" Topical isotretinoin vs. topical retinoic acid in the treatment of acne vulgaris Dominguez J, Hojyo MT, Celayo JL, Dominguez-Soto L, Teixeira F. Int J Dermatol. 1998 Jan;37 (1) : 54-5 "This is a clinical, prospective, and longitudinal study comparing the efficacy and incidence of averse effects of topical isotretinoin against those of topical retinoic acid in the treatment of acne vulgaris"

Active substance: TRETINOIN

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Document reference: 46732

Study title: Tretinoin gel microspheres 0,04% versus 0,1% in adolescents and adults with mild to moderate acne vulgaris: a 12-week, multicenter, randomized, double-blind, parallel-group, phase IV trial. Berger R, Rizer R, Barba A, Wilson D, Stewart D, Grossman R, Nighland M, Weiss J. Clin Ther. 2007 jun; 29(6): 1086-97 "This study was conducted to assess the efficacy and safety profile of a lower-dose TGM (0,04%) formulation compared with TGM 0,1% for the treatment of mild to moderate acne vulgaris. Patients ranged in age from 12 to 41 years" Tretinoin gel microspheres 0,04% versus 0,1% in adolescents and adults with mild to moderate acne vulgaris: a 12-week, multicenter, randomized, double-blind, parallel-group, phase IV trial. Berger R, Rizer R, Barba A, Wilson D, Stewart D, Grossman R, Nighla...

Active substance: TRETINOIN

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Document reference: 46733

Study title: A Phase III multicenter, open-label, long term safety study of Triamcinolone acetonide forte HFA-134a oral inhaler treatment in moderate to severe asthmatic children, involving 250 patients - No author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46822

Study title: Rev Esp Cardiol. 1983;36(3):239-46. [Thallium-201 in newborn infants and children with myocardial pathology] [Article in Spanish] Cazzaniga M, Casanova M, Castro Beiras J, Martín Curto M, Crespo A, Ramos A, Vázquez R. Rev Esp Cardiol. 1983;36(3):239-46. [Thallium-201 in newborn infants and children with myocardial pathology] [Article in Spanish] Cazzaniga M, Casanova M, Castro Beiras J, Martín Curto M, Crespo A, Ramos A, Vázquez R.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44697

Study title: Rev Esp Med Nucl. 1998;17(2):112-5. [False positive with Tl-201 in the study of Ewing's sarcoma of the astragalus caused by reflex sympathetic dystrophy] [Article in Spanish] Serrano Vicente J, Caballero Carpena O, Verdú Rico J, Alcalá Santaella R, MRev Esp Med Nucl. 1998;17(2):112-5. [False positive with Tl-201 in the study of Ewing's sarcoma of the astragalus caused by reflex sympathetic dystrophy] [Article in Spanish] Serrano Vicente J, Caballero Carpena O, Verdú Rico J, Alcalá Santaella R, M

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44698

Study title: Tolerability and efficacy of VIBROCIL paediatric drops: multicentric, open trial, in children aged between 1 and 6 years, suffering from nasal congestionVerhegge 1994

Active substance: PHENYLEPHRINE AND DEMETHINDENE MALEATE

Study summary document link (including results): 2011-EMA spreadsheet - Vibrocil - Verhegge_1994.xls

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Document reference: 48029

Study title: Treatment of rhinitis: not at the cost of mucosal injury! Ärzt. Praxis 34 (5), 102-103Gunther 1982

Active substance: PHENYLEPHRINE AND DEMETHINDENE MALEATE

Study summary document link (including results): 2011-EMA spreadsheet - Vibrocil - Gunther_1982.xls

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Document reference: 48027

Study title:

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33950

Study title:

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33951

Study title:

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33952

Study title: Wilson JT, Höjer B, Rane A. Loading and conventional dose therapy with phenytoin in children: kinetic profile of parent drug and main metabolite in plasma. Clin Pharmacol Ther. 1976 Jul;20(1):48-58Wilson JT, Höjer B, Rane A. Loading and conventional dose therapy with phenytoin in children: kinetic profile of parent drug and main metabolite in plasma. Clin Pharmacol Ther. 1976 Jul;20(1):48-58

Active substance: PHENYLEPHRINE

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Document reference: 33939

Study title:

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33953

Study title:

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33954

Study title: Oxatomide in children with allergic rhinoconjuctivitis. Comparison of two different dosage schemes.

Active substance: OXATOMIDE

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Document reference: 45378

Study title: Clinical study of Adumbran" syrup of Boehringer Ingelheim (generic name "oxazepam")."

Active substance: OXAZEPAM

Study summary document link (including results): Oxazepam_U76-0287_SYNOPSIS.pdf

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Document reference: 45387

Study title: Final report on the study of the product Z 10-TR at the university eye hospital in Mainz.

Active substance: OXAZEPAM

Study summary document link (including results): Oxazepam_U64-0066_SYNOPSIS.pdf

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Document reference: 45388

Study title: Investigations into the effect of Adumbran suppositories in children

Active substance: OXAZEPAM

Study summary document link (including results): Oxazepam_U70-0340_SYNOPSIS.pdf

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Document reference: 45389

Study title: Report on the experience with the use of Adumbran.

Active substance: OXAZEPAM

Study summary document link (including results): Oxazepam_U70-0342_SYNOPSIS.pdf

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Document reference: 45386

Study title:

Active substance: OXITRIPTAN

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Document reference: 32915

Study title:

Active substance: OXITRIPTAN

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Document reference: 32931

Study title:

Active substance: OXITRIPTAN

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Document reference: 32932

Study title:

Active substance: OXITRIPTAN

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Document reference: 32933

Study title:

Active substance: OXITRIPTAN

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Document reference: 32934

Study title:

Active substance: OXITRIPTAN

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Document reference: 32935

Study title:

Active substance: OXITRIPTAN

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Document reference: 32964

Study title:

Active substance: OXITRIPTAN

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Document reference: 32965

Study title:

Active substance: OXITRIPTAN

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Document reference: 32966

Study title:

Active substance: OXITRIPTAN

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Document reference: 32967

Study title: A comparison of the effect of a single intramuscular injection of Konakion MM pediatric formulation (Ro 016722-139 or Konakion Cremophor (castor oil) formulation (Ro 016722-119) administered at birth on plasma Vitman K levels in healthy breastfed neonates at day 1 and 14 days after birth (protocol no. BP16063)

Active substance: PHYTOMENADION

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Document reference: 34055

Study title: A comparison of the effect of a single intramuscular injection of Konakion MM pediatric formulation (Ro 016722-139 or Konakion Cremophor (castor oil) formulation (Ro 016722-119) administered at birth on plasma Vitman K levels in healthy breastfed neonates at day 1 and 14 days after birth (protocol no. BP16063)

Active substance: PHYTOMENADION

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Document reference: 34068

Study title: Bioavailability and efficacy of Konakion MM ampoules vs Konakion drops in healthy newborn at term (>2000g) breastfed infants 2mg per os

Active substance: PHYTOMENADION

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Document reference: 34061

Study title: Bioavailability and efficacy of Konakion MM Ro 01-6722/130, 1.5mg vitamin K1 i.m. versus 3.0mg vitamin K1 oral in healthy newborn breast-fed babies

Active substance: PHYTOMENADION

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Document reference: 34058

Study title: Bioavailability of Konakino MM, Ro 01-6722/130, oral and parenteral in mature neonates at birth (>2000g) and the evolution of vitamin K1 plasma level in breastfed babies

Active substance: PHYTOMENADION

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Document reference: 34059

Study title: Comparative bioavailability and kinetics of Konakion MM: Ro 01-6722/122, oral and parenteral in infants suffering from chronic cholestasis

Active substance: PHYTOMENADION

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Document reference: 34057

Study title: Comparative tolerability and efficacy study: vitamin K1 mixed micelles solution versus vitamin K1 solution containing Cremophor EL both administered in a single dose i.m. to babies suffering from chronic cholestasis

Active substance: PHYTOMENADION

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Document reference: 34063

Study title: Comparative tolerability of Ro 01-6722/120 (Konakion MM) and Ro 01-6722/092 (Konakion commercial form with Cremophor) 5 mg/0.5 ml i.m. in healthy new-born and premature babies.

Active substance: PHYTOMENADION

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Document reference: 34064

Study title: Efficacy and tolerability of Konakion MM Ro 01-6722/135, 1mg vitamin K1 i.v. and 2mg vitamin K1 p.o. in the prophylactic treatment against hemorrhagic disease in premature infants

Active substance: PHYTOMENADION

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Document reference: 34065

Study title: Efficacy and tolerability of Konakion MM1mg vitamin K1 orally versus 1mg vitamin K1 intramuscularly in newborn breastfed babies

Active substance: PHYTOMENADION

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Document reference: 34060

Study title: Evaluation of the interaction potential of Mixed micelles with the binding to albumin

Active substance: PHYTOMENADION

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Document reference: 34056

Study title: Final Study Report: A Comparison of the effect of Oral Viatamin K1 (Ro-6722/139) and intramuscular vitamin K(Konakion tween 80 Ro 01-6722/143) in exclusively breast-fed neonates on PIVKA II plasma concentrations and prothrombin time.

Active substance: PHYTOMENADION

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Document reference: 34047

Study title: Treatment of the so-called "minor" pediatric incontinence problems accompanied by mictional retraining with oxybutynin hydrochloride - Emilio Casolari - Reprint from : Medicina Rivista dell'Enciclopedia Medica Italiana (English Translation) - 1984 (N.1: 78-80) - Publication in UK registration file - Treatment of the so-called "minor" pediatric incontinence problems accompanied by mictional retraining with oxybutynin hydrochloride - Emilio Casolari - Reprint from : Medicina Rivista dell'Enciclopedia Medica Italiana (English Translation) - 1984 (N.1: 78-80) - Publication in UK registration file -

Active substance: OXITRIPTAN

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Document reference: 32919

Study title: Treatment of the so-called "minor" pediatric incontinence problems accompanied by mictional retraining with oxybutynin hydrochloride - Emilio Casolari - Reprint from : Medicina Rivista dell'Enciclopedia Medica Italiana (English Translation) - 1984 (N.1: 78-80) - Publication in UK registration file - Treatment of the so-called "minor" pediatric incontinence problems accompanied by mictional retraining with oxybutynin hydrochloride - Emilio Casolari - Reprint from : Medicina Rivista dell'Enciclopedia Medica Italiana (English Translation) - 1984 (N.1: 78-80) - Publication in UK registration file -

Active substance: OXITRIPTAN

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Document reference: 32929

Study title: Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369)Wilson−J−T et al. Acetaminophen controlled−release sprinkles versus acetaminophen immediate−release elixir in febrile children. {J−CLIN−PHARMACOL}, 2000, Vol/Iss/Pg. 40/4 (360−369)

Active substance: PARACETAMOL AND DIPHENHYDRAMINE

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Document reference: 33391

Study title: A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. Jan 1988.A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. Jan 1988.

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33605

Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992.A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992.

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33591

Study title: L'antibiotherapie dans le rhumatisme de l'enfant. 4ème Conférence internationale des maladies rhumatismales - Mozziconacci P. & Gautier M. - 1964 (Les Thérapeutiques médicales des affections rhumatismales. Grenoble, Edit. Imprimerie générale pp. 157 - 176)L'antibiotherapie dans le rhumatisme de l'enfant. 4ème Conférence internationale des maladies rhumatismales - Mozziconacci P. & Gautier M. - 1964 (Les Thérapeutiques médicales des affections rhumatismales. Grenoble, Edit. Imprimerie générale pp. 157 - 176)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45890

Study title: La scarlatine - Bastin R. & Pechere J. C. - 1966 (Presse méd., 74 (34) 1773.La scarlatine - Bastin R. & Pechere J. C. - 1966 (Presse méd., 74 (34) 1773.

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45878

Study title: Pharmacologic evaluation of orally administered antibiotics in infants and children: effect of feeding on bioavailability - Mc Cracken G. H, Jr, Ginsburb Ch. M., Clahsen J.C. & Thomas M. L. - 1978 (Pediatrics, 62 (5) 738 - 743, 10 réf.)Pharmacologic evaluation of orally administered antibiotics in infants and children: effect of feeding on bioavailability - Mc Cracken G. H, Jr, Ginsburb Ch. M., Clahsen J.C. & Thomas M. L. - 1978 (Pediatrics, 62 (5) 738 - 743, 10 réf.)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45881

Study title: Prophylaxie de la scarlatine dans les collectivités - Vilde J. C. - 1978 (Gaz. Méd. Fr., 85 (35) 4103)Prophylaxie de la scarlatine dans les collectivités - Vilde J. C. - 1978 (Gaz. Méd. Fr., 85 (35) 4103)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45882

Study title: Randomized, multicenter open study comparing the efficacy of potassium-phenoxymethylpenicillin V three times daily for 10 days versus benzathine penicillin V twice daily for 5 days in the treatment of acute group A ß-hemolytic streptococcal tonsillopharyngitis in children

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45891

Study title: Randomized, multicenter pilot study comparing the efficacy of potassium-phenoxymethylpenicillin granules for oral suspension 100.000 IU /kg/day tid for 10 days versus benzathine-phenoxymethylpenicillin suspension 100.000 IU /kg/day bid for 7 days versus benzathine-phenoxymethylpenicillin suspension 100.000 IU /kg/day bid for 5 days in the treatment of acute group A ß-hemolytic streptococcal tonsillopharyngitis in children

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45872

Study title: Rev Esp Med Nucl. 1999 Jun;18(3):197-203. [Thallium-201 uptake in lung and heart with different types of stress. Study in healthy volunteers] [Article in Spanish] Maceira AM, Cabrera A, Albaladejo VJ, García Velloso MJ, Richter JA, Coma-Canella I. Rev Esp Med Nucl. 1999 Jun;18(3):197-203. [Thallium-201 uptake in lung and heart with different types of stress. Study in healthy volunteers] [Article in Spanish] Maceira AM, Cabrera A, Albaladejo VJ, García Velloso MJ, Richter JA, Coma-Canella I.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44699

Study title: Rev Esp Med Nucl. 2004 Sep-Oct;23(5):330-7. [Value of thallium 201-SPECT in typing brain space-occupying lesions] [Article in Spanish] Martínez del Valle Torres MD, Gómez Rio M, Rodríguez Fernández A, Sabatel Hernandez G, Ortega Lozano S, Ramos FonRev Esp Med Nucl. 2004 Sep-Oct;23(5):330-7. [Value of thallium 201-SPECT in typing brain space-occupying lesions] [Article in Spanish] Martínez del Valle Torres MD, Gómez Rio M, Rodríguez Fernández A, Sabatel Hernandez G, Ortega Lozano S, Ramos Fon

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44700

Study title: Rinsho Hoshasen. 1990 Feb;35(2):253-7. [The role and clinical value of thallium-201 myocardial scintigraphy in ischemic heart disease] [Article in Japanese] Shimada T, Nakamori H, Kurimoto T, Karakawa M, Matsuura T, Iwasaka T, Inada M, Nishiyama Y. Rinsho Hoshasen. 1990 Feb;35(2):253-7. [The role and clinical value of thallium-201 myocardial scintigraphy in ischemic heart disease] [Article in Japanese] Shimada T, Nakamori H, Kurimoto T, Karakawa M, Matsuura T, Iwasaka T, Inada M, Nishiyama Y.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44701

Study title: Semin Nucl Med. 1980 Jan;10(1):16-26. Detection and quantitation of cardiovascular shunts with commonly available radionuclides. Treves S. Semin Nucl Med. 1980 Jan;10(1):16-26. Detection and quantitation of cardiovascular shunts with commonly available radionuclides. Treves S.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44702

Study title: Semin Nucl Med. 1993 Jul;23(3):243-54. Thallium-201 for oncological imaging in children. Nadel HR. Semin Nucl Med. 1993 Jul;23(3):243-54. Thallium-201 for oncological imaging in children. Nadel HR.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44703

Study title: Semin Pediatr Neurol. 1999 Dec;6(4):267-77. Neurocysticercosis and acquired cerebral toxoplasmosis in children. Mitchell WG. Semin Pediatr Neurol. 1999 Dec;6(4):267-77. Neurocysticercosis and acquired cerebral toxoplasmosis in children. Mitchell WG.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44704

Study title: South Med J. 1986 Nov;79(11):1337-8. Preoperative localization of parathyroid adenomas using thallium-technetium subtraction scintigraphy. Gordon L, Carr D. South Med J. 1986 Nov;79(11):1337-8. Preoperative localization of parathyroid adenomas using thallium-technetium subtraction scintigraphy. Gordon L, Carr D.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44705

Study title: A double-blind comparative trial of Tizanidine and diazepam in the treatment of chronic spasticity in patients with hemiplegia

Active substance: TIZANIDINE

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Document reference: 44783

Study title: A double−blind, placebo−controlled trial of tizanidine in the treatment of spasticity caused by multiple sclerosis. United Kingdom Tizanidine Trial Group. Neurology, Nov 1994, vol. 44, no. 11 Suppl 9, p. S70−8A double−blind, placebo−controlled trial of tizanidine in the treatment of spasticity caused by multiple sclerosis. United Kingdom Tizanidine Trial Group. Neurology, Nov 1994, vol. 44, no. 11 Suppl 9, p. S70−8

Active substance: TIZANIDINE

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Document reference: 38513

Study title: A multicenter, double-blind, randomised, placebo-controlled study to assess the efficacy and tolerability of Tizanidine tablets in patients suffering from spasticity resulting from spinal cord injury

Active substance: TIZANIDINE

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Document reference: 44780

Study title:

Active substance: OXITRIPTAN

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Document reference: 32969

Study title:

Active substance: OXITRIPTAN

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Document reference: 32970

Study title: Anticholinergic therapy for primary enuresis efficacy of oxybutynin chloride in a controlled clinical trial in 58 patients - Marconi A.M., Felici E., Roggia A., Torelli F. - Ped. Med. Chir - Med. Surg. Ped. - 1985 (7:573-576) - Publication in UK registration file - Anticholinergic therapy for primary enuresis efficacy of oxybutynin chloride in a controlled clinical trial in 58 patients - Marconi A.M., Felici E., Roggia A., Torelli F. - Ped. Med. Chir - Med. Surg. Ped. - 1985 (7:573-576) - Publication in UK registration file -

Active substance: OXITRIPTAN

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Document reference: 32927

Study title: Askie LM, Henderson-Smart DJ, Lirwig L, Simpson JM. Oxygen-saturation targets and outcomes in extremely preterm infants. N Engl J Med 2003; 349:959-67Askie LM, Henderson-Smart DJ, Lirwig L, Simpson JM. Oxygen-saturation targets and outcomes in extremely preterm infants. N Engl J Med 2003; 349:959-67

Active substance: OXITRIPTAN

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Document reference: 32936

Study title: Bakwin H. Oxygen therapy in premature babies with anoxemia. Am J Dis Child. 1923; 25:157–192.Bakwin H. Oxygen therapy in premature babies with anoxemia. Am J Dis Child. 1923; 25:157–192.

Active substance: OXITRIPTAN

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Document reference: 32937

Study title: Bass JL, Gozal D. Oxygen therapy for bronchiolitis. Pediatrics 2007; 119:611Bass JL, Gozal D. Oxygen therapy for bronchiolitis. Pediatrics 2007; 119:611

Active substance: OXITRIPTAN

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Document reference: 32938

Study title: A Blinded, Single-Dose, Parallel Study Comparing the Antipyretic Efficacy and Safety of Ibuprofen Pediatric Suspension and Acetaminophen Suspension in Children with Fever

Active substance: PARACETAMOL

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Document reference: 45784

Study title: A clinical trial comparing the safety and efficacy of aspirin 800mg with caffeine 64mg with that of acetaminophen 1000mg in the treatment of acute musculoskeletal injury

Active substance: PARACETAMOL

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Document reference: 45787

Study title: A clinical trial comparing the safety and efficacy of aspirin 800mg with caffeine 64mg with that of acetaminophen 1000mg in the treatment of acute musculoskeletal injury

Active substance: PARACETAMOL

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Document reference: 45794

Study title: A Combined Analysis of the Data Provided by Drs. J. Hopkinson, W. Bare, and R. Posatko's Tylenol 500 (Acetaminophen) Studies. Unpublished Report TA8A2, Nov 1972 and Teal TW. Dr. John Hopkinson's Tylenol 500 (Acetaminophen) Study. Unpublished Report TA8A3.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol TA8A2 and TA8A3.pdf

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Document reference: 47518

Study title: A double-blind comparison of the safety and efficacy of a single dose of Children's Advil ibuprofen suspension (10mg/kg), acetaminophen (15mg/kg), and a control vehicle in the relief of sore throat pain in children.

Active substance: PARACETAMOL

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Document reference: 45791

Study title: A double-blind comparison of the safety and efficacy of a single dose of Children's Advil ibuprofen suspension (10mg/kg), acetaminophen (15mg/kg), and a control vehicle in the relief of sore throat pain in children.

Active substance: PARACETAMOL

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Document reference: 45797

Study title:

Active substance: OXITRIPTAN

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Document reference: 32968

Study title: A double-blind comparison of the safety and efficacy of a single dose of Children's Advil Suspension (10 mg/kg), acetaminophen (15 mg/kg), and a vehicle control in the relief of sore throat pain in children

Active substance: PARACETAMOL

Study summary document link (including results): Ibuprofen-WM-375A.pdf

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Document reference: 45790

Study title: A Double-Blind Study of PARAFON FORTE, Acetaminophen, PARAFLEX, and Placebo in Outpatients Following Surgical Removal of Impacted Third Molars. Protocol ASD, Unpublished Report SR-199-02.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol ASD.pdf

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Document reference: 47516

Study title: UK Collaborative ECMO Trial Group. UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation. Lancet 1996; 348: 75-82UK Collaborative ECMO Trial Group. UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation. Lancet 1996; 348: 75-82

Active substance: OXITRIPTAN

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Document reference: 32950

Study title: Use of Oxybutynin Chloride (Ditropan) in Treatment of Enuresis - R. De Castro, E. Casolari, and S. Ricci - Riv Ital Ped - 1985 (11: 208-211) - Publication in UK registration file - Use of Oxybutynin Chloride (Ditropan) in Treatment of Enuresis - R. De Castro, E. Casolari, and S. Ricci - Riv Ital Ped - 1985 (11: 208-211) - Publication in UK registration file -

Active substance: OXITRIPTAN

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Document reference: 32920

Study title: Vento M, Asensi M, Sastre J, García-Sala F, Lloret A, Viña J. Oxidative stress in asphyxiated term infants resuscitated with 100% oxygen. Journal of Pediatrics 2003; 142:240-246Vento M, Asensi M, Sastre J, García-Sala F, Lloret A, Viña J. Oxidative stress in asphyxiated term infants resuscitated with 100% oxygen. Journal of Pediatrics 2003; 142:240-246

Active substance: OXITRIPTAN

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Document reference: 32951

Study title: Vento M, Asensi M, Sastre J, García-Sala F, Pallardó FV, Viña J. Resuscitation With Room Air Instead of 100% Oxygen Prevents Oxidative Stress in Moderately Asphyxiated Term Neonates. Pediatrics 2001;107;642-647Vento M, Asensi M, Sastre J, García-Sala F, Pallardó FV, Viña J. Resuscitation With Room Air Instead of 100% Oxygen Prevents Oxidative Stress in Moderately Asphyxiated Term Neonates. Pediatrics 2001;107;642-647

Active substance: OXITRIPTAN

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Document reference: 32956

Study title: Wiklund et al. The Efficacy of oxymetasoline Administered with a Nasal Bellows Container and Combined with Oral Phenoxymethyl-penicillin in the Treatment of Acute Maxillary Sinusitis. Acta Otolaryngol (Stockh) 1994; 515: 57-64Wiklund et al. The Efficacy of oxymetasoline Administered with a Nasal Bellows Container and Combined with Oral Phenoxymethyl-penicillin in the Treatment of Acute Maxillary Sinusitis. Acta Otolaryngol (Stockh) 1994; 515: 57-64

Active substance: OXITRIPTAN

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Document reference: 32958

Study title: Determination of dose-response curve for nebulised oxitropium-bromide in asthmatic preschool children using the Forced Oscillation Technique in a double blind randomized trial design.

Active substance: OXITROPIUM BROMIDE

Study summary document link (including results): oxitropium bromide_U98-0119_synopsis.pdf

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Document reference: 27100

Study title: Expertise clinique du produit C1491 oxolamine phosphate sirop adulte -prilon-

Active substance: OXOLAMINE

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Document reference: 45106

Study title: Expertise clinique du produit C1491 oxolamine phosphate sirop adulte -prilon-

Active substance: OXOLAMINE AND PROPYLPHENAZONE

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Document reference: 32971

Study title: Petrus−M. (Trial of oral paracetamol solution in febrile children). {Ann−Pediatr−Paris}, Feb 1983, vol. 30, no. 2, p. 131−3Petrus−M. (Trial of oral paracetamol solution in febrile children). {Ann−Pediatr−Paris}, Feb 1983, vol. 30, no. 2, p. 131−3

Active substance: PARACETAMOL

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Document reference: 45737

Study title: Phase IV Safety and Efficacy Study of C-30 Liquid Cough-Cold FormulaPhase IV Safety and Efficacy Study of C-30 Liquid Cough-Cold Formula

Active substance: PARACETAMOL

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Document reference: 45739

Study title: Polidori G., Titti G., Pieragostini P., Comito A., Scaricabarozzi I. : A comparison of nimesulide and paracetamol in the treatment of fever due to inflammatory diseases of the upper respiratory tract in children. Drugs (United States) 1993Polidori G., Titti G., Pieragostini P., Comito A., Scaricabarozzi I. : A comparison of nimesulide and paracetamol in the treatment of fever due to inflammatory diseases of the upper respiratory tract in children. Drugs (United States) 1993

Active substance: PARACETAMOL

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Document reference: 45740

Study title: Résultats et accidents de la prophylaxie par la pénicilline - Dagonet (Y.) & Gautier (M.) - 1969 (Journées parisiennes de Pédiatrie, 1 volume, Editions médicales Flammarion, p. 417 - 434)Résultats et accidents de la prophylaxie par la pénicilline - Dagonet (Y.) & Gautier (M.) - 1969 (Journées parisiennes de Pédiatrie, 1 volume, Editions médicales Flammarion, p. 417 - 434)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45883

Study title: Streptococcal infection in pediatric patients. Comparison of dicloxacillin with phenoxymethyl penicillin - Aronovitz (G. H.), Morgan (D. L.) & Spitzer (T. Q.) - 1968 (Amer. J. Dis. Child., 116, 66-69, July).Streptococcal infection in pediatric patients. Comparison of dicloxacillin with phenoxymethyl penicillin - Aronovitz (G. H.), Morgan (D. L.) & Spitzer (T. Q.) - 1968 (Amer. J. Dis. Child., 116, 66-69, July).

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45884

Study title: Table ronde sur l'infection streptococcique - Mozziconacci (P.) - 1969 (Journées parisiennes de Pédiatrie, 1 volume, Editions médicales Flammarion, p. 381 - 388)Table ronde sur l'infection streptococcique - Mozziconacci (P.) - 1969 (Journées parisiennes de Pédiatrie, 1 volume, Editions médicales Flammarion, p. 381 - 388)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45885

Study title: A phase III randomized multi-center study to assess the immunogenicity of three doses of Pediarix®, Prevnar® and ActHIB® given to healthy infants at 2, 4 and 6 months of age when administered with GlaxoSmithKline (GSK) Biologicals’ two-dose oral live attenuated human rotavirus (HRV) vaccine given during the same vaccination visit (at 2 and 4 months of age) or given separately (at 3 and 5 months of age).

Active substance: oral live attenuated human rotavirus

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Document reference: 45713

Study title: A phase IIIb, double-blind, randomized, placebo-controlled, multicentre study to assess the immunogenicity, safety and reactogenicity of 2 doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants (6-12 weeks of age at first dose) previously uninfected with human rotavirus.

Active substance: oral live attenuated human rotavirus

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Document reference: 45710

Study title: A phase IIIb, randomised, multicentre double-blind, placebo-controlled study of the immunogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (RIX4414) as primary dosing in healthy infants in India of approximately 8 weeks of age at the first dose.

Active substance: oral live attenuated human rotavirus

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Document reference: 45711

Study title: Oraalinen rehydraatio hypotonisella ja isotonisella liuoksella ja Lactobacillus GG-bakteeri akuutin ripulitaudin hoidossa

Active substance: ORAL REHYDRATION SALT FORMULATIONS

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Document reference: 32811

Study title: Rehydratation von Säuglingen und Kleinkindern mit einer neuen oralen Rehydrierungslösung; Guggenbichler et al; Dt. Apo. Zeitg. 130/35, 1912 - 1913 (1990)Rehydratation von Säuglingen und Kleinkindern mit einer neuen oralen Rehydrierungslösung; Guggenbichler et al; Dt. Apo. Zeitg. 130/35, 1912 - 1913 (1990)

Active substance: ORAL REHYDRATION SALT FORMULATIONS

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Document reference: 32810

Study title: Alupent syrup (H-304/1) and 20 mg tablets (H-741): dosage titration in pediatric use.

Active substance: ORCIPRENALINE

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Document reference: 45369

Study title: An association of orciprenaline+bromhexin and doxilamine for the treatment of bronchitis.

Active substance: ORCIPRENALINE

Study summary document link (including results): Orciprenaline sulphate_bromhexine hydrochloride_U70-0003_synopsis.pdf

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Document reference: 47647

Study title: Comparison of the effect of Alupent 20 mg and placebo when given as syrup (2 teaspoonsful) and tablet (one tablet) by pulmonary function tests in asthmatic children.

Active substance: ORCIPRENALINE

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Document reference: 45363

Study title: Determination of the safety and efficacy of Alupent syrup administered to children.

Active substance: ORCIPRENALINE

Study summary document link (including results): Orciprenaline sulphate_U76-0070_synopsis.pdf

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Document reference: 45371

Study title: An open−label dose−titration study of the efficacy and tolerability of tizanidine hydrochloride tablets in the prophylaxis of chronic daily headache.Saper JR, Winner PK, Lake AE−3rd. Headache, Apr 2001, vol. 41, no. 4, p. 357−68An open−label dose−titration study of the efficacy and tolerability of tizanidine hydrochloride tablets in the prophylaxis of chronic daily headache.Saper JR, Winner PK, Lake AE−3rd. Headache, Apr 2001, vol. 41, no. 4, p. 357−68

Active substance: TIZANIDINE

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Document reference: 38511

Study title: Chronic daily headache prophylaxis with tizanidine: a double−blind, placebo−controlled, multicenter outcome study. Saper JR, Lake AE−3rd, Cantrell DT, Winner PK, White JR. Headache, Jun 2002, vol. 42, no. 6, p. 470−82Chronic daily headache prophylaxis with tizanidine: a double−blind, placebo−controlled, multicenter outcome study. Saper JR, Lake AE−3rd, Cantrell DT, Winner PK, White JR. Headache, Jun 2002, vol. 42, no. 6, p. 470−82

Active substance: TIZANIDINE

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Document reference: 38510

Study title: Comparative double-blind trial between DS 103-282 and baclofen in the treatment of spasticity doe to cerebal palsy

Active substance: TIZANIDINE

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Document reference: 44781

Study title: (Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia). Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60(Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia). Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60

Active substance: TIZANIDINE

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Document reference: 38508

Study title: Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2. Granfors MT, Backman JT, Laitila J, Neuvonen PJ. Clinical pharmacology and therapeutics, Oct 2005, vol. 78, no. 4, p. 400−11Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2. Granfors MT, Backman JT, Laitila J, Neuvonen PJ. Clinical pharmacology and therapeutics, Oct 2005, vol. 78, no. 4, p. 400−11

Active substance: TIZANIDINE

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Document reference: 38507

Study title: Tizanidine treatment of spasticity: a meta−analysis of controlled, double−blind, comparative studies with baclofen and diazepam.Groves L, Shellenberger MK, Davis CS. Advances in therapy, Jul−Aug 1998, vol. 15, no. 4, p. 241−51.Tizanidine treatment of spasticity: a meta−analysis of controlled, double−blind, comparative studies with baclofen and diazepam.Groves L, Shellenberger MK, Davis CS. Advances in therapy, Jul−Aug 1998, vol. 15, no. 4, p. 241−51.

Active substance: TIZANIDINE

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Document reference: 38512

Study title: Treatments for spasticity and pain in multiple sclerosis: a systematic review.Beard S, Hunn A, Wight J. Health technology assessment (Winchester England), {Health−Technol− Assess}, 2003, vol. 7, no. 40, p. iii, ix−x, 1−111Treatments for spasticity and pain in multiple sclerosis: a systematic review.Beard S, Hunn A, Wight J. Health technology assessment (Winchester England), {Health−Technol− Assess}, 2003, vol. 7, no. 40, p. iii, ix−x, 1−111

Active substance: TIZANIDINE

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Document reference: 38509

Study title: A controlled, double-blind, clinical therapeutic, comparative study with two parallel groupd (DS 103-282 and diazepam) in ambulant/hospitalised patients with multiple sclerosis

Active substance: TIZANIDINE

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Document reference: 44782

Study title: 16. A placebo controlled 12 - week study of the safety and efficacy of one dose of topiramate versus lithium for the treatment of acute manic or mixed episodess in subjects with bipolar disorder i with an optionhal open -label extension.

Active substance: TOPIRAMATE

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Document reference: 44950

Study title: 18. Topiramate for the prophylactic treatment of cyclic vomiting syndrome in children.

Active substance: TOPIRAMATE

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Document reference: 44952

Study title: 19. Antiepilepsy drug effectiveness in pediatric partial epilepsy.

Active substance: TOPIRAMATE

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Document reference: 44953

Study title: 2. A double-blind trial comparing the efficacy, tolerability and safety of monotherapy topiramate versus phenytoin in subjects with seizures indicative of new onset epilepsy.

Active substance: TOPIRAMATE

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Document reference: 44936

Study title: A double-blind, single dose evaluation comparing the analgesic efficacy and adverse effect liability of acetaminophen 650 mg, acetaminophen 1000 mg and placebo in the treatment of postoperative pain following oral surgery.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol 0-223.pdf

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Document reference: 47505

Study title: A double-blind, single dose evaluation of the relative analgesia and safety of acetaminophen 2000 mg, 1500 mg, 1000 mg, 500 mg, and placebo in the treatment of pain following oral or periodontal surgery.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol 1-221.pdf

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Document reference: 47507

Study title: A double-blind, single-dose comparison of Advil 400 vs. APAP 1000 vs. placebo in the relief of post operative oral surgery pain

Active substance: PARACETAMOL

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Document reference: 45785

Study title: A double-blind, single-dose comparison of Advil 400 vs. APAP 1000 vs. placebo in the relief of post operative oral surgery pain

Active substance: PARACETAMOL

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Document reference: 45793

Study title: A double-dose, single dose evaluation comparing the analgesic efficacy and adverse effect liability of acetaminophen 650 mg, acetaminophen 1000 mg and placebo in the treatment of postoperative pain following oral surgery.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol 0-214.pdf

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Document reference: 47504

Study title: A multi-clinic report on the relative effectiveness of PARAFON FORTE® tablets, PARAFLEX® chlorzoxazone tablets, TYLENOL® acetaminophen tablets, and placebo as prescribed for the relief of pain associated with skeletal muscle spasms of the lower back.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol S and SIS 149-3-01.pdf

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Document reference: 47517

Study title: Antipyretic effectiveness of ibuprofen and paracetamol. An Pediatr Barc , Feb 2005, vol. 62, no. 2, p. 117-22 Antipyretic effectiveness of ibuprofen and paracetamol. An Pediatr Barc , Feb 2005, vol. 62, no. 2, p. 117-22

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33657

Study title: Antipyretic effects of dipyrone versus ibuprofen versus acetaminophen in children: Results of a multinational, randomized, modified double blind study. {CLIN PEDIATR}, 2001, Vol/Iss/Pg. 40/6 (313 324) Antipyretic effects of dipyrone versus ibuprofen versus acetaminophen in children: Results of a multinational, randomized, modified double blind study. {CLIN PEDIATR}, 2001, Vol/Iss/Pg. 40/6 (313 324)

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33658

Study title: Antipyretic effects of nimesulide, paracetamol and ibuprofen paracetamol. {INDIAN J PEDIATR}, 2000, Vol/Iss/Pg. 67 /12 (865-870) Antipyretic effects of nimesulide, paracetamol and ibuprofen paracetamol. {INDIAN J PEDIATR}, 2000, Vol/Iss/Pg. 67 /12 (865-870)

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33659

Study title: Bacteriology and treatment of purulent nasopharyngitis: a double blind, placebo-controlled evaluation. Todd JK, Todd N, Damato J, Todd WA. Pediatr Infect Dis. 1984 May-Jun;3(3):226-32.Bacteriology and treatment of purulent nasopharyngitis: a double blind, placebo-controlled evaluation. Todd JK, Todd N, Damato J, Todd WA. Pediatr Infect Dis. 1984 May-Jun;3(3):226-32.

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33643

Study title: Clinical trial of 3 days of treatment with oral pseudoephedrine for the common cold in the southern hemisphere. Am J Rhinol 2007; 21(4):452-5 Clinical trial of 3 days of treatment with oral pseudoephedrine for the common cold in the southern hemisphere. Am J Rhinol 2007; 21(4):452-5

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33631

Study title: Polidori−G et al. A comparison of nimesulide and paracetamol in the treatment of fever due to inflammatory diseases of the upper respiratory tract in children. {Drugs}, 1993, vol. 46 Suppl 1, p. 231−3Polidori−G et al. A comparison of nimesulide and paracetamol in the treatment of fever due to inflammatory diseases of the upper respiratory tract in children. {Drugs}, 1993, vol. 46 Suppl 1, p. 231−3

Active substance: PARACETAMOL

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Document reference: 45741

Study title: Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. {Lancet}, 9 Mar 1991, vol. 337, no. 8741, p. 591-4 Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. {Lancet}, 9 Mar 1991, vol. 337, no. 8741, p. 591-4

Active substance: PARACETAMOL

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Document reference: 45743

Study title: Russell−Fiona−M et al. Evidence on the use of paracetamol in febrile children. {Bull−World−Health−Organ}, 2003 (epub: 07 Jul 2003), vol. 81, no. 5, p. 367−72Russell−Fiona−M et al. Evidence on the use of paracetamol in febrile children. {Bull−World−Health−Organ}, 2003 (epub: 07 Jul 2003), vol. 81, no. 5, p. 367−72

Active substance: PARACETAMOL

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Document reference: 45744

Study title: Sarrell EM, et all. Antipyretic treatment in young children with fever: acetaminophen, ibuprofen, or both alternating in a randomized, double-blind study. Arch Pediatr Adolesc Med. 2006 Feb;160(2):197-202.Sarrell EM, et all. Antipyretic treatment in young children with fever: acetaminophen, ibuprofen, or both alternating in a randomized, double-blind study. Arch Pediatr Adolesc Med. 2006 Feb;160(2):197-202.

Active substance: PARACETAMOL

Study summary document link (including results):

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Document reference: 45745

Study title: Scolnik−D et al. Comparison of oral versus normal and high−dose rectal acetaminophen in the treatment of febrile children. {PEDIATRICS}, 2002, Vol/Iss/Pg. 110/3 (553−556)Scolnik−D et al. Comparison of oral versus normal and high−dose rectal acetaminophen in the treatment of febrile children. {PEDIATRICS}, 2002, Vol/Iss/Pg. 110/3 (553−556)

Active substance: PARACETAMOL

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Document reference: 45746

Study title: Sidler−J et al. A double−blind comparison of ibuprofen and paracetamol in juvenile pyrexia. {Br−J−Clin−Pract− Suppl}, Aug 1990, vol. 70, p. 22−5Sidler−J et al. A double−blind comparison of ibuprofen and paracetamol in juvenile pyrexia. {Br−J−Clin−Pract− Suppl}, Aug 1990, vol. 70, p. 22−5

Active substance: PARACETAMOL

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Document reference: 45747

Study title: Simila S. et Kylmamaa T. : Antipyretic effect of tenoxicam and paracetamol in febrile children. Drugs Exp. Clin. Res. 1985Simila S. et Kylmamaa T. : Antipyretic effect of tenoxicam and paracetamol in febrile children. Drugs Exp. Clin. Res. 1985

Active substance: PARACETAMOL

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Document reference: 45748

Study title: Kvien, T. K., Larheim, T. A., Hoyeraal, H. M., and Sandstad, B. Radiographic temporomandibular joint abnormalities in patients with juvenile chronic arthritis during a controlled study of sodium aurothiomalate and D-penicillamine Br.J.Rheumatol. 1986;25:59-66. Kvien, T. K., Larheim, T. A., Hoyeraal, H. M., and Sandstad, B. Radiographic temporomandibular joint abnormalities in patients with juvenile chronic arthritis during a controlled study of sodium aurothiomalate and D-penicillamine Br.J.Rheumatol. 1986;25:59-66.

Active substance: PENICILLAMINE

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Document reference: 33842

Study title: Open clinical trial using metaproterenol (Alupent) tablets.

Active substance: ORCIPRENALINE

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Document reference: 45359

Study title: Report on an efficacy and dosage study in children with bronchial asthma.

Active substance: ORCIPRENALINE

Study summary document link (including results): Orciprenaline sulphate_U85-0455_synopsis.pdf

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Document reference: 45372

Study title: Study to compare Alupent syrup with Quadrinal and Brondecon: serial pulmonary function studies to be the criteria after single doses of each.

Active substance: ORCIPRENALINE

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Document reference: 45358

Study title: Study to compare the duration of action of Alupent syrup, Quadrinal, and Brondecon.

Active substance: ORCIPRENALINE

Study summary document link (including results): Orciprenaline sulphate_U66-0252_synopsis.pdf

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Document reference: 45357

Study title: Study to compare the effect of two teaspoons of Alupent syrup with one 20 mg Alupent tablet, and with placebo.

Active substance: ORCIPRENALINE

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Document reference: 45360

Study title: Study to determine the safety of long term administration of Alupent syrup for the treatment of bronchial asthma in children.

Active substance: ORCIPRENALINE

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Document reference: 45368

Study title: AComparison of the Efficacy and Safety of CREON®20 and Placebo in the Treatment of Steatorrhea in Adult Cystic Fibrosis Patients with Clinical Exocrine Pancreatic Insufficiency

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-S223-3102.pdf

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Document reference: 47665

Study title: AComparison of the Efficacy and Safety ofCREON®20 and Placebo in the Treatment of Steatorrhea in Pediatric and Adolescent Cystic Fibrosis Patients with Clinical Exocrine Pancreatic Insufficiency

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-S223-3101.pdf

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Document reference: 47664

Study title: An open, multicenter, long-term study to assess the efficacy and tolerance of Kreon® in patients with pancreatic exocrine insufficiency caused by cystic fibrosis in comparison with a historical control group of healthy children.

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-KREO-584.pdf

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Document reference: 47656

Study title: Clinical Trial of High Lipase Pancreatic Enzyme Supplementation in Cystic Fibrosis: Evaluation of Creon® 25 000

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-K224-5006.pdf

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Document reference: 47654

Study title: Creon 8000 vs Creon 25: An Open Label Comparative Study

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-223-8-01.pdf

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Document reference: 47652

Study title: General efficacy and patient acceptance of Alupent Syrup.

Active substance: ORCIPRENALINE

Study summary document link (including results): Orciprenaline sulphate_U70-0089_synopsis.pdf

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Document reference: 45362

Study title: Double-blind, double-placebo controlled study comparing Creon® with Pancrex V Forte® tablets in the management of children with cystic fibrosis.

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-KREON-8402.pdf

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Document reference: 47661

Study title: Double-blind, multicenter, crossover study comparing the efficacy and tolerance of Creon® 25 000 versus Panzytrat® in patients with pancreatic exocrine insufficiency caused by cystic fibrosis.

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-K224-5001.pdf

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Document reference: 47653

Study title: Double-blind, multicenter, randomized, crossover study to prove equivalent efficacy of Creon® 10 000 minimicrospheresTM and Creon® 8 000 microspheres in patients with pancreatic exocrine insufficiency caused by cystic fibrosis

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-K245-5004.pdf

View full study record

Document reference: 45110

Study title: 2. Topamax (topiramate) monotherapy comparison trial to standard monotherapy in the treatment of newly diagnosed epilepsy (rwj-17021-000); phase IIIb

Active substance: TOPIRAMATE

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Document reference: 44835

Study title: 20. Low dose topiramate monotherapy substitution trial in young epilepsy patients failing first conventional anticonvulsant.

Active substance: TOPIRAMATE

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Document reference: 44954

Study title: 21. Adolescent migraine prophylaxis.

Active substance: TOPIRAMATE

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Document reference: 44955

Study title: 22. Pk/ tol phase 1 in infants.

Active substance: TOPIRAMATE

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Document reference: 44956

Study title: 23. Double blind trial for partial onset seizures efficacy.

Active substance: TOPIRAMATE

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Document reference: 44957

Study title: 25. Open-label monocenter study to investigate the tolerability, safety and efficacy of topamax in disabled or mentally handicapped patients aged 14 or older.

Active substance: TOPIRAMATE

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Document reference: 44959

Study title: 26. Infantile spasms with hypsarrhythmia.

Active substance: TOPIRAMATE

Study summary document link (including results):

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Document reference: 44960

Study title: 27. Compassionate use of Topamax.

Active substance: TOPIRAMATE

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Document reference: 44961

Study title: 27. n/a

Active substance: TOPIRAMATE

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Document reference: 44878

Study title: 27. n/a

Active substance: TOPIRAMATE

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Document reference: 44901

Study title: 28. Retrospective chart review of patients diagnosed with infantile spasms and hypsarrythmia.

Active substance: TOPIRAMATE

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Document reference: 44962

Study title: 29. A retrospective chart review of infants with infantile spasm of which some were treated with Topamax.

Active substance: TOPIRAMATE

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Document reference: 44963

Study title: 3. Evaluation of the optimal dose of topiramate in epilepsy monotherapy.

Active substance: TOPIRAMATE

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Document reference: 44937

Study title: 3. Open-label, single center, safety, pharmacokinetics, and efficacy clinical trial in pediatric subjects with epilepsy

Active substance: TOPIRAMATE

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Document reference: 44836

Study title: 30. Topiramate first add-on open label trial in pediatric subjects with inadequately controlled epilepsy

Active substance: TOPIRAMATE

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Document reference: 44879

Study title: 30. Topiramate first add-on open label trial in pediatric subjects with inadequately controlled epilepsy.

Active substance: TOPIRAMATE

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Document reference: 44964

Study title: 31. Prospective evaluation of epilepsy treatment with topiramate.

Active substance: TOPIRAMATE

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Document reference: 44965

Study title: 32. Safety and Efficacy of Topamax in Monotherapy or Combined Therapy in Children & Adult Patients with Epilepsy, in an Observational Study with Medium Duration of 8 Months.

Active substance: TOPIRAMATE

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Document reference: 44966

Study title: 33. Study of the optimization of anti-epileptic treatment in paediatric patients.

Active substance: TOPIRAMATE

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Document reference: 44967

Study title: 36. Topamax 1st line add on

Active substance: TOPIRAMATE

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Document reference: 44880

Study title: 36. Topamax in der Therapie kindlicher Epilepsien (Topamax in the Therapy of Childlike Epilepsy (patients > 2 years)).

Active substance: TOPIRAMATE

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Document reference: 44970

Study title: A placebo-controlled, double-blind study of the safety and efficacy of Nasacort AQ nasal spray in children with perennial allergic rhinitis - Simpson BE - 07/08/1996 - Report in Rapport d'Expert sur la documentation clinique - Staudinger H - Update Dossier 24/03/1997 -

Active substance: TRIAMCINOLONE

Study summary document link (including results): Triamcinolone Acetonide-Study 3.pdf

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Document reference: 46824

Study title: Effectiveness of pseudoephedrine plus acetaminophen for treatment of symptoms attributed to the paranasal sinuses associated with the common cold. Arch Fam Med 2000; 9(10):979-85 Effectiveness of pseudoephedrine plus acetaminophen for treatment of symptoms attributed to the paranasal sinuses associated with the common cold. Arch Fam Med 2000; 9(10):979-85

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33634

Study title: Effects of semprex-D and diphenhydramine on learning in young adults with seasonal allergic rhinitis. Vuurman EF, van Veggel LM, Sanders RL, Muntjewerff ND, O'Hanlon, JF. Ann Allergy Asthma Immunol. 1996 Mar;76(3):247-52.Effects of semprex-D and diphenhydramine on learning in young adults with seasonal allergic rhinitis. Vuurman EF, van Veggel LM, Sanders RL, Muntjewerff ND, O'Hanlon, JF. Ann Allergy Asthma Immunol. 1996 Mar;76(3):247-52.

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33641

Study title: Efficacy of acrivastine plus pseudoephedrine for symptomatic relief of seasonal allergic rhinitis due to mountain cedar. Ann Allergy Asthma Immunol 1996; 76(5):432-438Efficacy of acrivastine plus pseudoephedrine for symptomatic relief of seasonal allergic rhinitis due to mountain cedar. Ann Allergy Asthma Immunol 1996; 76(5):432-438

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33637

Study title: Efficacy of Sinubid (Sinutab® SA) in children. Research Report 932-0040.

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

Study summary document link (including results): paracetamol_pseudoephedrine RR932-0040.pdf

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Document reference: 47416

Study title: Borgmann et al.Cystine Stones in a Tree-Year Old Boy; Zeitschr-Kinderderchirurgie 1978; 25Borgmann et al.Cystine Stones in a Tree-Year Old Boy; Zeitschr-Kinderderchirurgie 1978; 25

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33963

Study title: Breitwieser et al.Conservative treatment of uric acid sone diathesis; Med. Welt 1967, 8: 2130-2135Breitwieser et al.Conservative treatment of uric acid sone diathesis; Med. Welt 1967, 8: 2130-2135

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33964

Study title: Careddu et al. Treatment of lower Urinary Tract infections in Children: single Dose Fosfomycin Trometamol Versus Pipemidic Acid. Chemioterapia, 6 pp 290-294, 1987 Careddu et al. Treatment of lower Urinary Tract infections in Children: single Dose Fosfomycin Trometamol Versus Pipemidic Acid. Chemioterapia, 6 pp 290-294, 1987

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33961

Study title: Cossolini M, Sonzogni V, Di Dedda G, Fruga F, Pansera C, Pirola C, et al. Paediatric cold heart surgery: experience with creatine phosphate added to cardioplegic solution heart surgery. Acts of 5th International Symposium on Cardiac Surgery - Rome (Italy), May 25-28, 1993: 442-443Cossolini M, Sonzogni V, Di Dedda G, Fruga F, Pansera C, Pirola C, et al. Paediatric cold heart surgery: experience with creatine phosphate added to cardioplegic solution heart surgery. Acts of 5th International Symposium on Cardiac Surgery - Rome (Italy), May 25-28, 1993: 442-443

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33959

Study title: Effect of pseudoephedrine on nasal airflow in patients with nasal congestion associated with common cold. Rhinology 1998; 36(2):73-6 Effect of pseudoephedrine on nasal airflow in patients with nasal congestion associated with common cold. Rhinology 1998; 36(2):73-6

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33635

Study title: Lakatos, L., Hatvani, I., Oroszlan, G., Balla, G., Karmazsin, L., Alaka, O., Kincses, E., Szabo, I., and Lakatos, Z. Controlled trial of D-penicillamine to prevent retinopathy of prematurity Acta Paediatr.Hung. 1986;27:47-56. Lakatos, L., Hatvani, I., Oroszlan, G., Balla, G., Karmazsin, L., Alaka, O., Kincses, E., Szabo, I., and Lakatos, Z. Controlled trial of D-penicillamine to prevent retinopathy of prematurity Acta Paediatr.Hung. 1986;27:47-56.

Active substance: PENICILLAMINE

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Document reference: 33843

Study title: Lakatos, L., Kover, B., and Peter, F. D-penicillamine therapy of neonatal hyperbilirubinaemia Acta Paediatr.Acad.Sci.Hung. 1974;15:77-85. Lakatos, L., Kover, B., and Peter, F. D-penicillamine therapy of neonatal hyperbilirubinaemia Acta Paediatr.Acad.Sci.Hung. 1974;15:77-85.

Active substance: PENICILLAMINE

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Document reference: 33846

Study title: Pradhan, A. M., Bhave, S. A., Joshi, V. V., Bavdekar, A. R., Pandit, A. N., and Tanner, M. S. Department of Paediatrics, K.E.M. Hospital, Pune, India Reversal of Indian childhood cirrhosis by D-penicillamine therapy J.Pediatr.Gastroenterol.Nutr. 1995;20:28-35. Pradhan, A. M., Bhave, S. A., Joshi, V. V., Bavdekar, A. R., Pandit, A. N., and Tanner, M. S. Department of Paediatrics, K.E.M. Hospital, Pune, India Reversal of Indian childhood cirrhosis by D-penicillamine therapy J.Pediatr.Gastroenterol.Nutr. 1995;20:28-35.

Active substance: PENICILLAMINE

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Document reference: 33840

Study title: Prieur, A. M., Piussan, C., Manigne, P., Bordigoni, P., and Griscelli, C. Evaluation of D-penicillamine in juvenile chronic arthritis. A double-blind, multicenter study Arthritis Rheum. 1985;28:376-382. Prieur, A. M., Piussan, C., Manigne, P., Bordigoni, P., and Griscelli, C. Evaluation of D-penicillamine in juvenile chronic arthritis. A double-blind, multicenter study Arthritis Rheum. 1985;28:376-382.

Active substance: PENICILLAMINE

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Document reference: 33844

Study title: Radiographic temporomandibular joint abnormalities in patients with juvenile chronic arthritis during a controlled study of sodium aurothiomalate and D-penicillamine Radiographic temporomandibular joint abnormalities in patients with juvenile chronic arthritis during a controlled study of sodium aurothiomalate and D-penicillamine

Active substance: PENICILLAMINE

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Document reference: 33849

Study title: Roelofs, R. I., de Arango, G. S., Law, P. K., Kinsman, D., Buchanan, D. C., and Park, J. H. Treatment of Duchenne's muscular dystrophy with penicillamine. Results of a double-blind trial Arch.Neurol. 1979;36:266-268. Roelofs, R. I., de Arango, G. S., Law, P. K., Kinsman, D., Buchanan, D. C., and Park, J. H. Treatment of Duchenne's muscular dystrophy with penicillamine. Results of a double-blind trial Arch.Neurol. 1979;36:266-268.

Active substance: PENICILLAMINE

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Document reference: 33845

Study title: Final Study Report: Bioavailability of three Vitamin K1 preparations (cremophore /119, mixed micelles /131, mixed micelles /141) relative to Tween 80/143 formulation (M10400/BK14677)

Active substance: PHYTOMENADION

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Document reference: 34049

Study title: Final Study report: Influence of intravenous, Intramuscular and oral administration of Konakion MM Paediatric on Bilirubin Binding to albumin in Full-Term Neonates (BK15055)

Active substance: PHYTOMENADION

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Document reference: 34048

Study title: Pharmacokinetics of a single dose of vitamin K1 (10mg) mixed micelles solution administered i.m. to four cholestatic babies

Active substance: PHYTOMENADION

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Document reference: 34066

Study title: Plasma levels of vitamin K1 and PIVKA levels in breast fed infants after repeated oral administration of 0.5 mg vitamin K1.

Active substance: PHYTOMENADION

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Document reference: 34051

Study title: Plasma Vitamin K1 and PIVKA-II Levels in Breast Fed Infants after Oral Administration of Ro 01-6722/141 (0.25 mg Vitamin K1) at Birth.

Active substance: PHYTOMENADION

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Document reference: 34052

Study title: Double-blind, placebo-controlled, randomized, multicenter, crossover study to investigate Whether the dose~dependent effect of Creon· MinimicrospheresTN on the postprandial fat assimilation can be shown with the 13C-mixed triglyceride breath test in patients with pancreatic exocrine insufficiency due to cystic fibrosis

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-S245-4004.pdf

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Document reference: 47670

Study title: Double-blind, randomized, cross-over study comparing the efficacy and tolerance of Creon® and Pancrease® in children and young adults with cystic fibrosis

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-KREON-586.pdf

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Document reference: 47660

Study title: Double~blind, bicenter, randomized, crossover study to prove equivalent efficacy and tolerance of Creon® 25 000 Minimicrospheres™ versus Creon® 25 000 Microspheres (Pankreon® forte) in patients with pancreatic exocrine insufficiency caused by cystic fibrosis.

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-S248-3002.pdf

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Document reference: 47672

Study title: George DE, Toskes PP, Sitren HS, Downey ::..r. Comparison of two pancreatic enzyme supplements in patients with cystic fibrosis. Adv Therapy 1990;7:109-118. (RR.1044-01).

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-RR1044-01.pdf

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Document reference: 47663

Study title: "OPEN LABEL. MULTICENTER, CROSSOVER STUDY TO DEMONSTRATE THE PATIENTS'PREFERENCE OF CREON 8000 OVER PANCREASE IN TilE TREATMENT OF PANCREATIC EXOCRINE INSUFFICIENCY INDUCED BY CYSTIC FIBROSIS

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-KREO-636.pdf

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Document reference: 47659

Study title: Open single-center study to investigate the pharmacodynamics of Creon® 25 000 minimicrospheres measured by 13C.triglyceride breath test and gastric emptying measured by 13C_octanoate breath test in cystic fibrosis patients using healthy children not receiving Creon® 25 000 minimicrospheres as controls

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-S248-2001.pdf

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Document reference: 47671

Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with sore throat pain. Dec 1992.A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with sore throat pain. Dec 1992.

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33606

Study title: A double-blind multiple dose study of the comparative antipyretic effectiveness and safety of standard and double standard doses of acetaminophen in febrile children. Jun 1986.A double-blind multiple dose study of the comparative antipyretic effectiveness and safety of standard and double standard doses of acetaminophen in febrile children. Jun 1986.

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33613

Study title: A phase II study comparing the efficacy and pharmacokinetic/pharmacodynamic profile of acetaminophen extended release suspension, acetaminophen extended release chewable tablets, and acetaminophen elixir in febrile children. Jun 1997.A phase II study comparing the efficacy and pharmacokinetic/pharmacodynamic profile of acetaminophen extended release suspension, acetaminophen extended release chewable tablets, and acetaminophen elixir in febrile children. Jun 1997.

Active substance: PARACETAMOL AND PHENYLEPHRINE

Study summary document link (including results):

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Document reference: 33608

Study title: A phase III combined study of efficacy and side effects profile of extended release acetaminophen pediatric chewable tablets compared to acetaminophen eight-hour extended release pediatric suspension in the treatment of febrile children. Aug 1998.A phase III combined study of efficacy and side effects profile of extended release acetaminophen pediatric chewable tablets compared to acetaminophen eight-hour extended release pediatric suspension in the treatment of febrile children. Aug 1998.

Active substance: PARACETAMOL AND PHENYLEPHRINE

Study summary document link (including results):

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Document reference: 33607

Study title: A randomize, multicenter, double-blind, placebo-controlled, parallel group study of the 12 month effect of treatment with once daily triamcinolone acetonide (NASACORT® AQ Nasal Spray 110 µg or NASACORT® HFA Nasal Aerosol 220 µg) on the growth velocity of children, 2 to 8 years of age, with perennial allergic rhinitis (PAR) - No author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46821

Study title: A randomized, double-blind, parallel group, placebo-controlled, four-week efficacy and safety evaluation of Nasacort AQ 110 μg QD, followed by six-month open-label safety in children ages 2-5 years with perennial allergic rhinitis

Active substance: TRIAMCINOLONE

Study summary document link (including results): Triamcinolone Acetonide-Study 1.pdf

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Document reference: 46825

Study title: A randomized, placebo-controlled, parallel-group, multiple dose study of RG 5029Y on Hypotalamic-pituitary-Adrenal (HPA) function and pharmacokinetic profile in pediatric patients with allergic rhinitis - Rom D - 22/12/1995 - Report in Rapport d'Expert sur la documentation clinique - Staudinger H - Update Dossier 24/03/1997 -

Active substance: TRIAMCINOLONE

Study summary document link (including results): Triamcinolone Acetonide-Study 4.pdf

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Document reference: 46826

Study title: A single-center, double-blind, placebo-controlled, randomized study to determine the time of onset of sustained relief after the first dose of NASACORT® AQ (TAA 220 µg) in symptomatic patients with allergic rhinitis - Pedersen M - No date

Active substance: TRIAMCINOLONE

Study summary document link (including results):

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Document reference: 46827

Study title: An open-label long term study of the safety of Nasacort 134a Nasal Inhaler in patients with perennial allergic rhinitis - Simpson BE - 15/11/1996

Active substance: TRIAMCINOLONE

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Document reference: 46828

Study title: An open-label, long-term study of WHR 5029 NasacortTM) in patients with perennial rhinitis - No Author - No date - Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 -

Active substance: TRIAMCINOLONE

Study summary document link (including results):

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Document reference: 46829

Study title: An Open-Label, Repeat Dose, Multicenter Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Intranasally Administered Triamcinolone Acetonide (Nasacort AQ) in Pediatric Allergic Rhinitis Patients 2 to 5 Years of Age Compared to Adult Patients 18 to 50 Years of Age

Active substance: TRIAMCINOLONE

Study summary document link (including results): Triamcinolone Acetonide-Study 2.pdf

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Document reference: 46830

Study title: Controlled clinical study comparing the efficacy of twice daily applications of westcort (hydrocortisone valerate) cream 0,2% and Kenalog (triamcinolonacetonide) cream 0,1% in the treatment of children with atopic dermatitis.

Active substance: TRIAMCINOLONE

Study summary document link (including results):

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Document reference: 46820

Study title: A Phase III multicenter, parallel group, randomized, open study of Triamcinolone acetonide HFA 75µg oral inhaler, compared to Beclomethasone dipropionate in mild symptomatic to moderate asthmatic children, involving 280 patients - No author - No date

Active substance: TRIAMCINOLONE

Study summary document link (including results):

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Document reference: 46823

Study title: Nasacort® (triamcinolone acetonide nasal aerosol) vs Claritin® (loratadine) in patients with seasonal ragweed allergic rhinitis - No Author - 22/04/1994 - Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/199 -

Active substance: TRIAMCINOLONE

Study summary document link (including results):

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Document reference: 46831

Study title: Phase III, Single Center, Randomized, Cross-Over Pediatric Trial With Nasacort AQ Nasal Spray Assessing Short Term Growth In Patients With Allergic Rhinitis

Active substance: TRIAMCINOLONE

Study summary document link (including results): Triamcinolone Acetonide-Study 5.pdf

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Document reference: 47347

Study title: Publication in CES - Ruuth E - 19/10/2001 Triamcinolone acetonide aqueous nasal inhaler and fluticasone propionate have no effect on short-term growth in children with allergic rhinitis - Skoner D - 2000 ( Allergy 2000; 55(Suppl 63): 184)

Active substance: TRIAMCINOLONE

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Document reference: 46832

Study title: Surgery. 1984 Dec;96(6):1078-82. Preliminary results of thallium 201 and technetium 99m subtraction scanning of parathyroid glands. Wheeler MH, Harrison BJ, French AP, Leach KG. Surgery. 1984 Dec;96(6):1078-82. Preliminary results of thallium 201 and technetium 99m subtraction scanning of parathyroid glands. Wheeler MH, Harrison BJ, French AP, Leach KG.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44707

Study title: Dal Monte A, Leonardi LM, Figura F, Cappozzo A, Marchetti M, De Santis AM. Effects of phosphocreatine administration on muscle strength in man. Gazz. Med. Ital. 1976; 135 (9): 439-448Dal Monte A, Leonardi LM, Figura F, Cappozzo A, Marchetti M, De Santis AM. Effects of phosphocreatine administration on muscle strength in man. Gazz. Med. Ital. 1976; 135 (9): 439-448

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33960

Study title: Efficacy and safety of phloroglucinol versus hyoscine-n-butylbromide for the treatment of dysmenorrheic pain. a clinical trial. Deligeoroglou E. et col. XI worl congress paediatric & adolescent gynaecology 1995. book of abstractEfficacy and safety of phloroglucinol versus hyoscine-n-butylbromide for the treatment of dysmenorrheic pain. a clinical trial. Deligeoroglou E. et col. XI worl congress paediatric & adolescent gynaecology 1995. book of abstract

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33956

Study title: Endo et al.The use of GC-120 to children with metabolic acidosis; Shinyaku to Rhinsho 1986;35(8): 8(1804) - 12(1808)Endo et al.The use of GC-120 to children with metabolic acidosis; Shinyaku to Rhinsho 1986;35(8): 8(1804) - 12(1808)

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33965

Study title: Hussain et al Aetiology, course and outcome of children admitted to paediatric intensive care with convulsive status epilepticus: a retrospective 5-year review. Seizure 2007, Jun; 16(4):305-12Hussain et al Aetiology, course and outcome of children admitted to paediatric intensive care with convulsive status epilepticus: a retrospective 5-year review. Seizure 2007, Jun; 16(4):305-12

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33955

Study title: Principi N. et al. Fosfomycin Trometamol versus Netilmicin in Children's Lower Urinary Tract Infections. Chemotherapy, 36 suppl. 1 pp 41-45 1990 Principi N. et al. Fosfomycin Trometamol versus Netilmicin in Children's Lower Urinary Tract Infections. Chemotherapy, 36 suppl. 1 pp 41-45 1990

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33962

Study title: Fitzgerald DA, Kilham HA. Croup: Assessment and evidence-based management. Medical Journal of Australia. 2003; 179(7):372-7.Fitzgerald DA, Kilham HA. Croup: Assessment and evidence-based management. Medical Journal of Australia. 2003; 179(7):372-7.

Active substance: OXITRIPTAN

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Document reference: 32939

Study title: Five medium term double blind controlled trials in children comparing Ditropan with placeboFive medium term double blind controlled trials in children comparing Ditropan with placebo

Active substance: OXITRIPTAN

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Document reference: 32921

Study title: Gleeson JG, Green S, Price JF. Air or oxygen as driving gas for nebulised salbutamol. Arch Dis Child 1988; 63:900-4.Gleeson JG, Green S, Price JF. Air or oxygen as driving gas for nebulised salbutamol. Arch Dis Child 1988; 63:900-4.

Active substance: OXITRIPTAN

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Document reference: 32940

Study title: Graf et al. Ten days' Use of Oxymetazoline Nasal Spray With or Without Benzalkonium Chloride in Patients With Vasomotor Rhinits. Arch Otolaryngol Head Neck Surg 1999; 125: 1128-1132Graf et al. Ten days' Use of Oxymetazoline Nasal Spray With or Without Benzalkonium Chloride in Patients With Vasomotor Rhinits. Arch Otolaryngol Head Neck Surg 1999; 125: 1128-1132

Active substance: OXITRIPTAN

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Document reference: 32960

Study title: Graf, Hallén. Effect on the Nasal Mucosa of Long-Term Treatment With Oxymetazoline, Benzalkonium Chloride, and Placebo Nasal Sprays. Laryngoscope 1996; 106:605-609Graf, Hallén. Effect on the Nasal Mucosa of Long-Term Treatment With Oxymetazoline, Benzalkonium Chloride, and Placebo Nasal Sprays. Laryngoscope 1996; 106:605-609

Active substance: OXITRIPTAN

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Document reference: 32959

Study title: Plasma vitamin K1 and PIVKA-II levels in breast fed infants after repeated oral administration of Ro 01-6722/141 (2x0.25 mg vitamin K1).

Active substance: PHYTOMENADION

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Document reference: 34050

Study title: Prophylaxis of hemorrhagic disease in the newborn

Active substance: PHYTOMENADION

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Document reference: 41624

Study title: Randomized comparative trial to evaluate efficacy and tolerability of Konakion MM, Ro 01-6722/135, Konakion drops Ro 01-6722/119 intramuscularly in the prophylaxis of hemorrhagic disease in newbord, breastfed infants

Active substance: PHYTOMENADION

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Document reference: 34062

Study title: Tolerability of Ro 01-6722/120 (vitamin K1) in infants with stable cholestasis

Active substance: PHYTOMENADION

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Document reference: 34067

Study title: Aivazis V, Hatzimichail A, Papachristou A, Valeri R, Iuga-Donca G. "Clinical evaluation and changes of the respiratory epithelium function after administration of Pidotimod in Greek children with recurrent respiratory tract infections."Publication: Minerva Pediatr 2002; 54: 315-319Aivazis V, Hatzimichail A, Papachristou A, Valeri R, Iuga-Donca G. "Clinical evaluation and changes of the respiratory epithelium function after administration of Pidotimod in Greek children with recurrent respiratory tract infections."Publication: Minerva Pediatr 2002; 54: 315-319

Active substance: PIDOTIMOD

Study summary document link (including results): Aivazis_2002_pidotimod.pdf

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Document reference: 34077

Study title: Arzneimittelforschung. 1994 Dec;44(12A):1490-4. Therapeutic efficacy and safety of pidotimod in the treatment of urinary tract infections in children. Clemente E, Solli R, Mei V, Cera R, Caramia G, Carnelli V, Ruffini E, Venturoli V, Corsini A.Arzneimittelforschung. 1994 Dec;44(12A):1490-4. Therapeutic efficacy and safety of pidotimod in the treatment of urinary tract infections in children. Clemente E, Solli R, Mei V, Cera R, Caramia G, Carnelli V, Ruffini E, Venturoli V, Corsini A.

Active substance: PIDOTIMOD

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Document reference: 34070

Study title: Arzneimittelforschung. 1994 Dec;44(12A):1506-11. Role of immunoactivation with pidotimod in recurrent respiratory infections in childhood. Careddu P. Arzneimittelforschung. 1994 Dec;44(12A):1506-11. Role of immunoactivation with pidotimod in recurrent respiratory infections in childhood. Careddu P.

Active substance: PIDOTIMOD

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Document reference: 34072

Study title: Arzneimittelforschung. 1994 Dec;44(12A):1525-9 Immunoactivation by pidotimod in children with recurrent respiratory infections. Burgio GR, Marseglia GL, Severi F, De Benedetti F, Masarone M, Ottolenghi A, Pagliano L, Serra U, Nespoli LArzneimittelforschung. 1994 Dec;44(12A):1525-9 Immunoactivation by pidotimod in children with recurrent respiratory infections. Burgio GR, Marseglia GL, Severi F, De Benedetti F, Masarone M, Ottolenghi A, Pagliano L, Serra U, Nespoli L

Active substance: PIDOTIMOD

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Document reference: 34076

Study title: Clin Evid. 2005 Jun;(13):444-57. Review Urinary tract infection in children. Larcombe J.Clin Evid. 2005 Jun;(13):444-57. Review Urinary tract infection in children. Larcombe J.

Active substance: PIDOTIMOD

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Document reference: 34073

Study title: Studio clinico dell'Uniplus. Rapporto sperimentale

Active substance: OXOLAMINE AND PROPYLPHENAZONE

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Document reference: 32972

Study title: 6847 R.P. DOXERGAN (Specia) - Pellerat P.J.- 1964 (Revue lyonnaise de médecine, 13 (8), 403-410,1964.) (translation) - Publication 4 in Clinical trial of a new antihistaminic -

Active substance: OXOMEMAZINE

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Document reference: 32973

Study title: DOXERGAN (OXOMEMAZINE)- Tablet 10mg, Syrup 01%.. Summary document. France validation dossier 17/06/1988. Clinical information. Reference to clinical Expert report from LARBRE F., Lyon 12/07/1962. Children 5months-13 years treated from 4 to 21 days. (French language)

Active substance: OXOMEMAZINE

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Document reference: 32974

Study title:

Active substance: OXYBUPROCAINE

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Document reference: 32975

Study title: A phase III double-blind, single dose study of the comparative antipyretic effectiveness and safety of standard and double standard (C-47) doses of acetaminophen in febrile children. Jan 1984.A phase III double-blind, single dose study of the comparative antipyretic effectiveness and safety of standard and double standard (C-47) doses of acetaminophen in febrile children. Jan 1984.

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33614

Study title: A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Chewable Tablets Compared to Children's Tylenol Chewable Tablets in the Treatment of Febrile Children. Dec 1994.A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Chewable Tablets Compared to Children's Tylenol Chewable Tablets in the Treatment of Febrile Children. Dec 1994.

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33610

Study title: A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Suspension Compared to Children's Tylenol Elixir in the Treatment of Febrile Children.   94-406, Unpublished Report CSR204. May 1997.A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Suspension Compared to Children's Tylenol Elixir in the Treatment of Febrile Children.   94-406, Unpublished Report CSR204. May 1997.

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33609

Study title: Traitement des angines aiguës de l'enfant - De Paillerets F., Rivron M. & Boussangant Y. - 1977 (Rev. Prat., 27 (59) 4129 - 4132)Traitement des angines aiguës de l'enfant - De Paillerets F., Rivron M. & Boussangant Y. - 1977 (Rev. Prat., 27 (59) 4129 - 4132)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45886

Study title: Un R.A.A. de l'enfant. Hambourg M. - 1973 (Gaz. Méd. France, 80 (3) 345 - 352)Un R.A.A. de l'enfant. Hambourg M. - 1973 (Gaz. Méd. France, 80 (3) 345 - 352)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45887

Study title: Utilisation de l'Oricilline en pédiatrie - Pennaforte F. & Pennaforte M. - 1970 (Ann. Méd. Reims, 159 - 165)Utilisation de l'Oricilline en pédiatrie - Pennaforte F. & Pennaforte M. - 1970 (Ann. Méd. Reims, 159 - 165)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45888

Study title: Gazzolo, D., Masetti, P., Kornacka, M., Abella, R., Bruschettini, P., and Michetti, F. Department of Pediatrics, G Gaslini University Hospital, Genoa, Italy. Phentolamine administration increases blood S100B protein levels in pediatric open-heart surgery patients Acta Paediatr. 2003;92:1427-1432.Gazzolo, D., Masetti, P., Kornacka, M., Abella, R., Bruschettini, P., and Michetti, F. Department of Pediatrics, G Gaslini University Hospital, Genoa, Italy. Phentolamine administration increases blood S100B protein levels in pediatric open-heart surgery patients Acta Paediatr. 2003;92:1427-1432.

Active substance: PHENTOLAMINE

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Document reference: 33929

Study title: Koner, O., Tekin, S., Koner, A., Soybir, N., Seren, S., and Karaoglu, K. Department of Anaesthesiology and Intensive Care, Cardiology Institute of Istanbul University, Turkey Effects of phentolamine on tissue perfusion in pediatric cardiac surgery J.Cardiothorac.Vasc.Anesth. 1999;13:191-197. Koner, O., Tekin, S., Koner, A., Soybir, N., Seren, S., and Karaoglu, K. Department of Anaesthesiology and Intensive Care, Cardiology Institute of Istanbul University, Turkey Effects of phentolamine on tissue perfusion in pediatric cardiac surgery J.Cardiothorac.Vasc.Anesth. 1999;13:191-197.

Active substance: PHENTOLAMINE

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Document reference: 33928

Study title:

Active substance: PHENYLEPHRINE

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Document reference: 33946

Study title: Abernathy RS. A survey of 156 seizure patients in a general pediatric clinic. J Lancet. 1966 Mar;86(3):115-20.Abernathy RS. A survey of 156 seizure patients in a general pediatric clinic. J Lancet. 1966 Mar;86(3):115-20.

Active substance: PHENYLEPHRINE

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Document reference: 33942

Study title: Thyroid. 2006 Dec;16(12):1243-9. Characterization of follicular thyroid nodules at fine needle aspiration biopsy using double phase thallium-201 imaging: comparison of visual and semiquantitative analyses. Kim SJ, Kim IJ, Kang YH, Kim YK. Thyroid. 2006 Dec;16(12):1243-9. Characterization of follicular thyroid nodules at fine needle aspiration biopsy using double phase thallium-201 imaging: comparison of visual and semiquantitative analyses. Kim SJ, Kim IJ, Kang YH, Kim YK.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44709

Study title: Tokai J Exp Clin Med. 1982 Jan;7(1):69-75. Thallium--201 myocardial imaging in Kawasaki disease. Kato S, Ohta T, Suzuki Y, Matsuyama S. Tokai J Exp Clin Med. 1982 Jan;7(1):69-75. Thallium--201 myocardial imaging in Kawasaki disease. Kato S, Ohta T, Suzuki Y, Matsuyama S.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44710

Study title: Wien Klin Wochenschr. 1988 Dec 16;100(24):792-7. [Value of myocardial scintigraphy of coronary anomaly in the differential diagnosis of pediatric cardiomegaly] [Article in German] Schlemmer M, Pachinger O, Sochor H, Strigl E, Salzer-Muhar U, Wimmer M. Wien Klin Wochenschr. 1988 Dec 16;100(24):792-7. [Value of myocardial scintigraphy of coronary anomaly in the differential diagnosis of pediatric cardiomegaly] [Article in German] Schlemmer M, Pachinger O, Sochor H, Strigl E, Salzer-Muhar U, Wimmer M.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44711

Study title: Z Gesamte Inn Med. 1989 Jan 15;44(2):54-7. [Hyperthyroidism and its relation to heart function] [Article in German] Marek H, Kellner K, Duck HJ, Neumann G, Krosse B, Machill K. Z Gesamte Inn Med. 1989 Jan 15;44(2):54-7. [Hyperthyroidism and its relation to heart function] [Article in German] Marek H, Kellner K, Duck HJ, Neumann G, Krosse B, Machill K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44712

Study title: Z Kardiol. 1988 Aug;77(8):503-7. [Disorders of myocardial perfusion in Kawasaki syndrome: noninvasive detection by 201 thallium tomography] [Article in German] Nienaber CA, Hausdorf G, Spielmann RP. Z Kardiol. 1988 Aug;77(8):503-7. [Disorders of myocardial perfusion in Kawasaki syndrome: noninvasive detection by 201 thallium tomography] [Article in German] Nienaber CA, Hausdorf G, Spielmann RP.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44713

Study title: Zhonghua Nei Ke Za Zhi. 1985 Dec;24(12):715-8, 767-8. [Clinical evaluation of thallium-201 myocardial imaging] [Article in Chinese] Liu XJ, Shi RF, Guo XZ. Zhonghua Nei Ke Za Zhi. 1985 Dec;24(12):715-8, 767-8. [Clinical evaluation of thallium-201 myocardial imaging] [Article in Chinese] Liu XJ, Shi RF, Guo XZ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44714

Study title: Surg Clin North Am. 1987 Apr;67(2):343-57. How to recognize and treat parathyroid carcinoma. Fujimoto Y, Obara T. Surg Clin North Am. 1987 Apr;67(2):343-57. How to recognize and treat parathyroid carcinoma. Fujimoto Y, Obara T.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44706

Study title: 214/92: Efficacy of BY158K vs. terbutaline on the oscillatory resistance in children aged 2 to 5 years suffering from bronchial asthma

Active substance: THEOPHYLLINE

Study summary document link (including results): Study report 214-92 Theopyhlline - synopsis.pdf

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Document reference: 44731

Study title: A Multiclinic Evaluation of the efficacy and safety of Ciprofloxacin Ophthalmic Ointment versus TOBREX Ophthalmic Ointment in treating bacterial conjuncivitis (C8824a).

Active substance: TOBRAMYCIN

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Document reference: 44815

Study title: Clinical and microbiological study comparing CILOXAN Ophthalmic Solution to TOBREX Ophthalmic Solution for treating bacterial conjunctivitis in children (C9174),

Active substance: TOBRAMYCIN

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Document reference: 44817

Study title: Inwald D, Roland M, Kuitert L, Sheila AM, Petros A. Oxygen treatment of acute severe asthma. BMJ (Indian ed) 2001; 17:732-4.Inwald D, Roland M, Kuitert L, Sheila AM, Petros A. Oxygen treatment of acute severe asthma. BMJ (Indian ed) 2001; 17:732-4.

Active substance: OXITRIPTAN

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Document reference: 32941

Study title: Inwald D, Roland M, Kuitert L, Sheila AM, Petros A. Oxygen treatment of acute severe asthma. BMJ (Indian ed) 2001;17:732-4.Inwald D, Roland M, Kuitert L, Sheila AM, Petros A. Oxygen treatment of acute severe asthma. BMJ (Indian ed) 2001;17:732-4.

Active substance: OXITRIPTAN

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Document reference: 32954

Study title: Kinsey VE. Cooperative study of retrolental fibroplasia and the use of oxygen. Arch Ophthalmol 1956;56:481-543. Kinsey VE. Cooperative study of retrolental fibroplasia and the use of oxygen. Arch Ophthalmol 1956;56:481-543.

Active substance: OXITRIPTAN

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Document reference: 32942

Study title: Macey PM, Woo MA, Harper RM. Hyperoxic brain effects are normalized by addition of CO2. PLoS Med. 2007 May;4(5):e173Macey PM, Woo MA, Harper RM. Hyperoxic brain effects are normalized by addition of CO2. PLoS Med. 2007 May;4(5):e173

Active substance: OXITRIPTAN

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Document reference: 32957

Study title: Neonatal inhaled nitric oxide study group. Inhaled nitric oxide in full term and nearly full term infants with hypoxic respiratory failure. NEJM 1997 Feb 27; 336(9):597-604.Neonatal inhaled nitric oxide study group. Inhaled nitric oxide in full term and nearly full term infants with hypoxic respiratory failure. NEJM 1997 Feb 27; 336(9):597-604.

Active substance: OXITRIPTAN

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Document reference: 32943

Study title: Oxybutynin does not affect cyclosporin blood levels - Springate JE - J Drug Monit - 2001; 23(2):155-156Oxybutynin does not affect cyclosporin blood levels - Springate JE - J Drug Monit - 2001; 23(2):155-156

Active substance: OXITRIPTAN

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Document reference: 32922

Study title: Plasma levels of Oxybutynin chloride in children - Autret E, Jonville AP, Dutertre JP, Bertiere MC, Robert M, Averous M. Couet W - Eur J Clin Pharmacol - 1994; 46:83-85Plasma levels of Oxybutynin chloride in children - Autret E, Jonville AP, Dutertre JP, Bertiere MC, Robert M, Averous M. Couet W - Eur J Clin Pharmacol - 1994; 46:83-85

Active substance: OXITRIPTAN

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Document reference: 32923

Study title: A phase III multiple dose use study of APAP extended release pediatric chewable tablets compared to Children’s Tylenol® chewable tablets in the treatment of febrile children.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol 93-341.pdf

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Document reference: 47511

Study title: A phase III multiple dose use study of APAP extended release pediatric suspension compared to Children’s Tylenol® elixir in the treatment of febrile children.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol 94-406.pdf

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Document reference: 47512

Study title: A Randomized, Double-Blind, Double-Dummy, Single-Center Pilot Study of the Speed of Onset of Analgesia of Extra Strength TylenolÒ Adult Liquid (1000 mg) Compared with Extra Strength Tylenol® Caplet (1000 mg) in Post-Operative Dental Pain

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol 98-046.pdf

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Document reference: 47514

Study title: A single dose study to compare the efficacy of acetaminophen sustained release pediatric chewable tablets to ibuprofen suspension in febrile children. Dec 1994.A single dose study to compare the efficacy of acetaminophen sustained release pediatric chewable tablets to ibuprofen suspension in febrile children. Dec 1994.

Active substance: PARACETAMOL

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Document reference: 33437

Study title: A Single-Dose, Double-Blind, Placebo-Controlled Study of the Relative Efficacy and Safety of Acetaminophen at Doses of 500 mg and 1000 mg in Postoperative Dental Pain

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol 02-156.pdf

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Document reference: 47508

Study title: Diclofenac vs oxybuprocaine eyedrops for analgesia in paediatric strabismus surgery. Morton NS, Benham SW, Lawson RA, McNicol LR. Paediatr Anaesth. 1997;7(3):221-6.Diclofenac vs oxybuprocaine eyedrops for analgesia in paediatric strabismus surgery. Morton NS, Benham SW, Lawson RA, McNicol LR. Paediatr Anaesth. 1997;7(3):221-6.

Active substance: OXYBUPROCAINE

Study summary document link (including results): Diclofenac vs oxybuprocaine eyedrops for analgesia.pdf

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Document reference: 45105

Study title: "An Aetiopathogenic and Therapeutic Study with Oxybutynin Chloride - Grassetti F et al. - Ped Oggi - 1986 (6(1): 47-51) - Publication in UK registration file - Enuresis -" "An Aetiopathogenic and Therapeutic Study with Oxybutynin Chloride - Grassetti F et al. - Ped Oggi - 1986 (6(1): 47-51) - Publication in UK registration file - Enuresis -"

Active substance: OXYBUTYNIN

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Document reference: 32981

Study title: "Anticholinergic therapy for primary enuresis efficacy of oxybutynin chloride in a controlled clinical trial in 58 patients - Marconi A.M., Felici E., Roggia A., Torelli F. - Ped. Med. Chir - Med. Surg. Ped. - 1985 (7:573-576) - Publication in UK registration file - " "Anticholinergic therapy for primary enuresis efficacy of oxybutynin chloride in a controlled clinical trial in 58 patients - Marconi A.M., Felici E., Roggia A., Torelli F. - Ped. Med. Chir - Med. Surg. Ped. - 1985 (7:573-576) - Publication in UK registration file - "

Active substance: OXYBUTYNIN

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Document reference: 32982

Study title: Clinical investigation I : Enuresis with diurnal micturitional trouble in children

Active substance: OXYBUTYNIN

Study summary document link (including results): Oxybutinin STUDY Debat 1.xls

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Document reference: 48016

Study title: Clinical investigation I continued: Enuresis with diurnal micturitional trouble in children

Active substance: OXYBUTYNIN

Study summary document link (including results): Oxybutinin STUDY Debat 2.xls

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Document reference: 48017

Study title: Clinical investigation Ill: Detrusor hyperreflexia

Active substance: OXYBUTYNIN

Study summary document link (including results): Oxybutinin STUDY Debat 3.xls

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Document reference: 48018

Study title: Five medium term double blind controlled trials in children comparing Ditropan with placebo Five medium term double blind controlled trials in children comparing Ditropan with placebo

Active substance: OXYBUTYNIN

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Document reference: 32994

Study title: Long term double blind controlled studies in children

Active substance: OXYBUTYNIN

Study summary document link (including results): Oxybutynin STUDY Marion 012-022.xls

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Document reference: 33000

Study title: Long term double blind controlled studies in children

Active substance: OXYBUTYNIN

Study summary document link (including results): Oxybutynin STUDY Marion 012-031.xls

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Document reference: 33001

Study title: Long term double blind controlled studies in children

Active substance: OXYBUTYNIN

Study summary document link (including results): Oxybutynin STUDY Marion 012-069.xls

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Document reference: 33003

Study title: Long term double blind controlled studies in children

Active substance: OXYBUTYNIN

Study summary document link (including results): Oxybutynin STUDY Marion 012-019.xls

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Document reference: 32999

Study title: Similä−S, Kylmämaa−T. Antipyretic effect of tenoxicam and paracetamol in febrile children. {Drugs−Exp−Clin−Res}, 1985, vol. 11, no. 10, p. 731−4Similä−S, Kylmämaa−T. Antipyretic effect of tenoxicam and paracetamol in febrile children. {Drugs−Exp−Clin−Res}, 1985, vol. 11, no. 10, p. 731−4

Active substance: PARACETAMOL

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Document reference: 45749

Study title: Single dose, placebo controlled comparative study of ibuprofen and acetaminophen antipyresis in children. {J Pediatr}, Nov 1991, vol. 119, no. 5, p. 803-11Single dose, placebo controlled comparative study of ibuprofen and acetaminophen antipyresis in children. {J Pediatr}, Nov 1991, vol. 119, no. 5, p. 803-11

Active substance: PARACETAMOL

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Document reference: 45750

Study title: Alonso EM, Piper JB, Echols G, Thistlethwaite JR, Whitington PF . (1996) . Allograft rejection in pediatric recipients of living related liver transplants . Hepatology 23 :40-43Alonso EM, Piper JB, Echols G, Thistlethwaite JR, Whitington PF . (1996) . Allograft rejection in pediatric recipients of living related liver transplants . Hepatology 23 :40-43

Active substance: PHENYLEPHRINE

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Document reference: 33944

Study title: Bacon CJ, Cranage JD, Hierons AM, Rawlins MD, Webb JK. Behavioural effects of phenobarbitone and phenytoin in small children. Arch Dis Child. 1981 Nov;56(11):836-40.Bacon CJ, Cranage JD, Hierons AM, Rawlins MD, Webb JK. Behavioural effects of phenobarbitone and phenytoin in small children. Arch Dis Child. 1981 Nov;56(11):836-40.

Active substance: PHENYLEPHRINE

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Document reference: 33934

Study title: Bacon CJ, Hierons AM, Mucklow JC, Webb JK, Rawlins MD, Weightman D. Placebo-controlled study of phenobarbitone and phenytoin in the prophylaxis of febrile convulsions. Lancet. 1981 Sep 19;2(8247):600-4.Bacon CJ, Hierons AM, Mucklow JC, Webb JK, Rawlins MD, Weightman D. Placebo-controlled study of phenobarbitone and phenytoin in the prophylaxis of febrile convulsions. Lancet. 1981 Sep 19;2(8247):600-4.

Active substance: PHENYLEPHRINE

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Document reference: 33935

Study title: Study to determine the safety and efficacy of long term administration of Alupent syrup for the treatment of bronchial asthma in children.

Active substance: ORCIPRENALINE

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Document reference: 45367

Study title: Study to determine the safety and efficacy of long-term administration of Alupent syrup for the treatment of bronchial asthma in children.

Active substance: ORCIPRENALINE

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Document reference: 45364

Study title: Study to determine the safety and efficacy of long-term administration of Alupent syrup for the treatment of bronchial asthma in children.

Active substance: ORCIPRENALINE

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Document reference: 45365

Study title: Study to determine the safety and efficacy of long-term administration of Alupent syrup to children.

Active substance: ORCIPRENALINE

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Document reference: 45366

Study title: Study to investigate the efficacy, side effects and possible development of tolerance associated with the use of Alupent syrup in asthmatic children, as compared with syrup of ephedrine. Effects of single doses of either medication on pulmonary function

Active substance: ORCIPRENALINE

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Document reference: 45361

Study title: To determine the safety and efficacy of Alupent Syrup administered to children.

Active substance: ORCIPRENALINE

Study summary document link (including results): Orciprenaline sulphate_U76-0064_synopsis.pdf

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Document reference: 45370

Study title: Comparative evaluation of intravenous and oral ornidazole vs. clindamycin in acute infections due to anaerobic bacteria.

Active substance: ORNIDAZOLE

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Document reference: 45375

Study title: Multiple i.v. dose pharmacokinetics of ornidazole (TIBERAL) in neonates

Active substance: ORNIDAZOLE

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Document reference: 45373

Study title: Prospective, non-comparative, one center study, evaluating the efficacy and safety of the combination of 2g ceftriaxone plus 1g ornidazole administered as a short intravenous infusion once daily in the treatment of severe chorioamnionitis.

Active substance: ORNIDAZOLE

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Document reference: 45374

Study title: Short term treatment of symptomatic and asymptomatic giardisis with ordinazole (Ro-07-0207). Comparaison of the efficacy of a single dose given once or for 2 or 3 consecutive days

Active substance: ORNIDAZOLE

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Document reference: 45376

Study title: Marsden CD The treatment of severe dystonia in children and adults. J.Neurol.Neurosurg.Psych. 1984;47:1166-1173.Marsden CD The treatment of severe dystonia in children and adults. J.Neurol.Neurosurg.Psych. 1984;47:1166-1173.

Active substance: ORPHENADINE

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Document reference: 32901

Study title: Oberbaum et al: Experimental treatment of Chemotherapy-Induced Stomatitis Using a Homeopathic Complex Preparation. Biol Ther 1998;(4):261-265 [IIT-publication]

Active substance: Traumeel - Ampullen

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Document reference: 40282

Study title: Oberbaum, M et al.: A Randomized, Controlled Clinical Trial of the Homeopathic Medication Traumeel S in the Treatment of Chemotherapy-Induced Stomatitis in Children Undergoing Stem Cell Transplantation. Cancer 2001;92(3):684-690 [IIT-publication]

Active substance: Traumeel - Ampullen

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Document reference: 40281

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (ampoules) [AWB-AT]

Active substance: Traumeel - Ampullen

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Document reference: 40284

Study title: Volosovetz A.P. et al: Efficience of antihomotoxic Traumeel S preparation applied in the form of intravenous injection in the combined intensive therapy of newborns suffering from brain hypoxia-ischemia. Biological Therapy (Ukraine), 2004, 2: 24-28 [IIT-publication]

Active substance: Traumeel - Ampullen

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Document reference: 40286

Study title: Report on a clinical trial of Rhinogutt" drops via nebulizer."

Active substance: TRAMAZOLINE

Study summary document link (including results): Tramazoline Hydrochloride_U73-0127_synopsis.pdf

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Document reference: 46702

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (tablets/drops) [AWB-009]

Active substance: Traumeel - Tropfen

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Document reference: 40278

Study title: Bannikov, Mihail Y.; Vasilenko, Inna V.: Anwendung von homöopathischen Komplexmitteln in der Behandlungakuter kindlicher Speiseröhrenverätzungen. Biol Med 2000 (29):253-254 [IIT-publication]

Active substance: Traumeel S

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Document reference: 40270

Study title: Oberbaum et al: Experimental treatment of Chemotherapy-Induced Stomatitis Using a Homeopathic Complex Preparation. Biol Ther 1998;(4):261-265 [IIT-publication

Active substance: Traumeel S

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Document reference: 40269

Study title: Oberbaum, M et al.: A Randomized, Controlled Clinical Trial of the Homeopathic Medication Traumeel S in the Treatment of Chemotherapy-Induced Stomatitis in Children Undergoing Stem Cell Transplantation. Cancer 2001;92(3):684-690 [IIT-publication]

Active substance: Traumeel S

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Document reference: 40268

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (tablets) in children aged up to 11 years old [AWB-090]

Active substance: Traumeel S

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Document reference: 40265

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (ointment) in children aged up to 11 years old [AWB-091]

Active substance: Traumeel S

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Document reference: 40274

Study title: Prospective, multicenter, observational study to document therapeutic data relating to the treatment of tendopathy with Traumeel S (ointment) [AWB-146];

Active substance: Traumeel S

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Document reference: 40275

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (tablets/drops) [AWB-009]

Active substance: Traumeel S

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Document reference: 40264

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (tablets) [AWB-112];

Active substance: Traumeel S

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Document reference: 40266

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (drops) [AWB-AT]; Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (tablets/drops) [AWB-009];

Active substance: Traumeel S

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Document reference: 40267

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (ampoules) [AWB-AT];

Active substance: Traumeel S

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Document reference: 40272

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (ointment) [AWB-AT]

Active substance: Traumeel S

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Document reference: 40273

Study title: Retrospective survey for documentation of appllication and dosage of Traumeel S (ointment) in children < 12 years of age [Bef-023]

Active substance: Traumeel S

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Document reference: 40276

Study title: Tsymbal, I.N.; Plahuta, T.G.; Vdovin, V.V. u.a.: Traumeel S in treatment of intramuscular hematomas in children with hemophilia. Thromb Haemostasis 1997;(suppl246):PS-1007 [IIT-publication]

Active substance: Traumeel S

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Document reference: 40263

Study title: Volosovetz A.P. et al: Efficience of antihomotoxic Traumeel S preparation applied in the form of intravenous injection in the combined intensive therapy of newborns suffering from brain hypoxia-ischemia. Biological Therapy (Ukraine), 2004, 2: 24-28 [IIT-

Active substance: Traumeel S

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Document reference: 40271

Study title: European Commission Scientific Committee on Food. Opinion of the Scientific Commitee on Food on the tolerable upper intake leval of vitamin B6 (http : // europa.eu.int/comm/food/fs/sc/scf/index en.htlm) - 11/2000 - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -European Commission Scientific Committee on Food. Opinion of the Scientific Commitee on Food on the tolerable upper intake leval of vitamin B6 (http : // europa.eu.int/comm/food/fs/sc/scf/index en.htlm) - 11/2000 - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31487

Study title: Experiencia clinica con el glutamate B6 en algunos deficits intelectuales infantilesM Knobel

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

Study summary document link (including results): CL-GB6_M.KNOBEL.pdf

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Document reference: 48081

Study title: Extract of submission to the UK's Food Standards Agency - P. Holford et al. - 2003 (Journal of Orthomolecular Medicine vol 18) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31482

Study title: Folch et al.

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

Study summary document link (including results): Folch-GABA+GABOB+piridoxine+magnesium bromhydrate glutamate.xls

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Document reference: 48082

Study title: High - dose pyridoxine and magnesium administration in children with autistic disorder : an absence of salutary effect in a double-blind, placebo-controlled study - R.L Finding et al. - 1997 (Journal of Autism and Developmental Disorders vol 27) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -High - dose pyridoxine and magnesium administration in children with autistic disorder : an absence of salutary effect in a double-blind, placebo-controlled study - R.L Finding et al. - 1997 (Journal of Autism and Developmental Disorders vol 27) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Eston...

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31488

Study title: Institute of Medicine (US). Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Food and Nutrition Board. Dietary Reference Intakes for folate, other B vitamins, and choline. - no author - 1999 (Washington DC : National Academy Press) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Institute of Medicine (US). Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Food and Nutrition Board. Dietary Reference Intakes for folate, other B vitamins, and choline. - no author - 1999 (Washington DC : National Academy Press) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised dur...

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31489

Study title: Matinez Mendoza 1991Martinez Mendoza 1991

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

Study summary document link (including results): Martinez2GABA+GABOB+piridoxine+magnesium bromhydrate glutamate.xls

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Document reference: 48086

Study title: Matinez Mendoza 1992Martinez Mendoza 1992

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

Study summary document link (including results): Martinez1GABA+GABOB+piridoxine+magnesium bromhydrate glutamate.xls

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Document reference: 48085

Study title:

Active substance: TIAGABINE

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Document reference: 38465

Study title:

Active substance: TIAGABINE

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Document reference: 38475

Study title:

Active substance: TIAGABINE

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Document reference: 38489

Study title:

Active substance: TIAGABINE

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Document reference: 38490

Study title:

Active substance: TIAGABINE

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Document reference: 38491

Study title:

Active substance: TIAGABINE

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Document reference: 38492

Study title:

Active substance: TIAGABINE

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Document reference: 38493

Study title:

Active substance: TIAGABINE

Study summary document link (including results):

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Document reference: 38494

Study title:

Active substance: TIAGABINE

Study summary document link (including results):

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Document reference: 38495

Study title:

Active substance: TIAGABINE

Study summary document link (including results):

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Document reference: 38496

Study title:

Active substance: TIAGABINE

Study summary document link (including results):

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Document reference: 38500

Study title:

Active substance: TIAGABINE

Study summary document link (including results):

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Document reference: 38501

Study title:

Active substance: TIAGABINE

Study summary document link (including results):

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Document reference: 38502

Study title:

Active substance: TIAGABINE

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Document reference: 38503

Study title: AJR Am J Roentgenol. 2007 Feb;188(2):572-8. The cause and clinical significance of central tumor photopenia on thallium scintigraphy of pediatric osteosarcoma of the extremity. McCarville MB, Barton EH, Cameron JR, Xiong X, Daw NC, Kaste SC, Wu S, GlassAJR Am J Roentgenol. 2007 Feb;188(2):572-8. The cause and clinical significance of central tumor photopenia on thallium scintigraphy of pediatric osteosarcoma of the extremity. McCarville MB, Barton EH, Cameron JR, Xiong X, Daw NC, Kaste SC, Wu S, Glass

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44494

Study title: Am Heart J. 1984 Apr;107(4):718-25. The cardiokymography exercise test compared to the thallium-201 perfusion exercise test in the diagnosis of coronary artery disease. Burke JF, Morganroth J, Soffer J, Panidis I, Chen CC, David D. Am Heart J. 1984 Apr;107(4):718-25. The cardiokymography exercise test compared to the thallium-201 perfusion exercise test in the diagnosis of coronary artery disease. Burke JF, Morganroth J, Soffer J, Panidis I, Chen CC, David D.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44495

Study title:

Active substance: TIAGABINE

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Document reference: 38464

Study title: Am Heart J. 1986 Apr;111(4):760-7. Resting thallium-201 myocardial perfusion patterns in patients with severe left ventricular dysfunction: differences between patients with primary cardiomyopathy, chronic coronary artery disease, or acute myocardial infAm Heart J. 1986 Apr;111(4):760-7. Resting thallium-201 myocardial perfusion patterns in patients with severe left ventricular dysfunction: differences between patients with primary cardiomyopathy, chronic coronary artery disease, or acute myocardial inf

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44496

Study title: Am Heart J. 1988 Dec;116(6 Pt 1):1575-9. Dipyridamole-thallium-201 tomography documenting improved myocardial perfusion with therapy in Kawasaki disease. Nienaber CA, Spielmann RP, Hausdorf G Am Heart J. 1988 Dec;116(6 Pt 1):1575-9. Dipyridamole-thallium-201 tomography documenting improved myocardial perfusion with therapy in Kawasaki disease. Nienaber CA, Spielmann RP, Hausdorf G

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44497

Study title: Am Heart J. 1988 Oct;116(4):1028-33. ECG findings after myocardial infarction in children after Kawasaki disease. Nakanishi T, Takao A, Kondoh C, Nakazawa M, Hiroe M, Matsumoto Y. Am Heart J. 1988 Oct;116(4):1028-33. ECG findings after myocardial infarction in children after Kawasaki disease. Nakanishi T, Takao A, Kondoh C, Nakazawa M, Hiroe M, Matsumoto Y.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44498

Study title: Kaku Igaku. 1983 Dec;20(10):1433-40. [Evaluation of myocardial involvement in Duchenne progressive muscular dystrophy with thallium-201 myocardial perfusion imaging] [Article in Japanese] Kawai N, Yamamoto S, Okada M, Iwase M, Miyakoda H, Yokota M, SoKaku Igaku. 1983 Dec;20(10):1433-40. [Evaluation of myocardial involvement in Duchenne progressive muscular dystrophy with thallium-201 myocardial perfusion imaging] [Article in Japanese] Kawai N, Yamamoto S, Okada M, Iwase M, Miyakoda H, Yokota M, So

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44639

Study title: Kaku Igaku. 1983 Jun;20(5):633-40. [ECG-gated single photon emission computed tomography for thallium-201 myocardial imaging in patients with hypertrophic cardiomyophathy.] [Article in Japanese] Futagami Y, Hamada M, Ichikawa T, Konishi T, Nakano T, TaKaku Igaku. 1983 Jun;20(5):633-40. [ECG-gated single photon emission computed tomography for thallium-201 myocardial imaging in patients with hypertrophic cardiomyophathy.] [Article in Japanese] Futagami Y, Hamada M, Ichikawa T, Konishi T, Nakano T, Ta

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44640

Study title: Kaku Igaku. 1983 Mar;20(2):179-91. [Quantitative evaluation of right ventricular overload with thallium-201 myocardial perfusion scintigraphy] [Article in Japanese] Watanabe T, Miyakoda H, Koike Y, Itatsu H, Kawai N, Sotobata I. Kaku Igaku. 1983 Mar;20(2):179-91. [Quantitative evaluation of right ventricular overload with thallium-201 myocardial perfusion scintigraphy] [Article in Japanese] Watanabe T, Miyakoda H, Koike Y, Itatsu H, Kawai N, Sotobata I.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44641

Study title: Kaku Igaku. 1985 Sep;22(9):1353-9. [Evaluation of cardiomyopathy in Duchenne muscular dystrophy by Tl-201 myocardial SPECT] [Article in Japanese] Jinnouchi S, Asai J, Inoue K, Hoshi H, Watanabe K. Kaku Igaku. 1985 Sep;22(9):1353-9. [Evaluation of cardiomyopathy in Duchenne muscular dystrophy by Tl-201 myocardial SPECT] [Article in Japanese] Jinnouchi S, Asai J, Inoue K, Hoshi H, Watanabe K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44642

Study title: Kaku Igaku. 1987 Feb;24(2):177-80. [Quantitative estimation of right ventricular pressure overloading by Tl-201 myocardial SPECT] [Article in Japanese] Kunieda E, Ogawa K, Nishiguchi I, Kubo A, Hashimoto S, Iwanaga S, Handa S. Kaku Igaku. 1987 Feb;24(2):177-80. [Quantitative estimation of right ventricular pressure overloading by Tl-201 myocardial SPECT] [Article in Japanese] Kunieda E, Ogawa K, Nishiguchi I, Kubo A, Hashimoto S, Iwanaga S, Handa S.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44643

Study title: Kaku Igaku. 1993 Jan;30(1):41-9. [Assessment of congenital heart disease by a thallium-201 SPECT study in children: accuracy of estimated right to left ventricular pressure ratio] [Article in Japanese] Ishii I, Nakajima K, Taki J, Taniguchi M, Bunko H,Kaku Igaku. 1993 Jan;30(1):41-9. [Assessment of congenital heart disease by a thallium-201 SPECT study in children: accuracy of estimated right to left ventricular pressure ratio] [Article in Japanese] Ishii I, Nakajima K, Taki J, Taniguchi M, Bunko H,

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44644

Study title: Clinical trial. Drops. Infants and Children - Larbre F. - 23/06/1973

Active substance: TIAPRIDE

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Document reference: 44750

Study title: Die behandlung extrapyramidaler bewegungsstorungen im kindes alter mit tiapridal R - Klepel H. Gebelt H. - 04/86 Traitement par le tiapridal des troubles moteurs extra-pyramidaux chez l'enfant - Klepel H. Gebelt H. - 04/86

Active substance: TIAPRIDE

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Document reference: 44751

Study title: Die behandlung extrapyramidaler hyperkinesen im kindes alter mit tiapridal R - Klepel H - 16/12/85

Active substance: TIAPRIDE

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Document reference: 44752

Study title: Expertise en pédiatrie du FLO 1347 soluté injectable - Fontaine G. - 02/02/73

Active substance: TIAPRIDE

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Document reference: 44744

Study title: Nippon Igaku Hoshasen Gakkai Zasshi. 1994 Jul 25;54(8):789-97. [Diffuse slow washout pattern (DSWO) on exercise stress thallium-201 myocardial SPECT: correlative study with coronary arteriography and the related clinical factors] [Article in Japanese] Nippon Igaku Hoshasen Gakkai Zasshi. 1994 Jul 25;54(8):789-97. [Diffuse slow washout pattern (DSWO) on exercise stress thallium-201 myocardial SPECT: correlative study with coronary arteriography and the related clinical factors] [Article in Japanese]

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44670

Study title: Nippon Kyobu Geka Gakkai Zasshi. 1989 Jan;37(1):103-9. [Follow-up study of coronary artery bypass grafting after Kawasaki disease--early and late postoperative evaluation] [Article in Japanese] Ohara K, Yagihara T, Kishimoto H, Isobe F, Yamamoto F, NabNippon Kyobu Geka Gakkai Zasshi. 1989 Jan;37(1):103-9. [Follow-up study of coronary artery bypass grafting after Kawasaki disease--early and late postoperative evaluation] [Article in Japanese] Ohara K, Yagihara T, Kishimoto H, Isobe F, Yamamoto F, Nab

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44671

Study title: Nippon Naika Gakkai Zasshi. 1986 Sep;75(9):1234-42. [Evaluation of myocardial and skeletal muscular involvement with thallium-201 myocardial emission computed tomography and whole body scintigraphy] [Article in Japanese] Yamamoto S, Matsushima H, SotobNippon Naika Gakkai Zasshi. 1986 Sep;75(9):1234-42. [Evaluation of myocardial and skeletal muscular involvement with thallium-201 myocardial emission computed tomography and whole body scintigraphy] [Article in Japanese] Yamamoto S, Matsushima H, Sotob

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44672

Study title: Nucl Med Commun. 1985 Dec;6(12):753-62. Idiopathic hypertrophic sub-aortic stenosis (IHSS): a new diagnostic method using ECG-gated thallium-201 myocardial scintigraphy. Garty I, Flatau E, Bloch L. Nucl Med Commun. 1985 Dec;6(12):753-62. Idiopathic hypertrophic sub-aortic stenosis (IHSS): a new diagnostic method using ECG-gated thallium-201 myocardial scintigraphy. Garty I, Flatau E, Bloch L.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44673

Study title: Nucl Med Commun. 1989 Jul;10(7):477-85. Role of thallium-201 in the diagnosis of solitary bone lesions. Elgazzar AH, Malki AA, Abdel-Dayem HM, Mahmoud A, Sahweil A, Razzak S, Jahan S, el-Sayed M, Omar YT. Nucl Med Commun. 1989 Jul;10(7):477-85. Role of thallium-201 in the diagnosis of solitary bone lesions. Elgazzar AH, Malki AA, Abdel-Dayem HM, Mahmoud A, Sahweil A, Razzak S, Jahan S, el-Sayed M, Omar YT.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44674

Study title: Nucl Med Commun. 2000 Aug;21(8):729-34. Thallium-201 myocardial SPET in patients with collagen disease. Ishida R, Murata Y, Sawada Y, Nishioka K, Shibuya H. Nucl Med Commun. 2000 Aug;21(8):729-34. Thallium-201 myocardial SPET in patients with collagen disease. Ishida R, Murata Y, Sawada Y, Nishioka K, Shibuya H.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44675

Study title: Nucl Med Commun. 2001 Sep;22(9):1015-9. Inhomogeneity of myocardial perfusion in heart transplant recipients: evaluation with dobutamine thallium-201 SPECT. Yen RF, Ho YL, Chou NK, Hsu RB, Huang PJ Nucl Med Commun. 2001 Sep;22(9):1015-9. Inhomogeneity of myocardial perfusion in heart transplant recipients: evaluation with dobutamine thallium-201 SPECT. Yen RF, Ho YL, Chou NK, Hsu RB, Huang PJ

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44676

Study title: Nucl Med Commun. 2003 Mar;24(3):327-30. Erratum in: Nucl Med Commun. 2003 Apr;24(4):483. Differentiation of soft tissue haemangioma by 201Tl scintigraphy. Higuchi T, Taki J, Nakajima K, Kinuya S, Nonomura A, Tsuchiya H, Bunko H, Namura M, Tonami NNucl Med Commun. 2003 Mar;24(3):327-30. Erratum in: Nucl Med Commun. 2003 Apr;24(4):483. Differentiation of soft tissue haemangioma by 201Tl scintigraphy. Higuchi T, Taki J, Nakajima K, Kinuya S, Nonomura A, Tsuchiya H, Bunko H, Namura M, Tonami N

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44677

Study title: A Multicentre Open Randomised Parallel-Group Trial of Meropenem versus Ceftoxamine plus Metronidazole in the Treatment of Abdominal Infections

Active substance: MEROPENEM TRIHYDRATE

Study summary document link (including results): 3591IL0027.xls

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Document reference: 31623

Study title: A Single-Blind Randomised Comparative Study of MERREM (Meropenem) Versus Cefotaxime in the Treatment of Acute Bacterial Meningitis in Hospitalised Infants and Children.

Active substance: MEROPENEM TRIHYDRATE

Study summary document link (including results): 3591IL0065.xls

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Document reference: 31621

Study title: Efficacy and tolerability of Meropenem 20 mg/kg tid in infants (3-12 months old) vs meropenem tid in children (1-14 years old) for the initial treatment of severe infections in hospitalised children.

Active substance: MEROPENEM TRIHYDRATE

Study summary document link (including results): 3591IL9003.xls

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Document reference: 31622

Study title: Meropenem versus Ceftazidime plus Amikacin as Empirical Therapy for Fever in Cancer Patients with Granulocytopenia; A Prospective, Randomised, Multicentre Study.

Active substance: MEROPENEM TRIHYDRATE

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Document reference: 31620

Study title: Support for recruitment to Turkish study comparing Merrem with Ceftazidime + Amikacin in the empirical treatment of febrile infective episodes in neutropenic padiatric patients in Latin America.

Active substance: MEROPENEM TRIHYDRATE

Study summary document link (including results): 3591IL9006.xls

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Document reference: 31624

Study title: A RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP STUDY TO DETERMINE THE PHARMACOKINETICS OF MESALAMINE FOLLOWING ADMINISTRATION OF 30 MG/KG/DAY, 60 MG/KG/DAY, AND 90 MG/KG/DAY AS 400 MG DELAYEDRELEASE TABLETS GIVEN EVERY 12 HOURS FOR 28 DAYS TO CHILDREN AND ADOLESCENTS WITH ACTIVE ULCERATIVE COLITIS

Active substance: MESALAZINE

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Document reference: 31644

Study title: A. Griffiths. et al. Slow-release 5-Aminosalicylic acid therapy in children with small intestinal Crohn’s Disease. Journal of Pediatric Gastroenterology and Nutrition 1993; 17: 186-92A. Griffiths. et al. Slow-release 5-Aminosalicylic acid therapy in children with small intestinal Crohn’s Disease. Journal of Pediatric Gastroenterology and Nutrition 1993; 17: 186-92

Active substance: MESALAZINE

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Document reference: 31635

Study title: B.S. Kirschner. Diagnosis and medical management of Crohn`s disease and ulcerative colitis in children. Problems in General Surgery 1993;10:16-32.B.S. Kirschner. Diagnosis and medical management of Crohn`s disease and ulcerative colitis in children. Problems in General Surgery 1993;10:16-32.

Active substance: MESALAZINE

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Document reference: 31641

Study title: Bioavailibility of 5-ASA from slow release 5-ASA drug and sulfasalazine in normal children; Christensen LA et al, Dig. Diseases and Sci., 1993, 38(10):1831-6

Active substance: MESALAZINE

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Document reference: 31628

Study title: Case-controlled, open study on the pharmacokinetics and treatment effect of 5-aminosalicylic acid in children with ulcerative colitis

Active substance: MESALAZINE

Study summary document link (including results): EUdraCT_reduced_datafields_paediatric data_Mesalazine_Salofallk enema_Dr Falk Pharma GmbH.xls

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Document reference: 31626

Study title: Efficacy of mesalazine 500 mg tablets in preventing relapses of quiescent Crohn’s disease in children

Active substance: MESALAZINE

Study summary document link (including results): Pentacomp9001_mesalazine_synopsis_EMA.pdf

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Document reference: 47387

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF IV AND/OR PO O.S. FLUCONAZOLE IN THE TREATMENT OF PEDIATRIC PATIENTS WITH SYSTEMIC CANDIDIASIS. THIS IS A COMPASSIONATE TREATMENT.

Active substance: FLUCONAZOLE

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Document reference: 27374

Study title: Am Heart J. 1998 Mar;135(3):482-7. Noninvasive evaluation of myocardial ischemia in Kawasaki disease: comparison between dipyridamole stress thallium imaging and exercise stress testing. Fukuda T, Akagi T, Ishibashi M, Inoue O, Sugimura T, Kato H. Am Heart J. 1998 Mar;135(3):482-7. Noninvasive evaluation of myocardial ischemia in Kawasaki disease: comparison between dipyridamole stress thallium imaging and exercise stress testing. Fukuda T, Akagi T, Ishibashi M, Inoue O, Sugimura T, Kato H.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44499

Study title: Am J Cardiol. 1978 Oct;42(4):675-80. Thallium-201 myocardial imaging in anomalous left coronary artery arising from the pulmonary artery. Applications before and after medical and surgical treatment. Finley JP, Howman-Giles R, Gilday DL, Olley PM, Rowe Am J Cardiol. 1978 Oct;42(4):675-80. Thallium-201 myocardial imaging in anomalous left coronary artery arising from the pulmonary artery. Applications before and after medical and surgical treatment. Finley JP, Howman-Giles R, Gilday DL, Olley PM, Rowe

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44500

Study title: AJR Am J Roentgenol. 1982 Feb;138(2):223-8. Hemodynamic significance of increased lung uptake of thallium-201. Tamaki N, Itoh H, Ishii Y, Yonekura Y, Yamamoto K, Torizuka K, Konishi Y, Hikasa Y, Kambara H, Kawai AJR Am J Roentgenol. 1982 Feb;138(2):223-8. Hemodynamic significance of increased lung uptake of thallium-201. Tamaki N, Itoh H, Ishii Y, Yonekura Y, Yamamoto K, Torizuka K, Konishi Y, Hikasa Y, Kambara H, Kawai

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44493

Study title: A comparison of single dose caudal tramadol, tramadol plus bupivacaine and bupivacaine administration for postoperative analgesia in children - Gunduz M, Ozengiz D, Ozbek H, Isik G - 2001 (Paediatric Anaesthesia, 2001; 11: 323-326)

Active substance: TRAMADOL

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Document reference: 45015

Study title: A double-blind, randomised, placebo-controlled clinical study to investigate the efficacy and safety of Tramal ® drops and midazolam in children undergoing dental extraction under general anaesthesia

Active substance: TRAMADOL

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Document reference: 45009

Study title: - A double-blind, randomised, placebo-controlled clinical study to investigate the efficacy and safety of Tramal ® drops and midazolam in children undergoing dental extraction under general anaesthesia - Treatment of postoperative pain with tramadol HCl in children - Open clinical study on the analgesic efficacy of tramadol (TRAMAL) in children with post-operative pain after abdominal surgery - Multizentrische Anwendungwendungsbeobachtung eines Analgetikums in der Behandlung mittelstarker bis starker Schmerzen

Active substance: TRAMADOL

Study summary document link (including results): Tramadol HCL STUDY 02-27.xls

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Document reference: 45013

Study title: A randomised, double-blind, multicenterclinical study to compare the analgesic efficacy and safety of intravenous tramadol and intravenous morphine in the treatment of postoperative pain in children - Habre W (Multicenter) - 2002

Active substance: TRAMADOL

Study summary document link (including results): Tramadol HCL STUDY PCP1.xls

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Document reference: 45016

Study title: A randomised, double-blind, multicentre clinical study to compare the analgesic efficacy and safety of intravenous tramadol and intravenous morphine in the treatment of postoperative pain in children

Active substance: TRAMADOL

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Document reference: 45004

Study title: An open multicenter study on the efficacy and safety of tramadol HCl (Tramal®) in the management of postoperative pain and other acute pain conditions in children - Lenkiewicz T - May 2, 1996

Active substance: TRAMADOL

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Document reference: 45017

Study title: An open, multicenter study on the efficacy and safety of tramadol hydrochloride (Tramal ®) in the management of postoperative pain and other acute pain conditions in children

Active substance: TRAMADOL

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Document reference: 45002

Study title: Huntington's Chorea: current concepts and improvement in one case after tiapride - G. Serratrice, G. Cremieux.

Active substance: TIAPRIDE

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Document reference: 44754

Study title: Le tiapridal dans la maladie des tics de l'enfant - Herbaut M. - 02/08/82

Active substance: TIAPRIDE

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Document reference: 44753

Study title: Paediatric clinical trial of FLO 1347 Drops - Fontaine G. - 02/02/73

Active substance: TIAPRIDE

Study summary document link (including results): Tiapride STUDY 73-00079-EN-00.xls

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Document reference: 44745

Study title: Relevance of tiapride in treatment of certain abnormal movements of the encephalopathic child - Gardisseaux J.F., Maloteaux J.M., Ferriere G. - neuropsych. Enf. Adolesc., 1985, 33, 139-143Relevance of tiapride in treatment of certain abnormal movements of the encephalopathic child - Gardisseaux J.F., Maloteaux J.M., Ferriere G. - neuropsych. Enf. Adolesc., 1985, 33, 139-143

Active substance: TIAPRIDE

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Document reference: 38472

Study title: Studie tiapridex bei stotternden kindern - Prof. Dr. A. Rothenberger - No date

Active substance: TIAPRIDE

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Document reference: 44746

Study title: Tiapridal treatment of extrapyramidal motor disorders in children - Klepel H. Gebelt H. - 04/1986

Active substance: TIAPRIDE

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Document reference: 44747

Study title: Tiapridal treatment of tic disease in children - Herbaut M. - No date

Active substance: TIAPRIDE

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Document reference: 44748

Study title: Traitement des hyperkinésiens de type exrtapyramidal chez l'enfant à l'aide du tiapridal - Klepel H. - 16/12/85

Active substance: TIAPRIDE

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Document reference: 44749

Study title: Treatment of pain due to drepanocytosis with tiapride - H. NyaméTreatment of pain due to drepanocytosis with tiapride - H. Nyamé

Active substance: TIAPRIDE

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Document reference: 38469

Study title: A pharmacokinetic study

Active substance: TICARCILLIN

Study summary document link (including results): Study HP-83-14 Ticarcillin (Timentin).xls

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Document reference: 47676

Study title: A Phase I open-label single center (historically controlled) study to evaluate the safety, tolerability and immunogenicity using three doses of polygeline free tick-borne encephalitis (TBE) vaccine in children.

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 48395

Study title: A Phase III multicenter, open label extension study of the safety and immunogenicity of a single booster dose of polygeline-free tick borne encephalitis (TBE) vaccine in children.

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 48402

Study title: a Phase III multicenter, single-blind, randomized, historically controlled-study of a new polygeline-free TBE vaccine in healthy children ages 1 to 11 years.

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 48401

Study title: Aust Paediatr J. 1983 Mar;19(1):47-50. Congenital left coronary artery - right ventricular fistula. Adams P, Morris L, Ross I. Aust Paediatr J. 1983 Mar;19(1):47-50. Congenital left coronary artery - right ventricular fistula. Adams P, Morris L, Ross I.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44525

Study title: Br Heart J. 1981 Feb;45(2):198-205. Quantitative thallium-201 myocardial imaging in assessing right ventricular pressure in patients with congenital heart defects. Rabinovitch M, Fischer KC, Treves S. Br Heart J. 1981 Feb;45(2):198-205. Quantitative thallium-201 myocardial imaging in assessing right ventricular pressure in patients with congenital heart defects. Rabinovitch M, Fischer KC, Treves S.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44526

Study title: (Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia).Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60.(Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia).Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60.

Active substance: TINZANIDINE

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Document reference: 44792

Study title: (Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia).Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60.(Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia).Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60.

Active substance: TINZANIDINE

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Document reference: 44804

Study title: Efficacy and safety of tizanidine in the treatment of spasticity in patients with spinal cord injury. North American Tizanidine Study Group.Efficacy and safety of tizanidine in the treatment of spasticity in patients with spinal cord injury. North American Tizanidine Study Group.

Active substance: TINZANIDINE

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Document reference: 44794

Study title: Efficacy of neuroprotectors in patients with tension headaches.Efficacy of neuroprotectors in patients with tension headaches.

Active substance: TINZANIDINE

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Document reference: 44784

Study title: Efficacy of neuroprotectors in patients with tension headaches.Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6Efficacy of neuroprotectors in patients with tension headaches.Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6

Active substance: TINZANIDINE

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Document reference: 44788

Study title: Efficacy of neuroprotectors in patients with tension headaches.Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6Efficacy of neuroprotectors in patients with tension headaches.Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6

Active substance: TINZANIDINE

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Document reference: 44800

Study title: Evaluation of a muscle relaxant on sequelae of third molar surgery: a pilot study.Kirmeier R, Truschnegg A, Payer M, Acham S, Schulz K, Jakse N. Oral surgery oral medicine oral pathology oral radiology and endodontics, Sep 2007 (epub: 06 Jul 2007), vol. 104, no. 3,p. e8−14Evaluation of a muscle relaxant on sequelae of third molar surgery: a pilot study.Kirmeier R, Truschnegg A, Payer M, Acham S, Schulz K, Jakse N. Oral surgery oral medicine oral pathology oral radiology and endodontics, Sep 2007 (epub: 06 Jul 2007), vol. 104, no. 3,p. e8−14

Active substance: TINZANIDINE

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Document reference: 44789

Study title: Evaluation of a muscle relaxant on sequelae of third molar surgery: a pilot study.Kirmeier R, Truschnegg A, Payer M, Acham S, Schulz K, Jakse N. Oral surgery oral medicine oral pathology oral radiology and endodontics, Sep 2007 (epub: 06 Jul 2007), vol. 104, no. 3,p. e8−14Evaluation of a muscle relaxant on sequelae of third molar surgery: a pilot study.Kirmeier R, Truschnegg A, Payer M, Acham S, Schulz K, Jakse N. Oral surgery oral medicine oral pathology oral radiology and endodontics, Sep 2007 (epub: 06 Jul 2007), vol. 104, no. 3,p. e8−14

Active substance: TINZANIDINE

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Document reference: 44801

Study title: Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2.Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2.

Active substance: TINZANIDINE

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Document reference: 44787

Study title: F. Hadziselimovic. Therapie der chronisch entzündlichen Darmkrankheiten im Kindesalter. Pädiat Prax 1991;42:443-51. F. Hadziselimovic. Therapie der chronisch entzündlichen Darmkrankheiten im Kindesalter. Pädiat Prax 1991;42:443-51.

Active substance: MESALAZINE

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Document reference: 31642

Study title: Efficacy and safety of Primacor in pediatric patients with congestive heart failure following cardiac surgery. Efficacy and safety of Primacor in pediatric patients with congestive heart failure following cardiac surgery.

Active substance: MILRINONE

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Document reference: 32023

Study title: Hemodynamic effect of IV milrinone lactate in pediatric patients with septic shock: a prospective, double-blinded, randomized, placebo-controlled, interventional study - Barton P. et al. - 1996 (Chest 1996, 109, 1032-12)Hemodynamic effect of IV milrinone lactate in pediatric patients with septic shock: a prospective, double-blinded, randomized, placebo-controlled, interventional study - Barton P. et al. - 1996 (Chest 1996, 109, 1032-12)

Active substance: MILRINONE

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Document reference: 32024

Study title: Intravenous arginin-vasopressin in children with vasodilatory shock after cardiac surgery - Rosenzweig EB et al. - 1999 (Circulation, 1999, 100, II 182-6)Intravenous arginin-vasopressin in children with vasodilatory shock after cardiac surgery - Rosenzweig EB et al. - 1999 (Circulation, 1999, 100, II 182-6)

Active substance: MILRINONE

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Document reference: 32025

Study title: Intravenous milrinone following cardiac surgery: effect of bolus infusion followed by variable dose maintenance infusion - Feneck RO. Et al. - 1992 (J Cardiothorac Anthes 1992, 6, 554-562)Intravenous milrinone following cardiac surgery: effect of bolus infusion followed by variable dose maintenance infusion - Feneck RO. Et al. - 1992 (J Cardiothorac Anthes 1992, 6, 554-562)

Active substance: MILRINONE

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Document reference: 32026

Study title: Milrinone in the treatment of low output states following cardiac surgery - Wright EM et al. - 1992 (Eur J Anaesthesiol 1992, 5 21-26)Milrinone in the treatment of low output states following cardiac surgery - Wright EM et al. - 1992 (Eur J Anaesthesiol 1992, 5 21-26)

Active substance: MILRINONE

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Document reference: 32027

Study title: Milrinone: systemic and pulmonary hemodynamic effects in neonates after cardiac surgery - Chang AC et al. - 1995 (Crit. Care Med. 1995, 23, 1907-14)Milrinone: systemic and pulmonary hemodynamic effects in neonates after cardiac surgery - Chang AC et al. - 1995 (Crit. Care Med. 1995, 23, 1907-14)

Active substance: MILRINONE

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Document reference: 32028

Study title: Pharmacokinetics and pharmacodynamics of milrinone lactate in pediatric patients with septic shock - Lindsay CA. et al. - 1998 (J Pediatr 1998; 132; 329-34)Pharmacokinetics and pharmacodynamics of milrinone lactate in pediatric patients with septic shock - Lindsay CA. et al. - 1998 (J Pediatr 1998; 132; 329-34)

Active substance: MILRINONE

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Document reference: 32029

Study title: Pharmacokinetics and side effects of milrinone in infants and children after open heart surgery - Ramamoorthy C et al. - 1998 (Anesth. Analg.1998, 86, 283-9)Pharmacokinetics and side effects of milrinone in infants and children after open heart surgery - Ramamoorthy C et al. - 1998 (Anesth. Analg.1998, 86, 283-9)

Active substance: MILRINONE

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Document reference: 32030

Study title: Platelet activation and aggregation during cardiopulmonary bypass - Rinder CS et al. - 1991 (Anesthesiology, 1991, 75, 388-393)Platelet activation and aggregation during cardiopulmonary bypass - Rinder CS et al. - 1991 (Anesthesiology, 1991, 75, 388-393)

Active substance: MILRINONE

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Document reference: 32031

Study title: Analgesia for adenotonsillectomy in children and young adults - Van den Berg AA, Montoya-Pelaez LF, Halliday EM, Hassan I, Baloch MS - 1997 (European Journal of Anaesthesiology 1997; 16: 186-194)Analgesia for adenotonsillectomy in children and young adults - Van den Berg AA, Montoya-Pelaez LF, Halliday EM, Hassan I, Baloch MS - 1997 (European Journal of Anaesthesiology 1997; 16: 186-194)

Active substance: TRAMADOL

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Document reference: 45018

Study title: Anesthesiologic and surgical problems of adenotonsillectomy in paediatric patients. Our current approach - Palmieri AM, Meglio M, Testa D, Salafia M, Lasiello A - 1998 (Minerva Anesthesiol 1998; 64: 545-552)Anesthesiologic and surgical problems of adenotonsillectomy in paediatric patients. Our current approach - Palmieri AM, Meglio M, Testa D, Salafia M, Lasiello A - 1998 (Minerva Anesthesiol 1998; 64: 545-552)

Active substance: TRAMADOL

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Document reference: 45020

Study title: AWB-MF/TRA/011096, 23-Jul-1997. Post marketing surveillance, Drug monitoring - Therapie mit Tramundin Tropfen N bei mittelstarken bis starken Schmerzen mit verschiedenen Ursachen. (Tramundin oral solution therapy in moderate to severe pain of various origin) (Germany)

Active substance: TRAMADOL

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Document reference: 45044

Study title: J Nucl Med. 1991 Dec;32(12):2215-20. Assessment of right ventricular overload by a thallium-201 SPECT study in children with congenital heart disease. Nakajima K, Taki J, Ohno T, Taniguchi M, Taniguchi M, Bunko H, Hisada K. J Nucl Med. 1991 Dec;32(12):2215-20. Assessment of right ventricular overload by a thallium-201 SPECT study in children with congenital heart disease. Nakajima K, Taki J, Ohno T, Taniguchi M, Taniguchi M, Bunko H, Hisada K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44610

Study title: J Nucl Med. 1991 Feb;32(2):237-41. Assessment of myocardial perfusion in patients after the arterial switch operation. Vogel M, Smallhorn JF, Gilday D, Benson LN, Ash J, Williams WG, Freedom RM. J Nucl Med. 1991 Feb;32(2):237-41. Assessment of myocardial perfusion in patients after the arterial switch operation. Vogel M, Smallhorn JF, Gilday D, Benson LN, Ash J, Williams WG, Freedom RM.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44611

Study title: J Nucl Med. 1993 Aug;34(8):1326-30. Comment in: J Nucl Med. 1993 Aug;34(8):1330-2. Thallium-201 scintigraphy for assessment of a gallium-67-avid mediastinal mass following therapy for Hodgkin's disease. Harris EW, Rakow JI, Weiner M, Agress H Jr. J Nucl Med. 1993 Aug;34(8):1326-30. Comment in: J Nucl Med. 1993 Aug;34(8):1330-2. Thallium-201 scintigraphy for assessment of a gallium-67-avid mediastinal mass following therapy for Hodgkin's disease. Harris EW, Rakow JI, Weiner M, Agress H Jr.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44612

Study title: J Nucl Med. 1993 Dec;34(12):2053-61. Comment in: J Nucl Med. 1993 Dec;34(12):2061-3. J Nucl Med. 1994 Dec;35(12):2055. Safety and clinical utility of combined intravenous dipyridamole/symptom-limited exercise stress test with thallium-201 imaginJ Nucl Med. 1993 Dec;34(12):2053-61. Comment in: J Nucl Med. 1993 Dec;34(12):2061-3. J Nucl Med. 1994 Dec;35(12):2055. Safety and clinical utility of combined intravenous dipyridamole/symptom-limited exercise stress test with thallium-201 imagin

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44613

Study title: J Nucl Med. 1993 Dec;34(12):2085-9. Comment in: J Nucl Med. 1993 Dec;34(12):2089-90. Clinical evaluation of thallium-201 SPECT in supratentorial gliomas: relationship to histologic grade, prognosis and proliferative activities. Oriuchi N, Tamura M,J Nucl Med. 1993 Dec;34(12):2085-9. Comment in: J Nucl Med. 1993 Dec;34(12):2089-90. Clinical evaluation of thallium-201 SPECT in supratentorial gliomas: relationship to histologic grade, prognosis and proliferative activities. Oriuchi N, Tamura M,

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44614

Study title: Can J Neurol Sci. 1984 Nov;11(4 Suppl):588-91. The cardiomyopathy in Friedreich's ataxia: isotopic ventriculography and myocardial imaging with thallium-201. Therriault L, Lamoureux G, Côté M, Plourde G, Lemieux B. Can J Neurol Sci. 1984 Nov;11(4 Suppl):588-91. The cardiomyopathy in Friedreich's ataxia: isotopic ventriculography and myocardial imaging with thallium-201. Therriault L, Lamoureux G, Côté M, Plourde G, Lemieux B.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44527

Study title: Cancer J. 2002 Nov-Dec;8(6):469-75. Thallium-201 imaging in evaluation of Hodgkin's disease. Dadparvar S, Hussain R, Esteves F, Yu JQ, Grewal RK, Arif S, Cruz R, Barbaria CJ, Woods K, Styler MJ. Cancer J. 2002 Nov-Dec;8(6):469-75. Thallium-201 imaging in evaluation of Hodgkin's disease. Dadparvar S, Hussain R, Esteves F, Yu JQ, Grewal RK, Arif S, Cruz R, Barbaria CJ, Woods K, Styler MJ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44528

Study title: Cancer. 1987 Dec 1;60(11):2621-3. Early and delayed thallium 201 imaging. Diagnosis of patients with cold thyroid nodules. Bleichrodt RP, Vermey A, Piers DA, de Langen ZJ. Cancer. 1987 Dec 1;60(11):2621-3. Early and delayed thallium 201 imaging. Diagnosis of patients with cold thyroid nodules. Bleichrodt RP, Vermey A, Piers DA, de Langen ZJ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44529

Study title: Cancer. 1997 Oct 15;80(8):1507-12. Thallium-201 scintigraphy for the evaluation of tumor response to preoperative chemotherapy in patients with osteosarcoma. Imbriaco M, Yeh SD, Yeung H, Zhang JJ, Healey JH, Meyers P, Huvos AG, Larson SM. Cancer. 1997 Oct 15;80(8):1507-12. Thallium-201 scintigraphy for the evaluation of tumor response to preoperative chemotherapy in patients with osteosarcoma. Imbriaco M, Yeh SD, Yeung H, Zhang JJ, Healey JH, Meyers P, Huvos AG, Larson SM.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44530

Study title: Chest. 1987 Aug;92(2):371-4. Hypertrophic cardiomyopathy and myocardial ischemia with normal coronary arteries. Kelly TA, Watson DD, DiMarco JP, Gibson RS. Chest. 1987 Aug;92(2):371-4. Hypertrophic cardiomyopathy and myocardial ischemia with normal coronary arteries. Kelly TA, Watson DD, DiMarco JP, Gibson RS.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44531

Study title: Chest. 1995 Feb;107(2):440-6. Comparison of thallium-201 and gallium-67 citrate scintigraphy in the diagnosis of pulmonary disease. Miller JA, Lee S, Lao R, Karetzky M. Chest. 1995 Feb;107(2):440-6. Comparison of thallium-201 and gallium-67 citrate scintigraphy in the diagnosis of pulmonary disease. Miller JA, Lee S, Lao R, Karetzky M.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44532

Study title: Circ J. 2002 Jan;66(1):63-9. Dobutamine stress radionuclide ventriculography reveals silent myocardial dysfunction in Kawasaki disease. Hamamichi Y, Ichida F, Tsubata S, Hirono K, Watanabe S, Rui C, Yu X, Uese K, Hashimoto I, Simizu M, Seto H, Origasa HCirc J. 2002 Jan;66(1):63-9. Dobutamine stress radionuclide ventriculography reveals silent myocardial dysfunction in Kawasaki disease. Hamamichi Y, Ichida F, Tsubata S, Hirono K, Watanabe S, Rui C, Yu X, Uese K, Hashimoto I, Simizu M, Seto H, Origasa H

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44533

Study title: The assessment of the safety and efficacy of tramadol suppositories compared to paracetamol suppositories when administered as pre-medication together with midazolam in subjects aged 3 to 7 years

Active substance: TRAMADOL

Study summary document link (including results): synopsis-tra-rsa-2.pdf

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Document reference: 44997

Study title: The Respiratory Effects of Tramadol in Children under Halothane Anaesthesia - A Double-Blind, Placebo Controlled Comparison with Pethidine

Active substance: TRAMADOL

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Document reference: 44994

Study title: The Respiratory Effects of Tramadol in Children under Halothane Anaesthesia - A Double-Blind, Placebo Controlled Comparison with Pethidine

Active substance: TRAMADOL

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Document reference: 45003

Study title: Endocr J. 2002 Feb;49(1):55-60. Quantitative estimation and clinical significance of accumulation and washout of thallium-201 chloride in follicular thyroid neoplasm. Yada H, Hozumi Y, Kanazawa K, Nagai H Endocr J. 2002 Feb;49(1):55-60. Quantitative estimation and clinical significance of accumulation and washout of thallium-201 chloride in follicular thyroid neoplasm. Yada H, Hozumi Y, Kanazawa K, Nagai H

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44562

Study title: Eur Heart J. 1990 Mar;11(3):213-8. Myocardial perfusion after aortic implantation for anomalous origin of the left coronary artery from the pulmonary artery. Seguchi M, Nakanishi T, Nakazawa M, Doi S, Momma K, Takao A, Imai Y, Kondoh C, Hiroe M. Eur Heart J. 1990 Mar;11(3):213-8. Myocardial perfusion after aortic implantation for anomalous origin of the left coronary artery from the pulmonary artery. Seguchi M, Nakanishi T, Nakazawa M, Doi S, Momma K, Takao A, Imai Y, Kondoh C, Hiroe M.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44563

Study title: Eur Heart J. 1990 Oct;11(10):916-24. Influence of age and sex on left ventricular volumes and ejection fraction during upright exercise in normal subjects. Younis LT, Melin JA, Robert AR, Detry JM. Eur Heart J. 1990 Oct;11(10):916-24. Influence of age and sex on left ventricular volumes and ejection fraction during upright exercise in normal subjects. Younis LT, Melin JA, Robert AR, Detry JM.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44564

Study title: Eur Heart J. 1996 Jul;17(7):1056-64. Comment in: Eur Heart J. 1996 Jul;17(7):982-4. Chest pain during daily life in patients with hypertrophic cardiomyopathy: an ambulatory electrocardiographic study. Elliott PM, Kaski JC, Prasad K, Seo H, Slade AKEur Heart J. 1996 Jul;17(7):1056-64. Comment in: Eur Heart J. 1996 Jul;17(7):982-4. Chest pain during daily life in patients with hypertrophic cardiomyopathy: an ambulatory electrocardiographic study. Elliott PM, Kaski JC, Prasad K, Seo H, Slade AK

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44565

Study title: Eur Heart J. 1998 Mar;19(3):500-7. Dipyridamole stress thallium-201 perfusion abnormalities in patients with hypertrophic cardiomyopathy. Relationship to clinical presentation and outcome. Yamada M, Elliott PM, Kaski JC, Prasad K, Gane JN, Lowe CM, Doi Eur Heart J. 1998 Mar;19(3):500-7. Dipyridamole stress thallium-201 perfusion abnormalities in patients with hypertrophic cardiomyopathy. Relationship to clinical presentation and outcome. Yamada M, Elliott PM, Kaski JC, Prasad K, Gane JN, Lowe CM, Doi

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44566

Study title: Eur J Nucl Med. 1984;9(3):99-105. Segmental analysis of stress thallium myocardial emission tomography for localization of coronary artery disease. Tamaki N, Yonekura Y, Mukai T, Fujita T, Nohara R, Kadota K, Kambara H, Kawai C, Torizuka K, Ishii Y.Eur J Nucl Med. 1984;9(3):99-105. Segmental analysis of stress thallium myocardial emission tomography for localization of coronary artery disease. Tamaki N, Yonekura Y, Mukai T, Fujita T, Nohara R, Kadota K, Kambara H, Kawai C, Torizuka K, Ishii Y.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44567

Study title: Eur J Nucl Med. 1984;9(3):99-105. Segmental analysis of stress thallium myocardial emission tomography for localization of coronary artery disease. Tamaki N, Yonekura Y, Mukai T, Fujita T, Nohara R, Kadota K, Kambara H, Kawai C, Torizuka K, Ishii Y. Eur J Nucl Med. 1984;9(3):99-105. Segmental analysis of stress thallium myocardial emission tomography for localization of coronary artery disease. Tamaki N, Yonekura Y, Mukai T, Fujita T, Nohara R, Kadota K, Kambara H, Kawai C, Torizuka K, Ishii Y.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44568

Study title: Eur J Nucl Med. 1986;11(9):368-70. 201Tl myocardial imaging in a cardiac rejection episode. Richter J, Herreros J, Serena A, Pardo J, Azanza JR, Charvet MA, Honorato J, Arcas R. Eur J Nucl Med. 1986;11(9):368-70. 201Tl myocardial imaging in a cardiac rejection episode. Richter J, Herreros J, Serena A, Pardo J, Azanza JR, Charvet MA, Honorato J, Arcas R.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44569

Study title: Postoperative course and hemodynamic profile after the arterial switch operation in neonates and infants: a comparison of low-flow ardiopulmonary bypass and circulatory arrest - Wernovsky G et al. - 1995 (Circulation, 1995, 92, 2226-2235)Postoperative course and hemodynamic profile after the arterial switch operation in neonates and infants: a comparison of low-flow ardiopulmonary bypass and circulatory arrest - Wernovsky G et al. - 1995 (Circulation, 1995, 92, 2226-2235)

Active substance: MILRINONE

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Document reference: 32032

Study title: PRIMACORP: Prophylactic Intravenous use of milrinone after cardiac operation in Pediatrics - Sanofi-Synthelabo Inc - August 2001

Active substance: MILRINONE

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Document reference: 32033

Study title: Study of the live attenuated Rubella vaccine among adults (≥ 15 years old)

Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN)

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Document reference: 47473

Study title: Study of the live attenuated Rubella vaccine among children and adolescent

Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN)

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Document reference: 21212

Study title: Vaccination with a live attenuated RA27/3 strain rubella vaccine, a follow up study

Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN)

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Document reference: 41362

Study title: A repeat dose, open-label, safety evaluation of a live yeast cell derivative wound healing ointment in out-patients with minor cuts, scrapes, abrasions, and burns

Active substance: Live Yeast Cell Derivative , Shark Liver Oil

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Document reference: 40031

Study title: Preparation H ointment (WH-66-228) repeated insult patch test

Active substance: Live Yeast Cell Derivative , Shark Liver Oil

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Document reference: 40030

Study title: C8559 - November 15, 1989; C8569 (011:37150:0688) - June 30, 1988; C8569 (016:38610:0490) - March 14, 1994; C8569 (010:34350:1287) - April 21, 1988; C8569 (015:38610:0490) - November 5, 1990; C8569 (017:38610:0490) - June 16, 1994; C8569 (02:38610:0194) - July 6, 1994; C8569 (009:34350:1287) - April 21, 1988; C8569 (008:34350:1287) - April 21, 1988; C8569A (055:38610:1189) - November 13, 1989; C8569A (022:38610:0490) - November 6, 1990; C8569A (024:38610:0490) - May 27, 1994; C8881 - June 2, 1994; C9126 - April 21, 1995; C9144 - June 30, 1993; C9151 - August 3, 1994; C9165 - March 8, 1994; C9171 - June 29, 1993; C9274 - October 3, 1995

Active substance: LODOXAMIDE

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Document reference: 46926

Study title: Efficacy and safety evaluation of Lodoxamide Ophthalmic Solution versus OPTICROM Ophthalmic Solution in patients with vernal conjunctivitis, giant papillary conjunctivitis and allergic/atopic conjunctivitis (C8559)

Active substance: LODOXAMIDE

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Document reference: 46925

Study title: Clarke I, Uchida Y, Jauch A, Fsadni M, Ikeda M. Combined analysis report. The combined experience of the safety of lomefloxacin 0.3% and lomefloxacin 0.5% and the efficacy of lomefloxacin 0.3% compared with ofloxacin 0.3% in the treatment of acute bacterial conjunctivitis and other infections of the eye in children under 15 years old reported upon in three previous studies of lomefloxacin in Japan. May 1996. Meta-analysis of Refs 2-20, Part IV of BIRD October 1993 (Refs 3, 14, 18-34, Part IV of BIRD November 1997)Clarke I, Uchida Y, Jauch A, Fsadni M, Ikeda M. Combined analysis report. The combined experience of the safety of lomefloxacin 0.3% and lomefloxacin 0.5% and the efficacy of lomefloxacin 0.3% compared with ofloxacin 0.3% in the treatment of acute bacterial conjunctivitis and o...

Active substance: LOMEFLOXACIN

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Document reference: 31380

Study title: Clinical effects of Lomefloxacin ophthalmic solutionClinical effects of Lomefloxacin ophthalmic solution

Active substance: LOMEFLOXACIN

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Document reference: 31343

Study title: Clinical Efficacy of Lomefloxacin ophthalmic solution for external bacterial eye infectionsClinical Efficacy of Lomefloxacin ophthalmic solution for external bacterial eye infections

Active substance: LOMEFLOXACIN

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Document reference: 31349

Study title: Rubella vaccine in school Children

Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN)

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Document reference: 41364

Study title: Rubella vaccine in school Children

Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN)

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Document reference: 41456

Study title: J Nucl Med. 1995 Apr;36(4):537-41. Indium-111-pentetreotide imaging in intra-axial brain tumors: comparison with thallium-201 SPECT and MRI. Lee JD, Kim DI, Lee JT, Chang JW, Park CY. J Nucl Med. 1995 Apr;36(4):537-41. Indium-111-pentetreotide imaging in intra-axial brain tumors: comparison with thallium-201 SPECT and MRI. Lee JD, Kim DI, Lee JT, Chang JW, Park CY.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44615

Study title: J Nucl Med. 1995 Aug;36(8):1372-6. Thallium-201 scintigraphy in pediatric soft-tissue tumors. Howman-Giles R, Uren RF, Shaw PJ. J Nucl Med. 1995 Aug;36(8):1372-6. Thallium-201 scintigraphy in pediatric soft-tissue tumors. Howman-Giles R, Uren RF, Shaw PJ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44616

Study title: J Nucl Med. 1995 Jan;36(1):107-10. Thallium-201 uptake in eosinophilic granuloma of the frontal bone: comparison with technetium-99m-MDP imaging. Flores LG 2nd, Hoshi H, Nagamachi S, Ohnishi T, Watanabe K, Fukiyama J, Nao-i N, Sawada A. J Nucl Med. 1995 Jan;36(1):107-10. Thallium-201 uptake in eosinophilic granuloma of the frontal bone: comparison with technetium-99m-MDP imaging. Flores LG 2nd, Hoshi H, Nagamachi S, Ohnishi T, Watanabe K, Fukiyama J, Nao-i N, Sawada A.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44617

Study title: J Nucl Med. 1996 Dec;37(12):2079-82. Radiation dose from breastfeeding following administration of thallium-201. Johnston RE, Mukherji SK, Perry RJ, Stabin MG J Nucl Med. 1996 Dec;37(12):2079-82. Radiation dose from breastfeeding following administration of thallium-201. Johnston RE, Mukherji SK, Perry RJ, Stabin MG

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44618

Study title: A randomized trial assessing dorzolamide in patients with glaucoma who are younger than 6 years. Ott EZ, Mills MD, Arango S, Getson AJ, Assaid CA, Adamsons IA. Arch Ophthalmol. 2005 Sep;123(9):1177-86. A randomized trial assessing dorzolamide in patients with glaucoma who are younger than 6 years. Ott EZ, Mills MD, Arango S, Getson AJ, Assaid CA, Adamsons IA. Arch Ophthalmol. 2005 Sep;123(9):1177-86.

Active substance: TIAGABINE

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Document reference: 38481

Study title: A Single Dose Study to Define Pharmacokinetic Parameters of Tiagabine HCl in Pediatric Patients with Complex Partial SeizuresEfficiency of pulmonary administration of tobramycin solution for inhalation in cystic fibrosis using an improved drug delivery system. (Chest. 2003 Jan;123(1):28-36)

Active substance: TIAGABINE

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Document reference: 38533

Study title: A single-blind, tolerability and preliminary efficacy study of tiagabine in children with epilepsyPhase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9.

Active substance: TIAGABINE

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Document reference: 38527

Study title: An open label extension study of safety and efficacy of tiagabine in children with epilepsy

Active substance: TIAGABINE

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Document reference: 38531

Study title: An Open-Label Extension Study of Tiagabine HCl in the Treatment of Patients with Partial Seizures

Active substance: TIAGABINE

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Document reference: 38522

Study title: An Open-Label Extension Study of Tiagabine HCl in the Treatment of Pediatric Patients with Partial Seizures

Active substance: TIAGABINE

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Document reference: 38535

Study title: An open-label study of the safety and efficacy of long-term tiagabine administration in patients with epilepsy3-day treatment with azithromycin 1.5% eye drops versus 7-day treatment with tobramycin 0.3% for purulent bacterial conjunctivitis: multicentre, randomised and controlled trial in adults and children. Cochereau I, Meddeb-Ouertani A, Khairallah M, Amraoui A, Zaghloul K, Pop M, Delval L, Pouliquen P, Tandon R, Garg P, Goldschmidt P, Bourcier T. Br J Ophthalmol. 2007 Apr;91(4):465-9;Epub 2006 Oct 18.

Active substance: TIAGABINE

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Document reference: 38528

Study title: The respiratory effects of tramadol in children under halothane anaesthesia - Bösenberg AT, Ratcliffe S - 1998 (Anaesthesia 1998; 53: 960-964)The respiratory effects of tramadol in children under halothane anaesthesia - Bösenberg AT, Ratcliffe S - 1998 (Anaesthesia 1998; 53: 960-964)

Active substance: TRAMADOL

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Document reference: 45036

Study title: Tramadol hydrochloride: analgesic pharmacodynamics-pharmacokinetics in dental-extraction pain

Active substance: TRAMADOL

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Document reference: 44991

Study title: Tramadol hydrochloride: analgesic pharmacodynamics-pharmacokinetics in dental-extraction pain

Active substance: TRAMADOL

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Document reference: 45817

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, acetaminophen with dextropropoxyphene and placebo in dental-extraction pain

Active substance: TRAMADOL

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Document reference: 44989

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, acetaminophen with propoxyphene napsylate and placebo in dental-extraction pain

Active substance: TRAMADOL

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Document reference: 44987

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, acetaminophen with propoxyphene napsylate and placebo in dental-extraction pain

Active substance: TRAMADOL

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Document reference: 45813

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine phosphate and placebo in dental-extraction pain

Active substance: TRAMADOL

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Document reference: 44986

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine phosphate and placebo in dental-extraction pain

Active substance: TRAMADOL

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Document reference: 44988

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine phosphate and placebo in dental-extraction pain

Active substance: TRAMADOL

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Document reference: 45812

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine phosphate and placebo in dental-extraction pain

Active substance: TRAMADOL

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Document reference: 45814

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine sulfate and placebo in pain following cesarean section

Active substance: TRAMADOL

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Document reference: 44984

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine sulfate and placebo in dental extraction pain

Active substance: TRAMADOL

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Document reference: 44985

Study title: Kaku Igaku. 1994 Aug;31(8):951-6. [Thallium-201 single photon emission computed tomography in the evaluation of therapeutic response for brain tumors] [Article in Japanese] Tomura N, Kobayashi M, Oyama Y, Satoh K, Kato K, Kusaka K, Watarai J, Sasaki K.Kaku Igaku. 1994 Aug;31(8):951-6. [Thallium-201 single photon emission computed tomography in the evaluation of therapeutic response for brain tumors] [Article in Japanese] Tomura N, Kobayashi M, Oyama Y, Satoh K, Kato K, Kusaka K, Watarai J, Sasaki K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44645

Study title: Comparison of epsilon aminocaproic acid and tranexamic acid in pediatric cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Apr;18(2):141-3.Comparison of epsilon aminocaproic acid and tranexamic acid in pediatric cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Apr;18(2):141-3.

Active substance: TRAXENAMIC ACID

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Document reference: 46712

Study title: Dose comparison of tranexamic acid in pediatric cardiac surgery. Asian Cardiovasc Thorac Ann. 2004 Jun;12(2):121-4.Dose comparison of tranexamic acid in pediatric cardiac surgery. Asian Cardiovasc Thorac Ann. 2004 Jun;12(2):121-4.

Active substance: TRAXENAMIC ACID

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Document reference: 46711

Study title: Double-blind trials with ethamsylate, batroxobin or tranexamic acid on blood loss after adenotonsillectomy. Verstraete M., Tyberghein J., De Greef Y. Daems L; Van Hoof A. Acta Clinica Belgica, 32 (2), 136-141 (1977) Tabulated summary, reprint of publicationDouble-blind trials with ethamsylate, batroxobin or tranexamic acid on blood loss after adenotonsillectomy. Verstraete M., Tyberghein J., De Greef Y. Daems L; Van Hoof A. Acta Clinica Belgica, 32 (2), 136-141 (1977) Tabulated summary, reprint of publication

Active substance: TRAXENAMIC ACID

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Document reference: 46707

Study title: Effect of tranexamic acid on postoperative bleeding in pediatric heart surgery. Rev Esp Anestesiol Reanim. 2007 Mar;54(3):155-61.Effect of tranexamic acid on postoperative bleeding in pediatric heart surgery. Rev Esp Anestesiol Reanim. 2007 Mar;54(3):155-61.

Active substance: TRAXENAMIC ACID

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Document reference: 46708

Study title: Hemostatic parameters and platelet activation marker expression in cyanotic and acyanotic pediatric patients undergoing cardiac surgery in the presence of tranexamic acid. Thromb Haemost. 2000 Jan;83(1):54-9Hemostatic parameters and platelet activation marker expression in cyanotic and acyanotic pediatric patients undergoing cardiac surgery in the presence of tranexamic acid. Thromb Haemost. 2000 Jan;83(1):54-9

Active substance: TRAXENAMIC ACID

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Document reference: 46716

Study title: Local antifibrinolytic treatment with tranexamic acid in hemophilic children undergoing dental extractions. Egypt Dent J. 1995 Jan;41(1):961-8.Local antifibrinolytic treatment with tranexamic acid in hemophilic children undergoing dental extractions. Egypt Dent J. 1995 Jan;41(1):961-8.

Active substance: TRAXENAMIC ACID

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Document reference: 46720

Study title: Publication in "CLINICAL SUMMARY on EXACYL" , written by Petr Salaj, M.D., Prague, June 2003 : Reid RW et al, Anesth Analg 1997 ; 84 : 990-996.

Active substance: TRAXENAMIC ACID

Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication - Ugurol (Tranexamic acid).pdf

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Document reference: 46705

Study title: A randomized trial of tranexamic acid to reduce blood transfusion for scoliosis surgery. Anesth Analg. 2001 Jul;93(1):82-7.A randomized trial of tranexamic acid to reduce blood transfusion for scoliosis surgery. Anesth Analg. 2001 Jul;93(1):82-7.

Active substance: TRAXENAMIC ACID

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Document reference: 46715

Study title: Result of an antifibrinolytic treatment using tranexamic acid for the reduction of blood-loss during and after tonsillectomy. Schweiz Med Wochenschr. 1977 Jun 4;107(22):780-4.Result of an antifibrinolytic treatment using tranexamic acid for the reduction of blood-loss during and after tonsillectomy. Schweiz Med Wochenschr. 1977 Jun 4;107(22):780-4.

Active substance: TRAXENAMIC ACID

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Document reference: 46723

Study title: Surgical repair of congenital diaphragmatic hernia during extracorporeal membrane oxygenation: hemorrhagic complications and the effect of tranexamic acid. J Pediatr Surg. 1997 Apr;32(4):594-9Surgical repair of congenital diaphragmatic hernia during extracorporeal membrane oxygenation: hemorrhagic complications and the effect of tranexamic acid. J Pediatr Surg. 1997 Apr;32(4):594-9

Active substance: TRAXENAMIC ACID

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Document reference: 46718

Study title: Meenan FO. A clinical trial of Tolnaftate in fungus infection of the skin. J Ir Med Assoc. 1967 Dec;60(366):450-2. Meenan FO. A clinical trial of Tolnaftate in fungus infection of the skin. J Ir Med Assoc. 1967 Dec;60(366):450-2.

Active substance: TOLNAFTATE

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Document reference: 44825

Study title: O'Brien JM. Common skin problems of infancy, childhood, and adolescence. Prim Care. 1995 Mar;22(1):99-115. O'Brien JM. Common skin problems of infancy, childhood, and adolescence. Prim Care. 1995 Mar;22(1):99-115.

Active substance: TOLNAFTATE

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Document reference: 44830

Study title: Schwartz RA, Janniger CK. Tinea capitis. Cutis. 1995 Jan;55(1):29-33. Schwartz RA, Janniger CK. Tinea capitis. Cutis. 1995 Jan;55(1):29-33.

Active substance: TOLNAFTATE

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Document reference: 44832

Study title: Theos A. Diagnosis and management of superficial cutaneous fungal infections in children. Pediatr Ann. 2007 Jan;36(1):46-54. Theos A. Diagnosis and management of superficial cutaneous fungal infections in children. Pediatr Ann. 2007 Jan;36(1):46-54.

Active substance: TOLNAFTATE

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Document reference: 44833

Study title: Tong MM, Altman PM, Barnetson RS. Tea tree oil in the treatment of tinea pedis. Friedlander SF, Suarez S. Pediatric antifungal therapy. Dermatol Clin. 1998 Jul;16(3):527-37. Tong MM, Altman PM, Barnetson RS. Tea tree oil in the treatment of tinea pedis. Friedlander SF, Suarez S. Pediatric antifungal therapy. Dermatol Clin. 1998 Jul;16(3):527-37.

Active substance: TOLNAFTATE

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Document reference: 44828

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Tonico-Injeel (ampoules) [AWB-AT]

Active substance: Tonico-Injeel

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Document reference: 40261

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Tonsilla comp. Ampullen (ampoules) [AWB-AT]

Active substance: Tonsilla compositum-Heel - Ampullen

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Document reference: 40277

Study title: 10. Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in pediatric subjects with uncontrolled partial onset seizures with or without secondarily generalized seizures

Active substance: TOPIRAMATE

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Document reference: 44843

Study title: 11. Phase 1, multicenter, open-label trial to gain additional experience with topiramate among subjects with infantile spasms.

Active substance: TOPIRAMATE

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Document reference: 44875

Study title: 11. Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in subjects with uncontrolled primary generalized tonic-clonic seizures

Active substance: TOPIRAMATE

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Document reference: 44844

Study title: 12. Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in subjects with uncontrolled primary (PGTC) seizures with or without other generalized seizure subtypes

Active substance: TOPIRAMATE

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Document reference: 44845

Study title: 12. Phase 3, double-blind, randomized, parallel group study comparing the safety and efficacy of 2 doses of topiramate as monotherapy in the treatment of newly diagnosed or recurrent epilepsy in pediatric and adult subjects. (plus OL ext)

Active substance: TOPIRAMATE

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Document reference: 44876

Study title: 13. Phase 3b, open-label, multicenter study designed to evaluate the efficacy and safety of topiramate as adjunctive therapy in pediatric subjects with inadequately controlled partial-onset seizures (with or without secondarily generalized seizures); seizures associated with Lennox-Gastaut Syndrome; and generalized tonic-clonic, myoclonic, or absence seizures.

Active substance: TOPIRAMATE

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Document reference: 44877

Study title: 14. Adjunctive to lithium versus placebo maintenance study, one year of therapy.

Active substance: TOPIRAMATE

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Document reference: 44948

Study title: 15. Open-label extension study of the safety and efficacy of RWJ-17021-001 in subjects with bipolar i disorder who completed protocol TOPMAT-PDMD-002.

Active substance: TOPIRAMATE

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Document reference: 44949

Study title: An open-label study of the safety and efficacy of long-term tiagabine administration in patients with epilepsy unsatisfactorily controlled with other antiepileptic medicationTreatment of acute bacterial conjunctivitis: 1% fusidic acid viscous drops vs. 0.3% tobramycin drops. Jackson WB, Low DE, Dattani D, Whitsitt PF, Leeder RG, MacDougall R. Can J Ophthalmol. 2002 Jun;37(4):228-37; discussion 237.

Active substance: TIAGABINE

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Document reference: 38529

Study title: An Open-Label Study of the Safety of Long-Term Tiagabine HCl Administration in Patients with Epilepsy

Active substance: TIAGABINE

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Document reference: 38526

Study title: A compassionate Program of Tiagabine HCl in Treatment of Pediatric Patients with Partial Seizures

Active substance: TIAGABINE

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Document reference: 38536

Study title: Clinical and Neurobiological findings in children suffering from tic disease following treatment with tiapride - Eggers C. et al. - 1988 (Eur Arch Psychiatry Neurol Sci.;237(4):223-9)Clinical and Neurobiological findings in children suffering from tic disease following treatment with tiapride - Eggers C. et al. - 1988 (Eur Arch Psychiatry Neurol Sci.;237(4):223-9)

Active substance: TIAGABINE

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Document reference: 38467

Study title: Cognitive effects of the new antiepileptic drugs ; KJ Meador, KJ Meador, Neurologist 1998, 4(5): S35-S39Cognitive effects of the new antiepileptic drugs ; KJ Meador, KJ Meador, Neurologist 1998, 4(5): S35-S39

Active substance: TIAGABINE

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Document reference: 38434

Study title: Compassionate Use of Tiagabine HCl in Patients with Refractory Epilepsy

Active substance: TIAGABINE

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Document reference: 38524

Study title: Am J Cardiol. 1979 Nov;44(6):1040-5. Idiopathic hypertrophic subaortic stenosis: evaluation of anginal symptoms with thallium-201 myocardial imaging. Rubin KA, Morrison J, Padnick MB, Binder AJ, Chiaramida S, Margouleff D, Padmanabhan VT, Gulotta SJ. Am J Cardiol. 1979 Nov;44(6):1040-5. Idiopathic hypertrophic subaortic stenosis: evaluation of anginal symptoms with thallium-201 myocardial imaging. Rubin KA, Morrison J, Padnick MB, Binder AJ, Chiaramida S, Margouleff D, Padmanabhan VT, Gulotta SJ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44501

Study title: Am J Cardiol. 1980 May;45(5):1013-8. Radionuclide assessment of right and left ventricular exercise reserve after total correction of tetralogy of Fallot. Reduto LA, Berger HJ, Johnstone DE, Hellenbrand W, Wackers FJ, Whittemore R, Cohen LS, Gottschalk Am J Cardiol. 1980 May;45(5):1013-8. Radionuclide assessment of right and left ventricular exercise reserve after total correction of tetralogy of Fallot. Reduto LA, Berger HJ, Johnstone DE, Hellenbrand W, Wackers FJ, Whittemore R, Cohen LS, Gottschalk

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44502

Study title: Am J Cardiol. 1982 Apr 1;49(5):1197-207. Noninvasive assessment of coronary stenoses by myocardial imaging during pharmacologic coronary vasodilation. VI. Detection of coronary artery disease in human beings with intravenous N-13 ammonia and positron coAm J Cardiol. 1982 Apr 1;49(5):1197-207. Noninvasive assessment of coronary stenoses by myocardial imaging during pharmacologic coronary vasodilation. VI. Detection of coronary artery disease in human beings with intravenous N-13 ammonia and positron co

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44503

Study title: Am J Cardiol. 1982 May;49(7):1632-7. Exercise thallium-201 myocardial scintigraphy in women: correlation with coronary arteriography. Friedman TD, Greene AC, Iskandrian AS, Hakki AH, Kane SA, Segal BL. Am J Cardiol. 1982 May;49(7):1632-7. Exercise thallium-201 myocardial scintigraphy in women: correlation with coronary arteriography. Friedman TD, Greene AC, Iskandrian AS, Hakki AH, Kane SA, Segal BL.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44504

Study title: Kaku Igaku. 1994 Dec;31(12):1477-94. [201Tl scintigraphic evaluation of tumor mass and viability of bone and soft-tissue tumors] [Article in Japanese] Tsuda T, Kubota M, Yoshida S, Shibata M, Wakabayashi J, Obata H, Matsuyama T, Usui M, Ishii S. Kaku Igaku. 1994 Dec;31(12):1477-94. [201Tl scintigraphic evaluation of tumor mass and viability of bone and soft-tissue tumors] [Article in Japanese] Tsuda T, Kubota M, Yoshida S, Shibata M, Wakabayashi J, Obata H, Matsuyama T, Usui M, Ishii S.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44646

Study title: Kaku Igaku. 1994 Jan;31(1):53-61. [Clinical usefulness of thallium-201 chloride in the diagnosis of tumors (I)--Evaluation in brain tumors] [Article in Japanese] Endo K, Yui N, Suzuki K, Torizuka K. Kaku Igaku. 1994 Jan;31(1):53-61. [Clinical usefulness of thallium-201 chloride in the diagnosis of tumors (I)--Evaluation in brain tumors] [Article in Japanese] Endo K, Yui N, Suzuki K, Torizuka K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44647

Study title: Kaku Igaku. 1994 Jan;31(1):63-74. [Clinical usefulness of thallium-201 chloride in the diagnosis of tumor (II)--An evaluation in bone, soft tissue and mediastinal tumors] [Article in Japanese] Tonami N, Itoh K, Yui N, Terui S, Torizuka K. Kaku Igaku. 1994 Jan;31(1):63-74. [Clinical usefulness of thallium-201 chloride in the diagnosis of tumor (II)--An evaluation in bone, soft tissue and mediastinal tumors] [Article in Japanese] Tonami N, Itoh K, Yui N, Terui S, Torizuka K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44648

Study title: Kaku Igaku. 1994 May;31(5):441-9. [Detection and localization of parathyroid adenomas and hyperplasias in patients with hyperparathyroidism using thallium-201/technetium-99m parathyroid subtraction scintigraphy] [Article in Japanese] Kanegae K, Itoh KKaku Igaku. 1994 May;31(5):441-9. [Detection and localization of parathyroid adenomas and hyperplasias in patients with hyperparathyroidism using thallium-201/technetium-99m parathyroid subtraction scintigraphy] [Article in Japanese] Kanegae K, Itoh K

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44649

Study title: Kardiologiia. 1989 Dec;29(12):68-73. [Tl-201 perfusion scintigraphy of the myocardium in patients with anomalous origin of the left coronary artery from the pulmonary trunk (clinico-anatomical comparisons)] [Article in Russian] Malov GA, Oblovatskaia OKardiologiia. 1989 Dec;29(12):68-73. [Tl-201 perfusion scintigraphy of the myocardium in patients with anomalous origin of the left coronary artery from the pulmonary trunk (clinico-anatomical comparisons)] [Article in Russian] Malov GA, Oblovatskaia O

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44650

Study title: Klin Padiatr. 1998 Jul-Aug;210(4):239-42. Monitoring tumor activity in low grade glioma of childhood. MÃlenkamp G, Riemann B, Kuwert T, Sträter R, Kurlemann G, Schober O, Jürgens H, Wolff JE. Klin Padiatr. 1998 Jul-Aug;210(4):239-42. Monitoring tumor activity in low grade glioma of childhood. MÃlenkamp G, Riemann B, Kuwert T, Sträter R, Kurlemann G, Schober O, Jürgens H, Wolff JE.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44651

Study title: Kokyu To Junkan. 1984 Feb;32(2):161-4. [Thallium-201 myocardial scintigram in primary pulmonary hypertension] [Article in Japanese] Fujii I, Handa S, Yamazaki H, Nakamura Y. Kokyu To Junkan. 1984 Feb;32(2):161-4. [Thallium-201 myocardial scintigram in primary pulmonary hypertension] [Article in Japanese] Fujii I, Handa S, Yamazaki H, Nakamura Y.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44652

Study title: A Phase IV Multicenter Randomized Double-blind study to assess the antibody response in healthy children aged 3 - 12 years after two vaccinations with FSME-IMMUN Inject

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 41106

Study title: A phase IV, single-blind, multi-centre, randomized, controlled study to evaluate the safety, tolerability and immunogenicity of two Tick-Borne Encephalitis (TBE) vaccines: Novartis Vaccines's Encepur® Kinder and "licensed comparator" vaccine (Baxter's FSME Immun® Junior) administered according to two different schedules in children.

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 48385

Study title: A post-marketing study with FSME-IMMUN Inject to assess the rate of fever reactions in 190 healthy children aged 3 to 12 years

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 41104

Study title: Pediatr Cardiol. 1991 Apr;12(2):78-82. Asymptomatic myocardial infarction in Kawasaki disease: long-term prognosis. Shiraishi I, Onouchi Z, Hayano T, Hamaoka K, Kiyosawa N. Pediatr Cardiol. 1991 Apr;12(2):78-82. Asymptomatic myocardial infarction in Kawasaki disease: long-term prognosis. Shiraishi I, Onouchi Z, Hayano T, Hamaoka K, Kiyosawa N.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44678

Study title: Pediatr Cardiol. 1993 Mar;14(2):67-74. Discordance between thallium-201 scintigraphy and coronary angiography in patients with Kawasaki disease: myocardial ischemia with normal coronary angiogram. Fukazawa M, Fukushige J, Takeuchi T, Narabayashi Pediatr Cardiol. 1993 Mar;14(2):67-74. Discordance between thallium-201 scintigraphy and coronary angiography in patients with Kawasaki disease: myocardial ischemia with normal coronary angiogram. Fukazawa M, Fukushige J, Takeuchi T, Narabayashi

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44679

Study title: Pediatr Cardiol. 1996 Mar-Apr;17(2):71-6. Long-term outcome of coronary abnormalities in patients after Kawasaki disease. Fukushige J, Takahashi N, Ueda K, Hijii T, Igarashi H, Ohshima A. Pediatr Cardiol. 1996 Mar-Apr;17(2):71-6. Long-term outcome of coronary abnormalities in patients after Kawasaki disease. Fukushige J, Takahashi N, Ueda K, Hijii T, Igarashi H, Ohshima A.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44680

Study title: Pediatr Hematol Oncol. 2005 Mar;22(2):153-62. Quantitative thallium-201 scintigraphy in childhood osteosarcoma: Comparison with technetuim-99m MDP and magnetic resonance imaging in the evaluation of chemotherapeutic response. Ilhan IE, Vural G, BerberogPediatr Hematol Oncol. 2005 Mar;22(2):153-62. Quantitative thallium-201 scintigraphy in childhood osteosarcoma: Comparison with technetuim-99m MDP and magnetic resonance imaging in the evaluation of chemotherapeutic response. Ilhan IE, Vural G, Berberog

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44681

Study title: Pediatr Neurol. 1991 Jul-Aug;7(4):249-57. 201Tl/99mTc-HMPAO SPECT imaging of treated childhood brain tumors. O'Tuama LA, Janicek MJ, Barnes PD, Scott RM, Black PM, Sallan SE, Tarbell NJ, Kupsky WJ, Wagenaar D, Ulanski JS, et al. Pediatr Neurol. 1991 Jul-Aug;7(4):249-57. 201Tl/99mTc-HMPAO SPECT imaging of treated childhood brain tumors. O'Tuama LA, Janicek MJ, Barnes PD, Scott RM, Black PM, Sallan SE, Tarbell NJ, Kupsky WJ, Wagenaar D, Ulanski JS, et al.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44682

Study title: Pediatr Neurol. 1998 Nov;19(5):351-7. Comparative value of thallium and glucose SPECT imaging in childhood brain tumors. Maria BL, Drane WE, Mastin ST, Jimenez LA. Pediatr Neurol. 1998 Nov;19(5):351-7. Comparative value of thallium and glucose SPECT imaging in childhood brain tumors. Maria BL, Drane WE, Mastin ST, Jimenez LA.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44683

Study title: Pediatr Neurol. 1998 Oct;19(4):259-62. Childhood brain tumor: neuroimaging correlated with disease outcome. O'Tuama LA, Poussaint TY, Anthony DC, Treves ST. Pediatr Neurol. 1998 Oct;19(4):259-62. Childhood brain tumor: neuroimaging correlated with disease outcome. O'Tuama LA, Poussaint TY, Anthony DC, Treves ST.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44684

Study title: Pediatr Neurosurg. 1991-1992;17(2):95-7. Thallium-201 single-photon emission computed tomography imaging in a pediatric brain tumor. A case report. Bhargava S, Coel M, Wilkinson R. Pediatr Neurosurg. 1991-1992;17(2):95-7. Thallium-201 single-photon emission computed tomography imaging in a pediatric brain tumor. A case report. Bhargava S, Coel M, Wilkinson R.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44685

Study title: Pediatr Neurosurg. 1994;20(1):11-8. Value of thallium-201 SPECT imaging in childhood brain tumors. Maria BL, Drane WE, Quisling RG, Ringdahl DM, Mickle JP, Mendenhall NP, Marcus RB Jr, McCollough WM, Hamed LM, Eskin TA, et al. Pediatr Neurosurg. 1994;20(1):11-8. Value of thallium-201 SPECT imaging in childhood brain tumors. Maria BL, Drane WE, Quisling RG, Ringdahl DM, Mickle JP, Mendenhall NP, Marcus RB Jr, McCollough WM, Hamed LM, Eskin TA, et al.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44686

Study title: A pilot study of topiramate in subjects with infantile spasms.

Active substance: TOPIRAMATE

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Document reference: 44853

Study title: A pilot study of topiramate in subjects with infantile spasms.

Active substance: TOPIRAMATE

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Document reference: 44944

Study title: A placebo controlled 12 - week study of the safety and efficacy of one dose of topiramate versus lithium for the treatment of acute manic or mixed episodess in subjects with bipolar disorder i with an optionhal open -label extension

Active substance: TOPIRAMATE

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Document reference: 44856

Study title: A randomized , open-label, multicenter study with open-label extension of the pharmacokinetics and safety of topiramate administered as the oral liquid and sprinkle formulations as an adjunct to concurrent anticonvulsivant therapy in infants (aged 1 to 24 months, inclusive) with refractory partial-onset seizures

Active substance: TOPIRAMATE

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Document reference: 44862

Study title: A randomized, double-blind, multicenter, placebo-controlled 4-week study of the safety and efficacy of topiramate in adolescents with acute manic or mixed episodes of bipolar i disorder, with an optional 6-month open-label extension.

Active substance: TOPIRAMATE

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Document reference: 44951

Study title: A randomized, double-blind, placebo-controlled, fixe dose-ranging study to assess the safety and tolerability and efficacy of topiramate oral liquid and sprinkle formulations as an adjunct to concurrent anticonvulsivant therapy for infants (1 to 23 months of age, inclusive) with refractoty partial onset seizures, with open-label extension.

Active substance: TOPIRAMATE

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Document reference: 44863

Study title: A randomized, open label extension of the pharmacokinetics and safety of topiramate administered as the oral liquid and sprinkle formulations as an adjunct to concurrent anticonvulsivant therapy in infants (Aged 1 to 24 months, inclusive) with refractory partial-onset seizures

Active substance: TOPIRAMATE

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Document reference: 44932

Study title: A retrospective chart review of infants with infantile spasm of which some were treated with Topamax

Active substance: TOPIRAMATE

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Document reference: 44868

Study title: A double-blind trial comparing the efficacy, tolerability and safety of monotherapy topiramate versus phenytoin in subjects with seizures indicative of new onset epilepsy

Active substance: TOPIRAMATE

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Document reference: 44846

Study title: A retrospective review of infants with infantile spasm of which some were treated with Topamax

Active substance: TOPIRAMATE

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Document reference: 44924

Study title: Adjunctive to lithium versus placebo maintenance study, one year of therapy

Active substance: TOPIRAMATE

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Document reference: 44854

Study title: Adjunctive to lithium versus placebo-maintenance study, one year of therapy

Active substance: TOPIRAMATE

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Document reference: 44915

Study title: Adolescent migraine prophylaxis

Active substance: TOPIRAMATE

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Document reference: 44861

Study title: A pilot study of topiramate in childhood absence epilepsy

Active substance: TOPIRAMATE

Study summary document link (including results):

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Document reference: 44848

Study title: A pilot study of topiramate in childhood absence epilepsy.

Active substance: TOPIRAMATE

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Document reference: 44907

Study title: A pilot study of topiramate in subjects with infantile spasms

Active substance: TOPIRAMATE

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Document reference: 44911

Study title: Adolescent migraine prophylaxis

Active substance: TOPIRAMATE

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Document reference: 44931

Study title: Antiepilepsy drug effectiveness in pediatric partial epilepsy

Active substance: TOPIRAMATE

Study summary document link (including results):

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Document reference: 44859

Study title: Antiepilepsy drug effectiveness in pediatric partial epilepsy

Active substance: TOPIRAMATE

Study summary document link (including results):

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Document reference: 44933

Study title: Compassionate use of Topamax

Active substance: TOPIRAMATE

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Document reference: 44867

Study title: Double-blind trial for partial onset seizures efficacy

Active substance: TOPIRAMATE

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Document reference: 44920

Study title: Double-blind, randomized, parallel group trial comparing 2 dosages of topiramate as monotherapy in pediatric and adult subjects with recently diagnosed epilepsy characterized by partial onset seizures.

Active substance: TOPIRAMATE

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Document reference: 44891

Study title: Am J Cardiol. 1990 May 1;65(16):1134-9. Decreased coronary vasodilatory capacity in hypertrophic cardiomyopathy determined by split-dose thallium-dipyridamole myocardial scintigraphy. Koga Y, Yamaguchi R, Ogata M, Kihara K, Toshima H. Am J Cardiol. 1990 May 1;65(16):1134-9. Decreased coronary vasodilatory capacity in hypertrophic cardiomyopathy determined by split-dose thallium-dipyridamole myocardial scintigraphy. Koga Y, Yamaguchi R, Ogata M, Kihara K, Toshima H.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44505

Study title: Am J Cardiol. 1992 Mar 1;69(6):673-6. Estimation of right ventricular pressure in children by thallium-201 myocardial imaging using single-photon emission computed tomography. Akiba T, Yoshikawa M, Otaki S, Nakasato M, Suzuki H, Sato S, Sato T. Am J Cardiol. 1992 Mar 1;69(6):673-6. Estimation of right ventricular pressure in children by thallium-201 myocardial imaging using single-photon emission computed tomography. Akiba T, Yoshikawa M, Otaki S, Nakasato M, Suzuki H, Sato S, Sato T.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44506

Study title: Am J Cardiol. 1992 Nov 1;70(13):1109-12. Detection of silent coronary artery disease in adolescents and young adults with familial hypercholesterolemia by single-photon emission computed tomography thallium-201 scanning. Mouratidis B, Vaughan-Neil EF, Am J Cardiol. 1992 Nov 1;70(13):1109-12. Detection of silent coronary artery disease in adolescents and young adults with familial hypercholesterolemia by single-photon emission computed tomography thallium-201 scanning. Mouratidis B, Vaughan-Neil EF,

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44507

Study title: MULTICENTRIC NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF FCA FOR THE TREATMENT OF SEVERE SYSTEMIC CANDIDIASIS AND CRYPTOCOCCAL MENINGITIS

Active substance: FLUCONAZOLE

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Document reference: 28035

Study title: Caudal bupivacaine-tramadol combination for postoperative analgesia in paediatric herniorrhaphy - Senel AC, Akyol A, Dohman D, Solak M, - 2001 (Acta. Anaesthesiologiol. Scand, 2001; 45: 786-789)Caudal bupivacaine-tramadol combination for postoperative analgesia in paediatric herniorrhaphy - Senel AC, Akyol A, Dohman D, Solak M, - 2001 (Acta. Anaesthesiologiol. Scand, 2001; 45: 786-789)

Active substance: TRAMADOL

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Document reference: 45021

Study title: Caudal tramadol for postoperative analgesia in paediatric hypospadias surgery - Prosser Dp, Davis A, Booker PD, Murray A - 1997 (Br J Anaesth 1997; 79: 293-296)Caudal tramadol for postoperative analgesia in paediatric hypospadias surgery - Prosser Dp, Davis A, Booker PD, Murray A - 1997 (Br J Anaesth 1997; 79: 293-296)

Active substance: TRAMADOL

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Document reference: 45022

Study title: Clinical investigation of the effect and safety of Tramal in paediatric postoperative administration

Active substance: TRAMADOL

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Document reference: 45007

Study title: Comparaison of caudal morphine and tramadol for postoperative pain control in children undergoing inguinal herniorrhapy - Ozcengiz D, Gunduz H, Ozbek H, Isik G, - 2001 (Paediatric Anaesthesia 2001, 11: 459-464)Comparaison of caudal morphine and tramadol for postoperative pain control in children undergoing inguinal herniorrhapy - Ozcengiz D, Gunduz H, Ozbek H, Isik G, - 2001 (Paediatric Anaesthesia 2001, 11: 459-464)

Active substance: TRAMADOL

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Document reference: 45023

Study title: Treatment of neuroblastoma with 131I-metaiodobenzylguanidine: experience of the Munster/Kassel GroupMedical and pediatric oncology (1987), 15(4), 196-8

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48314

Study title: Doppelblinde, randomisierte, multizentrische Dosisfindungs-Studie zur Untersuchung der Immunogenität und Verträglichkeit einer FSME Impfung mit FSME IMMUN neu nach der 2. Teilimpfung bei Kindern zwischen 6 und 16 Jahren

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 21205

Study title: Investigator's study (Dr. Rudolf Schosser): Post-authorisation observation Study, Booster Vaccination with FSME-IMMUN Adult und FSME-IMMUN 0,25ml Junior to achieve Protection if Irregular Vaccination scheme have occured in the vaccination history (duration: May 2005 - December 2006)

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 41102

Study title: Multicenter Phase IV Study to Investigate the Seropersistence of TBE Virus Antibodies Approximately Three Years After a Booster Vaccination with FSME-Immun 0.25 ml Junior in Children (Follow-up to Study 146A and 180)

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 41103

Study title: Multizentrische offene Studie zur Untersuchung der FSME-Antikörper 1 Jahr nach Impfung mit 0,25 oder 0,50 ml TicoVac - Anschlußstudie an die FSME-Kinderstudie 146

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 21214

Study title: Multizentrische offene Studie zur Untersuchung der FSME-Antikörper 1 Jahr nach Impfung mit 0,25 oder 0,50 ml TicoVac - Anschlußstudie an die FSME-Kinderstudie 146

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 41105

Study title: A phase III, controlled, open-label, randomized, multicenter study in children: evaluating the immunogenicity and safety of Novartis pediatric Tick Borne Encephalitis (TBE) vaccine using three different immunization schedules.

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 48396

Study title: Phase III, observer-blind, randomized, study to evaluate the safety and immunogenicity using three doses of polygeline free tick-borne encephalitis (TBE) vaccine in adolescents and adults.

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 48398

Study title: phase III, controlled, randomized, observer-blind, multicenter study in healthy, TBE negative children ages ≥1 to <12 years of age.

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 48382

Study title: Phase IV multicenter, open label extension study of the long-term immunogenicity of a single booster dose of polygeline-free tick borne encephalitis (TBE) vaccine in children.

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 48399

Study title: Phase IV multicenter, open label extension study of the long-term immunogenicity of a single booster dose of polygeline-free tick borne encephalitis (TBE) vaccine in children.

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 48400

Study title: Single-blind, randomized, multicenter comparison of FSME IMMUN NEW and ENCEPUR: safety and tolerability of two vaccinations in healthy volunteers aged 16 to 65 years

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 21204

Study title: Acute oral toxicity in the baboon (LSR report n°76/CAS4/176) - Lightowler - 28 July 1976

Active substance: TICLOPIDINE

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Document reference: 44755

Study title: Pharmacocinetique de la ticlopidine à dose unique et doses répétées chez des volontaires sains jeunes et agés. Rapport final. ICM 1161/ CL 3690 - Gabuzda G. - 01/12/86

Active substance: TICLOPIDINE

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Document reference: 44759

Study title: Publication: Effect of vitamin E and ticlopidine on platelet aggregation in Fabry's disease. Clin Gen; 31:349-54 - Sakuraba - 4 January 1987

Active substance: TICLOPIDINE

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Document reference: 44756

Study title: Publication: Treatment of angiomas with associated thrombocytopenia (Kasabach-Merrit syndrome) by ticlopidine-aspirin combination - Drouet - No date

Active substance: TICLOPIDINE

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Document reference: 44757

Study title: Studies on platelet functions and the protection of platelet consumption during extracorporeal circulation -Isomura - No date

Active substance: TICLOPIDINE

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Document reference: 44758

Study title: Circulation. 1980 Mar;61(3):596-9. Thallium-201 myocardial perfusion imaging in infants and children. Value in distinguishing anomalous left coronary artery from congestive cardiomyopathy. Gutgesell HP, Pinsky WW, DePuey EG. Circulation. 1980 Mar;61(3):596-9. Thallium-201 myocardial perfusion imaging in infants and children. Value in distinguishing anomalous left coronary artery from congestive cardiomyopathy. Gutgesell HP, Pinsky WW, DePuey EG.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44534

Study title: Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2. Granfors MT, Backman JT, Laitila J, Neuvonen PJ. Clinical pharmacology and therapeutics, Oct 2005, vol. 78, no. 4, p. 400−11Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2. Granfors MT, Backman JT, Laitila J, Neuvonen PJ. Clinical pharmacology and therapeutics, Oct 2005, vol. 78, no. 4, p. 400−11

Active substance: TINZANIDINE

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Document reference: 44791

Study title: Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2. Granfors MT, Backman JT, Laitila J, Neuvonen PJ. Clinical pharmacology and therapeutics, Oct 2005, vol. 78, no. 4, p. 400−11Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2. Granfors MT, Backman JT, Laitila J, Neuvonen PJ. Clinical pharmacology and therapeutics, Oct 2005, vol. 78, no. 4, p. 400−11

Active substance: TINZANIDINE

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Document reference: 44803

Study title: Spasmodic torticollis: treatment with Tizanidine.Spasmodic torticollis: treatment with Tizanidine.

Active substance: TINZANIDINE

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Document reference: 44799

Study title: Tizanidine treatment of spasticity caused by multiple sclerosis: results of a double−blind, placebo−controlled trial. US Tizanidine Study Group.Tizanidine treatment of spasticity caused by multiple sclerosis: results of a double−blind, placebo−controlled trial. US Tizanidine Study Group.

Active substance: TINZANIDINE

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Document reference: 44795

Study title: Treatment of spasticity with tizanidine in multiple sclerosis.Treatment of spasticity with tizanidine in multiple sclerosis.

Active substance: TINZANIDINE

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Document reference: 44798

Study title: Utilidad de la tizanidina. Seguimiento de un ano en el tratamiento de la espasticidad en la paralysis (The usefulness of tizanidine. A one−year follow−up of the treatment of spasticity in infantile cerebral palsy).Utilidad de la tizanidina. Seguimiento de un ano en el tratamiento de la espasticidad en la paralysis (The usefulness of tizanidine. A one−year follow−up of the treatment of spasticity in infantile cerebral palsy).

Active substance: TINZANIDINE

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Document reference: 44786

Study title: (The impact of diltiazem on aminophylline serum concentration−−a clinical study). Li X, Zhao JP, Chen BG. Zhonghua nei ke za zhi (Chinese journal of internal medicine),Nov 1994, vol. 33, no. 11, p. 773−5(The impact of diltiazem on aminophylline serum concentration−−a clinical study). Li X, Zhao JP, Chen BG. Zhonghua nei ke za zhi (Chinese journal of internal medicine),Nov 1994, vol. 33, no. 11, p. 773−5

Active substance: DILTIAZEM

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Document reference: 26131

Study title: Utilidad de la tizanidina. Seguimiento de un ano en el tratamiento de la espasticidad en la paralysis (The usefulness of tizanidine. A one−year follow−up of the treatment of spasticity in infantile cerebral palsy). Vásquez BA, Arellano SME, León HSR, Morales OMG. Revista de neurologia, Aug 1−15 2006, vol. 43, no. 3, p. 132−6Utilidad de la tizanidina. Seguimiento de un ano en el tratamiento de la espasticidad en la paralysis (The usefulness of tizanidine. A one−year follow−up of the treatment of spasticity in infantile cerebral palsy). Vásquez BA, Arellano SME, León HSR, Morales OMG. Revista de neurologia, Aug 1−15 2006, vol. 43, no. 3, p. 132−6

Active substance: TINZANIDINE

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Document reference: 44802

Study title: Pharmacokinetic Study of Tinzaparin Sodium in Paediatric Patients

Active substance: TINZAPARIN

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Document reference: 44805

Study title: A PROSPECTIVE RANDOMIZED TRIAL OF FCA VS. AMPHOTERICIN B FOR EMPERIC ANTI-FUNGAL THERAPY OF THE NEUTROPENIC FEBRILE PATIENTS.

Active substance: FLUCONAZOLE

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Document reference: 27986

Study title: Evaluation of the optimal dose of topiramate in epilepsy monotherapy

Active substance: TOPIRAMATE

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Document reference: 44847

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A placebo-controlled, double-blind study of Nasacort® (triamcinolone acetonide nasal aerosol) in pediatric patients with seasonal allergic rhinitis - No Author - 31/07/1992

Active substance: TRIAMCINOLONE

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Document reference: 46848

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A placebo-controlled, double-blind study of NasacortTM (triamcinolone acetonide nasal aerosol) in pediatric patients with perennial allergic rhinitis - No Author - 15/04/1991

Active substance: TRIAMCINOLONE

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Document reference: 46849

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A placebo-controlled, double-blind study of RG 5029Y aqueous nasal spray in pediatric patients with spring grass seasonal allergic rhinitis - Simpson BE - 31/08/1995

Active substance: TRIAMCINOLONE

Study summary document link (including results): Triamcinolone acetonide STUDY RG5029Y-312 CSR.xls

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Document reference: 46850

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A placebo-controlled, double-blind study of the safety and efficacy of RG5029Y (triamcinolone acetonide) aqueous nasal spray in adolescent patients with ragweed allergic rhinitis - Procaccini RL - 25/02/1994

Active substance: TRIAMCINOLONE

Study summary document link (including results): Triamcinolone acetonide STUDY RG5029Y-302 CSR.xls

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Document reference: 46851

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A study of the safety and efficacy of RG 5029Y (triamcinolone acetonide) aqueous nasal spray in patients with perennial allergic rhinitis - Cassel D- 22/11/1994

Active substance: TRIAMCINOLONE

Study summary document link (including results): Triamcinolone acetonide STUDY RG5029Y-305 CSR.xls

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Document reference: 46852

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 An open-label, long-term safety of WHR 5029 (triamcinolone acetonide nasal aerosol) in patients with perennial allergic rhinitis - No Author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46854

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 An open-label, long-term study of WHR 5029 (triamcinolone acetonide nasal aerosol) in patients with perennial allergic rhinitis - No Author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46855

Study title: Wilson disease in children: serum aminotransferases and urinary copper on triethylene tetramine dihydrochloride (trientine) treatmentArnon R et al. J Pediatr Gastroenterol Nutr 2007; 44:596-602.Wilson disease in children: serum aminotransferases and urinary copper on triethylene tetramine dihydrochloride (trientine) treatmentArnon R et al. J Pediatr Gastroenterol Nutr 2007; 44:596-602.

Active substance: TRIENTINE

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Document reference: 46734

Study title: DiMario FJ Jr. Childhood head tremor. J Child Neurol 2000 Jan; 15(1): 22-5.DiMario FJ Jr. Childhood head tremor. J Child Neurol 2000 Jan; 15(1): 22-5.

Active substance: TRIHEXYPHENIDYL

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Document reference: 46738

Study title: Fahn Systemic Therapy of Dystonia Can J Neurol Sci 1987;14:528-532Fahn Systemic Therapy of Dystonia Can J Neurol Sci 1987;14:528-532

Active substance: TRIHEXYPHENIDYL

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Document reference: 46743

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in pediatric patients with seasonal allergic rhinitis - No Author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46847

Study title: Fahn S. High dosage anticholinergic therapy in dystonia. Neurology 1983 Oct; 33(10): 1255-61.Fahn S. High dosage anticholinergic therapy in dystonia. Neurology 1983 Oct; 33(10): 1255-61.

Active substance: TRIHEXYPHENIDYL

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Document reference: 46745

Study title: Comparison of caudal tramadol versus bupivacaine for postoperative analgesia in children undergoing hypospadis surgery - Batra YK, Prasad MK, Arya VK, Chari P, Yaddnapudi LN - 1999 (Int J Clin Pharmacol Ther. 1999; 37(5): 238-242)Comparison of caudal tramadol versus bupivacaine for postoperative analgesia in children undergoing hypospadis surgery - Batra YK, Prasad MK, Arya VK, Chari P, Yaddnapudi LN - 1999 (Int J Clin Pharmacol Ther. 1999; 37(5): 238-242)

Active substance: TRAMADOL

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Document reference: 45024

Study title: Comparison of the efficacy and tolerability of tramadol, pethidine and nalbuphine in children with postoperative pain. An open randomised study - Barsoum MW - 1995 (Clin Drug Invest 1995; 9(4): 183-190)Comparison of the efficacy and tolerability of tramadol, pethidine and nalbuphine in children with postoperative pain. An open randomised study - Barsoum MW - 1995 (Clin Drug Invest 1995; 9(4): 183-190)

Active substance: TRAMADOL

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Document reference: 45025

Study title: Control of postoperative pain with tramadol in paediatric and adolescent patients with neurological lesions: our experience - Girotto T, Padovan L, Muraretto P, Marazza D, Marzeolini M, De Nobili E - 1998 (Acta Anaesth Italica 1998; 49: 257-262)Control of postoperative pain with tramadol in paediatric and adolescent patients with neurological lesions: our experience - Girotto T, Padovan L, Muraretto P, Marazza D, Marzeolini M, De Nobili E - 1998 (Acta Anaesth Italica 1998; 49: 257-262)

Active substance: TRAMADOL

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Document reference: 45026

Study title: Double-blind randomised study of tramadol vs. Paracetamol in analgeia afetr day-case tonsillectomy in children - Pendeville PE, Von Montigny S, Dort JP, Veyckemans F - 2000 (Eur. J Anaesthesiol 2000; 17: 576-582)Double-blind randomised study of tramadol vs. Paracetamol in analgeia afetr day-case tonsillectomy in children - Pendeville PE, Von Montigny S, Dort JP, Veyckemans F - 2000 (Eur. J Anaesthesiol 2000; 17: 576-582)

Active substance: TRAMADOL

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Document reference: 45027

Study title: J Nucl Med. 1996 Sep;37(9):1444-8. Thallium-201 scintigraphy to assess effect of chemotherapy in osteosarcoma. Ohtomo K, Terui S, Yokoyama R, Abe H, Terauchi T, Maeda G, Beppu Y, Fukuma H. J Nucl Med. 1996 Sep;37(9):1444-8. Thallium-201 scintigraphy to assess effect of chemotherapy in osteosarcoma. Ohtomo K, Terui S, Yokoyama R, Abe H, Terauchi T, Maeda G, Beppu Y, Fukuma H.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44619

Study title: J Nucl Med. 1997 Feb;38(2):223-6. The role of thallium-201 uptake and retention in intracranial tumors after radiotherapy. Lorberboym M, Mandell LR, Mosesson RE, Germano I, Lou W, DaCosta M, Linzer DG, Machac J. J Nucl Med. 1997 Feb;38(2):223-6. The role of thallium-201 uptake and retention in intracranial tumors after radiotherapy. Lorberboym M, Mandell LR, Mosesson RE, Germano I, Lou W, DaCosta M, Linzer DG, Machac J.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44620

Study title: J Nucl Med. 1998 Sep;39(9):1600-4. Midcourse thallium-201 scintigraphy to predict tumor response in bone and soft-tissue tumors. Sumiya H, Taki J, Tsuchiya H, Nonomura A, Miyauchi T, Tonami N. J Nucl Med. 1998 Sep;39(9):1600-4. Midcourse thallium-201 scintigraphy to predict tumor response in bone and soft-tissue tumors. Sumiya H, Taki J, Tsuchiya H, Nonomura A, Miyauchi T, Tonami N.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44621

Study title: J Orthop Sci. 1998;3(6):297-303. Value of thallium-201 scintigraphy in bone and soft tissue tumors. Sato O, Kawai A, Ozaki T, Kunisada T, Danura T, Inoue H. J Orthop Sci. 1998;3(6):297-303. Value of thallium-201 scintigraphy in bone and soft tissue tumors. Sato O, Kawai A, Ozaki T, Kunisada T, Danura T, Inoue H.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44622

Study title: Circulation. 1984 Jan;69(1):33-42. Alterations in regional myocardial metabolism, perfusion, and wall motion in Duchenne muscular dystrophy studied by radionuclide imaging. Perloff JK, Henze E, Schelbert HR. Circulation. 1984 Jan;69(1):33-42. Alterations in regional myocardial metabolism, perfusion, and wall motion in Duchenne muscular dystrophy studied by radionuclide imaging. Perloff JK, Henze E, Schelbert HR.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44535

Study title: Circulation. 1991 May;83(5):1660-7. Myocardial metabolic, hemodynamic, and electrocardiographic significance of reversible thallium-201 abnormalities in hypertrophic cardiomyopathy. Cannon RO 3rd, Dilsizian V, O'Gara PT, Udelson JE, Schenke WH, Quyyumi Circulation. 1991 May;83(5):1660-7. Myocardial metabolic, hemodynamic, and electrocardiographic significance of reversible thallium-201 abnormalities in hypertrophic cardiomyopathy. Cannon RO 3rd, Dilsizian V, O'Gara PT, Udelson JE, Schenke WH, Quyyumi

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44536

Study title: Circulation. 1996 Nov 1;94(9 Suppl):II38-43. Midterm results after surgical repair of the anomalous origin of the coronary artery. Lambert V, Touchot A, Losay J, Piot JD, Henglein D, Serraf A, Lacour-Gayet F, Planche C. Circulation. 1996 Nov 1;94(9 Suppl):II38-43. Midterm results after surgical repair of the anomalous origin of the coronary artery. Lambert V, Touchot A, Losay J, Piot JD, Henglein D, Serraf A, Lacour-Gayet F, Planche C.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44537

Study title: Clin Med Res. 2003 Jul;1(3):233-8. Unsuspected widespread cardiac sarcoma in a child. Spieth ME, Kasner DI, Prasannan L. Clin Med Res. 2003 Jul;1(3):233-8. Unsuspected widespread cardiac sarcoma in a child. Spieth ME, Kasner DI, Prasannan L.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44538

Study title: Clin Neurol Neurosurg. 2007 Sep;109(7):607-12. Epub 2007 Jun 6. Cerebral necrosis after 25Gy radiotherapy in childhood followed 28 years later by 54Gy radiotherapy. Koot RW, Stalpers LJ, Aronica E, Andries Bosch D Clin Neurol Neurosurg. 2007 Sep;109(7):607-12. Epub 2007 Jun 6. Cerebral necrosis after 25Gy radiotherapy in childhood followed 28 years later by 54Gy radiotherapy. Koot RW, Stalpers LJ, Aronica E, Andries Bosch D

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44539

Study title: Clin Nucl Med. 1985 Aug;10(8):562-6. Thallium-201 myocardial perfusion imaging in myocarditis. Tamaki N, Yonekura Y, Kadota K, Kambara H, Torizuka K. Clin Nucl Med. 1985 Aug;10(8):562-6. Thallium-201 myocardial perfusion imaging in myocarditis. Tamaki N, Yonekura Y, Kadota K, Kambara H, Torizuka K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44540

Study title: Clin Nucl Med. 1988 Apr;13(4):286-90. Experience with thallium-201 imaging in head and neck cancer. el-Gazzar AH, Sahweil A, Abdel-Dayem HM, Kubasik H, Halker R, Hassan IM, Jamil M, Rageb A, Abdul-Rahim SM, Mahmoud A, et al. Clin Nucl Med. 1988 Apr;13(4):286-90. Experience with thallium-201 imaging in head and neck cancer. el-Gazzar AH, Sahweil A, Abdel-Dayem HM, Kubasik H, Halker R, Hassan IM, Jamil M, Rageb A, Abdul-Rahim SM, Mahmoud A, et al.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44541

Study title: Clin Nucl Med. 1988 Mar;13(3):155-8. The reliability of thallium-201 myocardial tomography in a clinical setting without exclusions for drugs or suboptimal exercise. Coel M, Gushiken B. Clin Nucl Med. 1988 Mar;13(3):155-8. The reliability of thallium-201 myocardial tomography in a clinical setting without exclusions for drugs or suboptimal exercise. Coel M, Gushiken B.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44542

Study title: Tramadol hydrochloride: short-term efficacy in pain following dental surgery

Active substance: TRAMADOL

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Document reference: 45816

Study title: A CLINICAL STUDY ENTITLED TIOCONAZOL 6,5% SINGLE DOSE VAGINAL OINTMENT IN THE TREATMENT OF VAGINAL CANDIDASIS (DR. GRIGORIU ET ALL) (MULTICENTER STUDY)

Active substance: TIOCONAZOLE

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Document reference: 44807

Study title: Eur J Nucl Med. 1995 Jun;22(6):553-5. Quantitative evaluation of thallium-201 uptake in predicting chemotherapeutic response of osteosarcoma. Lin J, Leung WT, Ho SK, Ho KC, Kumta SM, Metreweli C, Johnson PJ. Eur J Nucl Med. 1995 Jun;22(6):553-5. Quantitative evaluation of thallium-201 uptake in predicting chemotherapeutic response of osteosarcoma. Lin J, Leung WT, Ho SK, Ho KC, Kumta SM, Metreweli C, Johnson PJ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44570

Study title: Eur J Nucl Med. 1995 May;22(5):419-26. Quantitative studies of monoclonal antibody targeting to disialoganglioside GD2 in human brain tumors. Arbit E, Cheung NK, Yeh SD, Daghighian F, Zhang JJ, Cordon-Cardo C, Pentlow K, Canete A, Finn R, Larson SM. Eur J Nucl Med. 1995 May;22(5):419-26. Quantitative studies of monoclonal antibody targeting to disialoganglioside GD2 in human brain tumors. Arbit E, Cheung NK, Yeh SD, Daghighian F, Zhang JJ, Cordon-Cardo C, Pentlow K, Canete A, Finn R, Larson SM.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44571

Study title: Eur J Nucl Med. 1995 Nov;22(11):1232-7. Erratum in: Eur J Nucl Med. 1996 Nov;23(11):1558. Correlation of the findings of thallium-201 chloride scans with those of other imaging modalities and histology following therapy in patients with bone and sofEur J Nucl Med. 1995 Nov;22(11):1232-7. Erratum in: Eur J Nucl Med. 1996 Nov;23(11):1558. Correlation of the findings of thallium-201 chloride scans with those of other imaging modalities and histology following therapy in patients with bone and sof

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44572

Study title: Eur J Nucl Med. 1996 May;23(5):504-10. Early and delayed thallium-201 scintigraphy in thyroid nodules: the relationship between early thallium-201 uptake and perfusion. Derebek E, Biberoglu S, Kut O, Yesil S, Saydam S, Yilmaz M, Yenici O, Igci E, GokceEur J Nucl Med. 1996 May;23(5):504-10. Early and delayed thallium-201 scintigraphy in thyroid nodules: the relationship between early thallium-201 uptake and perfusion. Derebek E, Biberoglu S, Kut O, Yesil S, Saydam S, Yilmaz M, Yenici O, Igci E, Gokce

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44573

Study title: Eur J Nucl Med. 2001 Mar;28(3):273-81. High uptake of L-3-[123I]iodo-alpha-methyl tyrosine in pilocytic astrocytomas. Weckesser M, Matheja P, Rickert CH, Sträter R, Palkovic S, LÃttgen J, Kurlemann G, Paulus W, Wassmann H, Schober O. Eur J Nucl Med. 2001 Mar;28(3):273-81. High uptake of L-3-[123I]iodo-alpha-methyl tyrosine in pilocytic astrocytomas. Weckesser M, Matheja P, Rickert CH, Sträter R, Palkovic S, LÃttgen J, Kurlemann G, Paulus W, Wassmann H, Schober O.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44574

Study title: Eur J Nucl Med. 2001 Oct;28(10):1471-81. Relationship between thallium-201 kinetics and proliferative activity assessed by monoclonal antibody MIB-1 in brain tumours. Motoyama K, Suga K, Kume N, Hara A, Ishikawa Y, Matsunaga N, Nishizaki T Eur J Nucl Med. 2001 Oct;28(10):1471-81. Relationship between thallium-201 kinetics and proliferative activity assessed by monoclonal antibody MIB-1 in brain tumours. Motoyama K, Suga K, Kume N, Hara A, Ishikawa Y, Matsunaga N, Nishizaki T

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44575

Study title: Eur J Surg Oncol. 2003 Dec;29(10):908-15. Thallium-201 scintigraphy--a predictor of tumour necrosis in soft tissue sarcoma following preoperative radiotherapy? Choong PF, Nizam I, Ngan SY, Schlict S, Powell G, Slavin J, Smith P, Toner G, Hicks R. Eur J Surg Oncol. 2003 Dec;29(10):908-15. Thallium-201 scintigraphy--a predictor of tumour necrosis in soft tissue sarcoma following preoperative radiotherapy? Choong PF, Nizam I, Ngan SY, Schlict S, Powell G, Slavin J, Smith P, Toner G, Hicks R.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44576

Study title: Hoon AH Jr, et al. Agedependent effects of trihexyphenidyl in extrapyramidal celebral palsy. Pediatric Neurol 2001; 25(1): 55-8.Hoon AH Jr, et al. Agedependent effects of trihexyphenidyl in extrapyramidal celebral palsy. Pediatric Neurol 2001; 25(1): 55-8.

Active substance: TRIHEXYPHENIDYL

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Document reference: 46737

Study title: Retardierte Theophyllin-Zubereitungen für Kinder; Zarkovic J. et al. (1991): Atemwegs- und Lungenkrankheiten, 17, 4, 131-137Retardierte Theophyllin-Zubereitungen für Kinder; Zarkovic J. et al. (1991): Atemwegs- und Lungenkrankheiten, 17, 4, 131-137

Active substance: THEOPHYLLINE

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Document reference: 44721

Study title: Study of theophylline metabolism in premature human newborns using stable isotope labelling Brazier Bioomed Mass Spectrom 1980 May 7(5) 189-92 in Annual Report 02Study of theophylline metabolism in premature human newborns using stable isotope labelling Brazier Bioomed Mass Spectrom 1980 May 7(5) 189-92 in Annual Report 02

Active substance: THEOPHYLLINE

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Document reference: 44725

Study title: Theophylline in childhood asthma pharmacokinetic and clinical study Bellon Rev Fr Mal Respir 1981;9(2): 113-21 in Annual Report 02Theophylline in childhood asthma pharmacokinetic and clinical study Bellon Rev Fr Mal Respir 1981;9(2): 113-21 in Annual Report 02

Active substance: THEOPHYLLINE

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Document reference: 44726

Study title: Theophylline-modulation of bronchial hyper-reactivity (direct and indirect) and T-cell subsets in atopic asthmatic children; Zarkovic J. et al. (1995); XVI European congress of allergology and clinical immunology; Basomba A. and Hernandez F. de Rojas M.D. Theophylline-modulation of bronchial hyper-reactivity (direct and indirect) and T-cell subsets in atopic asthmatic children; Zarkovic J. et al. (1995); XVI European congress of allergology and clinical immunology; Basomba A. and Hernandez F. de Rojas M.D.

Active substance: THEOPHYLLINE

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Document reference: 44720

Study title: Uncontrolled study of serum theophylline concentrations and lung function parameters in 18 children with bronchial asthma between 5 and 9 years of age after four days’administration of 450 mg theophylline (BY158K) per day.

Active substance: THEOPHYLLINE

Study summary document link (including results): Study report 13-89 Theophylline - synopsis.pdf

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Document reference: 21676

Study title: Uncontrolled study of serum theophylline concentrations and lung function parameters in 18 children with bronchial asthma between 5 and 9 years of age after four days` administration of 450 mg theophylline (BY158K) per day

Active substance: THEOPHYLLINE

Study summary document link (including results): Study report 13-89 Theophylline - synopsis.pdf

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Document reference: 44729

Study title: AWB-BL /UNI-300-400/151092, 22-Jan-1997, Wirksamkeit und Verträglichkeit einer individuelle angepassten Theophyllintherapie mit Uniphyllin/Uniphyllin 300 bei Patienten mit chronisch obstruktiver Bronchitis. Efficacy and safety of an individually adopted therapy with Theophyllin (Uniphyllin/Uniphyllin 300) in patient with chronic obstructive bronchitis (Germany)

Active substance: Theophylline anhydrous

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Document reference: 40255

Study title: Emrich D. et al., Dtsch. Med. Wochenschr. 35, 1261 1977Emrich D. et al., Dtsch. Med. Wochenschr. 35, 1261 1977

Active substance: THIAMAZOLE

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Document reference: 44733

Study title: Mora S. Longitudinal Changes of Bone Density and Bone Resorption in Hyperthyroid Girls During Treatment, J Bone Miner Res 1999; 14: 1971-77Mora S. Longitudinal Changes of Bone Density and Bone Resorption in Hyperthyroid Girls During Treatment, J Bone Miner Res 1999; 14: 1971-77

Active substance: THIAMAZOLE

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Document reference: 44734

Study title: J Orthop Sci. 2002;7(3):304-12. Clinical significance of thallium-201 scintigraphy in bone and soft tissue tumors. Goto Y, Ihara K, Kawauchi S, Ohi R, Sasaki K, Kawai S. J Orthop Sci. 2002;7(3):304-12. Clinical significance of thallium-201 scintigraphy in bone and soft tissue tumors. Goto Y, Ihara K, Kawauchi S, Ohi R, Sasaki K, Kawai S.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44623

Study title: J Pediatr. 1979 Feb;94(2):244-7. Thallium 201 scintigraphy in patients with anomalous origin of the left coronary artery from the main pulmonary artery. Rabinovitch M, Rowland TW, Castaneda AR, Treves S. J Pediatr. 1979 Feb;94(2):244-7. Thallium 201 scintigraphy in patients with anomalous origin of the left coronary artery from the main pulmonary artery. Rabinovitch M, Rowland TW, Castaneda AR, Treves S.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44624

Study title: J Pediatr. 1979 Feb;94(2):263-70. Transient myocardial ischemia of the newborn infant demonstrated by thallium myocardial imaging. Finley JP, Howman-Giles RB, Gilday DL, Bloom KR, Rowe RD. J Pediatr. 1979 Feb;94(2):263-70. Transient myocardial ischemia of the newborn infant demonstrated by thallium myocardial imaging. Finley JP, Howman-Giles RB, Gilday DL, Bloom KR, Rowe RD.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44625

Study title: J Pediatr. 1990 Jan;116(1):52-6. Myocardial performance and perfusion during exercise in patients with coronary artery disease caused by Kawasaki disease. Paridon SM, Ross RD, Kuhns LR, Pinsky WW. J Pediatr. 1990 Jan;116(1):52-6. Myocardial performance and perfusion during exercise in patients with coronary artery disease caused by Kawasaki disease. Paridon SM, Ross RD, Kuhns LR, Pinsky WW.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44626

Study title: J Surg Oncol. 1990 Dec;45(4):282-8. Multiple endocrine neoplasia type IIb: a clinicopathological report. Van Zyl JA, Muller GS, Rossouw DJ, Van Velden DJ. J Surg Oncol. 1990 Dec;45(4):282-8. Multiple endocrine neoplasia type IIb: a clinicopathological report. Van Zyl JA, Muller GS, Rossouw DJ, Van Velden DJ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44627

Study title: J Thorac Cardiovasc Surg. 1984 Jan;87(1):59-65. Single-trunk anomalous origin of both coronary arteries from the pulmonary artery. Diagnosis and surgical management. J Thorac Cardiovasc Surg. 1984 Jan;87(1):59-65. Single-trunk anomalous origin of both coronary arteries from the pulmonary artery. Diagnosis and surgical management.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44628

Study title: Efficacy of neuroprotectors in patients with tension headaches. Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6Efficacy of neuroprotectors in patients with tension headaches. Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6

Active substance: TIAGABINE

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Document reference: 38504

Study title: Follmann P., Wix K., Kenyeres A., Folia Ophthalmol 1990; 15: 167-171Follmann P., Wix K., Kenyeres A., Folia Ophthalmol 1990; 15: 167-171

Active substance: TIAGABINE

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Document reference: 38482

Study title: Four years later: a clinical update on latanoprost. Ravinet E, Mermoud A, Brignoli R. Eur J Ophthalmol. 2003 Mar;13(2):162-75. Four years later: a clinical update on latanoprost. Ravinet E, Mermoud A, Brignoli R. Eur J Ophthalmol. 2003 Mar;13(2):162-75.

Active substance: TIAGABINE

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Document reference: 38484

Study title: Huntington's Chorea: current concepts and improvement in one case after tiapride - G. Serratrice, G. Cremieux.Huntington's Chorea: current concepts and improvement in one case after tiapride - G. Serratrice, G. Cremieux.

Active substance: TIAGABINE

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Document reference: 38466

Study title: Tramadol infusion for pain therapy after major bladder surgery in paediatric wards - Griessinger N, Rösch W, Schott G - 1997 (Der Urologe 1997; 38: 552-556)Tramadol infusion for pain therapy after major bladder surgery in paediatric wards - Griessinger N, Rösch W, Schott G - 1997 (Der Urologe 1997; 38: 552-556)

Active substance: TRAMADOL

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Document reference: 45037

Study title: Tramadol iv vs nalbuphine iv, 47 children aged 1 to 10 years old. IIS on tramadol in children undergoing endoscopic surgery for reflux oesophagitis. One-year double-blind comparison of post-op tramadol (bolus of 2 mg/kg BW + infusion of 8 mg/kg BW over 24 h) vs nalbuphine.

Active substance: TRAMADOL

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Document reference: 45011

Study title: Tramal for pain control in children-continuous infusion versus repeated bolus administration: effectiveness and adverse effects - Kralinski K, Dluholucky S, Laho L - 1995 (Anesteziologie a Neonadkladne Pece 1995; 1: 19-21)Tramal for pain control in children-continuous infusion versus repeated bolus administration: effectiveness and adverse effects - Kralinski K, Dluholucky S, Laho L - 1995 (Anesteziologie a Neonadkladne Pece 1995; 1: 19-21)

Active substance: TRAMADOL

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Document reference: 45038

Study title: Tramal in the treatment of pain in children with malignancies - Kralinski K, Dluholucky S, Bajciova V, LahoL, Drobova Z - 1994 (Klinicka Onkologie 1994; 6: 182-185)Tramal in the treatment of pain in children with malignancies - Kralinski K, Dluholucky S, Bajciova V, LahoL, Drobova Z - 1994 (Klinicka Onkologie 1994; 6: 182-185)

Active substance: TRAMADOL

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Document reference: 45039

Study title: Tramal long 100 mg and Tramal long 100/150/200 mg Two multicentric post-marketing surveillance studies of an analgesic in the treatment of moderate to severe pain

Active substance: TRAMADOL

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Document reference: 44996

Study title: Tramal long 100 mg and Tramal long 100/150/200 mg Two multicentric post-marketing surveillance studies of an analgesic in the treatment of moderate to severe pain

Active substance: TRAMADOL

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Document reference: 45012

Study title: Treatment of pain in children older than one year of age - Kralinski K, Dluholucky S, Laho L. - 1994 (Cs Pediat 1994, 49(3): 169-171Treatment of pain in children older than one year of age - Kralinski K, Dluholucky S, Laho L. - 1994 (Cs Pediat 1994, 49(3): 169-171

Active substance: TRAMADOL

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Document reference: 45040

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine sulfate and placebo in dental extraction pain

Active substance: TRAMADOL

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Document reference: 45811

Study title: Treatment of postoperative pain with tramadol HCl in children

Active substance: TRAMADOL

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Document reference: 44993

Study title: - Treatment of postoperative pain with tramadol HCl in children - Multizentrische Anwendungwendungsbeobachtung eines Analgetikums in der Behandlung mittelstarker bis starker Schmerzen

Active substance: TRAMADOL

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Document reference: 45014

Study title: Treatment of postoperative pain with tramadol HCl in children - Tonic LJ - 1992Treatment of postoperative pain with tramadol HCl in children - Tonic LJ - 1992

Active substance: TRAMADOL

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Document reference: 45041

Study title: The efficacy of tranexamic acid versus placebo in decreasing blood loss in pediatric patients undergoing repeat cardiac surgery. Anesth Analg. 1997 May;84(5):990-6.The efficacy of tranexamic acid versus placebo in decreasing blood loss in pediatric patients undergoing repeat cardiac surgery. Anesth Analg. 1997 May;84(5):990-6.

Active substance: TRAXENAMIC ACID

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Document reference: 46717

Study title: Tranexamic acid as a means of reducing the need for blood and blood component therapy in children undergoing open heart surgery for congenital cyanotic heart disease. J Med Assoc Thai. 2002 Sep;85 Suppl 3:S904-9.Tranexamic acid as a means of reducing the need for blood and blood component therapy in children undergoing open heart surgery for congenital cyanotic heart disease. J Med Assoc Thai. 2002 Sep;85 Suppl 3:S904-9.

Active substance: TRAXENAMIC ACID

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Document reference: 46714

Study title: Tranexamic acid for control of haemorrhage in acute promyelocytic leukaemia. Lancet. 1989 Jul 15;2(8655):122-4.Tranexamic acid for control of haemorrhage in acute promyelocytic leukaemia. Lancet. 1989 Jul 15;2(8655):122-4.

Active substance: TRAXENAMIC ACID

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Document reference: 46721

Study title: Tranexamic acid in paediatric cardiac surgery. Indian J Med Res. 2003 Aug;118:86-9Tranexamic acid in paediatric cardiac surgery. Indian J Med Res. 2003 Aug;118:86-9

Active substance: TRAXENAMIC ACID

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Document reference: 46713

Study title: Tranexamic acid in the prevention of periventricular haemorrhage. Arch Dis Child. 1984 Aug;59(8):719-21.Tranexamic acid in the prevention of periventricular haemorrhage. Arch Dis Child. 1984 Aug;59(8):719-21.

Active substance: TRAXENAMIC ACID

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Document reference: 46722

Study title: Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery. Anesthesiology. 2005 Apr;102(4):727-32.Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery. Anesthesiology. 2005 Apr;102(4):727-32.

Active substance: TRAXENAMIC ACID

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Document reference: 46709

Study title: Tranexamic acid. A review of its use in surgery and other indications. Dunn CJ et al. Drugs 1999; 57: 1005-1037 - Publication in CES0406 for MA renewal in UK -

Active substance: TRAXENAMIC ACID

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Document reference: 46706

Study title: The effect of preoperative tranexamic acid on blood loss after cardiac operations in children. J Thorac Cardiovasc Surg. 1996 May;111(5):982-7.The effect of preoperative tranexamic acid on blood loss after cardiac operations in children. J Thorac Cardiovasc Surg. 1996 May;111(5):982-7.

Active substance: TRAXENAMIC ACID

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Document reference: 46719

Study title: Treatment by tranexamic acid in menorrhagia in women using intrauterine devices. Lakartidningen. 1971 Aug 11;68(33):3685-91. Swedish.Treatment by tranexamic acid in menorrhagia in women using intrauterine devices. Lakartidningen. 1971 Aug 11;68(33):3685-91. Swedish.

Active substance: TRAXENAMIC ACID

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Document reference: 46724

Study title: Which may be effective to reduce blood loss after cardiac operations in cyanotic children: tranexamic acid, aprotinin or a combination? Paediatr Anaesth. 2005 Jan;15(1):41-6.Which may be effective to reduce blood loss after cardiac operations in cyanotic children: tranexamic acid, aprotinin or a combination? Paediatr Anaesth. 2005 Jan;15(1):41-6.

Active substance: TRAXENAMIC ACID

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Document reference: 46710

Study title: Health Phys. 1989 Apr;56(4):539-41. Thallium-201 in human milk: observations and radiological consequences. Murphy PH, Beasley CW, Moore WH, Stabin MG. Health Phys. 1989 Apr;56(4):539-41. Thallium-201 in human milk: observations and radiological consequences. Murphy PH, Beasley CW, Moore WH, Stabin MG.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44577

Study title: Schendekehl TK. Therapie und Verlauf der Juvenilen Hyperthyreose, Schweiz Med Wochenschr 1997; 127 (Suppl 87): Abstract 51 Schendekehl TK. Therapie und Verlauf der Juvenilen Hyperthyreose, Schweiz Med Wochenschr 1997; 127 (Suppl 87): Abstract 51

Active substance: THIAMAZOLE

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Document reference: 44736

Study title: Neurology 2002;58:110-114.Neurology 2002;58:110-114.

Active substance: TETRACOSACTIDE

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Document reference: 44456

Study title: Priftis, K. N., Papadimitriou, A., Anthracopoulos, M. B., Gatsopoulou, E., Fretzayas, A., Nicolaidou, P., and Chrousos, G. P.Priftis, K. N., Papadimitriou, A., Anthracopoulos, M. B., Gatsopoulou, E., Fretzayas, A., Nicolaidou, P., and Chrousos, G. P.

Active substance: TETRACOSACTIDE

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Document reference: 44461

Study title: Seizure. 2005;14:552-556.Seizure. 2005;14:552-556.

Active substance: TETRACOSACTIDE

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Document reference: 44471

Study title: Study of the effects of hydrocortisone and hydrocortisone 17-butyrate ointments on plasma ACTH levels and Synacthen responses in children with eczemaStudy of the effects of hydrocortisone and hydrocortisone 17-butyrate ointments on plasma ACTH levels and Synacthen responses in children with eczema

Active substance: TETRACOSACTIDE

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Document reference: 44466

Study title: Use of ACTH and prednisolone in infantile spasms: experience from a developing countryUse of ACTH and prednisolone in infantile spasms: experience from a developing country

Active substance: TETRACOSACTIDE

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Document reference: 44470

Study title: West syndrome: individualized ACTH therapyWest syndrome: individualized ACTH therapy

Active substance: TETRACOSACTIDE

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Document reference: 44478

Study title: Yanagaki, S., Oguni, H., Hayashi, K., Imai, K., Funatuka, M., Tanaka, T., Yanagaki, M., and Osawa, M.Yanagaki, S., Oguni, H., Hayashi, K., Imai, K., Funatuka, M., Tanaka, T., Yanagaki, M., and Osawa, M.

Active substance: TETRACOSACTIDE

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Document reference: 44472

Study title: BERATO 1969, DESRUS FOURNIE 1969, REBOUILLAT 1966, WEBER 1986, BADY 1969, GENEVIEVE 1970, GERAUD 1968, GRIMAUD CHEVRIER 1971, 1968, JAROUSSE 1973, BERARD 1969, GILLE 1970, MASSE 1969, PREVOT 1969, VIALLE 1969, SCHILLIRO 1971 - Publications in the Clinical expert report - Dr.A.Hernandez vidal - No date -

Active substance: TETRAZEPAM

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Document reference: 44480

Study title: Fechner P. U., Teichmann, K. D., 4th ed., Enke Verlag Stuttgart New York 2000; Küchle H. J., Busse H., Augenerkrankungen im Kindesalter, Thieme Verlag Stuttgart New York 1985Fechner P. U., Teichmann, K. D., 4th ed., Enke Verlag Stuttgart New York 2000; Küchle H. J., Busse H., Augenerkrankungen im Kindesalter, Thieme Verlag Stuttgart New York 1985

Active substance: TETRYZOLINE

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Document reference: 44481

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Thalamus compositum (ampoules) [AWB-AT]

Active substance: Thalamus compositum-Heel - Ampullen

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Document reference: 40254

Study title: Acta Med Austriaca. 1990;17(2-3):55-8. [Clinical significance of Tl-201/Tc-99m subtraction scintigraphy as a parameter for surgical indication of cold struma nodules] [Article in German] Binter G, Lind P, Langsteger W, Klima G, KÃltringer P, Beham A, EActa Med Austriaca. 1990;17(2-3):55-8. [Clinical significance of Tl-201/Tc-99m subtraction scintigraphy as a parameter for surgical indication of cold struma nodules] [Article in German] Binter G, Lind P, Langsteger W, Klima G, KÃltringer P, Beham A, E

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44482

Study title: Pharmacocinetique de la ticlopidine à dose unique et doses répétées chez des volontaires sains jeunes et agés. Rapport final. ICM 1161/ CL 3690 - Gabuzda G. - 01/12/86Pharmacocinetique de la ticlopidine à dose unique et doses répétées chez des volontaires sains jeunes et agés. Rapport final. ICM 1161/ CL 3690 - Gabuzda G. - 01/12/86

Active substance: TIAGABINE

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Document reference: 38479

Study title: Publication: Effect of vitamin E and ticlopidine on platelet aggregation in Fabry's disease. Clin Gen; 31:349-54 - Sakuraba - 4 January 1987Publication: Effect of vitamin E and ticlopidine on platelet aggregation in Fabry's disease. Clin Gen; 31:349-54 - Sakuraba - 4 January 1987

Active substance: TIAGABINE

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Document reference: 38476

Study title: Publication: Treatment of angiomas with associated thrombocytopenia (Kasabach-Merrit syndrome) by ticlopidine-aspirin combination - Drouet - No datePublication: Treatment of angiomas with associated thrombocytopenia (Kasabach-Merrit syndrome) by ticlopidine-aspirin combination - Drouet - No date

Active substance: TIAGABINE

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Document reference: 38477

Study title: Quelques réflexions sur les tics de l'enfant. A propos d'un éssai clinique. - C. Pasquier, F. Pouplard -revue de neuropsychiatrie infantile, 1977, 25 (10) 645-651Quelques réflexions sur les tics de l'enfant. A propos d'un éssai clinique. - C. Pasquier, F. Pouplard -revue de neuropsychiatrie infantile, 1977, 25 (10) 645-651

Active substance: TIAGABINE

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Document reference: 38471

Study title: Randomised, double-blind placebo controlled cross-over study of efficacy and safety of tiagabine as adjunctive treatment of partial seizures in children with epilepsyTreatment with tobramycin solution for inhalation reduces hospitalizations in young CF subjects with mild lung disease. (Pediatr Pulmonol. 2004 Oct; 38(4):314-20)

Active substance: TIAGABINE

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Document reference: 38532

Study title: Randomised, Double-blind, Placebo-controlled, Parallel-group Study of the Safety and Efficacy of Tiagabine Administered TID as Adjunctive Treatment for Partial Seizures

Active substance: TIAGABINE

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Document reference: 38525

Study title: Safety and Efficacy of BID and QID Dosing with Tiagabine HCl versus Placebo as Adjunctive Treatment for Partial Seizures

Active substance: TIAGABINE

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Document reference: 38523

Study title: Am J Med. 1984 Aug;77(2):286-92. Myocardial perfusion abnormalities in asymptomatic patients with systemic lupus erythematosus. Hosenpud JD, Montanaro A, Hart MV, Haines JE, Specht HD, Bennett RM, Kloster FE. Am J Med. 1984 Aug;77(2):286-92. Myocardial perfusion abnormalities in asymptomatic patients with systemic lupus erythematosus. Hosenpud JD, Montanaro A, Hart MV, Haines JE, Specht HD, Bennett RM, Kloster FE.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44509

Study title: Ann Endocrinol (Paris). 1993;54(4):248-54. [Can benign and malignant thyroid nodules be differentiated with thallium 201?] [Article in French] Hermans J, Schmitz A, Merlo P, Bodart F, Beauduin M. Ann Endocrinol (Paris). 1993;54(4):248-54. [Can benign and malignant thyroid nodules be differentiated with thallium 201?] [Article in French] Hermans J, Schmitz A, Merlo P, Bodart F, Beauduin M.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44510

Study title: Ann Nucl Med. 1990 Jul;4(2):59-65. Evaluation of viral myocarditis in children by radionuclide method. Kawamura Y, Morishita T, Yamazaki J, Okuzumi I, Wakakura M, Muto T, Saji T, Matsuura H, Matsuo N, Yabe Y. Ann Nucl Med. 1990 Jul;4(2):59-65. Evaluation of viral myocarditis in children by radionuclide method. Kawamura Y, Morishita T, Yamazaki J, Okuzumi I, Wakakura M, Muto T, Saji T, Matsuura H, Matsuo N, Yabe Y.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44511

Study title: Kokyu To Junkan. 1985 Feb;33(2):191-7. [Thallium-201 myocardial imaging in children with heart disease; quantitative assessment of right ventricular pressure] [Article in Japanese] Mitomori T, Ono Y, Kamiya T, Nishimura T, Kozuka T, Kohata T, Tanimoto Kokyu To Junkan. 1985 Feb;33(2):191-7. [Thallium-201 myocardial imaging in children with heart disease; quantitative assessment of right ventricular pressure] [Article in Japanese] Mitomori T, Ono Y, Kamiya T, Nishimura T, Kozuka T, Kohata T, Tanimoto

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44653

Study title: Kokyu To Junkan. 1987 Jan;35(1):59-64. [Clinical evaluation of thallium-201 myocardial scintigram in myocarditis] [Article in Japanese] Shimonagata T, Nishimura T, Hayashida K, Uehara T, Takamiya M. Kokyu To Junkan. 1987 Jan;35(1):59-64. [Clinical evaluation of thallium-201 myocardial scintigram in myocarditis] [Article in Japanese] Shimonagata T, Nishimura T, Hayashida K, Uehara T, Takamiya M.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44654

Study title: Kokyu To Junkan. 1987 Jan;35(1):97-103. [Decreased coronary reserve in patients with hypertrophic cardiomyopathy--a study using split dose thallium-201 dipyridamole myocardial imaging] [Article in Japanese] Yamaguchi R. Kokyu To Junkan. 1987 Jan;35(1):97-103. [Decreased coronary reserve in patients with hypertrophic cardiomyopathy--a study using split dose thallium-201 dipyridamole myocardial imaging] [Article in Japanese] Yamaguchi R.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44655

Study title: Kokyu To Junkan. 1990 Dec;38(12):1247-51. [Usefulness for evaluation of the left ventricular disorders by apexcardiographic A-wave ratio in patients with hypertrophic cardiomyopathy] [Article in Japanese] Yada T, Nezuo S, Sawayama T, Hasegawa K, TadaokKokyu To Junkan. 1990 Dec;38(12):1247-51. [Usefulness for evaluation of the left ventricular disorders by apexcardiographic A-wave ratio in patients with hypertrophic cardiomyopathy] [Article in Japanese] Yada T, Nezuo S, Sawayama T, Hasegawa K, Tadaok

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44657

Study title: Kokyu To Junkan. 1991 Apr;39(4):355-60. [Evaluation of myocarditis using T1-201 myocardial scintigraphy with bull's eye functional map] [Article in Japanese] Satoh K, Utsumi J, Satoh H, Kasuya H, Mitsuyama H, Nakata Y, Yamaguchi H, Kawai Y, Okada R, KaKokyu To Junkan. 1991 Apr;39(4):355-60. [Evaluation of myocarditis using T1-201 myocardial scintigraphy with bull's eye functional map] [Article in Japanese] Satoh K, Utsumi J, Satoh H, Kasuya H, Mitsuyama H, Nakata Y, Yamaguchi H, Kawai Y, Okada R, Ka

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44658

Study title: Kokyu To Junkan. 1992 May;40(5):485-90. [Thallium-201 myocardial imaging in cases involving transposition of the great arteries after arterial switch operation] [Article in Japanese] Fukushima H, Satou S, Satou I, Iwatani H, Tsuda E, Nakamura H, Ono Y,Kokyu To Junkan. 1992 May;40(5):485-90. [Thallium-201 myocardial imaging in cases involving transposition of the great arteries after arterial switch operation] [Article in Japanese] Fukushima H, Satou S, Satou I, Iwatani H, Tsuda E, Nakamura H, Ono Y,

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44659

Study title: Kurume Med J. 1992;39(4):245-55. Myocardial ischemia in Kawasaki disease; evaluation by dipyridamole stress thallium-201 (Tl-201) myocardial imaging and exercise stress test. Fukuda T. Kurume Med J. 1992;39(4):245-55. Myocardial ischemia in Kawasaki disease; evaluation by dipyridamole stress thallium-201 (Tl-201) myocardial imaging and exercise stress test. Fukuda T.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44660

Study title: Kurume Med J. 1992;39(4):267-78. Clinical significance of thallium-201 single-photon emission computerized tomography (Tl-201 SPECT) in the evaluation of viability of gliomas. Taguchi A. Kurume Med J. 1992;39(4):267-78. Clinical significance of thallium-201 single-photon emission computerized tomography (Tl-201 SPECT) in the evaluation of viability of gliomas. Taguchi A.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44661

Study title: Ticlopidine. Chronic glomeruloneprhitis (pilot study) - Narita - 21 June 1977

Active substance: TICLOPIDINE

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Document reference: 44761

Study title: Relazione clinica sull'uso del trazodone nella medicazione pre-anestetica.

Active substance: TRAZODONE

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Document reference: 46727

Study title: Sperimentazione clinica del prodotto AF 1161 (Trazodone) usato come neurolettico nell'endoscopia urologica.

Active substance: TRAZODONE

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Document reference: 46726

Study title: Trazodon in der kinder-und jugendpsychiatrie

Active substance: TRAZODONE

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Document reference: 46725

Study title: Pediatr Neurosurg. 1995;22(1):8-14. Comparison of gadolinium-enhanced MR and thallium-201 single photon emission computed tomography in pediatric brain tumors. Rollins NK, Lowry PA, Shapiro KN. Pediatr Neurosurg. 1995;22(1):8-14. Comparison of gadolinium-enhanced MR and thallium-201 single photon emission computed tomography in pediatric brain tumors. Rollins NK, Lowry PA, Shapiro KN.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44687

Study title: Pediatr Radiol. 1980 Apr;9(3):183-5. Thallium 201 scintigraphy in an infant with myocardial infarction following mucocutaneous lymph node syndrome. Ueda K, Saito A, Nakano H, Yano M. Pediatr Radiol. 1980 Apr;9(3):183-5. Thallium 201 scintigraphy in an infant with myocardial infarction following mucocutaneous lymph node syndrome. Ueda K, Saito A, Nakano H, Yano M.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44688

Study title: Pediatr Radiol. 1996 Oct;26(10):739-41; discussion 742-3. Thallium-201 uptake in Langerhans cell histiocytosis of bone. Bar-Sever Z, Connolly LP, Jaramillo D, Treves ST. Pediatr Radiol. 1996 Oct;26(10):739-41; discussion 742-3. Thallium-201 uptake in Langerhans cell histiocytosis of bone. Bar-Sever Z, Connolly LP, Jaramillo D, Treves ST.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44689

Study title: Pediatr Radiol. 2000 May;30(5):352-4. Myocardial perfusion in children with sickle cell anaemia. Acar P, Sébahoun S, de Pontual L, Maunoury C. Pediatr Radiol. 2000 May;30(5):352-4. Myocardial perfusion in children with sickle cell anaemia. Acar P, Sébahoun S, de Pontual L, Maunoury C.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44690

Study title: Radioisotopes. 1977 Jul;26(7):458-64. [Whole body autoradiography with 201Tl and clinical results] [Article in Japanese] Ishii K, Kobayashi T, Matsubayashi T, Nakazawa K, Yoda K. Radioisotopes. 1977 Jul;26(7):458-64. [Whole body autoradiography with 201Tl and clinical results] [Article in Japanese] Ishii K, Kobayashi T, Matsubayashi T, Nakazawa K, Yoda K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44691

Study title: Radioisotopes. 1984 Oct;33(10):691-8. [Thallium-201 chloride dynamic analysis using thallium-201 chloride and sodium iodide-131 thyroid subtraction scintigraphy] [Article in Japanese] Morimoto S, Hiraki Y, Togami I, Kaji M, Niiya H, Joja I, Yamamoto H,Radioisotopes. 1984 Oct;33(10):691-8. [Thallium-201 chloride dynamic analysis using thallium-201 chloride and sodium iodide-131 thyroid subtraction scintigraphy] [Article in Japanese] Morimoto S, Hiraki Y, Togami I, Kaji M, Niiya H, Joja I, Yamamoto H,

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44692

Study title: Radiol Clin North Am. 1994 Jan;32(1):183-96. Radiologic diagnosis, staging, and follow-up of adult central nervous system primary malignant glioma. Madison MT, Hall WA, Latchaw RE, Loes DJ. Radiol Clin North Am. 1994 Jan;32(1):183-96. Radiologic diagnosis, staging, and follow-up of adult central nervous system primary malignant glioma. Madison MT, Hall WA, Latchaw RE, Loes DJ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44693

Study title: Radiology. 1979 Sep;132(3):707-10. Computed tomography of the heart using thallium-201 in children. Treves S, Hill TC, VanPraagh R, Holman BL. Radiology. 1979 Sep;132(3):707-10. Computed tomography of the heart using thallium-201 in children. Treves S, Hill TC, VanPraagh R, Holman BL.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44694

Study title: Acta Med Okayama. 2004 Apr;58(2):75-83. Differentiation of thyroid nodules using Tl-201 scintigraphy quantitative analysis and fine-needle aspiration biopsy. Yamamoto Y, Okumura Y, Sato S, Maki K, Mukai T, Mifune H, Akaki S, Takeda Y, Kanazawa S, HirakiActa Med Okayama. 2004 Apr;58(2):75-83. Differentiation of thyroid nodules using Tl-201 scintigraphy quantitative analysis and fine-needle aspiration biopsy. Yamamoto Y, Okumura Y, Sato S, Maki K, Mukai T, Mifune H, Akaki S, Takeda Y, Kanazawa S, Hiraki

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44483

Study title: Acta Med Scand. 1977;202(5):349-56. Myocardial scintigraphy as a supplementary diagnostic tool in heart disease. Gustafson A, Larsson I, Olsson L, Svensson SE, Westling H. Acta Med Scand. 1977;202(5):349-56. Myocardial scintigraphy as a supplementary diagnostic tool in heart disease. Gustafson A, Larsson I, Olsson L, Svensson SE, Westling H.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44484

Study title: JC-AWB TOP0003 (patients > 2 years) - Veränderungen durch Topamax - Die sicht des Patienten TOPAMAX - the view of the Patient)

Active substance: TOPIRAMATE

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Document reference: 44928

Study title: Long-term, open-label study of topamax (topiramate) used as adjunctive therapy in patients with partial onset seizures with or without secondary generalization

Active substance: TOPIRAMATE

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Document reference: 44852

Study title: Low dose topiramate monotherapy substitution trial in young epilepsy patients failing first conventional anticonvulsant.

Active substance: TOPIRAMATE

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Document reference: 44860

Study title: Open label monocenter study to investigate the tolerability, safety and efficacy of topamax in disabled or metally handicapped patients aged 14 or older

Active substance: TOPIRAMATE

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Document reference: 44923

Study title: Open label pilot study to evaluate the efficacy and safety of escalating doses of topamax (topiramate) in the treatment of typical absence seizures in children. Phase ii

Active substance: TOPIRAMATE

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Document reference: 44851

Study title: Open label pilot study to evaluate the efficacy and safety of escalating doses of topamax (topiramate) in the treatment of typical absence seizures in children. Phase II

Active substance: TOPIRAMATE

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Document reference: 44909

Study title: Open label pilot study to evaluate the efficacy and safety of escalating doses of topamax (topiramate) in the treatment of typical absence seizures in children. Phase II.

Active substance: TOPIRAMATE

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Document reference: 44942

Study title: Infantile spasms with hypsarrhythmia

Active substance: TOPIRAMATE

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Document reference: 44866

Study title: JC-AWB TOP 0009 (patients >12years) - Topamax 1st line add on

Active substance: TOPIRAMATE

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Document reference: 44927

Study title: Open naturalistic individual dose optimisation trial assessing tolerability and efficacy of topiramate

Active substance: TOPIRAMATE

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Document reference: 44908

Study title: Open study of topamax as adjunct treatment in patients with partial onset seizures : assessing the low and slow titration regimen

Active substance: TOPIRAMATE

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Document reference: 44850

Study title: Open-label extension study of the safety and efficacy of rwj-17021-001 in subjects with bipolar i disorder who completed protocol topmat-pdmd-002

Active substance: TOPIRAMATE

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Document reference: 44855

Study title: Open-label monocenter study to investigate the tolerability, safety and efficacy of topamax in disabled or mentally handicapped patients aged 14 or older

Active substance: TOPIRAMATE

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Document reference: 44865

Study title: Open-label, PK, safety, and tolerability study of TPM adjuctive therapy in pediatric subjectswith Lennox-Gastaut syndrome

Active substance: TOPIRAMATE

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Document reference: 44898

Study title: Open-label, safety and efficacy, adjunctive or monotherapy study in asubjects ≥ 14 years of age with any seizure type.

Active substance: TOPIRAMATE

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Document reference: 44871

Study title: Open-label, single center, safety, pharmacokinetics, and efficacy clinical trial in pediatric subjects with epilepsy

Active substance: TOPIRAMATE

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Document reference: 44894

Study title: Open-study of topamax as adjunct treatment in patients with partial onset seizures: assessing the low and slow titration regimen.

Active substance: TOPIRAMATE

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Document reference: 44906

Study title: Ann Nucl Med. 1993 Aug;7(3):147-52. Thallium-201 scintigraphy in the evaluation of thyroid nodules. A retrospective study of 246 cases. Koizumi M, Taguchi H, Goto M, Nomura T, Watari T. Ann Nucl Med. 1993 Aug;7(3):147-52. Thallium-201 scintigraphy in the evaluation of thyroid nodules. A retrospective study of 246 cases. Koizumi M, Taguchi H, Goto M, Nomura T, Watari T.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44512

Study title: Ann Nucl Med. 1994 Feb;8(1):71-4. Cardiac involvement of progressive muscular dystrophy (Becker type, Limb-girdle type and Fukuyama type) evaluated by radionuclide method. Nagamachi S, Inoue K, Jinnouchi S, Hoshi H, Ono S, Ohnishi T, Futami S, Watanabe Ann Nucl Med. 1994 Feb;8(1):71-4. Cardiac involvement of progressive muscular dystrophy (Becker type, Limb-girdle type and Fukuyama type) evaluated by radionuclide method. Nagamachi S, Inoue K, Jinnouchi S, Hoshi H, Ono S, Ohnishi T, Futami S, Watanabe

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44513

Study title: Ann Nucl Med. 2002 Apr;16(2):95-101. The usefulness of serum thyroglobulin levels and Tl-201 scintigraphy in differentiating between benign and malignant thyroid follicular lesions. Tamizu A, Okumura Y, Sato S, Takeda Y, Maki K, Hiraki T, Akaki S, KurodAnn Nucl Med. 2002 Apr;16(2):95-101. The usefulness of serum thyroglobulin levels and Tl-201 scintigraphy in differentiating between benign and malignant thyroid follicular lesions. Tamizu A, Okumura Y, Sato S, Takeda Y, Maki K, Hiraki T, Akaki S, Kurod

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44514

Study title: Ann Nucl Med. 2005 Sep;19(6):461-8. Thallium-201 scintigraphy in bone and soft-tissue tumors: a comparison of dynamic, early and delayed scans. Sugawara Y, Kikuchi T, Kajihara M, Semba T, Ochi T, Fujii T, Mochizuki T, Sakayama K, Nakata S Ann Nucl Med. 2005 Sep;19(6):461-8. Thallium-201 scintigraphy in bone and soft-tissue tumors: a comparison of dynamic, early and delayed scans. Sugawara Y, Kikuchi T, Kajihara M, Semba T, Ochi T, Fujii T, Mochizuki T, Sakayama K, Nakata S

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44515

Study title: Ann Nucl Med. 2006 Feb;20(2):161-3. Positive gallium-67 and thallium-201 scans in thymic rebound after chemotherapy for lymphoma. Akaki S, Shinya T, Sato S, Kuroda M, Kanazawa S Ann Nucl Med. 2006 Feb;20(2):161-3. Positive gallium-67 and thallium-201 scans in thymic rebound after chemotherapy for lymphoma. Akaki S, Shinya T, Sato S, Kuroda M, Kanazawa S

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44516

Study title: Evaluation of the population pharmacokinetic properties of tramadol (T) and Odemethyltramadol (M1) in children and the relation between exposure to T and M1 and different measurements of efficacy, based on data coming from study WIS-AL-TRA-PCP1

Active substance: TRAMADOL

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Document reference: 45005

Study title: Evaluation of the safety profile and clinical effectiveness of oral tramadol hydrochloride tablets for the treatment of postsurgical pain in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-005; Phase 2)

Active substance: TRAMADOL

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Document reference: 44979

Study title: Evaluation of the Safety Profile and Clinical Effectiveness of Two Dosing Levels of Oral Tramadol Hydrochloride with Acetaminophen for the Treatment of Postsurgical Pain in Children and Adolescents Aged Seven to Sixteen Years

Active substance: TRAMADOL

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Document reference: 44976

Study title: Publication #21 A double-blind, placebo-controlled trial of fexofenadine HCl in the treatment of CIU - Finn A et al - 1999 (J Allergy Clin Immunol 1999; 104(5):1071-78)

Active substance: FEXOFENADINE

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Document reference: 27251

Study title: Figueras−Nadal−C et al. Effectiveness and tolerability of ibuprofen−arginine versus paracetamol in children with fever of likely infectious origin. {ACTA−PAEDIATR− INT−J−PAEDIATR}, 2002, Vol/Iss/Pg. 91/4 (383−390)

Active substance: CODEINE_AND_PARACETAMOL

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Document reference: 24514

Study title: Beta Blockers and Lactation: An Update; Meghan E. Shan non, PharmD, Su san E. Malecha, PharmD, and Amy J. Cha, PharmD

Active substance: TIMOLOL

Study summary document link (including results): Beta Bockers and Lactation An Update.pdf

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Document reference: 47677

Study title: Cardiac and central nervous system toxicity with timolol eye drops in an infant: case report and discussion

Active substance: TIMOLOL

Study summary document link (including results): Cardiac and central nervous system toxicity with timolol.pdf

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Document reference: 47678

Study title: Clinical Experience With Timolol in Childhood Glaucoma

Active substance: TIMOLOL

Study summary document link (including results): Clinical Experience with Timolol in Childhood Glaucoma.pdf

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Document reference: 47679

Study title: Influence of Beta Adrenergic Antagonists on Tear Secretion

Active substance: TIMOLOL

Study summary document link (including results): Influence of Beta Adrenergic Antagonists on Tear Secretion i.pdf

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Document reference: 47680

Study title: Interventions to retard myopia progression in children: an evidence-based update. Saw SM, Shih-Yen EC, Koh A, Tan D. Ophthalmology. 2002 Mar;109(3):415-21; discussion 422-4; quiz 425-6, 443. Interventions to retard myopia progression in children: an evidence-based update. Saw SM, Shih-Yen EC, Koh A, Tan D. Ophthalmology. 2002 Mar;109(3):415-21; discussion 422-4; quiz 425-6, 443.

Active substance: TIMOLOL

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Document reference: 44765

Study title: Medical Therapy of Pediatric Glaucoma and Glaucoma in Pregnancy; Ophthalmol Clin N Am 18 (2005) 461 – 468

Active substance: TIMOLOL

Study summary document link (including results): Medical Therapy of Ped Glaucoma and Glaucoma in Pregnancy.pdf

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Document reference: 47681

Study title: Myopia progression in young school children. A prospective study of myopia progression and the effect of a trial with bifocal lenses and beta blocker eye drops. Jensen H. Acta Ophthalmol Suppl. 1991;(200):1-79. Myopia progression in young school children. A prospective study of myopia progression and the effect of a trial with bifocal lenses and beta blocker eye drops. Jensen H. Acta Ophthalmol Suppl. 1991;(200):1-79.

Active substance: TIMOLOL

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Document reference: 44766

Study title: Tclid. Acute and chronic pharmacokinetic study of ticlopidine hydrochloride in young and old normal subjects. Final report. ICM 1161/ CL 3690 - Gabuzda G. - 01/12/86

Active substance: TICLOPIDINE

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Document reference: 44760

Study title: Response to travoprost in black and nonblack patients with open-angle glaucoma or ocular hypertension. Netland PA, Robertson SM, Sullivan EK, Silver L, Bergamini MV, Krueger S, Weiner AL, Davis AA; Travoprost Study Groups. Adv Ther. 2003 May-Jun;20(3):149-63. Response to travoprost in black and nonblack patients with open-angle glaucoma or ocular hypertension. Netland PA, Robertson SM, Sullivan EK, Silver L, Bergamini MV, Krueger S, Weiner AL, Davis AA; Travoprost Study Groups. Adv Ther. 2003 May-Jun;20(3):149-63.

Active substance: TIMOLOL

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Document reference: 44763

Study title: Timolol and pediatric glaucomas. McMahon CD, Hetherington J Jr, Hoskins HD Jr, Shaffer RN. Ophthalmology. 1981 Mar;88(3):249-52. Timolol and pediatric glaucomas. McMahon CD, Hetherington J Jr, Hoskins HD Jr, Shaffer RN. Ophthalmology. 1981 Mar;88(3):249-52.

Active substance: TIMOLOL

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Document reference: 44767

Study title: Timolol in uncontrolled childhood glaucomas. Boger WP 3rd, Walton DS. Ophthalmology. 1981 Mar;88(3):253-8.Timolol in uncontrolled childhood glaucomas. Boger WP 3rd, Walton DS. Ophthalmology. 1981 Mar;88(3):253-8.

Active substance: TIMOLOL

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Document reference: 44768

Study title: Topical Timolol and the Nursing Mother

Active substance: TIMOLOL

Study summary document link (including results): Topical Timolol and the Nursing Mother.pdf

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Document reference: 47682

Study title: Radiology. 1995 Sep;196(3):851-5. Use of Tl-201 to detect untreated pediatric Hodgkin disease. Fletcher BD, Kauffman WM, Kaste SC, Winer-Muram HT, Fang L, Chen G, Hudson M. Radiology. 1995 Sep;196(3):851-5. Use of Tl-201 to detect untreated pediatric Hodgkin disease. Fletcher BD, Kauffman WM, Kaste SC, Winer-Muram HT, Fang L, Chen G, Hudson M.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44695

Study title: Radiology. 1998 Nov;209(2):471-5. Hodgkin disease: use of Tl-201 to monitor mediastinal involvement after treatment. Fletcher BD, Xiong X, Kauffman WM, Kaste SC, Hudson MM. Radiology. 1998 Nov;209(2):471-5. Hodgkin disease: use of Tl-201 to monitor mediastinal involvement after treatment. Fletcher BD, Xiong X, Kauffman WM, Kaste SC, Hudson MM.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44696

Study title: A Multicentre Study for the Evaluation of the Clinical Efficacy and of Local and General Safety of Tioconazole in the Gynaecological Use

Active substance: TIOCONAZOLE

Study summary document link (including results): TCN-I-88-004 EMA Pediatrics Web Synopsis.pdf

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Document reference: 48033

Study title: A Multicentre Study on the Efficacy and Tolerability of 1% Tioconazole Cream in Dermatomycoses

Active substance: TIOCONAZOLE

Study summary document link (including results): TCN-I-88-004 EMA Pediatrics Web Synopsis.pdf

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Document reference: 48034

Study title: A NON COMPARATIVE MULTICENTER STUDY OF TIOCONAZOLE 300MG VAGINAL OVULES FO THE SINGLE DOSE TREATMENT OF VAGINAL YEAST INFECTIONS

Active substance: TIOCONAZOLE

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Document reference: 44806

Study title: A NON-COMPARATIVE MULTICENTER STUDY OF TIOCONAZOLE 100MG VAGINAL OVULES FOR THE TREATMENT OF VAGINAL CANDIDIASIS WITH A 3 DAY COURSE OF THERAPY

Active substance: TIOCONAZOLE

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Document reference: 44809

Study title: An Open, Non-comparative Study of the Efficacy and Safety of Tioconazole in Neonates and Infants with Candidal Diaper Rash

Active substance: TIOCONAZOLE

Study summary document link (including results): TCN-TR-94-001A EMA Pediatric Web Synopsis.pdf

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Document reference: 48036

Study title: Double-Blind Comparison of the Efficacy, Toleration, and Safety of Tioconazole Base 1% and Tioconazole Base 2% w/w Creams in the Treatment of Patients with Fungal Infection of the Skin

Active substance: TIOCONAZOLE

Study summary document link (including results): EMEA Pediatrics Web Synopsis.pdf

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Document reference: 48031

Study title: Double-blind Comparison of the Efficacy, Toleration, and Safety of Tioconazole Hydrochloride 2% w/w and Econazole Nitrate 1% Creams in the Treatment of Patients with Fungal Infection of the Skin or with Erythrasma

Active substance: TIOCONAZOLE

Study summary document link (including results): 13-1 EMA Pediatric Web Synopsis.pdf

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Document reference: 44810

Study title: Efficacy and Safety of Tioconazole in the Treatment of Candidal Diaper Rash

Active substance: TIOCONAZOLE

Study summary document link (including results): TCN-TR-94-001B EMA Pediatrics Web Synopsis.pdf

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Document reference: 48037

Study title: A CLINICAL STUDY ENTITLED TROSID (TIOCONAZOL) SOLUTION. A EFFICACY OPEN LABEL STUDY IN THE TREATMENT OF ONYCHOMYCOSIS (ST. JOHAN´S HOSPITAL FOR DISEASE OF SKIN (LONDON) AND DEPARTMENT OF DERMATOLOGY-UNIVERSITY OF GRALGOW. CLINICAL AND EXPERIMENTAL DERMATOLOGY, 10, 11-115, 1985)

Active substance: TIOCONAZOLE

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Document reference: 44808

Study title: Efficacy and Tolerability of Dermatologic Tioconazole 1% Cream and Lotion vs Bifonazole 1% Cream and Lotion in the Treatment of Superficial Cutaneous Mycoses

Active substance: TIOCONAZOLE

Study summary document link (including results): TCN-I-86-004 EMA Pediatrics Web Synopsis.pdf

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Document reference: 48032

Study title: Efficacy, Safety, and Toleration of a 28% Tioconazole Solution Compared with a 2% Miconazole Tincture in Treatment of Fungal Nail Infection

Active substance: TIOCONAZOLE

Study summary document link (including results): EMA Pediatrics Web Synopsis.pdf

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Document reference: 48030

Study title: OPEN STUDY OF THE EFFICACY AND TOLERATION OF TIOCONAZOLE SINGLE DOSE OINTMENT IN THE TREATMENT OF PATIENTS WITH VAGINAL CANDIDOSIS (PEIOS SWITZERLAND)

Active substance: TIOCONAZOLE

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Document reference: 44811

Study title: Phase 1, multicenter, open-label trial to gain additional experience with topiramate among subjects with infantile spasms.

Active substance: TOPIRAMATE

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Document reference: 44884

Study title: Phase 3, double-blind, parallel-group, safety and efficacy study of TPM monotherapy in adults with refractory partial epilepsy.

Active substance: TOPIRAMATE

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Document reference: 44873

Study title: Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in subjects with uncontrolled primary eneralized tonic-clonic seizures.

Active substance: TOPIRAMATE

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Document reference: 44895

Study title: Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in subjects with uncontrolled primary (PGTC) seizures with or without other generalized seizure subtypes.

Active substance: TOPIRAMATE

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Document reference: 44896

Study title: Phase 3, double-blind, randomized, parallel group study comparing the safety and efficacy of 2 doses of topiramate as monotherapy in the treatment of newly diagnosed or recurrent epilepsy in pediatric and adult subjects. (plus OL ext)

Active substance: TOPIRAMATE

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Document reference: 44893

Study title: J Cardiogr. 1982 Dec;12(4):1009-21. [Myocardial imaging in patients with transposition of the great arteries: comparison between Mustard and Rastelli operations] [Article in Japanese] Ono Y, Tanimoto T, Kohata T, Arakaki Y, Takanashi S, Takahashi O, KaJ Cardiogr. 1982 Dec;12(4):1009-21. [Myocardial imaging in patients with transposition of the great arteries: comparison between Mustard and Rastelli operations] [Article in Japanese] Ono Y, Tanimoto T, Kohata T, Arakaki Y, Takanashi S, Takahashi O, Ka

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44594

Study title: J Cardiogr. 1982 Jun;12(2):387-99. [Myocardial imaging in patients with Kawasaki disease: exercise stress imaging and serial studies] [Article in Japanese] Ono Y, Tanimoto T, Kijima Y, Kohata T, Suzuki A, Kamiya T, Nishimura T, Kozuka T. J Cardiogr. 1982 Jun;12(2):387-99. [Myocardial imaging in patients with Kawasaki disease: exercise stress imaging and serial studies] [Article in Japanese] Ono Y, Tanimoto T, Kijima Y, Kohata T, Suzuki A, Kamiya T, Nishimura T, Kozuka T.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44595

Study title: J Cardiogr. 1984 Jun;14(1):59-73. [Diagnosis of myocardial ischemia in Kawasaki disease: thallium-201 myocardial imagings at rest, with exercise and with dipyridamole administration] [Article in Japanese] Mitomori T, Ono Y, Sugiyama H, Suzuki A, KamiyaJ Cardiogr. 1984 Jun;14(1):59-73. [Diagnosis of myocardial ischemia in Kawasaki disease: thallium-201 myocardial imagings at rest, with exercise and with dipyridamole administration] [Article in Japanese] Mitomori T, Ono Y, Sugiyama H, Suzuki A, Kamiya

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44596

Study title: J Cardiogr. 1984 Oct;14(3):565-75. [Thallium-201 myocardial imaging in patients with congenital heart disease following open-heart surgery] [Article in Japanese] Ono Y, Mitomori T, Watanabe K, Echigo S, Ryujin Y, Kamiya T, Nishimura T, Kozuka T, NaitoJ Cardiogr. 1984 Oct;14(3):565-75. [Thallium-201 myocardial imaging in patients with congenital heart disease following open-heart surgery] [Article in Japanese] Ono Y, Mitomori T, Watanabe K, Echigo S, Ryujin Y, Kamiya T, Nishimura T, Kozuka T, Naito

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44597

Study title: J Cardiogr. 1986 Jun;16(2):373-85. [Myocardial involvement in muscular dystrophy evaluated by thallium-201 emission computed tomography] [Article in Japanese] Yamamoto S, Matsushima H, Kawai N, Sotobata I. J Cardiogr. 1986 Jun;16(2):373-85. [Myocardial involvement in muscular dystrophy evaluated by thallium-201 emission computed tomography] [Article in Japanese] Yamamoto S, Matsushima H, Kawai N, Sotobata I.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44598

Study title: Influences of tramadol on emergence characteristics from sevoflurane anaesthesia in pediatric ambulatory surgery - Fan KT, Lee TH, Yu KL, Tang CS, Lu DV, Chen PY, Soo LY - 2000 (Kaohsiung J Med Sci, 2000; 16: 255-260)Influences of tramadol on emergence characteristics from sevoflurane anaesthesia in pediatric ambulatory surgery - Fan KT, Lee TH, Yu KL, Tang CS, Lu DV, Chen PY, Soo LY - 2000 (Kaohsiung J Med Sci, 2000; 16: 255-260)

Active substance: TRAMADOL

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Document reference: 45029

Study title: Investigation of paediatric postoperative analgesia with tramadol - Schaeffer J, Hageman H, holzapfel S, Panning B, Piepenbrock S - 1989 (Fortschr Anästh 1989; 3: 42-45)Investigation of paediatric postoperative analgesia with tramadol - Schaeffer J, Hageman H, holzapfel S, Panning B, Piepenbrock S - 1989 (Fortschr Anästh 1989; 3: 42-45)

Active substance: TRAMADOL

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Document reference: 45030

Study title: Multizentrische Anwendungwendungsbeobachtung eines Analgetikums in der Behandlung mittelstarker bis starker Schmerzen

Active substance: TRAMADOL

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Document reference: 44999

Study title: Nalbuphine and tramadol for the control of postoperative pain in children - Schaeffer J, Piepenbrock S, Kretz FJ, Schoenfeld C - 1986 (Anaesthesist 1986; 35: 408-413)Nalbuphine and tramadol for the control of postoperative pain in children - Schaeffer J, Piepenbrock S, Kretz FJ, Schoenfeld C - 1986 (Anaesthesist 1986; 35: 408-413)

Active substance: TRAMADOL

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Document reference: 45031

Study title: Evaluation of the multiple-dose steady-state pharmacokinetic profile or oral tramadol HCl in children and adolescents aged seven to sisteen years - Multicenter - 2000

Active substance: TRAMADOL

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Document reference: 45028

Study title: Nalbuphine vs. Tramadol. Efficacy and safety of nalbuphine in postoperative pain after surgery in children

Active substance: TRAMADOL

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Document reference: 45008

Study title: Open clinical study on the analgesic effect of tramadol in patients with burn pain

Active substance: TRAMADOL

Study summary document link (including results): Tramadol STUDY 86-03-95.xls

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Document reference: 45010

Study title: J Thorac Cardiovasc Surg. 1997 May;113(5):942-8. Comment in: J Thorac Cardiovasc Surg. 1997 Dec;114(6):1127-8. Effect of preoperative supplementation with alpha-tocopherol and ascorbic acid on myocardial injury in patients undergoing cardiac operatiJ Thorac Cardiovasc Surg. 1997 May;113(5):942-8. Comment in: J Thorac Cardiovasc Surg. 1997 Dec;114(6):1127-8. Effect of preoperative supplementation with alpha-tocopherol and ascorbic acid on myocardial injury in patients undergoing cardiac operati

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44629

Study title: J Thorac Cardiovasc Surg. 1999 Feb;117(2):352-7. Surgical angioplasty of the main coronary arteries in children. Bonnet D, Bonhoeffer P, Sidi D, Kachaner J, Acar P, Villain E, Vouhé PR. J Thorac Cardiovasc Surg. 1999 Feb;117(2):352-7. Surgical angioplasty of the main coronary arteries in children. Bonnet D, Bonhoeffer P, Sidi D, Kachaner J, Acar P, Villain E, Vouhé PR.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44630

Study title: Jpn Circ J. 1981 Jan;45(1):148-58. The quantitative diagnosis of thallium-201 myocardial perfusion images and vectorcardiograms in myocardial infarction and hypertrophic cardiomyopathy. Watanabe Y, Yasui S, Inagaki H, Kawai N, Sotobata I. Jpn Circ J. 1981 Jan;45(1):148-58. The quantitative diagnosis of thallium-201 myocardial perfusion images and vectorcardiograms in myocardial infarction and hypertrophic cardiomyopathy. Watanabe Y, Yasui S, Inagaki H, Kawai N, Sotobata I.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44631

Study title: Clin Nucl Med. 1988 Sep;13(9):629-31. The use and diagnostic significance of thallium-201 SPECT imaging in a case of anomalous left coronary artery. Petrozzo PJ, Woodard ML, Vitullo DA, Bekerman C, Blend MJ, Pinsky SM. Clin Nucl Med. 1988 Sep;13(9):629-31. The use and diagnostic significance of thallium-201 SPECT imaging in a case of anomalous left coronary artery. Petrozzo PJ, Woodard ML, Vitullo DA, Bekerman C, Blend MJ, Pinsky SM.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44543

Study title: Clin Nucl Med. 1989 Jul;14(7):492-3. Thallium-201 imaging in anomalous left coronary artery originating from pulmonary trunk. Kim SM, Park CH, Intenzo CM, Baht AM. Clin Nucl Med. 1989 Jul;14(7):492-3. Thallium-201 imaging in anomalous left coronary artery originating from pulmonary trunk. Kim SM, Park CH, Intenzo CM, Baht AM.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44544

Study title: Clin Nucl Med. 1989 Nov;14(11):827-30. Tl-201 myocardial SPECT in patients with Duchenne's muscular dystrophy: a long-term follow-up. Nagamachi S, Jinnouchi S, Ono S, Hoshi H, Inoue K, Watanabe K. Clin Nucl Med. 1989 Nov;14(11):827-30. Tl-201 myocardial SPECT in patients with Duchenne's muscular dystrophy: a long-term follow-up. Nagamachi S, Jinnouchi S, Ono S, Hoshi H, Inoue K, Watanabe K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44545

Study title: Clin Nucl Med. 1990 Sep;15(9):636-9. Cardiac sarcoidosis demonstrated by Tl-201 and Ga-67 SPECT imaging. Taki J, Nakajima K, Bunko H, Ohguchi M, Tonami N, Hisada K. Clin Nucl Med. 1990 Sep;15(9):636-9. Cardiac sarcoidosis demonstrated by Tl-201 and Ga-67 SPECT imaging. Taki J, Nakajima K, Bunko H, Ohguchi M, Tonami N, Hisada K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44546

Study title: Clin Nucl Med. 1991 Dec;16(12):931-5. Tl-201 uptake in brown tumors of hyperparathyroidism. Durak H, Aras T, Sungur C, Erbengi G, Bekdik CF. Clin Nucl Med. 1991 Dec;16(12):931-5. Tl-201 uptake in brown tumors of hyperparathyroidism. Durak H, Aras T, Sungur C, Erbengi G, Bekdik CF.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44547

Study title: Clin Nucl Med. 1991 Dec;16(12):947-8. Giant rhabdomyosarcoma with necrosis visualized with Tl-201 chloride. Durak H, Ugur O, Ozgur F. Clin Nucl Med. 1991 Dec;16(12):947-8. Giant rhabdomyosarcoma with necrosis visualized with Tl-201 chloride. Durak H, Ugur O, Ozgur F.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44548

Study title: Clin Nucl Med. 1992 Mar;17(3):191-4. Noninvasive assessment of myocardium at risk by Tl-201 SPECT imaging in a child with Kawasaki disease. A case report. Civelek AC, Kavanaugh-McHugh A, Ozguven MA, Durski K, Camargo EE. Clin Nucl Med. 1992 Mar;17(3):191-4. Noninvasive assessment of myocardium at risk by Tl-201 SPECT imaging in a child with Kawasaki disease. A case report. Civelek AC, Kavanaugh-McHugh A, Ozguven MA, Durski K, Camargo EE.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44549

Study title: Clin Nucl Med. 1992 Oct;17(10):806-11. Early and delayed imaging of Tc-99m HMPAO versus Tl-201 in benign and malignant thyroid tumors. Similar uptake but different retention. Ohnishi T, Noguchi S, Murakami N, Harao M, Jinnouchi S, Hoshi H, Futami S, NagClin Nucl Med. 1992 Oct;17(10):806-11. Early and delayed imaging of Tc-99m HMPAO versus Tl-201 in benign and malignant thyroid tumors. Similar uptake but different retention. Ohnishi T, Noguchi S, Murakami N, Harao M, Jinnouchi S, Hoshi H, Futami S, Nag

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44550

Study title: Clin Nucl Med. 1993 Jul;18(7):551-7. The role of thallium scintigraphy in excluding malignancy in bone. Van der Wall H, Murray IP, Huckstep RL, Philips RL. Clin Nucl Med. 1993 Jul;18(7):551-7. The role of thallium scintigraphy in excluding malignancy in bone. Van der Wall H, Murray IP, Huckstep RL, Philips RL.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44551

Study title: ULTRAM® tramadol HCl: Safety and efficacy in dental-extraction pain

Active substance: TRAMADOL

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Document reference: 45818

Study title: OPEN STUDY OF THE EFFICACY AND TOLERATION OF TIOCONAZOLE SINGLE DOSE OINTMENT IN THE TREATMENT OF PATIENTS WITH VAGINAL CANDIDOSIS (ARTNER AUSTRIA)

Active substance: TIOCONAZOLE

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Document reference: 44812

Study title: OPEN STUDY OF THE EFFICACY AND TOLERATION OF TIOCONAZOLE SINGLE DOSE OINTMENT IN THE TREATMENT OF PATIENTS WITH VAGINAL CANDIDOSIS (GRANETZNY WEST GERMANY)

Active substance: TIOCONAZOLE

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Document reference: 44813

Study title: OPEN STUDY OF THE EFFICACY AND TOLERATION OF TIOCONAZOLE SINGLE DOSE OINTMENT IN THE TREATMENT OF PATIENTS WITH VAGINAL CANDIOSIS (DR PEIOS SWITZERLAND)

Active substance: TIOCONAZOLE

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Document reference: 44814

Study title: Treatment of Dermatomycosis with Tioconazole 2% Dermal Cream

Active substance: TIOCONAZOLE

Study summary document link (including results): TCN-MEX-87-001 EMA Pediatrics Web Synopsis.pdf

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Document reference: 48035

Study title: A comparative trial of DS 103-282 and diazepam in patients with spasticity due to cerebrovascular accidents

Active substance: TIZANIDINE

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Document reference: 44779

Study title: Heart Rhythm. 2006 Apr;3(4):424-32. Comment in: Heart Rhythm. 2006 Apr;3(4):433-4. QT peak dispersion, not QT dispersion, is a more useful diagnostic marker for detecting exercise-induced myocardial ischemia Masaki N, Takase B, Matsui T, Kosuda S, OHeart Rhythm. 2006 Apr;3(4):424-32. Comment in: Heart Rhythm. 2006 Apr;3(4):433-4. QT peak dispersion, not QT dispersion, is a more useful diagnostic marker for detecting exercise-induced myocardial ischemia Masaki N, Takase B, Matsui T, Kosuda S, O

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44578

Study title: Heart Vessels Suppl. 1985;1:111-5. Myocardial bioptic findings in correlation with TL-201 imaging and hemodynamic parameters in patients with latent cardiomyopathies suspected of having myocarditis. Müller S, Müller P, Meyer R, Volkmann H, Gottschild Heart Vessels Suppl. 1985;1:111-5. Myocardial bioptic findings in correlation with TL-201 imaging and hemodynamic parameters in patients with latent cardiomyopathies suspected of having myocarditis. Müller S, Müller P, Meyer R, Volkmann H, Gottschild

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44579

Study title: Heart Vessels. 1989;5(1):47-51. Long-term prognosis of Kawasaki disease patients with coronary artery obstruction. Tatara K, Kusakawa S, Itoh K, Kazuma N, Lee K, Hashimoto K, Shinohara T, Kondoh C, Hiroe M. Heart Vessels. 1989;5(1):47-51. Long-term prognosis of Kawasaki disease patients with coronary artery obstruction. Tatara K, Kusakawa S, Itoh K, Kazuma N, Lee K, Hashimoto K, Shinohara T, Kondoh C, Hiroe M.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44580

Study title: Int J Cardiol. 1986 Sep;12(3):309-20. Systolic compression of coronary artery in hypertrophic cardiomyopathy. Navarro-Lopez F, Soler J, Magriña J, Esplugues E, Pare JC, Sanz G, Betriu A. Int J Cardiol. 1986 Sep;12(3):309-20. Systolic compression of coronary artery in hypertrophic cardiomyopathy. Navarro-Lopez F, Soler J, Magriña J, Esplugues E, Pare JC, Sanz G, Betriu A.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44581

Study title: Int J Cardiol. 1989 Aug;24(2):219-24. Hemodynamic and prognostic value of thallium-201 myocardial imaging in patients with dilated cardiomyopathy. Tamai J, Nagata S, Nishimura T, Yutani C, Miyatake K, Sakakibara H, Nimura Y. Int J Cardiol. 1989 Aug;24(2):219-24. Hemodynamic and prognostic value of thallium-201 myocardial imaging in patients with dilated cardiomyopathy. Tamai J, Nagata S, Nishimura T, Yutani C, Miyatake K, Sakakibara H, Nimura Y.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44582

Study title: Int J Cardiol. 1994 Jan;43(1):1-9. Abnormal exercise electrocardiogram in an asymptomatic person--what next? Juneja R, Wasir HS. Int J Cardiol. 1994 Jan;43(1):1-9. Abnormal exercise electrocardiogram in an asymptomatic person--what next? Juneja R, Wasir HS.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44583

Study title: J Cardiol. 1991;21(2):437-44. [Usefulness and limitations of stress 201-thallium myocardial imaging in patients with Kawasaki disease] [Article in Japanese] Ono Y, Kohata T, Iwatani H, Okuno M, Suzuki A, Kamiya T, Nishimura T, Takamiya M. J Cardiol. 1991;21(2):437-44. [Usefulness and limitations of stress 201-thallium myocardial imaging in patients with Kawasaki disease] [Article in Japanese] Ono Y, Kohata T, Iwatani H, Okuno M, Suzuki A, Kamiya T, Nishimura T, Takamiya M.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44599

Study title: J Cardiol. 1992;22(1):21-6. [Ischemic myocardial injury evaluated using positron emission tomography in children with coronary artery disease: comparison with thallium-201 SPECT] [Article in Japanese] Yoshibayashi M, Tamaki N, Nishioka K, Matsumura M, J Cardiol. 1992;22(1):21-6. [Ischemic myocardial injury evaluated using positron emission tomography in children with coronary artery disease: comparison with thallium-201 SPECT] [Article in Japanese] Yoshibayashi M, Tamaki N, Nishioka K, Matsumura M,

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44600

Study title: J Child Neurol. 1997 Sep;12(6):341-8. Correlation between gadolinium-diethylenetriaminepentaacetic acid contrast enhancement and thallium-201 chloride uptake in pediatric brainstem glioma. Maria BL, Drane WB, Quisling RJ, Hoang KB. J Child Neurol. 1997 Sep;12(6):341-8. Correlation between gadolinium-diethylenetriaminepentaacetic acid contrast enhancement and thallium-201 chloride uptake in pediatric brainstem glioma. Maria BL, Drane WB, Quisling RJ, Hoang KB.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44601

Study title: Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396 Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396

Active substance: THIAMAZOLE

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Document reference: 44735

Study title: Efficacy of Thiobactin in the treatment of acute non tuberculosis lower respiratory tract infections in children

Active substance: THIAMPHENICOL

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Document reference: 44737

Study title: EFFECT ON FETUSES AND NEWBORN YOUNG OF TORESTEN INJECTABLE SOLUTION ADMINISTERED TO PREGNANT ANIMALS

Active substance: THIETHYLPERAZINE

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Document reference: 44739

Study title: TORECAN - FERTILITY AND GENERAL REPRODUCTIVE PERFORMANCE STUDY IN RATS

Active substance: THIETHYLPERAZINE

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Document reference: 44738

Study title: A multicentre, double-blind, placebo-controlled clinical trial with Muscoril® capsules and ampoules in orthopedic and post-traumatic disorders (PHX 89 00 101)

Active substance: THIOCOLCHICOSIDE

Study summary document link (including results): Thiocolchicoside - Study 2.pdf

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Document reference: 44742

Study title: Clinical study (phase IV) in dossier MAA0051: A multicentre, randomised, double bind, placebo-controlled clinical trial with Muscoril® Capsules and Ampoulesin orthopedic and post-traumatic disorders (protocol PHX 89 00 101) - Blondin P, Derde MP- 1989

Active substance: THIOCOLCHICOSIDE

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Document reference: 44741

Study title: Comparative Efficacy and Safety of Muscoril® 4 mg BID Ampoules versus Placebo in Orthopedo-Traumatologic Pathologies : a Monocentre Double-Blind Randomised Clinical Trial

Active substance: THIOCOLCHICOSIDE

Study summary document link (including results): Thiocolchicoside - Study 1.pdf

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Document reference: 44740

Study title: Controlled clinical researches on the activity and tolerability of different preparations of Muscoril (ampoules, capsules, cream, ointment) for the comparison with other active injectable preparation or with placebo per os and for local application, in patients with painful contractures of different origin STUDY MARIANI

Active substance: THIOCOLCHICOSIDE

Study summary document link (including results): Thiocolchicoside STUDY Mariani.xls

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Document reference: 47996

Study title: Jpn Circ J. 1982 Jul;46(7):715-24. Quantitative estimation of the right ventricular overloading by thallium-201 myocardial scintigraphy. Owada K, Machii K, Tsukahara Y, Awano N, Kijima M, Miyazaki Y, Ono K, Ebitani S, Muroi S, Ikeda K, Uchida T, KariyoJpn Circ J. 1982 Jul;46(7):715-24. Quantitative estimation of the right ventricular overloading by thallium-201 myocardial scintigraphy. Owada K, Machii K, Tsukahara Y, Awano N, Kijima M, Miyazaki Y, Ono K, Ebitani S, Muroi S, Ikeda K, Uchida T, Kariyo

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44632

Study title: Jpn Circ J. 1986 Dec;50(12):1275-9. Myocarditis with myocardial infarction like findings in a 3-year old girl. Tsukada K, Takemura N, Itoh K, Tatara K, Tahara K, Lee K, Kiguchi H, Kusakawa S. Jpn Circ J. 1986 Dec;50(12):1275-9. Myocarditis with myocardial infarction like findings in a 3-year old girl. Tsukada K, Takemura N, Itoh K, Tatara K, Tahara K, Lee K, Kiguchi H, Kusakawa S.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44633

Study title: Jpn Circ J. 2001 Feb;65(2):99-105. Thallium-201 single photon emission computed tomography (SPECT) in patients with duchenne's progressive muscular dystrophy: a histopathologic correlation study. Nishimura T, Yanagisawa A, Sakata H, Sakata K, ShimoyamaJpn Circ J. 2001 Feb;65(2):99-105. Thallium-201 single photon emission computed tomography (SPECT) in patients with duchenne's progressive muscular dystrophy: a histopathologic correlation study. Nishimura T, Yanagisawa A, Sakata H, Sakata K, Shimoyama

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44634

Study title: Jpn Heart J. 1985 May;26(3):413-23. Radionuclide imaging for assessment of myocarditis and postmyocarditic state in infant and children. Thallium-201 myocardial imaging and technetium-99m-HSA gated equilibrium ventriculography. Saji T, Matsuo N, HashiguJpn Heart J. 1985 May;26(3):413-23. Radionuclide imaging for assessment of myocarditis and postmyocarditic state in infant and children. Thallium-201 myocardial imaging and technetium-99m-HSA gated equilibrium ventriculography. Saji T, Matsuo N, Hashigu

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44635

Study title: Jpn Heart J. 1985 Sep;26(5):767-75. Evaluation of myocardial involvement in Duchenne's progressive muscular dystrophy with thallium-201 myocardial perfusion imaging. Kawai N, Sotobata I, Okada M, Iwase M, Yamamoto S, Matsushima H, Miyakoda H, Yokota M, Jpn Heart J. 1985 Sep;26(5):767-75. Evaluation of myocardial involvement in Duchenne's progressive muscular dystrophy with thallium-201 myocardial perfusion imaging. Kawai N, Sotobata I, Okada M, Iwase M, Yamamoto S, Matsushima H, Miyakoda H, Yokota M,

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44636

Study title: Safety and Efficacy of Tiagabine HCl Monotherapy for the Inpatient Treatment of Complex Partial Seizures: A Placebo–Controlled Study

Active substance: TIAGABINE

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Document reference: 38520

Study title: Safety and Efficacy of Tiagabine HCl Monotherapy in the Treatment for Partial Seizures: High Dose versus Low Dose

Active substance: TIAGABINE

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Document reference: 38530

Study title: Safety of tiagabine: Summary of 53 trials ; IEGram LDeaton RSommerville KW Leppik, IE Leppik, Epilepsy Research 1999, 33(2-3): 235-246Safety of tiagabine: Summary of 53 trials ; IEGram LDeaton RSommerville KW Leppik, IE Leppik, Epilepsy Research 1999, 33(2-3): 235-246

Active substance: TIAGABINE

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Document reference: 38433

Study title: Studies on platelet functions and the protection of platelet consumption during extracorporeal circulation -Isomura - No dateStudies on platelet functions and the protection of platelet consumption during extracorporeal circulation -Isomura - No date

Active substance: TIAGABINE

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Document reference: 38478

Study title: Tclid. Acute and chronic pharmacokinetic study of ticlopidine hydrochloride in young and old normal subjects. Final report. ICM 1161/ CL 3690 - Gabuzda G. - 01/12/86Tclid. Acute and chronic pharmacokinetic study of ticlopidine hydrochloride in young and old normal subjects. Final report. ICM 1161/ CL 3690 - Gabuzda G. - 01/12/86

Active substance: TIAGABINE

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Document reference: 38480

Study title: Use of tramal during minor surgery in children - Ostreykov IF, Senkov Vn, Kurilova ES, Bershinksy VP, Pivovarov SA, Babayev BD - 1993 (Anesthesiol Resuscitation 1993; 24: 28-31)Use of tramal during minor surgery in children - Ostreykov IF, Senkov Vn, Kurilova ES, Bershinksy VP, Pivovarov SA, Babayev BD - 1993 (Anesthesiol Resuscitation 1993; 24: 28-31)

Active substance: TRAMADOL

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Document reference: 45042

Study title: Clinical trial of Rhinogutt" drops via nebulizer."

Active substance: TRAMAZOLINE

Study summary document link (including results): Tramazoline Hydrochloride_U73-0126_synopsis.pdf

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Document reference: 46701

Study title: Clinical trial of the drug KB 227 (Rhinogutt).

Active substance: TRAMAZOLINE

Study summary document link (including results): Tramazoline Hydrochloride_U74-0094_synopsis.pdf

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Document reference: 46703

Study title: Evaluation and comparison of safety and effectiveness of L.A.N.D., phenylephrine, and a vehicle control in patients with allergic and non-allergic rhinitis.

Active substance: TRAMAZOLINE

Study summary document link (including results): Tramazoline Hydrochloride_U70-0210_synopsis.pdf

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Document reference: 46699

Study title: Evaluation of the effects of L.A.N.D., phenylephrine, and vehicle control nasal sprays in children with acute and chronic rhinitis due to coryza or allergy.

Active substance: TRAMAZOLINE

Study summary document link (including results): Tramazoline Hydrochloride_U70-0222_synopsis.pdf

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Document reference: 46700

Study title: Excerpt from the addendum to the final report on K 43 - KB 227 and K 41 - KB 277.

Active substance: TRAMAZOLINE

Study summary document link (including results): Tramazoline Hydrochloride_U64-0042_synopsis.pdf

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Document reference: 46697

Study title: Final report on the additional trials of K 41 - KB 227 in children (in response to the question of reversing the age related recommendation of the Bundesgesundheitsamtes.

Active substance: TRAMAZOLINE

Study summary document link (including results): Tramazoline Hydrochloride_U93-0588_synopsis.pdf

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Document reference: 46704

Study title: Final report on the test of K 41 - KB 227 in children.

Active substance: TRAMAZOLINE

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Document reference: 46695

Study title: ULTRAM® tramadol HCl: Safety and efficacy in dental-extraction pain

Active substance: TRAMADOL

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Document reference: 44983

Study title: Final report on the test of K 41 - KB 227.

Active substance: TRAMAZOLINE

Study summary document link (including results): Tramazoline Hydrochloride_U62-0011_synopsis.pdf

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Document reference: 46696

Study title: Final report on the test of K 43 - KB 227.

Active substance: TRAMAZOLINE

Study summary document link (including results): Tramazoline Hydrochloride_U62-0008_synopsis.pdf

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Document reference: 46694

Study title: CLINICAL EVALUATION OF DIFLUCAN ON SEVERE CANDIDEMIA

Active substance: FLUCONAZOLE

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Document reference: 27536

Study title: Int J Radiat Oncol Biol Phys. 1991 Mar;20(3):593-7. Blood flow of human soft tissue sarcomas measured by thallium-201 scanning: prediction of tumor response to radiation. Nishizawa K, Okunieff P, Elmaleh D, McKusick KA, Strauss HW, Suit HD. Int J Radiat Oncol Biol Phys. 1991 Mar;20(3):593-7. Blood flow of human soft tissue sarcomas measured by thallium-201 scanning: prediction of tumor response to radiation. Nishizawa K, Okunieff P, Elmaleh D, McKusick KA, Strauss HW, Suit HD.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44584

Study title: Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1503-6. Thallium-201 scintigraphy is not predictive of late cardiac complications in patients with Hodgkin's disease treated with mediastinal radiation. Girinsky T, Cordova A, Rey A, Cosset JM, Tertian G, PInt J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1503-6. Thallium-201 scintigraphy is not predictive of late cardiac complications in patients with Hodgkin's disease treated with mediastinal radiation. Girinsky T, Cordova A, Rey A, Cosset JM, Tertian G, P

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44585

Study title: Levocabastina contra cetirizina en ninBs con rinitis alCrgica perenne. Revista Alergia Mexico 45(3), p.7-11, 1998Levocabastina contra cetirizina en ninBs con rinitis alCrgica perenne. Revista Alergia Mexico 45(3), p.7-11, 1998

Active substance: LEVOCABASTINE

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Document reference: 31131

Study title: Levocabastine collyre dans le traitement de las conjonctivite allergique non infectieuse

Active substance: LEVOCABASTINE

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Document reference: 31062

Study title: Levocabastine eye drops and nasal spray in seasonal allergic rhino conjunctivitis: a single-blind comparison with antazolineaphazoline eye drops and flunisolide nasal spray (17-54 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD43871_Interventional_Levocabastine.xls

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Document reference: 31094

Study title: CLINICAL USEFULNESS OF DIFLUCAN FOR SYSTEMIC MYCOSIS IN HOSPITALIZED PATIENTS IN ICU.

Active substance: FLUCONAZOLE

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Document reference: 27877

Study title: Levocabastine eye drops in the treatment of allergic conjunctivitis

Active substance: LEVOCABASTINE

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Document reference: 31060

Study title: Levocabastine eye drops in the treatment of allergic conjunctivitis. An open multicentric trial

Active substance: LEVOCABASTINE

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Document reference: 31061

Study title: Levocabastine eye drops in the treatment of seasonal allergic conjunctivitis: a double-blind comparison with sodium cromoglycate (11-71 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62120_Interventional_Levocabastine.xls

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Document reference: 31108

Study title: Levocabastine eye drops in the treatment of seasonal allergic conjunctivitis: a double-blind comparison with sodium cromoglycate (12-46 yrs)

Active substance: LEVOCABASTINE

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Document reference: 31111

Study title: Levocabastine eye drops in the treatment of seasonal allergic conjunctivitis: a double-blind comparison with sodium cromoglycate (3-66 yrs)

Active substance: LEVOCABASTINE

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Document reference: 31112

Study title: Levocabastine eye drops in the treatment of vernal conjunctivitis: a double-blind comparison with placebo (5-59 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62491_Interventional_Levocabastine.xls

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Document reference: 31104

Study title: Levocabastine in perennial allergic rhinoconjunctivitis: an open, long-term trial in children. Clinical Research Report Dated October 1997

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD40441_Interventional_Levocabastine.xls

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Document reference: 31070

Study title: Levocabastine in perennial allergic rhinoconjunctivitis: an open, long-term trial in children. Clinical Research Report Dated October 1997Levocabastine in perennial allergic rhinoconjunctivitis: an open, long-term trial in children. Clinical Research Report Dated October 1997

Active substance: LEVOCABASTINE

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Document reference: 31123

Study title: Levocabastine nasal spray in seasonal allergic rhinitis in doctors and their families: a double-blind placebo-controlled study (12-72 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD59392_Interventional_Levocabastine.xls

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Document reference: 31087

Study title: To systematically document under practice conditions satisfactory tolerance, and accordingly the safety of therapy with Aspecton® Cough drops in accordance with the manufacturer’s dosage recommendations, in children with bronchitis or inflammatory bronchial disease with production of mucus.

Active substance: THYME

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Document reference: 47262

Study title: Data collection for observational study (AWB) on tolerability of thyme preparations in children up to 12 years

Active substance: Thyme , liquid extract (1:2-2,5)

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Document reference: 40256

Study title: Wirkung und Verträglichkeit von Tussamag Hustensaft bei Kindern mit akuter Bronchitis

Active substance: Thymi Extractum Fluidum

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Document reference: 40257

Study title: Muz V.A., Zubkova S.T. : Effects of antihomotoxic Thyreoidea compositum preparation in the treatment of children suffering from autoimmune thyreoiditis. Biological Therapy (Ukraine), 2003, 3: 31-34 [IIT-publication];

Active substance: Thyreoidea compositum

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Document reference: 40259

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Thyreoidea compositum (ampoules) [AWB-AT]

Active substance: Thyreoidea compositum

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Document reference: 40260

Study title: Sysoeva N.A: Dynamics of selected homeostatic parameters in children suffering from thyroid gland pathology under the influence of combined treatment. Therapeutic Medico-Biological Vestnik, 2006, 9(2) [IIT-publication];

Active substance: Thyreoidea compositum

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Document reference: 40258

Study title:

Active substance: TIAGABINE

Study summary document link (including results): M91-603TIA-106.xls

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Document reference: 38439

Study title:

Active substance: TIAGABINE

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Document reference: 38440

Study title:

Active substance: TIAGABINE

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Document reference: 38441

Study title:

Active substance: TIAGABINE

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Document reference: 38442

Study title: Acta Neurochir (Wien). 2005 Jul;147(7):795-9; discussion 799. Epub 2005 May 23. Incidentally detected parafalcine chondrosarcoma. Tosaka M, Fukasawa Y, Takahashi A, Sasaki A, Saito N Acta Neurochir (Wien). 2005 Jul;147(7):795-9; discussion 799. Epub 2005 May 23. Incidentally detected parafalcine chondrosarcoma. Tosaka M, Fukasawa Y, Takahashi A, Sasaki A, Saito N

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44485

Study title: Acta Radiol Suppl. 1992;378 ( Pt 3):51-70. Polar presentation of coronary angiography and thallium-201 single photon emission computed tomography. Studies of patients examined for heart disease. Svane B. Acta Radiol Suppl. 1992;378 ( Pt 3):51-70. Polar presentation of coronary angiography and thallium-201 single photon emission computed tomography. Studies of patients examined for heart disease. Svane B.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44486

Study title: Acta Radiol. 1989 Nov-Dec;30(6):561-74. Polar presentation of coronary angiography and thallium-201 single photon emission computed tomography. A method for comparing anatomic and pathologic findings in coronary angiography with isotope distribution in tActa Radiol. 1989 Nov-Dec;30(6):561-74. Polar presentation of coronary angiography and thallium-201 single photon emission computed tomography. A method for comparing anatomic and pathologic findings in coronary angiography with isotope distribution in t

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44487

Study title: Acta Radiol. 2001 Nov;42(6):548-54. Pre-operative grading of intracranial glioma. Lam WW, Chan KW, Wong WL, Poon WS, Metreweli C. Acta Radiol. 2001 Nov;42(6):548-54. Pre-operative grading of intracranial glioma. Lam WW, Chan KW, Wong WL, Poon WS, Metreweli C.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44488

Study title: AJNR Am J Neuroradiol. 1991 Nov-Dec;12(6):1187-92. Radiation necrosis vs high-grade recurrent glioma: differentiation by using dual-isotope SPECT with 201TI and 99mTc-HMPAO. Schwartz RB, Carvalho PA, Alexander E 3rd, Loeffler JS, Folkerth R, Holman BL. AJNR Am J Neuroradiol. 1991 Nov-Dec;12(6):1187-92. Radiation necrosis vs high-grade recurrent glioma: differentiation by using dual-isotope SPECT with 201TI and 99mTc-HMPAO. Schwartz RB, Carvalho PA, Alexander E 3rd, Loeffler JS, Folkerth R, Holman BL.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44489

Study title: Tiagabine therapy for complex partial seizures: A dose-frequency study RC Sachdeo, et al., RC Sachdeo, Archives of Neurology 1997, 54(5): 595-601Tiagabine therapy for complex partial seizures: A dose-frequency study RC Sachdeo, et al., RC Sachdeo, Archives of Neurology 1997, 54(5): 595-601

Active substance: TIAGABINE

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Document reference: 38436

Study title: Tiagabine: The safety landscape IE Leppik &  IE Leppik,  IE Leppik, Epilepsia 1996, 36(SUPPL.): S10-S13Tiagabine: The safety landscape IE Leppik &  IE Leppik,  IE Leppik, Epilepsia 1996, 36(SUPPL.): S10-S13

Active substance: TIAGABINE

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Document reference: 38437

Study title: Tiagabine. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential in the management of epilepsy ; JCNoble S Adkins &  JC Adkins,  JC Adkins, Drugs 1998, 55(3): 437-460Tiagabine. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential in the management of epilepsy ; JCNoble S Adkins &  JC Adkins,  JC Adkins, Drugs 1998, 55(3): 437-460

Active substance: TIAGABINE

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Document reference: 38435

Study title: Tiapride treatment of tics in children and adolescents - J. Daléry, J. Maillet, R. de VillardTiapride treatment of tics in children and adolescents - J. Daléry, J. Maillet, R. de Villard

Active substance: TIAGABINE

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Document reference: 38468

Study title: Safety and Efficacy of Three Dose Levels of Tiagabine HCl versus Placebo as Adjunctive Treatment for Complex Partial Seizures

Active substance: TIAGABINE

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Document reference: 38521

Study title: Safety and efficacy of Tiagabine HCl in the treatment of Pediatric Patients with Partial Seizures

Active substance: TIAGABINE

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Document reference: 38534

Study title: Timolol and pediatric glaucomas. McMahon CD, Hetherington J Jr, Hoskins HD Jr, Shaffer RN. Ophthalmology. 1981 Mar;88(3):249-52. Timolol and pediatric glaucomas. McMahon CD, Hetherington J Jr, Hoskins HD Jr, Shaffer RN. Ophthalmology. 1981 Mar;88(3):249-52.

Active substance: TIAGABINE

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Document reference: 38487

Study title: Unexpected side effects of tiagabine in five children with therapy resistant epileptic syndromes ; ABaumgarten-Walczak AStephani U Rabenhorst &  U Stephani,  U Stephani, Nervenheilkunde 1999, 18(6): 308-310Unexpected side effects of tiagabine in five children with therapy resistant epileptic syndromes ; ABaumgarten-Walczak AStephani U Rabenhorst &  U Stephani,  U Stephani, Nervenheilkunde 1999, 18(6): 308-310

Active substance: TIAGABINE

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Document reference: 38432

Study title: Clinical and Neurobiological findings in children suffering from tic disease following treatment with tiapride - Eggers C. et al. - 1988 (Eur Arch Psychiatry Neurol Sci.;237(4):223-9)

Active substance: TIAPRIDE

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Document reference: 44743

Study title: Aust N Z J Med. 1998 Feb;28(1):33-8. Erratum in: Aust N Z J Med 1998 Apr;28(2):197. Comparison of thallium-201 and gallium-67 scintigraphy in the evaluation of non-Hodgkin's lymphoma. Roach PJ, Cooper RA, Arthur CK, Ravich RB. Aust N Z J Med. 1998 Feb;28(1):33-8. Erratum in: Aust N Z J Med 1998 Apr;28(2):197. Comparison of thallium-201 and gallium-67 scintigraphy in the evaluation of non-Hodgkin's lymphoma. Roach PJ, Cooper RA, Arthur CK, Ravich RB.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44524

Study title: Anticancer Res. 2000 Sep-Oct;20(5C):3967-70. Assessment of chemosensitivity in patients with malignant bone and soft tissue tumors using thallium-201 scintigraphy and doxorubicin binding assay. Murata H, Kusuzaki K, Takeshita H, Hirata M, Hashiguchi S, Anticancer Res. 2000 Sep-Oct;20(5C):3967-70. Assessment of chemosensitivity in patients with malignant bone and soft tissue tumors using thallium-201 scintigraphy and doxorubicin binding assay. Murata H, Kusuzaki K, Takeshita H, Hirata M, Hashiguchi S,

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44517

Study title: Kyobu Geka. 1979 Oct 1;32(10):772-80. [Thallium-201 myocardial scintigraphy and cardiac pool scintigraphy with technetium-99m labelled human serum albumin of complicated anomalous heart--their comparison with contrast angiography (author's transl] [ArtiKyobu Geka. 1979 Oct 1;32(10):772-80. [Thallium-201 myocardial scintigraphy and cardiac pool scintigraphy with technetium-99m labelled human serum albumin of complicated anomalous heart--their comparison with contrast angiography (author's transl] [Arti

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44662

Study title: Med Pediatr Oncol. 1998 May;30(5):297-300. Misleading leads. Thallium-201 uptake in rebound thymic hyperplasia. Roebuck DJ, Nicholls WD, Bernard EJ, Kellie SJ, Howman-Giles R. Med Pediatr Oncol. 1998 May;30(5):297-300. Misleading leads. Thallium-201 uptake in rebound thymic hyperplasia. Roebuck DJ, Nicholls WD, Bernard EJ, Kellie SJ, Howman-Giles R.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44663

Study title: Minn Med. 1983 Apr;66(4):229-33. A comparison of thallium-201 myocardial imaging with exercise-ECG and coronary angiography in 28 patients with suspected ischemic heart disease. Forstrom LA, Cook AM, Schwartz JS, Loken MK. Minn Med. 1983 Apr;66(4):229-33. A comparison of thallium-201 myocardial imaging with exercise-ECG and coronary angiography in 28 patients with suspected ischemic heart disease. Forstrom LA, Cook AM, Schwartz JS, Loken MK.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44664

Study title: Neurol Med Chir (Tokyo). 1997 Aug;37(8):594-9. Thallium-201 single photon emission computed tomography imaging of meningioma cells in hyperostosis. Mori K, Cho K, Suda K, Ishimaru S, Maeda M. Neurol Med Chir (Tokyo). 1997 Aug;37(8):594-9. Thallium-201 single photon emission computed tomography imaging of meningioma cells in hyperostosis. Mori K, Cho K, Suda K, Ishimaru S, Maeda M.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44665

Study title: Neuromuscul Disord. 2001 Jul;11(5):464-9. Depressed myocardial fatty acid metabolism in patients with muscular dystrophy. Momose M, Iguchi N, Imamura K, Usui H, Ueda T, Miyamoto K, Inaba S. Neuromuscul Disord. 2001 Jul;11(5):464-9. Depressed myocardial fatty acid metabolism in patients with muscular dystrophy. Momose M, Iguchi N, Imamura K, Usui H, Ueda T, Miyamoto K, Inaba S.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44666

Study title: Neurosurg Rev. 2005 Apr;28(2):96-103. Epub 2004 Dec 3. 201Tl-SPECT and 1H-MRS study of benign lateral ventricle tumors: differential diagnosis of subependymoma. Kawaguchi T, Kumabe T, Shimizu H, Watanabe M, Tominaga T Neurosurg Rev. 2005 Apr;28(2):96-103. Epub 2004 Dec 3. 201Tl-SPECT and 1H-MRS study of benign lateral ventricle tumors: differential diagnosis of subependymoma. Kawaguchi T, Kumabe T, Shimizu H, Watanabe M, Tominaga T

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44667

Study title: Neurosurgery. 1999 Jul;45(1):183-7; discussion 187. Thallium-201 single-photon emission computed tomographic and proton magnetic resonance spectroscopic characteristics of intracranial ganglioglioma: three technical case reports. Kumabe T, Shimizu H, SoNeurosurgery. 1999 Jul;45(1):183-7; discussion 187. Thallium-201 single-photon emission computed tomographic and proton magnetic resonance spectroscopic characteristics of intracranial ganglioglioma: three technical case reports. Kumabe T, Shimizu H, So

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44668

Study title: Nippon Igaku Hoshasen Gakkai Zasshi. 1989 Dec 25;49(12):1567-72. [Clinical evaluation of Tl-201 ECG-gated myocardial SPECT--comparison with ECG-gated blood pool SPECT] [Article in Japanese] Mochizuki T. Nippon Igaku Hoshasen Gakkai Zasshi. 1989 Dec 25;49(12):1567-72. [Clinical evaluation of Tl-201 ECG-gated myocardial SPECT--comparison with ECG-gated blood pool SPECT] [Article in Japanese] Mochizuki T.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44669

Study title: COMPARE EFFICACY OF PROPHYLACTIC PREOPERATIVE DOSES OF FASIGYN 500 AND METROGYL AS ADJUNCTS TO ANTIMICROBIAL REGIMENS OF AMPICILLIN AND/OR GENTAMICIN IN ELECTIVE INTRAABDOMINAL OR PELVIC SURGERY.

Active substance: TINIDAZOLE

Study summary document link (including results): TND-II-88-003 EMEA Pediatrics Web Synopsis.pdf

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Document reference: 44775

Study title: Levocabastine nasal spray in the treatment of perennial rhinitis: a double-blind comparison with placebo following by an open comparison with beclomethasone (6.5-70 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62486_Interventional_Levocabastine.xls

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Document reference: 31083

Study title: Levocabastine nasal spray in the treatment of rhinitis in asthmatic children: a double-blind comparison with placebo (6-15 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62485_Interventional_Levocabastine.xls

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Document reference: 31077

Study title: Levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a double-blind comparison with sodium cromoglycate (17-63 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62437_Interventional_Levocabastine.xls

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Document reference: 31091

Study title: Levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a single blind comparison with beclomethasone and placebo

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD126855_Interventional_Levocabastine.xls

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Document reference: 31057

Study title: Levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a single-blind comparison with beclomethasone and placebo (12-50 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62488_Interventional_Levocabastine.xls

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Document reference: 31080

Study title: Levocabastine versus cetirizine in children with perennial allergic rhinitis (PAR). Journal of Allergy and Clinical Immunology 97 (1) (part 3), p.437, 1996Levocabastine versus cetirizine in children with perennial allergic rhinitis (PAR). Journal of Allergy and Clinical Immunology 97 (1) (part 3), p.437, 1996

Active substance: LEVOCABASTINE

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Document reference: 31130

Study title: Levocabstine vs placebo in the treatment of seasonal allergic conjunctivitis

Active substance: LEVOCABASTINE

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Document reference: 31064

Study title: Metabolic aspects of myocardial disease and a role for L-carnitine in the tratment of childhood cardiomyopathy. Helton E, Darragh R, Francis P, Fricker FJ, Jue K, Koch G, Mair D, Pierpont ME, Prochazka JV, Linn LS, Winter SC. Pediatrics. 2000 Jun; 105(6):1260-70. Metabolic aspects of myocardial disease and a role for L-carnitine in the tratment of childhood cardiomyopathy. Helton E, Darragh R, Francis P, Fricker FJ, Jue K, Koch G, Mair D, Pierpont ME, Prochazka JV, Linn LS, Winter SC. Pediatrics. 2000 Jun; 105(6):1260-70.

Active substance: LEVOCABASTINE

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Document reference: 31140

Study title: Multicentre double-blind comparison of levocabastine eye drops with sodium cromoglycate in the treatment of seasonal allergic conjunctivitis (8-74 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD59786_Interventional_Levocabastine.xls

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Document reference: 31110

Study title: Multicentre study of levocabastine in children - interim report

Active substance: LEVOCABASTINE

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Document reference: 31067

Study title: Ocena skutecznosci klinicznej i bezpieczenstwa lewokabastyny wleczeniu pylkowicy u dzieci ponizej 12.roku zycia. Polski Merkuriusz Lekarski 24(4), p.269-272, 1998Ocena skutecznosci klinicznej i bezpieczenstwa lewokabastyny wleczeniu pylkowicy u dzieci ponizej 12.roku zycia. Polski Merkuriusz Lekarski 24(4), p.269-272, 1998

Active substance: LEVOCABASTINE

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Document reference: 31125

Study title: Levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a double-blind placebo-controlled trial (17-41 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62505_Interventional_Levocabastine.xls

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Document reference: 31081

Study title: Onset of action, effectiveness and tolerance of levocabastine and nedocromil in topical therapy of seasonal allergic rhinoconjunctivitis. Arzneirnittel-Forschung 48(II) (9), p.925-930, 1998Onset of action, effectiveness and tolerance of levocabastine and nedocromil in topical therapy of seasonal allergic rhinoconjunctivitis. Arzneirnittel-Forschung 48(II) (9), p.925-930, 1998

Active substance: LEVOCABASTINE

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Document reference: 31128

Study title: Oral treatment of perennial allergic rhinitis with R 50 547. A 2-week double-blind placebo-controlled study (16-75 yrs)

Active substance: LEVOCABASTINE

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Document reference: 31072

Study title: AJNR Am J Neuroradiol. 1996 May;17(5):925-32. Preoperative grading of glioma malignancy with thallium-201 single-photon emission CT: comparison with conventional CT. Källén K, Heiling M, Andersson AM, Brun A, Holtås S, Ryding E. AJNR Am J Neuroradiol. 1996 May;17(5):925-32. Preoperative grading of glioma malignancy with thallium-201 single-photon emission CT: comparison with conventional CT. Källén K, Heiling M, Andersson AM, Brun A, Holtås S, Ryding E.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44490

Study title: AJNR Am J Neuroradiol. 1998 May;19(5):801-6. Comment in: AJNR Am J Neuroradiol. 1998 May;19(5):807-9. AJNR Am J Neuroradiol. 1998 May;19(5):810. AJNR Am J Neuroradiol. 1998 May;19(5):811. Cerebral gangliogliomas: preoperative grading using FDGAJNR Am J Neuroradiol. 1998 May;19(5):801-6. Comment in: AJNR Am J Neuroradiol. 1998 May;19(5):807-9. AJNR Am J Neuroradiol. 1998 May;19(5):810. AJNR Am J Neuroradiol. 1998 May;19(5):811. Cerebral gangliogliomas: preoperative grading using FDG

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44491

Study title: AJNR Am J Neuroradiol. 2000 May;21(5):901-9. Posttherapeutic intraaxial brain tumor: the value of perfusion-sensitive contrast-enhanced MR imaging for differentiating tumor recurrence from nonneoplastic contrast-enhancing tissue. Sugahara T, Korogi Y, TAJNR Am J Neuroradiol. 2000 May;21(5):901-9. Posttherapeutic intraaxial brain tumor: the value of perfusion-sensitive contrast-enhanced MR imaging for differentiating tumor recurrence from nonneoplastic contrast-enhancing tissue. Sugahara T, Korogi Y, T

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44492

Study title: Phase 3, open-label, PK, safety, and tolerability study of TPM adjuctive therapy in pediatric subjects with Lennox-Gastaut syndrome.

Active substance: TOPIRAMATE

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Document reference: 44897

Study title: Phase 3, open-label, safety and efficacy, adjunctive or monotherapy study in adults with refractory partial epilepsy originally entered in Studies Y1/Y2/Y3, and who received PBO in the original study.

Active substance: TOPIRAMATE

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Document reference: 44872

Study title: Phase 3, randomized, double-blind, placebo-controlled, parallel study with an open-label extension designed to evaluate the safety and efficacy of topiramate in subjects 6 to 15 years of age who had headache symptoms that met the proposed IHS Classification of Pediatric Migraine with or without aura.

Active substance: TOPIRAMATE

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Document reference: 44935

Study title: Phase 3b, open-label, multicenter study designed to evaluate the efficacy and safety of topiramate as adjunctive therapy in pediatric subjects with inadequately controlled partial-onset seizures (with or without secondarily generalized seizures); seizures associated with Lennox-Gastaut Syndrome; and generalized tonic-clonic, myoclonic, or absence seizures.

Active substance: TOPIRAMATE

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Document reference: 44886

Study title: Phase 3b, open-label, multicenter study designed to evaluate the efficacy and safety of topiramate as adjunctive therapy in pediatric subjects with inadequately controlled-seizures (with or without secondarily genralized seizures) seizures. Open label extension study of the safety and efficacy of rwj-17021-001 in subjects with bipolar disorder who completed topmat-pdmd-002. A placebo-controlled 12-week study of the safety and efficacy of one dose of topiramate versus lithium for the treatment of acute manic or mixed episodes in subjects with bipolar disorder I with an optional open-label extension.

Active substance: TOPIRAMATE

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Document reference: 44914

Study title: Pk/toi phase I in infants

Active substance: TOPIRAMATE

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Document reference: 44917

Study title: PRI/TOP GER 4 (Patients > 2 years) - Topamax in der Therapie kindlicher Epilepsien (Topamax in the therapy of Chillike Epilepsy)

Active substance: TOPIRAMATE

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Document reference: 44929

Study title: Prospective evaluation of epilepsy treatment with topiramate

Active substance: TOPIRAMATE

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Document reference: 44869

Study title: Retrospective, non-interventional evaluation of pharmacovigilance and clinical experiences with topiramate in the treatment of epilepsy in Slovakia

Active substance: TOPIRAMATE

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Document reference: 44934

Study title: Safety & efficacy of tpm in children (aged 12 years and younger) with difficult to treat epilepsy

Active substance: TOPIRAMATE

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Document reference: 44864

Study title: Safety and efficacy of Topamax in monotherapy or combined therapy in children and adult patient with epilepsy in an observational study with medium duration of 6 months.

Active substance: TOPIRAMATE

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Document reference: 44925

Study title: Anticancer Res. 2003 Jul-Aug;23(4):3513-6. Differentiating recurrent or residual nasopharyngeal carcinomas from post-radiotherapy changes with 18-fluoro-2-deoxyglucose positron emission tomography and thallium-201 single photon emission computed tomograpAnticancer Res. 2003 Jul-Aug;23(4):3513-6. Differentiating recurrent or residual nasopharyngeal carcinomas from post-radiotherapy changes with 18-fluoro-2-deoxyglucose positron emission tomography and thallium-201 single photon emission computed tomograp

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44518

Study title: Arch Fr Pediatr. 1993 Oct;50(8):653-6. [Left ventricular involvement in mucoviscidosis after 2 years of age] [Article in French] Ambrosi P, Chazalettes JP, Viard L, Raynaud M, Faugere G, Noirclerc M, Bernard PJ. Arch Fr Pediatr. 1993 Oct;50(8):653-6. [Left ventricular involvement in mucoviscidosis after 2 years of age] [Article in French] Ambrosi P, Chazalettes JP, Viard L, Raynaud M, Faugere G, Noirclerc M, Bernard PJ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44519

Study title: Arch Intern Med. 1992 Apr;152(4):769-72. Utility of various radionuclide techniques for distinguishing ischemic from nonischemic dilated cardiomyopathy. Glamann DB, Lange RA, Corbett JR, Hillis LD. Arch Intern Med. 1992 Apr;152(4):769-72. Utility of various radionuclide techniques for distinguishing ischemic from nonischemic dilated cardiomyopathy. Glamann DB, Lange RA, Corbett JR, Hillis LD.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44520

Study title: Arch Mal Coeur Vaiss. 1987 Apr;80(4):470-82. [Current role of radionuclide imaging in pediatric cardiology] [Article in French] Brunotte F, Laurens MH, Marçon F, Cloez JL, Robert J, Pernot C. Arch Mal Coeur Vaiss. 1987 Apr;80(4):470-82. [Current role of radionuclide imaging in pediatric cardiology] [Article in French] Brunotte F, Laurens MH, Marçon F, Cloez JL, Robert J, Pernot C.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44521

Study title: Arch Mal Coeur Vaiss. 1997 May;90(5):631-7. [Alteration of myocardial viability and systemic ventricular dysfunction after Senning procedure] [Article in French] Labbé L, Douard H, Barat JL, Broustet JP, Bordenave L, Ducassou D, Valli N, Jimenez M, BaArch Mal Coeur Vaiss. 1997 May;90(5):631-7. [Alteration of myocardial viability and systemic ventricular dysfunction after Senning procedure] [Article in French] Labbé L, Douard H, Barat JL, Broustet JP, Bordenave L, Ducassou D, Valli N, Jimenez M, Ba

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44522

Study title: Arch Mal Coeur Vaiss. 2003 May;96(5):507-10. [Abnormalities of myocardial perfusion in sickle cell disease in childhood: a study of myocardial scintigraphy] [Article in French] Acar P, Maunoury C, de Montalembert M, Dulac Y. Arch Mal Coeur Vaiss. 2003 May;96(5):507-10. [Abnormalities of myocardial perfusion in sickle cell disease in childhood: a study of myocardial scintigraphy] [Article in French] Acar P, Maunoury C, de Montalembert M, Dulac Y.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44523

Study title: Open clinical study on the analgesic efficacy of tramadol (TRAMAL) in children with post-operative pain after abdominal surgery

Active substance: TRAMADOL

Study summary document link (including results): Tramadol STUDY 86-04-95.xls

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Document reference: 44995

Study title: OPEN CLINICAL STUDY ON THE ANALGESIC EFFICACY OF TRAMADOL (TRAMAL) IN CHILDREN WITH POST-OPERATIVE PAIN AFTER ABDOMINAL SURGERY

Active substance: TRAMADOL

Study summary document link (including results): synopsis-wis-al-tra86-04-95.pdf

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Document reference: 45006

Study title: Open randomized clinical trial study to compare the efficacy and safety of Tramadol 2mg/Kg to pethidine 1 mg/Kg and to nalbuphine 0,1 mg/Kg in children with postoperative pain after lower abdominal surgery

Active substance: TRAMADOL

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Document reference: 44998

Study title: EFFICACY AND TOLERABILITY OF TINIDAZOLE IN 2 DIFFERENT DOSES.

Active substance: TINIDAZOLE

Study summary document link (including results): TND-II-90-001 EMEA Pediatric Web Synopsis.pdf

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Document reference: 44776

Study title: EFFICACY AND TOLERABILITY OF TINIDAZOLE, 2 DIFFERENT DOSES, IN INTESTINAL AMEBIASIS.

Active substance: TINIDAZOLE

Study summary document link (including results): TND-II-90-002 EMA Paediatric Web Synopsis.pdf

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Document reference: 44777

Study title: EFFICACY OF PROPHYLACTIC PREOPERATIVE USE OF FASIGYN AS AN ADJUNCT TO ANTIMICROBIAL REGIMENS OF AMPICILLIN AND/OR GENTAMICIN IN ELECTIVE INTRA-ABDOMINAL OR PELVIC SURGERY.

Active substance: TINIDAZOLE

Study summary document link (including results): TND-II-88-002 EMEA Pediatric Web Synopsis.pdf

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Document reference: 44774

Study title: EVALUATE EFFICACY AND TOLERATION OF FASIGYN 500 MG IN SYMPTOMATIC INTESTINAL AMEBIASIS.

Active substance: TINIDAZOLE

Study summary document link (including results): TND-II-88-001 EMEA Pediatrics Web Synopsis.pdf

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Document reference: 44773

Study title: THE TREATMENT OF AMOEBIASIS IN CHILDREN

Active substance: TINIDAZOLE

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Document reference: 44771

Study title: THE TREATMENT OF AMOEBIC LIVER ABSCESS IN CHILDREN

Active substance: TINIDAZOLE

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Document reference: 44772

Study title: A RANDOMIZED, ASSESSOR-BLIND, PARALLEL GROUP COMPARISON OF FASIGYN OS TBS. AND ENTAMIZOLE FORTE TBS. IN INTESTINAL AMEBIASIS WITH COLONIC SYMPTOMS.

Active substance: TINIDAZOLE

Study summary document link (including results): TND-II-91-001 EMEA Pediatrics Web Synopsis.pdf

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Document reference: 44778

Study title: THE TREATMENT OF GIARDIASIS IN CHILDREN

Active substance: TINIDAZOLE

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Document reference: 44770

Study title: THE TREATMENT OF T VAGINALIS INFECTIONS IN CHILDREN

Active substance: TINIDAZOLE

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Document reference: 44769

Study title: A double−blind, placebo−controlled trial of tizanidine in the treatment of spasticity caused by multiple sclerosis. United Kingdom Tizanidine Trial Group.A double−blind, placebo−controlled trial of tizanidine in the treatment of spasticity caused by multiple sclerosis. United Kingdom Tizanidine Trial Group.

Active substance: TINZANIDINE

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Document reference: 44793

Study title: A multi−centre, double−blind trial of tizanidine, a new antispastic agent, in spasticity associated with hemiplegia.A multi−centre, double−blind trial of tizanidine, a new antispastic agent, in spasticity associated with hemiplegia.

Active substance: TINZANIDINE

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Document reference: 44797

Study title: A multicentre placebo−controlled study in general practice to evaluate the efficacy and safety of tizanidine in acute low−back pain.A multicentre placebo−controlled study in general practice to evaluate the efficacy and safety of tizanidine in acute low−back pain.

Active substance: TINZANIDINE

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Document reference: 44796

Study title: Clin Nucl Med. 1994 Nov;19(11):975-8. Resting Tl-201 scintigraphy in the evaluation of coronary artery disease in children with Hurler syndrome. du Cret RP, Weinberg EJ, Jackson CA, Braunlin EA, Boudreau RJ, Kuni CC, Carpenter BM, Hunter DW, Krivit W, BClin Nucl Med. 1994 Nov;19(11):975-8. Resting Tl-201 scintigraphy in the evaluation of coronary artery disease in children with Hurler syndrome. du Cret RP, Weinberg EJ, Jackson CA, Braunlin EA, Boudreau RJ, Kuni CC, Carpenter BM, Hunter DW, Krivit W, B

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44552

Study title: Protective action of levocabastine PEG in antigen nasal challenge (17-32 yrs)

Active substance: LEVOCABASTINE

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Document reference: 31073

Study title: Randomized, double-blind study comparing efficacy and tolerance of 2 anti-allergic eye drops LEVOPHTA versus ALMIDE in allergic conjunctivitis

Active substance: LEVOCABASTINE

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Document reference: 31056

Study title: Results of the treatment of the seasonal pollinosis allergic rhinitis with topical preparations Livostin, Bicromat and Vibrocil. Allergy 52(37) (suppl.), p.200-201, 1997Results of the treatment of the seasonal pollinosis allergic rhinitis with topical preparations Livostin, Bicromat and Vibrocil. Allergy 52(37) (suppl.), p.200-201, 1997

Active substance: LEVOCABASTINE

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Document reference: 31127

Study title: Comparison of the onset of (i) Levocabastine nasal spray and (ii) levocabastine nasal spray plus eye drops with oral loratadine in subjects with seasonal allergic rhinitis

Active substance: LEVOCABASTINE

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Document reference: 31058

Study title: Conjunctival provocation test comparing levocabastine with cromoglycate and placebo (9-17 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62434_Interventional_Levocabastine.xls

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Document reference: 31095

Study title: Double-blind comparison of levocabastine eye drops with placebo in patients with seasonal allergic conjunctivitis: a Belgian multicentre study (5-67 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62497_Interventional_Levocabastine.xls

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Document reference: 31103

Study title: Double-blind comparison of levocabastine eye drops with placebo in the topical treatment of seasonal allergic conjunctivitis (7-66 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62494_Interventional_Levocabastine.xls

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Document reference: 31102

Study title: Double-blind comparison of levocabastine eye drops with sodium cromoglycate and placebo in the topical treatment of seasonal allergic conjunctivitis (9-55 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62496_Interventional_Levocabastine.xls

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Document reference: 31100

Study title: Double-blind comparison of levocabastine eye drops with sodium cromoglycate eye drops in the treatment of the ocular symptoms of seasonal allergic rhinoconjunctivitis

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62703_Interventional_Levocabastine.xls

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Document reference: 31069

Study title: Double-blind comparison of levocabastine eye drops with sodium cromoglycate in the topical treatment of season allergic conjunctivitis (9-54 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD59785_Interventional_Levocabastine.xls

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Document reference: 31098

Study title: Double-blind comparison of levocabastine nasal spray with sodium cromoglycate in the topical treatment of perennial allergic rhinitis (8-49 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD59788_Interventional_Levocabastine.xls

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Document reference: 31089

Study title: Double-blind comparison of levocabastine nasal spray with sodium cromoglycate in the topical treatment of season allergic rhinitis (8-42 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62484_Interventional_Levocabastine.xls

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Document reference: 31078

Study title: Double-blind comparison of levocabastine nasal spray with sodium cromoglycate nasal spray in the treatment of seasonal allergic rhinitis (11-50 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62483_Interventional_Levocabastine.xls

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Document reference: 31090

Study title: Double-blind placebo-controlled evaluation of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a Belgian multicentre study (5-64 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62489_Interventional_Levocabastine.xls

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Document reference: 31085

Study title: Double-blind placebo-controlled evaluation of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a Dutch multicentre study (9-52 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62500_Interventional_Levocabastine.xls

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Document reference: 31086

Study title: Safety and efficacy of tpm in children (aged 12 years and younger) with difficult to treat epilepsy

Active substance: TOPIRAMATE

Study summary document link (including results):

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Document reference: 44921

Study title: Study of the optimization of anti-epileptic treatment in paediatric patients

Active substance: TOPIRAMATE

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Document reference: 44870

Study title: Topamax (topiramate) monotherapy comparison trial to standard monotherapy in the treatment of newly diagnosed epilepsy (rwj-17021-000); phase iiib

Active substance: TOPIRAMATE

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Document reference: 44892

Study title: Topamax 1st line add on (patients >12 years).

Active substance: TOPIRAMATE

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Document reference: 44968

Study title: TOPAMAX in der Behandlung des WEST Syndrom (TOPAMAX in the treatment of West Syndrom) (patients < 2 years)

Active substance: TOPIRAMATE

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Document reference: 44890

Study title: Topamax in der Therapie kindlicher Epilepsien (Topamax in the Therapy of Childlike Epilepsy) (patients > 2 years)

Active substance: TOPIRAMATE

Study summary document link (including results):

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Document reference: 44889

Study title: Topiramate clinical trial in primary generalized tonic-clonic seizures (long-term extension)

Active substance: TOPIRAMATE

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Document reference: 44849

Study title: Topiramate for the prophylactic treatment of cyclic vomiting syndrome in children

Active substance: TOPIRAMATE

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Document reference: 44858

Study title: Veränderungen durch Topamax - Die Sicht des Patienten (Changes through TOPAMAX - The View of the Patient) (patients > 2 years)

Active substance: TOPIRAMATE

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Document reference: 44888

Study title: J Clin Neurosci. 2002 Nov;9(6):653-8. Comparison of thallium-201 uptake and retention indices for evaluation of brain lesions with SPECT. Katano H, Karasawa K, Sugiyama N, Yamashita N, Ohkura A, Watanabe K, Kamiya K. J Clin Neurosci. 2002 Nov;9(6):653-8. Comparison of thallium-201 uptake and retention indices for evaluation of brain lesions with SPECT. Katano H, Karasawa K, Sugiyama N, Yamashita N, Ohkura A, Watanabe K, Kamiya K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44602

Study title: J Clin Neurosci. 2005 Jan;12(1):27-31. Thallium-201 versus Tc99m-glucoheptonate SPECT for evaluation of recurrent brain tumours: a within-subject comparison with pathological correlation. Barai S, Rajkamal , Bandopadhayaya GP, Pant GS, Haloi AK, MalhotJ Clin Neurosci. 2005 Jan;12(1):27-31. Thallium-201 versus Tc99m-glucoheptonate SPECT for evaluation of recurrent brain tumours: a within-subject comparison with pathological correlation. Barai S, Rajkamal , Bandopadhayaya GP, Pant GS, Haloi AK, Malhot

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44603

Study title: J Clin Oncol. 1999 Feb;17(2):554-60. Value of combined approach with thallium-201 single-photon emission computed tomography and Epstein-Barr virus DNA polymerase chain reaction in CSF for the diagnosis of AIDS-related primary CNS lymphoma. Antinori A, J Clin Oncol. 1999 Feb;17(2):554-60. Value of combined approach with thallium-201 single-photon emission computed tomography and Epstein-Barr virus DNA polymerase chain reaction in CSF for the diagnosis of AIDS-related primary CNS lymphoma. Antinori A,

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44604

Study title: J Neurol Neurosurg Psychiatry. 1997 Nov;63(5):569-74. Evaluation of malignancy in ring enhancing brain lesions on CT by thallium-201 SPECT. Källén K, Heiling M, Andersson AM, Brun A, Holtås S, Ryding E, Rosén I. J Neurol Neurosurg Psychiatry. 1997 Nov;63(5):569-74. Evaluation of malignancy in ring enhancing brain lesions on CT by thallium-201 SPECT. Källén K, Heiling M, Andersson AM, Brun A, Holtås S, Ryding E, Rosén I.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44605

Study title: J Nucl Cardiol. 2002 Nov-Dec;9(6):632-7. Myocardial ischemia in Kawasaki disease: evaluation with dipyridamole stress technetium 99m tetrofosmin scintigraphy. Fukuda T, Ishibashi M, Yokoyama T, Otaki M, Shinohara T, Nakamura Y, Miyake T, Kudoh T, Oku H J Nucl Cardiol. 2002 Nov-Dec;9(6):632-7. Myocardial ischemia in Kawasaki disease: evaluation with dipyridamole stress technetium 99m tetrofosmin scintigraphy. Fukuda T, Ishibashi M, Yokoyama T, Otaki M, Shinohara T, Nakamura Y, Miyake T, Kudoh T, Oku H

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44606

Study title: Open-label evaluation of the pharmacokinetic profile of oral tramadol hydrochloride tablets in children and adolescents aged between seven to sixteen years - Multicenter - 2000

Active substance: TRAMADOL

Study summary document link (including results):

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Document reference: 45032

Study title: Pharmacokinetics of tramadol in children after IV or caudal epidural administration - Murthy BVS, Pandya KS, Booker PD, Murray W, Lintz W, Terlinden R - 2000 (British Journal of Anaesthesia, 2000; 84 (3): 346-349)Pharmacokinetics of tramadol in children after IV or caudal epidural administration - Murthy BVS, Pandya KS, Booker PD, Murray W, Lintz W, Terlinden R - 2000 (British Journal of Anaesthesia, 2000; 84 (3): 346-349)

Active substance: TRAMADOL

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Document reference: 45033

Study title: Postoperative analgesia with tramadol in children recovering from major surgery - Maldini B, Radesic L, Javorovic B, Fattorini I - 1997 (Paediatr Croat 1997; 41: 39-42) Postoperative analgesia with tramadol in children recovering from major surgery - Maldini B, Radesic L, Javorovic B, Fattorini I - 1997 (Paediatr Croat 1997; 41: 39-42)

Active substance: TRAMADOL

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Document reference: 45034

Study title: Preemptive analgesia with tramadol and fentamyl in paediatric neurosurgery - Chiaretti A and Coll. - 2000 (Child's Nerv Syst, 2000; 16: 93-100)Preemptive analgesia with tramadol and fentamyl in paediatric neurosurgery - Chiaretti A and Coll. - 2000 (Child's Nerv Syst, 2000; 16: 93-100)

Active substance: TRAMADOL

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Document reference: 45043

Study title: Relief of posttonsillectomy pain with low-dose tramadol given at induction of anaesthesia in children - Özköse and Coll. - 2000 (Int. J. Pediatr. Otorhinolaryngol., 2000, 53: 207-214)Relief of posttonsillectomy pain with low-dose tramadol given at induction of anaesthesia in children - Özköse and Coll. - 2000 (Int. J. Pediatr. Otorhinolaryngol., 2000, 53: 207-214)

Active substance: TRAMADOL

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Document reference: 45035

Study title: Serum concentrations and pharmacokinetics of tramadol and its metabolite M1 in children after intravenous or extradural caudal administration of tramadol HCl

Active substance: TRAMADOL

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Document reference: 45001

Study title: Serum concentrations of tramadol and its metabolite M1 in children after intravenous or caudal extradural administration of tramadol HCl

Active substance: TRAMADOL

Study summary document link (including results): synopsis-fo-pk401.pdf

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Document reference: 45000

Study title: Jpn Heart J. 1990 Nov;31(6):867-74. Dipyridamole-induced ischemia in a child with jeopardized collaterals after Kawasaki syndrome. Yamamoto S, Matsuura H, Umezawa T, Saji T, Matsuo N, Yabe Y. Jpn Heart J. 1990 Nov;31(6):867-74. Dipyridamole-induced ischemia in a child with jeopardized collaterals after Kawasaki syndrome. Yamamoto S, Matsuura H, Umezawa T, Saji T, Matsuo N, Yabe Y.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44637

Study title: Jpn Heart J. 1993 Jan;34(1):51-61. Evaluation of myocardial damage in Duchenne's muscular dystrophy with thallium-201 myocardial SPECT. Tamura T, Shibuya N, Hashiba K, Oku Y, Mori H, Yano K. Jpn Heart J. 1993 Jan;34(1):51-61. Evaluation of myocardial damage in Duchenne's muscular dystrophy with thallium-201 myocardial SPECT. Tamura T, Shibuya N, Hashiba K, Oku Y, Mori H, Yano K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44638

Study title: Clin Nucl Med. 1995 Jul;20(7):601-4. Detection of a 2.1 cm hepatocellular carcinoma in an 11-year-old boy by Tl-201 chloride. Case presentation and correlative imaging findings. Kempf JS, Abdel-Dayem H. Clin Nucl Med. 1995 Jul;20(7):601-4. Detection of a 2.1 cm hepatocellular carcinoma in an 11-year-old boy by Tl-201 chloride. Case presentation and correlative imaging findings. Kempf JS, Abdel-Dayem H.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44553

Study title: Clin Nucl Med. 1997 Dec;22(12):835-7. Tl-201 positive, Ga-67 negative hepatoblastoma: a case report of a 12-year-old boy. Bernard EJ, Nicholls W, Howman-Giles R, Kan A, Stevens M Clin Nucl Med. 1997 Dec;22(12):835-7. Tl-201 positive, Ga-67 negative hepatoblastoma: a case report of a 12-year-old boy. Bernard EJ, Nicholls W, Howman-Giles R, Kan A, Stevens M

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44554

Study title: Clin Nucl Med. 1997 Nov;22(11):752-5. Thallium-201 SPECT in differentiating bone infarction from metastatic lesions in osteosarcoma. Hori A, Sumiya H, Taki J, Tonami N, Tsuchiya H, Tomita K. Clin Nucl Med. 1997 Nov;22(11):752-5. Thallium-201 SPECT in differentiating bone infarction from metastatic lesions in osteosarcoma. Hori A, Sumiya H, Taki J, Tonami N, Tsuchiya H, Tomita K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44555

Study title: Clin Nucl Med. 2000 Jan;25(1):56. Bilateral increased Tl-201 uptake of lacrimal glands caused by crying of a child during injection. Capa G, DeÄŸirmenci B, Durak H. Clin Nucl Med. 2000 Jan;25(1):56. Bilateral increased Tl-201 uptake of lacrimal glands caused by crying of a child during injection. Capa G, DeÄŸirmenci B, Durak H.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44557

Study title: Clin Nucl Med. 2000 Jan;25(1):77-8. Detection of Coxsackie B2 virus myocarditis in a neonate using Tl-201 and I-123 BMIPP myocardial imaging. Sawada T, Kohno Y, Ikegami H, Tsujii H, Ikuta H, Okabe H, Sugihara H. Clin Nucl Med. 2000 Jan;25(1):77-8. Detection of Coxsackie B2 virus myocarditis in a neonate using Tl-201 and I-123 BMIPP myocardial imaging. Sawada T, Kohno Y, Ikegami H, Tsujii H, Ikuta H, Okabe H, Sugihara H.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44558

Study title: Clin Nucl Med. 2001 Dec;26(12):1028-31. Bone and Tl-201 scintigraphy in a case of hereditary multiple exostoses. Tani A, Tsuchimochi S, Nakabeppu Y, Nakajo M Clin Nucl Med. 2001 Dec;26(12):1028-31. Bone and Tl-201 scintigraphy in a case of hereditary multiple exostoses. Tani A, Tsuchimochi S, Nakabeppu Y, Nakajo M

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44559

Study title: Clin Nucl Med. 2003 Jul;28(7):591-3. Bizarre parosteal osteochondromatous proliferation detected by Tl-201 scintigraphy. Mackie GC. Clin Nucl Med. 2003 Jul;28(7):591-3. Bizarre parosteal osteochondromatous proliferation detected by Tl-201 scintigraphy. Mackie GC.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44560

Study title: Clin Orthop Relat Res. 1993 Aug;(293):302-6. Serial thallium-201 scintigraphy in osteosarcoma. Correlation with tumor necrosis after preoperative chemotherapy. Rosen G, Loren GJ, Brien EW, Ramana L, Waxman A, Lowenbraun S, Eckardt JJ, Eilber F, MenendezClin Orthop Relat Res. 1993 Aug;(293):302-6. Serial thallium-201 scintigraphy in osteosarcoma. Correlation with tumor necrosis after preoperative chemotherapy. Rosen G, Loren GJ, Brien EW, Ramana L, Waxman A, Lowenbraun S, Eckardt JJ, Eilber F, Menendez

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44561

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (drops) [AWB-AT]

Active substance: Traumeel - Tropfen

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Document reference: 40279

Study title: Retrospective survey for documentation of appllication and dosage of Traumeel S (drops) in children < 12 years of age [Bef-022]

Active substance: Traumeel - Tropfen

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Document reference: 40280

Study title: Bannikov, Mihail Y.; Vasilenko, Inna V.: Anwendung von homöopathischen Komplexmitteln in der Behandlungakuter kindlicher Speiseröhrenverätzungen. Biol Med 2000 (29):253-254 [IIT-publication]

Active substance: Traumeel - Ampullen

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Document reference: 40283

Study title: Double-blind, placebo controlled evaluation of levocabastine eyedrops in the treatment of seasonal allergic conjunctivitis

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD93245_Interventional_Levocabastine.xls

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Document reference: 31065

Study title: Double-blind, placebo-controlled, dose-response study of levocabastine nasal spray in the treatment of seasonal allergic rhinitis (11-65 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62490_Interventional_Levocabastine.xls

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Document reference: 31082

Study title: Effect of a new selective H1 receptor antagonist (levocabastine) in a nasal and conjunctival provocation test (11-44 yrs)

Active substance: LEVOCABASTINE

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Document reference: 31074

Study title: Effecto de la soluci6n oftilmica de levocabastina (antagonista de receptores HI) en 10s sintomas de la conjunctivitis primaveral. Gaceta Medica de Mexico 130(6), p.481-486, 1994Effecto de la soluci6n oftilmica de levocabastina (antagonista de receptores HI) en 10s sintomas de la conjunctivitis primaveral. Gaceta Medica de Mexico 130(6), p.481-486, 1994

Active substance: LEVOCABASTINE

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Document reference: 31119

Study title: Efficacia della levocabastina nei confronti dell'antazolina in giovani pazienti affetti da congiuntivite prima verile. Annali di Oftalmologia e Clinica Occulista 122(12), p.629-634, 1996Efficacia della levocabastina nei confronti dell'antazolina in giovani pazienti affetti da congiuntivite prima verile. Annali di Oftalmologia e Clinica Occulista 122(12), p.629-634, 1996

Active substance: LEVOCABASTINE

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Document reference: 31129

Study title: Efficacy and safety of carebastine compared to levocabastine, both nasal sprays, in the management of seasonal allergic rhinitis. Annual Meeting of the European Academy of Allergology and Clinical Immunology, Lisbon, Portugal, July 1-5,2000Efficacy and safety of carebastine compared to levocabastine, both nasal sprays, in the management of seasonal allergic rhinitis. Annual Meeting of the European Academy of Allergology and Clinical Immunology, Lisbon, Portugal, July 1-5,2000

Active substance: LEVOCABASTINE

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Document reference: 31117

Study title: Efficacy and safety of carebastine compared to levocabastine, both nasal sprays, in the management of seasonal allergic rhinitis. Annual Meeting of the European Academy of Allergology and Clinical Immunology, Lisbon, Portugal, July 1-5,2000Efficacy and safety of carebastine compared to levocabastine, both nasal sprays, in the management of seasonal allergic rhinitis. Annual Meeting of the European Academy of Allergology and Clinical Immunology, Lisbon, Portugal, July 1-5,2000

Active substance: LEVOCABASTINE

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Document reference: 31133

Study title: Efficacy of topical levocabastine in the treatment of allergic rhinitis. Korean Journal of Rhinology 3(1), p.58-65, 1996Efficacy of topical levocabastine in the treatment of allergic rhinitis. Korean Journal of Rhinology 3(1), p.58-65, 1996

Active substance: LEVOCABASTINE

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Document reference: 31121

Study title: Efficacy of topical levocabastine in the treatment of allergic rhinitis. Korean Journal of Rhinology 3(1), p.58-65, 1996Efficacy of topical levocabastine in the treatment of allergic rhinitis. Korean Journal of Rhinology 3(1), p.58-65, 1996

Active substance: LEVOCABASTINE

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Document reference: 31122

Study title: Eosinophil cationic protein (ECP) and tryptase in the nasal lavage fluid (NLF) of children with grass pollen rhinitis: levocabastine effect. Allergy and Asthma Proceedings 19(2), p.75-80, 1998Eosinophil cationic protein (ECP) and tryptase in the nasal lavage fluid (NLF) of children with grass pollen rhinitis: levocabastine effect. Allergy and Asthma Proceedings 19(2), p.75-80, 1998

Active substance: LEVOCABASTINE

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Document reference: 31120

Study title: Epidemiologische Begleituntersuchungen yur Gruppenprophylaxe 2000 - Gutachten (Prof. Dr. K. Pieper, im Auftrag der Deutschen Arbeitsgemeinschaft fuer Jugendzahnpflege, 2001 ISBN 3/926 228 16-4)

Active substance: COLECALCIFEROL AND SODIUM FLUORIDE

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Document reference: 24625

Study title: Functional improvement in upper limb following BOTOX® treatment

Active substance: CLOSTRIDIUM BOTULINUM TOXIN TYPE A

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Document reference: 22681

Study title: J Nucl Med. 1981 Oct;22(10):849-55. Clinical evaluation of thallium-201 emission myocardial tomography using a rotating gamma camera: comparison with seven-pinhole tomography. Tamaki N, Mukai T, Ishii Y, Yonekura Y, Kambara H, Kawai C, Torizuka K. J Nucl Med. 1981 Oct;22(10):849-55. Clinical evaluation of thallium-201 emission myocardial tomography using a rotating gamma camera: comparison with seven-pinhole tomography. Tamaki N, Mukai T, Ishii Y, Yonekura Y, Kambara H, Kawai C, Torizuka K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44607

Study title: EFFICACY AND SAFETY OF FLUCONAZOLE IN PATIENTS WITH OROPHARINGEAL CANDIDIASIS WITHOUT AIDS

Active substance: FLUCONAZOLE

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Document reference: 27404

Study title: J Nucl Med. 1990 May;31(5):567-72. Thallium-201 scintigraphy in bone sarcoma: comparison with gallium-67 and technetium-MDP in the evaluation of chemotherapeutic response. Ramanna L, Waxman A, Binney G, Waxman S, Mirra J, Rosen G. J Nucl Med. 1990 May;31(5):567-72. Thallium-201 scintigraphy in bone sarcoma: comparison with gallium-67 and technetium-MDP in the evaluation of chemotherapeutic response. Ramanna L, Waxman A, Binney G, Waxman S, Mirra J, Rosen G.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44609

Study title:

Active substance: TIAGABINE

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Document reference: 38446

Study title:

Active substance: TIAGABINE

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Document reference: 38447

Study title:

Active substance: TIAGABINE

Study summary document link (including results): M93-090 (TIA-120).xls

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Document reference: 38448

Study title:

Active substance: TIAGABINE

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Document reference: 38449

Study title:

Active substance: TIAGABINE

Study summary document link (including results): M94 189 TIA 125CNS1.xls

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Document reference: 38450

Study title:

Active substance: TIAGABINE

Study summary document link (including results): M94-244.xls

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Document reference: 38451

Study title:

Active substance: TIAGABINE

Study summary document link (including results): M96-421.xls

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Document reference: 38452

Study title:

Active substance: TIAGABINE

Study summary document link (including results): M96-460.xls

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Document reference: 38453

Study title:

Active substance: TIAGABINE

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Document reference: 38443

Study title:

Active substance: TIAGABINE

Study summary document link (including results): M93-043 TIA-113CNS1.xls

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Document reference: 38445

Study title:

Active substance: TIAGABINE

Study summary document link (including results): M98-886.xls

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Document reference: 38454

Study title:

Active substance: TIAGABINE

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Document reference: 38455

Study title:

Active substance: TIAGABINE

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Document reference: 38456

Study title:

Active substance: TIAGABINE

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Document reference: 38458

Study title:

Active substance: TIAGABINE

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Document reference: 38459

Study title:

Active substance: TIAGABINE

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Document reference: 38460

Study title:

Active substance: TIAGABINE

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Document reference: 38461

Study title:

Active substance: TIAGABINE

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Document reference: 38462

Study title:

Active substance: TIAGABINE

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Document reference: 38463

Study title: Treatment of the West syndrome with high-dose pyridoxal phosphate - Y. Ohtsuka et al. - 1987 (Brain Dev vol 9) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of the West syndrome with high-dose pyridoxal phosphate - Y. Ohtsuka et al. - 1987 (Brain Dev vol 9) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31501

Study title: Vendrell et al. Vendrell et al.

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

Study summary document link (including results): Vendrell-GABA+GABOB+piridoxine+magnesium bromhydrate glutamate.xls

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Document reference: 48088

Study title: The influence of mucolytic treatment on patency of airways.

Active substance: MESNA

Study summary document link (including results): DE80H064P - Mesna.pdf

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Document reference: 31681

Study title: The role of Mesna in teh tretment of status asthmaticus in children.

Active substance: MESNA

Study summary document link (including results): DE79G271P - Mesna.pdf

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Document reference: 31674

Study title: The role of mesna in the treatment of status asthmaticus in children.

Active substance: MESNA

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Document reference: 31676

Study title: Therapeutic bronchoscopy in ventilated neonates.

Active substance: MESNA

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Document reference: 31666

Study title: Treatment of recurrent sarcomas in children and young adults : the use of a multimodality approach including ifosfamide and etoposide (Miser.J. Et al. - Proc. Ann,.Meet. Am. Soc. Clin.Oncol. 7 - 1988-Abstr.999)Treatment of recurrent sarcomas in children and young adults : the use of a multimodality approach including ifosfamide and etoposide (Miser.J. Et al. - Proc. Ann,.Meet. Am. Soc. Clin.Oncol. 7 - 1988-Abstr.999)

Active substance: MESNA

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Document reference: 31650

Study title: 131(I)-meta-iodobenzylguanidine treatment of 32 children with therapyrefractory neuroblastomaBerthold et al.

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48311

Study title: 131I-metaiodobenzylguanidine (131I-MIBG) therapy for residual neuroblastoma: a mono-institutional experience with 43 patientsBritish Journal of Cancer (1999), 81(8), 1378-1384

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48316

Study title: Dahllof et al. Severe oral mucositis after therapeutic administration of [131I] MIBG in a child with neuroblastomaOral Surg Oral Med Oral Pathol Oral Radiol Endod. 2001 Oct; 92(4):420-3

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): Dahllof G 2001.pdf

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Document reference: 48329

Study title: Hoefnagel et al. 131I-MIBG as a first-line treatment in high-risk neuroblastoma patients, Nuclear medicine communications (1994), 15(9), 712-7

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48319

Study title: EFFECT OF PIROXICAM AND NAPROXEN ON MENSTRUAL PAIN AND ASSOCIATED SYMPTOMS IN PATIENTS WITH PRIMARY DYSMENORRHEA.

Active substance: PIROXICAM

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Document reference: 34425

Study title: EFFECT OF PIROXICAM ON PAIN, RESTRICTION OF FUNCTION AND DURATION OF SICK LEAVE IN PATIENTS WITH ACUTE LUMBAGO.

Active substance: PIROXICAM

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Document reference: 34424

Study title: EFFECT OF PIROXICAM ON POST OPERATIVE DENTAL PAIN, SWELLING AND TRISMUS FOLLOWING REMOVAL OF BILATERALLY IMPACKED THIRD MOLAR TEETH.

Active substance: PIROXICAM

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Document reference: 34476

Study title: Michel G et al. Use of recombinant human granulocyte colony-stimulating factor to increase chemotherapy dose-intensity: a randomized trial in very high-risk childhood acute lymphoblastic leukemia. J Clin Oncol. 2000 Apr;18(7):1517-24Michel G et al. Use of recombinant human granulocyte colony-stimulating factor to increase chemotherapy dose-intensity: a randomized trial in very high-risk childhood acute lymphoblastic leukemia. J Clin Oncol. 2000 Apr;18(7):1517-24

Active substance: MITOXANTRONE

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Document reference: 32211

Study title: Michelagnoli MP et al Ifosfamide/etoposide alternating with high-dose methotrexate: evaluation of a chemotherapy regimen for poor-risk osteosarcoma Br J Cancer. 1999 Mar;79(7-8):1174-8Michelagnoli MP et al Ifosfamide/etoposide alternating with high-dose methotrexate: evaluation of a chemotherapy regimen for poor-risk osteosarcoma Br J Cancer. 1999 Mar;79(7-8):1174-8

Active substance: MITOXANTRONE

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Document reference: 32137

Study title: Michon JM et al. An open-label, multicentre, randomised phase 2 study of recombinant human granulocyte colony-stimulating factor (filgrastim) as an adjunct to combination chemotherapy in paediatric patients with metastatic neuroblastoma. Eur J Cancer. 1998 Jun;34(7):1063-9Michon JM et al. An open-label, multicentre, randomised phase 2 study of recombinant human granulocyte colony-stimulating factor (filgrastim) as an adjunct to combination chemotherapy in paediatric patients with metastatic neuroblastoma. Eur J Cancer. 1998 Jun;34(7):1063-9

Active substance: MITOXANTRONE

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Document reference: 32240

Study title: Milano GM et al High histologic and overall response to dose intensification of ifosfamide, carboplatin, and etoposide with cyclophosphamide, doxorubicin, and vincristine in patients with high-risk Ewing sarcoma family tumors: the Bambino Gesù Children's Hospital experience Cancer. 2006 Apr 15;106(8):1838-45. Erratum in: Cancer. 2006 Sep 15;107(6):1421Milano GM et al High histologic and overall response to dose intensification of ifosfamide, carboplatin, and etoposide with cyclophosphamide, doxorubicin, and vincristine in patients with high-risk Ewing sarcoma family tumors: the Bambino Gesù Children's Hospital experience Cancer. 2006 Apr 15;106(8):1838-45. Erratum in: Cancer. 2006 Sep 15;107(6):1421

Active substance: MITOXANTRONE

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Document reference: 32093

Study title: Milpied N et al. Initial treatment of aggressive lymphoma with high-dose chemotherapy and autologous stem-cell support. N Engl J Med. 2004 Mar 25;350(13):1287-95Milpied N et al. Initial treatment of aggressive lymphoma with high-dose chemotherapy and autologous stem-cell support. N Engl J Med. 2004 Mar 25;350(13):1287-95

Active substance: MITOXANTRONE

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Document reference: 32248

Study title: Miser JS et al Treatment of metastatic Ewing sarcoma/primitive neuroectodermal tumor of bone: evaluation of increasing the dose intensity of chemotherapy--a report from theChildren's Oncology Group Pediatr Blood Cancer. 2007 Dec;49(7):894-900Miser JS et al Treatment of metastatic Ewing sarcoma/primitive neuroectodermal tumor of bone: evaluation of increasing the dose intensity of chemotherapy--a report from theChildren's Oncology Group Pediatr Blood Cancer. 2007 Dec;49(7):894-900

Active substance: MITOXANTRONE

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Document reference: 32107

Study title: EFFECT OF FELDENE CAP 10 MG IN ACUTE MUSCULOSKELETAL DISORDERS. AN OPEN MULTICENTER CLINICAL STUDY IN MOROCCO.

Active substance: PIROXICAM

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Document reference: 34412

Study title: Gschnait F. [Oral photochemotherapy (author's transl)], Wien Klin Wochenschr Suppl. 1977;75:1-30.Gschnait F. [Oral photochemotherapy (author's transl)], Wien Klin Wochenschr Suppl. 1977;75:1-30.

Active substance: METHOZSALEN

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Document reference: 31715

Study title: Langner A. Comparison of the effectiveness of 5-Methoxypsoralen and 8-Methoxypsoralen in photochemotherapy (PUVA) Przegl Dermatol 1991; 21-25.Langner A. Comparison of the effectiveness of 5-Methoxypsoralen and 8-Methoxypsoralen in photochemotherapy (PUVA) Przegl Dermatol 1991; 21-25.

Active substance: METHOZSALEN

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Document reference: 31716

Study title: Metz D. [Photochemotherapy of psoriasis using 8-MOP and UVA. Results of interval treatment. Clinical experiences from 6 dermatology hospitals], Dermatol Monatsschr. 1980 Jun;166(6):415-7.Metz D. [Photochemotherapy of psoriasis using 8-MOP and UVA. Results of interval treatment. Clinical experiences from 6 dermatology hospitals], Dermatol Monatsschr. 1980 Jun;166(6):415-7.

Active substance: METHOZSALEN

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Document reference: 31714

Study title: Oesterwitz H. Photochemical donor pretreatment in clinical kidney transplantation--preliminary report, Urol Res. 1987;15(4):211-3.Oesterwitz H. Photochemical donor pretreatment in clinical kidney transplantation--preliminary report, Urol Res. 1987;15(4):211-3.

Active substance: METHOZSALEN

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Document reference: 31723

Study title: Ruszczak Z. [Immunological findings in photochemotherapy of psoriasis][Article in German], Dermatol Monatsschr. 1982 Sep;168(9):598-607.Ruszczak Z. [Immunological findings in photochemotherapy of psoriasis][Article in German], Dermatol Monatsschr. 1982 Sep;168(9):598-607.

Active substance: METHOZSALEN

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Document reference: 31718

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2003

Active substance: METAMIZOLE

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Document reference: 31702

Study title: Painless dental extraction in children.

Active substance: LIDOCAINE

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Document reference: 31222

Study title: Randomisierte doppelblinde Pilotstudie mit parallelen Gruppen zum Vergleich von Dynexan A Gel (Prüfname KRL) mit Placebo zur Prüfung der Wirksamkeit und Verträglichkeit bei Zahnungsbeschwerden bei Kleinkindern und Festlegen geeigneter Instrumente.

Active substance: LIDOCAINE

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Document reference: 31216

Study title: Statement on the safety of medicinal products used by children. Contribution to the safety of medicinal products used by children younger than 12 years in Germany by data on compulsory rebate on OTC medicinal products and surveillance of adverse drug effects. Here: Dynexan Mundgel.

Active substance: LIDOCAINE

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Document reference: 31225

Study title: The effectiveness of a teething solution in infants. A clinical study.

Active substance: LIDOCAINE

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Document reference: 31224

Study title: The intraoral use of EMLA cream in children: a clinical investigation.

Active substance: LIDOCAINE

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Document reference: 31217

Study title: Tramadol hydrochloride: analgesic pharmacodynamics-pharmacokinetics in dental-extraction pain

Active substance: LIDOCAINE

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Document reference: 31237

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, acetaminophen with propoxyphene napsylate and placebo in dental-extraction pain

Active substance: LIDOCAINE

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Document reference: 31234

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine phosphate and placebo in dental-extraction pain

Active substance: LIDOCAINE

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Document reference: 31233

Study title: Social functioning in children with ADHD treated with long-term methylphenidate and multimodal psychosocial treatment.

Active substance: METOPIMAZINE

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Document reference: 31964

Study title: Study of Vogalene drops in gastro-oesophageal reflux in nursing infants clinical, radiological, endoscopic and histological assessment - Ghisolfi J., Olives J.P., Rives J.J. - 09/1979

Active substance: METOPIMAZINE

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Document reference: 31962

Study title: Vogalene suppositoire enfant et nourisson-dossier pharmaceutique (dossier de validation du 09/01/87) - No author - No date

Active substance: METOPIMAZINE

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Document reference: 31963

Study title: A Safety, Tolerability and Pharmacokinetics Study of TOPROL XL® (metoprolol succinate) Extended-release Tablets (metoprolol CR/XL) in Hypertensive Pediatric Patients: A Multicenter, Open-Label Extension of Protocol 307A

Active substance: METOPROLOL

Study summary document link (including results): D4020C00001 CSR Synopsis.pdf

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Document reference: 31965

Study title: Dose Ranging, Safety and Tolerability of TOPROL-XL® (metoprolol succinate) Extended-release Tablets (metoprolol CR/XL) in Hypertensive Pediatric Subjects: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Study.

Active substance: METOPROLOL

Study summary document link (including results): D4020C00033 CSR Synopsis.pdf

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Document reference: 31966

Study title: Blood pressure results on patients treated with intravenous Metronidazole (FLAGYL). Study Blood Pressure

Active substance: METRONIDAZOLE

Study summary document link (including results): Metronidazole STUDY Blood Pressure.xls

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Document reference: 47999

Study title: Disposition kinetics of metronidazole in children - AmonI; et al. - 1983 - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommendation for use in children also included - 12/1985Disposition kinetics of metronidazole in children - AmonI; et al. - 1983 - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommendation for use in children also included - 12/1985

Active substance: METRONIDAZOLE

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Document reference: 31967

Study title: Metronidazole and anaerobic sepsis.

Active substance: METRONIDAZOLE

Study summary document link (including results): Metronidazole STUDY Anaerobic sepsis.xls

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Document reference: 48002

Study title: Metronidazole FLAGYL injection 0.5% v/v. Adverse reactions.

Active substance: METRONIDAZOLE

Study summary document link (including results): Metronidazole STUDY Safety Review.xls

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Document reference: 48000

Study title: Clinical study comparing the effects of Lisuride and placebo in hyperkinetic children.

Active substance: LISURIDE

Study summary document link (including results): Bayer Pharma_Lisuride Hydrogen Maleate_EXC009_study_synopsis.pdf

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Document reference: 31301

Study title: Effects of Lisuride and placebo on psychomotor instability syndrome in children in controlled study

Active substance: LISURIDE

Study summary document link (including results): Bayer Pharma_Lisuride Hydrogen Maleate_EXC008_study_synopsis.pdf

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Document reference: 31298

Study title: Effects of lisuride hydrogen maleate in behaviorally disturbed children - double-blind controlled study with dexamphetamine sulphate

Active substance: LISURIDE

Study summary document link (including results): Bayer Pharma_Lisuride Hydrogen Maleate_HZI43_study_synopsis.pdf

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Document reference: 31300

Study title:

Active substance: LITHIUM

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Document reference: 31311

Study title: 107.208 - A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis.

Active substance: MELOXICAM

Study summary document link (including results): Meloxicam_U03-1727_synopsis.pdf

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Document reference: 31592

Study title: A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis.

Active substance: MELOXICAM

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Document reference: 31594

Study title: A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis.

Active substance: MELOXICAM

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Document reference: 31595

Study title: A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis.

Active substance: MELOXICAM

Study summary document link (including results): Meloxicam_U03-1429_synopsis.pdf

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Document reference: 31596

Study title: An open trial to investigate pharmacokinetics as well as efficacy and safety of 0.25 mg/kg meloxicam suspension administered once daily in children with juvenile rheumatoid arthritis over a treatment period of up to 52 weeks (3 months results).

Active substance: MELOXICAM

Study summary document link (including results): Meloxicam_U00-1093_synopsis.pdf

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Document reference: 31593

Study title: Melperone in low doses in anxious neurotic patients. A double-blind placebo-controlled clinical study.

Active substance: MELPERONE

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Document reference: 31599

Study title: The treatment of dandruff and/or seborrhoeic dermatitits of the hair-covered scalp with 2% ketoconazole scalp gel

Active substance: KETOCONAZOLE

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Document reference: 30835

Study title: Comparative study of Ibuprofen syrup and Paracetamol syrup in soft-tissue injuries in children

Active substance: IBUPROFEN

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Document reference: 29425

Study title: Smith-Lemli-Opitz syndrome and other sterol disorders among Finns with developmental disabilities.

Active substance: MELPERONE

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Document reference: 31600

Study title: The effect of methylperon (Eunerpan) on aggressive and auto-aggressive behaviour in mentally retarded patients--a double blind study (author's transl)a

Active substance: MELPERONE

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Document reference: 31602

Study title: The pharmacological management of aggressive and autoaggressive behaviour in mentally retarded patients with melperone

Active substance: MELPERONE

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Document reference: 31601

Study title:

Active substance: MELPHALAN

Study summary document link (including results): Study-OM2000-00006-00 Melphalan.xls

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Document reference: 47617

Study title: Clinical study of Alkeran Injection as a pretreatment of hematopoietic stem cell transplantation in patients with pediatric cancer (including 1-year follow-up survey)

Active substance: MELPHALAN

Study summary document link (including results): Study-OM2000-00004-00 Melphalan.xls

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Document reference: 31603

Study title: Metronidazole in surgical infections.

Active substance: METRONIDAZOLE

Study summary document link (including results): Metronidazole STUDY Surgery.xls

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Document reference: 47998

Study title: Nathan PC et al Adjuvant chemotherapy for the treatment of advanced pediatric nonrhabdomyosarcomasoft tissue sarcoma: the National Cancer Institute experience Pediatr Blood Cancer. 2005 May;44(5):449-54Nathan PC et al Adjuvant chemotherapy for the treatment of advanced pediatric nonrhabdomyosarcomasoft tissue sarcoma: the National Cancer Institute experience Pediatr Blood Cancer. 2005 May;44(5):449-54

Active substance: MITOXANTRONE

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Document reference: 32167

Study title: Navid F et al Concomitant administration of vincristine, doxorubicin, cyclophosphamide,ifosfamide, and etoposide for high-risk sarcomas: the St. Jude Children's Research Hospital experience Cancer. 2006 Apr 15;106(8):1846-56Navid F et al Concomitant administration of vincristine, doxorubicin, cyclophosphamide,ifosfamide, and etoposide for high-risk sarcomas: the St. Jude Children's Research Hospital experience Cancer. 2006 Apr 15;106(8):1846-56

Active substance: MITOXANTRONE

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Document reference: 32158

Study title: A double-blind comparison study of pivampicillin suspension and cefaclor suspension in the treatment of acute otitis media

Active substance: PIVAMPICILLIN

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Document reference: 46047

Study title: Absorption in children and Infants following oral administration of Pivampicillin; Part of SE/DK expert report. Prof. C simon (Kiel)

Active substance: PIVAMPICILLIN

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Document reference: 46048

Study title: Antibiotics in the treatment of gastroenteritis caused by enteropathgenic E. coliAntibiotics in the treatment of gastroenteritis caused by enteropathgenic E. coli

Active substance: PIVAMPICILLIN

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Document reference: 46050

Study title: Comparative efficacy of mecillinam, mecillinam/ amoxicillin and trimethoprim/ sulfamethazole for treatment of typhoid fever in childrenComparative efficacy of mecillinam, mecillinam/ amoxicillin and trimethoprim/ sulfamethazole for treatment of typhoid fever in children

Active substance: PIVAMPICILLIN

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Document reference: 46051

Study title: Comparative efficacy of pivmecillinam and cotrimoxazole in acute shigellosis in childrenComparative efficacy of pivmecillinam and cotrimoxazole in acute shigellosis in children

Active substance: PIVAMPICILLIN

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Document reference: 46052

Study title: Comparison of long-term, low dose pivmecillinam and nitrofurantoin in the control of recurrent urinary tract infection in childrenComparison of long-term, low dose pivmecillinam and nitrofurantoin in the control of recurrent urinary tract infection in children

Active substance: PIVAMPICILLIN

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Document reference: 46063

Study title: Comparison of pivmecillinam and nalidixic acid in the treatment of acute shigellosis in childrenComparison of pivmecillinam and nalidixic acid in the treatment of acute shigellosis in children

Active substance: PIVAMPICILLIN

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Document reference: 46062

Study title: Efficacy, pharmacology, and safety of amdinocillin in treatment of neonatesEfficacy, pharmacology, and safety of amdinocillin in treatment of neonates

Active substance: PIVAMPICILLIN

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Document reference: 46056

Study title: Long term, low dose treatment with pivmecillinam alone and in combination with pivampicillin in patients prone to recurrent bacteriuria; Barclay R.P.C. et al. 1982, Current medical research and opinion, 8: 82-88 LEO sponsored

Active substance: PIVAMPICILLIN

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Document reference: 46049

Study title: ULTRAM® tramadol HCl: Safety and efficacy in dental-extraction pain

Active substance: LIDOCAINE

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Document reference: 31230

Study title: Use of EMLA: is it an injection free alternative?

Active substance: LIDOCAINE

Study summary document link (including results):

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Document reference: 31221

Study title:

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 02_3-EML-06 CSR Synopsis.pdf

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Document reference: 47224

Study title:

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 03_89 EM 01 CSR Synopsis.pdf

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Document reference: 47225

Study title:

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 04_85-EM 24 CSR Synopsis.pdf

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Document reference: 47226

Study title: A clinical study of plasma concentrations of lidocaine and prilocaine and methaemoglobin formation after dermal application of EMLA in infants. (Part B)

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 20_85-EM09 (Part B) CSR Synopsis.pdf

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Document reference: 31240

Study title: A clinical study of plasma concentrations of lidocaine and prilocaine and methaemoglobin formation after dermal application of EMLA in infants. (Part B)

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 20_85-EM09 (Part B) CSR Synopsis.pdf

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Document reference: 47238

Study title: A clinical study of the plasma concentrations of lidocaine, prilocaine and methaemoglobin formation after dermal application of EMLA in infants. (Part C)

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 21_85-EM09 (Part C) CSR Synopsis.pdf

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Document reference: 47237

Study title: Double-blind, randomised, active-control, dose-response, 4 parallel groups, 72-hour study.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD83859_Interventional_Loperamide oxide.xls

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Document reference: 47583

Study title: Double-blind, randomised, placebo-control study.; Male and female children with acute infantile diarrhoea.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD57014_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31436

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine sulfate and placebo in dental extraction pain

Active substance: LIDOCAINE

Study summary document link (including results):

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Document reference: 31232

Study title: efficacy of loperamide oxide in AIDS associated diarrhoea

Active substance: LOPERAMIDE

Study summary document link (including results):

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Document reference: 31414

Study title: Infants and children with acute and chronic diarrhoea

Active substance: LOPERAMIDE

Study summary document link (including results): LMD11242_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31443

Study title: Motala C, et al. Effect of loperamide on stool output and duration of acute infectious diarrhea in infants. J Pediatr 1990; 117: 467–471.Motala C, et al. Effect of loperamide on stool output and duration of acute infectious diarrhea in infants. J Pediatr 1990; 117: 467–471.

Active substance: LOPERAMIDE

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Document reference: 31437

Study title: No study title available; Nineteen infants, between the age from 25 days and 2 years, having acute watery diarrhoea.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD79083_Noninterventional_Loperamide hydrochloride.xls

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Document reference: 31434

Study title: Open label ; Infants and young children with acute diarrhoea.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD11203_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31446

Study title: A double blind placebo-controlled study of lithium in hospitalized aggressive children and adolescents with conduct disorder. - Malone R, Delaney M, Luebbert J, et al (2000) - (Arch Gen Psychiatry 57:649-54)A double blind placebo-controlled study of lithium in hospitalized aggressive children and adolescents with conduct disorder. - Malone R, Delaney M, Luebbert J, et al (2000) - (Arch Gen Psychiatry 57:649-54)

Active substance: LITHIUM

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Document reference: 31302

Study title: A prospective 4-5 year follow up of juvenile onset bipolar disorder. - Jairam R, Srinath S, Girimaji, SC, Seshadri SP (2004) - (Bipolar Disorder 6:386-394)A prospective 4-5 year follow up of juvenile onset bipolar disorder. - Jairam R, Srinath S, Girimaji, SC, Seshadri SP (2004) - (Bipolar Disorder 6:386-394)

Active substance: LITHIUM

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Document reference: 31303

Study title: A systematic chart review of the naturalistic course and treatment of early-onset bipolar disorder in a child and adolescent psychiatry center. - Rajeev J, Srinath S, Girimaji S, et al. (2004) - (Compr. Psychiatry 45:148-54)A systematic chart review of the naturalistic course and treatment of early-onset bipolar disorder in a child and adolescent psychiatry center. - Rajeev J, Srinath S, Girimaji S, et al. (2004) - (Compr. Psychiatry 45:148-54)

Active substance: LITHIUM

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Document reference: 31304

Study title: Drug treatment of conduct disorder in young people. - Geradin P, Cohen D, Mazet P, Flament MF (2002) - (Eur. Neuropsychopharmacol 12:361-70)Drug treatment of conduct disorder in young people. - Geradin P, Cohen D, Mazet P, Flament MF (2002) - (Eur. Neuropsychopharmacol 12:361-70)

Active substance: LITHIUM

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Document reference: 31305

Study title: Effect size oh lithium, divalproex sodium and carbamazepine in children and adolescents with bipolar disorder. - Kowatch RA, Suppes T, Carmody TJ, et al. (2000) - (J AM Acad Child Adolesc Psychiatry 39:713-20)Effect size oh lithium, divalproex sodium and carbamazepine in children and adolescents with bipolar disorder. - Kowatch RA, Suppes T, Carmody TJ, et al. (2000) - (J AM Acad Child Adolesc Psychiatry 39:713-20)

Active substance: LITHIUM

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Document reference: 31306

Study title: Elevated thyrotropin in bipolar youths prescribed both lithium and divalproex sodium. - Gracious BL, Findling RL, Seman C et al (2004) - (J AM Acad Child Adolesc Psychiatry 43:215-20)Elevated thyrotropin in bipolar youths prescribed both lithium and divalproex sodium. - Gracious BL, Findling RL, Seman C et al (2004) - (J AM Acad Child Adolesc Psychiatry 43:215-20)

Active substance: LITHIUM

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Document reference: 31307

Study title: Loracarbef concentrations in sinus secretions/mucosa in children

Active substance: LORACARBEF

Study summary document link (including results): Loracarbef - B9U-MC-AZCT Synopsis.PDF

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Document reference: 47386

Study title: Loracarbef in acute maxiliary sinusitis

Active substance: LORACARBEF

Study summary document link (including results): Loracarbef - B9U-US-AZDE Synopsis with AE table.pdf

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Document reference: 31452

Study title: Loracarbef in pediatric patients with skeletal infections

Active substance: LORACARBEF

Study summary document link (including results): Loracarbef - B9U-US-AZDD Synopsis with AE table.pdf

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Document reference: 31451

Study title: Loracarbef vs clarithromycin in acute otitis media with effusion

Active substance: LORACARBEF

Study summary document link (including results): Loracarbef - B9U-MC-AZCR Synopsis.pdf

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Document reference: 31449

Study title: Loracarbef: Multiple dose pharmacokinetics in paediatric patients

Active substance: LORACARBEF

Study summary document link (including results): Loracarbef - B9U-MC-AZAC Synopsis.pdf

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Document reference: 31456

Study title: LY163892 vs Augmentin in otitis media - South Africa

Active substance: LORACARBEF

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Document reference: 31457

Study title: LY163892 vs V-Cillin-K in streptococcal pharyngitis/tonsillitis

Active substance: LORACARBEF

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Document reference: 31458

Study title: Pharmacokinetics and tissue distribution of metronidazole in the newborn infant - Jager.Roman, E. et al. - 1982 - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommandation for use in children also included - 12/1985Pharmacokinetics and tissue distribution of metronidazole in the newborn infant - Jager.Roman, E. et al. - 1982 - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommandation for use in children also included - 12/1985

Active substance: METRONIDAZOLE

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Document reference: 31968

Study title: Publication 12 dans Rapport d'expertise clinique - Rôle thérapeutique du metronidazole dans les infections à bactéries anaérobies (A. Bertrand - 24 mars 1978): Treatment of a brain abscess due to Bacteroides fragilis with metronidazole - George R.H., Bint - 1976Publication 12 dans Rapport d'expertise clinique - Rôle thérapeutique du metronidazole dans les infections à bactéries anaérobies (A. Bertrand - 24 mars 1978): Treatment of a brain abscess due to Bacteroides fragilis with metronidazole - George R.H., Bint - 1976

Active substance: METRONIDAZOLE

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Document reference: 31969

Study title: Publication: Giardiasis in infant and chidhood - Siavash Kavousi - 1979Publication: Giardiasis in infant and chidhood - Siavash Kavousi - 1979

Active substance: METRONIDAZOLE

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Document reference: 31970

Study title: Publication: Single-dose treatment of giardiasis in children: a comparison of tinidazole and metronidazole - A.J. Gazder & coll. - 1977Publication: Single-dose treatment of giardiasis in children: a comparison of tinidazole and metronidazole - A.J. Gazder & coll. - 1977

Active substance: METRONIDAZOLE

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Document reference: 31971

Study title: Schmör 1967

Active substance: METRONIDAZOLE

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Document reference: 47562

Study title: Single day prophylaxis with metronidazole in infants during abdominal surgery: a pharmacokinetic surgery - Rubenson A., Rosetzsky A. - No date - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommandation for use in children also included - 12/1985Single day prophylaxis with metronidazole in infants during abdominal surgery: a pharmacokinetic surgery - Rubenson A., Rosetzsky A. - No date - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommandation for use in children also included - 12/1985

Active substance: METRONIDAZOLE

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Document reference: 31972

Study title: The bacteriology and chemotherapy of otogenic cerebral abscesses.

Active substance: METRONIDAZOLE

Study summary document link (including results): Metronidazole STUDY Otogenic Cerebral Abcesses.xls

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Document reference: 48001

Study title: Rapport d'expertise clinique - Professeur Pierre Benoît - 20/06/1969

Active substance: METRONIDAZOLE AND SPIRAMYCIN

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Document reference: 31973

Study title: Electrophysiological clinical evaluation of mexiletine

Active substance: MEXILETINE

Study summary document link (including results): Mexiletine hydrochloride_U85-0802_synopsis.pdf

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Document reference: 31979

Study title: Long term, low dose treatment with pivmecillinam alone and in combination with pivampicillin in patients prone to recurrent bacteriuriaLong term, low dose treatment with pivmecillinam alone and in combination with pivampicillin in patients prone to recurrent bacteriuria

Active substance: PIVAMPICILLIN

Study summary document link (including results):

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Document reference: 46061

Study title: Mecillinam in cerebrospinal fluid in childrenMecillinam in cerebrospinal fluid in children

Active substance: PIVAMPICILLIN

Study summary document link (including results):

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Document reference: 46057

Study title: Mecillinam in enteric feverMecillinam in enteric fever

Active substance: PIVAMPICILLIN

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Document reference: 46054

Study title: " The ""Berlin model"", Multicentre study with prednicarbate in different vehicles - G. Albrecht - 1986 (Z. Hautkr vol 61) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" " The ""Berlin model"", Multicentre study with prednicarbate in different vehicles - G. Albrecht - 1986 (Z. Hautkr vol 61) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -"

Active substance: PREDNICARBATE

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Document reference: 34661

Study title: " The topical application of prednicarbate preparations in children -H. Schulz et al. - 1986 (Z. Hautkr vol 61) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" " The topical application of prednicarbate preparations in children -H. Schulz et al. - 1986 (Z. Hautkr vol 61) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -"

Active substance: PREDNICARBATE

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Document reference: 34662

Study title: "The treatment of psoriasis capitis. Investigation of the efficacity of prednicarbate solution in comparison with commercially available, potent corticosteroid solution - M. Stander et al. - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-" "The treatment of psoriasis capitis. Investigation of the efficacity of prednicarbate solution in comparison with commercially available, potent corticosteroid solution - M. Stander et al. - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-"

Active substance: PREDNICARBATE

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Document reference: 34680

Study title: 1-a-hydroxyvitamin D in Nutritional Rickets Glasgow J.R.T., and Reid M. One-Alpha-hydroxyvitamin D in Nutritional Rickets The Lancet (1977) iii, 3021-a-hydroxyvitamin D in Nutritional Rickets Glasgow J.R.T., and Reid M. One-Alpha-hydroxyvitamin D in Nutritional Rickets The Lancet (1977) iii, 302

Active substance: ALFACALCIDOL

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Document reference: 46331

Study title: Butenandt O. "Kinderkrankheiten" in: Kaiser H., Kley H. K. "Cortisontherapie", 11th ed. Thieme Verlag Stuttgart New York 2002; Fechner P. U., Teichmann, K. D., 4th ed., Enke Verlag Stuttgart New York 2000 Butenandt O. "Kinderkrankheiten" in: Kaiser H., Kley H. K. "Cortisontherapie", 11th ed. Thieme Verlag Stuttgart New York 2002; Fechner P. U., Teichmann, K. D., 4th ed., Enke Verlag Stuttgart New York 2000

Active substance: PREDNISOLONE

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Document reference: 25644

Study title:

Active substance: ACICLOVIR

Study summary document link (including results): Study BKCT-86-003 Aciclovir.xls

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Document reference: 47637

Study title: Open-label Children with acute diarrhoea were enrolled.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD5600_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31410

Study title: Open-label The study was conducted to evaluate the loperamide solutions since, it was found that the capsule form was not suitable for children on account of age. Children from 9 days to 2 years of age, hospitalised in a general paediatric assistance service for acute diarrhoea.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD10146_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31428

Study title: Open-label study in children with acute and chronic diarrhoea.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD5507_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31407

Study title: Open-label study; Children aged between 5 and 14 years with acute diarrhea due to viral infection or food allergy

Active substance: LOPERAMIDE

Study summary document link (including results): LMD5513_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31409

Study title: Open-label study; Male and female children with acute diarrhoea.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD5508_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31408

Study title: Open-label study; Male and female children with moderately severe or severe diarrhoea.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD8741_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31418

Study title: Open-label study.; Male and female children suffering from acute or sub-acute diarrhoea for 1 day to 3 weeks were included in the study.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD8742_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31419

Study title: Open-label, placebo-control study.; Male children between the age of 6 and 36 months with a history of diarrhoea who were at least 5% dehydrated clinically.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD67655_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31435

Study title: MAPROTILINE HYDROCHLORIDE (= BA 34276, LUDIOMIL), APPRAISAL OF REPRODUCTIVE TOXICITY STUDIES.; ORIGIN=PCS CH; CONTRACTOR=1;

Active substance: MAPROTILINE

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Document reference: 31526

Study title: Open-label pilot study

Active substance: MAPROTILINE

Study summary document link (including results): EMA spreadsheet_Ludiomil.xls

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Document reference: 47272

Study title: PLASMA AND MILK CONCENTRATIONS OF TOTAL 14C-COMPOUNDS AND OF UNCHANGED DRUG IN THE RAT AFTER ADMINISTRATION OF 14C-LABELLED PREPARATION

Active substance: MAPROTILINE

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Document reference: 31525

Study title: REPORT ON REPRODUCTIVE STUDY ON MAPROTILINE (BA 34276) IN RATS. (SEGMENT I AND SEGMENT III STUDY); ORIGIN=PCS JAPAN; CONTRACTOR=1;

Active substance: MAPROTILINE

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Document reference: 31527

Study title: REPRODUCTIVE STUDY, SEGMENT I - RAT EXPERIMENT. (EFFECT OF DRUG ON FERTILITY AND REPRODUCTIVE PERFORMANCE.; ORIGIN=PCS US / SU; CONTRACTOR=1;

Active substance: MAPROTILINE

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Document reference: 31528

Study title: REPRODUCTIVE STUDY, SEGMENT III - RAT EXPERIMENT. (EFFECT OF DRUG ON LACTATION AND THE SUCKLING YOUNG); ORIGIN=PCS US / SU; CONTRACTOR=1;

Active substance: MAPROTILINE

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Document reference: 31529

Study title: A comparative study of the effectiveness of Pyrantel pamoate, mebendazol (Janssen) and generically equivalent mebendazole (Nordia) in intestinal helminthiasis in Papua New Guinea children.

Active substance: MEBENDAZOLE

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Document reference: 31548

Study title: A new broad spectrum anthelminhtic.

Active substance: MEBENDAZOLE

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Document reference: 31544

Study title: "Clean-up" follow-up sludy of mebendazale in an eradication program of trichuriasis. 1973

Active substance: MEBENDAZOLE

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Document reference: 31545

Study title: Clinical evaluation of mebendazole in Taenia infestations. 1973

Active substance: MEBENDAZOLE

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Document reference: 31541

Study title: Clinical Study of Vermox Trichoencaphalosis and other Helminthiases

Active substance: MEBENDAZOLE

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Document reference: 31535

Study title: Pharmacokinetics of loracarbef in infants and children

Active substance: LORACARBEF

Study summary document link (including results): Loracarbef - B9U-MC-AZAN Summary.PDF

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Document reference: 31455

Study title: Efficacy and safety of loratadina-betamethasone combination in the initial treatment of severe perennial allergic rhinitis in children

Active substance: LORATADINE

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Document reference: 31466

Study title: Efficacy and Safety of SCH 29851 8 mg in Subjects with Allergic Rhinitis

Active substance: LORATADINE

Study summary document link (including results): Claritine_Clarityn Syrup_Loratadine_P00677.pdf

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Document reference: 31464

Study title: Efficacy and Safety of SCH 29851 in 8 mg in Subjects with Allergic Rhinitis

Active substance: LORATADINE

Study summary document link (including results): Claritine_Clarityn Syrup_Loratadine_P00687.pdf

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Document reference: 31465

Study title: LORATADINE SYRUP FOR CHILDREN 2 - 5 YEARS OLD

Active substance: LORATADINE

Study summary document link (including results): Claritine_Clarityn Syrup_Loratadine_C98566.pdf

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Document reference: 31461

Study title: Safety of Loratadine Syrup in children 6 months - 2 Years Old.

Active substance: LORATADINE

Study summary document link (including results): Claritine_Clarityn Syrup_Loratadine_P00256.pdf

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Document reference: 31463

Study title: SCH 29851: SINGLE DOSE BIOAVAILABILITY OF LORATADINE IN HEALTHY PEDIATRIC VOLUNTEERS

Active substance: LORATADINE

Study summary document link (including results): Claritine_Clarityn Syrup_Loratadine_C97033.pdf

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Document reference: 31460

Study title: SCH 29851: Single-Dose Bioavailability of Loratadine Syrup in Pediatric Volunteers 6 Months to 2 Years of Age

Active substance: LORATADINE

Study summary document link (including results): Claritine_Clarityn Syrup_Loratadine_P00241.pdf

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Document reference: 31462

Study title: Determination of lormetazepam and glucuronide in plasma and milk in mothers and in plasma of babies, women 2 - 3 days after delivery p.o. for 10 days

Active substance: LORMETAZEPAM

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Document reference: 31469

Study title: Intraoperative tolerance of lormetazepam I.V. (intravenous) in infants, children and adolescents

Active substance: LORMETAZEPAM

Study summary document link (including results): Bayer Pharma_Lormetazepam_80011_study_synopsis.pdf

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Document reference: 31468

Study title: Trial of prostaglandin-synthetase inhibitors in primary dysmenorrhoea.; Anderson AB et al. , Lancet. 1978 Feb 18;1(8060):345-8.Trial of prostaglandin-synthetase inhibitors in primary dysmenorrhoea.; Anderson AB et al. , Lancet. 1978 Feb 18;1(8060):345-8.

Active substance: MEFENAMIC ACID

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Document reference: 31580

Study title: Double-blind studies with mefloquine and in combination with sulfadoxine-pyrimethamine in 120 adults and 120 children with falciparum malaria in Vietnam. Leimer R*,Anh T K,Kim N V,Arnold K,Chien V V,Bich N N,Thoa K,Ladinsky J

Active substance: MEFLOQUINE

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Document reference: 31585

Study title: Single dose pharmacokinetics of sulfadoxine, pyrimethamine and mefloquine in thai children following administration of one tablet Fansimef, Schwartz D E*,Weidekamm E,Heizmann P,Chongsuphajaisiddhi T,Portmann R

Active substance: MEFLOQUINE

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Document reference: 31586

Study title: Melatonine in ADHD children

Active substance: MELATONIN

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Document reference: 31588

Study title:

Active substance: MELOXICAM

Study summary document link (including results): Meloxicam_U04-3227-01_synopsis.pdf

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Document reference: 31589

Study title:

Active substance: MELOXICAM

Study summary document link (including results): Meloxicam_U00-1833_synopsis.pdf

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Document reference: 31598

Study title: Lithium treatment in children and adolescents: a select review and integration of reserch findings. - Duffy A (2006) - (In: Bauer M, Grof P, Müller-Oerlinghausen B Lithium in neuropsychiatry. The comprehensive guide. Informa healthcare, London, pp. 193-205)Lithium treatment in children and adolescents: a select review and integration of reserch findings. - Duffy A (2006) - (In: Bauer M, Grof P, Müller-Oerlinghausen B Lithium in neuropsychiatry. The comprehensive guide. Informa healthcare, London, pp. 193-205)

Active substance: LITHIUM

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Document reference: 31308

Study title: Lithium treatment of acute mania in adolescents: a placebo-controlled discontinuation study. - Kafantaris V, Coletti DJ, Dicker R et al. (2004) - (J Am Acad Child Adolesc Psychiatry 43: 984-993)Lithium treatment of acute mania in adolescents: a placebo-controlled discontinuation study. - Kafantaris V, Coletti DJ, Dicker R et al. (2004) - (J Am Acad Child Adolesc Psychiatry 43: 984-993)

Active substance: LITHIUM

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Document reference: 31309

Study title: Summary and comment on: Clinical study comparing the effects of Lisuride and placebo in hyperkinetic children

Active substance: LITHIUM

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Document reference: 31312

Study title: Update on lithium carbonate therapy in children and adolescents. - Alessi N, Naylor MW, Ghaziuddin M, Zubieta JK - ( J A Child Adolesc Psychiatry, 1994 Mar Apr; 33(3)291-304Update on lithium carbonate therapy in children and adolescents. - Alessi N, Naylor MW, Ghaziuddin M, Zubieta JK - ( J A Child Adolesc Psychiatry, 1994 Mar Apr; 33(3)291-304

Active substance: LITHIUM

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Document reference: 31310

Study title: A comparative field trial of five measles vaccines produced in human diploid cell, MRC-5

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41234

Study title: A comparative field trial of five measles vaccines produced in human diploid cell, MRC-5

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41370

Study title: A study comparing the association of yellow fever and measles vaccine and of both vaccine administered separately

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41244

Study title: A study comparing the association of yellow fever and measles vaccine and of both vaccine administered separately

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41380

Study title: Clinical study of a live attenuated measles vaccine, in susceptible aged 6 months to 4 years

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41231

Study title: Clinical study of a live attenuated measles vaccine, in susceptible aged 6 months to 4 years

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41367

Study title: Clinical study of the measles vaccine of Merieux Institute : rouvax - European multicenter study

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41248

Study title: Dose response study of live attenuated Schwarz strain measles vaccine Rouvax in young French children

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41232

Study title: Dose response study of live attenuated Schwarz strain measles vaccine Rouvax in young French children

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41368

Study title: Efficacity, safety and immunogenicity of two high-titer measles vaccines. A study in Niakhar, Senegal

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41243

Study title: Efficacity, safety and immunogenicity of two high-titer measles vaccines. A study in Niakhar, Senegal

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41379

Study title: European multicentre clinical study of the rouvax measles vaccine

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41245

Study title: European multicentre clinical study of the rouvax measles vaccine

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41381

Study title: Immunogenicity and reactogenicity study of Rouvax vaccine in differents age-group children in France

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41240

Study title: Cleary-S-F, Link-M-P, Donaldson-S-S. Department of Radiation Oncology, Stanford University School of Medicine, Stanford University Hospital, CA 94305. Hodgkin's disease in the very young. International journal of radiation oncology biology physics, {Int-J- Radiat-Oncol-Biol-Phys}, 1 Jan 1994, vol. 28, no. 1, p. 77-83, ISSN: 0360-3016.Cleary-S-F, Link-M-P, Donaldson-S-S. Department of Radiation Oncology, Stanford University School of Medicine, Stanford University Hospital, CA 94305. Hodgkin's disease in the very young. International journal of radiation oncology biology physics, {Int-J- Radiat-Oncol-Biol-Phys}, 1 Jan 1994, vol. 28, no. 1, p. 77-83, ISSN: 0360-3016.

Active substance: PREDNISOLONE

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Document reference: 34684

Study title: EFFECT OF PRX CAP 10 MG IN ACUTE MUSCULOSKELETAL DISORDERS (A.M.D.) AN OPEN MULTICENTER CLINICAL STUDY IN TUNISIA

Active substance: PIROXICAM

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Document reference: 34471

Study title: EFFICACY AND SAFETY OF FELDENE IN PATIENTS WITH PRIMARY DYSMENORRHEA.

Active substance: PIROXICAM

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Document reference: 34360

Study title: EFFICACY AND SAFETY OF FELDENE VS. INDOMETHACIN IN PATIENTS WITH R.A.

Active substance: PIROXICAM

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Document reference: 34309

Study title: EFFICACY AND SAFETY OF PIROXICAM AND MEFENAMIC ACID TAKEN AT THE ONSET OF MENSTRUAL PAIN BY PATIENTS SUFFERING FROM PRIMARY DYSMENORRHEA.

Active substance: PIROXICAM

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Document reference: 34337

Study title: EFFICACY AND SAFETY OF PIROXICAM AT THE ONSET OF PAIN DUE TO PRIMARY DYSMENORRHEA.

Active substance: PIROXICAM

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Document reference: 34432

Study title: EFFICACY AND SAFETY OF PIROXICAM DISPERSIBLE TABLETS IN THE TREATMENT OF PRIMARY DYSMENORRHEA COMPARED TO MEFENAMIC ACID AND HYOSCINE BUTILBROMIDE AND PYRAZOLONE.

Active substance: PIROXICAM

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Document reference: 34361

Study title: EFFICACY AND SAFETY OF PIROXICAM IM IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS.

Active substance: PIROXICAM

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Document reference: 34395

Study title: EFFICACY AND SAFETY OF PIROXICAM IN AMD & POSTTRAUMATIC CONDITIONS

Active substance: PIROXICAM

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Document reference: 34333

Study title: EFFICACY AND SAFETY OF PIROXICAM IN JUVENILE RHEUMOTOID ARTERITIC PATIENTS

Active substance: PIROXICAM

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Document reference: 34418

Study title: EFFICACY AND SAFETY OF PIROXICAM IN PATIENTS WITH JUVENILE RHEUMATOID ARTHRITIS.

Active substance: PIROXICAM

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Document reference: 34419

Study title: EFFICACY AND SAFETY OF PIROXICAM IN PATIENTS WITH OSTEROARTHRITIS OF THE KNEE.

Active substance: PIROXICAM

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Document reference: 34349

Study title: EFFICACY AND SAFETY OF PIROXICAM VS. KETOPROFENE IN PATIENTS WITH ACUTE MUSCULOSKELETAL DISORDERS.

Active substance: PIROXICAM

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Document reference: 34396

Study title: EFFICACY AND SAFETY OF PIROXICAM VS. PLACEBO IN THE TREATMENT OF CANCER PATIENTS.

Active substance: PIROXICAM

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Document reference: 34380

Study title: EFFICACY AND SAFETY OF PIROXICAM WHEN TAKEN AT THE ONSET OF PAIN DUE TO PRIMARY DYSMENORRHEA IN YOUNG WOMEN FROM 12 - 16 YEARS OF AGE.

Active substance: PIROXICAM

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Document reference: 34431

Study title: EFFICACY AND SAFETY OF THE SHORT-TERM USE OF INTRAMUSCULAR PIROXICAM FOLLOWED BY ORAL ADMINISTRATION WHEN NECESSARY.

Active substance: PIROXICAM

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Document reference: 34391

Study title: EFFICACY AND TOLERANCE OF FELDENE SUPP. WITH BEDTIME IN PATIENTS WITH OA OF KNEES AND OR HIPS.

Active substance: PIROXICAM

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Document reference: 34338

Study title: EFFICACY AND TOLERANCE OF PIROXICAM IN THE TREATMENT OF POSTOPERATIVE ABDOMINAL PAIN IN CHOLECYSTECTOMIZED PATIENTS.

Active substance: PIROXICAM

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Document reference: 34346

Study title: EFFICACY AND TOLERANCE OF PRX GEL IN ACUTE MUSCULOSKELETAL DISORDERS

Active substance: PIROXICAM

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Document reference: 34373

Study title: EFFICACY AND TOLERATION OF FELDENE DISPERSIBLE TABLETS IN COMPARISON WITH DISPERSIBLE ASA (DISPRIN) IN PATIENTS WITH NON-ARTICULRHEUMATIS.

Active substance: PIROXICAM

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Document reference: 34486

Study title: EFFICACY AND TOLERATION OF FELDENE DISPERSIBLE TBS. COMPARED TO PARACETAMOL IN POST EPISIOTOMY CASES ESP.IN REGARD TO ITS RELIEF OF POST SURGICAL PAIN.

Active substance: PIROXICAM

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Document reference: 34487

Study title: Clinical Trials an Mebendazole in the treatment of intestinal Nemalodes

Active substance: MEBENDAZOLE

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Document reference: 31530

Study title: Comparative drug trials on the efficacy of Mebendazole and Flubendazole in the treatrment of Trichuris trichiura and Ascaris lumbricoides infections In children.

Active substance: MEBENDAZOLE

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Document reference: 31532

Study title: Dose Range Study of Flubendazole in Children vith Ascaris lumbricoides and/ or Trichuris trichiura infections.1979

Active substance: MEBENDAZOLE

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Document reference: 31533

Study title: Dose-range study of Flubendazole in the treatment of hookworm disease and trichuriasis. 1980

Active substance: MEBENDAZOLE

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Document reference: 31540

Study title: Efficacy of single dose Mebendazole against soil- transmitted infestinal nematodes in elementary school chlldren.

Active substance: MEBENDAZOLE

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Document reference: 31551

Study title: Experiences uin the treatment of childhood oxyuriasis with Mebendazole

Active substance: MEBENDAZOLE

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Document reference: 31538

Study title: Mebendazole in the treatment of intestinal helminthiasis in low socie-economic group In Ujung Pandang, South Sulawesi 1974

Active substance: MEBENDAZOLE

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Document reference: 31550

Study title: Mebendazole in the treatment of Symptomatic Trichuriasis. A preliminary Efficiency report. 1973

Active substance: MEBENDAZOLE

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Document reference: 31546

Study title: Open trial of mebendazola in Trichuris trichiura and Hookworm Infections. 1972

Active substance: MEBENDAZOLE

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Document reference: 31543

Study title: Prevention effort of erratic migration on medical treatment of intestinal worm disease with combination of Mebendazole and Pyrantel pamoate.

Active substance: MEBENDAZOLE

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Document reference: 31536

Study title: Clinical trial of Vermox supplied by the hungarien finn Medimpex 1976

Active substance: MEBENDAZOLE

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Document reference: 31534

Study title: Clinical trial with mebendazole in schoolchildren 1972

Active substance: MEBENDAZOLE

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Document reference: 31542

Study title: Single-blind comparison of flubendazole, mebendazole and placebo in the treatment of trichiuriasis ascariasis and hookworm disease. 1981

Active substance: MEBENDAZOLE

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Document reference: 31531

Study title: Ruszczak Z. [Photochemotherapy and activity of lysosomal enzymes in the serum of psoriasis patients][Article in German], Dermatol Monatsschr. 1984;170(9):573-7.Ruszczak Z. [Photochemotherapy and activity of lysosomal enzymes in the serum of psoriasis patients][Article in German], Dermatol Monatsschr. 1984;170(9):573-7.

Active substance: METHOZSALEN

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Document reference: 31717

Study title: Siddiqui AH. Comparison of serum levels and clinical results of PUVA therapy with three different dosage forms of 8-methoxypsoralen, Arch Dermatol Res. 1984;276(5):343-5.Siddiqui AH. Comparison of serum levels and clinical results of PUVA therapy with three different dosage forms of 8-methoxypsoralen, Arch Dermatol Res. 1984;276(5):343-5.

Active substance: METHOZSALEN

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Document reference: 31719

Study title: Tanew A. Photochemotherapy for severe psoriasis without or in combination with acitretin: a randomized, double-blind comparison study, J Am Acad Dermatol. 1991 Oct;25(4):682-4.Tanew A. Photochemotherapy for severe psoriasis without or in combination with acitretin: a randomized, double-blind comparison study, J Am Acad Dermatol. 1991 Oct;25(4):682-4.

Active substance: METHOZSALEN

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Document reference: 31720

Study title: Volc-Platzer B. Photochemotherapy improves chronic cutaneous graft-versus-host disease, J Am Acad Dermatol. 1990 Aug;23(2 Pt 1):220-8.Volc-Platzer B. Photochemotherapy improves chronic cutaneous graft-versus-host disease, J Am Acad Dermatol. 1990 Aug;23(2 Pt 1):220-8.

Active substance: METHOZSALEN

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Document reference: 31721

Study title: Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trialClinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trial

Active substance: LOMEFLOXACIN

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Document reference: 31352

Study title: Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198)Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198)

Active substance: LOMEFLOXACIN

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Document reference: 31351

Study title: Clinical evaluation of topical Lome-floxacin (NY-198) for external eye infection.Clinical evaluation of topical Lome-floxacin (NY-198) for external eye infection.

Active substance: LOMEFLOXACIN

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Document reference: 31347

Study title: Clinical experience with 0.3% LFLX ophthalmic solution,Clinical experience with 0.3% LFLX ophthalmic solution,

Active substance: LOMEFLOXACIN

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Document reference: 31348

Study title: H. Machida. The pediatric patients with inflammatory bowel disease – “I am special?”. Canadian J Gastroenterol Vol.6 No 6 Nov/Dec 1992 H. Machida. The pediatric patients with inflammatory bowel disease – “I am special?”. Canadian J Gastroenterol Vol.6 No 6 Nov/Dec 1992

Active substance: MESALAZINE

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Document reference: 31639

Study title: J. B. Punati et al. Safety of high dose oral mesalamine in pediatric patients with inflammatory bowel disease. Abstract # 1267 DDW New Orleans, 2004. J. B. Punati et al. Safety of high dose oral mesalamine in pediatric patients with inflammatory bowel disease. Abstract # 1267 DDW New Orleans, 2004.

Active substance: MESALAZINE

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Document reference: 31638

Study title: J.C. Escher et al. Treatment of inflammatory bowel disease in childhood: Best available evidence. Inflammatory bowel disease 2003;9:34-58. J.C. Escher et al. Treatment of inflammatory bowel disease in childhood: Best available evidence. Inflammatory bowel disease 2003;9:34-58.

Active substance: MESALAZINE

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Document reference: 31640

Study title: L. Barden et. al. Mesalazine in childhood in inflammatory bowel disease. Aliment Pharmacol Ther 1989;3:597-603.L. Barden et. al. Mesalazine in childhood in inflammatory bowel disease. Aliment Pharmacol Ther 1989;3:597-603.

Active substance: MESALAZINE

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Document reference: 31636

Study title: L.D. D`Agata et al. Mesalazine in pediatric inflammatory bowel disease: a 10 year experience. Gastroenterology 1995;108(4):A805. L.D. D`Agata et al. Mesalazine in pediatric inflammatory bowel disease: a 10 year experience. Gastroenterology 1995;108(4):A805.

Active substance: MESALAZINE

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Document reference: 31637

Study title: Observational study of the efficacy and safety of Salofalk 500mg/1000mg Granu-Stix for the acute and maintenance of remission treatment of ulcerative colitis patients

Active substance: MESALAZINE

Study summary document link (including results): EUdraCT_reduced_datafields_paediatric data_Mesalazine_Salofalk granules_Dr Falk Pharma GmbH.xls

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Document reference: 31627

Study title: Prevention or recurrence by mesalamine (Pentasa) in pediatric Crohn's disease. A multicentre double-blind trial; Cezard JP et al, Abstract, Digestive disease Wk, Orlando, Florida, May, 2003Prevention or recurrence by mesalamine (Pentasa) in pediatric Crohn's disease. A multicentre double-blind trial; Cezard JP et al, Abstract, Digestive disease Wk, Orlando, Florida, May, 2003

Active substance: MESALAZINE

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Document reference: 31630

Study title: Lormetazepam intravenous as premedication in paediatric surgery

Active substance: LORMETAZEPAM

Study summary document link (including results): Bayer Pharma_Lormetazepam_79137_study_synopsis.pdf

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Document reference: 46902

Study title: A Double-Blind, Randomized Dose-Response Study of Losartan in Children With Hypertension

Active substance: LOSARTAN

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Document reference: 31470

Study title: An Open-Label Study to Investigate the Pharmacokinetics of Losartan in Hypertensive Children and Infants

Active substance: LOSARTAN

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Document reference: 31471

Study title: A Double-Blind, Randomized Dose-Response Study of Losartan in Children With Hypertension

Active substance: LOSARTAN POTASSIUM

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Document reference: 46656

Study title: An Open-Label Study to Investigate the Pharmacokinetics of Losartan in Hypertensive Children and Infants

Active substance: LOSARTAN POTASSIUM

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Document reference: 46657

Study title: A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Lovastatin in Adolescent Girls.

Active substance: LOVASTATIN

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Document reference: 31472

Study title: Arrighi, Antonello: Homotoxicological versus conventional treatment regimens in the prophylaxis and treatment of pediatric seasonal allergic rhinitis. Biol Ther 2006 (journal spring):8-10 [IIT-publication]

Active substance: Luffa comp.-Heel/ Luffa compositum-Heel - Tabletten/ Luffeel - Nasenspray

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Document reference: 40049

Study title: Prospective, multicenter, observational study to document therapeutic data in the use of Luffa compositum-Heel (tablets) and Luffa comp.-Heel (nose drops) in the treatment of hay fever [AWB-008]

Active substance: Luffa comp.-Heel/ Luffa compositum-Heel - Tabletten/ Luffeel - Nasenspray

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Document reference: 40050

Study title: Retrospective survey for documentation of appllication and dosage of Luffeel comp. (nose drops) in children < 6 years of age [Bef-017]

Active substance: Luffa comp.-Heel/ Luffa compositum-Heel - Tabletten/ Luffeel - Nasenspray

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Document reference: 40051

Study title: Wirksamkeit von Luffa Nasenspray bei chronischer Rhinitis

Active substance: Luffa operculata

Study summary document link (including results): 010330_LU002_Synopsis[1].pdf

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Document reference: 39742

Study title: Assessment of the efficacy and safety of lymecycline compared to minocycline in the treatment of acne

Active substance: LYMECYCLINE

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Document reference: 31476

Study title: Clinical safety and efficacy evaluation of oral lymecycline versus minocycline in the treatment of inflammatory acne - Mexico

Active substance: LYMECYCLINE

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Document reference: 31475

Study title: Efficacy and safety of Tetralysal 300mg compared to Vibramycin-D 100mg in subjects with acne vulgaris

Active substance: LYMECYCLINE

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Document reference: 31477

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Lymphomyosot (tablets) [AWB-027]

Active substance: Lymphomyosot

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Document reference: 40053

Study title: Retrospective survey for documentation of appllication and dosage of Lymphomyosot N (tablets) in children < 12 years of age [Bef-024]

Active substance: Lymphomyosot

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Document reference: 40052

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Lymphomyosot (ampoules) [AWB-AT]

Active substance: Lymphomyosot - Ampullen

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Document reference: 40054

Study title: Arrighi, Antonello: Homotoxicological versus conventional treatment regimens in the prophylaxis and treatment of pediatric seasonal allergic rhinitis [IIT-publication]

Active substance: Lymphomyosot - Tropfen

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Document reference: 40055

Study title: Klingebiel et al. Initial experiences in the treatment of children with metastatic and recurrent neuroblastoma using meta-iodobenzylguanidine Klinische Padiatrie (1986), 198(3), 230-6

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48320

Study title: Lashford et al. Phase I/II study of iodine 131 metaiodobenzylguanidine in chemoresistant neuroblastoma: a United Kingdom Children's Cancer Study Group investigationJournal of clinical oncology : official journal of the American Society of Clinical Oncology (1992), 10(12), 1889-96

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48321

Study title: Leung et al. Specificity of radioiodinated MIBG for neural crest tumors in childhoodJ Nucl Med. 1997 Sep; 38(9):1352-7

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): Leung A 1997.pdf

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Document reference: 48322

Study title: ND: 29874 AU: Azeka-E. IN: Dr. E. Azeka, Hospital das Clinicas, Medicine School, Universidade de Sao Paulo (FMUSP), Sao Paulo, SP. TI: The impact of L-carnitine on nutritional status in juvenile idiopathic dilated cardiomyopathy.; SO: Jornal de Pediatria {J-PEDIATR}, 2005, Vol/Iss/Pg. 81/5 (355-356), ISSN: 0021-7557ND: 29874 AU: Azeka-E. IN: Dr. E. Azeka, Hospital das Clinicas, Medicine School, Universidade de Sao Paulo (FMUSP), Sao Paulo, SP. TI: The impact of L-carnitine on nutritional status in juvenile idiopathic dilated cardiomyopathy.; SO: Jornal de Pediatria {J-PEDIATR}, 2005, Vol/Iss/Pg. 81/5 (355-356), ISSN: 0021-7557

Active substance: LEVOCARNITINE

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Document reference: 31143

Study title: The role of L-carnitine in nutritional status and echocardiographic parameters in idiopathic dilated cardiomyopathy in children. Azevedo VM, Albanesi Filho FM, Santos MA, Castier MB, Cunha MO. J Pediatr (Rio J). 2005 Sep-Oct; 81(5): 368-72The role of L-carnitine in nutritional status and echocardiographic parameters in idiopathic dilated cardiomyopathy in children. Azevedo VM, Albanesi Filho FM, Santos MA, Castier MB, Cunha MO. J Pediatr (Rio J). 2005 Sep-Oct; 81(5): 368-72

Active substance: LEVOCARNITINE

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Document reference: 31142

Study title: A non-controlled, pilot, multi-centric, open study of the efficacy and safety of levocetirizine dihydrochloride 5 mg/mL oral drops given 0.125 mg/kg b.i.d. during 90 days in the treatment of recurrent cough associated with other allergic symptoms, e.g. wheezing, in children aged 1-2 years.

Active substance: LEVOCETIRIZINE

Study summary document link (including results): A00315 - Levocetirizine - RRCE03C1301.pdf

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Document reference: 47308

Study title: Anwendungsbeobachtung zur Therapie allergischer Erkrankungen mit Xusal Tropfen bei Kindern ab 2 Jahren.

Active substance: LEVOCETIRIZINE

Study summary document link (including results): A00315 - Levocetirizine - RRLE03E1601.pdf

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Document reference: 31149

Study title: Anwendungsbeobachtung. Xusal Filmtabletten. Untersuchung zur Therapie allergischer Erkrankungen bei Kindern.

Active substance: LEVOCETIRIZINE

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Document reference: 31153

Study title: Anwendungsbeobachtung. Xusal Filmtabletten. Untersuchung zur Therapie allergischer Erkrankungen.

Active substance: LEVOCETIRIZINE

Study summary document link (including results): A00309 - Levocetirizine - RRCE06L3017.pdf

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Document reference: 31152

Study title: Bacillus clausii effects in children with allergic rhinitis.

Active substance: LEVOCETIRIZINE

Study summary document link (including results): ADPE05F0825.pdf

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Document reference: 31155

Study title: Levocetirizine in the treatment of perennial allergic rhinitis.

Active substance: LEVOCETIRIZINE

Study summary document link (including results): ADPE04B0905.pdf

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Document reference: 31157

Study title: Wolff K. Oral photochemotherapy - results, follow-up, and pathology , From the Dep. of Dermatology, University Innsbruck and the Division for Experimental Dermatology, Dep. of Dermatology I, University of Vienna. 1975.Wolff K. Oral photochemotherapy - results, follow-up, and pathology , From the Dep. of Dermatology, University Innsbruck and the Division for Experimental Dermatology, Dep. of Dermatology I, University of Vienna. 1975.

Active substance: METHOZSALEN

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Document reference: 31722

Study title: Wolff K. Oral photochemotherapy - results, follow-up, and pathology , From the Dep. of Dermatology, University Innsbruck and the Division for Experimental Dermatology, Dep. of Dermatology I, University of Vienna. 1975.Wolff K. Oral photochemotherapy - results, follow-up, and pathology , From the Dep. of Dermatology, University Innsbruck and the Division for Experimental Dermatology, Dep. of Dermatology I, University of Vienna. 1975.

Active substance: METHOZSALEN

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Document reference: 31724

Study title: A randomized, multi-center, single-blind, placebo-controlled cross-over study planned to assess the efficacy in the early part of the school day of two methylphenidate delivery system, Ritalin LA® 20 mg versus Concerta 18 and 36 mg.

Active substance: METHYLPHENIDATE

Study summary document link (including results): Ritalin-EMA spreadsheet_CRIT124DUS07.xls

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Document reference: 47443

Study title: AWB: Wirksamkeit und Verträglichkeit von Medikinet; Beurteilung der Anwendung von Medikinet bei hyperkinetischen Kindern im Schulkindesalter mit Aufmerksamkeitsdefizistörungen- (ADS) Hyperaktivitätsstörungen

Active substance: METHYLPHENIDATE

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Document reference: 31728

Study title: Bioavailability of methylphenidate hydrochloride from a 20mg sustained release tablet in children (1980)

Active substance: METHYLPHENIDATE

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Document reference: 31727

Study title: Multizentrische Studie zur Optimierung der Methylphenidat-Therapie bei Kindern mit Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung (OMA)

Active substance: METHYLPHENIDATE

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Document reference: 31729

Study title: Randomized, double-blind, placebo/active controlled, 3-period cross-over, multicenter study

Active substance: METHYLPHENIDATE

Study summary document link (including results): Ritalin-EMA spreadsheet_CRIT124DDE01.xls

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Document reference: 47441

Study title: Single- blinded, single center, 10-week, placebo-controlled efficacy study

Active substance: METHYLPHENIDATE

Study summary document link (including results): Ritalin-EMA spreadsheet_CRIT124DUS05.xls

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Document reference: 47442

Study title: A double-blind parallel group study comparing EMLA cream 5% with placebo in capillary blood sampling of neonates

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 15_AG-EML-002 (87EM10) CSR Synopsis.pdf

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Document reference: 47243

Study title: A randomized, double-blind, placebo-controlled trial to measure the antibody response to immunisation with diphtheria-tetanus-pertussis-inactivated poliovirus-haemophilus influenzae b and hepatitis B vaccines using

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 14_DC-EMB-0002 CSR Synopsis.pdf

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Document reference: 47244

Study title: A randomized, double-blind, placebo-controlled trial to measure the antibody response to immunization with measles-mumbs-rubella vaccines using EMLA patch for the reduction of pain associated with subcutaneous injection in twelve month old infants, 1998

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 13_DC-EMB-0001 CSR Synopsis.pdf

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Document reference: 47245

Study title: Analgesia for the surgical removal of molluscum contagiosum in children: a double-blind, placebo-controlled, time-repsonse study of EMLA(R) (lidocaine/prilocaine) cream. Astra Report 802-10 AC 082-1, February 05, 1990.

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 06_86EM25 CSR Synopsis.pdf

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Document reference: 47251

Study title: R.J. Grand et al. Inflammatory bowel disease in the pediatric patient. Gastroenerol Clinics of North America, Vol 24 No 24. September 1995;24:613-632 10. R.J. Grand et al. Inflammatory bowel disease in the pediatric patient. Gastroenerol Clinics of North America, Vol 24 No 24. September 1995;24:613-632 10.

Active substance: MESALAZINE

Study summary document link (including results):

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Document reference: 31643

Study title:

Active substance: MESNA

Study summary document link (including results): DF78K105S - Mesna.pdf

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Document reference: 31669

Study title:

Active substance: MESNA

Study summary document link (including results): DF83B212S - Mesna.pdf

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Document reference: 31675

Study title: A clinical evaluation of UCB in paediatrics

Active substance: MESNA

Study summary document link (including results): DE75C051 - Mesna.pdf

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Document reference: 31653

Study title: A clinical test of ucb 3983, a new mucolytic agent, in a department for anesthesia and intensive care.

Active substance: MESNA

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Document reference: 31687

Study title: A controlled trial of intermittent aerosol therapy with sodium 2 mercaptoethane sulfonate in patients with cystic fibrosis.

Active substance: MESNA

Study summary document link (including results): DE79A151 - Mesna.pdf

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Document reference: 31659

Study title: A controlled trial of intermittent aerosol therapy with sodium 2-mercaptoethane sulphonate in patients with cystic fibrosis.

Active substance: MESNA

Study summary document link (including results): CE70L242 - Mesna.pdf

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Document reference: 31661

Study title: A double-blind cross-over trial of sodium 2-mercaptoethane sulphonate (mistabron) in children with cystic fibrosis.

Active substance: MESNA

Study summary document link (including results): DPL78F061 - Mesna.pdf

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Document reference: 31660

Study title: Bronchial secretion in infants with obstructive bronchitis during aerosols therapy.

Active substance: MESNA

Study summary document link (including results): DE80H229C - Mesna.pdf

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Document reference: 31677

Study title: Changes in the composition of the bronchial secretion after mucolytic therapy.

Active substance: MESNA

Study summary document link (including results): DE80H226C - Mesna.pdf

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Document reference: 31683

Study title: Berezniuk V.V., Lamza H.B: Application of composite antihomotoxic preparations in the treatment of children suffering from acute sinusites. Biological Therapy (Ukraine), 2006, 2: 26-29 [IIT-publication]

Active substance: Lymphomyosot - Tropfen

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Document reference: 40064

Study title: A Pilot Evaluation of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Memantine in Pediatric Patients with Attention-Deficit/Hyperactivity Disorder (ADHD) Combined Type

Active substance: Memantine Hydrochloride

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Document reference: 41492

Study title: Clinical observation and experience with memantine in the treatment of spastic movement disorders.

Active substance: Memantine Hydrochloride

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Document reference: 41487

Study title: Clinical study of the new antispastic agent Akatinol Memantine.

Active substance: Memantine Hydrochloride

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Document reference: 41488

Study title: Efficacy and tolerability of Akatinol Memantine in patients with neurogenic bladder dysfunction due to transverse lesion of the cord.

Active substance: Memantine Hydrochloride

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Document reference: 41490

Study title: Experience with memantine in the treatment of severe spastic and extrapyramidal movement disturbances in combination or following stereotactic surgery.

Active substance: Memantine Hydrochloride

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Document reference: 41489

Study title: Study on the efficacy of peroral memantine in spastic patients (secondary to infantile cerebral lesion).

Active substance: Memantine Hydrochloride

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Document reference: 41484

Study title: Surveillance of the clinical course of severe post-contusion functional psychosis under neuro-psychiatric intensive care treatment.

Active substance: Memantine Hydrochloride

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Document reference: 41491

Study title: Therapy of spasticity with memantine - experiences of a multicentre trial.

Active substance: Memantine Hydrochloride

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Document reference: 41486

Study title: Use of Akatinol Memantine in spasticity syndrome.

Active substance: Memantine Hydrochloride

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Document reference: 41485

Study title: Epidemic of meningococcal meningitis in Bamako, Mali: epidemiological features and analysis of vaccine efficacy.

Active substance: Meningococcal Polysaccharide Vaccine (Strains A + C)

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Document reference: 41251

Study title: A controlled field trial of serogroup A meningococcal polysaccharide vaccine.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41269

Study title: A second controlled field trial of a serogroup A meningococcal polysaccharide vaccine in Alexandria.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41271

Study title: A serogroup A meningococcal polysaccharide vaccine: studies in the Sudan to combat cerebrospinal meningitidis caused by Neisseria meningitidis group A.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41270

Study title: Adverse events after polysaccharide meningococcal A & C vaccine.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41258

Study title: Adverse events temporally associated with meningoccal vaccines.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

Study summary document link (including results): link to document

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Document reference: 41257

Study title: Assessment of the immunogenicity and safety of a meningococcal A/C diptheria conjugate vaccine administered in two-year old children in comparison with a licensed meningococcal A/C polysaccharide vaccine.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41268

Study title: Control of epidemic meningococcal meningitis by mass vaccination.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 47477

Study title: Control of serogroup C meningococcal meningitis by mass vaccination in Catalonia (Spain).

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41254

Study title: Controlled tests of anti-meningococcal polysaccharide A vaccine in the African Sahel area (upper Volta and Mali).

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41273

Study title: Levocetirizine: pharmacokinetics and pharmacodynamics in children age 6 to 11 years.

Active substance: LEVOCETIRIZINE

Study summary document link (including results): ADPE05F0305.pdf

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Document reference: 31156

Study title: Pharmacokinetic evaluation and ex vivo serum protein binding. levocetirizine dihydrochloride (ucb 28556). a non-controlled, pilot, multi-centric, open study of the efficacy and safety of levocetirizine dihydrochloride 5 mg/ml oral drops given 0.125 mg/kg b.i.d. during 90 days in the treatment of recurrent cough associated with other allergic symptoms, e.g. wheezing, in children aged 1-2 years.

Active substance: LEVOCETIRIZINE

Study summary document link (including results): ARVD04B1001 - Levocetirizine.pdf

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Document reference: 31151

Study title: The early prevention of asthma in atopic children (EPAAC(TM)) study. a multi-country, double blind, placebo-controlled, randomized, parallel group trial: evaluation of the efficacy and safety of levocetirizine (5 mg/ml oral drops - 0.125 mg/kg b.w. b.i.d.) administered for 18 months in preventing the onset of asthma in 12 to 24 months old children who suffer from atopic dermatitis and are sensitized to grass pollen and / or house dust mite allergens.

Active substance: LEVOCETIRIZINE

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Document reference: 31154

Study title: Sei-ichi Ishimoto, Department of Ophthalmology, Faculty of Medicine, Kyusyu University, Clinical evaluation of topical Lomefloxacin (NY-198) for external eye infection. No report date.Sei-ichi Ishimoto, Department of Ophthalmology, Faculty of Medicine, Kyusyu University, Clinical evaluation of topical Lomefloxacin (NY-198) for external eye infection. No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31383

Study title: Takashi Kiyohora, Departement of ophthalmology, School of medicine, Nihon University, Therapeutical effects of Lomefloxacin ophthalmic solution with t.i.d. administration in the external bacterial infection of the eyes. 1989-1990.Takashi Kiyohora, Departement of ophthalmology, School of medicine, Nihon University, Therapeutical effects of Lomefloxacin ophthalmic solution with t.i.d. administration in the external bacterial infection of the eyes. 1989-1990.

Active substance: LOMEFLOXACIN

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Document reference: 31365

Study title: Takeo Shimo et al, Central Research Laboratory, Hokuriku Seiyaku Co., Ltd. Oral Arthrotoxicity Study of NY-198 in adolescent rats. Internal Report 13.10.108.

Active substance: LOMEFLOXACIN

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Document reference: 31403

Study title: Takeo Shimo et al, Central Research Laboratory, Hokuriku Seiyaku Co., Ltd. Oral Arthrotoxicity Study of NY-198 in juvenile rats with recovery. Internal Report 13.10.1086.

Active substance: LOMEFLOXACIN

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Document reference: 31404

Study title: Takeo Shimo et al, Central Research Laboratory, Hokuriku Seiyaku Co., Ltd. Oral Arthrotoxicity Study of NY-198 in adult rats. Internal report.Vernal keratoconjunctivitis in Thailand. Kosrirukvongs P, Vichyanond P, Wongsawad W. Asian Pac J Allergy Immunol. 2003 Mar;21(1):25-30.

Active substance: LOMEFLOXACIN

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Document reference: 31405

Study title: The combined experience of the safety of lome-floxacin 0.3% and lomefloxacin 0.5% and the efficacy of lomefloxacin 0.3% compared with ofloxacin 0.3% in the treatment of acute bacterial conjunctivitis and other infections of the eye in children under 15 years old reported upon in three previous studies of lome-floxacin in JapanThe combined experience of the safety of lome-floxacin 0.3% and lomefloxacin 0.5% and the efficacy of lomefloxacin 0.3% compared with ofloxacin 0.3% in the treatment of acute bacterial conjunctivitis and other infections of the eye in children under 15 years old reported upon in three previous studies of lome-floxacin in Japan

Active substance: LOMEFLOXACIN

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Document reference: 31360

Study title: Therapeutical effects of Lomefloxacin ophthalmic solution with t.i.d. administration in the external bacterial infection of the eyesTherapeutical effects of Lomefloxacin ophthalmic solution with t.i.d. administration in the external bacterial infection of the eyes

Active substance: LOMEFLOXACIN

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Document reference: 31345

Study title: Astra Report A randomized, open label, comparative parallel group study to evaluate the efficacy and safety of EMLA® Cream and 1% Xylocaine® infiltration in males for relief of pain associated with the removal of genital warts by cryotherapy.

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 11_93-EML-18 CSR Synopsis.pdf

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Document reference: 47247

Study title: Astra Report No 802 10 AC 093-1 A Clinical Study On A Single Unit Dose Package of Emla (Emla Patch) and Emla 5% Cream Used to Reduse Pain From Venupuncture in Children.

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 24_89 EM 04 CSR Synopsis.pdf

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Document reference: 47236

Study title: Astra Report No 802-10 AC 064-1 Local anaesthesia with EMLA Cream for cautery of condylomata acuminata of the genital mucosa in women - effect of application time. 86EM04 (Part I)

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 09_86-EM04 CSR Synopsis.pdf

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Document reference: 47249

Study title: Astra Report No. 802-10 AC 062-1 Local Anaesthesia with Emla Cream for Laser Treatment of Condylomata Acuminata in Women. A Double-blind Comparison with Placebo to Evaluate the Time of Onset and Duration of Anaesthesia of the Genital Mucosa. 86EM07

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 10_86-EM07 CSR Synopsis.pdf

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Document reference: 47248

Study title: Astra Report No. 802-10 AC 094 Clinical Study On Two Single Unit Dose Packages (Emla Patch) and Emla 5 % Cream Used to Reduce Pain at I.V Cannulation in Children

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 29_88EM01 CSR Synopsis.pdf

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Document reference: 47231

Study title: Biometrical analysis of a controlled double-blind crossover study on 48 patients. EMLA vs Placebo WG85EM01 (Astra Study 802-10 AC 068-1)

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 25_85-EM01 (WG85EM01) CSR Synopsis.pdf

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Document reference: 47235

Study title: Determination of a minimum application time for efficacy of a 5% lidocaine-prilocaine cream, EMLA (Eutectic Mixture of Local Anaesthetics), used for relief of venipuncture pain in children. Astra Report 802-10 AC 015-2, March 31, 1983.

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 07_81PO34 CSR Synopsis.pdf

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Document reference: 47250

Study title: Double-blind evaluation of a lidocaine-prilocaine cream (EMLA) for venous cannulation pain in children

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 31_83-P029 CSR Synopsis.pdf

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Document reference: 47229

Study title: Open-label, randomised, multicentre study; Patients aged between 24-47 months inclusive; had symptoms of diarrhoea for no longer than 48 hours just prior to entering the study; no history of chronic diarrhoea, had not received any other antidiarrhoeal treatment during this episode, and over 10 kg in weight.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD15842_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31439

Study title: Open-label; Children aged between 1 month and 7 years with acute or chronic diarrhoea.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD10145_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31427

Study title: Open-label; Children between the ages of 4 and 12 years with acute diarrhoea and the duration of diarrhoea prior to treatment should not have been more than 48 hours.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD15843_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31438

Study title: Open-label; Children with acute diarrhoea.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD5720_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31411

Study title: Open-label; Children with acute diarrhoea.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD9535_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31421

Study title: Changes in the composition of the bronchial secretion after mucolytic therapy.

Active substance: MESNA

Study summary document link (including results):

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Document reference: 31685

Study title: Clinical Experience with a combination Endoxan/Mesna in pediatric. Contributions to Oncology. New Experience with the Oxazaphosphoriens with special reference to the Uroprotector Uromitexan . (de Kraker, J., Voute, P.A. and Stassen, M. - eds. Burkert, H. and Nagel, G.A.; S. Karger, 1981, 99-101)Clinical Experience with a combination Endoxan/Mesna in pediatric. Contributions to Oncology. New Experience with the Oxazaphosphoriens with special reference to the Uroprotector Uromitexan . (de Kraker, J., Voute, P.A. and Stassen, M. - eds. Burkert, H. and Nagel, G.A.; S. Karger, 1981, 99-101)

Active substance: MESNA

Study summary document link (including results):

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Document reference: 31645

Study title: "Reversed vVntilation Perfusion Mismatch Involving a pediatric Patient in Congestive Heart Failure - Evan Zucker, Sydney Heyman and Savas Ozdemir - The Journal of Nuclear Medicine Vol 38 - No 11- November 1997" "Reversed vVntilation Perfusion Mismatch Involving a pediatric Patient in Congestive Heart Failure - Evan Zucker, Sydney Heyman and Savas Ozdemir - The Journal of Nuclear Medicine Vol 38 - No 11- November 1997"

Active substance: MILRINONE

Study summary document link (including results):

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Document reference: 32037

Study title: Serial blood lactate measurements predict early mortality following neonatal repair or palliation for complex congenital heart disease - Charpie JR et al. - 1999 (Circulation suppl 1, 1999, 100 (18) 1399)Serial blood lactate measurements predict early mortality following neonatal repair or palliation for complex congenital heart disease - Charpie JR et al. - 1999 (Circulation suppl 1, 1999, 100 (18) 1399)

Active substance: MILRINONE

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Document reference: 32034

Study title: Serial blood lactate measurements predict early outcome after neonatal repair or palliation for complex congenital heart disease - Charpie JR et al. - 2000 (J Thorac Cardiovasc Surg 2000, 120, 73-80)Serial blood lactate measurements predict early outcome after neonatal repair or palliation for complex congenital heart disease - Charpie JR et al. - 2000 (J Thorac Cardiovasc Surg 2000, 120, 73-80)

Active substance: MILRINONE

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Document reference: 32035

Study title: The effects of milrinone on platelets in patients undergoing cardiac surgery - Kikura M et al. - 1995 (Anest Analg 1995, 81, 44 -48)The effects of milrinone on platelets in patients undergoing cardiac surgery - Kikura M et al. - 1995 (Anest Analg 1995, 81, 44 -48)

Active substance: MILRINONE

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Document reference: 32036

Study title: The platelet function defect of cardiopulmonary bypass - Kestin AS et al. - 1993 (Blood, 1993, 82, 107-117)The platelet function defect of cardiopulmonary bypass - Kestin AS et al. - 1993 (Blood, 1993, 82, 107-117)

Active substance: MILRINONE

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Document reference: 32038

Study title: Altomare M.,Bugnoni L.,Riva M. La Biochetasi nella terapia dell’emesi gravidica Eur.Rev.Med.Pharm.Sci.,6,573-576,1984Altomare M.,Bugnoni L.,Riva M. La Biochetasi nella terapia dell’emesi gravidica Eur.Rev.Med.Pharm.Sci.,6,573-576,1984

Active substance: MINERALS AND VITAMINS

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Document reference: 32040

Study title: Barzani G.,Liotta M.,Merli B.,Olivieri M.,Tamburini G. Sul trattamento delle sindromi acetonemiche infantili Clin.Ter.,76(5),437,1976Barzani G.,Liotta M.,Merli B.,Olivieri M.,Tamburini G. Sul trattamento delle sindromi acetonemiche infantili Clin.Ter.,76(5),437,1976

Active substance: MINERALS AND VITAMINS

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Document reference: 32044

Study title: Bieber G.,Casario S. Risultati preliminari di un trattamento farmacologico di un gruppo di insufficienti mentali in eta scolare Ming.Med.,60,2151,1969 Bieber G.,Casario S. Risultati preliminari di un trattamento farmacologico di un gruppo di insufficienti mentali in eta scolare Ming.Med.,60,2151,1969

Active substance: MINERALS AND VITAMINS

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Document reference: 32049

Study title: Febrile seizures after immunization with meningococcal A + C vaccine.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41256

Study title: Mexiletine as a treatment of the Thomsen-Becker myotonia

Active substance: MEXILETINE

Study summary document link (including results): Mexiletine hydrochloride_U85-0306_synopsis.pdf

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Document reference: 31981

Study title: Mexiletine in the relief of tinnitus

Active substance: MEXILETINE

Study summary document link (including results): Mexiletine hydrochloride_U80-0320_synopsis.pdf

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Document reference: 31980

Study title: Mexitil vs. Norpace: Multicenter study

Active substance: MEXILETINE

Study summary document link (including results): Mexiletine hydrochloride_U83-0384_synopsis.pdf

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Document reference: 31978

Study title: Chabrol H, Netter JC, Carriere JP. Arch Fr Pediatr 1982;39:650.Chabrol H, Netter JC, Carriere JP. Arch Fr Pediatr 1982;39:650.

Active substance: MIANSERIN

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Document reference: 31984

Study title: Chand S, Crome P, Dawling S. Pharmacopsychiatrie 14, 15-17 1981Chand S, Crome P, Dawling S. Pharmacopsychiatrie 14, 15-17 1981

Active substance: MIANSERIN

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Document reference: 31993

Study title: Dugas M, Mouren MC, Halfon O, Moron P. Acta Psychiatr Scand Suppl. 1985;320:48-53 Dugas M, Mouren MC, Halfon O, Moron P. Acta Psychiatr Scand Suppl. 1985;320:48-53

Active substance: MIANSERIN

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Document reference: 31987

Study title: Use of Positron Emission Tomography for Presurgical Localization of Eloquent Brain Areas in Children with Seizures.Pediatr Neurosurg 1997;26:144-156. Jolznily D. Dtlncane, S. David h foss a, Daniel J. Baiidy, Kiln rManwaringa, Allen Af. Kaplan, Eric AL Rei~nalt, Kewei Cheizd, Michael A. La~son, David L. CVodrichc.

Active substance: Steripet

Study summary document link (including results): duncan-1997.pdf

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Document reference: 48727

Study title: Langer DH, Rapoport JL, Ebert MH, Lake CR, Nee LE. In: Greenhill, LL; Shopsin, B (Eds). The psychobiology of childhood; A Profile of current issues. Lancaster, MTP, 1984. P.197-210.Langer DH, Rapoport JL, Ebert MH, Lake CR, Nee LE. In: Greenhill, LL; Shopsin, B (Eds). The psychobiology of childhood; A Profile of current issues. Lancaster, MTP, 1984. P.197-210.

Active substance: MIANSERIN

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Document reference: 31989

Study title: Mouren MC, Denis HP, Dugas M. Neuropsychiatr Enfance Adolesc. 1983;31(10):485-90Mouren MC, Denis HP, Dugas M. Neuropsychiatr Enfance Adolesc. 1983;31(10):485-90

Active substance: MIANSERIN

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Document reference: 31986

Study title: Newman B, Crome P. Vet. Hum. Toxicol. 21, Suppl., 60-63 1979Newman B, Crome P. Vet. Hum. Toxicol. 21, Suppl., 60-63 1979

Active substance: MIANSERIN

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Document reference: 31992

Study title: Propper L, Hrdlicka M, Bares M, Kajlikova M, Goetz M, Lorenc J, Koutek J. Ceska Slov Psychiatr 2000;96:376-80.Propper L, Hrdlicka M, Bares M, Kajlikova M, Goetz M, Lorenc J, Koutek J. Ceska Slov Psychiatr 2000;96:376-80.

Active substance: MIANSERIN

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Document reference: 31991

Study title: Winsberg B, Suckow R, Cooper T, Camp J, Dunbar G, Vink J. In: Congress of the colloquim internationale neuro-psychopharmacologicum; Florence, June 19-23, 1984; Book of abstracts. S.L., S.N., 1984. P.190, Abstract No. P74.Winsberg B, Suckow R, Cooper T, Camp J, Dunbar G, Vink J. In: Congress of the colloquim internationale neuro-psychopharmacologicum; Florence, June 19-23, 1984; Book of abstracts. S.L., S.N., 1984. P.190, Abstract No. P74.

Active substance: MIANSERIN

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Document reference: 31990

Study title: Winsberg BG, Camp-Bruno JA, Vink J, Timmer CJ, Sverd J. J Clin Psychopharmacol. 1987 Jun;7(3):143-7Winsberg BG, Camp-Bruno JA, Vink J, Timmer CJ, Sverd J. J Clin Psychopharmacol. 1987 Jun;7(3):143-7

Active substance: MIANSERIN

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Document reference: 31988

Study title: Near asphyxiation of a neonate due to miconazole oral gelNear asphyxiation of a neonate due to miconazole oral gel

Active substance: MICONAZOLE

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Document reference: 31996

Study title: Toyokazu Okami, Tomoko Nozaki, Department of Ophthalmology, Kansai Medical University, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in infectious diseases of external eye.Toyokazu Okami, Tomoko Nozaki, Department of Ophthalmology, Kansai Medical University, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in infectious diseases of external eye.

Active substance: LOMEFLOXACIN

Study summary document link (including results):

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Document reference: 31359

Study title: Toyokazu Okami, Tomoko Nozaki, Department of Ophthalmology, Kansai Medical University, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in infectious diseases of external eye. No report date.Toyokazu Okami, Tomoko Nozaki, Department of Ophthalmology, Kansai Medical University, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in infectious diseases of external eye. No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31379

Study title: Uchida Y et al. Phase II study of NY-198 ophthalmic solution in multicenter double-blind design; Phase II study of NY-198 ophthalmic solution. No report date. Amendment to clinical trial report by Dr. A. Jauch, January 4, 1994, + Appendix 1 and 2.Uchida Y et al. Phase II study of NY-198 ophthalmic solution in multicenter double-blind design; Phase II study of NY-198 ophthalmic solution. No report date. Amendment to clinical trial report by Dr. A. Jauch, January 4, 1994, + Appendix 1 and 2.

Active substance: LOMEFLOXACIN

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Document reference: 31361

Study title: Vitamin B6, Magnesium and combined B6-Mg : therapeutic effects in childhood autism - J. Martineau et al. - 1985 (Biol. Psychiatry vol 20) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Vitamin B6, Magnesium and combined B6-Mg : therapeutic effects in childhood autism - J. Martineau et al. - 1985 (Biol. Psychiatry vol 20) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

Study summary document link (including results):

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Document reference: 31502

Study title:

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31523

Study title: Brief report : an open middle term study of combined vitamin B6 - Magnesium in a subgroup of autistic children selected on their sensitivity to this treatment - J. Martineau et al. - 1988 ( Journal of Autitism and Developmental disorders vol 18) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31505

Study title: Current perspectives on pyridoxin-dependant seizures - S.M Gospe - 1998 (J. Pediatr vol 132) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Current perspectives on pyridoxin-dependant seizures - S.M Gospe - 1998 (J. Pediatr vol 132) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31507

Study title: Efficacy of vitamin B6 and magnesium in the treatment of autism : a methodology review an summary of outcomes - S.I Pfeiffer et al. - 1995 (Journal of Autism and Developmental Disorders vol 25) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Convulsions hypomagnésemique chez le nouveau-né - Stern L, Harpur ER - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31506

Study title: Open-label; Children with acute or sub-acute diarrhoea

Active substance: LOPERAMIDE

Study summary document link (including results): LMD8740_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31417

Study title: Open-label; Hospitalised infants and young children with acute diarrhoea.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD12173_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31442

Study title: Open-label; Male and female children with acute and chronic diarrhoea.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD9658_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31423

Study title: Open-label; Male and female children with acute and chronic diarrhoea.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD9659_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31424

Study title: Open-label; Male and female patients aged between 2 and 72 months suffering from acute diarrhoea.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD7234_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31412

Study title: Open-label; Out-patients suffering from acute diarrhoea of different aetiologies.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD7451_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31413

Study title: Open-label; Out-patients with different types of acute diarrhoea.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD7570_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31416

Study title: Randomised, double-blind, parallel, multi-site, placebo-controlled factorial designed study.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD115307_Interventional_Loperamide hydrochloride.xls

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Document reference: 31432

Study title: Randomised, parallel, double blind, multisite, placebo-controlled.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD162326_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31431

Study title: Turck D et al. Comparison of racecadotril and loperamide in children with acute diarrhoea. Aliment Pharmacol Ther 1999; 13 (Suppl. 6): 27-32.Turck D et al. Comparison of racecadotril and loperamide in children with acute diarrhoea. Aliment Pharmacol Ther 1999; 13 (Suppl. 6): 27-32.

Active substance: LOPERAMIDE

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Document reference: 31440

Study title: The effect of single dose mebendazole on the egg reduction rates (ERR) and cure rates (CR) in patients with Ascaris-, Trichuris- and hookworm infestations. 1985

Active substance: MEBENDAZOLE

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Document reference: 31549

Study title: The efficacy of rnebendazole in the treatment of enterobius 1973

Active substance: MEBENDAZOLE

Study summary document link (including results):

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Document reference: 31552

Study title: The use of Mebendazol in the treatment of enterobiasis

Active substance: MEBENDAZOLE

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Document reference: 31537

Study title: Therapeutical effectiveness and safety of 2% mebendazole syrup In various helminthiases. 1975

Active substance: MEBENDAZOLE

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Document reference: 31547

Study title: Baume P. Mebeverine, an effective agent in the irritable colon syndrome.; Aust N Z J Med. 1972 Feb;2(1):34-6.

Active substance: MEBEVERINE

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Document reference: 31555

Study title: Connell AM. Physiological and clinical assessment of the effect of the musculotropic agent mebeverine on the human colon.; Br Med J. 1965 Oct 9;2(5466):848-51.

Active substance: MEBEVERINE

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Document reference: 31556

Study title: Downey, L.J. A multicentre, double-blind, placebo-controlled study of the efficacy and acceptability of mebeverine liquid in the treatment of the irritable bowel syndrome of childhood. (Non-organic recurrent abdominal pain).; Duphar Report 1985 No. H. 103.905/M

Active substance: MEBEVERINE

Study summary document link (including results): Mebeverinr-H.103.905M.pdf

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Document reference: 31559

Study title: Bonati E.,Olivani P:F. Risultati preliminari sull’impiego nell’età pediatrica di un farmaco ad azione psicotropa Arch.Med.Int.,26(2),39,1974Bonati E.,Olivani P:F. Risultati preliminari sull’impiego nell’età pediatrica di un farmaco ad azione psicotropa Arch.Med.Int.,26(2),39,1974

Active substance: MINERALS AND VITAMINS

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Document reference: 32048

Study title: Cancemi G. La chetonuria nei bambini operati di adenotonsillectomia Boll.Mal.Orecchio,Gola,Nano, 87,307,1969Cancemi G. La chetonuria nei bambini operati di adenotonsillectomia Boll.Mal.Orecchio,Gola,Nano, 87,307,1969

Active substance: MINERALS AND VITAMINS

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Document reference: 32045

Study title: Falcone R.,Giannotti G.,Calenduccia A.,Mannino O. Impiego della Biochetasi fiale e bustine in pediatria Aggiorn.Pediat.,35(1),147-150,1984Falcone R.,Giannotti G.,Calenduccia A.,Mannino O. Impiego della Biochetasi fiale e bustine in pediatria Aggiorn.Pediat.,35(1),147-150,1984

Active substance: MINERALS AND VITAMINS

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Document reference: 32043

Study title: Clinical study of a new synthetic antimicrobial agent, Lomeflox-acin ophthalmic solution in bacterial external eye infections.Clinical study of a new synthetic antimicrobial agent, Lomeflox-acin ophthalmic solution in bacterial external eye infections.

Active substance: LOMEFLOXACIN

Study summary document link (including results):

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Document reference: 31346

Study title: Clinical study of the Pyridonecarboxylic Acid Antimicrobial Lomefloxacin ophthalmic solution Clinical study of the Pyridonecarboxylic Acid Antimicrobial Lomefloxacin ophthalmic solution

Active substance: LOMEFLOXACIN

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Document reference: 31344

Study title: Contrast of the effect of alomide and sodium cromoglycate in the treatment of allergic eye diseases. Zhang W, Lin Z. Yan Ke Xue Bao. 2000 Sep;16(3):214-6. Contrast of the effect of alomide and sodium cromoglycate in the treatment of allergic eye diseases. Zhang W, Lin Z. Yan Ke Xue Bao. 2000 Sep;16(3):214-6.

Active substance: LOMEFLOXACIN

Study summary document link (including results):

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Document reference: 31406

Study title: Efficacy of Lomefloxacin ophthalmic solution (NY-198) for infectous disease of outer segment of eyeEfficacy of Lomefloxacin ophthalmic solution (NY-198) for infectous disease of outer segment of eye

Active substance: LOMEFLOXACIN

Study summary document link (including results):

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Document reference: 31353

Study title: Efficacy of topical Lomefloxacin for external eye infectionEfficacy of topical Lomefloxacin for external eye infection

Active substance: LOMEFLOXACIN

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Document reference: 31350

Study title: Huguet P. Use of topically applied DR 1303 (lomefloxacin 0.3%) in comparison with ofloxacin 0.3% in the treatment of acute bacterial conjunctivitis. August 31, 1993.

Active substance: LOMEFLOXACIN

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Document reference: 31398

Study title: Jun Sugazawa, Department of Ophthalmology, Osaka Medical College, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infectionJun Sugazawa, Department of Ophthalmology, Osaka Medical College, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infection

Active substance: LOMEFLOXACIN

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Document reference: 31358

Study title: Jun Sugazawa, Department of Ophthalmology, Osaka Medical College, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.Jun Sugazawa, Department of Ophthalmology, Osaka Medical College, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31378

Study title: Jun Sugazawa, Department of Ophthalmology, Osaka Medical College, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.Jun Sugazawa, Department of Ophthalmology, Osaka Medical College, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31393

Study title: Prospektiver vergleich von miconazol-gel und nystatin-suspension in der therapie des mundsoorsProspektiver vergleich von miconazol-gel und nystatin-suspension in der therapie des mundsoors

Active substance: MICONAZOLE

Study summary document link (including results):

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Document reference: 31995

Study title: Immunogenicity studies on thermostable Rouvax vaccine

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

Study summary document link (including results):

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Document reference: 41241

Study title: Immunogenicity studies on thermostable Rouvax vaccine

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

Study summary document link (including results):

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Document reference: 41377

Study title: Immunogenicity trial of Edmonston-Zagreb, Schwarz and AIK-C strain measles vaccines given at different ages and at differents titers in Togolese children

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41246

Study title: Immunogenicity trial of Edmonston-Zagreb, Schwarz and AIK-C strain measles vaccines given at different ages and at differents titers in Togolese children

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41382

Study title: Immunogenicity trial of Rouvax vaccine with a new stabiliser in tunisian children

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41375

Study title: Persistence of antibodies five years after measles vaccination

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

Study summary document link (including results):

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Document reference: 41237

Study title: Persistence of antibodies five years after measles vaccination

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

Study summary document link (including results):

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Document reference: 41373

Study title: Randomized double blind, controlled trail on dose-Response of AIK-C strain measles vaccine among togolese children .

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41247

Study title: Randomized double blind, controlled trail on dose-Response of AIK-C strain measles vaccine among togolese children .

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41383

Study title: Serological response to measles vaccine (Schwartz strain) in relation to the age of the children, in low-income population at Rio de Janeiro

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41238

Study title: Immunogenicity and reactogenicity study of Rouvax vaccine in differents age-group children in France

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41376

Study title: Immunogenicity and safety of Rouvax vaccine in different age-group Thai children

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41378

Study title: Serological response to measles vaccine (Schwartz strain) in relation to the age of the children, in low-income population at Rio de Janeiro

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41374

Study title: Study of measles vaccination in child health centres in Paris

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41233

Study title: Study of measles vaccination in child health centres in Paris

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41369

Study title: Study of the humoral response and persistence of antibody titer to measles vaccination in relation with the age at vaccination

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41236

Study title: Study of the humoral response and persistence of antibody titer to measles vaccination in relation with the age at vaccination

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41372

Study title: Study with combenied meningococcal, measles and tetanus vaccine in Nigerian children

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41235

Study title: Study with combenied meningococcal, measles and tetanus vaccine in Nigerian children

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41371

Study title:

Active substance: Live attenuated measles, mumps, rubella, varicella vaccine

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Document reference: 47683

Study title: Etude des variations du Magnesium erythrocitaire et plasmatique dans les dystrophies muscularies - Astier-Dumas M et al - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Etude des variations du Magnesium erythrocitaire et plasmatique dans les dystrophies muscularies - Astier-Dumas M et al - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31508

Study title: European Commission Scientific Committee on Food. Opinion of the Scientific Commitee on Food on the tolerable upper intake leval of vitamin B6 (http : // europa.eu.int/comm/food/fs/sc/scf/index en.htlm) - 11/2000 - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -European Commission Scientific Committee on Food. Opinion of the Scientific Commitee on Food on the tolerable upper intake leval of vitamin B6 (http : // europa.eu.int/comm/food/fs/sc/scf/index en.htlm) - 11/2000 - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31509

Study title: Mastrangelo et al. 131I-metaiodobenzylguanidine in the treatment of neuroblastoma at diagnosisThe American journal of pediatric hematology/oncology (1989), 11(1), 28-31

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48323

Study title: Mastrangelo et al. Critical observations on neuroblastoma treatment with 131-Imetaiodobenzylguanidine at diagnosisMedical and pediatric oncology (1993), 21(6), 411-5

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48324

Study title: Modak et al. Transient sialoadenitis: a complication of 131I-metaiodobenzylguanidine therapyPediatric blood & cancer (2008), 50(6), 1271-3

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48325

Study title: Phase II study of high-dose [131I] metaiodobenzylguanidine therapy for patients with metastatic pheochromocytoma and paragangliomaJ Clin Oncol. 2009 Sep 1; 27(25):4162-8. Epub 2009 Jul 27

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48317

Study title: Schwabe et al. 131-Metaiodobenzylguanedine therapy of neuroblastoma in childhood.One year of therapeutic experience European journal of pediatrics (1987), 146(3), 246-50

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48327

Study title: Stable disease and improved health-related quality of life (HRQoL) following fractionated low dose 131I-metaiodobenzylguanidine (MIBG) therapy in metastatic paediatric paraganglioma: observation on false "reverse" discordance during pre-therapy work up and its implication for patient selection for high dose targeted therapyBasu et al.

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48310

Study title: Therapeutic use of 131I-metaiodobenzylguanidine (MIBG) in neuroblastoma: a phase II study in nine patientsMedical and pediatric oncology (1987), 15(4), 205-11

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48318

Study title: Treatment of advanced neuroblastoma with I-131 meta-iodobenzylguanidineCancer (1991), 67(4), 922-8

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48315

Study title: Grillage MG et al. A randomised, double-blind study of mebeverine versus dicyclomine in the treatment of functional abdominal pain in young adults.; Br J Clin Pract. 1990 May;44(5):176-9.

Active substance: MEBEVERINE

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Document reference: 31554

Study title: Martin, Dr. A.J. A multi-centre double-blind placebo controlled study of the efficacy and acceptability of the Mebeverine liquid in the treatment of the irritable bowel syndrome of childhood (non-organic recurrent abdominal pain); Duphar Report 1982 No. H.103.905

Active substance: MEBEVERINE

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Document reference: 31558

Study title: MEBEVERINE SUSPENSION. AMULTICENTRE BASELINE CONTROLLED STUDY IN CHILDREN WITH FUNCTIONAL DISORDERS OF THE GASTRO-INTESTINAL TRACT.

Active substance: MEBEVERINE

Study summary document link (including results): Mebeverine-H.103.5002M.pdf

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Document reference: 31560

Study title: Otte, RA. Medical report of a randomized, double-blind, placebo controlled study of Mebeverine liquid in the treatment of the acute symptoms of the irritable bowel syndrome of childhood (non-organic recurrent abdominal pain).; Duphar Report 1983

Active substance: MEBEVERINE

Study summary document link (including results): Mebeverine-H.103.907.pdf

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Document reference: 31557

Study title: Antibiotics in the treatment of gastroenteritis caused by enteropathgenic E. coli

Active substance: MECILLINAM

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Document reference: 31562

Study title: BASSALY M., BOROLOSSY A.W., MOUSA A.H. Oral therapy of urinary schistosomiasis with Lucanthone HCl. The effect of Meclizine HCl on the incidence of its side effects. J.EGYPT.MED.ASSOC. 1961. 44:704-11.

Active substance: MECLIZINE HYDROCHLORIDE

Study summary document link (including results): Bassaly.xls

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Document reference: 47882

Study title: FAGAN J.E., KAPLAN B.J., RAYMOND J.E., EDGINGTON E.S. & AL. The failure of antimotion sickness medication to improve reading in developmental dyslexia: results of a randomized trial. J.DEV.BEHAV.PEDIATR. DEC-1988. 9(6):359-366.

Active substance: MECLIZINE HYDROCHLORIDE

Study summary document link (including results): Fagan.xls

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Document reference: 47883

Study title: LEVINSON H.N. Dramatic favorable responses of children with learning disabilities or dyslexia and attention deficit disorder to antimotion sickness medications : four case reports. PERCEPT.MOT.SKILLS 1991. 73/3 PT 1,723-738

Active substance: MECLIZINE HYDROCHLORIDE

Study summary document link (including results): Levinson.xls

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Document reference: 47884

Study title:

Active substance: MECLOZINE

Study summary document link (including results): ADPE91M0302.pdf

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Document reference: 31564

Study title:

Active substance: MECLOZINE

Study summary document link (including results): PDEE92L0503.pdf

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Document reference: 31565

Study title:

Active substance: MECLOZINE

Study summary document link (including results): RAE90C1918P.pdf

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Document reference: 31566

Study title: "Comparison of an intravenous pulse of methylprednisolone versus oral corticosteroid in severe acute rheumatic carditis: a randomized clinical trial - Camara EJ - March 2002 (Cardiol Young 12(2):119-24) - Publication in CES0735-EN-E01 - Leonetti L - 29/09/2007 -"

Active substance: METHYLPREDNISOLONE

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Document reference: 31921

Study title: Controlled, double-blind group comparison of a twice daily (maximum 3 weeks) use of methylprednisolone aceponate 0.1 % cream and prednicarbate 0.25 % cream (Dermatop) in children with atopic dermatitis

Active substance: METHYLPREDNISOLONE

Study summary document link (including results): Bayer Intendis_Methylprednisolone Aceponate_87105_study_synopsis.pdf

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Document reference: 47736

Study title: "Corticosteroids improve survival of children with AIDS and Pneumocystis carinii pneumonia - Sleasman JW - 1993 (Am J Dis Child 147 30-34) - Publication in CER - Simons G - July 1997 -" Clinical Expert Report July 1997

Active substance: METHYLPREDNISOLONE

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Document reference: 31922

Study title: Double-blind, randomized, reference-controlled, multicenter, parallelgroup study to compare the efficacy and safety of Advantan ointment once daily with Protopic 0.03% ointment twice daily over maximum 3 weeks in 250 children and adolescents with atopic dermatitis

Active substance: METHYLPREDNISOLONE

Study summary document link (including results): Bayer Intendis_Methylprednisolone Aceponate_308962_study_synopsis.pdf

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Document reference: 47734

Study title: Kazuo Ichikawa, Department of Ophthalmology, Shakaihoken Chukyuuo Hospital, Lomefloxacin ophthalmic solution (NY-198) for bacterial external eye infection. No report date.Kazuo Ichikawa, Department of Ophthalmology, Shakaihoken Chukyuuo Hospital, Lomefloxacin ophthalmic solution (NY-198) for bacterial external eye infection. No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31374

Study title: Kazuo Ichikawa, Department of Ophthalmology, Shakaihoken Chukyuuo Hospital, Lomefloxacin ophthalmic solution (NY-198) for bacterial external eye infection. No report date.Kazuo Ichikawa, Department of Ophthalmology, Shakaihoken Chukyuuo Hospital, Lomefloxacin ophthalmic solution (NY-198) for bacterial external eye infection. No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31389

Study title: Kazuto Kajihara, Department of Ophthalmology Ohtahara Red Cross Hospital, Keio University School of Medicine, Clinical study of a new synthetic antimicrobial agent, Lomefloxacin ophthalmic solution in bacterial external eye infections. 1989-1990.Kazuto Kajihara, Department of Ophthalmology Ohtahara Red Cross Hospital, Keio University School of Medicine, Clinical study of a new synthetic antimicrobial agent, Lomefloxacin ophthalmic solution in bacterial external eye infections. 1989-1990.

Active substance: LOMEFLOXACIN

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Document reference: 31366

Study title: Slow-release 5-ASA therapy in children with small intestinal Crohn's disease; Griffits A et al J. of Pediatric Gastroent. and Nutrition, 1993,17:186-192 Slow-release 5-ASA therapy in children with small intestinal Crohn's disease; Griffits A et al J. of Pediatric Gastroent. and Nutrition, 1993,17:186-192

Active substance: MESALAZINE

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Document reference: 31632

Study title: Study to evaluate the clinical efficacy and tolerability of mesalazine in microgranules in the treatment of active ulcerative colitis, mild to moderate, and in maintenance in childrenStudy to evaluate the clinical efficacy and tolerability of mesalazine in microgranules in the treatment of active ulcerative colitis, mild to moderate, and in maintenance in children

Active substance: MESALAZINE

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Document reference: 31629

Study title: Symptoms of sulphasalazine or 5-aminosalicylic acid intolerance in children with ulcerative colitis; Iwaneczak B et al, Pediatria Polska, 1999, 74(8): 777-781Symptoms of sulphasalazine or 5-aminosalicylic acid intolerance in children with ulcerative colitis; Iwaneczak B et al, Pediatria Polska, 1999, 74(8): 777-781

Active substance: MESALAZINE

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Document reference: 31631

Study title: Treatment of IBD with oral 5-ASA (Pentasa) in the pediatric age group; Scagnelli GP et al, Gastroenterology (100, No 5, Pt.2, A248, 1991) Treatment of IBD with oral 5-ASA (Pentasa) in the pediatric age group; Scagnelli GP et al, Gastroenterology (100, No 5, Pt.2, A248, 1991)

Active substance: MESALAZINE

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Document reference: 31633

Study title: V. Tolia et al.. Oral 5-Aminosalicylic acid in children with colonic chronic inflammatory bowel disease: Clinical and pharmacokinetic experience. Journal of Pediatric Gastroenterology and Nutrition 8: 333-338, 1989 V. Tolia et al.. Oral 5-Aminosalicylic acid in children with colonic chronic inflammatory bowel disease: Clinical and pharmacokinetic experience. Journal of Pediatric Gastroenterology and Nutrition 8: 333-338, 1989

Active substance: MESALAZINE

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Document reference: 31634

Study title:

Active substance: MESNA

Study summary document link (including results): CE72D261 - Mesna.pdf

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Document reference: 31652

Study title: A phase II, open, case-controlled clinical study to assess the immunogenicity, reactogenicity and safety of a 2nd dose of GlaxoSmithKline Biologicals’ measles-mumps-rubella-varicella (MeMuRu-OKA) vaccine given in healthy children of 5 to 6 years of age

Active substance: Live attenuated measles, mumps, rubella, varicella vaccine

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Document reference: 47877

Study title: Kostromina V.P. et al: Estimation of detoxicational effects of antihomotoxic medicines in the treatment of children suffering from relapsing bronchitis and infected with mycobacteria. Biological Therapy (Ukraine), 2007, 3: 20-23 [IIT-publication]

Active substance: Lymphomyosot - Tropfen

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Document reference: 40060

Study title: Kostromina V.P. et al: Estimation of detoxicational effects of antihomotoxic medicines in the treatment of children suffering from relapsing bronchitis and infected with mycobacteria. Biological Therapy (Ukraine), 2007, 3: 20-23 [IIT-publication]

Active substance: Lymphomyosot - Tropfen

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Document reference: 40061

Study title: Krivopustov S.P., Domanskiy O.B: Effectiveness of antihomotoxic remedies to treat pediatric mesenterial adenitis patients. Biological Therapy (Ukraine), 2006, 1: 30-32 [IIT-publication]

Active substance: Lymphomyosot - Tropfen

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Document reference: 40059

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Lymphomyosot (drops) [AWB-AT]

Active substance: Lymphomyosot - Tropfen

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Document reference: 40062

Study title: Rinneberg, Anna-Luisa: Behandlung und Rezidivprophylaxe der Tonsillitis mit Lymphomyosot. Biol Med 1988;(17):179-182 [IIT-publication]

Active substance: Lymphomyosot - Tropfen

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Document reference: 40065

Study title: Samoilenko I.G.,Yulish E.I., Gadetskaya S.G., Buchtiarov E.V.: New approach to treat pediatric patients suffering from bronchial asthma associated with intracellular infection. Biological Therapy (Ukraine), 2006, 4: 10-13 [IIT-publication]

Active substance: Lymphomyosot - Tropfen

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Document reference: 40057

Study title: Seniuta L.M: Efficiency of nosodes in the treatment of infants suffering from complicated pneumonia. Biological Therapy (Ukraine), 2006, 1: 26-29 [IIT-publication]

Active substance: Lymphomyosot - Tropfen

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Document reference: 40058

Study title: Bereznoi V.V., Marushko T.V., Orliuk I.B. et al.: Application of antihomotoxic preparations in the combined treatment of rheumatoid arthritis in pediatric patients.Biological Therapy (Ukraine), 2004, 1: 23-27 [IIT-publication]

Active substance: Lymphomyosot - Tropfen

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Document reference: 40056

Study title: Godovanetz Yu.D., et al: Effectiveness of antihomotoxic therapy in the correction of neurological and metabolical impairments in newborns suffered from perinatal hypoxic stress. Biological Therapy (Ukraine), 2004, 2: 16-23 and 3-4: 36-45 [IIT-publication

Active substance: Lymphomyosot - Tropfen

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Document reference: 40063

Study title: Venomenhal Bee/Wasp. Observational cohort study

Active substance: Lyophilised bee venom/ Lyophilised wasp venom

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Document reference: 39789

Study title: Beclomethasone dipropionate versus budesonide inhalation suspension in children with mild to moderate persistent asthma. (Terzano C Allegra L Barkai L , Cremonesi G. Eur Rev Med Pharmacol Sci. 2000, 4:17-24.)

Active substance: MADIPIDINE

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Document reference: 31480

Study title: Double-blind, multinational, multicentre, parallel-group, placebo-controlled design clinical trial of the efficacy and safety of nebulized beclomethasone dipropionate (400 mcg b.i.d.) plus as needed salbutamol versus as needed salbutamol or as needed salbutamol/beclomethasone fixed combination, in the 12-week treatment of young childrem with asthma symptoms.

Active substance: MADIPIDINE

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Document reference: 31478

Study title: Once daily nebulized beclomethasone is effective in maintaining pulmonary function and improving symptoms in asthmatic children. La Grutta S , Nicolini G, Capristo C, Bellodi SC, Rossi GA (Monaldi Arch Chest Dis. 2007 Mar;67:30-8.)

Active substance: MADIPIDINE

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Document reference: 31479

Study title:

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31503

Study title: Comparative study of an acellular (P.M.sv.) and a whole cell (Wellcome) Pertussis vaccines com bined with Diphtheria and Tetanus vaccines in healthy infants according to 2 schedules in the U.K.

Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed.

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Document reference: 41410

Study title: Treatment of neuroblastoma with 131I-metaiodobenzylguanidine: the experience of an Italian Study GroupBestagno et al.

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48312

Study title: Van Hasselt et al. Pretreatment with [131I] metaiodobenzylguanidine and surgical resection of advanced neuroblastoma, European journal of pediatric surgery official journal of Austrian Association of Pediatric Surgery = Zeitschrift fur Kinderchirurgie (1996), 6(3), 155-8

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48328

Study title: Whole-body dosimetry for individualized treatment planning of 131I-MIBG radionuclide therapy for neuroblastomaBuckley S

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): Buckley S 2009.pdf

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Document reference: 48313

Study title: Antipyretic efficacy and tolerability of oral ibuprfen, oral dipyrone and intramuscular dipyrone in children:a randomized controlled trial - Prado J. et al. - 2006 (Sao Paulo Med, 124(3):135-140) - Publication in CES EXPRC-CES0691-EN-E01 -

Active substance: METAMIZOLE

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Document reference: 31711

Study title: The prolongation of the EPAAC(TM) trial (early prevention of asthma in atopic children), a multi-country, double-blind, placebo controlled, follow-up trial with 3 parallel groups (lctz-lctz, lctz-plc and plc-plc): evaluating the long term efficacy and safety of levocetirizine (5 mg/ml oral drops - 0.125 mg/kg b.w. b.i.d.) administered for an additional 18-month period in preventing the onset of asthma in children coming from the epaactm trial (A00309).

Active substance: LEVOCETIRIZINE

Study summary document link (including results): ARVD02J2302 - Levocetirizine.pdf

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Document reference: 31150

Study title: The prolongation of the EPAAC™ trial (Early Prevention of Asthma in Atopic Children), a multi-country, double-blind, placebo controlled, follow-up trial with 3 parallel groups (LCTZ-LCTZ, LCTZ-PLC and PLC-PLC) : Evaluating the long term efficacy and safety of levocetirizine (5 mg/mL oral drops - 0.125 mg/kg b.w. b.i.d.) administered for an additional 18-month period in preventing the onset of asthma in children coming from the EPAAC™ trial (A00309)

Active substance: LEVOCETIRIZINE

Study summary document link (including results): A00384 - Levocetirizine - RPCE04B0203.pdf

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Document reference: 47307

Study title: A Multiclinic Study of the Efficacy, Safety Tolerance and Pharmacology of a Range of Doses of PRIMAXIN (MK0787/MK0791) or Imipenem/Cilastatin in low Birth weight (LBW) Infants.

Active substance: LEVODROPROPIZINE

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Document reference: 31160

Study title: A Study of the Efficacy, Pharmaco-kinetics, Safety and Tolerability of Intravenously Administered Multiple doses of MK-787/MK-791 in Neonates, including Premature Infants.

Active substance: LEVODROPROPIZINE

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Document reference: 31161

Study title: A Study of the Pharmacology Profile, Safety and Tolerability of Intravenously Administered Single and Multiple Doses of MK0787/MK0791 in Neonates.

Active substance: LEVODROPROPIZINE

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Document reference: 31159

Study title: Humanitarian Use of Imipenem/Cilastatin Sodium in Neonates.Corboz RJ. Klinische Aspekte depressiver Zustände. Helv. Paediat. Acta 1983; 38: 425-437

Active substance: LEVODROPROPIZINE

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Document reference: 31162

Study title: Paradis B. Analgesic and Anaesthetic Properties of Levomepromazine (Nozinan) (R.P. 7044). Canad Anaesth Soc J 1962; 9/2: 153-160Paradis B. Analgesic and Anaesthetic Properties of Levomepromazine (Nozinan) (R.P. 7044). Canad Anaesth Soc J 1962; 9/2: 153-160

Active substance: LEVODROPROPIZINE

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Document reference: 31163

Study title: Methylprednisolone aceponate milk (1x daily for 14 days): Its efficacy and tolerance in comparison to Alfason® Crelo (2x daily) in the treatment of acute eczema in children.

Active substance: METHYLPREDNISOLONE

Study summary document link (including results): Bayer Intendis_Methylprednisolone Aceponate_93116_study_synopsis.pdf

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Document reference: 47735

Study title: "Nisli G et al . (1993) . High dose intravenous methylprednisolone therapy in hematological disorders in childhood . Doga-Tr.J.ofMedical Sciences 17 :313-6." "Nisli G et al . (1993) . High dose intravenous methylprednisolone therapy in hematological disorders in childhood . Doga-Tr.J.ofMedical Sciences 17 :313-6."

Active substance: METHYLPREDNISOLONE

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Document reference: 31923

Study title: "Özsoylu S et al . (1984) . High dose intravenous glucocorticoid in the treatment of childhood acquired aplastic anaemia . Scand J Haematol 33(3) :309-16." "Özsoylu S et al . (1984) . High dose intravenous glucocorticoid in the treatment of childhood acquired aplastic anaemia . Scand J Haematol 33(3) :309-16."

Active substance: METHYLPREDNISOLONE

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Document reference: 31924

Study title: Rosthoj S et al. (1996). Randomized trial comparing intravenous immunoglobulin with methylprednisolone pulse therapy in acute idiopathic thrombocytopenic purpura . Danish I .T .P. Study Group. Acta Paediatr 85(8):910-5.Rosthoj S et al. (1996). Randomized trial comparing intravenous immunoglobulin with methylprednisolone pulse therapy in acute idiopathic thrombocytopenic purpura . Danish I .T .P. Study Group. Acta Paediatr 85(8):910-5.

Active substance: METHYLPREDNISOLONE

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Document reference: 31925

Study title: Rubin BK, Marcushamer S, Priel I, App EM . (1990) . Emergency management of the child with asthma [published erratum appears in Pediatr Pulmonol 1990 ;8(3):219-20].Pediatr Pulmonol 8(1) :45-57. Rubin BK, Marcushamer S, Priel I, App EM . (1990) . Emergency management of the child with asthma [published erratum appears in Pediatr Pulmonol 1990 ;8(3):219-20].Pediatr Pulmonol 8(1) :45-57.

Active substance: METHYLPREDNISOLONE

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Document reference: 31926

Study title: Sarna S, Hoppu K, Holmberg C . (1996) . Relation of methylprednisolone pharmacokinetics to adrenal suppression in children with liver transplants . Horm Res 46 :90 Sarna S, Hoppu K, Holmberg C . (1996) . Relation of methylprednisolone pharmacokinetics to adrenal suppression in children with liver transplants . Horm Res 46 :90

Active substance: METHYLPREDNISOLONE

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Document reference: 31927

Study title: EMLA cream 5% for removal of mollusca. A clinical study of plasma concentrations of lidocaine and prilocaine and analgesic effect in children.

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 19_86EM13 CSR Synopsis.pdf

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Document reference: 47239

Study title: EMLA cream for the removal of mollusca contagiosa on patients with atopic dermatitis.

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 27_86-EM14 CSR Synopsis.pdf

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Document reference: 47233

Study title: Epicutaneous application of EMLA in newborn children. An open, clinical investigation of blood concentrations of methaemoglobin and plasma concentrations of prilocaine and lidocaine. Part I: Full term infants.

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 22_85-EM15 (Part I) CSR Synopsis.pdf

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Document reference: 31239

Study title: Epicutaneous application of EMLA in newborn children. An open, clinical investigation of blood concentrations of methaemoglobin and plasma concentrations of prilocaine and lidocaine. Part II: Full term infants.

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 23_85-EM15 (Part II) CSR Synopsis.pdf

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Document reference: 47222

Study title: Evaluate the pain relieving effect of EMLA Cream in oriental infants and possible adverse reactions.

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 01_83-P013 CSR Synopsis.pdf

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Document reference: 47223

Study title:

Active substance: MESNA

Study summary document link (including results): DF81J183 - Mesna.pdf

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Document reference: 31654

Study title:

Active substance: MESNA

Study summary document link (including results): DF73D061 - Mesna.pdf

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Document reference: 31655

Study title: Randomised comaprison of olsalazine and mesalazine in prevention of relapses in ulcerative colitis

Active substance: MESALAZINE

Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication - Asavixin (Mesalazine).pdf

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Document reference: 47626

Study title:

Active substance: MESNA

Study summary document link (including results): DF78K104S - Mesna.pdf

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Document reference: 31667

Study title: Clinical experience with a new mucolytic.

Active substance: MESNA

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Document reference: 31663

Study title: Clinical study of ucb 3983 as aerosols.

Active substance: MESNA

Study summary document link (including results): DE75G314 - Mesna.pdf

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Document reference: 31658

Study title: Effect of inhaled azidocillin, mistabron and combination therapy in children with cystic fibrosis.

Active substance: MESNA

Study summary document link (including results): DE84H032C - Mesna.pdf

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Document reference: 31671

Study title: Effect of inhaled azlocillin, mistabron and combination therapy in children with c.f.

Active substance: MESNA

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Document reference: 31673

Study title: Etude de l'activite therapeutique du mucofluid enquete clinique multi-centre

Active substance: MESNA

Study summary document link (including results): CF77F224 - Mesna.pdf

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Document reference: 31651

Study title: Etude in vivo de l’activite mucolytique du mesna (mucofluid spray nasal a 2,5 %) + analyse statistique.

Active substance: MESNA

Study summary document link (including results): CE69L071 - Mesna.pdf

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Document reference: 31656

Study title: General and regional lung function in relation to the inhalatory mucolytic treatment.

Active substance: MESNA

Study summary document link (including results): DE80H066C - Mesna.pdf

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Document reference: 31682

Study title: General and regional lung function in relation to the inhalatory mucolytic treatment.

Active substance: MESNA

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Document reference: 31684

Study title: Brief report : an open middle term study of combined vitamin B6 - Magnesium in a subgroup of autistic children selected on their sensitivity to this treatment - J. Martineau et al. - 1988 ( Journal of Autitism and Developmental disorders vol 18) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

Study summary document link (including results): Mg lactate_mg pidolate_pyridoxine chlorhydrate STUDY 246-6-004.xls

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Document reference: 31504

Study title: Humoral antibody responses to a biannual multiantigen vaccination: report of a field trial on children in Sudan.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41262

Study title: Immunogenicity of meningococcal A + C vaccine in Naval recruits.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41264

Study title: Impact of a mass immunization campaign against serogroup C meningococcus in the Province of Quebec, Canada.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

Study summary document link (including results): link to document

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Document reference: 41253

Study title: Incidence of reactions to meningococcal A + C vaccine among U. K. school children.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41255

Study title: Meningococcal C polysaccharide vaccine induces immunologic hyporesponsiveness in adults that is overcome by meningococcal C conjugate vaccine.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41266

Study title: Mucosal immune responses to meningococcal groupe C conjugate and group A and C polysaccharide vaccines in adolescents.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41267

Study title: Prevention of secondary cases of meningococcal disease in household contacts by vaccination.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

Study summary document link (including results): link to document

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Document reference: 41274

Study title: Results of a vaccination campaign in Brazil (1974 - 1975) using the meningococcal polysaccharide A + C vaccine.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41272

Study title: Serogroups A and C meningococcal polysaccharide vaccine. Clinical expert report.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41260

Study title: Study with combined meningococcal vaccines. II. A combined meningococcal and tetanus vaccine.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41261

Study title: Targeted vaccination with meningococcal polysaccharide vaccine in one district of the Czech Republic.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

Study summary document link (including results): link to document

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Document reference: 41252

Study title: The immunological responses observed in field studies in Africa with group A meningococcal vaccines

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41259

Study title: The persistence of antibodies induced by meningococcal polysaccharides of groups A and C in human volunteers.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41263

Study title: Tolerance and immunogenicity of a new combined meningococcal (A + C) - Yellow Fever vaccine.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41265

Study title: A Multicenter, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Levofloxacin in the Treatment of Children Who Have RecUlTent and/or Persistent Acute Otitis Media

Active substance: Levofloxacin

Study summary document link (including results): LO FBO-OTMD-002.pdf

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Document reference: 45233

Study title: A Multicenter, Randomized, Open-Label, Comparative Study to Compare the Efficacy and Safety of Levofloxacin and Standard of Care Therapy in the Treatment of Children With Community-Acquired Pneumonia in the Hospitalized or Outpatient Setting

Active substance: Levofloxacin

Study summary document link (including results): LOFBIV-PCAP-003.pdf

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Document reference: 45231

Study title: An Open-Label Single Oral Dose Study to Evaluate the Safety and Pharmacokinetics of Levofloxacin Suspension Formulation in Infants and Children (~ 16 Years of Age)

Active substance: Levofloxacin

Study summary document link (including results): LOFBO-PHI-l10.pdf

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Document reference: 45235

Study title: An Open-Label Study of Levofloxacin to Evaluate Bacteriologic Outcome in the Treatment of Children Who are at Risk for Acute Otitis Media That is Difficult to Treat

Active substance: Levofloxacin

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Document reference: 45232

Study title: Pharmacokinetics and Middle Ear Fluid Penetration of Levofloxacin in Children Undergoing Tympanostomy Tube Placement for Serious Otitis Media

Active substance: Levofloxacin

Study summary document link (including results): LOFBO-PHI-I09.pdf

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Document reference: 45234

Study title: Uchida Y et al. Phase II study of NY-198 ophthalmic solution in multicenter double-blind design; Phase II study of NY-198 ophthalmic solution. No report date. Amendment to clinical trial report by Dr. A. Jauch, January 4, 1994, + Appendix 1 and 2.Uchida Y et al. Phase II study of NY-198 ophthalmic solution in multicenter double-blind design; Phase II study of NY-198 ophthalmic solution. No report date. Amendment to clinical trial report by Dr. A. Jauch, January 4, 1994, + Appendix 1 and 2.

Active substance: LOMEFLOXACIN

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Document reference: 31381

Study title: Uchida Y. Clinical efficacy of topical lomefloxacin (NY-198) in bacterial infections of the external eye – A multicenter double-blind phase III study. No report date.Uchida Y. Clinical efficacy of topical lomefloxacin (NY-198) in bacterial infections of the external eye – A multicenter double-blind phase III study. No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31382

Study title: Umemura T, Tanimoto Y, Ilzuka T, Ynagita T, Sasa H, Suzuki S, Kamil M. Teratological study of NY-198 in rabbits, a preliminary 2-week study. 1987, Internal Report. Teratological study of NY-198 in rabbits by administration during fetal organogenesis. 1987. Internal Report.

Active substance: LOMEFLOXACIN

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Document reference: 31402

Study title: Voutilainen R et al. Masked clinical trial between lomefloxacin 0.3% (DR 1303) eye drops and fusidic acid 1% in patients with acute bacterial conjunctivitis. October 4, 1994.

Active substance: LOMEFLOXACIN

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Document reference: 31396

Study title: Willoughby CR, Tesh JM, McAnulty PA, Higgins C, Tesh SA, Wilby OK. Peri- and postnatal study in the rat (segment III). 1986. Internal Report

Active substance: LOMEFLOXACIN

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Document reference: 31401

Study title: Willoughby CR, Tesh JM, McAnulty PA, Higgins C, Wilby OK, Tesh SA. Reproductive function and fertility study of NY-198 in the rat (segment I). 1987. Internal report.

Active substance: LOMEFLOXACIN

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Document reference: 31399

Study title: Yasyski Morikawa, Teruo Nishida and Toshifumi Otori, Department of Ophthalmology, Kinki University, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198). No report date.Yasyski Morikawa, Teruo Nishida and Toshifumi Otori, Department of Ophthalmology, Kinki University, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198). No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31371

Study title: Yasyski Morikawa, Teruo Nishida and Toshifumi Otori, Department of Ophthalmology, Kinki University, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198). No report date.Yasyski Morikawa, Teruo Nishida and Toshifumi Otori, Department of Ophthalmology, Kinki University, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198). No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31386

Study title: Evaluation of analgesic effect and tolerability of EMLA Cream 5% in the laser treatment of port wine stains. Multicentre, randomised, double-blind versus placebo.

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 28_EM 9301 CSR Synopsis.pdf

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Document reference: 47232

Study title: Evaluation of Emla 5% Cream for Alleviation of Pain in Connection with Tetanus Vaccination in School Children. 83P027

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 26_83-P027 CSR Synopsis.pdf

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Document reference: 47234

Study title: Evaluation of the Safety of EMLA Cream 5% on Intact Skin of Full-term Neonates

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 16_95EM24 CSR Synopsis.pdf

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Document reference: 47242

Study title: Lidocaine/prilocaine Cream (EMLA(R) Versus Infiltration Anaesthesia: A Comparison of the Analgesic Efficacy for Punch Biopsy and Electrocoagulation of Genital Warts in Men

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 32_86-EM26 CSR Synopsis.pdf

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Document reference: 47228

Study title: Open clinical investigation of plasma levels of prilocaine and lidocaine after the dermal application of EMLA to children aged between 2 and 3 years

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 18_86EM16 CSR Synopsis.pdf

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Document reference: 47240

Study title: Plasma concentrations of prilocaine and lidocaine and methaemoglobin formation in infants after dermal application of a 5% lidocaine-prilocaine cream (EMLA).

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 17_84-EM02 CSR Synopsis.pdf

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Document reference: 47241

Study title: The Safety and Efficacy of EMLA® for Anaesthesia in Neonates prior to Venous Puncture

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 12_051-50 CSR Synopsis.pdf

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Document reference: 47246

Study title: Topical analgesia with EMLA cream for curettage of molluscum contagiosum in children. 85-EM24

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 30_85EM24 CSR Synopsis.pdf

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Document reference: 47230

Study title: Multi-centre, double-blind, randomised, placebo-control, dose-response, 4 parallel groups, 72-hour study.

Active substance: loperamide oxide

Study summary document link (including results): LMD84718_Interventional_Loperamide oxide.xls

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Document reference: 47587

Study title: A Retrospective Analysis of the Effect of Kaletra (lopinavir/ritonavir) Compared with Viracept (nelfinavir) and Norvir (ritonavir) in HIV-Infected Pediatric Patients - Switzerland

Active substance: lopinavir / ritonavir

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Document reference: 41523

Study title: ABT-378/r (ABT-378/ritonavir) Brun et al. ABT-378/r (ABT-378/ritonavir) Early Access Program

Active substance: lopinavir / ritonavir

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Document reference: 41520

Study title: An international study on the treatment of NRTI-experienced HIV-infected children

Active substance: lopinavir / ritonavir

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Document reference: 41526

Study title: De Luca M, Miccinesi G, Chiappini E, Zappa M, Galli L, De Martino M. Different kinetics of immunologic recovery using nelfinavir or lopinavir/ritonavir-based regimens in children with perinatal HIV-1 infection. Int J Immunopathol Pharmacol. 2005 Oct-Dec;18(4):729-35.De Luca M, Miccinesi G, Chiappini E, Zappa M, Galli L, De Martino M. Different kinetics of immunologic recovery using nelfinavir or lopinavir/ritonavir-based regimens in children with perinatal HIV-1 infection. Int J Immunopathol Pharmacol. 2005 Oct-Dec;18(4):729-35.

Active substance: lopinavir / ritonavir

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Document reference: 41532

Study title: Reflex increase in blood pressure during the intracoronary administration of adenosine in Man - Cox D et al. - 1989 ( J. Clin. Invest, 84, 592-596)Reflex increase in blood pressure during the intracoronary administration of adenosine in Man - Cox D et al. - 1989 ( J. Clin. Invest, 84, 592-596)

Active substance: ADENOSINE

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Document reference: 46303

Study title: Ifosfamide (IFO) is an active drug in Wilms´tumor (WT). A phase II Study of the French Society of Pediatric Oncology. (Demeoq, F. et al. - Proc. Ann. Meet. Am. Soc. Clin. Oncol. 5 (1986): Abstr. 8000)Ifosfamide (IFO) is an active drug in Wilms´tumor (WT). A phase II Study of the French Society of Pediatric Oncology. (Demeoq, F. et al. - Proc. Ann. Meet. Am. Soc. Clin. Oncol. 5 (1986): Abstr. 8000)

Active substance: MESNA

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Document reference: 31646

Study title: Influence of mistabron on the viscoelasticity of tracheo- bronchial secretions in children with cystic fibrosis

Active substance: MESNA

Study summary document link (including results):

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Document reference: 31665

Study title: Intensive therapy of status asthmaticus in children

Active substance: MESNA

Study summary document link (including results): DE77K187P - Mesna.pdf

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Document reference: 31679

Study title: Safety and efficacy comparison of emedastine 0.05% ophthalmic solution compared to levocabastine 0.05% ophthalmic suspension in pediatric subjects with allergic conjunctivitis. Acta Ophthalmica Scandinavica 78, p.42-47,2000Safety and efficacy comparison of emedastine 0.05% ophthalmic solution compared to levocabastine 0.05% ophthalmic suspension in pediatric subjects with allergic conjunctivitis. Acta Ophthalmica Scandinavica 78, p.42-47,2000

Active substance: LEVOCABASTINE

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Document reference: 31135

Study title: Single-blind comparison of levocabastine eye drops with sodium cromoglycate eye drops in the treatment of season allergic conjunctivitis (15-59 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62436_Interventional_Levocabastine.xls

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Document reference: 31097

Study title: The effect of levocabastine compared with sodium cromoglycate in patients with both birch and grass pollen allergy

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD125356_Interventional_Levocabastine.xls

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Document reference: 31068

Study title: The effect of levocabastine nasal spray in nasal provocation test (14-60 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62438_Interventional_Levocabastine.xls

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Document reference: 31075

Study title: The efficacy and safety of levocabastine eye drops in grass and birch pollinosis (17-52 yrs)

Active substance: LEVOCABASTINE

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Document reference: 31113

Study title: The efficacy of levocabastine eye drops in birch pollinosis a double-blind comparison with sodium cromoglycate in the area surrounding Linköping, Motala and Mjölby (6-19 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62429_Interventional_Levocabastine.xls

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Document reference: 31106

Study title: The efficacy of levocabastine eye drops inn birch pollinosis: a double-blind comparison with sodium cromoglycate in the area surrounding Umeå (7-19 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62121_Interventional_Levocabastine.xls

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Document reference: 31107

Study title: The role of L-carnitine in pediatric cardiomyopathy. Winter S, Jue K, Prochazka J, Frances P, Hamilton W, Linn L, Helton E. J Child Neurol. 1995 Nov; 10 Suppl 2: S45-51.The role of L-carnitine in pediatric cardiomyopathy. Winter S, Jue K, Prochazka J, Frances P, Hamilton W, Linn L, Helton E. J Child Neurol. 1995 Nov; 10 Suppl 2: S45-51.

Active substance: LEVOCABASTINE

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Document reference: 31139

Study title: The therapeutic value of levocabastine eye drops in the treatment of allergic conjunctivitis: a double, placebo-controlled dose-finding study (6-72 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62492_Interventional_Levocabastine.xls

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Document reference: 31101

Study title: A double-blind, randomised crossover trial to compare the efficacy of SARNA Lotion with Eurax Lotion in patients with generalised pruritus as a consequence of renal disease (uraemic pruritis).

Active substance: MENTHOL/CAMPHOR

Study summary document link (including results): Article 45_Ref_C0147_Final For Submission_27 Oct 2011.xlsx

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Document reference: 40067

Study title: Strotzka H. Die Kombinationsbehandlung der behandlungsresistenten Epilepsie. Wien Med Wochenschr 1951; 101/24-25: 465-468Strotzka H. Die Kombinationsbehandlung der behandlungsresistenten Epilepsie. Wien Med Wochenschr 1951; 101/24-25: 465-468

Active substance: MEPHENYTOIN

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Document reference: 31605

Study title: Susceptibility to antifungal agents of Candida species isolated from paediatric and adult patients with haematological diseases; U. Nawrot, J. Nowicka, K. Juszczak and B. Gusin; 2005 Mycoses, 48, 385–390Susceptibility to antifungal agents of Candida species isolated from paediatric and adult patients with haematological diseases; U. Nawrot, J. Nowicka, K. Juszczak and B. Gusin; 2005 Mycoses, 48, 385–390

Active substance: MICONAZOLE

Study summary document link (including results): nawrot_miconazole.pdf

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Document reference: 47618

Study title: Treatment of oropharyngeal candidiasis and candidal diaper dermatitis in neonates and infants: review and reappraisalTreatment of oropharyngeal candidiasis and candidal diaper dermatitis in neonates and infants: review and reappraisal

Active substance: MICONAZOLE

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Document reference: 31997

Study title: An exploratory unblinded trail of Levovist (SH U 508A) used in B-mode sonography in comparison with radiologically monitored voiding cystourethrography in diagnosis of vesicoureterorenal reflux in children (with subsequent blinded reading of the results)

Active substance: MICROPARTICLES OF GALACTOSE

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Document reference: 31999

Study title: Open, uncontrolled dose finding study with SH U 454 as an echocardiographic contrast agent for clarification of congenital malformations involving the right heart in patients from 0 - 18 years

Active substance: MICROPARTICLES OF GALACTOSE

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Document reference: 32000

Study title: de Gast-Bakker, D.A., et al., Age is of influence on midazolam requirements in a paediatric intensive care unit. Acta Paediatr, 2007. 96(3): p. 414-7. 2.de Gast-Bakker, D.A., et al., Age is of influence on midazolam requirements in a paediatric intensive care unit. Acta Paediatr, 2007. 96(3): p. 414-7. 2.

Active substance: MIDAZOLAM

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Document reference: 32001

Study title: Dorman, M.L., et al., Is intravenous conscious sedation for surgical orthodontics in children a viable alternative to general anaesthesia?--a case review. Br Dent J, 2007. 202(11): p. E30. Dorman, M.L., et al., Is intravenous conscious sedation for surgical orthodontics in children a viable alternative to general anaesthesia?--a case review. Br Dent J, 2007. 202(11): p. E30.

Active substance: MIDAZOLAM

Study summary document link (including results):

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Document reference: 32002

Study title: Hayashi, K., et al., Efficacy of intravenous midazolam for status epilepticus in childhood. Pediatr Neurol, 2007. 36(6): p. 366-72. 4. Hayashi, K., et al., Efficacy of intravenous midazolam for status epilepticus in childhood. Pediatr Neurol, 2007. 36(6): p. 366-72. 4.

Active substance: MIDAZOLAM

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Document reference: 32003

Study title: Kain, Z.N., et al., Effects of age and emotionality on the effectiveness of midazolam administered preoperatively to children. Anesthesiology, 2007. 107(4): p. 545-52Kain, Z.N., et al., Effects of age and emotionality on the effectiveness of midazolam administered preoperatively to children. Anesthesiology, 2007. 107(4): p. 545-52

Active substance: MIDAZOLAM

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Document reference: 32004

Study title: Lucas da Silva, P.S., et al., Procedural sedation for insertion of central venous catheters in children: comparison of midazolam/fentanyl with midazolam/ketamine. Paediatr Anaesth, 2007. 17(4): p. 358-63. 6. Lucas da Silva, P.S., et al., Procedural sedation for insertion of central venous catheters in children: comparison of midazolam/fentanyl with midazolam/ketamine. Paediatr Anaesth, 2007. 17(4): p. 358-63. 6.

Active substance: MIDAZOLAM

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Document reference: 32005

Study title: Yoshie Ishiryu, Katsuhiro Suzuki, Department of Ophthalmology, Fukushima Medical College, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in bacterial external eye infections. No report date.Yoshie Ishiryu, Katsuhiro Suzuki, Department of Ophthalmology, Fukushima Medical College, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in bacterial external eye infections. No report date.

Active substance: LOMEFLOXACIN

Study summary document link (including results):

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Document reference: 31375

Study title: Yuichi Ohashi, Department of Ophthalmology, Osaka University Medical School, Efficacy of topical Lomefloxacin for external eye infection. No report date.Yuichi Ohashi, Department of Ophthalmology, Osaka University Medical School, Efficacy of topical Lomefloxacin for external eye infection. No report date.

Active substance: LOMEFLOXACIN

Study summary document link (including results):

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Document reference: 31370

Study title: Yuichi Ohashi, Department of Ophthalmology, Osaka University Medical School, Efficacy of topical Lomefloxacin for external eye infection. No report date.Yuichi Ohashi, Department of Ophthalmology, Osaka University Medical School, Efficacy of topical Lomefloxacin for external eye infection. No report date.

Active substance: LOMEFLOXACIN

Study summary document link (including results):

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Document reference: 31385

Study title:

Active substance: LOPERAMIDE

Study summary document link (including results): LMD79271_Interventional_Loperemide oxide.xls

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Document reference: 47582

Study title: Extract of submission to the UK's Food Standards Agency - P. Holford et al. - 2003 (Journal of Orthomolecular Medicine vol 18) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Extract of submission to the UK's Food Standards Agency - P. Holford et al. - 2003 (Journal of Orthomolecular Medicine vol 18) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31510

Study title: Furosemide and mannitol suppressionof epileptic activity in the human brain (please refer to this study by its PMID: 15728766) Furosemide and mannitol suppressionof epileptic activity in the human brain (please refer to this study by its PMID: 15728766)

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31522

Study title: Institute of Medicine (US). Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Food and Nutrition Board. Dietary Reference Intakes for folate, other B vitamins, and choline. - No author - 1999 (Washington DC : National Academy Press) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Institute of Medicine (US). Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Food and Nutrition Board. Dietary Reference Intakes for folate, other B vitamins, and choline. - No author - 1999 (Washington DC : National Academy Press) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised dur...

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31511

Study title: MAGNE B6 - solution buvable - Rapport d'expertise clinique complémentaireMAGNE B6 - solution buvable - Rapport d'expertise clinique complémentaire - Dr Ch. BLATRIX 11.04.72

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

Study summary document link (including results): Magnesium lactate, pyridoxine chlorhydrate STUDY 246.6.004.xls

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Document reference: 31512

Study title: A multicenter, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of zafirlukast (Accolate) and loratadine in subjects with seasonal allergic rhinitis - 9188IL0126

Active substance: ZAFIRLUKAST

Study summary document link (including results): 9188L0126 Summary.pdf

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Document reference: 45595

Study title:

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33648

Study title: Drug Metabolism Report No. 35: Tabulation of Plasma Concentration Data for a Four-Week Oral Toxicity Study of Abbott-157378 in Combination with Ritonavir (Abbott-84538) in Immature (Juvenile) RatsDrug Metabolism Report No. 35: Tabulation of Plasma Concentration Data for a Four-Week Oral Toxicity Study of Abbott-157378 in Combination with Ritonavir (Abbott-84538) in Immature (Juvenile) Rats

Active substance: lopinavir / ritonavir

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Document reference: 41524

Study title: HIV-NAT 017: Lopinavir with saquinavir in HIV-infected children: PK and 2-year treatment follow-up

Active substance: lopinavir / ritonavir

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Document reference: 41525

Study title: Jullien V, Urien S, Hirt D, Delaugerre C, Rey E, Teglas JP, Vaz P, Rouzioux C, Chaix ML, Macassa E, Firtion G, Pons G, Blanche S, Tréluyer JM. Population analysis of weight-, age-, and sex-related differences in the pharmacokinetics of lopinavir in children from birth to 18 years.Antimicrob Agents Chemother. 2006; Nov;50(11):3548-55. Epub 2006 Aug 28.

Active substance: lopinavir / ritonavir

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Document reference: 21187

Study title: Phase I trial of the effectiveness and safety of loperamide oxide in the treatment of diarrhoea resulting from different pathophysiological mechanisms (12-75 yrs)

Active substance: LOPERAMIDE AND SIMETICONE

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Document reference: 31448

Study title: Kline MW, Rugina S, Ilie M, Matusa RF, Schweitzer AM, Calles NR, Schwarzwald HL. Long-term follow-up of 414 HIV-infected Romanian children and adolescents receiving lopinavir/ritonavir-containing highly active antiretroviral therapy. Pediatrics. 2007 May;119(5):e1116-20. Epub 2007 Apr 9.Kline MW, Rugina S, Ilie M, Matusa RF, Schweitzer AM, Calles NR, Schwarzwald HL. Long-term follow-up of 414 HIV-infected Romanian children and adolescents receiving lopinavir/ritonavir-containing highly active antiretroviral therapy. Pediatrics. 2007 May;119(5):e1116-20. Epub 2007 Apr 9.

Active substance: lopinavir / ritonavir

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Document reference: 41529

Study title: Larrú B, Resino S, Bellón JM, de José MI, Fortuny C, Navarro ML, Gurbindo MD, Ramos JT, Soler P, Léon JA, Asensi M, Mellado MJ, Muñoz-Fernández MA. Long-term response to highly active antiretroviral therapy with lopinavir/ritonavir in pre-treated vertically HIV-infected children.Larrú B, Resino S, Bellón JM, de José MI, Fortuny C, Navarro ML, Gurbindo MD, Ramos JT, Soler P, Léon JA, Asensi M, Mellado MJ, Muñoz-Fernández MA. Long-term response to highly active antiretroviral therapy with lopinavir/ritonavir in pre-treated vertically HIV-infected children.

Active substance: lopinavir / ritonavir

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Document reference: 41528

Study title: An evaluation of antiemetic agents in the control of vomiting in children.

Active substance: MECLOZINE

Study summary document link (including results): DE76M282P.pdf

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Document reference: 31563

Study title: A comparison of tiaprofenic acid, mefenamic acid and placebo in the treatment of dysmenorrhoea in general practice; Tilyard MW et al. , Aust N Z J Obstet Gynaecol. 1992 May;32(2):165-8.

Active substance: MEDROXYPROGESTERONE ACETATE

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Document reference: 31569

Study title: A double-blind comparison of nimesulide and mefenamic acid in the treatment of acute upper respiratory tract infections in children.; Salzberg R et al., Drugs. 1993;46 Suppl 1:208-11

Active substance: MEDROXYPROGESTERONE ACETATE

Study summary document link (including results): A679_M-5400-0144 EMA Pediatrics Web Synopsis.pdf

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Document reference: 31567

Study title: Aspirin-induced asthma in children; Botey J et al., Allergol Immunopathol (Madr). 1988 May-Jun;16(3):145-9.

Active substance: MEDROXYPROGESTERONE ACETATE

Study summary document link (including results): MPAASC-0012-277 EMA Pediatrics Web Synopsis.pdf

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Document reference: 31568

Study title: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non Hormonal Contraceptive Users

Active substance: MEDROXYPROGESTERONE ACETATE

Study summary document link (including results): A6791022 PhRMA Web Synopsis.pdf

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Document reference: 48025

Study title: Therapeutic value of levocabastine eye drops in the treatment of seasonal allergic conjunctivitis: a double-blind comparison with sodium cromoglycate (9-46 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD56650_Interventional_Levocabastine.xls

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Document reference: 31109

Study title: Therapeutic value of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a double-blind comparison with sodium cromoglycate and placebo (9-52 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62487_Interventional_Levocabastine.xls

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Document reference: 31079

Study title: Therapeutic value of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a double-blind comparison with placebo (12-81 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62507_Interventional_Levocabastine.xls

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Document reference: 31084

Study title: Therapeutic value of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a double blind placebo-controlled study (7-43 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62503_Interventional_Levocabastine.xls

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Document reference: 31088

Study title: Keiko Yano, Department of Ophthalmology, St. John Sakuramachi Hospital, Clinical experience with 0.3% LFLX ophthalmic solution, 1989-1990Keiko Yano, Department of Ophthalmology, St. John Sakuramachi Hospital, Clinical experience with 0.3% LFLX ophthalmic solution, 1989-1990

Active substance: LOMEFLOXACIN

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Document reference: 31368

Study title: Keizo Chiba, Department of Ophthalmology, Dokkyo University School of Medicine, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infectionsKeizo Chiba, Department of Ophthalmology, Dokkyo University School of Medicine, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections

Active substance: LOMEFLOXACIN

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Document reference: 31356

Study title: Keizo Chiba, Department of Ophthalmology, Dokkyo University School of Medicine, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.Keizo Chiba, Department of Ophthalmology, Dokkyo University School of Medicine, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31376

Study title: Keizo Chiba, Department of Ophthalmology, Dokkyo University School of Medicine, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.Keizo Chiba, Department of Ophthalmology, Dokkyo University School of Medicine, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31391

Study title: Kenji Urata, Department of Ophthalmology, University of Tokyo School of Medicine, Efficacy of Lomefloxacin ophthalmic solution (NY-198) for infectous disease of outer segment of eye. No report date.Kenji Urata, Department of Ophthalmology, University of Tokyo School of Medicine, Efficacy of Lomefloxacin ophthalmic solution (NY-198) for infectous disease of outer segment of eye. No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31373

Study title: Kenji Urata, Department of Ophthalmology, University of Tokyo School of Medicine, Efficacy of Lomefloxacin ophthalmic solution (NY-198) for infectous disease of outer segment of eye. No report date.Kenji Urata, Department of Ophthalmology, University of Tokyo School of Medicine, Efficacy of Lomefloxacin ophthalmic solution (NY-198) for infectous disease of outer segment of eye. No report date.

Active substance: LOMEFLOXACIN

Study summary document link (including results):

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Document reference: 31388

Study title: Kunitoshi Ohara, Department of Ophthalmology, Jichi Medical School, Clinical Efficacy of Lomefloxacin ophthalmic solution for external bacterial eye infections. No report date.Kunitoshi Ohara, Department of Ophthalmology, Jichi Medical School, Clinical Efficacy of Lomefloxacin ophthalmic solution for external bacterial eye infections. No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31369

Study title: Mamula, P., et al., Safety of intravenous midazolam and fentanyl for pediatric GI endoscopy: prospective study of 1578 endoscopies. Gastrointest Endosc, 2007. 65(2): p. 203-10. 7. Mamula, P., et al., Safety of intravenous midazolam and fentanyl for pediatric GI endoscopy: prospective study of 1578 endoscopies. Gastrointest Endosc, 2007. 65(2): p. 203-10. 7.

Active substance: MIDAZOLAM

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Document reference: 32006

Study title: A phase III, open, randomised, controlled multicentre study to evaluate the immunogenicity and safety of one dose of GlaxoSmithKline Biologicals’ combined measles-mumps-rubella-varicella vaccine (MeMuRu- OKA) given to healthy children 4 to 6 years of age previously primed with one dose of measles-mumpsrubella vaccine (either Priorix™ or M-M-R II™) in their second year of life and presumed seronegative for varicella.

Active substance: Live attenuated measles, mumps, rubella, varicella vaccine

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Document reference: 47878

Study title: A phase III, open, randomized, controlled study to evaluate the immunogenicity and safety of one dose of GlaxoSmithKline Biologicals’ measles-mumps-rubella-varicella vaccine (MeMuRu-OKA) given to healthy children of 4 to 6 years of age previously primed with one dose of measles-mumps-rubella vaccine (GlaxoSmithKline Biologicals’ PriorixÔ or Merck & Co.’s M-M-R IIÔ)

Active substance: Live attenuated measles, mumps, rubella, varicella vaccine

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Document reference: 47876

Study title: Assessment of the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ live attenuated Measles (Schwarz strain) - Mumps (RIT 4385 strain) - Rubella (RA 27/3 strain) - Varicella (Oka-strain) vaccine. An open clinical study in healthy 12 to 24 month old children.

Active substance: Live attenuated measles, mumps, rubella, varicella vaccine

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Document reference: 47879

Study title: Assessment of the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ live attenuated Measles (Schwarz strain) - Mumps (RIT 4385 strain) - Rubella (RA 27/3 strain) - Varicella (Oka-strain) vaccine. An open clinical study in healthy 12 to 24 month old children.

Active substance: Live attenuated measles, mumps, rubella, varicella vaccine

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Document reference: 47880

Study title: A controlled clinical study to assess the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ varicella vaccine in children aged between 1 and 12 years with a known history of neurodermatitis.

Active substance: Live attenuated varicella vaccine (OKA strain)

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Document reference: 47335

Study title: Assessment of the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ live attenuated varicella vaccine (Oka-strain) when administered at the same time as routine MMR (measles, mumps, rubella) vaccine but at different injection sites. An open clinical study in healthy 15- to 18-month-old children.

Active substance: Live attenuated varicella vaccine (OKA strain)

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Document reference: 47336

Study title: A double-blind, randomised, controlled multi-centre safety study of a refrigerator-stable formulation of VARIVAX® in healthy 12 to 15 month-old children.

Active substance: Live attenuated varicella virus [Oka/ Merck strain]

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Document reference: 47287

Study title: Use of Oka/Merck Varicella Vaccine in Children With Acute Lymphocytic Leukemia in Remission

Active substance: Live attenuated varicella virus [Oka/ Merck strain]

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Document reference: 47286

Study title: Clinical and immunological evaluation of the live attenuated RA27/3 rubella vaccine in seronegative children and adults in Switzerland

Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN)

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Document reference: 41359

Study title: Clinical and immunological study on RA27/3 and cendehill strains of rubella vaccines during a vaccination campaign in Brittany and Mayenne in France

Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN)

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Document reference: 41361

Study title: Clinical and serological evaluation of the live attenuated RA27/3 strain rubella vaccine in a population of susceptible children in France

Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN)

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Document reference: 41363

Study title: Clinical evaluation of the live attenuated rubella vaccine, RA27/3 on seronegative children in Dakar (Senegal)

Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN)

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Document reference: 41358

Study title: Clinical study of the vaccine against rubella rudivax Italy stydy

Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN)

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Document reference: 41366

Study title: Comparative study of 3 different strains of rubella vaccines

Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN)

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Document reference: 41360

Study title: Evaluation of the side effects occuring with two RA27/3 strains of rubella vaccine in a population of schoolgirl

Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN)

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Document reference: 41365

Study title: Evaluation of the side effects occuring with two RA27/3 strains of rubella vaccine in a population of schoolgirl

Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN)

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Document reference: 41457

Study title: Randomized, controlled trial of high-dose intravenous pyridoxine in the treatment of recurrent seizures in children - F.Y Jiao et al. - 1997 (Pediatric Neurology vol 17) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Randomized, controlled trial of high-dose intravenous pyridoxine in the treatment of recurrent seizures in children - F.Y Jiao et al. - 1997 (Pediatric Neurology vol 17) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31513

Study title: Rapport d'expertise clinique sur MAGNE B6 Comprimés dragéifiés (50mg de Mg). - Pr. GASTAUTRapport d'expertise clinique sur MAGNE B6 Comprimés dragéifiés (50mg de Mg). - Pr. GASTAUT- 12/1967

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

Study summary document link (including results): Magnesium lactate, pyridoxine chlorhydrate STUDY 444.6.002.xls

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Document reference: 31514

Study title: Rapport d'expertise clinique sur MAGNE B6 Comprimés dragéifiés (50mg de Mg)Rapport d'expertise clinique sur MAGNE B6 Comprimés dragéifiés (50mg de Mg). - Pr. NAYRAC- 11/1967

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

Study summary document link (including results): Magnesium lactate, pyridoxine chlorhydrate STUDY 444.6.001.xls

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Document reference: 31515

Study title: "Antipyretic efficacy and tolerability of oral ibuprfen, oral dipyrone and intramuscular dipyrone in children:a randomized controlled trial - Prado J. et al. - 2006 (Sao Paulo Med, 124(3):135-140) - Publication in CES EXPRC-CES0691-EN-E01 -"

Active substance: METAMIZOLE

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Document reference: 31712

Study title: Antipyretic therapy - Rajeshwari K. - 1997 (Indian Pediatr., 34; 5, 407-413) - Publication in a clinical overview - No author - 24/05/2006 -

Active substance: METAMIZOLE

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Document reference: 31691

Study title: Clinical experience and results of treatment with suprofen in pediatrics - Giovannini M. et al. - 1986 (Arzneim.-Forsch/Drug Res.36(I).Nr.6)

Active substance: METAMIZOLE

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Document reference: 31692

Study title: Metamizole (dipyrone) drops versus paracetamol suppositories in the treatment of fever in childood. Switzerland

Active substance: METAMIZOLE

Study summary document link (including results): Metamizol STUDY X107-4028 SWITZERLAND.xls

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Document reference: 47986

Study title: Metamizole (dipyrone) drops versus paracetamol suppositories in the treatment of fever in children. Mexico

Active substance: METAMIZOLE

Study summary document link (including results): Metamizol STUDY X107-4028 MEXICO.xls

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Document reference: 47987

Study title: Metamizole (dipyrone) suppositories versus paracetamol suppositories in the treatment of fever in children. Final clinical and statistical report No.X107/4037 respectively X107/4/M/T/401/FI-Thailand, Hoechst AG, Frankfurt. Simasathien S. et al.;1995 - Publication in Part IC3 Clinical Documentation - HAUKE - 28/02/2000 -

Active substance: METAMIZOLE

Study summary document link (including results): Metamizol STUDY X107-4037 THAILAND.xls

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Document reference: 31708

Study title: Pharmacokinetics and therapeutic study with Nimesulide suppositories in children with postoperative pain and inflammation - SCHARLI - No date

Active substance: METAMIZOLE

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Document reference: 31693

Study title: Salgydal à la noramidopyrine : suppositoire enfant. Rapport d'expertise clinique (étude de la tolérance clinique et éventuellement biologique)

Active substance: METAMIZOLE

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Document reference: 31709

Study title: The Incidence of Bone Fractures in Depo-Medroxyprogesterone Acetate (DMPA) Users and Non-users in Women in the General Practice Research Database (GPRD)

Active substance: MEDROXYPROGESTERONE ACETATE

Study summary document link (including results): DMPA GPRD EMA Pediatrics Web Synopsis.pdf

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Document reference: 48024

Study title: Therapy of symptomatic patent ductus arteriosus in preterms using mefenemic acid and indomethacin; Sakhalkar VS et al., Indian Pediatr. 1992 Mar;29(3):313-8

Active substance: MEDROXYPROGESTERONE ACETATE

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Document reference: 31570

Study title: A comparison of tiaprofenic acid, mefenamic acid and placebo in the treatment of dysmenorrhoea in general practice; Tilyard MW et al. , Aust N Z J Obstet Gynaecol. 1992 May;32(2):165-8.A comparison of tiaprofenic acid, mefenamic acid and placebo in the treatment of dysmenorrhoea in general practice; Tilyard MW et al. , Aust N Z J Obstet Gynaecol. 1992 May;32(2):165-8.

Active substance: MEFENAMIC ACID

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Document reference: 31575

Study title: A double-blind comparison of nimesulide and mefenamic acid in the treatment of acute upper respiratory tract infections in children.; Salzberg R et al., Drugs. 1993;46 Suppl 1:208-11A double-blind comparison of nimesulide and mefenamic acid in the treatment of acute upper respiratory tract infections in children.; Salzberg R et al., Drugs. 1993;46 Suppl 1:208-11

Active substance: MEFENAMIC ACID

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Document reference: 31574

Study title: Analgesic and antipyretic effect of mefenaminic acid in children and adolescents; Fehlhaber C et al., Med Welt. 1967 Jul 15;28:1655-8. Analgesic and antipyretic effect of mefenaminic acid in children and adolescents; Fehlhaber C et al., Med Welt. 1967 Jul 15;28:1655-8.

Active substance: MEFENAMIC ACID

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Document reference: 41621

Study title: Aspirin-induced asthma in children; Botey J et al., Allergol Immunopathol (Madr). 1988 May-Jun;16(3):145-9. Aspirin-induced asthma in children; Botey J et al., Allergol Immunopathol (Madr). 1988 May-Jun;16(3):145-9.

Active substance: MEFENAMIC ACID

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Document reference: 31578

Study title: Choice of antipyretic in children; Khubchandani RP et al., J Assoc Physicians India. 1995 Sep;43(9):614-6Choice of antipyretic in children; Khubchandani RP et al., J Assoc Physicians India. 1995 Sep;43(9):614-6

Active substance: MEFENAMIC ACID

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Document reference: 31572

Study title: Storr J et al. (1987) . Effect of a single oral dose of prednisolone in acute childhood asthma. Lancet 1(8538) :879-82.Storr J et al. (1987) . Effect of a single oral dose of prednisolone in acute childhood asthma. Lancet 1(8538) :879-82.

Active substance: METHYLPREDNISOLONE

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Document reference: 31928

Study title: Tönschoff B, Haffner D, Mehls O et al . (1993) . Efficacy and safety of growth hormone treatment in short children with renal allografts : three year experience . Kidney Int 44 :199-207Tönschoff B, Haffner D, Mehls O et al . (1993) . Efficacy and safety of growth hormone treatment in short children with renal allografts : three year experience . Kidney Int 44 :199-207

Active substance: METHYLPREDNISOLONE

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Document reference: 31929

Study title: "Tuncer AM et al . (1995) . The effect of high-dose methylprednisolone on CD34-positive bone marrow cells in children with acute myeloblastic leukemia . Turk J Pediatr 37(4) :345-9." "Tuncer AM et al . (1995) . The effect of high-dose methylprednisolone on CD34-positive bone marrow cells in children with acute myeloblastic leukemia . Turk J Pediatr 37(4) :345-9."

Active substance: METHYLPREDNISOLONE

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Document reference: 31930

Study title: Kunitoshi Ohara, Department of Ophthalmology, Jichi Medical School, Clinical Efficacy of Lomefloxacin ophthalmic solution for external bacterial eye infections. No report date.Kunitoshi Ohara, Department of Ophthalmology, Jichi Medical School, Clinical Efficacy of Lomefloxacin ophthalmic solution for external bacterial eye infections. No report date.

Active substance: LOMEFLOXACIN

Study summary document link (including results):

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Document reference: 31384

Study title: Lomefloxacin ophthalmic solution (NY-198) for bacterial external eye infection.Lomefloxacin ophthalmic solution (NY-198) for bacterial external eye infection.

Active substance: LOMEFLOXACIN

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Document reference: 31354

Study title: Masakazu Funahashi, Department of Ophthalmology, Gifu University Hospital, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infectionsMasakazu Funahashi, Department of Ophthalmology, Gifu University Hospital, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections

Active substance: LOMEFLOXACIN

Study summary document link (including results):

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Document reference: 31357

Study title: Pyridoxine in atopic dermatitis - D.C Mabin et al. - 1995 (British Journal of Dermatology vol 133) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Pyridoxine in atopic dermatitis - D.C Mabin et al. - 1995 (British Journal of Dermatology vol 133) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

Study summary document link (including results):

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Document reference: 31490

Study title: Pyridoxine treatment in a subgroup of children with pervasive developmental disorders - S. Kuriyama et al. - 2002 (Developmental Medicine and Child Neurology vol 44) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Pyridoxine treatment in a subgroup of children with pervasive developmental disorders - S. Kuriyama et al. - 2002 (Developmental Medicine and Child Neurology vol 44) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31491

Study title: Randomized, controlled trial of high-dose intravenous pyridoxine in the treatment of recurrent seizures in children - F.Y Jiao et al. - 1997 (Pediatric Neurology vol 17) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Randomized, controlled trial of high-dose intravenous pyridoxine in the treatment of recurrent seizures in children - F.Y Jiao et al. - 1997 (Pediatric Neurology vol 17) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31492

Study title: Rapport d'expertise clinique complémentaire sur le MAGNE B6 Solution buvable. - Blatrix Ch.- 11/04/1972Rapport d'expertise clinique complémentaire sur le MAGNE B6 Solution buvable. - Blatrix Ch.- 11/04/1972

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31493

Study title: Response to questions raised by the Estonian health authorities during MAGNE B6 tablets & Oral solution renewal. 04/2004.Response to questions raised by the Estonian health authorities during MAGNE B6 tablets & Oral solution renewal. 04/2004.

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31494

Study title: Evaluation of the side effects occuring with two RA27/3 strains of rubella vaccine in a population of schoolgirls

Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN)

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Document reference: 47475

Study title: Evaluation study of the side effects occumng after two RA27/3 strains of rubella vaccines in a population of schoolgirls.

Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN)

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Document reference: 47476

Study title: Rubella vaccination in school Children

Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN)

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Document reference: 47474

Study title: Current perspectives on pyridoxin-dependant seizures - S.M Gospe - 1998 (J. Pediatr vol 132) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Current perspectives on pyridoxin-dependant seizures - S.M Gospe - 1998 (J. Pediatr vol 132) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31483

Study title: Efficacy of vitamin B6 and magnesium in the treatment of autism : a methodology review an summary of outcomes - S.I Pfeiffer et al. - 1995 (Journal of Autism and Developmental Disorders vol 25) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Efficacy of vitamin B6 and magnesium in the treatment of autism : a methodology review an summary of outcomes - S.I Pfeiffer et al. - 1995 (Journal of Autism and Developmental Disorders vol 25) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31484

Study title: El Bromhidrato de Glutamato de Magnesio Y Gaba como Tratamineto de la ansiedadZamora L Perez Valera

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

Study summary document link (including results): A-ZAMORA_L.PEREZ VALERA .pdf

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Document reference: 48080

Study title: El Galamate B6 en paidopsiquiatriaFolch y Soler

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

Study summary document link (including results): GB6-Folch y Soler.pdf

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Document reference: 48084

Study title: El GB6 en la disfuncion cerebral minimaEspadaler

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

Study summary document link (including results): GB6-Espadaler.pdf

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Document reference: 48083

Study title: Electrophysiological effects of fenfluramine or combined vitamin B6 and magnesium on children with autistic behaviour - J. Martineau et al. - 1989 (Developmental Medicine and Child Neurology vol 31) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Electrophysiological effects of fenfluramine or combined vitamin B6 and magnesium on children with autistic behaviour - J. Martineau et al. - 1989 (Developmental Medicine and Child Neurology vol 31) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31485

Study title: Etude des variations du Magnesium erythrocitaire et plasmatique dans les dystrophies muscularies - Astier-Dumas M et al - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Etude des variations du Magnesium erythrocitaire et plasmatique dans les dystrophies muscularies - Astier-Dumas M et al - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31486

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/1994

Active substance: METAMIZOLE

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Document reference: 31694

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/1995

Active substance: METAMIZOLE

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Document reference: 31695

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/1996

Active substance: METAMIZOLE

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Document reference: 31696

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/1998

Active substance: METAMIZOLE

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Document reference: 31697

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/1999

Active substance: METAMIZOLE

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Document reference: 31698

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2000

Active substance: METAMIZOLE

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Document reference: 31699

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2001

Active substance: METAMIZOLE

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Document reference: 31700

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2002

Active substance: METAMIZOLE

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Document reference: 31701

Study title: A four-weeks evaluation of HOE777 fatty ointment 0,25%in young patients with severe atopic dermatitis of long duration - G. Rajka - 1987 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - A four-weeks evaluation of HOE777 fatty ointment 0,25%in young patients with severe atopic dermatitis of long duration - G. Rajka - 1987 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -

Active substance: LEVONORGESTREL

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Document reference: 31168

Study title:

Active substance: LEVOPROMAZINE

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Document reference: 31166

Study title: Analgesia Agents. Canad Anaesth Soc J 1972; 19/1: 87-96Analgesia Agents. Canad Anaesth Soc J 1972; 19/1: 87-96

Active substance: LEVOPROMAZINE

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Document reference: 31165

Study title: Efficacy and Safety of SCH 29851 8 mg in Subjects with Allergic Rhinitis

Active substance: LEVOPROMAZINE

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Document reference: 31167

Study title: Hemodynamics and Pharmacokinetics of 24 Hour Infusion of Levosimendan in Children with Congenital Heart Disease after Cardiopulmonary Bypass Surgery: A Prospective, Randomised, Placebo-Controlled, Double-Blind, Single-Center Study

Active substance: LEVOSIMENDAN

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Document reference: 31169

Study title: Pharmacokinetics and pharmscodynamics of levosimendan in Children with Congenital Heart Disease

Active substance: LEVOSIMENDAN

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Document reference: 31170

Study title: Congenital Hyperthyroidism: optimal management in light of 15 years experience of screening, Arch Dis Child 72, 185-189, 1995 Congenital Hyperthyroidism: optimal management in light of 15 years experience of screening, Arch Dis Child 72, 185-189, 1995

Active substance: LEVOTHYROXINE

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Document reference: 31171

Study title: Hehrmann R., Jodmangelstruma: Medikamentöse Therapie bei Kindern, Jugendlichen, jungen Erwachsenen und Schwangeren, Apotheker J. 16, 29-34, 1994 Hehrmann R., Jodmangelstruma: Medikamentöse Therapie bei Kindern, Jugendlichen, jungen Erwachsenen und Schwangeren, Apotheker J. 16, 29-34, 1994

Active substance: LEVOTHYROXINE

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Document reference: 31172

Study title: Weinberger M . (1988) . Corticosteroids for exacerbations of asthma : current status of the controversy . Pediatrics 81(5) :726-9.Weinberger M . (1988) . Corticosteroids for exacerbations of asthma : current status of the controversy . Pediatrics 81(5) :726-9.

Active substance: METHYLPREDNISOLONE

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Document reference: 31931

Study title: Wolfson DH et al . (1994) . A controlled trial of methylprednisolone in the early emergency department treatment of acute asthma in children . Pediatr Emerg Care 10(6) :335-8.Wolfson DH et al . (1994) . A controlled trial of methylprednisolone in the early emergency department treatment of acute asthma in children . Pediatr Emerg Care 10(6) :335-8.

Active substance: METHYLPREDNISOLONE

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Document reference: 31932

Study title: Hrachovy, R. A., Frost, J. D., Jr., Glaze, D. G., and Rose, D. Department of Neurology, Baylor College of Medicine, Houston, Texas 77030 Treatment of infantile spasms with methysergide and alpha-methylparatyrosine Epilepsia 1989;30:607-610. Hrachovy, R. A., Frost, J. D., Jr., Glaze, D. G., and Rose, D. Department of Neurology, Baylor College of Medicine, Houston, Texas 77030 Treatment of infantile spasms with methysergide and alpha-methylparatyrosine Epilepsia 1989;30:607-610.

Active substance: METHYLSERGIDE

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Document reference: 31957

Study title: Patten, B. M. and Zeller, R. S. Clinical trials of vasoactive and antiserotonin drugs in Duchenne muscular dystrophy Ann.Clin.Res 1983;15:164-166.Patten, B. M. and Zeller, R. S. Clinical trials of vasoactive and antiserotonin drugs in Duchenne muscular dystrophy Ann.Clin.Res 1983;15:164-166.

Active substance: METHYLSERGIDE

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Document reference: 31958

Study title: Alizaprida, nuevo antiemetico en pediatria. Evaluacion clinica comparativa a metoclopramida STUDY 89-00616- ES-00

Active substance: METOCLOPRAMIDE

Study summary document link (including results): Metoclopramide STUDY 89-00616-ES-00.xls

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Document reference: 47988

Study title: Applications du metoclopramide aux vomissements du nourrisson et de l'enfant. STUDY 1267R449

Active substance: METOCLOPRAMIDE

Study summary document link (including results): Metoclopramide STUDY 1267R449.xls

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Document reference: 47989

Study title: Etude comparative Alizapride/Metoclopramide (forme gouttes buvables). Prevention et traitement des nausees et vomissements provoques par Ia chimiotherapie antineoplasique chez le nourrisson et l'enfant.

Active substance: METOCLOPRAMIDE

Study summary document link (including results): Metoclopramide STUDY 1813D635.xls

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Document reference: 47991

Study title: Reazione clinica sui Plasil., Ospitale Infantile Alessandra

Active substance: METOCLOPRAMIDE

Study summary document link (including results): Metroclopramide STUDY Mengoli.xls

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Document reference: 47993

Study title: Treatment for congenital hypothyroidism: Thyroxine alone or thyroxine plus triiodothyronine?Cassio A., 2003 Pediatrics 2003, 111, 5: 1055-60

Active substance: LIOTHYRONINE

Study summary document link (including results): 20140709_Art 45 Studies.xlsx

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Document reference: 31281

Study title: Colls F. et.al, Changes in plasma thyroid hormones levels after a single dose of triiodothyronine in prmature infants of less than 30 weeks gestational age, Eur. J. Endocrinology 143, 733-740, 2000

Active substance: LIOTHYRONINE

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Document reference: 47215

Study title: Drugdex Evaluations: Liothyronine. Micro Medex Health Care Series Volume 99 (1999)

Active substance: LIOTHYRONINE

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Document reference: 31282

Study title: 48 Hour Human Patch Test for Skin Irritation of a range of Oilatum Plus Lotion Formulations.A comparative study: the efficacy of liquid paraffin and lactulose in management of chronic functional constipation. Urganci N, Akyildiz B, Polat TB. Pediatr Int. 2005 Feb;47(1):15-9.

Active substance: LIQUID PARAFFIN

Study summary document link (including results): Article 45_Ref_C0472_Final For Submission_27 Oct 2011.xlsx

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Document reference: 31284

Study title: A single-centre, randomised, evaluator-blinded parallel-group study to compare the efficacy and safety of Oilatum Plus (antiseptic oil-based additive) and Q.V.Bath Oil (non antiseptic oil-based bath additive) in the treatment of atopic eczema.

Active substance: LIQUID PARAFFIN

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Document reference: 31283

Study title: Symptomastic magnesium deficiency in severe infantile gastroenteritis in Jamaica - Back EH, Montgomery RSD, Ward EE - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Symptomastic magnesium deficiency in severe infantile gastroenteritis in Jamaica - Back EH, Montgomery RSD, Ward EE - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31496

Study title: Jürgens H et al High-dose ifosfamide with mesna uroprotection in Ewing's sarcoma Cancer Chemother Pharmacol. 1989;24 Suppl 1:S40-4Jürgens H et al High-dose ifosfamide with mesna uroprotection in Ewing's sarcoma Cancer Chemother Pharmacol. 1989;24 Suppl 1:S40-4

Active substance: MESNA

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Document reference: 31647

Study title: Mistabron in the treatment of certain laryngological diseases.

Active substance: MESNA

Study summary document link (including results): RAE90E102P - Mesna.pdf

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Document reference: 31672

Study title: Mistabron treatment of patients with pulmonary complications in intensive medical care unit.

Active substance: MESNA

Study summary document link (including results):

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Document reference: 31680

Study title: On teh mucolytic effect of Mistabron.

Active substance: MESNA

Study summary document link (including results): DE77K058 - Mesna.pdf

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Document reference: 31662

Study title: On the mucolytic effect of mistabron.

Active substance: MESNA

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Document reference: 31664

Study title: Phase II trial of ifosfamode with mesna in patients with pediatric malignant solid tumors (Pratt, C.B. Et al.-Proc.Ann. Meet.Am.Soc.Clin.Oncol.4 1985: Abstr. C-912)Phase II trial of ifosfamode with mesna in patients with pediatric malignant solid tumors (Pratt, C.B. Et al.-Proc.Ann. Meet.Am.Soc.Clin.Oncol.4 1985: Abstr. C-912)

Active substance: MESNA

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Document reference: 31648

Study title: Physiological assessment of therapy of children with profuse retention of secretion in the bronchi.

Active substance: MESNA

Study summary document link (including results): DE77F241P - Mesna.pdf

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Document reference: 31670

Study title: Rapport concernant l’etude d’un mucolytique – le mistabron- chez l’enfant atteint d’un syndrome asthmatique.

Active substance: MESNA

Study summary document link (including results): DF73J231.pdf

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Document reference: 31657

Study title: Serum magnesium levels in children with cirrhosis - Kaya G, Ozsoylu S - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Serum magnesium levels in children with cirrhosis - Kaya G, Ozsoylu S - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31495

Study title: European Commission Scientific Committee on Food. Opinion of the Scientific Commitee on Food on the tolerable upper intake leval of vitamin B6 (http : // europa.eu.int/comm/food/fs/sc/scf/index en.htlm) - 11/2000 - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31481

Study title: A double blind study comparing the local anaesthetic efficacy of 3 per cent Mepivacaine containing a vasoconstrictor. Aronson, M et al, J. Dent. Assoc. S. Afr. 1991A double blind study comparing the local anaesthetic efficacy of 3 per cent Mepivacaine containing a vasoconstrictor. Aronson, M et al, J. Dent. Assoc. S. Afr. 1991

Active substance: MEPIVACAINE

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Document reference: 31608

Study title: Bilateral versus unilateral mandibular block anesthesia in a pediatric population. College, C. et al., Pediatr Dent. 2000Bilateral versus unilateral mandibular block anesthesia in a pediatric population. College, C. et al., Pediatr Dent. 2000

Active substance: MEPIVACAINE

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Document reference: 31607

Study title: Clinical evaluation of mepivacaine and lidocaine; Bradley, D.j. et al, Aust Dent. J. 1969Clinical evaluation of mepivacaine and lidocaine; Bradley, D.j. et al, Aust Dent. J. 1969

Active substance: MEPIVACAINE

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Document reference: 31609

Study title: Clinical and biological tolerance of long term (3 months) of children with Mequitazine

Active substance: MEQUITAZINE

Study summary document link (including results): primalan L0013SOC003.xls

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Document reference: 31617

Study title: Clinical effect of an anti histaminic agent MQZ on perennial nasal allergy. A double blind study with clemastine fumarate

Active substance: MEQUITAZINE

Study summary document link (including results): Primalan L0013CPC44.xls

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Document reference: 31615

Study title: Etude de l'efficacité du Primalan sirop versus Placebo dans le traitement des poussées d'urticaire intermittente isolée et non compliquée de l'enfant

Active substance: MEQUITAZINE

Study summary document link (including results): Synopsis L00013S0402_EN.doc

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Document reference: 31614

Study title: Study of Primalan in the child (Clinical, efficacy, tolérance)

Active substance: MEQUITAZINE

Study summary document link (including results): primalan L0013CPC011.xls

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Document reference: 31616

Study title: Tolerance of Primalan in children (21 days)

Active substance: MEQUITAZINE

Study summary document link (including results): Primalan L0013SOC002.xls

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Document reference: 31618

Study title: Garofalo, Salvatore; Briganti, Vito; Cavallaro, Sebastiano; Pepe, Ernesto; Prete, Marina; Suteu, Liana; Tavormino, Paolo: Nickel Gluconate - Mercurius Heel - Potentised Swine Organ Preparations. International Journal of Pediatric Otorhinolaryngology 2007

Active substance: Mercurius-Heel S

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Document reference: 40068

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Mercurius-Heel S (tablets) [AWB-AT]

Active substance: Mercurius-Heel S

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Document reference: 40070

Study title: Retrospective survey for documentation of appllication and dosage of Mercurius-Heel S (tablets) in children < 12 years of age [Bef-018]

Active substance: Mercurius-Heel S

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Document reference: 40069

Study title:

Active substance: MEROPENEM TRIHYDRATE

Study summary document link (including results): 3591IL0020 21 22.xls

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Document reference: 31625

Study title:

Active substance: MEROPENEM TRIHYDRATE

Study summary document link (including results): 3591IL0045.xls

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Document reference: 45255

Study title:

Active substance: MEROPENEM TRIHYDRATE

Study summary document link (including results): 3591US0001.xls

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Document reference: 45256

Study title:

Active substance: MEROPENEM TRIHYDRATE

Study summary document link (including results): 3591IL0062.xls

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Document reference: 45257

Study title: Tümer L. et al., Bone minaral density and metabolism in children treated with L-Thyroxine Tümer L. et al., Bone minaral density and metabolism in children treated with L-Thyroxine

Active substance: LEVOTHYROXINE

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Document reference: 31174

Study title: Allaert; Comparison of Dynexan 2 % against Placebo; 2001

Active substance: LIDOCAINE

Study summary document link (including results): Lidocaine_Dynexan study_00576.xls

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Document reference: 45236

Study title: Clinical investigations.

Active substance: PENTOXYVERINE

Study summary document link (including results): ARCE92G0609 - Pentoxyverine.pdf

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Document reference: 45859

Study title: Evaluating the efficacy of EMLA topical anesthetic in sealant placement with rubber dam.

Active substance: LIDOCAINE

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Document reference: 31223

Study title: Evaluation of the safety profile and clinical effectiveness of oral tramadol hydrochloride tablets for the treatment of postsurgical pain in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-005; Phase 2)

Active substance: LIDOCAINE

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Document reference: 31227

Study title: Evaluation of three topical anaesthetic agents against pain: a clinical study.

Active substance: LIDOCAINE

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Document reference: 31219

Study title: Four types of topical anaesthetic agents: evaluation of clinical effectiveness.

Active substance: LIDOCAINE

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Document reference: 31220

Study title:

Active substance: LOPERAMIDE

Study summary document link (including results): LMD84716_Interventional_Loperamide Oxide.xls

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Document reference: 47585

Study title:

Active substance: LOPERAMIDE

Study summary document link (including results): LMD84717_Interventional_Loperamide oxide.xls

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Document reference: 47586

Study title: A multi-centre, double-blind, randomised, placebo-control, two parallel groups, 72 hour study in patients with chronic diarrhoea.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD86872_Interventional_Loperamide oxide.xls

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Document reference: 47588

Study title: A placebo-controlled, double-blind study;Children hospitalised with acute gastro-enteritis with diarrhea, necessitating intravenous rehydration.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD15027_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31441

Study title: A Study of the Effectiveness of Loperamide Vs. Bismuth Subsalicylate in the Symptomatic Treatment of Acute Diarrhea: Intention to Treat Analysis

Active substance: LOPERAMIDE

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Document reference: 31415

Study title: Anderson J. Double-blind comparison of loperamide HCl and placebo in the treatment of acute diarrhea in children. Adv Ther 1984; 1: 14–18Anderson J. Double-blind comparison of loperamide HCl and placebo in the treatment of acute diarrhea in children. Adv Ther 1984; 1: 14–18

Active substance: LOPERAMIDE

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Document reference: 31422

Study title: Klinischer Erfahrungsbericht zu L-Thyroxin Tropfen, Grütter 1999 Klinischer Erfahrungsbericht zu L-Thyroxin Tropfen, Grütter 1999

Active substance: LEVOTHYROXINE

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Document reference: 31173

Study title: Bowie MD, et al. Loperamide for treatment of acute diarrhoea in infants and young children. A double-blind placebo controlled trial. S Afr Med J 1995; 85: 885–7Bowie MD, et al. Loperamide for treatment of acute diarrhoea in infants and young children. A double-blind placebo controlled trial. S Afr Med J 1995; 85: 885–7

Active substance: LOPERAMIDE

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Document reference: 31425

Study title: Chapoy P, Louchet E (1983) Treatment of acute infant diarrhea: Advantages of loperamide. Med Chir Dig 1983; 12: 619–622Chapoy P, Louchet E (1983) Treatment of acute infant diarrhea: Advantages of loperamide. Med Chir Dig 1983; 12: 619–622

Active substance: LOPERAMIDE

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Document reference: 31426

Study title: Drugdex Evaluations: Liothyronine. Micro Medex Health Care Series Volume 99 (1999)Drugdex Evaluations: Liothyronine. Micro Medex Health Care Series Volume 99 (1999)

Active substance: LIQUID PARAFFIN

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Document reference: 31285

Study title: Multicentre open clinical trial, in parallel groups, on the value of Oleatum emollient oil in the treatment of atopic eczema with topical corticosteroid therapy (Betamethasone-17-Valerate).

Active substance: LIQUID PARAFFIN

Study summary document link (including results): Article 45_Ref_C0474_Final For Submission_27 Oct 2011.xlsx

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Document reference: 31286

Study title: Double blind, placebo controlled study of the efficacy of polytar in treatment of seborrhoeic dermatitis and eczema of the scalp.

Active substance: LIQUID PARAFFIN AND TAR

Study summary document link (including results): Article 45_Ref_C0200_Final For Submission_27 Oct 2011.xlsx

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Document reference: 31287

Study title: E-BRO-AWB 1 (Nov. 2005 - Mar. 2006): not-randomized, open post-marketing surveillance study

Active substance: liquid thyme extract (extracting ratio: 1 : 2 - 2.5, extracting agents: ammonia solution 10% [m/m] : glycerol 85% [m/m]: ethanol 90 % [V/V] : water (1:20:70:109)) liquid Ivy leaf extract (extracting ratio: 1:1, extracting agent: ethanol 70 % [V/V])

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Document reference: 40048

Study title: A Double Blind Randomized Dose Response Study of Lisinopril in Children with Hypertension. (Protocol 115) and An Open Two Period Crossover Study to Determine the Relative Bioavailability of Lisinopril Suspension

Active substance: LISINOPRIL

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Document reference: 31291

Study title: A Double Blind Randomized Dose Response Study of Lisinopril in Children with Hypertension.

Active substance: LISINOPRIL

Study summary document link (including results): US No. 115_116 CSR Synopsis.pdf

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Document reference: 31290

Study title: A multicenter, open-label, single-dose study to investigate the phamacokinetics of lisinopril in hypertensive children and infants.

Active substance: LISINOPRIL

Study summary document link (including results): US No. 114_117 CSR Synopsis.pdf

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Document reference: 31296

Study title: An Open Two Period Crossover Study to Determine the Relative Bioavailability of Lisinopril Suspension.

Active substance: LISINOPRIL

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Document reference: 31295

Study title: An open two period crossover study to determine the relative bioavailability of lisinopril suspension (20 mg and marketed 20 mg tablets)

Active substance: LISINOPRIL

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Document reference: 31293

Study title: MRL Clinical Study Report: An Open, Two-Period Crossover Study to Determine the Relative Bioavailability of Lisinopril Suspension 20 mg and Marketed PRINIVIL™ 20-mg Tablets (Protocol 037).

Active substance: LISINOPRIL

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Document reference: 31288

Study title: Treatment of needle punlcture pain in children with a new topical lidocaine/prilocaine preparation

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 05_81-P008 CSR Synopsis.pdf

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Document reference: 47227

Study title: Lopinavir/ritonavir once-daily in HIV-1 infected children: A pharmacokinetic and dose finding study. Published as Verweel G, Burger DM, Sheehan NL, Bergshoeff AS, Warris A, van der Knaap LC,Driessen G, de Groot R, Hartwig NG. Plasma concentrations of the HIV-protease inhibitor lopinavir are suboptimal in children aged 2 years and below. Antivir Ther. 2007;12(4):453-8. Lopinavir/ritonavir once-daily in HIV-1 infected children: A pharmacokinetic and dose finding study. Published as Verweel G, Burger DM, Sheehan NL, Bergshoeff AS, Warris A, van der Knaap LC,Driessen G, de Groot R, Hartwig NG. Plasma concentrations of the HIV-protease inhibitor lopinavir are suboptimal in children aged 2 years and below. Antivir Ther. 2007;12(4):453-8.

Active substance: lopinavir / ritonavir

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Document reference: 41521

Study title: Efficacy and tolerability of Ambroxol Lozenges 20mg in relieving the pain of sore throat in adolescent patients with acute viral pharyngitis – A randomised, double-blind, placebo-controlled parallel group...

Active substance: AMBROXOL

Study summary document link (including results): Ambroxol Hydrochloride_U06-1404_Synopsis.pdf

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Document reference: 46554

Study title: Theralene pectoral bebe, rapport d'expertise clinique - Manciaux M. - 19/03/66

Active substance: ALIMEMAZINE

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Document reference: 46440

Study title: Sarcoma - Soft Tissue SarcomaSarcoma - Soft Tissue Sarcoma

Active substance: MESNA

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Document reference: 31649

Study title: Sodium 2-mercapto-ethane sulfonate (mesna) in respiratory resuscitation.

Active substance: MESNA

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Document reference: 31668

Study title: Szintigraphische und radiologische kontrolle der mesna- therapie bei zystischer fibrose (mucoviscidose) von kindern.

Active substance: MESNA

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Document reference: 31678

Study title: Therapeutic value of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a double-blind comparison with sodium cromoglycate (6-39 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62504_Interventional_Levocabastine.xls

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Document reference: 31092

Study title: Tolerance of levocabastine eye drops; an open study in volunteers and patients (13-65 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62435_Interventional_Levocabastine.xls

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Document reference: 31096

Study title: Young patients with both birch and grass pollen allergy - the effect of levocabastine compared with sodium cromoglycate (7-16 yrs)

Active substance: LEVOCABASTINE

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Document reference: 31114

Study title: L-carnitine in children with idiopathic dilated cardiomyopathy. Kothari SS, Sharma M. Indian Heart J. 1998 Jan-Feb; 50(1):59-61. L-carnitine in children with idiopathic dilated cardiomyopathy. Kothari SS, Sharma M. Indian Heart J. 1998 Jan-Feb; 50(1):59-61.

Active substance: LEVOCARNITINE

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Document reference: 31141

Study title: Regional lung function after different forms of mucolytic treatment.

Active substance: MESNA

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Document reference: 31686

Study title: ND: 20138 AU: Winter-S, Jue-K, Prochazka-J, Francis-P, Hamilton-W, Linn-L, Helton- E. IN: Genetics/Metabolism, Valley Children's Hospital, 3151 North Millbrook, Fresno, CA 93703, United States. TI: The role of L-carnitine in pediatric cardiomyopathy.; SO: J-CHILD-NEUROL, 1995, VOL/ISS/PG. 10/SUPPL. 2 (2S45-2S51)ND: 20138 AU: Winter-S, Jue-K, Prochazka-J, Francis-P, Hamilton-W, Linn-L, Helton- E. IN: Genetics/Metabolism, Valley Children's Hospital, 3151 North Millbrook, Fresno, CA 93703, United States. TI: The role of L-carnitine in pediatric cardiomyopathy.; SO: J-CHILD-NEUROL, 1995, VOL/ISS/PG. 10/SUPPL. 2 (2S45-2S51)

Active substance: LEVOCARNITINE

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Document reference: 31146

Study title: ND: 27179 AU: BOUISSOU F, FABRE C, REMESY M, MESTERY D,YUNG M, CABAL G, PIQUEMAL J, MARMIN G, BOESEN G, FOURES M F, BARTHE PH. IN: NEPHROLOGIE PEDIATRIQUE, HOPITAL DES ENFANTS, TOULOUSE, FRANCE. TI: CARNITINE SUPPLEMENTATION IN HEMODIALYSED CHILDREN: EFFECTS ON HEMATOLOGICAL FINDINGS, LIPID PROFILE AND MUSCLES. UROPEAN SOCIETY FOR PAEDIATRIC NEPHROLOGY; SO: 33RD ANNUAL MEETING OF THE EUROPEAN SOCIETY FOR PAEDIATRIC NEPHROLOGY, PRAGUE, CZECH REPUBLIC, SEPTEMBER 2-5, 1999 SPONSORED BY: EUROPEAN SOCIETY FORPAEDIATRIC NEPHROLOGY. PEDIATRIC-NEPHROLOGY, SEPT., 1999, VOL. 13, NO. 7, C82;REUNION ANNUELLE NOVEMBER 1998, LUXEMBOURGND: 27179 AU: BOUISSOU F, FABRE C, REMESY M, MESTERY D,YUNG M, CABAL G, PIQUEMAL J, MARMIN G, BOESEN G, FOURES M F, BARTHE PH. IN: NEPHROLOGIE PEDIATRIQUE, HOPITAL DES ...

Active substance: LEVOCARNITINE

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Document reference: 31145

Study title:

Active substance: MEROPENEM TRIHYDRATE

Study summary document link (including results): 3591US0013.xls

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Document reference: 45258

Study title:

Active substance: MEROPENEM TRIHYDRATE

Study summary document link (including results): 1946600600.xls

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Document reference: 45259

Study title: Riad, W., et al., Effect of midazolam, dexamethasone and their combination on the prevention of nausea and vomiting following strabismus repair in children. Eur J Anaesthesiol, 2007. 24(8): p. 697-701..Riad, W., et al., Effect of midazolam, dexamethasone and their combination on the prevention of nausea and vomiting following strabismus repair in children. Eur J Anaesthesiol, 2007. 24(8): p. 697-701..

Active substance: MIDAZOLAM

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Document reference: 32007

Study title: Shany, E., O. Benzaqen, and N. Watemberg, Comparison of continuous drip of midazolam or lidocaine in the treatment of intractable neonatal seizures. J Child Neurol, 2007. 22(3): p. 255-9Shany, E., O. Benzaqen, and N. Watemberg, Comparison of continuous drip of midazolam or lidocaine in the treatment of intractable neonatal seizures. J Child Neurol, 2007. 22(3): p. 255-9

Active substance: MIDAZOLAM

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Document reference: 32008

Study title: A survey of the side effects of midecamycin acetate (Miocamycin) dry syrup after marketing - T. Mayama, K. Maruyama, T. Nakazawa and M. Iida - International journal of clinical Pharmacology, therapy and toxicology, vol.28 nr6 - 1990 (245-250)

Active substance: MIDECAMYCIN

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Document reference: 32012

Study title: Comparison of Miocamycin versus Amoxicillin in lower respiratory tract infections in children. Clinical response and effect on natural killer activity - C. Agostini et al. - Journal Internat. Medical Research 1988, 16; 305-311

Active substance: MIDECAMYCIN

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Document reference: 32016

Study title: Determination des caracteristiques pharmacocinetiques du diacétate de midecamycine chez lénfant (1 mois à 12 ans) aprés la 1ère administration d'un traitement

Active substance: MIDECAMYCIN

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Document reference: 32009

Study title: Effect of Miocamycin on theophylline kinetics in children - N. Principi, J. Onorato, M.G. Guiliani, and A. Vigano - Eur. J. Clin Pharmacol (1987)31:701-704

Active substance: MIDECAMYCIN

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Document reference: 32010

Study title: La miocamicina nel tratamento di infezione delle vie aeree in pazienti di età pediatrica - N. Principi, P. Marchisio, J. Onorato - G. Ital. Chemioter., 33, 129-134, 1986

Active substance: MIDECAMYCIN

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Document reference: 32015

Study title: Studio comparativo tra miocamicina ed eritromicina nell'erradicazione di streptococco B-emolitico di Gruppo a ed influenza di miocamicina sulla fagocitosi dei polimorfonucleati verso streptococco autologo - M. Borzani, F. Varotto, L.Garlaschi, et al. - Riv. Inf. Ped. 1989, 1, 29-35

Active substance: MIDECAMYCIN

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Document reference: 32014

Study title: Studio multicentrico sulla faringotonsillite in età pediatrica - P. Marchisio, A. Calanchi, J. Onorato, A. Plebani, E. Reali, L. Rancilio, E. Grasso, L. Magni, G. Caramia, et al. - Riv. Inf. Ped. (1989), 4, 239-249

Active substance: MIDECAMYCIN

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Document reference: 32011

Study title: Studio preliminare sulla Farmacocinetica della miocamicina nell'età pediatrica - L. Tarani, A. Teggi, L. Bruni, et al Riv. Inf. Ped. 1989, 4, 251-255

Active substance: MIDECAMYCIN

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Document reference: 32013

Study title: Upper respiratory tract infections in children: Antibiotic treatment - Marchisio P., Principi, N. - Drugs Exptl. Clin. Res. XIII(9) 585-588 (1987)

Active substance: MIDECAMYCIN

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Document reference: 32017

Study title: Clinical trial for efficacy and safety of miglitol ( Bay m 1099) in insulin - dependent diabetic children - Petzinna D. and al. - 16/06/1994 Miglitol Initial Registration Dossier - 1995 - Part IV Vol 294

Active substance: MIGLITOL

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Document reference: 32018

Study title: Clinical trial to assess the efficacy and tolerability of Bay m 1099 (Miglitol) in insulin-dependent diabetic children - H Schulz and al. - 27/11/1990 Migliotl Initial Registration Dossier - 1995 - Part IV Vol 292

Active substance: MIGLITOL

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Document reference: 32019

Study title: Effect of milrinone on postbypass pulmonary hypertension in children after tetralogy of Fallot repair - Chu CC. et al. - No date (Clin Med J. 200, 63, 294-300)Effect of milrinone on postbypass pulmonary hypertension in children after tetralogy of Fallot repair - Chu CC. et al. - No date (Clin Med J. 200, 63, 294-300)

Active substance: MILRINONE

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Document reference: 32021

Study title: Chavarria AP, et al. Control of pediatric diarrhea. Adv Ther 1984 1: 115–119Chavarria AP, et al. Control of pediatric diarrhea. Adv Ther 1984 1: 115–119

Active substance: LOPERAMIDE

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Document reference: 31444

Study title: Cornett JWD, et al. Double-Blind Comparative Evaluation of Loperamide versus Diphenoxylate with Atropine in Acute Diarrhea. Curr Ther Res 1977; 21: 629-37Cornett JWD, et al. Double-Blind Comparative Evaluation of Loperamide versus Diphenoxylate with Atropine in Acute Diarrhea. Curr Ther Res 1977; 21: 629-37

Active substance: LOPERAMIDE

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Document reference: 31429

Study title: Diarrhoeal Diseases Study Group (UK). Loperamide in acute diarrhoea in childhood: Results of a double blind, placebo controlled multicentre clinical trial. Br Med J 1984; 289: 1263–67.Diarrhoeal Diseases Study Group (UK). Loperamide in acute diarrhoea in childhood: Results of a double blind, placebo controlled multicentre clinical trial. Br Med J 1984; 289: 1263–67.

Active substance: LOPERAMIDE

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Document reference: 31430

Study title: Double-blind, placebo-controlled study. Male and female paediatric patients; who had 4 or more watery bowel movements in the last 24 hours.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD10972_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31447

Study title: Double-blind, randomised, comparative study; Patients of 14 or more years of age with presence of incapacitating acute diarrhoea (four or more unformed stools during the 24-hour period prior to consultation)

Active substance: LOPERAMIDE

Study summary document link (including results): LMD8743_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31420

Study title:

Active substance: LOPERAMIDE

Study summary document link (including results): LMD83934_Interventional_Loperamide oxide.xls

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Document reference: 47584

Study title: Review article : High-dose vitamin B6 treatment in West syndrome - Y. Toribe - 2001 (Brain and Development vol 23) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Review article : High-dose vitamin B6 treatment in West syndrome - Y. Toribe - 2001 (Brain and Development vol 23) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31516

Study title: Serum magnesium levels in children with cirrhosis - Kaya G, Ozsoylu S - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Serum magnesium levels in children with cirrhosis - Kaya G, Ozsoylu S - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31517

Study title: Taux comparés magnésiques du milieu intra et extra-cellulaire des enfants et des adultes sains - Melles Z - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Taux comparés magnésiques du milieu intra et extra-cellulaire des enfants et des adultes sains - Melles Z - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31518

Study title: Treatment of infantile spasms with high-dosage vitamin B6 - J. Pietz et al. - 1993 (Epilepsia vol 34) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of infantile spasms with high-dosage vitamin B6 - J. Pietz et al. - 1993 (Epilepsia vol 34) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31519

Study title: Ramos JT, De José MI, Dueñas J, Fortuny C, González-Montero R, Mellado MJ, Mur A, Navarro M, Otero C, Pocheville I, Muñoz-Fernández MA, Cabrero E; Spanish Collaborative Group on HIV Infection in Children. Safety and antiviral response at 12 months of lopinavir/ritonavir therapy in human immunodeficiency virus-1-infected children experienced with three classes of antiretrovirals. Pediatr Infect Dis J. 2005 Oct;24(10):867-73Ramos JT, De José MI, Dueñas J, Fortuny C, González-Montero R, Mellado MJ, Mur A, Navarro M, Otero C, Pocheville I, Muñoz-Fernández MA, Cabrero E; Spanish Collaborative Group on HIV Infection in Children. Safety and antiviral response at 12 months of lopinavir/ritonavir therapy in human immunodeficiency virus-1-infected children experienced with three classes of anti...

Active substance: lopinavir / ritonavir

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Document reference: 41531

Study title: Resino S, Bellón JM, Muñoz-Fernández MA; Spanish Group of HIV Infection. Antiretroviral activity and safety of lopinavir/ritonavir in protease inhibitor-experienced HIV-infected children with severe-moderate immunodeficiency. J Antimicrob Chemother. 2006Resino S, Bellón JM, Muñoz-Fernández MA; Spanish Group of HIV Infection. Antiretroviral activity and safety of lopinavir/ritonavir in protease inhibitor-experienced HIV-infected children with severe-moderate immunodeficiency. J Antimicrob Chemother. 2006

Active substance: lopinavir / ritonavir

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Document reference: 41530

Study title: van der Lee M, Verweel G, de Groot R, Burger D. Pharmacokinetics of a once-daily regimen of lopinavir/ritonavir in HIV-1-infected children. Antivir Ther. 2006;11(4):439-45 See Neth 378-00-66van der Lee M, Verweel G, de Groot R, Burger D. Pharmacokinetics of a once-daily regimen of lopinavir/ritonavir in HIV-1-infected children. Antivir Ther. 2006;11(4):439-45 See Neth 378-00-66

Active substance: lopinavir / ritonavir

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Document reference: 41522

Study title: Virological and immunological response in HIV infected children with lopinavir/r qd vs. lopinavir/r bid. Published as:Lopinavir/ritonavir exposure in treatment-naive HIV-infected children following twice or once daily administration. J Antimicrob Chemother. 2006 Jun;57(6):1168-71. Epub 2006 Apr 10. Virological and immunological response in HIV infected children with lopinavir/r qd vs. lopinavir/r bid. Published as:Lopinavir/ritonavir exposure in treatment-naive HIV-infected children following twice or once daily administration. J Antimicrob Chemother. 2006 Jun;57(6):1168-71. Epub 2006 Apr 10.

Active substance: lopinavir / ritonavir

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Document reference: 41527

Study title: A Comparative Trial of a Loperamide and Simethicone Combination Product vs Loperamide Alone, Simethicone Alone and Placebo in the Treatment of Acute Diarrhea With Gas-Related Abdominal Discomfort

Active substance: LORACARBEF

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Document reference: 31459

Study title: Lorabid in acute otitis media: 10-day vs 5-day therapy

Active substance: LORACARBEF

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Document reference: 31453

Study title: Lorabid in acute otitis media: 10-day vs 5-day therapy

Active substance: LORACARBEF

Study summary document link (including results): Loracarbef - B9U-MC-AZAZ aCSR redacted.PDF

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Document reference: 31454

Study title: Loracarbef concentration in sinus secretions/mucosa in children

Active substance: LORACARBEF

Study summary document link (including results): Loracarbef - B9U-MC-AZCX Synopsis.pdf

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Document reference: 31450

Study title: Comparison of fennel and mefenamic acid for the treatment of primary dysmenorrhea; Namavar Jahromi B et al. , Int J Gynaecol Obstet. 2003 Feb;80(2):153-7.Comparison of fennel and mefenamic acid for the treatment of primary dysmenorrhea; Namavar Jahromi B et al. , Int J Gynaecol Obstet. 2003 Feb;80(2):153-7.

Active substance: MEFENAMIC ACID

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Document reference: 41620

Study title: Comparison of the effectiveness of fennel and mefenamic acid on pain intensity in dysmenorrhoea.; Modaress Nejad V et al., East Mediterr Health J. 2006 May-Jul;12(3-4):423-7.Comparison of the effectiveness of fennel and mefenamic acid on pain intensity in dysmenorrhoea.; Modaress Nejad V et al., East Mediterr Health J. 2006 May-Jul;12(3-4):423-7.

Active substance: MEFENAMIC ACID

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Document reference: 41619

Study title: ND: 27405 AU: Van-Oudheusden-L-J, Scholte-H-R. IN: Westfries Gasthuis, Dept Pediat, POB 600, NL-1620 AR Hoorn, Netherlands. Erasmus Univ, Rotterdam, Netherlands. TI: Efficacy of carnitine in the treatment of children with attention- deficithyperactivity disorder; SO: PROSTAGLANDINS-LEUKOTRIENES-AND-ESSENTIAL-FATTY-ACIDS, 2002, V67, N1, JUL,pp 33-38 ND: 27405 AU: Van-Oudheusden-L-J, Scholte-H-R. IN: Westfries Gasthuis, Dept Pediat, POB 600, NL-1620 AR Hoorn, Netherlands. Erasmus Univ, Rotterdam, Netherlands. TI: Efficacy of carnitine in the treatment of children with attention- deficithyperactivity disorder; SO: PROSTAGLANDINS-LEUKOTRIENES-AND-ESSENTIAL-FATTY-ACIDS, 2002, V67, N1, JUL,pp 33-38

Active substance: LEVOCARNITINE

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Document reference: 31144

Study title: Masakazu Funahashi, Department of Ophthalmology, Gifu University Hospital, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.Masakazu Funahashi, Department of Ophthalmology, Gifu University Hospital, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31377

Study title: Masakazu Funahashi, Department of Ophthalmology, Gifu University Hospital, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.Masakazu Funahashi, Department of Ophthalmology, Gifu University Hospital, Clinical experience with Lomefloxacin ophthalmic solution (NY-198) in external eye infections. No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31392

Study title: Mayumi Takabatake, Department of Ophthalmology, Okayama University Medical School, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trial. No report date.Mayumi Takabatake, Department of Ophthalmology, Okayama University Medical School, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trial. No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31372

Study title: Mayumi Takabatake, Department of Ophthalmology, Okayama University Medical School, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trial. No report date.Mayumi Takabatake, Department of Ophthalmology, Okayama University Medical School, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trial. No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31387

Study title: Mizuto Suzuki, Department of ophthalmology, Nagatsuda Kosei General Hospital, Clinical study of the Pyridonecarboxylic Acid Antimicrobial Lomefloxacin ophthalmic solution (NY-198) in bacterial external eye infection. 1989-1990.Mizuto Suzuki, Department of ophthalmology, Nagatsuda Kosei General Hospital, Clinical study of the Pyridonecarboxylic Acid Antimicrobial Lomefloxacin ophthalmic solution (NY-198) in bacterial external eye infection. 1989-1990.

Active substance: LOMEFLOXACIN

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Document reference: 31364

Study title: Montero J, Pastor JC et al. Double blind clinical trial between lomefloxacin 0.3% (DR 1303) eye drops and gentamicin 0.3% in patients with acute bacterial conjunctivitis. December 15, 1994.

Active substance: LOMEFLOXACIN

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Document reference: 31395

Study title: Orzalesi N et al. Double masked double dummy clinical trial between Lomefloxacin (DR 1303) and Tobramycin eye drops in 2x40 subjects with microbiologically confirmed acute bacterial conjunctivitis with the objective to compare efficacy, safety and local tolerance. December 9, 1994.

Active substance: LOMEFLOXACIN

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Document reference: 31394

Study title: Patterson A, Agius-Fernandez A. Use of topically applied lomefloxacin 0.3% (DR 1303) in comparison to chloramphenicol 0.5% in the treatment of acute bacterial conjunctivitis. July 7, 1993.

Active substance: LOMEFLOXACIN

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Document reference: 31397

Study title: Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease - Hoffman, TM et al. - 2003 (Circulation 2003; 107: 996-1002)Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease - Hoffman, TM et al. - 2003 (Circulation 2003; 107: 996-1002)

Active substance: MILRINONE

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Document reference: 32022

Study title: ANALGESIC EFFICACY AND SAFETY OF PIROXICAM IN PRIMARY DYSMENORRHEA.

Active substance: PIROXICAM

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Document reference: 34399

Study title: ASSESS THE ANALGESIC EFFICACY OF PIROXICAM IN A VARIETY OF PAINFUL CONDITIONS IN SPORTS MEDICINE, NOT SEVER ENOUGH TO REQUIRE M.S..

Active substance: PIROXICAM

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Document reference: 34484

Study title: CLINICAL STUDY OF PIROXICAM SUPPOSITORY IN PATIENTS WITH OSTEOARTHRITIS LOW BACK PAIN AND PERIARTHRITIS HUMEROSCAPULARIS (III): A NATIONWIDE STUDY BY GENERAL PRACTIONERS.

Active substance: PIROXICAM

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Document reference: 34468

Study title: CLINICAL STUDY OF PRX DISPERSIBLE IN SPORT TRAUMATISMS.

Active substance: PIROXICAM

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Document reference: 34415

Study title: COMPARE SAFETY AND EFFICACY OF PIROXICAM WITH PROPOXYPHENE IN POST- OPERATIVE PAIN.

Active substance: PIROXICAM

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Document reference: 34463

Study title: COMPARISON OF PIROXICAM VS PARACETAMOL IN PATIENTS WITH DENTAL SURGERY

Active substance: PIROXICAM

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Document reference: 34433

Study title: D/B PARALLEL COMPARISON OF SINGLE DOSES OF PIROXICAM (TWO DOSE LEVELS), ASPIRIN & PLACEBO IN PATIENTS WITH POST-OPERATIVE PAIN

Active substance: PIROXICAM

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Document reference: 34310

Study title: D/B, PARALLEL, COMPARATIVE STUDY OF PIROXICAM(3-DOSAGE REGIMENS),IBUPROFEN & PLACEBO IN PATS WITH ACUTE MUSCULOSKELETAL DISORDERS

Active substance: PIROXICAM

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Document reference: 34311

Study title: DB, PARALLEL COMPARATIVE STUDY OF PIROXICAM (TWO DOSES) ASPIRIN & PLACEBO IN PATIENTS WITH POSTOPERATIVE DENTAL PAIN

Active substance: PIROXICAM

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Document reference: 34317

Study title: AN OPEN, NON-COMPARATIVE STUDY WITH PIROXICAM (FELDENE) IM IN THE TREATMENT OF PATIENTS WITH ACUTE LOW BACK PAIN

Active substance: PIROXICAM

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Document reference: 34356

Study title: DOUBLE BLIND CLINICAL TRIAL OF PIROXICAM IN THE TREATMENT OF DYSMENORRHEA

Active substance: PIROXICAM

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Document reference: 34359

Study title: DOUBLE BLIND PARALLEL COMPARATIVE STUDY OF PIROXICAM (TWO DOSES), ASPIRIN AND PLACEBO IN PATIENTS WITH POSTEPISIOTOMY PAIN. A MULTIPLE-CENTER STUDY.

Active substance: PIROXICAM

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Document reference: 34316

Study title: DOUBLE BLIND PARALLEL COMPARATIVE STUDY OF PIROXICAM (TWO DOSES), AND PLACEBO IN PATIENTS WITH PRIMART DYSMENORRHEA.

Active substance: PIROXICAM

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Document reference: 34314

Study title: DOUBLE BLIND PARALLEL COMPARATIVE STUDY OF PIROXICAM (TWO DOSES), AND PLACEBO IN PATIENTS WITH PRIMART DYSMENORRHEA.

Active substance: PIROXICAM

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Document reference: 34315

Study title: DOUBLE BLIND TRIAL OF PIROXICAM AND NAPROXEN IN TREATMENT OF JUVENILE RHEUMATOID ARTHRITIS

Active substance: PIROXICAM

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Document reference: 34325

Study title: DOUBLE-BLIND PARALLEL COMPARATIVE STUDY OF PIROXICAM (THREE DOSAGE REGIMENS), IBUPROFEN AND PLACEBO IN PATIENTS WITH PRIMARY DY SMENORRHEA

Active substance: PIROXICAM

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Document reference: 34319

Study title: DOUBLE-BLIND PARALLEL COMPARATIVE STUDY OF PIROXICAM (THREE DOSAGE REGIMENS), IBUPROFEN AND PLACEBO IN PATIENTS WITH PRIMARY DYSMENORRHEA

Active substance: PIROXICAM

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Document reference: 34320

Study title: DOUBLE-BLIND RANDOMIZED COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF PIROXICAM DT VS PLACEBO IN THE TREATMENT OF PATIENTS WITH NON- BACTERIAL PHARYNGOAMYGDALITIS

Active substance: PIROXICAM

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Document reference: 34350

Study title: DOUBLE-BLIND, PARALLEL, COMAPRATIVE STUDY OF ONCE DAILY DOSING OF PIROXICAM (THREE DOSAGE REGIMENS) IBUPROFEN AND PLACEBO IN PATIENTS WITH PRIMARY DYSMENORRHEA

Active substance: PIROXICAM

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Document reference: 34321

Study title: DRUG USE INVESTIGATIONAL OF FELDENE SUPPOSITORY IN THE TREATMENT OF VARIOUS DISEASES WITH PAIN

Active substance: PIROXICAM

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Document reference: 34467

Study title: Treatment of the West syndrome with high-dose pyridoxal phosphate - Y. Ohtsuka et al. - 1987 (Brain Dev vol 9) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of the West syndrome with high-dose pyridoxal phosphate - Y. Ohtsuka et al. - 1987 (Brain Dev vol 9) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31520

Study title: Vitamin B6, Magnesium and combined B6-Mg : therapeutic effects in childhood autism - J. Martineau et al. - 1985 (Biol. Psychiatry vol 20) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Vitamin B6, Magnesium and combined B6-Mg : therapeutic effects in childhood autism - J. Martineau et al. - 1985 (Biol. Psychiatry vol 20) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31521

Study title: Troubles during dentition. Study concerning treatment with a homeopatic complex preparation

Active substance: Magnesium phosphoricum C6, Chamomilla recutita D6, Calcium carbonicum C8, Passiflora D6

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Document reference: 40066

Study title: "ARDOUIN P. Intérêt du NECYRANE dans la pratique O.R.L courante. Revue de Méd. De Tours ; 1973 – T.7 – N°8."

Active substance: Magnesium Ritiometan

Study summary document link (including results): Necyrane-option1.xls

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Document reference: 47881

Study title: "Furosemide and mannitol suppression of epileptic activity in the human brain"http://www.ncbi.nlm.nih.gov/pubmed?term=15728766 "Furosemide and mannitol suppression of epileptic activity in the human brain"http://www.ncbi.nlm.nih.gov/pubmed?term=15728766

Active substance: MANNITOL

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Document reference: 31524

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2004

Active substance: METAMIZOLE

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Document reference: 31703

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2005

Active substance: METAMIZOLE

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Document reference: 31704

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2006

Active substance: METAMIZOLE

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Document reference: 31705

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2007

Active substance: METAMIZOLE

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Document reference: 31706

Study title: The analgesic effect of Tilidin in comparaison to Metamizol drops in posttraumatic pain in childhood - Von Bülow - 1988 (Therapiwoche 1988; 38: 1232-1234)

Active substance: METAMIZOLE

Study summary document link (including results): Metamizole magnesium_U05-1666_synopsis.pdf

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Document reference: 31710

Study title: Three-year experience with Novalgin inj. In the treatment of acute pain in child age: analgetic effect, safety of treatment and incidence of indesirable effects. Kralinsky K. et al.; Cs Pediat 1998; 53:689-692 - Publication in Part IC3 Clinical Documentation - HAUKE - 28/02/2000 -

Active substance: METAMIZOLE

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Document reference: 31707

Study title: Ensayo clinico a doble ciego para el tratamiento de las afecciones respiratorias agudas con metoxibutropato en jarabe al 3%

Active substance: METHOXYBUTROPATE

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Document reference: 31726

Study title: Studio clinico controllato sull’efficacia e tollerabilità del metoxibutropato vs nimesulide in campo otorino laringoiatrico

Active substance: METHOXYBUTROPATE

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Document reference: 31725

Study title: Drug-associated admissions to a district hospital in Saudi Arabia; Ahmed M el-B., J Clin Pharm Ther. 1997 Feb;22(1):61-6.Drug-associated admissions to a district hospital in Saudi Arabia; Ahmed M el-B., J Clin Pharm Ther. 1997 Feb;22(1):61-6.

Active substance: MEFENAMIC ACID

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Document reference: 31571

Study title: Intensive cardiac management in patients with trisomy 13 or trisomy 18.; Kaneko Y et al., Am J Med Genet A. 2008 Jun 1;146A(11):1372-80Intensive cardiac management in patients with trisomy 13 or trisomy 18.; Kaneko Y et al., Am J Med Genet A. 2008 Jun 1;146A(11):1372-80

Active substance: MEFENAMIC ACID

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Document reference: 31583

Study title: Mefanamic acid--an antipyretic for use in children.; Weiss CF et al., J Pediatr. 1968 Jun;72(6):867-70Mefanamic acid--an antipyretic for use in children.; Weiss CF et al., J Pediatr. 1968 Jun;72(6):867-70

Active substance: MEFENAMIC ACID

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Document reference: 31582

Study title: Oral antipyretic therapy. Evaluation of mefenamic acid (short communication).; Similä S et al., Arzneimittelforschung. 1977;27(3):687-8Oral antipyretic therapy. Evaluation of mefenamic acid (short communication).; Similä S et al., Arzneimittelforschung. 1977;27(3):687-8

Active substance: MEFENAMIC ACID

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Document reference: 31581

Study title: Perichondritis; Kadzombe EA et al., Lancet. 1988 Oct 29;2(8618):1010-1Perichondritis; Kadzombe EA et al., Lancet. 1988 Oct 29;2(8618):1010-1

Active substance: MEFENAMIC ACID

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Document reference: 31577

Study title: Therapy of symptomatic patent ductus arteriosus in preterms using mefenemic acid and indomethacin; Sakhalkar VS et al., Indian Pediatr. 1992 Mar;29(3):313-8Therapy of symptomatic patent ductus arteriosus in preterms using mefenemic acid and indomethacin; Sakhalkar VS et al., Indian Pediatr. 1992 Mar;29(3):313-8

Active substance: MEFENAMIC ACID

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Document reference: 31576

Study title: Tolfenamic acid and mefenamic acid in the treatment of primary dysmenorrhoea.; Delgado J et al., Pharmacol Toxicol. 1994;75 Suppl 2:89-91. Tolfenamic acid and mefenamic acid in the treatment of primary dysmenorrhoea.; Delgado J et al., Pharmacol Toxicol. 1994;75 Suppl 2:89-91.

Active substance: MEFENAMIC ACID

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Document reference: 31573

Study title: Treatment of primary dysmenorrhea with mefenamic acid.Kintis GA et al, Int J Gynaecol Obstet. 1980;18(3):172-5. Treatment of primary dysmenorrhea with mefenamic acid.Kintis GA et al, Int J Gynaecol Obstet. 1980;18(3):172-5.

Active substance: MEFENAMIC ACID

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Document reference: 31579

Study title: Report lnstituti Ospitalieri Cremona

Active substance: METOCLOPRAMIDE

Study summary document link (including results): Metroclopramide STUDY Brogi.xls

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Document reference: 47992

Study title: Sperimentazione clinica con Plasil. STUDY Scarsella

Active substance: METOCLOPRAMIDE

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Document reference: 47990

Study title: Zusammenfassung der einzelberichte von 13 klinischen prufern uber paspertin-suppositorien fur kinder(8 mg metoclopramid pro zapfchen) - Hennies - 05/10/1971

Active substance: METOCLOPRAMIDE

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Document reference: 31959

Study title: Estudio del vogalen gotas en los reflujos gastroesofagios del lactante confrontacion clinica-radiologica-endoscopia e histologica - Ghisolfi J., Olives J.P., Rives J.J. - 09/1979

Active substance: METOPIMAZINE

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Document reference: 31960

Study title: Etude comprative en double aveugle Alizapride versus Metopimazine dans les traitements des vomissements chez le nourrisson et l'enfant - Pr. Tron et coll. - 09/1988

Active substance: METOPIMAZINE

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Document reference: 31961

Study title: Reiko Minagawa, Department of Ophthalmology, Kounan Hospital, Clinical effects of Lomefloxacin ophthalmic solution (NY-198) for bacterial external eye infection. 1989.Reiko Minagawa, Department of Ophthalmology, Kounan Hospital, Clinical effects of Lomefloxacin ophthalmic solution (NY-198) for bacterial external eye infection. 1989.

Active substance: LOMEFLOXACIN

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Document reference: 31363

Study title: Sei-ichi Ishimoto, Department of Ophthalmology, Faculty of Medicine, Kyusyu University, Clinical evaluation of topical Lomefloxacin (NY-198) for external eye infection. No report date.Sei-ichi Ishimoto, Department of Ophthalmology, Faculty of Medicine, Kyusyu University, Clinical evaluation of topical Lomefloxacin (NY-198) for external eye infection. No report date.

Active substance: LOMEFLOXACIN

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Document reference: 31367

Study title: Taux comparés magnésiques du milieu intra et extra-cellulaire des enfants et des adultes sains - Melles Z - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Taux comparés magnésiques du milieu intra et extra-cellulaire des enfants et des adultes sains - Melles Z - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31497

Study title: The safety of vitamin B6 - A.R Gaby - 1997 (J. Nutr Environ. Med vol 7) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -The safety of vitamin B6 - A.R Gaby - 1997 (J. Nutr Environ. Med vol 7) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31498

Study title: TRATAMIENTO DE LOS TRASTORNOS CONDUCTUALES EN NINOS CON RETRASO MENTAL LIGERO Y MODERADO. EFICACIA Y SEGURIDAD DE GAMALATE 86R Novell

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

Study summary document link (including results): R Novell.pdf

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Document reference: 48087

Study title: Treatment of infantile spasms with high-dosage vitamin B6 - J. Pietz et al. - 1993 (Epilepsia vol 34) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of infantile spasms with high-dosage vitamin B6 - J. Pietz et al. - 1993 (Epilepsia vol 34) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31499

Study title: Treatment of infantile spasms with high-dosage vitamin B6 : the Heidelberg experience 1989-1999 - J. Scholl et al. - 2000 (Neuropediatrics vol 31) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of infantile spasms with high-dosage vitamin B6 : the Heidelberg experience 1989-1999 - J. Scholl et al. - 2000 (Neuropediatrics vol 31) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31500

Study title: Observational use study of the tolerability of Octenisept in premature infants in the neonatal intensive care unit of Innsbruck University Hospital. University clinic for paediatric and juvenile medicine. 2000.

Active substance: OCTENIDINE

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Document reference: 32739

Study title: Early intravenous indomethacin prolongs respiratory support in very low birth weight infants.

Active substance: INDOMETHACIN

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Document reference: 29871

Study title: HAB-053

Active substance: inactivated hepatitis a virus and hepatitis b surface antigen (rdna)

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Document reference: 41482

Study title: Immunogenicity trial of Rouvax vaccine with a new stabiliser in tunisian children

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41239

Study title: Naproxen versus indomethacin as night-time medication for patients with rheumatoid arthritis

Active substance: INDOMETHACIN

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Document reference: 29971

Study title: Erfahrungen mit dem Präparat Bebulin bei Therapie von Patienten mit Hämophilie B (Lechner K 1974) (BEBULIN Experiences with Bebulin in the Therapy of Hemophilia B patients

Active substance: FACTOR VIII INHIBITOR BYPASSING ACT

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Document reference: 26992

Study title: Sposto R et al. Comparison of long-term outcome of children and adolescents with disseminated non-lymphoblastic non-Hodgkin lymphoma treated with COMP or daunomycin-COMP: A report from the Children's Cancer Group. Med Pediatr Oncol. 2001 Nov;37(5):432-41.Sposto R et al. Comparison of long-term outcome of children and adolescents with disseminated non-lymphoblastic non-Hodgkin lymphoma treated with COMP or daunomycin-COMP: A report from the Children's Cancer Group. Med Pediatr Oncol. 2001 Nov;37(5):432-41.

Active substance: MITOXANTRONE

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Document reference: 32208

Study title: Starling KA et al Mitoxantrone in refractory acute leukemia in children: a phase I study Invest New Drugs. 1985;3(2):191-5 Starling KA et al Mitoxantrone in refractory acute leukemia in children: a phase I study Invest New Drugs. 1985;3(2):191-5

Active substance: MITOXANTRONE

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Document reference: 32080

Study title: Steinherz PG et al. Development of a new intensive therapy for acute lymphoblastic leukemia in children at increased risk of early relapse. The Memorial Sloan-Kettering-New York-II protocol. Cancer. 1993 Nov 15;72(10):3120-30.Steinherz PG et al. Development of a new intensive therapy for acute lymphoblastic leukemia in children at increased risk of early relapse. The Memorial Sloan-Kettering-New York-II protocol. Cancer. 1993 Nov 15;72(10):3120-30.

Active substance: MITOXANTRONE

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Document reference: 32218

Study title: Steuber CP et al Toxicity evaluation of dihydroxyanthracenedione (DHAD) in combination with cytosine arabinoside (Ara-C) Invest New Drugs. 1987 Dec;5(4):379-82 Steuber CP et al Toxicity evaluation of dihydroxyanthracenedione (DHAD) in combination with cytosine arabinoside (Ara-C) Invest New Drugs. 1987 Dec;5(4):379-82

Active substance: MITOXANTRONE

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Document reference: 32088

Study title: Stevens MC et al Treatment of nonmetastatic rhabdomyosarcoma in childhood and adolescence: third study of the International Society of Paediatric Oncology--SIOP Malignant Mesenchymal Tumor 89 J Clin Oncol. 2005 Apr 20;23(12):2618-28. Epub 2005 Feb 22Stevens MC et al Treatment of nonmetastatic rhabdomyosarcoma in childhood and adolescence: third study of the International Society of Paediatric Oncology--SIOP Malignant Mesenchymal Tumor 89 J Clin Oncol. 2005 Apr 20;23(12):2618-28. Epub 2005 Feb 22

Active substance: MITOXANTRONE

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Document reference: 32148

Study title: Statement on the safety of medicinal products used by children. Contribution to the safety of medicinal products used by children younger than 12 years in Germany by data on compulsory rebate on OTC medicinal products and surveillance of adverse drug effects. Here: Recessan.Statement on the safety of medicinal products used by children. Contribution to the safety of medicinal products used by children younger than 12 years in Germany by data on compulsory rebate on OTC medicinal products and surveillance of adverse drug effects. Here: Recessan.

Active substance: POLIDOCANOL

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Document reference: 46072

Study title: Ten years experience with paravariceal injection sclerotherapy of esophageal varices in children; Paquet,K.J.;J. Pediatr. Surg.(1985) vol.20, n°2, p.109-112Ten years experience with paravariceal injection sclerotherapy of esophageal varices in children; Paquet,K.J.;J. Pediatr. Surg.(1985) vol.20, n°2, p.109-112

Active substance: POLIDOCANOL

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Document reference: 46069

Study title: Upper gastro-intestinal tract bleeding in cirrhotic children candidates for liver transplantation. Sokal,E.M.;Eur. J.Pediatr.(1992) vol.151p.326-328Upper gastro-intestinal tract bleeding in cirrhotic children candidates for liver transplantation. Sokal,E.M.;Eur. J.Pediatr.(1992) vol.151p.326-328

Active substance: POLIDOCANOL

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Document reference: 46071

Study title:

Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD

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Document reference: 34566

Study title:

Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD

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Document reference: 34567

Study title: Renal function and cardiac angiography; NIBOSHI A; Indian J. Pediatr.; 2006 vol.73 n.1 p.49 53Renal function and cardiac angiography; NIBOSHI A; Indian J. Pediatr.; 2006 vol.73 n.1 p.49 53

Active substance: IOVERSOL

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Document reference: 30426

Study title: A double-blind, single dose evaluation of the comparative analgesic efficacy of acetaminophen 1000 mg, ibuprofen 400 mg, ibuprofen 200 mg, and placebo in the treatment of pain following oral surgery. Stat Rpt 58. Protocol 3-278, Unpublished Report 172.

Active substance: IBUPROFEN AND PARACETAMOL

Study summary document link (including results): ibuprofen_paracetamol 3-278.pdf

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Document reference: 47389

Study title: Kubba, H., MacAndie, C., Botma, M., Robison, J., O'Donnell, M., Robertson, G., and Geddes, N. Department of Otolaryngology Head and Neck Surgery, Royal Hospital for Sick Children, Yorkhill, Glasgow, UK. A prospective, single-blind, randomized controlled trial of antiseptic cream for recurrent epistaxis in childhood Clin.Otolaryngol.Allied Sci. 2001;26:465-468.

Active substance: CHLORHEXIDINE_AND_NEOMYCIN

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Document reference: 23934

Study title: Open label pharmacokinetic evaluation of single oral doses of dolasetron mesilate for the prevention of acute (24-hour) nausea and vomiting in paediatric cancer patients receiving moderately to highly emetogenic chemotherapy - Lariviere - 28 April 1995

Active substance: DOLASETRON

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Document reference: 26302

Study title: Extension of Study LUI-01-00 in Austria: LUIVAC treatment under daily life conditions in patients with recurrent respiratory tract infections including obstructive pulmonary diseases

Active substance: Bacterial lysate

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Document reference: 41833

Study title: Gastrointestinal absorption of doxapram in neonates.Bairam et al. (Am J Perinatol. 1991 Mar;8(2):110-3)

Active substance: Doxapram

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Document reference: 48440

Study title: Morphine combined with doxapram or naloxone. A study of post-operative pain relief.Gupta et al. (Anaesthesia, 1974, Volume 29, pages 33-39)

Active substance: Doxapram

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Document reference: 48441

Study title: Teratological study in rats

Active substance: CICLOSPORIN

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Document reference: 24111

Study title: Expertise clinique Claforan 1g I.M. préparation injectable solvant: Lidocaine - Pr J. Kermarec - 1979Expertise clinique Claforan 1g I.M. préparation injectable solvant: Lidocaine - Pr J. Kermarec - 1979

Active substance: CEFOTAXIME

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Document reference: 23479

Study title: The influence of a synthetic antihistamine upon the bodyweight and height in children

Active substance: Buclizine

Study summary document link (including results): CE70A063-translation.pdf

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Document reference: 42014

Study title: Heron-B, Gautier-A, Dulac-O, Ponsot-G. Service de Neurologie Pediatrique, Hopital Saint-Vincent-de-Paul, Paris. Biotinidase deficiency. Progressive encephalopathy curable with biotin. Archives francaises de pediatrie, {Arch-Fr-Pediatr}, Dec 1993, vol. 50, no. 10, p. 875-8, ISSN: 0003-9764.Heron-B, Gautier-A, Dulac-O, Ponsot-G. Service de Neurologie Pediatrique, Hopital Saint-Vincent-de-Paul, Paris. Biotinidase deficiency. Progressive encephalopathy curable with biotin. Archives francaises de pediatrie, {Arch-Fr-Pediatr}, Dec 1993, vol. 50, no. 10, p. 875-8, ISSN: 0003-9764.

Active substance: BIOTIN

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Document reference: 22625

Study title:

Active substance: BUDESONIDE

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Document reference: 48422

Study title: Short term treatment of acute urinary tract infection in girlsShort term treatment of acute urinary tract infection in girls

Active substance: PIVAMPICILLIN

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Document reference: 46053

Study title: Short term treatment with pivmecillinam in uncomplicated urinary tract infections in childrenShort term treatment with pivmecillinam in uncomplicated urinary tract infections in children

Active substance: PIVAMPICILLIN

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Document reference: 46059

Study title:

Active substance: PIVMECILLINAM

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Document reference: 34541

Study title: A comparison of Pivmecillinam and Co-trimoxazole in the treatment of simple cystitis in general practice; D. Guttmann, J of antimicrobial chemotherapy 1977, 3 suppl. B 137-140 A comparison of Pivmecillinam and Co-trimoxazole in the treatment of simple cystitis in general practice; D. Guttmann, J of antimicrobial chemotherapy 1977, 3 suppl. B 137-140

Active substance: PIVMECILLINAM

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Document reference: 34528

Study title: Antibiotics in the treatment of gastroenteritis caused by enteropathgenic E. coli; Thoren A. et al Journal of Infectious Diseases, 1980, 141: 27-31 Antibiotics in the treatment of gastroenteritis caused by enteropathgenic E. coli; Thoren A. et al Journal of Infectious Diseases, 1980, 141: 27-31

Active substance: PIVMECILLINAM

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Document reference: 34530

Study title: Cohen-M-E, Duffner-P-K. Street; Buffalo, NY 14222., United States. Long-term consequences of CNS treatment for childhood cancer, Part I: Pathologic consequences and potential for oncogenesis. Pediatric Neurology {PEDIATR-NEUROL}, 1991, Vol/Iss/Pg. 7/3 (157-63), ISSN: 0887-8994.Cohen-M-E, Duffner-P-K. Street; Buffalo, NY 14222., United States. Long-term consequences of CNS treatment for childhood cancer, Part I: Pathologic consequences and potential for oncogenesis. Pediatric Neurology {PEDIATR-NEUROL}, 1991, Vol/Iss/Pg. 7/3 (157-63), ISSN: 0887-8994.

Active substance: PREDNISOLONE

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Document reference: 34685

Study title: "Short term linear growth in asmathic children during treatment with prednisolone - Wolthers OD., Pedersen S. - 21/071990 (BMJ;301(6744):145-148) - Publication in Response Document Nasacort Triamcinolone Acetonide Aquaeous nasal spray -" "Short term linear growth in asmathic children during treatment with prednisolone - Wolthers OD., Pedersen S. - 21/071990 (BMJ;301(6744):145-148) - Publication in Response Document Nasacort Triamcinolone Acetonide Aquaeous nasal spray -"

Active substance: PREDNISOLONE

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Document reference: 45113

Study title: "Viral inception of Asthma: Prospective study from infancy to early school age "

Active substance: PREDNISOLONE

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Document reference: 34683

Study title: Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans. Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6.Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans. Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6.

Active substance: PREDNISOLONE AND SULFACETAMIDE

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Document reference: 46113

Study title:

Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD

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Document reference: 34568

Study title:

Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD

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Document reference: 34569

Study title:

Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD

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Document reference: 34570

Study title:

Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD

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Document reference: 34571

Study title:

Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD

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Document reference: 34572

Study title:

Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD

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Document reference: 34577

Study title: Clinical comparison of methylprednisolone aceponate and prednicarbate in chronic eczema - G. Albrecht - 1994 ( J Eur Acad Dermatol Venereol vol 3) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - Clinical comparison of methylprednisolone aceponate and prednicarbate in chronic eczema - G. Albrecht - 1994 ( J Eur Acad Dermatol Venereol vol 3) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -

Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD

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Document reference: 34563

Study title: A twelve week, double-blind, parallel group, multicenter study to compare the efficacy and safety of piracetam with placebo in children with specific written language difficulties (dyslexia).

Active substance: PIRACETAM

Study summary document link (including results): DE84G047 - Piracetam.pdf

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Document reference: 45895

Study title: Acao do piracetam no tratamento de criancas com paralisia cerebral.

Active substance: PIRACETAM

Study summary document link (including results): DP76D141P - Piracetam.pdf

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Document reference: 45971

Study title: Accion terapeutica del piracetam en los problemas de aprendizaje en ninos con disfuncion cerebral minima.

Active substance: PIRACETAM

Study summary document link (including results): DS88C251P - Piracetam.pdf

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Document reference: 46031

Study title: Action du piracetam sur les effets secondaires des explora- tions neuroradiologiques utilisant un produit de contraste.

Active substance: PIRACETAM

Study summary document link (including results): DF76C221P - Piracetam.pdf

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Document reference: 45967

Study title: Action of piracetam in childbirth.

Active substance: PIRACETAM

Study summary document link (including results): DE80D011P - Piracetam.pdf

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Document reference: 45962

Study title: Action of piracetam in the treatment of infants with cerebral lesions.

Active substance: PIRACETAM

Study summary document link (including results): PDEE92H1004 - Piracetam.pdf

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Document reference: 45932

Study title: Action of piracetam on fetal vitality.

Active substance: PIRACETAM

Study summary document link (including results): DE89A115P - Piracetam.pdf

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Document reference: 45991

Study title: Action therapeutique du piracetam chez des enfants et des adolescents presentant un handicap mental (traitement de longue duree).

Active substance: PIRACETAM

Study summary document link (including results): DD80K151P - Piracetam.pdf

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Document reference: 45956

Study title: SPECIAL INVESTIGATION FOR LONG-TERM USE ON RELPAX

Active substance: ELETRIPTAN

Study summary document link (including results): A1601093 EMA Paediatrics Web Synopsis.pdf

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Document reference: 26360

Study title: Efficacy and tolerability of dimethindene maleate solution (DMM; Fenistil drops) in two different concentrations vs. placebo in children suffering from chicken-pox.

Active substance: DIMETINDENE

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Document reference: 26159

Study title: Theralene pectoral, clinical expertise - Giraud - 06/01/65

Active substance: ALIMEMAZINE

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Document reference: 46441

Study title: EFFICACY AND SAFETY OF CIPROFLOXACIN VS TOBRAMYCIN AND CEFTAZIDIME IN THE TREATMENT OF CHILDREN AND JUVENILES SUFFERING FROM ACUTE PULMONARY EXACERBATION OF CYSTIC FIBROSIS (AMENDMENT NO.3/09.MARCH 95)

Active substance: CIPROFLOXACIN

Study summary document link (including results): Bayer Pharma_Ciprofloxacin_1310_study_synopsis.pdf

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Document reference: 24219

Study title: Large scale multicentre safety study of inactivated hepatitis A vaccine (80 U) in children - SOUTH AMERICA

Active substance: Hepatitis A Vaccine for Children (80 U/dose)

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Document reference: 40915

Study title: A double blind, cross-over study to examine the effect of an inhaled corticosteroid (BUD) on the response to histamine challenge in a group of 12 mild asthmatics (aged 17 to 54 years) subjects

Active substance: BUDESONIDE

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Document reference: 48406

Study title: A double blind, cross-over, randomized study with 2 periods of 2 weeks with 2weeks washout. To investigate the mechanisms for the clinical effects of budesonide on LAR, by measuring inflammatory cells and markers in bronchoalveolar lavage (BAL) fluid. Mean age (range): 24.5 years (17 - 30 years)

Active substance: BUDESONIDE

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Document reference: 48404

Study title: A double-blind crossover study to assess the efficacy of nebulized BUD (0.5 mg BID) against placebo in the management of asthma in 23 infants aged 3 to 17 months.

Active substance: BUDESONIDE

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Document reference: 48427

Study title: A double-blind study to investigate whether prolonged corticosteroid therapy potentiates the effects of beta-2 agonist on pulmonary function in 14 asthmatic children (8-15 years).

Active substance: BUDESONIDE

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Document reference: 48407

Study title: A double-blind, cross-over study to investigate the effects of inhaled BUD on wheezy infants <18 months of age (aged 4-17 months).

Active substance: BUDESONIDE

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Document reference: 48429

Study title: A double-blind, placebo-controlled study to compare different treatments for acute wheezy bronchitis in 123 children aged 1.5-18 months.

Active substance: BUDESONIDE

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Document reference: 48430

Study title: A double-blind, randomised, comparative study of the effect of nebulised budesonide (Pulmiocort) and adrenaline in acute laryngo-tracheo-bronchitis (croup)

Active substance: BUDESONIDE

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Document reference: 48426

Study title: A double-blind, randomized, cross-over studytTo determine whether the inhaled glucocorticoid BUD has any adverse effect on short-term linear growth in 15 children (6-13 years) with mild asthma.

Active substance: BUDESONIDE

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Document reference: 48419

Study title: A double-blind, placebo-controlled, randomized, cross-over study to determine whether BUD administered by the Nebuhaler was an effective prophylactic therapy for asthma in pre-school children aged 2-6 years.

Active substance: BUDESONIDE

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Document reference: 48420

Study title: A new mode of administering metered-dose inhalers (MDIs) to infants by adapting a face-mask to a spacer through a connection with an adjustable expiratory flow resistance. 8 infants with intermittent clinical signs of obstructive lung function aged 12-36 months

Active substance: BUDESONIDE

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Document reference: 48417

Study title: A prospective, double-blind study to evaluate whether nebulised local steroid treatment is effective in the treatment of croup in infants and young children 3 months to 4.9 years.

Active substance: BUDESONIDE

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Document reference: 48436

Study title: A prospective, double-blind, parallel study to investigate the effect on the baseline adrenal function of increasing doses of topical steroids in 41 children (aged 7-15 years) with mild bronchial asthma.

Active substance: BUDESONIDE

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Document reference: 48408

Study title: A randomised cross-over study of two consecutive week treatment periods to compare the ease of handling and application by the parents and the acceptability by the child of two spacer devices, NebuChamber® and Babyhaler®, in the treatment of young children aged 6 – 59 months with symptoms of asthma.

Active substance: BUDESONIDE

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Document reference: 48424

Study title: A randomized, double-blind placebo controlled study to determine the effectiveness of nebulized budesonide in the treatment of acute bronchiolitis and in the prevention of postbronchiolitic wheezing in Infants with bronchiolitis < 12 months old.

Active substance: BUDESONIDE

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Document reference: 48423

Study title: A randomized, double-blind study to test the hypothesis that a reduction of bronchial hyperresponsiveness after treatment with an inhaled corticosteroid would result in an enhanced tolerance to an antigen in 38 patients (7-14 years).

Active substance: BUDESONIDE

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Document reference: 48414

Study title: Comparison of three topical antimicrobials for acute bacterial conjunctivitis. Lohr JA, Austin RD, Grossman M, Hayden GF, Knowlton GM, Dudley SM. Pediatr Infect Dis J. 1988 Sep;7(9):626-9. Comparison of three topical antimicrobials for acute bacterial conjunctivitis. Lohr JA, Austin RD, Grossman M, Hayden GF, Knowlton GM, Dudley SM. Pediatr Infect Dis J. 1988 Sep;7(9):626-9.

Active substance: PREDNISOLONE AND SULFACETAMIDE

Study summary document link (including results): Comparison of three topical antimicrobials.pdf

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Document reference: 46112

Study title: Ehrich JHH. Long versus standard prednisone therapy for initial treatment of idiopathic nephritic dyndrome in children Eur J Pediatr 1993; 152: 357-361Ehrich JHH. Long versus standard prednisone therapy for initial treatment of idiopathic nephritic dyndrome in children Eur J Pediatr 1993; 152: 357-361

Active substance: PREDNISONE

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Document reference: 34689

Study title: Hoyer PF. Initial Treatment of Idiopathic Nephrotic Syndrome in Children: Prednisone versus Prednisone Plus Cyclosprorine A: A Prospective, Randomized Trial J Am Soc Nephrol 2006; 17: 1151-1157Hoyer PF. Initial Treatment of Idiopathic Nephrotic Syndrome in Children: Prednisone versus Prednisone Plus Cyclosprorine A: A Prospective, Randomized Trial J Am Soc Nephrol 2006; 17: 1151-1157

Active substance: PREDNISONE

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Document reference: 34688

Study title: Pregabalin BID Add-On Trial: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study in Patients With Partial Seizures (Protocol 1008-034)

Active substance: pregabalin

Study summary document link (including results): 1008-034 EMA Pediatrics Web Synopsis.pdf

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Document reference: 48039

Study title: PREGABALIN BID OPEN-LABEL ADD-ON TRIAL: AN OPEN-LABEL, MULTICENTER FOLLOW-ON STUDY TO DETERMINE LONG-TERM SAFETY AND EFFICACY IN PATIENTS WITH PARTIAL SEIZURES

Active substance: pregabalin

Study summary document link (including results): 1008-035 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41578

Study title: Rosenmayr FW. Therapie der Epilepsien im Säuglingsalter. Wien Med Wochenschr 1973; 42-43: 626-629Rosenmayr FW. Therapie der Epilepsien im Säuglingsalter. Wien Med Wochenschr 1973; 42-43: 626-629

Active substance: PRIMIDONE

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Document reference: 34690

Study title: Foresti F. Sul trattamento medico delle insufficienze mentali infantili. (Rilievo su 60 casi trattati con un prodotto di associazione di farmaci ad azione psiconeurotrofica) Il Lavoro Neuropsichiatrico,56(1), gennaio-febbraio, 1975Foresti F. Sul trattamento medico delle insufficienze mentali infantili. (Rilievo su 60 casi trattati con un prodotto di associazione di farmaci ad azione psiconeurotrofica) Il Lavoro Neuropsichiatrico,56(1), gennaio-febbraio, 1975

Active substance: MINERALS AND VITAMINS

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Document reference: 32046

Study title: Montefusco S.,Masciullo V.,Fiorani F.,Longo A. Biochetasi fiale e bustine nel trattamento del vomito nella gestosi gravidica Quad.Clin.Ostet.Ginecol.,39(2),139-143,1984Montefusco S.,Masciullo V.,Fiorani F.,Longo A. Biochetasi fiale e bustine nel trattamento del vomito nella gestosi gravidica Quad.Clin.Ostet.Ginecol.,39(2),139-143,1984

Active substance: MINERALS AND VITAMINS

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Document reference: 32042

Study title: Pisana F.,De Pasquale C.,Foresti F. Attività psicotrofica di una associazione farmacologica nel ritardo mentale Neuropsichiatria Infantile ,n.164-165, (nuova serie), 225,1975Pisana F.,De Pasquale C.,Foresti F. Attività psicotrofica di una associazione farmacologica nel ritardo mentale Neuropsichiatria Infantile ,n.164-165, (nuova serie), 225,1975

Active substance: MINERALS AND VITAMINS

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Document reference: 32047

Study title: Safety and tolerability of Kiddi Pharmaton Fizz effervescent tablets, comparing the marketed formula with an improved one with a reduced mineral amount, and a comparator product: A double-blind, controlled, randomised, three arm cross-over study in children.

Active substance: MINERALS AND VITAMINS

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Document reference: 32039

Study title: Add-on treatment with non-antiepileptic drugs in children with epilepsy.

Active substance: PIRACETAM

Study summary document link (including results): ADPE99L2306 - Piracetam.pdf

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Document reference: 46000

Study title: Amine oxidase activity in blood serum of children with mental deficiency.

Active substance: PIRACETAM

Study summary document link (including results): DRU88L281P - Piracetam.pdf

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Document reference: 45981

Study title: Antimyoclonic and antiepileptic properties of piracetam.

Active substance: PIRACETAM

Study summary document link (including results): ADAE96A1009 - Piracetam.pdf

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Document reference: 45977

Study title: Apraxies constructives de l'enfance et piracetam.

Active substance: PIRACETAM

Study summary document link (including results): DJ75F274P - Piracetam.pdf

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Document reference: 45924

Study title: Avaliacao do possivel efeito do piracetam associado aos anticonvulsivantes no tratamento das epilepsias especificas e de dificil controle.

Active substance: PIRACETAM

Study summary document link (including results): MRCP91B2801 - Piracetam.pdf

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Document reference: 45904

Study title: CGS 5649 B, a new compound, reverses age-related cognitive dysfunctions in rats.

Active substance: PIRACETAM

Study summary document link (including results): PDEE92G0101 - Piracetam.pdf

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Document reference: 46037

Study title: Clinical and biological tolerance of piracetam in children treated for 8 weeks at 3.3 g daily.

Active substance: PIRACETAM

Study summary document link (including results): CE80L141 - Piracetam.pdf

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Document reference: 45914

Study title: Clinical and EEG effects of piracetam in children with learning disorders.

Active substance: PIRACETAM

Study summary document link (including results): ARCE04H1614 - Piracetam.pdf

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Document reference: 45909

Study title: Baker KS et al Benefit of intensified therapy for patients with local or regional embryonal rhabdomyosarcoma: results from the Intergroup Rhabdomyosarcoma Study IV J Clin Oncol. 2000 Jun;18(12):2427-34Baker KS et al Benefit of intensified therapy for patients with local or regional embryonal rhabdomyosarcoma: results from the Intergroup Rhabdomyosarcoma Study IV J Clin Oncol. 2000 Jun;18(12):2427-34

Active substance: MITOXANTRONE

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Document reference: 32146

Study title: Behrendt H et alMitoxantrone is effective in treating childhood T-cell lymphoma/T-cell acute lymphoblastic leukemiaCancer. 1995 Jul 15;76(2):339-42.Behrendt H et alMitoxantrone is effective in treating childhood T-cell lymphoma/T-cell acute lymphoblastic leukemiaCancer. 1995 Jul 15;76(2):339-42.

Active substance: MITOXANTRONE

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Document reference: 32072

Study title: Ben Arush MW et al Postsurgical etoposide-ifosfamide regimen in poor-risk nonmetastatic osteogenic sarcoma Am J Clin Oncol. 1998 Feb;21(1):72-4Ben Arush MW et al Postsurgical etoposide-ifosfamide regimen in poor-risk nonmetastatic osteogenic sarcoma Am J Clin Oncol. 1998 Feb;21(1):72-4

Active substance: MITOXANTRONE

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Document reference: 32139

Study title: Bernstein ML et al Intensive therapy with growth factor support for patients with Ewing tumormetastatic at diagnosis: Pediatric Oncology Group/Children's Cancer Group Phase II Study 9457--a report from the Children's Oncology Group J Clin Oncol. 2006 Jan 1;24(1):152-9Bernstein ML et al Intensive therapy with growth factor support for patients with Ewing tumormetastatic at diagnosis: Pediatric Oncology Group/Children's Cancer Group Phase II Study 9457--a report from the Children's Oncology Group J Clin Oncol. 2006 Jan 1;24(1):152-9

Active substance: MITOXANTRONE

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Document reference: 32108

Study title: Massimino M et al, Hyperfractionated radiotherapy and chemotherapy for childhood ependymoma: final results of the first prospective AIEOP (Associazione Italiana di, Ematologia-Oncologia Pediatrica) study, Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1336-45

Active substance: ETOPOSIDE

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Document reference: 26826

Study title: Successful left trisegmentectomy for ruptured hepatoblastoma using intraoperative transarterial embolization.

Active substance: Ethyl esters of iodized fatty acids of poppy seed oil

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Document reference: 39934

Study title: A randomized, double-blind study to test the hypothesis that treatment with an inhaled anti-inflammatory drug (BUD) but not an inhaled beta-agonist (terbutaline) would reduce bronchial responsiveness in children with asthma ad with minimal or no bronchoconstriction in 19 children (7-16 years) with allergic asthma and minimal or no bronchoconstriction attending an outpatient respiratory clinic.

Active substance: BUDESONIDE

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Document reference: 48411

Study title: A randomized, double-blind to compare the long-term effect in children (7-16 years) of regular bronchodilator plus antiinfalmmatory treatment using inhaled corticosteroids with regular bronchodilator treatment alone

Active substance: BUDESONIDE

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Document reference: 48421

Study title: An open study to assess the optimal dose of BUD for patients (7-80 years) with asthma of mild to moderate severity.

Active substance: BUDESONIDE

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Document reference: 48428

Study title: An open-label study to evaluate the efficacy and tolerability of budesonide (Pulmicort®) administered by Nebuhaler® (a large volume spacer) in a Kenyan Negroid population (Men or women, 16 years or above) who had not been treated with inhaled GCS during the previous three months.

Active substance: BUDESONIDE

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Document reference: 48425

Study title: An open, prospective study to assess the long-term safety, as well as efficacy, of BUD in 52 asthmatic children aged 4-13 years (mean 9.6) whose asthma was not adequately controlled by their current therapy.

Active substance: BUDESONIDE

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Document reference: 48413

Study title: An open, prospective study to evalute the efficacy and safety of a 1-year administration of inhaled BUD via a spacer device in 16 children (3.5-7 years) with severe asthma lasting from 1 to 4 years (mean 3 years).

Active substance: BUDESONIDE

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Document reference: 48412

Study title: An open, prospective study to investigate the respiratory membrane permeability to plasma proteins and its relatio to bronchial hyperreactivity. In addition, the effect of therapy with inhaled glucocorticosteroids in 14 patients with stable bronchial asthma and eight healthy volunteers (range, 16 to 68 yr).

Active substance: BUDESONIDE

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Document reference: 48418

Study title: An open, randomised, cross over, active control study with two periods each of 2 weeks duration to investigate the stýstemic effects of low daily doses of ICS in 12 asthmatic children.

Active substance: BUDESONIDE

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Document reference: 48415

Study title: Tolerability of cetirizine in children. results of a prospective clinical observation study in 305 children suffering from allergic disorders of the upper respiratory tract and allergic pruritus.

Active substance: CETIRIZINE

Study summary document link (including results): SRCE92E2202 - Cetirizine.pdf

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Document reference: 23783

Study title: Comparision of equal dose of budesonide inhaled from a Nebuhaler (aerosol) and from a Turbuhaler (powder) in a 4-weeks cross-over study in asthmatic children 10 - 15 years old

Active substance: BUDESONIDE

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Document reference: 48435

Study title: Spata N. Esperienza clinica con preparato ad azione antiacetonemica Agg.Pediat.,35(2),275-278,1984Spata N. Esperienza clinica con preparato ad azione antiacetonemica Agg.Pediat.,35(2),275-278,1984

Active substance: MINERALS AND VITAMINS

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Document reference: 32041

Study title: Campese VM. Minoxidil: a review of its pharmacological properties and therapeutic use. Drugs 1981; 22(4):257-278Campese VM. Minoxidil: a review of its pharmacological properties and therapeutic use. Drugs 1981; 22(4):257-278

Active substance: MINOXIDIL

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Document reference: 32055

Study title: Double-blind, randomized, placebo-controlled trial of the efficacy and safety of 5% minoxidil foam in the treatment of androgenetic alopecia in males

Active substance: MINOXIDIL

Study summary document link (including results): minoxidil A6221001.pdf

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Document reference: 32064

Study title: Effect of methyldopa, propranolol, and propranolol plus minoxidil in the management of hypertension associated with renal disease in children.

Active substance: MINOXIDIL

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Document reference: 32063

Study title: Effect of minoxidil on arterial blood pressure, cardiac index, nd plasma rennin activity in 6 severely hypertensive children

Active substance: MINOXIDIL

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Document reference: 32062

Study title: Falkner B, Lurbe E and Schaefer F. High Blood Pressure in Children: Clinical and Health Policy Implications. The Journal of Clinical Hypertension. 2010; 12 (4): 261-76Falkner B, Lurbe E and Schaefer F. High Blood Pressure in Children: Clinical and Health Policy Implications. The Journal of Clinical Hypertension. 2010; 12 (4): 261-76

Active substance: MINOXIDIL

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Document reference: 32053

Study title: Halling SE et al., Minoxidil therapy in children and young adult patients with renal disease and refractory hypertension: value when multidrug regimens have failed to achieve blood pressure control. Journal of Human Hypertension 2010;24:552-554Halling SE et al., Minoxidil therapy in children and young adult patients with renal disease and refractory hypertension: value when multidrug regimens have failed to achieve blood pressure control. Journal of Human Hypertension 2010;24:552-554

Active substance: MINOXIDIL

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Document reference: 32056

Study title: Packer RJ et al Phase III study of craniospinal radiation therapy followed by adjuvant chemotherapy for newly diagnosed average-risk medulloblastoma. J Clin Oncol. 2006 Sep 1;24(25):4202-8Packer RJ et al Phase III study of craniospinal radiation therapy followed by adjuvant chemotherapy for newly diagnosed average-risk medulloblastoma. J Clin Oncol. 2006 Sep 1;24(25):4202-8

Active substance: MITOXANTRONE

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Document reference: 32232

Study title: Pappo AS et al A phase II trial of ifosfamide in previously untreated children and adolescents with unresectable rhabdomyosarcoma Cancer. 1993 Mar 15;71(6):2119-25Pappo AS et al A phase II trial of ifosfamide in previously untreated children and adolescents with unresectable rhabdomyosarcoma Cancer. 1993 Mar 15;71(6):2119-25

Active substance: MITOXANTRONE

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Document reference: 32157

Study title: Pappo AS et al Phase II trial of neoadjuvant vincristine, ifosfamide, and doxorubicin with granulocyte colony-stimulating factor support in children and adolescents with advanced-stage nonrhabdomyosarcomatous soft tissue sarcomas: a Pediatric Oncology Group Study J Clin Oncol. 2005 Jun 20;23(18):4031-8. Epub 2005 Mar 14Pappo AS et al Phase II trial of neoadjuvant vincristine, ifosfamide, and doxorubicin with granulocyte colony-stimulating factor support in children and adolescents with advanced-stage nonrhabdomyosarcomatous soft tissue sarcomas: a Pediatric Oncology Group Study J Clin Oncol. 2005 Jun 20;23(18):4031-8. Epub 2005 Mar 14

Active substance: MITOXANTRONE

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Document reference: 32168

Study title: Patte C et al. FAB/LMB96 International Study Committee. Results of the randomized international FAB / LMB96 trial for intermediate risk B-cell non-Hodgkin lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients. Blood. 2007 Apr 1;109(7):2773-80Patte C et al. FAB/LMB96 International Study Committee. Results of the randomized international FAB / LMB96 trial for intermediate risk B-cell non-Hodgkin lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients. Blood. 2007 Apr 1;109(7):2773-80

Active substance: MITOXANTRONE

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Document reference: 32202

Study title: Bernstein ML et al. Intensive therapy with growth factor support for patients with Ewing tumor metastatic at diagnosis: Pediatric Oncology Group/Children's Cancer Group Phase II Study 9457--a report from the Children's Oncology Group. J Clin Oncol. 2006 Jan 1;24(1):152-9.Bernstein ML et al. Intensive therapy with growth factor support for patients with Ewing tumor metastatic at diagnosis: Pediatric Oncology Group/Children's Cancer Group Phase II Study 9457--a report from the Children's Oncology Group. J Clin Oncol. 2006 Jan 1;24(1):152-9.

Active substance: MITOXANTRONE

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Document reference: 32176

Study title: Berrak SG et al High-dose ifosfamide in relapsed pediatric osteosarcoma: therapeutic effects and renal toxicity Pediatr Blood Cancer. 2005 Mar;44(3):215-9Berrak SG et al High-dose ifosfamide in relapsed pediatric osteosarcoma: therapeutic effects and renal toxicity Pediatr Blood Cancer. 2005 Mar;44(3):215-9

Active substance: MITOXANTRONE

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Document reference: 32132

Study title: Berthold F et al. Myeloablative megatherapy with autologous stem-cell rescue versus oral maintenance chemotherapy as consolidation treatment in patients with high-risk neuroblastoma: a randomised controlled trial. Lancet Oncol. 2005 Sep;6(9):649-58.Berthold F et al. Myeloablative megatherapy with autologous stem-cell rescue versus oral maintenance chemotherapy as consolidation treatment in patients with high-risk neuroblastoma: a randomised controlled trial. Lancet Oncol. 2005 Sep;6(9):649-58.

Active substance: MITOXANTRONE

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Document reference: 32234

Study title: Berthold F et al. The role of chemotherapy in the treatment of children with neuroblastoma stage IV: the GPO (German Pediatric Oncology Society) experience. Klin Padiatr. 1990 Jul-Aug;202(4):262-9.Berthold F et al. The role of chemotherapy in the treatment of children with neuroblastoma stage IV: the GPO (German Pediatric Oncology Society) experience. Klin Padiatr. 1990 Jul-Aug;202(4):262-9.

Active substance: MITOXANTRONE

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Document reference: 32245

Study title: Stewart RJ et al Treatment of children with nonmetastatic paratesticular rhabdomyosarcoma: results of the Malignant Mesenchymal Tumors studies (MMT 84 and MMT 89) of the International Society of Pediatric Oncology J Clin Oncol. 2003 Mar 1;21(5):793-8Stewart RJ et al Treatment of children with nonmetastatic paratesticular rhabdomyosarcoma: results of the Malignant Mesenchymal Tumors studies (MMT 84 and MMT 89) of the International Society of Pediatric Oncology J Clin Oncol. 2003 Mar 1;21(5):793-8

Active substance: MITOXANTRONE

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Document reference: 32149

Study title: Strauss SJ et al Single center experience of a new intensive induction therapy for ewing's family of tumors: feasibility, toxicity, and stem cell mobilization properties J Clin Oncol. 2003 Aug 1;21(15):2974-81Strauss SJ et al Single center experience of a new intensive induction therapy for ewing's family of tumors: feasibility, toxicity, and stem cell mobilization properties J Clin Oncol. 2003 Aug 1;21(15):2974-81

Active substance: MITOXANTRONE

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Document reference: 32110

Study title: Sullivan MP et al. High-dose cyclophosphamide-high-dose methotrexate with coordinated intrathecal therapy for advanced nonlymphoblastic lymphoma of childhood: results of a Pediatric Oncology Group study. Am J Pediatr Hematol Oncol. 1991 Fall;13(3):288-95. Sullivan MP et al. High-dose cyclophosphamide-high-dose methotrexate with coordinated intrathecal therapy for advanced nonlymphoblastic lymphoma of childhood: results of a Pediatric Oncology Group study. Am J Pediatr Hematol Oncol. 1991 Fall;13(3):288-95.

Active substance: MITOXANTRONE

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Document reference: 32251

Study title: Tanaka K et al High-dose chemotherapy and autologous peripheral blood stem-cell transfusionafter conventional chemotherapy for patients with high-risk Ewing's tumors J Orthop Sci. 2002;7(4):477-82Tanaka K et al High-dose chemotherapy and autologous peripheral blood stem-cell transfusionafter conventional chemotherapy for patients with high-risk Ewing's tumors J Orthop Sci. 2002;7(4):477-82

Active substance: MITOXANTRONE

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Document reference: 32111

Study title: Doppelblinde, randomisierte, Placebo-kontrollierte klinische Studie zum Nachweis der therapeutischen Wirksamkeit und Verträglichkeit von Natriumbituminosulfonat-haltigen Dragees bei Akne vulgarisTraumatic lesions of adrenal glands in paediatrics: about three cases; Capaccio E; Radiol. Med.; 2006 vol.111 p.906-910

Active substance: GADOTERIC ACID

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Document reference: 28873

Study title: Edick MJ et al, Pharmacokinetics and pharmacodynamics of oral etoposide in children with relapsed or refractory acute lymphoblastic leukemia, J Clin Oncol. 2003 Apr 1;21(7):1340-6

Active substance: ETOPOSIDE

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Document reference: 26881

Study title: Wells RJ et al, Treatment of newly diagnosed children and adolescents with acute myeloid leukemia: a Childrens Cancer Group study, J Clin Oncol. 1994 Nov;12(11):2367-77

Active substance: ETOPOSIDE

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Document reference: 26910

Study title: Immunogenicity and safety study of two doses of Fluvirin (0.25 mL and 0.5 mL) with Vaxigrip (0.25 mL), in Healthy naive pediatric subjects aged 6 to 35 months.

Active substance: INFLUENZA VACCINE

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Document reference: 48403

Study title: An open, uncontrolled study with 3 periods, each of 3 weeks duration to assess the clinical efficacy of budesonide via nebilizer, 1000 mg bid, in chronically weezing infants, aged 2 to 12 months, and to evaluate any adrenal side-effects .

Active substance: BUDESONIDE

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Document reference: 48416

Study title: AN 16018227 Medline 20070101. TI The treatment of pediatric migraine. SO Pediatric annals, {Pediatr-Ann}, Jun 2005, vol. 34, no. 6, p. 448-60, 52 refs, ISSN: 0090-4481.AN 16018227 Medline 20070101. TI The treatment of pediatric migraine. SO Pediatric annals, {Pediatr-Ann}, Jun 2005, vol. 34, no. 6, p. 448-60, 52 refs, ISSN: 0090-4481.

Active substance: CYPROHEPTADINE

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Document reference: 25238

Study title: Tebbi CK et al, Treatment of stage I, IIA, IIIA1 pediatric Hodgkin disease with doxorubicin,, bleomycin, vincristine and etoposide (DBVE) and radiation: a Pediatric Oncology Group (POG) study, Pediatr Blood Cancer. 2006 Feb;46(2):198-202Tebbi CK et al, Treatment of stage I, IIA, IIIA1 pediatric Hodgkin disease with doxorubicin,, bleomycin, vincristine and etoposide (DBVE) and radiation: a Pediatric Oncology Group (POG) study, Pediatr Blood Cancer. 2006 Feb;46(2):198-202

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 25145

Study title: Pharmacokinetics and Pharmacodynamics in Elderly Adults, Young Adults, and Children, Simons, K.J., J.Clin. Pharmacol. 1990; 30: 665-671Pharmacokinetics and Pharmacodynamics in Elderly Adults, Young Adults, and Children, Simons, K.J., J.Clin. Pharmacol. 1990; 30: 665-671

Active substance: DEXAMETHASONE AND DIPHENHYDRAMINE

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Document reference: 25720

Study title: Olgun N et al Experience of the Izmir Pediatric Oncology Group on Neuroblastoma: IPOG-NBL-92 Protocol Pediatr Hematol Oncol. 2003 Apr-May;20(3):211-8Olgun N et al Experience of the Izmir Pediatric Oncology Group on Neuroblastoma: IPOG-NBL-92 Protocol Pediatr Hematol Oncol. 2003 Apr-May;20(3):211-8

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 25047

Study title: Early detection of persistent trophoblastic tumour by serum human chorionic gonadotrophin monitoring after molar pregnancy.

Active substance: DACTINOMYCIN

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Document reference: 25336

Study title: Patte C et al. Granulocyte colony-stimulating factor in induction treatment of children withnon-Hodgkin's lymphoma: a randomized study of the French Society of PediatricOncology. J Clin Oncol. 2002 Jan 15;20(2):441-8.Patte C et al. Granulocyte colony-stimulating factor in induction treatment of children withnon-Hodgkin's lymphoma: a randomized study of the French Society of PediatricOncology. J Clin Oncol. 2002 Jan 15;20(2):441-8.

Active substance: MITOXANTRONE

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Document reference: 32207

Study title: Paulussen M et al Localized Ewing tumor of bone: final results of the cooperative Ewing's Sarcoma Study CESS 86 J Clin Oncol. 2001 Mar 15;19(6):1818-29Paulussen M et al Localized Ewing tumor of bone: final results of the cooperative Ewing's Sarcoma Study CESS 86 J Clin Oncol. 2001 Mar 15;19(6):1818-29

Active substance: MITOXANTRONE

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Document reference: 32096

Study title: Paulussen M et al. EICESS 92 (European Intergroup Cooperative Ewing's Sarcoma Study)-preliminary results Klin Padiatr. 1999 Jul-Aug;211(4):276-83Paulussen M et al. EICESS 92 (European Intergroup Cooperative Ewing's Sarcoma Study)-preliminary results Klin Padiatr. 1999 Jul-Aug;211(4):276-83

Active substance: MITOXANTRONE

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Document reference: 32182

Study title: Paulussen M et al. Second malignancies after ewing tumor treatment in 690 patients from a cooperative German/Austrian/Dutch study. Ann Oncol. 2001 Nov;12(11):1619-30.Paulussen M et al. Second malignancies after ewing tumor treatment in 690 patients from a cooperative German/Austrian/Dutch study. Ann Oncol. 2001 Nov;12(11):1619-30.

Active substance: MITOXANTRONE

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Document reference: 32179

Study title: Pfreundschuh M et al. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomisedcontrolled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006 May;7(5):379-91Pfreundschuh M et al. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomisedcontrolled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006 May;7(5):379-91

Active substance: MITOXANTRONE

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Document reference: 32247

Study title: Comparison of pivmecillinam and nalidixic acid in the treatment of acute shigellosis in children; Alam A.N. et al, 1994, Scand J Gastroenterol, 29: 313-317 Comparison of pivmecillinam and nalidixic acid in the treatment of acute shigellosis in children; Alam A.N. et al, 1994, Scand J Gastroenterol, 29: 313-317

Active substance: PIVMECILLINAM

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Document reference: 34537

Study title: Efficacy, pharmacology, and safety of amdinocillin in treatment of neonates; de Louvois et al, 1983, American Journal of medicine, 29 August, 119-124 Efficacy, pharmacology, and safety of amdinocillin in treatment of neonates; de Louvois et al, 1983, American Journal of medicine, 29 August, 119-124

Active substance: PIVMECILLINAM

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Document reference: 34533

Study title: FL 1039, a new Semisynthetic Penicillin, Preliminary Report on Its Use in Enteric Fever ; B. Limson FL 1039, a new Semisynthetic Penicillin, Preliminary Report on Its Use in Enteric Fever ; B. Limson

Active substance: PIVMECILLINAM

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Document reference: 34527

Study title: Long term, low dose treatment with pivmecillinam alone and in combination with pivampicillin in patients prone to recurrent bacteriuria; Barclay R.P.C. et al. 1982, Current medical research and opinion, 8: 82-88 Long term, low dose treatment with pivmecillinam alone and in combination with pivampicillin in patients prone to recurrent bacteriuria; Barclay R.P.C. et al. 1982, Current medical research and opinion, 8: 82-88

Active substance: PIVMECILLINAM

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Document reference: 34536

Study title: Mecillinam in cerebrospinal fluid in children; Garborg O. 1981, Clinical Pharmacokinetics, 6:475-479 Mecillinam in cerebrospinal fluid in children; Garborg O. 1981, Clinical Pharmacokinetics, 6:475-479

Active substance: PIVMECILLINAM

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Document reference: 34534

Study title: Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans. Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6. Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans. Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6.

Active substance: POLYMYXIN B AND TRIMETHOPRIM

Study summary document link (including results): Clinical evaluation of trimethoprim-containing.pdf

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Document reference: 25749

Study title: Results of a survey of children with acute bacterial conjunctivitis treated with trimethoprim-polymyxin B ophthalmic solution.Wagner RS. Clin Ther. 1995 Sep-Oct;17(5):875-81. J Antimicrob Chemother. 1989 Feb;23(2):261-6.Results of a survey of children with acute bacterial conjunctivitis treated with trimethoprim-polymyxin B ophthalmic solution.Wagner RS. Clin Ther. 1995 Sep-Oct;17(5):875-81. J Antimicrob Chemother. 1989 Feb;23(2):261-6.

Active substance: POLYMYXIN B AND TRIMETHOPRIM

Study summary document link (including results): Results of a survey of children with acute bacterial conjunc.pdf

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Document reference: 34586

Study title: Trimethoprim-polymyxin B ophthalmic solution in treatment of surface ocular bacterial infections.Nozik RA, Smolin G, Knowlton G, Austin R. Ann Ophthalmol. 1985 Dec;17(12):746-8.Trimethoprim-polymyxin B ophthalmic solution in treatment of surface ocular bacterial infections.Nozik RA, Smolin G, Knowlton G, Austin R. Ann Ophthalmol. 1985 Dec;17(12):746-8.

Active substance: POLYMYXIN B AND TRIMETHOPRIM

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Document reference: 34585

Study title: Trimethoprim-polymyxin eye drops versus neomycin-polymyxin-gramicidin eye drops in the treatment of presumptive bacterial conjunctivitis - a double-blind study.Genée E, Schlechtweg C, Bauerreiss P, Gibson JR. Ophthalmologica. 1982;184(2):92-6. Trimethoprim-polymyxin eye drops versus neomycin-polymyxin-gramicidin eye drops in the treatment of presumptive bacterial conjunctivitis - a double-blind study.Genée E, Schlechtweg C, Bauerreiss P, Gibson JR. Ophthalmologica. 1982;184(2):92-6.

Active substance: POLYMYXIN B AND TRIMETHOPRIM

Study summary document link (including results): Trimethoprim-polymyxin eye drops versus neomycin-polymixin-g.pdf

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Document reference: 34582

Study title: Adler – Effective Treatment of Constipation and Encopresis with MOVICOL (Macrogol 3350 with electrolytes) in Children and Adolescents.

Active substance: POLIDOCANOL COMBINATIONS

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Document reference: 34581

Study title: Dyslexia: diagnosis and treatment in children with piracetam on an out-patient basis.

Active substance: PIRACETAM

Study summary document link (including results): DE84D277 - Piracetam.pdf

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Document reference: 45982

Study title: Early postnatal effects of noopept and piracetam on declarative and procedural memory of adult male and female rats.

Active substance: PIRACETAM

Study summary document link (including results): ADPE06C0607 - Piracetam.pdf

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Document reference: 46044

Study title: Effect of acupuncture in improving intelligence and language disorder of autistic children.

Active substance: PIRACETAM

Study summary document link (including results): ADPZ06C2119 - Piracetam.pdf

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Document reference: 46032

Study title: Effect of piracetam on endocrine activities, linear growth, puberty and cognitive functions in 60 children with learning disabilities. a double-blind study of 24 and 52 weeks. Part I - endocrinological aspects. Part II - psychological aspects.

Active substance: PIRACETAM

Study summary document link (including results): CE88K241 - Piracetam.pdf

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Document reference: 45901

Study title: Effect of piracetam on the mean intrasplenic red cell transit time (MST) in sickle cell disease and sickle cell thalassaemia.

Active substance: PIRACETAM

Study summary document link (including results): DE88A153P - Piracetam.pdf

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Document reference: 45941

Study title: Effect of pirazetam on brain development in newborn rats exposed to hypoxia.

Active substance: PIRACETAM

Study summary document link (including results): DE84G025P - Piracetam.pdf

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Document reference: 46036

Study title: Multicenter, double-blind, multiple-dose, placebo-controlled dose-response study of ebastine in children with seasonal ragweed allergy

Active substance: EBASTINE

Study summary document link (including results): RP-64305X-106_Ebastine_EUdraCT_reduced datafields-CP-Almirall.xls

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Document reference: 48069

Study title: A phase II, controlled, single-center study to assess safety and immunogenicity of a primary vaccination course with one dose of Haemophilus influenzae type b (Hib) conjugate vaccine containing Aluminum Phosphate (Hib/AlPO4 vaccine), given alone or concomitantly with Measles, Mumps and Rubella Vaccine (MMR, Morupar®, licensed by Chiron, now Novartis Vaccines and Diagnostics), in healthy children 12-15 months of age.

Active substance: Influenza Vaccine (Split Virion, Inactivated)

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Document reference: 48391

Study title: A Phase II, observer-blind, randomized, multicenter, controlled study of 3 Haemophilus influenzae type b (Hib) vaccines in infants.

Active substance: Influenza Vaccine (Split Virion, Inactivated)

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Document reference: 48389

Study title: General toxicity of formoterol fumarate (D2522) given orally to young rats for three months.

Active substance: FORMOTEROL

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Document reference: 47844

Study title: An extension, phase III, open-label, multicenter study in healthy toddlers, of two Haemophilus influenzae type b (Hib) vaccines administered as a booster dose.

Active substance: Influenza Vaccine (Split Virion, Inactivated)

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Document reference: 48392

Study title: an observer blind, randomized, parallel groups, single-center, exploratory Phase IV study to evaluate immunogenicity of two intramuscular doses of influenza vaccine in pediatric subjects.

Active substance: Influenza Vaccine (Split Virion, Inactivated)

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Document reference: 48387

Study title: An open label, single-center, pilot study to assess the safety, tolerability and immunogenicity of three injections of the HibCRM/AlPO4 vaccine, when given at 2, 3, 4 months of age to healthy infants.

Active substance: Influenza Vaccine (Split Virion, Inactivated)

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Document reference: 48390

Study title: Clinical Testing of Influsplit SSW®93

Active substance: Influenza Vaccine (Split Virion, Inactivated)

Study summary document link (including results): Influsplit-1993_ synopsis.pdf

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Document reference: 48377

Study title: Prasad Uta. Malays J Surg June 1975;1(1): Juvenile layrngeal papillomaPrasad Uta. Malays J Surg June 1975;1(1): Juvenile layrngeal papilloma

Active substance: INOSINE

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Document reference: 30158

Study title: Efficacy and usability of Sch 1000 in capsules with powder inhalator in paediatrics (pilot study). Phase III.

Active substance: IPRATROPIUM

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Document reference: 30569

Study title: Improved Acidosis Correction and Recovery of Mesothelial Cell Mass with Neutral-pH Bicarbonate Dialysis Solution among Children Undergoing Automated Peritoneal Dialysis, 2003 Effects of pH-neutral, bicarbonate-buffered dialysis fluid on peritoneal transport kinetics in children, 2002 Reduced Advanced Glycation Endproduct (AGE) Levels in Children on Automated Peritoneal Dialysis (PD) with PD-Fluids Containing Less Glucose Degradation Products (GDPs), 2003

Active substance: ISOTONIC SOLUTIONS

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Document reference: 30757

Study title: Effectiveness of a Vi capsular polysaccharide vaccine

Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32)

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Document reference: 41209

Study title: Mecillinam in enteric fever; Mandal BK et al, BMJ, 1979, 1:586-587 Mecillinam in enteric fever; Mandal BK et al, BMJ, 1979, 1:586-587

Active substance: PIVMECILLINAM

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Document reference: 34531

Study title: Mecillinam in the treatment of neonates; de Louvois J et al, 1981, J. Pernat. Med. 9: 87-95 Mecillinam in the treatment of neonates; de Louvois J et al, 1981, J. Pernat. Med. 9: 87-95

Active substance: PIVMECILLINAM

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Document reference: 34532

Study title: Pivmecillinam cotrimoxazole and oral mecillinam in gastro enteritis due to vibrio spp; Uylangco C. et al, 1984, JAC, 13: 171-175 Pivmecillinam cotrimoxazole and oral mecillinam in gastro enteritis due to vibrio spp; Uylangco C. et al, 1984, JAC, 13: 171-175

Active substance: PIVMECILLINAM

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Document reference: 34538

Study title: Pivmecillinam in the treatment of recurrent urinary infection in girls; (Deasy P.F: and Lynch K., 1980, Irish Medical Journal, 73: 388-389 Pivmecillinam in the treatment of recurrent urinary infection in girls; (Deasy P.F: and Lynch K., 1980, Irish Medical Journal, 73: 388-389

Active substance: PIVMECILLINAM

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Document reference: 34535

Study title: Randomised trial of pivampicillin plus pivmecillinam vs pivampicillin in children and young adults with chronic obstructive pulmonary disease and infection with Haemophilus influenzae; Johansen HK et al 1999 Curr Med Res Opin, 15: 300-309 Randomised trial of pivampicillin plus pivmecillinam vs pivampicillin in children and young adults with chronic obstructive pulmonary disease and infection with Haemophilus influenzae; Johansen HK et al 1999 Curr Med Res Opin, 15: 300-309

Active substance: PIVMECILLINAM

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Document reference: 34539

Study title: Slow replenishment of carnitine deficiency after cessation of longterm treatment with pivaloyl-containing antibiotics; Diep, Pharmacy World Sci Vol. 15(5), 1993. 225-229 Slow replenishment of carnitine deficiency after cessation of longterm treatment with pivaloyl-containing antibiotics; Diep, Pharmacy World Sci Vol. 15(5), 1993. 225-229

Active substance: PIVMECILLINAM

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Document reference: 34529

Study title: Double blind, placebo controlled study of the efficacy of polytar in treatment of seborrhoeic dermatitis and eczema of the scalp.

Active substance: Pix pini, Pix juniperi, Solutio picis lithantracis, Extractum oleatum picis lithantracis

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Document reference: 40132

Study title: Roth G. Zur Kombinationstherapie epileptischer Anfälle. Wien Med Wochenschr 1968; 118/6: 116-118Roth G. Zur Kombinationstherapie epileptischer Anfälle. Wien Med Wochenschr 1968; 118/6: 116-118

Active substance: PRIMIDONE

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Document reference: 34691

Study title: Bibliography - Pyostacine and Cutaneous infections in children - Larregue et al. - 1982 - Revue Int. Pediatric (122:1-4)Bibliography - Pyostacine and Cutaneous infections in children - Larregue et al. - 1982 - Revue Int. Pediatric (122:1-4)

Active substance: PRISTINAMYCIN

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Document reference: 46114

Study title: Bibliography - Resistant pneumococci in paediatrics : therapeutic indications - E. Bingen and A. Bourrillon - January 4th, 1995 - La Presse Médicale (24:N°2)Bibliography - Resistant pneumococci in paediatrics : therapeutic indications - E. Bingen and A. Bourrillon - January 4th, 1995 - La Presse Médicale (24:N°2)

Active substance: PRISTINAMYCIN

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Document reference: 46115

Study title: Bibliography - Treatment with pristinamycin of acute dermohypodermitis. Open study in 42 patients - P. Bernard et al. - 1996 - Ann Dermatol. Venereol. (123: 16-20) English VersionBibliography - Treatment with pristinamycin of acute dermohypodermitis. Open study in 42 patients - P. Bernard et al. - 1996 - Ann Dermatol. Venereol. (123: 16-20) English Version

Active substance: PRISTINAMYCIN

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Document reference: 46116

Study title: Bibliography - Treatment with pristinamycin of bone and joint infections in children - P. Beauvais et al. - 1981 - Arch. Fr. Pediatr. (38:489-493)Bibliography - Treatment with pristinamycin of bone and joint infections in children - P. Beauvais et al. - 1981 - Arch. Fr. Pediatr. (38:489-493)

Active substance: PRISTINAMYCIN

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Document reference: 46117

Study title: Effect of yizhi koufuye on intelligence structure in children with intelligence retardation.

Active substance: PIRACETAM

Study summary document link (including results): ADPE05J1308 - Piracetam.pdf

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Document reference: 46012

Study title: Effectiveness of Nootropil treatment in children with inhibited expressive speech.

Active substance: PIRACETAM

Study summary document link (including results): DRU90B131P - Piracetam.pdf

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Document reference: 45998

Study title: Effects of nootropic drugs on some behavioural and bioche- mical changes after early postnatal hypoxia in the rat.

Active substance: PIRACETAM

Study summary document link (including results): DE87A291P - Piracetam.pdf

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Document reference: 46035

Study title: Effects of piracetam administration to suckling rats on morphometry of neocortex and hippocampus.

Active substance: PIRACETAM

Study summary document link (including results): ADPE98J0910 - Piracetam.pdf

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Document reference: 46040

Study title: Effects of piracetam in childbirth: anatomical aspects.

Active substance: PIRACETAM

Study summary document link (including results): PDEE92K2710 - Piracetam.pdf

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Document reference: 45990

Study title: Effects of piracetam in childbirth: clinical aspects.

Active substance: PIRACETAM

Study summary document link (including results): PDEE92K2709 - Piracetam.pdf

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Document reference: 45961

Study title: Effects of piracetam in children with learning disorders.

Active substance: PIRACETAM

Study summary document link (including results): DS86C182P - Piracetam.pdf

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Document reference: 45927

Study title: Effects of treatment based on piracetam on 30 neurologically damaged children of under one year old.

Active substance: PIRACETAM

Study summary document link (including results): DE77E091P - Piracetam.pdf

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Document reference: 45985

Study title: Esperienza cliniche con il piracetam nel resveglio postanes-tetico.

Active substance: PIRACETAM

Study summary document link (including results): DJ76H171P - Piracetam.pdf

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Document reference: 45966

Study title: Buchanan GR et al. Alternating drug pairs with or without periodic reinduction in children with acute lymphoblastic leukemia in second bone marrow remission: a Pediatric Oncology Group Study. Cancer. 2000 Mar 1;88(5):1166-74.Buchanan GR et al. Alternating drug pairs with or without periodic reinduction in children with acute lymphoblastic leukemia in second bone marrow remission: a Pediatric Oncology Group Study. Cancer. 2000 Mar 1;88(5):1166-74.

Active substance: MITOXANTRONE

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Document reference: 32212

Study title: Buchanan GR et al. Improved treatment results in boys with overt testicular relapse during or shortly after initial therapy for acute lymphoblastic leukemia. A Pediatric Oncology group study. Cancer. 1991 Jul 1;68(1):48-55.Buchanan GR et al. Improved treatment results in boys with overt testicular relapse during or shortly after initial therapy for acute lymphoblastic leukemia. A Pediatric Oncology group study. Cancer. 1991 Jul 1;68(1):48-55.

Active substance: MITOXANTRONE

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Document reference: 32226

Study title: Büchner T et al. Double induction containing either two courses or one course of high-dose cytarabine plus mitoxantrone and postremission therapy by either autologous stem-cell transplantation or by prolonged maintenance for acute myeloid leukemia. J Clin Oncol. 2006 Jun 1;24(16):2480-9.Büchner T et al. Double induction containing either two courses or one course of high-dose cytarabine plus mitoxantrone and postremission therapy by either autologous stem-cell transplantation or by prolonged maintenance for acute myeloid leukemia. J Clin Oncol. 2006 Jun 1;24(16):2480-9.

Active substance: MITOXANTRONE

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Document reference: 32192

Study title: Endovascular treatment of acute and subacute hemorrhage in the head and neck. ; Remonda-L. Archives of Otolaryngology - Head and Neck Surgery, 2000, Vol/Iss/Pg. 126/10 (1255-1262)Endovascular treatment of acute and subacute hemorrhage in the head and neck. ; Remonda-L. Archives of Otolaryngology - Head and Neck Surgery, 2000, Vol/Iss/Pg. 126/10 (1255-1262)

Active substance: IODINE

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Document reference: 30249

Study title: Phase IV, double- blind, double-dummy, multicenter clinical study randomized in two parallel groups comparing the efficacy and safety of pristinamycin (PYOSTACINE) at an oral dose of 1 gram twice a day for ten days versus oxacillin (BRISTOPEN) at an oral dose of 1 gram twice a day for 10 days in the treatment of superficial bacterial skin infections in 250 outpatients. Study report PY 403 - Phase IV, double blind, double-dummy, multicenter clinical study, randomised, in two parallel groups, comparing the efficacy and safety of pristinamycin (Pyostacine®) at the posology of 1 gramm orally twice a day for 10 days, versus oxacilline (Bristopen®) at the posology of 1 gramm orally twice a day for 10 days, in the treatment of superficial cutaneous bacterial infections in 250 out-patient. -...

Active substance: PRISTINAMYCIN

Study summary document link (including results): Pristinamycin STUDY SPECIA PY 403.xls

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Document reference: 46118

Study title: Doireau-V, Grill-J, Zerah-M, Lellouch-Tubiana-A, Couanet-D, Chastagner-P, Marchal-J-C, Grignon-Y, Chouffai-Z, Kalifa-C. Department of Paediatrics, Gustave Roussy Institute, Villejuif, France. Chemotherapy for unresectable and recurrent intramedullary glial tumours in children. Brain Tumours Subcommittee of the French Society of Paediatric Oncology (SFOP). British journal of cancer, {Br-J-Cancer}, Nov 1999, vol. 81, no. 5, p. 835-40, ISSN: 0007-0920.Doireau-V, Grill-J, Zerah-M, Lellouch-Tubiana-A, Couanet-D, Chastagner-P, Marchal-J-C, Grignon-Y, Chouffai-Z, Kalifa-C. Department of Paediatrics, Gustave Roussy Institute, Villejuif, France. Chemotherapy for unresectable and recurrent intramedullary glial tumours in children. Brain Tumours Subcommi...

Active substance: PROCARBAZINE

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Document reference: 34697

Study title: Miller K. Pharmacological management of hypertension in paediatric patients. A comprehensive review of the efficacy, safety and dosage guidelines of the available agents. Drugs 1994; 48: 868-87, Update on the 1987 Task Force Report on High Blood Pressure in Children and Adolescents: A Working Group Report from the National High Blood Pressure Education Program. Pediatrics 1996;98;649-658Miller K. Pharmacological management of hypertension in paediatric patients. A comprehensive review of the efficacy, safety and dosage guidelines of the available agents. Drugs 1994; 48: 868-87, Update on the 1987 Task Force Report on High Blood Pressure in Children and Adolescents: A Working Group Report from the National High Blood Pressure Education Program. Pediatrics 1996;98;649-658

Active substance: MINOXIDIL

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Document reference: 32051

Study title: Pennisi A J et al. Minoxidil therapy in children with severe hypertension. Journal of Pediatrics.1977;90:813-9Pennisi A J et al. Minoxidil therapy in children with severe hypertension. Journal of Pediatrics.1977;90:813-9

Active substance: MINOXIDIL

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Document reference: 32058

Study title: Puri H C et al. Severe hypertension in children with renal disease: treatment with minoxidil. American Journal of Kidney Diseases.1983;3:71-5Puri H C et al. Severe hypertension in children with renal disease: treatment with minoxidil. American Journal of Kidney Diseases.1983;3:71-5

Active substance: MINOXIDIL

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Document reference: 32059

Study title: Sandhiya S & Dkhar SA. Potassium channels in health, disease and development of channel modulators. Indian J Med Res 2009; 129:223-232.Sandhiya S & Dkhar SA. Potassium channels in health, disease and development of channel modulators. Indian J Med Res 2009; 129:223-232.

Active substance: MINOXIDIL

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Document reference: 32054

Study title: Sinaiko and Mirkin. Management of severe childhood hypertension with minoxidil: a controlled clinical study. Journal of Pediatrics 1977;91:138-42Sinaiko and Mirkin. Management of severe childhood hypertension with minoxidil: a controlled clinical study. Journal of Pediatrics 1977;91:138-42

Active substance: MINOXIDIL

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Document reference: 32052

Study title: Sinaiko et al. Clinical response of hypertensive children to long-term minoxidil therapy. Journal of Cardiovascular Pharmacology.1980;2 Suppl 2:S181-8Sinaiko et al. Clinical response of hypertensive children to long-term minoxidil therapy. Journal of Cardiovascular Pharmacology.1980;2 Suppl 2:S181-8

Active substance: MINOXIDIL

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Document reference: 32060

Study title: The "Berlin model", Multicentre study with prednicarbate in different vehicles - G. Albrecht - 1986 (Z. Hautkr vol 61) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - The "Berlin model", Multicentre study with prednicarbate in different vehicles - G. Albrecht - 1986 (Z. Hautkr vol 61) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -

Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD

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Document reference: 34574

Study title: The topical application of prednicarbate preparations in children -H. Schulz et al. - 1986 (Z. Hautkr vol 61) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - The topical application of prednicarbate preparations in children -H. Schulz et al. - 1986 (Z. Hautkr vol 61) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -

Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD

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Document reference: 34575

Study title: Topical corticosteroids and adrenal : suppression Special aspects in pediatrics with prednicarbate - G. Herz et al. - 1988 (Raven Press) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - Topical corticosteroids and adrenal : suppression Special aspects in pediatrics with prednicarbate - G. Herz et al. - 1988 (Raven Press) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -

Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD

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Document reference: 34576

Study title: Dry and Itching Skin - therapy with a new preparation, containing urea and polidocanol.

Active substance: POLIDOCANOL AND UREA

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Document reference: 34578

Study title: Clinical evaluation of Nootropil (piracetam) in severe cranio-cerebral injuries.

Active substance: PIRACETAM

Study summary document link (including results): DE82E051P - Piracetam.pdf

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Document reference: 46029

Study title: Clinical experimentation of pyracetam in an infantile neuropsychiatry service.

Active substance: PIRACETAM

Study summary document link (including results): DJ78L132P - Piracetam.pdf

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Document reference: 46025

Study title: Clinical observations with regard to the effects of UCB 6215 on some brain functions in schoollchildren.

Active substance: PIRACETAM

Study summary document link (including results): DE73C201 - Piracetam.pdf

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Document reference: 46017

Study title: Clinical study of piracetam in paediatric neuro-psychiatry.

Active substance: PIRACETAM

Study summary document link (including results): DE73G025 - Piracetam.pdf

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Document reference: 45925

Study title: Clinical use of piracetam in epileptic patients.

Active substance: PIRACETAM

Study summary document link (including results): PDEE91A1702 - Piracetam.pdf

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Document reference: 45928

Study title: Clinics and treatment of nocturnal enuresis in children.

Active substance: PIRACETAM

Study summary document link (including results): DRU85L073P - Piracetam.pdf

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Document reference: 45964

Study title: Combined treatment of sudden sensorineural hearing loss with steroid, dextran and piracetam: experience with 68 cases.

Active substance: PIRACETAM

Study summary document link (including results): ADPE04E0611 - Piracetam.pdf

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Document reference: 46006

Study title: Comparison effects of vascular preparates in patients with cerebrovascular pathology.

Active substance: PIRACETAM

Study summary document link (including results): PDEE97C1402 - Piracetam.pdf

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Document reference: 46005

Study title: Lactobacillus GG and acute diarrhoea in young children in the tropics – PANT A.R., GRAHAM S.M. and al. – 1996. Lactobacillus GG and acute diarrhoea in young children in the tropics – PANT A.R., GRAHAM S.M. and al. – 1996.

Active substance: LACTIC ACID PRODUCING ORGANISMS AND COMBINATIONS

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Document reference: 30965

Study title: Radiation therapy in Ewing's sarcoma: an update of the CESS 86 trial.

Active substance: DACTINOMYCIN

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Document reference: 25436

Study title: Comparison of cimetidine and diphenhydramine in the treatment of acute urticaria, Moscati R.M., Ann. Emerg. Med. 1990; 19: 12-15

Active substance: Dextromethorphan + Diphenhydramine + L-Menthol

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Document reference: 25867

Study title: Strife C F et al, Pediatrics. Minoxidil for control of acute blood pressure elevation in chronically hypertensive children. 1986;78: 861-5Strife C F et al, Pediatrics. Minoxidil for control of acute blood pressure elevation in chronically hypertensive children. 1986;78: 861-5

Active substance: MINOXIDIL

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Document reference: 32061

Study title: Suresh et al. Emergency management of pediatric hypertension. Clinical Pediatrics. 2005; 44/9:739-745Suresh et al. Emergency management of pediatric hypertension. Clinical Pediatrics. 2005; 44/9:739-745

Active substance: MINOXIDIL

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Document reference: 32057

Study title: Hamann K.-F. and Bonkowsky V., Minzöl - Wirkung auf die Nasenschleimhaut von Gesunden, DAZ 15/1987 pp.:855-858

Active substance: Mint oil, partly dementolised (HERB)

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Document reference: 40072

Study title: Clinical report on the efficacy and tolerability of miocamycin (HM/MIO) in paediatric patients with respiratory tract infections

Active substance: MIOCAMYCIN

Study summary document link (including results): Miocamycin_Synopses.doc

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Document reference: 47538

Study title: A 24 week double−blind, randomised controlled trial comparing the efficacy, tolerability and health economic aspects of mirtazapine and paroxetine in depressed patients presenting to their general practitioners in the United Kingdom.

Active substance: MIRTAZAPINE

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Document reference: 32069

Study title: A multicenter, randomized, double−blind, placebo−controlled, efficacy and safety study of Remeron in outpatient children and adolescents with major depressive disorder

Active substance: MIRTAZAPINE

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Document reference: 32065

Study title: A single dose, pharmacokinetic trial of Remeron (mirtazipine) in children and adolescents with major depression

Active substance: MIRTAZAPINE

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Document reference: 32066

Study title: Philip T et al High-dose methotrexate and HELP [Holoxan (ifosfamide), eldesine (vindesine), platinum]--doxorubicin in non-metastatic osteosarcoma of the extremity: a French multicentre pilot study. Fédération Nationale des Centres de Lutte contre le Cancer and Société Française d'Oncologie Pédiatrique Ann Oncol. 1999 Sep;10(9):1065-71Philip T et al High-dose methotrexate and HELP [Holoxan (ifosfamide), eldesine (vindesine), platinum]--doxorubicin in non-metastatic osteosarcoma of the extremity: a French multicentre pilot study. Fédération Nationale des Centres de Lutte contre le Cancer and Société Française d'Oncologie Pédiatrique Ann Oncol. 1999 Sep;10(9):1065-71

Active substance: MITOXANTRONE

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Document reference: 32136

Study title: Pratt CB et al Novantrone for childhood malignant solid tumors. A pediatric oncology group phase II study Invest New Drugs. 1986;4(1):43-8Pratt CB et al Novantrone for childhood malignant solid tumors. A pediatric oncology group phase II study Invest New Drugs. 1986;4(1):43-8

Active substance: MITOXANTRONE

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Document reference: 32078

Study title: Pratt CB et al Novantrone for childhood malignant solid tumors. A pediatric oncology group phase II study Invest New Drugs. 1986;4(1):43-8Pratt CB et al Novantrone for childhood malignant solid tumors. A pediatric oncology group phase II study Invest New Drugs. 1986;4(1):43-8

Active substance: MITOXANTRONE

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Document reference: 32086

Study title: Pratt CB et al. Role of adjuvant chemotherapy in the treatment of surgically resected pediatric non-rhabdomyosarcomatous soft tissue sarcomas: A Pediatric Oncology Group Study. J Clin Oncol. 1999 Apr;17(4):1219Pratt CB et al. Role of adjuvant chemotherapy in the treatment of surgically resected pediatric non-rhabdomyosarcomatous soft tissue sarcomas: A Pediatric Oncology Group Study. J Clin Oncol. 1999 Apr;17(4):1219

Active substance: MITOXANTRONE

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Document reference: 32181

Study title: Pratt CB et al. Treatment of unresectable or metastatic pediatric soft tissue sarcomas withsurgery, irradiation, and chemotherapy: a Pediatric Oncology Group study. Med Pediatr Oncol. 1998 Apr;30(4):201-9.Pratt CB et al. Treatment of unresectable or metastatic pediatric soft tissue sarcomas withsurgery, irradiation, and chemotherapy: a Pediatric Oncology Group study. Med Pediatr Oncol. 1998 Apr;30(4):201-9.

Active substance: MITOXANTRONE

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Document reference: 32185

Study title: Wofford MM et al. Treatment of occult or late overt testicular relapse in children with acute lymphoblastic leukemia: a Pediatric Oncology Group study. J Clin Oncol. 1992 Apr;10(4):624-30Wofford MM et al. Treatment of occult or late overt testicular relapse in children with acute lymphoblastic leukemia: a Pediatric Oncology Group study. J Clin Oncol. 1992 Apr;10(4):624-30

Active substance: MITOXANTRONE

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Document reference: 32225

Study title: Worden FP et al Randomized phase II evaluation of 6 g/m2 of ifosfamide plus doxorubicin and granulocyte colony-stimulating factor (G-CSF) compared with 12 g/m2 of ifosfamide plus doxorubicin and G-CSF in the treatment of poor-prognosis soft tissue sarcoma J Clin Oncol. 2005 Jan 1;23(1):105-12. Erratum in: J Clin Oncol. 2006 Sep1;24(25):4223Worden FP et al Randomized phase II evaluation of 6 g/m2 of ifosfamide plus doxorubicin and granulocyte colony-stimulating factor (G-CSF) compared with 12 g/m2 of ifosfamide plus doxorubicin and G-CSF in the treatment of poor-prognosis soft tissue sarcoma J Clin Oncol. 2005 Jan 1;23(1):105-12. Erratum in: J Clin Oncol. 2006 Sep1;24(25):4223

Active substance: MITOXANTRONE

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Document reference: 32171

Study title: Yalcin B et al High-dose ifosfamide with hematopoietic growth factor support in advanced bone and soft tissue sarcomas Exp Oncol. 2004 Dec;26(4):320-5Yalcin B et al High-dose ifosfamide with hematopoietic growth factor support in advanced bone and soft tissue sarcomas Exp Oncol. 2004 Dec;26(4):320-5

Active substance: MITOXANTRONE

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Document reference: 32170

Study title: Yang CP et al. Treatment of childhood acute lymphoblastic leukemia with protocol TCL-842 inTaiwan: the Taiwan Children's Cancer Study Group. J Formos Med Assoc. 1993 May;92(5):431-9.Yang CP et al. Treatment of childhood acute lymphoblastic leukemia with protocol TCL-842 inTaiwan: the Taiwan Children's Cancer Study Group. J Formos Med Assoc. 1993 May;92(5):431-9.

Active substance: MITOXANTRONE

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Document reference: 32222

Study title: Yock TI et al. Local control in pelvic Ewing sarcoma: analysis from INT-0091--a report from the Children's Oncology Group. J Clin Oncol. 2006 Aug 20;24(24):3838-43.Yock TI et al. Local control in pelvic Ewing sarcoma: analysis from INT-0091--a report from the Children's Oncology Group. J Clin Oncol. 2006 Aug 20;24(24):3838-43.

Active substance: MITOXANTRONE

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Document reference: 32175

Study title: Results of plasma samples analysis for mivacurium from a study of the efficacy and safety of mivacurium in paediatric patients (P45-19). TBZZ/89/0014/00 referenced in THRS/89/0031 as available on request (in D921698) .

Active substance: MIVACURIUM

Study summary document link (including results): Study TBZZ-89-0014-00-Mivacurium Chloride.xls

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Document reference: 32256

Study title: Trimethoprim-polymyxin ophthalmic solution versus chloramphenicol ophthalmic solution in the treatment of bacterial conjunctivitis.van Rensburg SF, Gibson JR, Harvey SG, Burke CA. Pharmatherapeutica. 1982;3(4):274-7. Trimethoprim-polymyxin ophthalmic solution versus chloramphenicol ophthalmic solution in the treatment of bacterial conjunctivitis.van Rensburg SF, Gibson JR, Harvey SG, Burke CA. Pharmatherapeutica. 1982;3(4):274-7.

Active substance: POLYMYXIN B AND TRIMETHOPRIM

Study summary document link (including results): Trimethoprim-polymyxin B sulphate ophthalmic ointment versus chloramphenicol ophthalmic intment in the treatment of bacterial conjunctivitis.pdf

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Document reference: 34583

Study title: Code 9115 2015 USA 90 - Tremblements instabilité emotionnelle. Malformation vasculaire intra-cranienne hemorragie cerebrale. Diplopie.Code 9115 2015 USA 90 - Tremblements instabilité emotionnelle. Malformation vasculaire intra-cranienne hemorragie cerebrale. Diplopie.

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46074

Study title: Duran J.P., Ensel J., Verneuil M.F., Essai clinique du Tranxene en premedication, en anestheie infantile, Ouest Med., 1976, 29, (3), 235-237Duran J.P., Ensel J., Verneuil M.F., Essai clinique du Tranxene en premedication, en anestheie infantile, Ouest Med., 1976, 29, (3), 235-237

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46075

Study title: CLINICAL EXPERIENCE OF COMPARISON OF THREE DIFFERENT DOSE REGIMENS OF LEUPROLIDE ACETATE FOR PUBERAL BLOCKADE IN PATIENTS WITH PRECOCIOUS CENTRAL PUBERTY

Active substance: LEUPRORELIN

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Document reference: 31042

Study title: Friedman−A−D, Barton−L−L. Efficacy of sponging vs acetaminophen for reduction of fever. Sponging Study Group. {Pediatr−Emerg−Care}, Mar 1990, vol. 6, no. 1, p. 6−7

Active substance: CODEINE_AND_PARACETAMOL

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Document reference: 24540

Study title: Double-blind comparison of cefixime and cefaclor in the treatment of acute otitis media in children; Scand J Infect Dis 1991; 23:459-465Double-blind comparison of cefixime and cefaclor in the treatment of acute otitis media in children; Scand J Infect Dis 1991; 23:459-465

Active substance: CEFACLOR

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Document reference: 23381

Study title: Kantar M et al Treatment results of osteosarcoma of the extremity in children and adolescents at Ege University Hospital Pediatr Hematol Oncol. 2002 Oct-Nov;19(7):475-82Kantar M et al Treatment results of osteosarcoma of the extremity in children and adolescents at Ege University Hospital Pediatr Hematol Oncol. 2002 Oct-Nov;19(7):475-82

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 24947

Study title: Report/protocol/study N°: NGB 8855

Active substance: CLEMASTINE

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Document reference: 24315

Study title: Clinical evaluation of perphenazine, triflupromazine, and hydroxyzine for postoperative sedation in children

Active substance: HYDROXYZINE

Study summary document link (including results): ADPE92B0408.pdf

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Document reference: 29255

Study title: Fluoxetine Versus Placebo in the Treatment of Children and Adolescents with Obsessive-Compulsive Disorder

Active substance: FLUOXETINE

Study summary document link (including results): fluoxetine B1Y-MC-HCJW Clinical Study Summary.pdf

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Document reference: 47359

Study title: Pritchard J et al. High dose melphalan in the treatment of advanced neuroblastoma: results of arandomised trial (ENSG-1) by the European Neuroblastoma Study Group. Pediatr Blood Cancer. 2005 Apr;44(4):348-57.Pritchard J et al. High dose melphalan in the treatment of advanced neuroblastoma: results of arandomised trial (ENSG-1) by the European Neuroblastoma Study Group. Pediatr Blood Cancer. 2005 Apr;44(4):348-57.

Active substance: MITOXANTRONE

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Document reference: 32236

Study title: Rees JK et al. Dose intensification in acute myeloid leukaemia: greater effectiveness at lower cost. Principal report of the Medical Research Council's AML9 study. MRC Leukaemia in Adults Working Party. Br J Haematol. 1996 Jul;94(1):89-98.Rees JK et al. Dose intensification in acute myeloid leukaemia: greater effectiveness at lower cost. Principal report of the Medical Research Council's AML9 study. MRC Leukaemia in Adults Working Party. Br J Haematol. 1996 Jul;94(1):89-98.

Active substance: MITOXANTRONE

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Document reference: 32195

Study title: Reiter A et al Chemotherapy in 998 unselected childhood acute lymphoblastic leukemia patients. Results and conclusions of the multicenter trial ALL-BFM 86Blood. 1994 Nov 1;84(9):3122-33.Reiter A et al Chemotherapy in 998 unselected childhood acute lymphoblastic leukemia patients. Results and conclusions of the multicenter trial ALL-BFM 86Blood. 1994 Nov 1;84(9):3122-33.

Active substance: MITOXANTRONE

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Document reference: 32070

Study title: Reiter A et al Chemotherapy in 998 unselected childhood acute lymphoblastic leukemia patients. Results and conclusions of the multicenter trial ALL-BFM 86Blood. 1994 Nov 1;84(9):3122-33.Reiter A et al Chemotherapy in 998 unselected childhood acute lymphoblastic leukemia patients. Results and conclusions of the multicenter trial ALL-BFM 86Blood. 1994 Nov 1;84(9):3122-33.

Active substance: MITOXANTRONE

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Document reference: 32082

Study title: To study the effects of Fongitar (Polytar AF) in Pityriasis and squamous conditions of the scalp.

Active substance: Pix pini, Pix juniperi, Solutio picis lithantracis, Extractum oleatum picis lithantracis

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Document reference: 40133

Study title: PASSAGE OF BC 105 INTO RAT MILK.; N/A - Klybeck archive

Active substance: PIZOTIFEN

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Document reference: 34543

Study title: TOXICOLOGICAL EXPERIMENTS IN ANIMALS

Active substance: PIZOTIFEN

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Document reference: 34544

Study title: TOXICOLOGICAL EXPERIMENTS IN ANIMALS

Active substance: PIZOTIFEN

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Document reference: 45114

Study title: Immunotherapy in children with allergic asthma: Effect on bronchial hyperreactivity and pharmacotherapy

Active substance: Placenta compositum

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Document reference: 40136

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Placenta compositum (ampoules) [AWB-AT]

Active substance: Placenta compositum-Heel - Ampullen

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Document reference: 40137

Study title: Five-year follow-up on the PAT study: specific immunotherapy and long-term prevention of asthma in children

Active substance: Plantago Ovata Tinnevelly Senna Pods

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Document reference: 40138

Study title: Nolan T et al., Randomized trial of laxatives in treatment of childhood encopresis.The Lancet 338, 1991, 8766: 523-527

Active substance: Plantago Ovata Tinnevelly Senna Pods/ (HERB) Ispaghula seed Ispaghula husk/ Ispaghula husk/Ispaghula seeds/Senna pods (HERB)

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Document reference: 40036

Study title: Roth OA., Therapeutic observations on constipation; Med. Welt 1969;20:536-7

Active substance: Plantago Ovata Tinnevelly Senna Pods/ (HERB) Ispaghula seed Ispaghula husk/ Ispaghula husk/Ispaghula seeds/Senna pods (HERB)

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Document reference: 40038

Study title: Sölter et al., Summary of clinical results with Prodiem Plain, a bowel-regulating agent; Today´s Therapeutic Trends (1983);1(1):45-59

Active substance: Plantago Ovata Tinnevelly Senna Pods/ (HERB) Ispaghula seed Ispaghula husk/ Ispaghula husk/Ispaghula seeds/Senna pods (HERB)

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Document reference: 40039

Study title: Zawodsky L., Problems of a double-blind trial, as exemplified by a laxative; Der Praktische Arzt 1976;30:1182-92

Active substance: Plantago Ovata Tinnevelly Senna Pods/ (HERB) Ispaghula seed Ispaghula husk/ Ispaghula husk/Ispaghula seeds/Senna pods (HERB)

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Document reference: 40037

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Plantago-Homaccord (drops) [AWB-AT]

Active substance: Plantago-Homaccord

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Document reference: 39767

Study title: Effets chez le nouveau-né des benzodiazépines administrée à la mère - Bavoux F., Olivier C., Pons G. - Journées Parisiennes de PediatrieEffets chez le nouveau-né des benzodiazépines administrée à la mère - Bavoux F., Olivier C., Pons G. - Journées Parisiennes de Pediatrie

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46076

Study title: Étude de l'activit+é d'un anxiolytique administré par voie intraveineuse au cours de l'accouchement et de ses effets sur la fréquence cardiaque foetale - Schick A.R., Dellenbach P., Muller P. - Rev. Fr. Gynécol. Obstétr., 1977, 72, (2), 155-160Étude de l'activit+é d'un anxiolytique administré par voie intraveineuse au cours de l'accouchement et de ses effets sur la fréquence cardiaque foetale - Schick A.R., Dellenbach P., Muller P. - Rev. Fr. Gynécol. Obstétr., 1977, 72, (2), 155-160

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46077

Study title: Experimentation du clorazepate dipotassique en psychiatrie infantile - Lacnay Cl.m Houzel D. - Rev. Neuropsychiatr. Infant., 1972, 20, (Mai), 491-495.Experimentation du clorazepate dipotassique en psychiatrie infantile - Lacnay Cl.m Houzel D. - Rev. Neuropsychiatr. Infant., 1972, 20, (Mai), 491-495.

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46078

Study title: Expérimentation du Clorazepate dipotassique en psychiatrie infantile - Launay Cl., Houzel D. - Ver. Neuropsychiatr. Infant., 1972, 20, (Mai), 491-495Expérimentation du Clorazepate dipotassique en psychiatrie infantile - Launay Cl., Houzel D. - Ver. Neuropsychiatr. Infant., 1972, 20, (Mai), 491-495

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46079

Study title: Indications du Tranxene en cure ambulatoire en pédo-psychiatrie. Étude de 31 observations. - Sallou Cl. - Ver. Neuropsychiatr. Infant., 1973, 21, 701-705Indications du Tranxene en cure ambulatoire en pédo-psychiatrie. Étude de 31 observations. - Sallou Cl. - Ver. Neuropsychiatr. Infant., 1973, 21, 701-705

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46080

Study title: Pharmacokinatics of the placental transfer and distribution of Clorazepate and its metabolite nordiazepam in the feto-placental unit and in the neonate - Rey E., Giraux P., d'Athis Ph., Turquais J.M., Chavinie J., Olive G. - Europ. J. Clin. Pharmacol., 1979, 15, 181-185Pharmacokinatics of the placental transfer and distribution of Clorazepate and its metabolite nordiazepam in the feto-placental unit and in the neonate - Rey E., Giraux P., d'Athis Ph., Turquais J.M., Chavinie J., Olive G. - Europ. J. Clin. Pharmacol., 1979, 15, 181-185

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46081

Study title: Utilisation du Chlorazepate dipotassium en debut de travail - Amandruz M., Extermann Ph., Beguin F. - Med.-Hyg., 1983, 41, (1520) 2061-2065Utilisation du Chlorazepate dipotassium en debut de travail - Amandruz M., Extermann Ph., Beguin F. - Med.-Hyg., 1983, 41, (1520) 2061-2065

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46082

Study title: Essai therapeutique du Nootropyl en O.R.L.

Active substance: PIRACETAM

Study summary document link (including results): DF74L151P - Piracetam.pdf

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Document reference: 45918

Study title: Etude du Nootropil (forme sirop) chez des enfants presentant un retard de developpement.

Active substance: PIRACETAM

Study summary document link (including results): DD79B131 - Piracetam.pdf

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Document reference: 45905

Study title: Evaluation clinico-psychologique de l'effet therapeutique de deux medicaments a action neurotrope chez des sujets jeunes.

Active substance: PIRACETAM

Study summary document link (including results): DJ75B261 - Piracetam.pdf

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Document reference: 45939

Study title: Evaluation of efficacy of piracetam in add-on treatment of partial epilepsy in children.

Active substance: PIRACETAM

Study summary document link (including results): ADPE98L2605 - Piracetam.pdf

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Document reference: 46014

Study title: Evaluation of the effect of piracetam upon learning impairments in subjects with a border-line intellectual level.

Active substance: PIRACETAM

Study summary document link (including results): DE79E081 - Piracetam.pdf

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Document reference: 45976

Study title: Doz F et al Etoposide and carboplatin in extraocular retinoblastoma: a study by the Société Française d'Oncologie Pédiatrique J Clin Oncol 1995 Apr;13(4):902-9Doz F et al Etoposide and carboplatin in extraocular retinoblastoma: a study by the Société Française d'Oncologie Pédiatrique J Clin Oncol 1995 Apr;13(4):902-9

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 24851

Study title: TRIAL OF VOLTAREN IN THE TREATMENT OF SORE THROAT IN THE CHILDTRIAL OF VOLTAREN IN THE TREATMENT OF SORE THROAT IN THE CHILD

Active substance: DICLOFENAC

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Document reference: 26079

Study title: Feltman R, Kosel G: Prenatal and postnatal ingestion of fluorides – forteen years of investigation - final report. J Dent Med 1961; 16: 190-1999

Active substance: COLECALCIFEROL AND SODIUM FLUORIDE

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Document reference: 24630

Study title: Clinical trial of the pneumococcal 23-valent vaccine in children with sickle cell disease or splenectomy (> 6 months-15 years old)

Active substance: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENCES)

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Document reference: 41324

Study title: Safety and immunogenicity of the 23-valent pneumococcal vaccine after storage at 4°C for one year. (age 10-52 years old)

Active substance: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENCES)

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Document reference: 41325

Study title: Safety and immunogenicity of the 23-valent vaccine in healthy children at increased risk of pneumococcal infection. (2-18 years old)

Active substance: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENCES)

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Document reference: 41323

Study title: A Pilot Study of the Safety, Tolerability and Immunogenicity of Monovalent Pneumococcal Type 6B Conjugate Vaccine in Adults, Children and Infants

Active substance: Pneumococcal polysaccharides (serotypes 1,2,3,4,5,6B,7F,8,9N,9V,10A,11A,12F,14,15B,17F,18C, 19F,20,22F,23F,33F)

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Document reference: 47769

Study title: A Multicenter, Open-Label Study of Safety and Immunogenicity of Heptavalent Pneumococcal Conjugate Vaccine in Healthy Infants

Active substance: Pneumococcal saccharide conjugated vaccine, absorbed

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Document reference: 41586

Study title: A Phase II Randomized, Controlled Study to Determine the Safety and Immunogenicity of Two Combination Vaccines Containing Meningococcal C and Pneumococcal Capsular Polysaccharide-CRM197 Conjugates with or without PRP-CRM197 (HibTITER) in Healthy Infants

Active substance: Pneumococcal saccharide conjugated vaccine, absorbed

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Document reference: 41587

Study title: A Phase III Randomized Single-Blind Study to Evaluate the Safety of the 9-Valent Pneumococcal, Meningococcal Group C Saccharide-CRM197 Conjugate Combination Vaccine Compared to Licensed 7-Valent Pneumococcal Conjugate Vaccine (Prevnar®) Administered to Healthy Infants

Active substance: Pneumococcal saccharide conjugated vaccine, absorbed

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Document reference: 41588

Study title: A Phase III Randomized, Controlled Study to Compare the Safety and Immunogenicity of Two Different Formulations of a 9-Valent Pneumococcal, Meningococcal Group C Saccharide Conjugate Combination Vaccine Concurrently Administered at Two Different Sites With DTaP-IPV- HepB/Hib in Healthy Infants at 3, 4 and 5 Months of Age

Active substance: Pneumococcal saccharide conjugated vaccine, absorbed

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Document reference: 41589

Study title: EXPRES (EXacerbation PRevention with Elidel Survey)

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CNL01 Art45 listing 2011.xls

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Document reference: 34115

Study title: Naturalistic, open-label, multicenter study of long-term management in patients >=3 months of age with mild to moderate atopic dermatitis using Elidel (pimecrolimus) cream 1%.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CTR01 Art45 listing 2011.xls

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Document reference: 34122

Study title: Naturalistic, open-label, multicenter study of long-term management in patients >=3 months of age with mild to moderate atopic dermatitis using Elidel (pimecrolimus) cream 1%.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CTR01 Art45 listing 2011.xls

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Document reference: 47711

Study title: Naturalistic, open-label, multicenter study of short-term management in early school-aged 6-10 years old) children with mild or moderate atopic dermatitis using Elidel (pimecrolimus) cream 1%.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CPL01 Art45 listing 2011.xls

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Document reference: 34101

Study title: Oncogenicity study by dermal administration to CD-1 mice for 52 weeks

Active substance: PIMECROLIMUS

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Document reference: 34128

Study title: Conclusions regarding the influence of Piracetam upon the cognitive learning symptoms of children with learning disabilities.

Active substance: PIRACETAM

Study summary document link (including results): DE75G011 - Piracetam.pdf

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Document reference: 47899

Study title: Controlled pilot study of piracetam for pediatric opsoclonus-myoclonus.

Active substance: PIRACETAM

Study summary document link (including results): ADPE02B0805 - Piracetam.pdf

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Document reference: 45999

Study title: Cortical myoclonus in Angelman syndrome.

Active substance: PIRACETAM

Study summary document link (including results): PDEE96L1307 - Piracetam.pdf

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Document reference: 45950

Study title: Cortical reflex myoclonus in Rett syndrome.

Active substance: PIRACETAM

Study summary document link (including results): ADPE98G1004 - Piracetam.pdf

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Document reference: 45951

Study title: Depistage des grossesses a risque eleve a la maternite du centre hospitalier departemental Felix Guyon (St. Denis - Ile de la Reunion) et surveillance de l'evolution des nouveaux-nes. Chapitre IV : essai de prophylaxie et de traitement de l'asphyxie perinatale par la 2-pyrrolidone acetamide ou piracetam (Nootropyl).

Active substance: PIRACETAM

Study summary document link (including results): DF76E241T - Piracetam.pdf

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Document reference: 45957

Study title: Die wirkung von piracetam auf die hirnfunktion bei jugendlichen.

Active substance: PIRACETAM

Study summary document link (including results): DD75K161P - Piracetam.pdf

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Document reference: 45943

Study title: Drug therapy in sensorineural hearing loss in childhood.

Active substance: PIRACETAM

Study summary document link (including results): PDED91L0712 - Piracetam.pdf

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Document reference: 46033

Study title: Drug therapy of progressive sensorineural hearing loss in childhood.

Active substance: PIRACETAM

Study summary document link (including results): PDED91G0115 - Piracetam.pdf

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Document reference: 45986

Study title: Bhatia S et al. Therapy-related myelodysplasia and acute myeloid leukemia after Ewing sarcoma and primitive neuroectodermal tumor of bone: A report from the Children's Oncology Group. Blood. 2007 Jan 1;109(1):46-51. Epub 2006 Sep 19. Bhatia S et al. Therapy-related myelodysplasia and acute myeloid leukemia after Ewing sarcoma and primitive neuroectodermal tumor of bone: A report from the Children's Oncology Group. Blood. 2007 Jan 1;109(1):46-51. Epub 2006 Sep 19.

Active substance: MITOXANTRONE

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Document reference: 32174

Study title: Bisogno G et al Desmoplastic small round cell tumour in children and adolescents Med Pediatr Oncol. 2000 May;34(5):338-42Bisogno G et al Desmoplastic small round cell tumour in children and adolescents Med Pediatr Oncol. 2000 May;34(5):338-42

Active substance: MITOXANTRONE

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Document reference: 32090

Study title: Bisogno G et al Intensive chemotherapy for children and young adults with metastatic primitive neuroectodermal tumors of the soft tissue Bone Marrow Transplant. 2002 Sep;30(5):297-302Bisogno G et al Intensive chemotherapy for children and young adults with metastatic primitive neuroectodermal tumors of the soft tissue Bone Marrow Transplant. 2002 Sep;30(5):297-302

Active substance: MITOXANTRONE

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Document reference: 32172

Study title: Bisogno G et al The IVADo regimen--a pilot study with ifosfamide, vincristine, actinomycin D, and doxorubicin in children with metastatic soft tissue sarcoma: a pilot study of behalf of the European pediatric Soft tissue sarcoma Study Group Cancer. 2005 Apr 15;103(8):1719-24Bisogno G et al The IVADo regimen--a pilot study with ifosfamide, vincristine, actinomycin D, and doxorubicin in children with metastatic soft tissue sarcoma: a pilot study of behalf of the European pediatric Soft tissue sarcoma Study Group Cancer. 2005 Apr 15;103(8):1719-24

Active substance: MITOXANTRONE

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Document reference: 32169

Study title: Bacci G et al Long-term outcome for patients with nonmetastatic osteosarcoma of the extremity treated at the istituto ortopedico rizzoli according to the istituto ortopedicorizzoli/osteosarcoma-2 protocol: an updated report J Clin Oncol. 2000 Dec 15;18(24):4016-27Bacci G et al Long-term outcome for patients with nonmetastatic osteosarcoma of the extremity treated at the istituto ortopedico rizzoli according to the istituto ortopedicorizzoli/osteosarcoma-2 protocol: an updated report J Clin Oncol. 2000 Dec 15;18(24):4016-27

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 24740

Study title: A Stratified, Randomized, Double-Blind, Parallel-Group Trial Assessing the Efficacy and Safety of Fluticasone Propionate via the Multi-Dose Powder Inhaler 50mcg BID, 100mcg QD, and Placebo in Subjects Aged 4 to 11 Years With Chronic Asthma.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FLTA2007-ICHE3.pdf

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Document reference: 28376

Study title: Comparative study of the activity and tolerability of new glycoactive corticosteroid (deflazacort) compared to prednisone in the long-term treatment of systemic lupus erythematosus and rheumatoid arthritis - Schiavetti L - 6 October 1979 - Report (reference 76 in the clinical documentation deflazacort 6mg tablet - 04/1991 -

Active substance: DEFLAZACORT

Study summary document link (including results): Deflazacort STUDY Schiavetti.xls

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Document reference: 25635

Study title: DTPa-HBV-IPV-103

Active substance: diphtheria, tetanus, acellular pertussis, hepatitis b recombinant (adsorbed), inactivated poliovirus, adsorbed conjugated haemophilus influenzae type b vaccine

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Document reference: 41516

Study title: Retrospective Review of Routine Prophylaxis and Inhibitor Treatment with Fanhdi (Bonn)

Active substance: HUMAN COAGULATION FACTOR VIII

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Document reference: 29147

Study title: PMS: Pimecrolimus Cream 1% in childhood atopic dermatitis

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CHU02 Art45 listing 2011.xls

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Document reference: 34112

Study title: StabiEL Stabilisierung des Hautzustandes mit Elidel® (Pimecrolimus) – Post Marketing Surveillance Study.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CDE18 Art45 listing 2011.xls

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Document reference: 34097

Study title: Study title: A Multicentre, single arm prospective, open label study to assess the safety of Elidelâ (SDZ ASM 981 - pimecrolimus) cream 1% in patients with atopic dermatitis (Rainbow study)

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CAE01 Art45 listing 2011.xls

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Document reference: 34111

Study title: Two prospective studies each conducted during 7 months in different locations: * with tacrolimus ointment 0.1%, a randomized, double-blind, placebo-controlled * with pimecrolimus cream 1%, a nonrandomized control study.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CBE02 Art45 listing 2011.xls

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Document reference: 48118

Study title: Clinical Evaluation of 1717 L

Active substance: PINAVERIUM

Study summary document link (including results): pinaverium-bromide-s221.pdf

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Document reference: 48113

Study title: Mirtazapine in the treatment of adolescents with major depression, an open−label, multicenter pilot study; Haapasalo-Pesu KM, Vuola T, Lahelma L, Marttunen M.J Child Adolesc Psychopharmacol. 2004 Summer;14(2):175-84.Mirtazapine in the treatment of adolescents with major depression, an open−label, multicenter pilot study; Haapasalo-Pesu KM, Vuola T, Lahelma L, Marttunen M.J Child Adolesc Psychopharmacol. 2004 Summer;14(2):175-84.

Active substance: MIRTAZAPINE

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Document reference: 32067

Study title: Protocol for a multi−centre, open−labelled, randomised, prospective, clinical naturalistic pharmacokinetic and pharmacodynamic postmarketing surveillance study based on Therapeutic Drug Monitoring (TDM) with mirtazapine in depressed patients

Active substance: MIRTAZAPINE

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Document reference: 32068

Study title: Post-marketing study 2004- 2005 with NHD Mites/Pollen Cluster-dose escalation

Active substance: MITES

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Document reference: 47785

Study title: Anderson JR et al. Long-term follow-up of patients treated with COMP or LSA2L2 therapy for childhood non-Hodgkin's lymphoma: a report of CCG-551 from the Childrens Cancer Group. J Clin Oncol. 1993 Jun;11(6):1024-32Anderson JR et al. Long-term follow-up of patients treated with COMP or LSA2L2 therapy for childhood non-Hodgkin's lymphoma: a report of CCG-551 from the Childrens Cancer Group. J Clin Oncol. 1993 Jun;11(6):1024-32

Active substance: MITOXANTRONE

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Document reference: 32221

Study title: Annino L et al. Treatment of adult acute lymphoblastic leukemia (ALL): long-term follow-up of the GIMEMA ALL 0288 randomized study. Blood. 2002 Feb 1;99(3):863-71Annino L et al. Treatment of adult acute lymphoblastic leukemia (ALL): long-term follow-up of the GIMEMA ALL 0288 randomized study. Blood. 2002 Feb 1;99(3):863-71

Active substance: MITOXANTRONE

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Document reference: 32206

Study title: Evaluation of the results of a study in children with unprogressive syndromes of CNS disturbances and simultaneous retarded mental development, treated with Nootropil.

Active substance: PIRACETAM

Study summary document link (including results): DE76C096 - Piracetam.pdf

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Document reference: 46022

Study title: Evolution of coma in children with chlorinated insecticides intoxication treated with piracetam.

Active substance: PIRACETAM

Study summary document link (including results): DE85G241P - Piracetam.pdf

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Document reference: 46010

Study title: Experience clinique du Nootropil dans le traitement d'enfants presentant un leger dysfonctionnement cerebral.

Active substance: PIRACETAM

Study summary document link (including results): PDEF92K2728 - Piracetam.pdf

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Document reference: 45992

Study title: Experience with piracetam for cerebral lesions in children and adults.

Active substance: PIRACETAM

Study summary document link (including results): PDEE92K2615 - Piracetam.pdf

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Document reference: 45987

Study title: Experiences with piracetam in children with cerebral insufficiency.

Active substance: PIRACETAM

Study summary document link (including results): DE79G023 - Piracetam.pdf

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Document reference: 46002

Study title: Experimental education of mentally retarded children. Organization and preliminary results.

Active substance: PIRACETAM

Study summary document link (including results): DRU81B232P - Piracetam.pdf

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Document reference: 45972

Study title: Experimentation clinique du piracetam en neuro-chirurgie.

Active substance: PIRACETAM

Study summary document link (including results): DF74L157P - Piracetam.pdf

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Document reference: 45989

Study title: Experimentation clinique du piracetam.

Active substance: PIRACETAM

Study summary document link (including results): DF73K021P - Piracetam.pdf

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Document reference: 45936

Study title: Gender differences in the effect of the nootropic medicine, noopept, in the model of early postnatal hypoxia.

Active substance: PIRACETAM

Study summary document link (including results): ADPE05L2910 - Piracetam.pdf

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Document reference: 46043

Study title: Improvement of acupuncture on independent walking ability in children with cerebral paralysis.

Active substance: PIRACETAM

Study summary document link (including results): ADPE05B0306 - Piracetam.pdf

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Document reference: 45969

Study title: Improvement of intellectual performance contribution of a specific cortical therapy.

Active substance: PIRACETAM

Study summary document link (including results): DE73G026 - Piracetam.pdf

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Document reference: 46019

Study title: Chou AJ et al Treatment of osteosarcoma at first recurrence after contemporary therapy: the Memorial Sloan-Kettering Cancer Center experience Cancer. 2005 Nov 15;104(10):2214-21Chou AJ et al Treatment of osteosarcoma at first recurrence after contemporary therapy: the Memorial Sloan-Kettering Cancer Center experience Cancer. 2005 Nov 15;104(10):2214-21

Active substance: MITOXANTRONE

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Document reference: 32121

Study title: Coze C et al. NB87 induction protocol for stage 4 neuroblastoma in children over 1 year of age: a report from the French Society of Pediatric Oncology. Clin Oncol. 1997 Dec;15(12):3433-40Coze C et al. NB87 induction protocol for stage 4 neuroblastoma in children over 1 year of age: a report from the French Society of Pediatric Oncology. Clin Oncol. 1997 Dec;15(12):3433-40

Active substance: MITOXANTRONE

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Document reference: 32241

Study title: On the antipyretic effect of paracetamol. Clinical investigation with two different forms of application - Med Klin, 6 Jan 1978, vol. 73, no. 1, p. 28-33On the antipyretic effect of paracetamol. Clinical investigation with two different forms of application - Med Klin, 6 Jan 1978, vol. 73, no. 1, p. 28-33

Active substance: PARACETAMOL

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Document reference: 45734

Study title: Joynt, RL et al.: Dantrolene sodium suspension in treatment of spastic cerebral palsy; Dev.Med. Child. Neurol. 22, 755-767 (1980)Joynt, RL et al.: Dantrolene sodium suspension in treatment of spastic cerebral palsy; Dev.Med. Child. Neurol. 22, 755-767 (1980)

Active substance: DANTROLENE

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Document reference: 25531

Study title: atomoxetine B4Z-MC-LYAFb Clinical Study Summary

Active substance: ATOMOXETINE

Study summary document link (including results): atomoxetine B4Z-MC-LYAFb Clinical Study Summary.pdf

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Document reference: 47093

Study title: Rapid and safe termination of supraventricular tachycardia in children by adenosine - Clarke B., Rowland E, Barnes PJ - 1987 (Lancet, i : 299-301) Rapid and safe termination of supraventricular tachycardia in children by adenosine - Clarke B., Rowland E, Barnes PJ - 1987 (Lancet, i : 299-301)

Active substance: ADENOSINE

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Document reference: 46302

Study title: Final medical report Acceptance study with Mucosolvan 15 mg and 30 mg in children.

Active substance: AMBROXOL

Study summary document link (including results): Ambroxol Hydrochloride_U87-0438_Synopsis.pdf

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Document reference: 46537

Study title: ZANNINO L, et al. CONTROLLED CLINICAL STUDY ON A NEW MUCOLYTIC AGENT - AMBROXOL HYDROCHLORIDE - IN HYPERSECRETORY BRONCHIALDISEASE IN CHILDREN. “La Clinica Pediatrica” Vol. 64 - Number 4 - 1982

Active substance: AMBROXOL

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Document reference: 48437

Study title: Guarnieri J.,Ciliberto R. Osservazioni cliniche sull’impiego di una nuova associazione antibiotica Aggior.Pediat.,23(1-2-3)1-10,1972Guarnieri J.,Ciliberto R. Osservazioni cliniche sull’impiego di una nuova associazione antibiotica Aggior.Pediat.,23(1-2-3)1-10,1972

Active substance: AMPICILLIN AND CLOXACILLIN

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Document reference: 46653

Study title: Pyloric stenosis: is over-reliance on ultrasound scans leading to negative explorations?. Misra D. and al; European Journal of Pediatric Surgery. 7(6):328-30, 1997 Dec.Pyloric stenosis: is over-reliance on ultrasound scans leading to negative explorations?. Misra D. and al; European Journal of Pediatric Surgery. 7(6):328-30, 1997 Dec.

Active substance: BARIUM SULPHATE

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Document reference: 22198

Study title: Antman KH et al Response to ifosfamide and mesna: 124 previously treated patients with metastatic or unresectable sarcoma J Clin Oncol. 1989 Jan;7(1):126-31. Erratum in: J Clin Oncol 1989 Sep;7(9):1369Antman KH et al Response to ifosfamide and mesna: 124 previously treated patients with metastatic or unresectable sarcoma J Clin Oncol. 1989 Jan;7(1):126-31. Erratum in: J Clin Oncol 1989 Sep;7(9):1369

Active substance: MITOXANTRONE

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Document reference: 32163

Study title: Arndt C et al A feasibility, toxicity, and early response study of etoposide, ifosfamide, andvincristine for the treatment of children with rhabdomyosarcoma: a report from the Intergroup Rhabdomyosarcoma Study (IRS) IV pilot study J Pediatr Hematol Oncol. 1997 Mar-Apr;19(2):124-9Arndt C et al A feasibility, toxicity, and early response study of etoposide, ifosfamide, andvincristine for the treatment of children with rhabdomyosarcoma: a report from the Intergroup Rhabdomyosarcoma Study (IRS) IV pilot study J Pediatr Hematol Oncol. 1997 Mar-Apr;19(2):124-9

Active substance: MITOXANTRONE

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Document reference: 32156

Study title: Arndt C et al. Age is a risk factor for chemotherapy-induced hepatopathy with vincristine,dactinomycin, and cyclophosphamide. J Clin Oncol. 2004 May 15;22(10):1894-901.Arndt C et al. Age is a risk factor for chemotherapy-induced hepatopathy with vincristine,dactinomycin, and cyclophosphamide. J Clin Oncol. 2004 May 15;22(10):1894-901.

Active substance: MITOXANTRONE

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Document reference: 32178

Study title: Arndt CA et al Treatment of intermediate risk rhabdomyosarcoma and undifferentiated sarcoma with alternating cycles of vincristine/doxorubicin/cyclophosphamide and etoposide/ifosfamide Eur J Cancer. 1998 Jul;34(8):1224-9Arndt CA et al Treatment of intermediate risk rhabdomyosarcoma and undifferentiated sarcoma with alternating cycles of vincristine/doxorubicin/cyclophosphamide and etoposide/ifosfamide Eur J Cancer. 1998 Jul;34(8):1224-9

Active substance: MITOXANTRONE

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Document reference: 32154

Study title: Reiter A et al. NHL-BFM 90 therapy study in treatment of malignant non-Hodgkin's lymphomas in children and adolescents. Part 2: An intermediate term analysis of the non-B-NHL therapy group. BFM Study group Klin Padiatr. 1994 Jul-Aug;206(4):234-41.Reiter A et al. NHL-BFM 90 therapy study in treatment of malignant non-Hodgkin's lymphomas in children and adolescents. Part 2: An intermediate term analysis of the non-B-NHL therapy group. BFM Study group Klin Padiatr. 1994 Jul-Aug;206(4):234-41.

Active substance: MITOXANTRONE

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Document reference: 32219

Study title: Rosito P et al Italian Cooperative Study for the treatment of children and young adults with localized Ewing sarcoma of bone: a preliminary report of 6 years of experience Cancer. 1999 Aug 1;86(3):421-8. Erratum in: Cancer. 2005 Aug 1;104(3):667. dosage error in textRosito P et al Italian Cooperative Study for the treatment of children and young adults with localized Ewing sarcoma of bone: a preliminary report of 6 years of experience Cancer. 1999 Aug 1;86(3):421-8. Erratum in: Cancer. 2005 Aug 1;104(3):667. dosage error in text

Active substance: MITOXANTRONE

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Document reference: 32099

Study title: Rousseau P et al Primary chemotherapy in rhabdomyosarcomas and other malignant mesenchymal tumors of the orbit: results of the International Society of Pediatric Oncology MMT 84 Study J Clin Oncol. 1994 Mar;12(3):516-21Rousseau P et al Primary chemotherapy in rhabdomyosarcomas and other malignant mesenchymal tumors of the orbit: results of the International Society of Pediatric Oncology MMT 84 Study J Clin Oncol. 1994 Mar;12(3):516-21

Active substance: MITOXANTRONE

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Document reference: 32151

Study title: Sackmann-Muriel F et al. Hodgkin disease in children: results of a prospective randomized trial in a single institution in Argentina. Med Pediatr Oncol. 1997 Dec;29(6):544-52.Sackmann-Muriel F et al. Hodgkin disease in children: results of a prospective randomized trial in a single institution in Argentina. Med Pediatr Oncol. 1997 Dec;29(6):544-52.

Active substance: MITOXANTRONE

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Document reference: 32246

Study title: Bunin N et al. Randomized trial of busulfan vs total body irradiation containing conditioning regimens for children with acute lymphoblastic leukemia: a Pediatric Blood and Marrow Transplant Consortium study. Bone Marrow Transplant. 2003 Sep;32(6):543-8Bunin N et al. Randomized trial of busulfan vs total body irradiation containing conditioning regimens for children with acute lymphoblastic leukemia: a Pediatric Blood and Marrow Transplant Consortium study. Bone Marrow Transplant. 2003 Sep;32(6):543-8

Active substance: MITOXANTRONE

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Document reference: 32200

Study title: Burgert EO et al. Multimodal therapy for the management of nonpelvic, localized Ewing's sarcoma of bone: intergroup study IESS-II. J Clin Oncol. 1990 Sep;8(9):1514-24.Burgert EO et al. Multimodal therapy for the management of nonpelvic, localized Ewing's sarcoma of bone: intergroup study IESS-II. J Clin Oncol. 1990 Sep;8(9):1514-24.

Active substance: MITOXANTRONE

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Document reference: 32191

Study title: Cairo MS et al. FAB LMB96 International Study Committee. Results of a randomized international study of high-risk central nervous system B non-Hodgkin lymphoma and B acute lymphoblastic leukemia in children and adolescents. Blood. 2007 Apr 1;109(7):2736-43.Cairo MS et al. FAB LMB96 International Study Committee. Results of a randomized international study of high-risk central nervous system B non-Hodgkin lymphoma and B acute lymphoblastic leukemia in children and adolescents. Blood. 2007 Apr 1;109(7):2736-43.

Active substance: MITOXANTRONE

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Document reference: 32199

Study title: Castleberry RP et al. Radiotherapy improves the outlook for patients older than 1 year with Pediatric Oncology Group stage C neuroblastoma.J Clin Oncol. 1991 May;9(5):789-95Castleberry RP et al. Radiotherapy improves the outlook for patients older than 1 year with Pediatric Oncology Group stage C neuroblastoma.J Clin Oncol. 1991 May;9(5):789-95

Active substance: MITOXANTRONE

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Document reference: 32244

Study title: Castleberry RP et al.Phase II investigational window using carboplatin, iproplatin, ifosfamide, and epirubicin in children with untreated disseminated neuroblastoma: a Pediatric Oncology Group study. J Clin Oncol. 1994 Aug;12(8):1616-20.Castleberry RP et al.Phase II investigational window using carboplatin, iproplatin, ifosfamide, and epirubicin in children with untreated disseminated neuroblastoma: a Pediatric Oncology Group study. J Clin Oncol. 1994 Aug;12(8):1616-20.

Active substance: MITOXANTRONE

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Document reference: 32243

Study title: Weston CL et al Establishing long-term survival and cure in young patients with Ewing's sarcoma Br J Cancer. 2004 Jul 19;91(2):225-32Weston CL et al Establishing long-term survival and cure in young patients with Ewing's sarcoma Br J Cancer. 2004 Jul 19;91(2):225-32

Active substance: MITOXANTRONE

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Document reference: 32094

Study title: Wexler LH et al Ifosfamide and etoposide plus vincristine, doxorubicin, and cyclophosphamide for newly diagnosed Ewing's sarcoma family of tumors Cancer. 1996 Aug 15;78(4):901-11. Erratum in: Cancer 1997 Feb 15;79(4):867Wexler LH et al Ifosfamide and etoposide plus vincristine, doxorubicin, and cyclophosphamide for newly diagnosed Ewing's sarcoma family of tumors Cancer. 1996 Aug 15;78(4):901-11. Erratum in: Cancer 1997 Feb 15;79(4):867

Active substance: MITOXANTRONE

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Document reference: 32114

Study title: Wiltshaw E et al Ifosfamide plus mesna with and without adriamycin in soft tissue sarcoma Cancer Chemother Pharmacol. 1986;18 Suppl 2:S10-2Wiltshaw E et al Ifosfamide plus mesna with and without adriamycin in soft tissue sarcoma Cancer Chemother Pharmacol. 1986;18 Suppl 2:S10-2

Active substance: MITOXANTRONE

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Document reference: 32173

Study title: Winick NJ et al. Treatment of CNS relapse in children with acute lymphoblastic leukemia: A Pediatric Oncology Group study. J Clin Oncol. 1993 Feb;11(2):271-8Winick NJ et al. Treatment of CNS relapse in children with acute lymphoblastic leukemia: A Pediatric Oncology Group study. J Clin Oncol. 1993 Feb;11(2):271-8

Active substance: MITOXANTRONE

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Document reference: 32224

Study title: Relazione clinical sull'ascriptin

Active substance: acetylsalicylic acide and Magnesium Hydroxide and Algeldrate

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Document reference: 47961

Study title: Effect of Madecassol on healing of skin grafts among severely burned children

Active substance: Asiaticoside (Hydrocotyle Reconstituted Dry Extract (Centella Asiatica))

Study summary document link (including results): Bayer CC_Asiaticoside_CC-02607_study_synopsis.pdf

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Document reference: 47908

Study title: "Risks of intravenous amiodarone in neonates. Gandy J et al. - 1998 (Canad. J. Cardiol., 14 (6):855-858) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" "Risks of intravenous amiodarone in neonates. Gandy J et al. - 1998 (Canad. J. Cardiol., 14 (6):855-858) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -"

Active substance: AMIODARONE

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Document reference: 45158

Study title: Kaplan E.L. Dwight R.J.: Unexplained reduced microbiological efficacy of intramuscolar benzathine penicillin G of oral penicillin V in eradication of group A streptococci from children with acute pharyngitis. Pediatrics 2001;108:1180-1186Kaplan E.L. Dwight R.J.: Unexplained reduced microbiological efficacy of intramuscolar benzathine penicillin G of oral penicillin V in eradication of group A streptococci from children with acute pharyngitis. Pediatrics 2001;108:1180-1186

Active substance: BENZENTHONIUM AND LIDOCAINE

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Document reference: 22285

Study title: Einfachblinde, randomisierte, Verum-kontrollierte, monozentrische Studie zum Nachweis der Nicht-Unterlegenheit von Leukichtan Gel vs. Betaisodona Salbe in der Behandlung von Schnitt-, Schürfwunden und Verbrennungen

Active substance: ICHTASOL

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Document reference: 29767

Study title: Betaxolol SL75.212-10 Acute oral toxicity in "young" rats - AM. Orloff, D. Branceni Betaxolol Core Dossier - April 1999 - Part III Pharmaco-toxicological documentation Volume 2

Active substance: BETAXOLOL

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Document reference: 41927

Study title: Effects of inhaled budesonide on serum markers of bone metabolism in children with asthma.

Active substance: BUDESONIDE

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Document reference: 48431

Study title: Inhaled budesonide aerosols in treatment of childhood asthma (6–16 years).

Active substance: BUDESONIDE

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Document reference: 48433

Study title: Nebulized budesonide for children with mild-to-moderate croup.

Active substance: BUDESONIDE

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Document reference: 48439

Study title: One-year follow-up of young children hospitalized for wheezing: the influence of early anti-inflammatory therapy and risk factors for subsequent wheezing and asthma.

Active substance: BUDESONIDE

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Document reference: 48438

Study title: Study 1: An open label study to investigate whether BUD tehrapy given for four weeks could possibly potentiate the effect of terbutaline inhaled 15 minutes before exercise challenge in 14 children with exercise-induced asthma; Study 2: A double-blind, placebo controlled, cross-over study to investigate the effect of inhaled BUD on exercise-induced asthma in children in 14 asthmatic children (different from those in Study 1)

Active substance: BUDESONIDE

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Document reference: 48409

Study title: The efficacy and side effects of a new corticosteroid aerosol, Budesonide, were assessed in 28 patients with chronic asthma in a double-blind cross-over study comparing it with Beclomethasone Dipropionate.

Active substance: BUDESONIDE

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Document reference: 48405

Study title: The use of nebulised budesonide in croup.

Active substance: BUDESONIDE

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Document reference: 22929

Study title: 1α-hydroxycholecalciferol treatment of long-term haemodialysis patients1α-hydroxycholecalciferol treatment of long-term haemodialysis patients

Active substance: ALFACALCIDOL

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Document reference: 46332

Study title: Use of budesonide administered through Nebuhaler together with a Laerdal face mask in severe asthmatics aged 1-3 years with at least a six month history of troublesome asthma and thought by their parents to be responsive to bronchodilators. Two weeks of run-in was followed by six months treatment period. Double-blind, parallell group

Active substance: BUDESONIDE

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Document reference: 48434

Study title: Sadowitz PD et al. Treatment of late bone marrow relapse in children with acute lymphoblastic leukemia: a Pediatric Oncology Group study. Blood. 1993 Feb 1;81(3):602-9.Sadowitz PD et al. Treatment of late bone marrow relapse in children with acute lymphoblastic leukemia: a Pediatric Oncology Group study. Blood. 1993 Feb 1;81(3):602-9.

Active substance: MITOXANTRONE

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Document reference: 32223

Study title: Sampi K et al Phase II trial of mitoxantrone in patients with relapsed and refractory acute leukemia Gan To Kagaku Ryoho. 1986 Oct;13(10):3021-7. JapaneseSampi K et al Phase II trial of mitoxantrone in patients with relapsed and refractory acute leukemia Gan To Kagaku Ryoho. 1986 Oct;13(10):3021-7. Japanese

Active substance: MITOXANTRONE

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Document reference: 32077

Study title: Sampi K et al Phase II trial of mitoxantrone in patients with relapsed and refractory acute leukemia Gan To Kagaku Ryoho. 1986 Oct;13(10):3021-7. JapaneseSampi K et al Phase II trial of mitoxantrone in patients with relapsed and refractory acute leukemia Gan To Kagaku Ryoho. 1986 Oct;13(10):3021-7. Japanese

Active substance: MITOXANTRONE

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Document reference: 32085

Study title: Sandler E et al Efficacy of ifosfamide and doxorubicin given as a phase II "window" in children with newly diagnosed metastatic rhabdomyosarcoma: a report from the IntergroupRhabdomyosarcoma Study Group Med Pediatr Oncol. 2001 Nov;37(5):442-8Sandler E et al Efficacy of ifosfamide and doxorubicin given as a phase II "window" in children with newly diagnosed metastatic rhabdomyosarcoma: a report from the IntergroupRhabdomyosarcoma Study Group Med Pediatr Oncol. 2001 Nov;37(5):442-8

Active substance: MITOXANTRONE

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Document reference: 32145

Study title: Santini G et al. VACOP-B versus VACOP-B plus autologous bone marrow transplantation for advanced diffuse non-Hodgkin's lymphoma: results of a prospective randomized trial by the non-Hodgkin's Lymphoma Cooperative Study Group. J Clin Oncol. 1998 Aug;16(8):2796-802.Santini G et al. VACOP-B versus VACOP-B plus autologous bone marrow transplantation for advanced diffuse non-Hodgkin's lymphoma: results of a prospective randomized trial by the non-Hodgkin's Lymphoma Cooperative Study Group. J Clin Oncol. 1998 Aug;16(8):2796-802.

Active substance: MITOXANTRONE

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Document reference: 32214

Study title: A Phase III Randomized, Double-Blind Trial to Compare the Immunogenicity of Three Unique Lots of 9-Valent Pneumococcal, Meningococcal Group C Saccharide Conjugate Combination Vaccine in Infants. Amendment to Evaluate the Responses to a Fourth Dose of DTaP Vaccine Given Concurrently with 9-Valent Pneumococcal, Meningococcal Group C Saccharide Conjugate Combination Vaccine

Active substance: Pneumococcal saccharide conjugated vaccine, absorbed

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Document reference: 41590

Study title: A Randomized, Controlled, Single-Blinded Study to Determine Equivalence of Immunogenicity Between a 7-Valent Pneumococcal Conjugate Vaccine and a 9-Valent Pneumococcal Conjugate Vaccine Administered Concurrently at Separate Sites with a DTPa/IPV+Hib Vaccine in Healthy Infants

Active substance: Pneumococcal saccharide conjugated vaccine, absorbed

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Document reference: 41591

Study title: A Randomized, Double Blind, Study of the Safety and Immunogenicity of Nine Valent (1, 4, 5, 6B, 9V, 14, 18C, 19F, 23F) Pneumococcal Conjugate Vaccine in Healthy Infants at 2, 4, and 6 Months of Age. Amendment # 1: Safety and Immunogenicity of a Booster Dose of Nine Valent (1, 4, 5, 6B, 9V, 14, 18C, 19F, 23F) Pneumococcal Conjugate Vaccine Administered Concurrently with MMR in Toddlers 12-15 Months of Age.

Active substance: Pneumococcal saccharide conjugated vaccine, absorbed

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Document reference: 41592

Study title: An Open Label Phase I/III Study to Evaluate the Safety and Immunogenicity of Pneumococcal 7-Valent Conjugate Vaccine (DIPHTHERIA CRM197 PROTEIN) (PREVNARTM) in Healthy Infants Phase III

Active substance: Pneumococcal saccharide conjugated vaccine, absorbed

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Document reference: 41593

Study title: An Open Label Phase I/III Study to Evaluate the Safety and Immunogenicity of Pneumococcal 7-Valent Conjugate Vaccine (DIPHTHERIA CRM197 PROTEIN) (PREVNARTM) in Healthy Infants Phase III

Active substance: Pneumococcal saccharide conjugated vaccine, absorbed

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Document reference: 41594

Study title: An Open-Label Pilot Study to Evaluate the Safety Of Pneumococcal 7-Valent Conjugate Vaccine [Diphtheria Crm197 Protein] (Prevenar) in Healthy Adults and Children at 3 to 5 Years Old.

Active substance: Pneumococcal saccharide conjugated vaccine, absorbed

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Document reference: 41595

Study title: An Open-Label Trial of the Immunogenicity and Safety of Prevenar in Healthy Infants at 2, 4 and 6 months of age.

Active substance: Pneumococcal saccharide conjugated vaccine, absorbed

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Document reference: 41597

Study title: Boulad F et al High-dose induction chemoradiotherapy followed by autologous bone marrow transplantation as consolidation therapy in rhabdomyosarcoma, extraosseous Ewing's sarcoma, and undifferentiated sarcoma J Clin Oncol. 1998 May;16(5):1697-706Boulad F et al High-dose induction chemoradiotherapy followed by autologous bone marrow transplantation as consolidation therapy in rhabdomyosarcoma, extraosseous Ewing's sarcoma, and undifferentiated sarcoma J Clin Oncol. 1998 May;16(5):1697-706

Active substance: MITOXANTRONE

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Document reference: 32113

Study title: Bramwell VH et al. Cyclophosphamide versus ifosfamide: a randomized phase II trial in adult soft-tissue sarcomas. The European Organization for Research and Treatment of Cancer [EORTC], Soft Tissue and Bone Sarcoma Group. Cancer Chemother Pharmacol. 1993;31 Suppl 2:S180-4.Bramwell VH et al. Cyclophosphamide versus ifosfamide: a randomized phase II trial in adult soft-tissue sarcomas. The European Organization for Research and Treatment of Cancer [EORTC], Soft Tissue and Bone Sarcoma Group. Cancer Chemother Pharmacol. 1993;31 Suppl 2:S180-4.

Active substance: MITOXANTRONE

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Document reference: 32189

Study title: Brecher ML et al. Fractionated cylophosphamide and back to back high dose methotrexate and cytosinearabinoside improves outcome in patients with stage III high grade small non-cleaved cell lymphomas (SNCCL): a randomized trial of the Pediatric Oncology Group. Med Pediatr Oncol. 1997 Dec;29(6):526-33.Brecher ML et al. Fractionated cylophosphamide and back to back high dose methotrexate and cytosinearabinoside improves outcome in patients with stage III high grade small non-cleaved cell lymphomas (SNCCL): a randomized trial of the Pediatric Oncology Group. Med Pediatr Oncol. 1997 Dec;29(6):526-33.

Active substance: MITOXANTRONE

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Document reference: 32249

Study title: Breitfeld PP et al Ifosfamide and etoposide are superior to vincristine and melphalan for pediatric metastatic rhabdomyosarcoma when administered with irradiation and combination chemotherapy: a report from the Intergroup Rhabdomyosarcoma Study Group J Pediatr Hematol Oncol. 2001 May;23(4):225-33Breitfeld PP et al Ifosfamide and etoposide are superior to vincristine and melphalan for pediatric metastatic rhabdomyosarcoma when administered with irradiation and combination chemotherapy: a report from the Intergroup Rhabdomyosarcoma Study Group J Pediatr Hematol Oncol. 2001 May;23(4):225-33

Active substance: MITOXANTRONE

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Document reference: 32144

Study title: Uderzo C et al. High-dose vincristine, fractionated total-body irradiation and cyclophosphamide as conditioning regimen in allogeneic and autologous bone marrow transplantation for childhood acute lymphoblastic leukaemia in second remission: a 7-year Italian multicentre study. Br J Haematol. 1995 Apr;89(4):790-7.Uderzo C et al. High-dose vincristine, fractionated total-body irradiation and cyclophosphamide as conditioning regimen in allogeneic and autologous bone marrow transplantation for childhood acute lymphoblastic leukaemia in second remission: a 7-year Italian multicentre study. Br J Haematol. 1995 Apr;89(4):790-7.

Active substance: MITOXANTRONE

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Document reference: 32217

Study title: Ungerleider RS et al Phase I trial of mitoxantrone in children Cancer Treat Rep. 1985 Apr;69(4):403-7Ungerleider RS et al Phase I trial of mitoxantrone in children Cancer Treat Rep. 1985 Apr;69(4):403-7

Active substance: MITOXANTRONE

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Document reference: 32079

Study title: Ungerleider RS et al Phase I trial of mitoxantrone in children Cancer Treat Rep. 1985 Apr;69(4):403-7Ungerleider RS et al Phase I trial of mitoxantrone in children Cancer Treat Rep. 1985 Apr;69(4):403-7

Active substance: MITOXANTRONE

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Document reference: 32087

Study title: Van Winkle P et al Ifosfamide, carboplatin, and etoposide (ICE) reinduction chemotherapy in a large cohort of children and adolescents with recurrent/refractory sarcoma: the Children's Cancer Group (CCG) experience Pediatr Blood Cancer. 2005 Apr;44(4):338-47Van Winkle P et al Ifosfamide, carboplatin, and etoposide (ICE) reinduction chemotherapy in a large cohort of children and adolescents with recurrent/refractory sarcoma: the Children's Cancer Group (CCG) experience Pediatr Blood Cancer. 2005 Apr;44(4):338-47

Active substance: MITOXANTRONE

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Document reference: 32159

Study title: Endoluminal instillation of bisacodyl in patients with severe (slow transit type) constipation is useful to test residual colonic propulsive activity. Bassotti-G, and al; Digestion {DIGESTION}, 1999, Vol/Iss/Pg. 60/1 (69-73), ISSN: 0012-2823. Endoluminal instillation of bisacodyl in patients with severe (slow transit type) constipation is useful to test residual colonic propulsive activity. Bassotti-G, and al; Digestion {DIGESTION}, 1999, Vol/Iss/Pg. 60/1 (69-73), ISSN: 0012-2823.

Active substance: BISACODYL

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Document reference: 22726

Study title: Evaluation of the Safety of a Topical baby Care Product Using an Investigator-Blinded Study Design Following Four Weeks of Use in a Panel of Normal Healthy Babies and Babies with Mild Diaper Rash (2000).Evaluation of the Safety of a Topical baby Care Product Using an Investigator-Blinded Study Design Following Four Weeks of Use in a Panel of Normal Healthy Babies and Babies with Mild Diaper Rash (2000).

Active substance: CAMPHOR AND DIPHENHYDRAMINE AND ZINC

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Document reference: 23184

Study title: Cabergoline in the Treatment of Macroprolactinoma

Active substance: CABERGOLINE

Study summary document link (including results): 95CAPL041 EMA Pediatrics Web Synopsis.pdf

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Document reference: 48060

Study title: Randomized Controlled Comparison of PREVEsNAR booster Dose Administration at 15 or 18 Months of Age.

Active substance: Pneumococcal saccharide conjugated vaccine, absorbed

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Document reference: 41598

Study title:

Active substance: PODOPHYLLOTOXIN

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Document reference: 34546

Study title: An open, comparative study of the efficacy of 0.5% podophyllotoxin lotion (self-application) and 25% podophyllin solution (hospital based application) in the treatment of Condylomata acuminata in males and females.

Active substance: PODOPHYLLOTOXIN

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Document reference: 34545

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Podophyllum compositum (drops) [AWB-AT]

Active substance: Podophyllum compositum

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Document reference: 39768

Study title: A double-blind randomized, uninational, multicenter, two parallel groups, active controlled study to compare the effects of the treatment with Transipeg 2,95 g or Forlax Junior 4 g in children with constipation

Active substance: POLIDOCANOL

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Document reference: 46073

Study title: A long term post sclerotherapy follow up of EHPVO children with upper gastrointestinal haemorrhage. Patrawala, V.;Bombay Hosp.J. (2001) vol.43 p.1-4A long term post sclerotherapy follow up of EHPVO children with upper gastrointestinal haemorrhage. Patrawala, V.;Bombay Hosp.J. (2001) vol.43 p.1-4

Active substance: POLIDOCANOL

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Document reference: 46070

Study title: Current therapeutic strategy in bleeding esophageal varices in babies and children and long-term results of endoscopic paravariceal sclerotherapy over twenty years. Paquet,K.J.;Eur. J. Pediatr.Surg.(1994) vol.4 p.165-172 Current therapeutic strategy in bleeding esophageal varices in babies and children and long-term results of endoscopic paravariceal sclerotherapy over twenty years. Paquet,K.J.;Eur. J. Pediatr.Surg.(1994) vol.4 p.165-172

Active substance: POLIDOCANOL

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Document reference: 46068

Study title: Gallet JP, Dicetel capsules, report of the clinical expert evaluation (in children), report no 20, May 7, 1975.

Active substance: PINAVERIUM

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Document reference: 34139

Study title: A Single- and Multiple-Dose Pharmacokinetic and Safety Study of 15 mg, 30 mg, and 45 mg ACTOS® (Pioglitazone HCl) Administered Orally to Adolescents With Type 2 (Non-Insulin-Dependent) Diabetes Mellitus

Active substance: pioglitazone

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Document reference: 47468

Study title: "Etude clinique chez l'enfant d'un nouveau neuroleptique, la pipotiazine (Piportil) - De Villard et Maillet - 1974 (J. Med. Lyon, 55, 949-952) - Publication mentioned in the summary report -" Doc. 102843"Etude clinique chez l'enfant d'un nouveau neuroleptique, la pipotiazine (Piportil) - De Villard et Maillet - 1974 (J. Med. Lyon, 55, 949-952) - Publication mentioned in the summary report -" Doc. 102843

Active substance: PIPOTIAZINE

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Document reference: 34140

Study title: "Interet de l'utilisation de la pipotiazine chez les sujets ages de 8 a 24 ans. Bilan de 18 mois d'experimentation - Campanie et al. - 1974 (Psychol. Med., 6, 8, 1603-1611) - Publication mentioned in the summary report -" Doc. 102843 "Interet de l'utilisation de la pipotiazine chez les sujets ages de 8 a 24 ans. Bilan de 18 mois d'experimentation - Campanie et al. - 1974 (Psychol. Med., 6, 8, 1603-1611) - Publication mentioned in the summary report -" Doc. 102843

Active substance: PIPOTIAZINE

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Document reference: 34141

Study title: A 36-week, double blind, parallel group, multicenter study to compare the efficacy and safety of piracetam with placebo in children with developmental reading disorder (dyslexia).

Active substance: PIRACETAM

Study summary document link (including results): RRCE92E1404 - Piracetam.pdf

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Document reference: 45915

Study title: A clinical investigation of piracetam in children.

Active substance: PIRACETAM

Study summary document link (including results): DE73J051 - Piracetam.pdf

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Document reference: 46026

Study title: Craft A et al Ifosfamide-containing chemotherapy in Ewing's sarcoma: The Second United Kingdom Children's Cancer Study Group and the Medical Research Council Ewing's Tumor Study J Clin Oncol. 1998 Nov;16(11):3628-33Craft A et al Ifosfamide-containing chemotherapy in Ewing's sarcoma: The Second United Kingdom Children's Cancer Study Group and the Medical Research Council Ewing's Tumor Study J Clin Oncol. 1998 Nov;16(11):3628-33

Active substance: MITOXANTRONE

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Document reference: 32101

Study title: Crist W et al. The Third Intergroup Rhabdomyosarcoma Study. J Clin Oncol. 1995 Mar;13(3):610-30Crist W et al. The Third Intergroup Rhabdomyosarcoma Study. J Clin Oncol. 1995 Mar;13(3):610-30

Active substance: MITOXANTRONE

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Document reference: 32187

Study title: Crist WM et a lIntergroup rhabdomyosarcoma study-IV: results for patients with nonmetastaticDiseaseJ Clin Oncol. 2001 Jun 15;19(12):3091-102Crist WM et a lIntergroup rhabdomyosarcoma study-IV: results for patients with nonmetastaticDiseaseJ Clin Oncol. 2001 Jun 15;19(12):3091-102

Active substance: MITOXANTRONE

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Document reference: 32143

Study title: Culbert SJ Remission induction and continuation therapy in children with their first relapse of acute lymphoid leukemia. A Pediatric Oncology Group study.Cancer. 1991 Jan 1;67(1):37-42.Culbert SJ Remission induction and continuation therapy in children with their first relapse of acute lymphoid leukemia. A Pediatric Oncology Group study.Cancer. 1991 Jan 1;67(1):37-42.

Active substance: MITOXANTRONE

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Document reference: 32228

Study title: D'Angio GJ et al. Treatment of Wilms' tumor. Results of the Third National Wilms' Tumor Study. Cancer. 1989 Jul 15;64(2):349-60D'Angio GJ et al. Treatment of Wilms' tumor. Results of the Third National Wilms' Tumor Study. Cancer. 1989 Jul 15;64(2):349-60

Active substance: MITOXANTRONE

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Document reference: 32255

Study title: de Andrea ML et al. A new treatment protocol for childhood non-Hodgkin's lymphoma: preliminaryevaluation. J Clin Oncol. 1990 Apr;8(4):666-71de Andrea ML et al. A new treatment protocol for childhood non-Hodgkin's lymphoma: preliminaryevaluation. J Clin Oncol. 1990 Apr;8(4):666-71

Active substance: MITOXANTRONE

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Document reference: 32229

Study title: Donaldson SS et al. A multidisciplinary study investigating radiotherapy in Ewing's sarcoma: end results of POG #8346. Pediatric Oncology Group. Int J Radiat Oncol Biol Phys. 1998 Aug 1;42(1):125-35.Donaldson SS et al. A multidisciplinary study investigating radiotherapy in Ewing's sarcoma: end results of POG #8346. Pediatric Oncology Group. Int J Radiat Oncol Biol Phys. 1998 Aug 1;42(1):125-35.

Active substance: MITOXANTRONE

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Document reference: 32183

Study title: Dunst J et al. Radiation therapy in Ewing's sarcoma: an update of the CESS 86 trial. Int J Radiat Oncol Biol Phys. 1995 Jul 15;32(4):919-30.Dunst J et al. Radiation therapy in Ewing's sarcoma: an update of the CESS 86 trial. Int J Radiat Oncol Biol Phys. 1995 Jul 15;32(4):919-30.

Active substance: MITOXANTRONE

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Document reference: 32186

Study title: Dusenbery KE et al. Autologous bone marrow transplantation in acute myeloid leukemia: the University of Minnesota experience. Int J Radiat Oncol Biol Phys. 1996 Sep 1;36(2):335-43.Dusenbery KE et al. Autologous bone marrow transplantation in acute myeloid leukemia: the University of Minnesota experience. Int J Radiat Oncol Biol Phys. 1996 Sep 1;36(2):335-43.

Active substance: MITOXANTRONE

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Document reference: 32194

Study title: Use of Mivacron (mivacurium chloride) in Paediatric Patients

Active substance: MIVACURIUM

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Document reference: 32257

Study title: Use of Mivacron (mivacurium chloride) in Paediatric Patients

Active substance: MIVACURIUM

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Document reference: 32258

Study title: A double-blind, placebo controlled, randomized, cross over study of the efficacy and safety of mizolastine 10mg in patients suffreing from primary acquired cold uticaria (URICOLD study). Dubertret L. Murrietta Aguguttes M. Ben-Soussen P. Magnier G. Pelenc M.-N. Pellegri-Guegnault B., Tudor D. 13/02/1997.

Active substance: MIZOLASTINE

Study summary document link (including results): Mizolastine-Study 1.pdf

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Document reference: 32259

Study title: Fusi−G et al. A double blind clinical trial of the effectiveness and safety of an association of paracetamol−sobrerol vs paracetamol in pediatrics. {G−ITAL−RIC− CLIN−TER}, 1991, Vol/Iss/Pg. 12/1 (17−23)

Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL

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Document reference: 23987

Study title: A multicenter study of pharmacokinetics of oral fexofenadine hydrochloride administered as granulation powder in applesauce in children from 6 months to 2 years of age (MO164559/1123)

Active substance: FEXOFENADINE

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Document reference: 27266

Study title: AN OPEN COMPARATIVE STUDY TO COMPARE THE EFFICACY, TOLERATION AND SAFETY OF IV AND ORAL FLUCONAZOLE WITH ORAL KETOCONAZOLE IN THE PROPHYLAXIS OF FUNGAL COLONIZATION AND INFECTION IN PATIENTS WITH ALLOGENEIC BONE MARROW TRANSPLANT.

Active substance: FLUCONAZOLE

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Document reference: 27361

Study title: COMPASSIONATE USE PROTOCOL FOR THE TREATMENT OF A THREE-YEAR OLD CHILD WITH SCEDOSPORIUM INFECTION

Active substance: FLUCONAZOLE

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Document reference: 27341

Study title: TO COMPARE THE EFFICACY OF FLUCONAZOLE VS. ORAL KETOCONAZOLE IN THE PREVENTION OF FUNGAL INFECTION IN PATIENTS RECEIVING CHEMOTHERAPY FOR HEMATOLOGICAL DISEASE.

Active substance: FLUCONAZOLE

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Document reference: 28028

Study title: AN OPEN NONCOMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF ORAL FCA IN THE PREVENTION OF SYSTEMIC FUNGAL INFECTIONS IN PATIENTS RECEIVING CHEMOTHERAPY FOR HAEMOTOLOGICAL DISEASE

Active substance: FLUCONAZOLE

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Document reference: 27847

Study title: EFFICACY, SAFETY AND PRACTICABILITY OF FLUCONAZOLE VS. LOCAL CLOTRIMAZOLE THERAPY IN PATIENTS WITH VAGINAL CANDIDIASIS.

Active substance: FLUCONAZOLE

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Document reference: 27788

Study title: Comparison of oral transmucosal fentanyl citrate and intramuscular meperidine, promethazine, and chlorpromazine for conscious sedation of children undergoing laceration repair; Annals of Emergency Medicine 1996, 28(4): 385-90

Active substance: FENTANYL

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Document reference: 27140

Study title: Hiddemann W et al. Antifungal treatment by amphotericin B and 5-fluorocytosine delays the recovery of normal hematopoietic cells after intensive cytostatic therapy for acute myeloid leukemia. Cancer. 1991 Jul 1;68(1):9-14

Active substance: FLUCOCYTOSIN

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Document reference: 27303

Study title: CLINICAL USEFULNESS OF DIFLUCAN FOR SYSTEMIC MYCOSES ASSOCIATED WITH DIGESTIVE MALIGNANCY

Active substance: FLUCONAZOLE

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Document reference: 27925

Study title: A phase II, open-label, randomized, single-center, comparative study evaluating safety, tolerability and immunogenicity of three vaccinations of the DTPHib combined vaccine (Chiron Vaccines; now Novartis Vaccines) in comparison to separate vaccinations of DTP (Chiron Behring; now Novartis Vaccines) and Hib/AlPO4 (Chiron Vaccines; now Novartis Vaccines) vaccines, when administered to 2, 3, 4 months old healthy infants.

Active substance: Adorbed, inactivated diphteria, tetanus, acellular pertussis and poliomyelitis vaccine

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Document reference: 48393

Study title: A phase II, open-label, single-centre, singal-arm, extension study to evaluate the safety and immunogenicity of a booster vaccination of the DTPHib combined vaccine (Chiron Vaccines; now Novartis Vaccines) administered to 18-20 months old healthy infants who had previously received either DTPHib combined vaccine or separate administrations of DTP (Chiron Behring; now Novartis Vaccines) and Hib/AlPO4 (Chiron Vaccines; now Novartis Vaccines) vaccines at 2, 3 and 4 months of age.

Active substance: Adorbed, inactivated diphteria, tetanus, acellular pertussis and poliomyelitis vaccine

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Document reference: 48394

Study title: EFFICACY AND TOLERATION OF FELDENE GEL IN ACUTE MUSCULOSKELETAL DISORDERS.

Active substance: PIROXICAM

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Document reference: 34334

Study title: EFFICACY AND TOLERATION OF IM PIROXICAM IN PATIENTS SUFFERING FROM SPORTS RELATED INJURIES.

Active substance: PIROXICAM

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Document reference: 34472

Study title: EFFICACY AND TOLERATION OF ORAL PIROXICAM IN PATIENTS SUFFERING FROM NON ARTICULAR RHEUMATISM.

Active substance: PIROXICAM

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Document reference: 34375

Study title: EFFICACY AND TOLERATION OF PIROXICAM AND NAPROXEN SODIUM IN TREATMENT OF PRIMARY DYSMENORRHEA.

Active substance: PIROXICAM

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Document reference: 34353

Study title: EFFICACY AND TOLERATION OF PIROXICAM DISPERSABLE TABLETS IN CHRONIC RHEUMATIC DISEASES.

Active substance: PIROXICAM

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Document reference: 34358

Study title: Nesbit ME et al. Chemotherapy for induction of remission of childhood acute myeloid leukemia followed by marrow transplantation or multiagent chemotherapy: a report from the Childrens Cancer Group. J Clin Oncol. 1994 Jan;12(1):127-35Nesbit ME et al. Chemotherapy for induction of remission of childhood acute myeloid leukemia followed by marrow transplantation or multiagent chemotherapy: a report from the Childrens Cancer Group. J Clin Oncol. 1994 Jan;12(1):127-35

Active substance: MITOXANTRONE

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Document reference: 32197

Study title: Neudorf S et al. Allogeneic bone marrow transplantation for children with acute myelocytic leukemia in first remission demonstrates a role for graft versus leukemia in the maintenance of disease-free survival. Blood. 2004 May 15;103(10):3655-61. Epub 2004 Jan 29Neudorf S et al. Allogeneic bone marrow transplantation for children with acute myelocytic leukemia in first remission demonstrates a role for graft versus leukemia in the maintenance of disease-free survival. Blood. 2004 May 15;103(10):3655-61. Epub 2004 Jan 29

Active substance: MITOXANTRONE

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Document reference: 32193

Study title: Obata H et al Clinical outcome of patients with Ewing sarcoma family of tumors of bone in Japan: the Japanese Musculoskeletal Oncology Group cooperative study Cancer. 2007 Feb 15;109(4):767-75Obata H et al Clinical outcome of patients with Ewing sarcoma family of tumors of bone in Japan: the Japanese Musculoskeletal Oncology Group cooperative study Cancer. 2007 Feb 15;109(4):767-75

Active substance: MITOXANTRONE

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Document reference: 32092

Study title: Oberlin O et al No benefit of ifosfamide in Ewing's sarcoma: a nonrandomized study of the French Society of Pediatric Oncology J Clin Oncol. 1992 Sep;10(9):1407-12Oberlin O et al No benefit of ifosfamide in Ewing's sarcoma: a nonrandomized study of the French Society of Pediatric Oncology J Clin Oncol. 1992 Sep;10(9):1407-12

Active substance: MITOXANTRONE

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Document reference: 32105

Study title: A clinical trial of pyrrolidine acetamide (piracetam) "Nootrobil" alone and combined with other drugs in the treatment of enuresis nocturna.

Active substance: PIRACETAM

Study summary document link (including results): SRCE92J2801 - Piracetam.pdf

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Document reference: 45896

Study title: A double-blind, parallel group, study to compare the efficacy and safety of piracetam with placebo in children with specific learning disabilities.

Active substance: PIRACETAM

Study summary document link (including results): RAE91A102 - Piracetam.pdf

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Document reference: 45902

Study title: A non-blind, uncontrolled pilot study of the effects of piracetam on the pattern of hemolysis and sickle cell crisis in patients with sickle cell anemia.

Active substance: PIRACETAM

Study summary document link (including results): ARCE00G0418 - Piracetam.pdf

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Document reference: 45910

Study title: A preliminary report on piracetam in sickle cell anemia: a double blind cross over clinical trial and effect on erythrocyte survival.

Active substance: PIRACETAM

Study summary document link (including results): DE84B023P - Piracetam.pdf

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Document reference: 45978

Study title: A randomised, cross-over, double blind, placebo controlled clinical study to evaluate the effficacy of piracetam 400 mg/kg/day as add-on therpay in the treatment of cortical myoclonus of angelman syndrome.

Active substance: PIRACETAM

Study summary document link (including results): RRCE01G1902 -Piracetam.pdf

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Document reference: 45899

Study title: A trial of piracetam in two subgroups of students with dyslexia enrolled in summer tutoring.

Active substance: PIRACETAM

Study summary document link (including results): SDPE91L1801 - Piracetam.pdf

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Document reference: 45916

Study title: A trial of UCB 6215 (piracetam) in infantile neuro-psychiatry.

Active substance: PIRACETAM

Study summary document link (including results): DE73L152 - Piracetam.pdf

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Document reference: 45965

Study title: Arndt CA et al Comparison of results of a pilot study of alternating vincristine/doxorubicin/cyclophosphamide and etoposide/ifosfamide with IRS-IV in intermediate risk rhabdomyosarcoma: a report from the Children's Oncology Group Pediatr Blood Cancer. 2008 Jan;50(1):33-6Arndt CA et al Comparison of results of a pilot study of alternating vincristine/doxorubicin/cyclophosphamide and etoposide/ifosfamide with IRS-IV in intermediate risk rhabdomyosarcoma: a report from the Children's Oncology Group Pediatr Blood Cancer. 2008 Jan;50(1):33-6

Active substance: MITOXANTRONE

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Document reference: 32153

Study title: Bacci G et al Long-term outcome for patients with nonmetastatic osteosarcoma of the extremity treated at the istituto ortopedico rizzoli according to the istituto ortopedico rizzoli/osteosarcoma-2 protocol: an updated report J Clin Oncol. 2000 Dec 15;18(24):4016-27Bacci G et al Long-term outcome for patients with nonmetastatic osteosarcoma of the extremity treated at the istituto ortopedico rizzoli according to the istituto ortopedico rizzoli/osteosarcoma-2 protocol: an updated report J Clin Oncol. 2000 Dec 15;18(24):4016-27

Active substance: MITOXANTRONE

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Document reference: 32126

Study title: Bacci G et al Neoadjuvant chemotherapy for Ewing's sarcoma of bone: no benefit observed afteradding ifosfamide and etoposide to vincristine, actinomycin, cyclophosphamide,and doxorubicin in the maintenance phase--results of two sequential studies Cancer. 1998 Mar 15;82(6):1174-83Bacci G et al Neoadjuvant chemotherapy for Ewing's sarcoma of bone: no benefit observed afteradding ifosfamide and etoposide to vincristine, actinomycin, cyclophosphamide,and doxorubicin in the maintenance phase--results of two sequential studies Cancer. 1998 Mar 15;82(6):1174-83

Active substance: MITOXANTRONE

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Document reference: 32102

Study title: Taylor RE et al. Outcome for patients with metastatic (M2-3) medulloblastoma treated withSIOP/UKCCSG PNET-3 chemotherapy Eur J Cancer. 2005 Mar;41(5):727-34. Epub 2005 Jan 18Taylor RE et al. Outcome for patients with metastatic (M2-3) medulloblastoma treated withSIOP/UKCCSG PNET-3 chemotherapy Eur J Cancer. 2005 Mar;41(5):727-34. Epub 2005 Jan 18

Active substance: MITOXANTRONE

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Document reference: 32235

Study title: Taylor RE et al. Results of a randomized study of preradiation chemotherapy versus radiotherapy alone for nonmetastatic medulloblastoma: The International Society of Paediatric Oncology/United Kingdom Children's Cancer Study Group PNET-3 Study. J Clin Oncol. 2003 Apr 15;21(8):1581-91Taylor RE et al. Results of a randomized study of preradiation chemotherapy versus radiotherapy alone for nonmetastatic medulloblastoma: The International Society of Paediatric Oncology/United Kingdom Children's Cancer Study Group PNET-3 Study. J Clin Oncol. 2003 Apr 15;21(8):1581-91

Active substance: MITOXANTRONE

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Document reference: 32237

Study title: Tubergen DG et al. Comparison of treatment regimens for pediatric lymphoblastic non-Hodgkin's lymphoma: a Childrens Cancer Group study. J Clin Oncol. 1995 Jun;13(6):1368-76Tubergen DG et al. Comparison of treatment regimens for pediatric lymphoblastic non-Hodgkin's lymphoma: a Childrens Cancer Group study. J Clin Oncol. 1995 Jun;13(6):1368-76

Active substance: MITOXANTRONE

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Document reference: 32215

Study title: Uchida A et al Neoadjuvant chemotherapy for pediatric osteosarcoma patients Cancer. 1997 Jan 15;79(2):411-5Uchida A et al Neoadjuvant chemotherapy for pediatric osteosarcoma patients Cancer. 1997 Jan 15;79(2):411-5

Active substance: MITOXANTRONE

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Document reference: 32129

Study title: Determination of efficacity and compatibility of the new prednicarbate product, prednicarbate solution, for dermatoses in children and adolescents - G. Herz - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - Determination of efficacity and compatibility of the new prednicarbate product, prednicarbate solution, for dermatoses in children and adolescents - G. Herz - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -

Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD

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Document reference: 34564

Study title: Eczematous disorders and corticoid-sensitive dermatoses - Treatment with prednicarbate 0,25% solution- S. Nolting et al. - 1994 (Z Allg Med vol 70) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - Eczematous disorders and corticoid-sensitive dermatoses - Treatment with prednicarbate 0,25% solution- S. Nolting et al. - 1994 (Z Allg Med vol 70) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -

Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD

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Document reference: 34565

Study title: Multicentre study (HOE777 5D-402DT) Evaluation of efficacity and tolerance of prednicarbate 0,25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses - No author -1991 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - Multicentre study (HOE777 5D-402DT) Evaluation of efficacity and tolerance of prednicarbate 0,25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses - No author -1991 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -

Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD

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Document reference: 34573

Study title: OPEN, NON-COMPARATIVE STUDY OF FLUCONAZOLE IN PATIENTS WITH COCCIDIOIDAL MENINGITIS

Active substance: FLUCONAZOLE

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Document reference: 28052

Study title: Legeler HJ. Bericht über die klinische Prüfung von 9alpha-Fluorhydrocortison zur Behandlung hypotoner und orthostatischer Kreislaufregulationsstörungen Arzneim Forsch (Drug Research) 1971; 21: 1144-1149

Active substance: FLUDOCORTISONE

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Document reference: 28210

Study title: Antibiotics in Acute Osteomyelitis in Children;Blockey N J, McAllister T A J Bone Jt Surg Ser B 1972; 54(2): 299-309

Active substance: FUSIDIC ACID

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Document reference: 28707

Study title:

Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT)

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Document reference: 41160

Study title: A double-blind, single dose parallel study to compare analgesic efficacy and side effects profile of acetaminophen 1000 mg, ibuprofen 400 mg, ibuprofen 200 mg, and placebo in the treatment of muscle contraction ('tension') headache

Active substance: IBUPROFEN

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Document reference: 29478

Study title: AN OPEN-LABEL EXTENSION STUDY OF GABAPENTIN IN CHILDREN WITH EPILEPSY WHO HAVE PARTICIPATED IN THE DOUBLE-BLIND STUDY 945-186

Active substance: GABAPENTIN

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Document reference: 28763

Study title: Mylonas I, Friese K. Fetal cytomegalovirus infection: From research to clinical application. Geburtshilfe und Frauenheilkunde. 2005; 65(5):465-473.Mylonas I, Friese K. Fetal cytomegalovirus infection: From research to clinical application. Geburtshilfe und Frauenheilkunde. 2005; 65(5):465-473.

Active substance: FOSCARNET

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Document reference: 39593

Study title: Eur J Nucl Med Mol Imaging. 2005 Jun;32(6):674-81. Epub 2005 Mar 4. The value of [18F]FDG-PET in the diagnosis of large-vessel vasculitis and the assessment of activity and extent of disease. Walter MA, Melzer RA, Schindler C, Müller-Brand J, Tyndall A, Nitzsche EU.

Active substance: FLUDEOXYGLUCOSE

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Document reference: 28108

Study title: Use of gentamicin in chlildren with cystic fibrosis 6 Boxerbaum B. - 1971 (J. of Infectious Dis. Supl. 124:293) - Publication in Gentamicin Registration Dossier - 1978 -

Active substance: GENTAMYCIN

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Document reference: 28948

Study title: The dry, nonproductive cough in children.

Active substance: HYDROXYZINE

Study summary document link (including results): ADPE91C2858.pdf

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Document reference: 29286

Study title: L'impiego di un mucolitico orale (Lisomucil) nel trattamento delle otiti sieromucose - Spigno G, Teatini G - 1977 - Nuovo Archivio italiano di Otologia, Rinologia e Laringologia - vol V - n. 1

Active substance: CARBOCYSTEINE

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Document reference: 23260

Study title: A multicenter comparative trial of cefprozil (500 mg QD) versus cefaclor (250 mg TID) in the treatment of mild to moderate skin and skin structure infections in pediatric patients (final report on study AI414-075).

Active substance: CEFPROZIL

Study summary document link (including results): Protocol ai414-075 All centers Cefprozil.pdf

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Document reference: 23570

Study title: Santana VM et al, MACOP-B treatment in children and adolescents with advanced diffuse large-cell non-Hodgkin's lymphoma, Leukemia. 1993 Feb;7(2):187-91Santana VM et al, MACOP-B treatment in children and adolescents with advanced diffuse large-cell non-Hodgkin's lymphoma, Leukemia. 1993 Feb;7(2):187-91

Active substance: BLEOMYCIN

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Document reference: 22797

Study title: Effect of long-term treatment with the h 1 -receptor antagonist cetirizine in the prevention of urticaria in children with atopic dermatitis

Active substance: CETIRIZINE

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Document reference: 23697

Study title: Olivieri A et al. Upfront high-dose sequential therapy (HDS) versus VACOP-B with or without HDS in aggressive non-Hodgkin's lymphoma: long-term results by the NHLCSG. Ann Oncol. 2005 Dec;16(12):1941-8. Epub 2005 Sep 12Olivieri A et al. Upfront high-dose sequential therapy (HDS) versus VACOP-B with or without HDS in aggressive non-Hodgkin's lymphoma: long-term results by the NHLCSG. Ann Oncol. 2005 Dec;16(12):1941-8. Epub 2005 Sep 12

Active substance: MITOXANTRONE

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Document reference: 32201

Study title: Orbach D et al Soft tissue sarcoma or malignant mesenchymal tumors in the first year of life: experience of the International Society of Pediatric Oncology (SIOP) Malignant Mesenchymal Tumor Committee J Clin Oncol. 2005 Jul 1;23(19):4363-71Orbach D et al Soft tissue sarcoma or malignant mesenchymal tumors in the first year of life: experience of the International Society of Pediatric Oncology (SIOP) Malignant Mesenchymal Tumor Committee J Clin Oncol. 2005 Jul 1;23(19):4363-71

Active substance: MITOXANTRONE

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Document reference: 32166

Study title: Otten J et al Treatment of rhabdomyosarcoma and other malignant mesenchymal tumours ofchildhood with ifosfamide + vincristine + dactinomycin (IVA) as front-line therapy (a SIOP study) Cancer Chemother Pharmacol. 1989;24 Suppl 1:S30. No abstract availableOtten J et al Treatment of rhabdomyosarcoma and other malignant mesenchymal tumours ofchildhood with ifosfamide + vincristine + dactinomycin (IVA) as front-line therapy (a SIOP study) Cancer Chemother Pharmacol. 1989;24 Suppl 1:S30. No abstract available

Active substance: MITOXANTRONE

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Document reference: 32152

Study title: Mecillinam in the treatment of neonatesMecillinam in the treatment of neonates

Active substance: PIVAMPICILLIN

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Document reference: 46055

Study title: Pivmecillinam cotrimoxazole and oral mecillinam in gastro enteritis due to vibrio sppPivmecillinam cotrimoxazole and oral mecillinam in gastro enteritis due to vibrio spp

Active substance: PIVAMPICILLIN

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Document reference: 46064

Study title: Pivmecillinam in the treatment of childhood pyelonephritisPivmecillinam in the treatment of childhood pyelonephritis

Active substance: PIVAMPICILLIN

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Document reference: 46058

Study title: Pivmecillinam in the treatment of recurrent urinary infection in girlsPivmecillinam in the treatment of recurrent urinary infection in girls

Active substance: PIVAMPICILLIN

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Document reference: 46060

Study title: Randomised trial of pivampicillin plus pivmecillinam vs pivampicillin in children and young adults with chronic obstructive pulmonary disease and infection with Haemophilus influenzaeRandomised trial of pivampicillin plus pivmecillinam vs pivampicillin in children and young adults with chronic obstructive pulmonary disease and infection with Haemophilus influenzae

Active substance: PIVAMPICILLIN

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Document reference: 46067

Study title: Randomized trial of cefamandole plus amdinocillin versus cefamandole in serious pediatric infectionsRandomized trial of cefamandole plus amdinocillin versus cefamandole in serious pediatric infections

Active substance: PIVAMPICILLIN

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Document reference: 46066

Study title: Randomized, double blinded comparison of ciprofloxacin brasionc and pivamdinocillin tablets in the treatment of shigellosis in childrenRandomized, double blinded comparison of ciprofloxacin brasionc and pivamdinocillin tablets in the treatment of shigellosis in children

Active substance: PIVAMPICILLIN

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Document reference: 46065

Study title: Bacci G et al Neoadjuvant chemotherapy for osteosarcoma of the extremities with metastases atpresentation: recent experience at the Rizzoli Institute in 57 patients treated with cisplatin, doxorubicin, and a high dose of methotrexate and ifosfamide Ann Oncol. 2003 Jul;14(7):1126-34Bacci G et al Neoadjuvant chemotherapy for osteosarcoma of the extremities with metastases atpresentation: recent experience at the Rizzoli Institute in 57 patients treated with cisplatin, doxorubicin, and a high dose of methotrexate and ifosfamide Ann Oncol. 2003 Jul;14(7):1126-34

Active substance: MITOXANTRONE

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Document reference: 32123

Study title: Bacci G et al Neoadjuvant chemotherapy for osteosarcoma of the extremities with synchronous lung metastases: treatment with cisplatin, adriamycin and high dose of methotrexate and ifosfamide Oncol Rep. 2000 Mar-Apr;7(2):339-46Bacci G et al Neoadjuvant chemotherapy for osteosarcoma of the extremities with synchronous lung metastases: treatment with cisplatin, adriamycin and high dose of methotrexate and ifosfamide Oncol Rep. 2000 Mar-Apr;7(2):339-46

Active substance: MITOXANTRONE

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Document reference: 32127

Study title: Bacci G et al Neoadjuvant chemotherapy for radioinduced osteosarcoma of the extremity: The Rizzoli experience in 20 cases Int J Radiat Oncol Biol Phys. 2007 Feb 1;67(2):505-11. Epub 2006 Nov 21Bacci G et al Neoadjuvant chemotherapy for radioinduced osteosarcoma of the extremity: The Rizzoli experience in 20 cases Int J Radiat Oncol Biol Phys. 2007 Feb 1;67(2):505-11. Epub 2006 Nov 21

Active substance: MITOXANTRONE

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Document reference: 32119

Study title: Bacci G et al Neoadjuvant treatment of Ewing's sarcoma: results obtained in 122 patientstreated with a 6-drug chemotherapeutic protocol (vincristine, adriamycin,cyclophosphamide, dactinomycin, ifosfamide and etoposide) Minerva Pediatr. 1995 Nov;47(11):457-69. ItalianBacci G et al Neoadjuvant treatment of Ewing's sarcoma: results obtained in 122 patientstreated with a 6-drug chemotherapeutic protocol (vincristine, adriamycin,cyclophosphamide, dactinomycin, ifosfamide and etoposide) Minerva Pediatr. 1995 Nov;47(11):457-69. Italian

Active substance: MITOXANTRONE

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Document reference: 32103

Study title: Bacigalupo A et al.Increased risk of leukemia relapse with high-dose cyclosporine A after allogeneic marrow transplantation for acute leukemia. Blood. 1991 Apr 1;77(7):1423-8Bacigalupo A et al.Increased risk of leukemia relapse with high-dose cyclosporine A after allogeneic marrow transplantation for acute leukemia. Blood. 1991 Apr 1;77(7):1423-8

Active substance: MITOXANTRONE

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Document reference: 32198

Study title: Shamberger RC et al. Ewing sarcoma of the rib: results of an intergroup study with analysis of outcome by timing of resection. J Thorac Cardiovasc Surg. 2000 Jun;119(6):1154-61Shamberger RC et al. Ewing sarcoma of the rib: results of an intergroup study with analysis of outcome by timing of resection. J Thorac Cardiovasc Surg. 2000 Jun;119(6):1154-61

Active substance: MITOXANTRONE

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Document reference: 32180

Study title: Simon T et al. Topotecan, cyclophosphamide, and etoposide (TCE) in the treatment of high-risk neuroblastoma. Results of a phase-II trial. J Cancer Res Clin Oncol. 2007 Sep;133(9):653-61. Epub 2007 May 4.Simon T et al. Topotecan, cyclophosphamide, and etoposide (TCE) in the treatment of high-risk neuroblastoma. Results of a phase-II trial. J Cancer Res Clin Oncol. 2007 Sep;133(9):653-61. Epub 2007 May 4.

Active substance: MITOXANTRONE

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Document reference: 32230

Study title: Smeland S et al Scandinavian Sarcoma Group Osteosarcoma Study SSG VIII: prognostic factors foroutcome and the role of replacement salvage chemotherapy for poor histological responders Eur J Cancer. 2003 Mar;39(4):488-94Smeland S et al Scandinavian Sarcoma Group Osteosarcoma Study SSG VIII: prognostic factors foroutcome and the role of replacement salvage chemotherapy for poor histological responders Eur J Cancer. 2003 Mar;39(4):488-94

Active substance: MITOXANTRONE

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Document reference: 32124

Study title: Sokolov T et al Treatment of Ewing's sarcoma with 2 different protocols Ann Med Interne (Paris). 2001 Dec;152(8):497-501. FrenchSokolov T et al Treatment of Ewing's sarcoma with 2 different protocols Ann Med Interne (Paris). 2001 Dec;152(8):497-501. French

Active substance: MITOXANTRONE

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Document reference: 32095

Study title: Verdonck LF et al.Intensified 12-week CHOP (I-CHOP) plus G-CSF compared with standard 24-week CHOP (CHOP-21) for patients with intermediate-risk aggressive non-Hodgkin lymphoma: a phase 3 trial of the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON). Blood. 2007 Apr 1;109(7):2759-66.Verdonck LF et al.Intensified 12-week CHOP (I-CHOP) plus G-CSF compared with standard 24-week CHOP (CHOP-21) for patients with intermediate-risk aggressive non-Hodgkin lymphoma: a phase 3 trial of the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON). Blood. 2007 Apr 1;109(7):2759-66.

Active substance: MITOXANTRONE

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Document reference: 32203

Study title: Voûte PA et al A phase II study of cisplatin, ifosfamide and doxorubicin in operable primary, axial skeletal and metastatic osteosarcoma. European Osteosarcoma Intergroup (EOI)Ann Oncol. 1999 Oct;10(10):1211-8Voûte PA et al A phase II study of cisplatin, ifosfamide and doxorubicin in operable primary, axial skeletal and metastatic osteosarcoma. European Osteosarcoma Intergroup (EOI)Ann Oncol. 1999 Oct;10(10):1211-8

Active substance: MITOXANTRONE

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Document reference: 32135

Study title: Walter AW et al A pilot study of vincristine, ifosfamide, and doxorubicin in the treatment of pediatric non-rhabdomyosarcoma soft tissue sarcomas Med Pediatr Oncol. 1998 Apr;30(4):210-6Walter AW et al A pilot study of vincristine, ifosfamide, and doxorubicin in the treatment of pediatric non-rhabdomyosarcoma soft tissue sarcomas Med Pediatr Oncol. 1998 Apr;30(4):210-6

Active substance: MITOXANTRONE

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Document reference: 32155

Study title: Wang WQ et alClinical study on mitoxantrone contained regimen for treatment of newly diagnosed childhood acute lymphoblastic leukemiaZhong Nan Da Xue Xue Bao Yi Xue Ban. 2004 Oct;29(5):602-3 Chinese (No abstract available) .Wang WQ et alClinical study on mitoxantrone contained regimen for treatment of newly diagnosed childhood acute lymphoblastic leukemiaZhong Nan Da Xue Xue Bao Yi Xue Ban. 2004 Oct;29(5):602-3 Chinese (No abstract available) .

Active substance: MITOXANTRONE

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Document reference: 32073

Study title: Wells RJ et al Cytosine arabinoside and mitoxantrone treatment of relapsed or refractory childhood leukemia: initial response and relationship to multidrug resistance gene 1 Med Pediatr Oncol. 1994;22(4):244-9Wells RJ et al Cytosine arabinoside and mitoxantrone treatment of relapsed or refractory childhood leukemia: initial response and relationship to multidrug resistance gene 1 Med Pediatr Oncol. 1994;22(4):244-9

Active substance: MITOXANTRONE

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Document reference: 32076

Study title: Candy D et al Study title: A single centre study to assess the safety and efficacy of Movicol in the treatment of faecal impaction in children followed by a double-blind randomised phase to compare the safety and efficacy of Movicol and lactulose for maintenance therapy. J of Paediatric Gastro Enterol & Nutrition 2006;43: 65-70

Active substance: POLIDOCANOL COMBINATIONS

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Document reference: 34579

Study title: Guest JF, Candy D, Clegg JP et al – Clinical and economic impact of using macrogol 3350 plus electrolytes in an outpatient setting compared to enemas and suppositories and manual evacuation to treat paediatric faecal impaction based on actual clinical proactive in England and Wales. Curr Med Res Opin. 2007 Sep;23(9):2213-25

Active substance: POLIDOCANOL COMBINATIONS

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Document reference: 34580

Study title: JF Mougenot non blind controlled study on 32 patients aged from 3 to 13.5 years old in Feb 1995.

Active substance: POLIDOCANOL COMBINATIONS

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Document reference: 47214

Study title: lodixanol in paediatric gastrointestinal imaging: safety and efficacy comparison with iohexolWright NB 2002. The British Journal of Radiology, 75 (2002), 127- 135

Active substance: IODIXANOL

Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc

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Document reference: 48194

Study title: Pertl C, Odell E, Hofmann-Wellenhof R, Lorenzoni M, Eskici A: A differential therapy concept fort he treatment of recurrent stomatitis aphthosa. Stomatologie, Austria 94/4; 175-179, 1997 Pertl C, Odell E, Hofmann-Wellenhof R, Lorenzoni M, Eskici A: A differential therapy concept fort he treatment of recurrent stomatitis aphthosa. Stomatologie, Austria 94/4; 175-179, 1997

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35093

Study title: MULTICENTER STUDY. FELDENE DISPERSIBLE 20 MG IN THE TREATMENT OF CERVICAL ARTHROSIS.

Active substance: PIROXICAM

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Document reference: 34413

Study title: Pugh RNH. Single dose oral treatment in urinary schistosomiasis: a double blind trial. BMJ 1983; 286: 429-432. Pugh RNH. Single dose oral treatment in urinary schistosomiasis: a double blind trial. BMJ 1983; 286: 429-432.

Active substance: PRAZIQUANTEL

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Document reference: 34646

Study title: Schutte CH. Effectiveness of Praziquantel against the south African strains of Schistosoma haematobium and S. Mansoni. Sa Med J 1983; 64: 7-10.Schutte CH. Effectiveness of Praziquantel against the south African strains of Schistosoma haematobium and S. Mansoni. Sa Med J 1983; 64: 7-10.

Active substance: PRAZIQUANTEL

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Document reference: 34648

Study title: CROSSOVER COMPARATIVE PHARMACOKINETIC STUDY OF TWO 3MG PRAZOSIN SUSTAINED RELEASE DELIVERY SYSTEMS: SIXTEEN HOUR VS TWENTY HOUR 85% RELEASE TIMES

Active substance: PRAZOCIN

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Document reference: 46105

Study title: TO CONFIRM THE EFFICACY AND TOLERANCE OF TREATMENT WITH PRAZOSIN ASSOCIATED WITH CHLORTHALIDONE AND WITH FUROSEMIDE IN PATIENTS WITH ESSENTIAL HYPERTENSION.

Active substance: PRAZOCIN

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Document reference: 46110

Study title: TO DETERMINE WHETHER THE ADDITION OF ORALLY ADMINISTERED PRAZOSIN IMPROVES PULMONARY FUNCTION IN PATIENTS WITH CHRONIC ASTHMA.

Active substance: PRAZOCIN

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Document reference: 46111

Study title: TOLERATION OF PIROXICAM IN PATIENTS WITH PRIMARY DYSMENORRHOEA.

Active substance: PRAZOCIN

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Document reference: 46106

Study title: LONG TERM FOLLOW-UP EXPERIENCE IN A MINIZIDE TABLET (0.5MG PRAZOSIN/0.25MG POLYTHIAZIDE) MULTICENTER TRIAL

Active substance: PRAZOCIN /POLYTHIAZIDE

Study summary document link (including results): MZ-76-03 EMA Pediatrics Web Synopsis.pdf

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Document reference: 46107

Study title: Minizide (Brand of Prazosin/Polythiazide) Tablets (0.5 mg/0.25 mg) Clinical Experience in a Non-Comparative, Multicenter Trial

Active substance: PRAZOCIN /POLYTHIAZIDE

Study summary document link (including results): MZ-76-01 and MZ-76-02 EMA Pediatric Web Synopsis.pdf

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Document reference: 46108

Study title: Shawdon A, Kiss ZS, Fuller P. The bipartite tarsal navicular bone: radiographic and computed tomography findings. Australas Radiol. 1995 May;39(2):192-4. Shawdon A, Kiss ZS, Fuller P. The bipartite tarsal navicular bone: radiographic and computed tomography findings. Australas Radiol. 1995 May;39(2):192-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43601

Study title: Myoglobinuria with acute renal failure and hot kidneys seen on bone imaging. Sheth KJ, Sty JR, Johnson F, Tisdale P. Clin Nucl Med. 1984 Sep;9(9):498-501.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43985

Study title: Shewring DJ, Savage R, Thomas G. Experience of the early use of technetium 99 bone scintigraphy in wrist injury. J Hand Surg [Br]. 1994 Feb;19(1):114-7. Shewring DJ, Savage R, Thomas G. Experience of the early use of technetium 99 bone scintigraphy in wrist injury. J Hand Surg [Br]. 1994 Feb;19(1):114-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43634

Study title: Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44206

Study title: Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44253

Study title: Transient ischaemia of the proximal femoral epiphysis in the child. Interpretation of bone scintimetry for diagnosis in hip pain. Wingstrand H, Bauer GC, Brismar J, Carlin NO, Pettersson H, Sundén G. Acta Orthop Scand. 1985 Jun;56(3):197-203.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43942

Study title: Transient synovitis of the hip in the child. Wingstrand H. Acta Orthop Scand Suppl. 1986;219:1-61. No abstract available. PMID: 3518331 [PubMed - indexed for MEDLINE]

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43923

Study title: [SAPHO syndrome: case report of an 18-year-old man and review of the literature] German. Wolf G, Aigner RM, Schwarz T, Lorbach MP. Wien Klin Wochenschr. 2002 May 15;114(8-9):341-4. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43439

Study title: Wolff MH, Sty JR. Painful ankle. Os trigonum vs fracture. Clin Nucl Med. 1985 Mar;10(3):197. No abstract available. Wolff MH, Sty JR. Painful ankle. Os trigonum vs fracture. Clin Nucl Med. 1985 Mar;10(3):197. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43954

Study title: Use of Stereotactic PET Images in Dosimetry Planning of Radiosurgery for Brain Tumors: Clinical Experience and Proposed ClassificationTHE JOURNAL OF NUCLEAR MEDICINE, Vol. 45, No. 7, July 2004. Marc Levivier, MD, PhD1; Nicolas Massager, MD1; David Wikler, MS2; Jose´ Lorenzoni, MD1; Salvador Ruiz, MD1; Daniel Devriendt, MD3; Philippe David, MD4; Franc¸oise Desmedt, MS3; Ste´phane Simon, MS3; Paul Van Houtte, MD3; Jacques Brotchi, MD1; and Serge Goldman, MD2

Active substance: Steripet

Study summary document link (including results): levivier-2004.pdf

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Document reference: 48737

Study title: TO STUDY THE ANALGESIC EFFECT AND TOLERATION OF FELDENE ADMINISTERED BY INTRAMUSCULAR ROUTE AT THE BEGINNING OF TREATMENT IN PATIENTS SUFFERING FROM RHEUMATOLOGY.

Active substance: PIROXICAM

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Document reference: 34383

Study title: TO STUDY THE EFFECT, INCIDENCE, SEVERITY OF LOCAL AND SYSTEMIC SIDE EFFECTS OF INTERMUSCULAR PIROXICAM IN ACUTE MUSCULOSKELETAL DISEASE.

Active substance: PIROXICAM

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Document reference: 34355

Study title: TO STUDY THE EFFICACY AND INCIDENCE IN THE SEVERITY OF LOCAL AND SYSTEMIC ADVERSE REACTIONS OF INTRAMUSCULAR PIROXICAM ADMINISTRATION IN ACUTE MUSCULOSKELETAL DISORDERS.

Active substance: PIROXICAM

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Document reference: 34429

Study title: TO STUDY THE EFFICACY AND SAFETY OF PIROXICAM DISPERSIBLE TABLETS IN PATIENTS WITH ACUTE MUSCULOSKELETAL DISORDERS.

Active substance: PIROXICAM

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Document reference: 34392

Study title: TO STUDY THE EFFICACY AND SAFETY OF PIROXICAM INJECTION VERSUS DICLOFENAC INJECTION IN PATIENTS WITH ACUTE MUSCULOSKELETAL DISORDERS, OCCURRED WHILE PRACTISING SPORTS.

Active substance: PIROXICAM

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Document reference: 34393

Study title: TO STUDY THE EFFICACY AND TOLERATION OF PIROXICAM DISPERSIBLE TABLETS IN PAINFUL ACUTE LOW BACK DISORDERS.

Active substance: PIROXICAM

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Document reference: 34370

Study title: TO STUDY THE EFFICACY AND TOLERATION OF PIROXICAM DISPERSIBLE TABLETS IN THE TREATMENT OF SPRAINED ANKLE.

Active substance: PIROXICAM

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Document reference: 34348

Study title: TO STUDY THE EFFICACY AND TOLERATION OF PIROXICAM GEL 0.5% IN THE TREATMENT OF SELECTED MUSCULOSKELETAL DISORDERS.

Active substance: PIROXICAM

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Document reference: 34410

Study title: TO STUDY THE EFFICACY AND TOLERATION OF PIROXICAM GEL 0.5% IN THE TREATMENT OF SELECTED MUSCULOSKELETAL DISORDERS.

Active substance: PIROXICAM

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Document reference: 34434

Study title: Vrasse, R., Schuhmann, C., and Regenstreif, P. [Action of the anthraquinone derivatives of the rhubarb in 47 cases of gingivostomatitis] Action des derives anthraquinoniques de la rhubarbe dans 47 cas de gingivostomatites. Rev.Fr.Odontostomatol. 1967. 14: (7) 1215-1220 47 subjects, 11f, 36 m, 16-84 yVrasse, R., Schuhmann, C., and Regenstreif, P. [Action of the anthraquinone derivatives of the rhubarb in 47 cases of gingivostomatitis] Action des derives anthraquinoniques de la rhubarbe dans 47 cas de gingivostomatites. Rev.Fr.Odontostomatol. 1967. 14: (7) 1215-1220 47 subjects, 11f, 36 m, 16-84 y

Active substance: RHUBARB AND SALICYLIC ACID

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Document reference: 35295

Study title: TO STUDY THE EFFICACY, INCIDENCE AND SEVERITY OF LOCAL AND SYSTEMIC ADVERSE REACTIONS OF IM PIROXICAM ADMINISTRATION IN ACUTE LOW BACK PAIN FOLLOWED BY ORAL TREATMENT WHEN NECESSARY.

Active substance: PIROXICAM

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Document reference: 34354

Study title: TO STUDY THE ONSET OF ACTION OF INTRAMUSCULAR PIROXICAM IN COMPARISON WITH THE ORAL FORM IN PATIENTS WITH ACUTE LOW BACK PAIN, SCIATALGIA.

Active substance: PIROXICAM

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Document reference: 34381

Study title: TO STUDY THE PAIN-RELIEVING EFFECT OF PIROXICAM VS. BARALGIN AND FELDENE.

Active substance: PIROXICAM

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Document reference: 34344

Study title: TO EVALUATE THE EFFICACY AND SAFETY OF PIROXICAM SUPPOSITORY IN PATIENTS WITH OSTEOARTHRITIS OF HIP/KNEE LUMBAGO OR TRAUMA.

Active substance: PIROXICAM

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Document reference: 34405

Study title: TO STUDY THE SAFETY AND EFFICACY OF PIROXICAM INTERMUSCULAR AS THE INITIAL TREATMENT FOR ACUTE MUSCULOSKELETAL CONDITIONS.

Active substance: PIROXICAM

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Document reference: 34363

Study title: A comparison of Pondocillin® and Calcipen® in children with acute otitis media

Active substance: PIVAMPICILLIN

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Document reference: 46046

Study title: Clinical and diagnostic features of osteomyelitis occurring in the first three months of life. Wong M, Isaacs D, Howman-Giles R, Uren R. Pediatr Infect Dis J. 1995 Dec;14(12):1047-53.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43574

Study title: Serum osteocalcin and other indices of bone formation: an 8-decade population study in healthy men and women. Worsfold M, Sharp CA, Davie MW. Clin Chim Acta. 1988 Dec 15;178(2):225-35.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43800

Study title: Yalcin S, Turoglu HT, Ozdamar S, Sadikoglu Y, Gurbuzer B, Yenici O. Ewing's tumor of the mandible. Oral Surg Oral Med Oral Pathol. 1993 Sep;76(3):362-7. Yalcin S, Turoglu HT, Ozdamar S, Sadikoglu Y, Gurbuzer B, Yenici O. Ewing's tumor of the mandible. Oral Surg Oral Med Oral Pathol. 1993 Sep;76(3):362-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43652

Study title: Mathews J, Slavin JD Jr, Spencer RP. Technetium-99m MDP demonstration of neoplastic lesions involving bone and adjacent soft tissue. Clin Nucl Med. 1986 Feb;11(2):98-101. Mathews J, Slavin JD Jr, Spencer RP. Technetium-99m MDP demonstration of neoplastic lesions involving bone and adjacent soft tissue. Clin Nucl Med. 1986 Feb;11(2):98-101.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43916

Study title: Maurer AH, Chen DC, Camargo EE, Wong DF, Wagner HN Jr, Alderson PO. Utility of three-phase skeletal scintigraphy in suspected osteomyelitis: concise communication. J Nucl Med. 1981 Nov;22(11):941-9. Maurer AH, Chen DC, Camargo EE, Wong DF, Wagner HN Jr, Alderson PO. Utility of three-phase skeletal scintigraphy in suspected osteomyelitis: concise communication. J Nucl Med. 1981 Nov;22(11):941-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44108

Study title: Maurer AH, Holder LE, Espinola DA, Rupani HD, Wilgis EF. Three-phase radionuclide scintigraphy of the hand. Radiology. 1983 Mar;146(3):761-75. Maurer AH, Holder LE, Espinola DA, Rupani HD, Wilgis EF. Three-phase radionuclide scintigraphy of the hand. Radiology. 1983 Mar;146(3):761-75.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44047

Study title: Maurice H, Watt I. Technetium-99m hydroxymethylene diphosphonate scanning of acute injuries to the lateral ligaments of the ankle. Br J Radiol. 1989 Jan;62(733):31-4. Maurice H, Watt I. Technetium-99m hydroxymethylene diphosphonate scanning of acute injuries to the lateral ligaments of the ankle. Br J Radiol. 1989 Jan;62(733):31-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43795

Study title: McCarthy KE, Heyman S. Diphosphonate intestinal activity seen on two bone images in neuroblastoma. Clin Nucl Med. 1986 Jul;11(7):501-2. McCarthy KE, Heyman S. Diphosphonate intestinal activity seen on two bone images in neuroblastoma. Clin Nucl Med. 1986 Jul;11(7):501-2.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43901

Study title: Pineoblastoma imaged during bone scintigraphy. McCormack S, Raftery R, Palmgren D, Leonard JC. Clin Nucl Med. 1995 Nov;20(11):1023-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43580

Study title: McCullough RW, Gandsman EJ, Litchman H, Schatz SL, Deutsch SD. Computerized blood-flow analysis in osteochondritis dissecans. Clin Nucl Med. 1986 Jul;11(7):511-3. McCullough RW, Gandsman EJ, Litchman H, Schatz SL, Deutsch SD. Computerized blood-flow analysis in osteochondritis dissecans. Clin Nucl Med. 1986 Jul;11(7):511-3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43900

Study title: Sandler MS, Heyman S, Watts H. Localization of 99mTc methylene diphosphonate within synovial fluid in osteosarcoma. AJR Am J Roentgenol. 1984 Aug;143(2):349-50. No abstract available. Sandler MS, Heyman S, Watts H. Localization of 99mTc methylene diphosphonate within synovial fluid in osteosarcoma. AJR Am J Roentgenol. 1984 Aug;143(2):349-50. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43990

Study title: Sartoris DJ, Resnick DL. Tarsal coalition. Arthritis Rheum. 1985 Mar;28(3):331-8. No abstract available. Sartoris DJ, Resnick DL. Tarsal coalition. Arthritis Rheum. 1985 Mar;28(3):331-8. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43955

Study title: Criteria and quantification of fibrous dysplasia on MDP scanning. Sathekge MM, Clauss RP. Nuklearmedizin. 1995 Dec;34(6):229-31.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43576

Study title: Sato K, Sugiura S. Naviculo-cuneiform coalition--report of three cases. Nippon Seikeigeka Gakkai Zasshi. 1990 Jan;64(1):1-6. Sato K, Sugiura S. Naviculo-cuneiform coalition--report of three cases. Nippon Seikeigeka Gakkai Zasshi. 1990 Jan;64(1):1-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43771

Study title: Shi QX. [Bone imaging in the detection of skeletal metastasis] Zhonghua Zhong Liu Za Zhi. 1989 May;11(3):196-8. Chinese. Shi QX. [Bone imaging in the detection of skeletal metastasis] Zhonghua Zhong Liu Za Zhi. 1989 May;11(3):196-8. Chinese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43786

Study title: Extraosseous localization of 99mTc-MDP in ganglioneuroblastoma. Shih WJ, DeLand FH, Domstad PA, Johnston EH. Eur J Nucl Med. 1982;7(7):336-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44100

Study title: Pulmonary metastases on bone scan in a patient with osteogenic sarcoma. Shikare S, Tilve GH. J Postgrad Med. 1992 Oct-Dec;38(4):201-2, 198.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43687

Study title: Secondary ossification center of transverse process: a bone-scan normal variant. Shore RM, Cain GP, Lloyd TV. Eur J Nucl Med. 1985;10(1-2):88-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43971

Study title: Shore RM, Frye TR, Weis LD, Mulne AF. Pleural metastasis with osteosarcoma. Dramatic presentation on skeletal scintigraphy. Clin Nucl Med. 1984 Nov;9(11):622-4. No abstract available. Shore RM, Frye TR, Weis LD, Mulne AF. Pleural metastasis with osteosarcoma. Dramatic presentation on skeletal scintigraphy. Clin Nucl Med. 1984 Nov;9(11):622-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43976

Study title: Shulkin BL, Shapiro B, Hutchinson RJ. Iodine-131-metaiodobenzylguanidine and bone scintigraphy for the detection of neuroblastoma. J Nucl Med. 1992 Oct;33(10):1735-40. Shulkin BL, Shapiro B, Hutchinson RJ. Iodine-131-metaiodobenzylguanidine and bone scintigraphy for the detection of neuroblastoma. J Nucl Med. 1992 Oct;33(10):1735-40.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43686

Study title: Sarcoma -Ewing Sarcoma

Active substance: ETOPOSIDE

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Document reference: 26776

Study title: Brain Tumors

Active substance: ETOPOSIDE

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Document reference: 26817

Study title: Treatment of pain in pediatric patients; Journal of Pharmacy Practice 2003, 16(4): 261-275

Active substance: FENTANYL

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Document reference: 27189

Study title: McCullough RW, Gandsman EJ, Litchman HE, Schatz SL. Dynamic bone scintigraphy in osteochondritis dissecans. Int Orthop. 1988;12(4):317-22. McCullough RW, Gandsman EJ, Litchman HE, Schatz SL. Dynamic bone scintigraphy in osteochondritis dissecans. Int Orthop. 1988;12(4):317-22.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43837

Study title: Clival osteoblastoma in a child. Case illustration. McDonald PJ, Matouk CC, Papsin B, Rutka JT. J Neurosurg. 2003 May;98(5):1133. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43422

Study title: McKendry RJ, Hamdy H. Acne, arthritis and sacroiliitis. Can Med Assoc J. 1983 Jan 15;128(2):156-8. No abstract available. McKendry RJ, Hamdy H. Acne, arthritis and sacroiliitis. Can Med Assoc J. 1983 Jan 15;128(2):156-8. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44053

Study title: Sakai T, Sugano N, Nishii T, Haraguchi K, Yoshikawa H, Ohzono K. Bone scintigraphy for osteonecrosis of the knee in patients with non-traumatic osteonecrosis of the femoral head: comparison with magnetic resonance imaging. Ann Rheum Dis. 2001 Jan;60(1):14-20. Sakai T, Sugano N, Nishii T, Haraguchi K, Yoshikawa H, Ohzono K. Bone scintigraphy for osteonecrosis of the knee in patients with non-traumatic osteonecrosis of the femoral head: comparison with magnetic resonance imaging. Ann Rheum Dis. 2001 Jan;60(1):14-20.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43471

Study title: Sakai T, Sugano N, Nishii T, Haraguchi K, Yoshikawa H, Ohzono K. Bone scintigraphy for osteonecrosis of the knee in patients with non-traumatic osteonecrosis of the femoral head: comparison with magnetic resonance imaging. Ann Rheum Dis. 2001 Jan;60(1):14-20. Sakai T, Sugano N, Nishii T, Haraguchi K, Yoshikawa H, Ohzono K. Bone scintigraphy for osteonecrosis of the knee in patients with non-traumatic osteonecrosis of the femoral head: comparison with magnetic resonance imaging. Ann Rheum Dis. 2001 Jan;60(1):14-20.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44156

Study title: Sakai T, Sugano N, Nishii T, Haraguchi K, Yoshikawa H, Ohzono K. Bone scintigraphy for osteonecrosis of the knee in patients with non-traumatic osteonecrosis of the femoral head: comparison with magnetic resonance imaging. Ann Rheum Dis. 2001 Jan;60(1):14-20. Sakai T, Sugano N, Nishii T, Haraguchi K, Yoshikawa H, Ohzono K. Bone scintigraphy for osteonecrosis of the knee in patients with non-traumatic osteonecrosis of the femoral head: comparison with magnetic resonance imaging. Ann Rheum Dis. 2001 Jan;60(1):14-20.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44203

Study title: Sakai T, Sugano N, Nishii T, Haraguchi K, Yoshikawa H, Ohzono K. Bone scintigraphy for osteonecrosis of the knee in patients with non-traumatic osteonecrosis of the femoral head: comparison with magnetic resonance imaging. Ann Rheum Dis. 2001 Jan;60(1):14-20. Sakai T, Sugano N, Nishii T, Haraguchi K, Yoshikawa H, Ohzono K. Bone scintigraphy for osteonecrosis of the knee in patients with non-traumatic osteonecrosis of the femoral head: comparison with magnetic resonance imaging. Ann Rheum Dis. 2001 Jan;60(1):14-20.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44250

Study title: Sakai T, Sugano N, Nishii T, Miki H, Ohzono K, Yoshikawa H. Bone scintigraphy screening for osteonecrosis of the shoulder in patients with non-traumatic osteonecrosis of the femoral head. Skeletal Radiol. 2002 Nov;31(11):650-5. Epub 2002 Aug 21. Sakai T, Sugano N, Nishii T, Miki H, Ohzono K, Yoshikawa H. Bone scintigraphy screening for osteonecrosis of the shoulder in patients with non-traumatic osteonecrosis of the femoral head. Skeletal Radiol. 2002 Nov;31(11):650-5. Epub 2002 Aug 21.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43432

Study title: Madanat-F-F. Department of Pediatrics, Jordan University Medical School and Hospital, Amman. MOPP therapy in children with Hodgkin's disease. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Winter 1989, vol. 11, no. 4, p. 407-10, ISSN: 0192-8562.Madanat-F-F. Department of Pediatrics, Jordan University Medical School and Hospital, Amman. MOPP therapy in children with Hodgkin's disease. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Winter 1989, vol. 11, no. 4, p. 407-10, ISSN: 0192-8562.

Active substance: PROCARBAZINE

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Document reference: 34778

Study title: Abdominal masses in children: multiorgan imaging with 99mTc methylene diphosphonate. Siddiqui AR, Cohen M, Moran DP. AJR Am J Roentgenol. 1982 Jul;139(1):35-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44079

Study title: "Cold spot" on bone scan at the site of primary osteosarcoma. Siddiqui AR, Ellis JH. Eur J Nucl Med. 1982;7(10):480-1.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44098

Study title: Nuclear medicine studies in evaluation of skeletal lesions in children with histiocytosis X. Siddiqui AR, Tashjian JH, Lazarus K, Wellman HN, Baehner RL. Radiology. 1981 Sep;140(3):787-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44111

Study title: Siddiqui AR. Increased uptake of technetium-99m-labeled bone imaging agents in the kidneys. Semin Nucl Med. 1982 Jan;12(1):101-2. No abstract available. Siddiqui AR. Increased uptake of technetium-99m-labeled bone imaging agents in the kidneys. Semin Nucl Med. 1982 Jan;12(1):101-2. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44105

Study title: [Clinical evaluation of multiple exostoses (17 cases) on bone scintigraphy] Japanese. Yamada T, Nakamura M, Sugita R, Satou A, Sakamoto K. Nippon Igaku Hoshasen Gakkai Zasshi. 1991 Mar 25;51(3):282-8. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43744

Study title: Tc-99m MDP uptake by an advanced colon cancer lesion in a juvenile patient. Yamada T, Shuke N, Takahashi K, Katada R, Mineta M, Nagasawa K, Hanaoka H, Aburano T, Miyamoto K, Suzuki Y. Clin Nucl Med. 2000 Apr;25(4):295-6. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43487

Study title: Yamagishi Y, Komata K, Yamamoto H, Takahashi M, Hikita F, Sato M, Watanabe H. [Usefulness of 99mTc-MDP scintigraphy for normal roentgen variants of bone] Kaku Igaku. 1993 May;30(5):549-56. Japanese. Yamagishi Y, Komata K, Yamamoto H, Takahashi M, Hikita F, Sato M, Watanabe H. [Usefulness of 99mTc-MDP scintigraphy for normal roentgen variants of bone] Kaku Igaku. 1993 May;30(5):549-56. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43667

Study title: Yamagishi Y. [Bone scintigraphy] Nippon Ika Daigaku Zasshi. 1992 Feb;59(1):70-4. Japanese. No abstract available. Yamagishi Y. [Bone scintigraphy] Nippon Ika Daigaku Zasshi. 1992 Feb;59(1):70-4. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43709

Study title: Yamagishi Y. [Role of the scintigram in the diagnosis of bones and calcifications] Rinsho Hoshasen. 1986 Apr;31(4):499-504. Japanese. No abstract available. Yamagishi Y. [Role of the scintigram in the diagnosis of bones and calcifications] Rinsho Hoshasen. 1986 Apr;31(4):499-504. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43913

Study title: Yang CC, Wu CC, Chen MF. [Bone metastases of malignancies. A radionuclide study] Gaoxiong Yi Xue Ke Xue Za Zhi. 1986 Jul;2(7):435-45. Chinese. No abstract available. Yang CC, Wu CC, Chen MF. [Bone metastases of malignancies. A radionuclide study] Gaoxiong Yi Xue Ke Xue Za Zhi. 1986 Jul;2(7):435-45. Chinese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43903

Study title: Van Den Bossche B, Lambert B, De Winter F, Kolindou A, Dierckx RA, Noens L, et al.. 18FDG PET versus high-dose 67Ga scintigraphy for restaging and treatment follow-up of lymphoma patients. [vanden-bossche-2002]Nucl Med Commun. 2002 Nov;23(11):1079-83. Van Den Bossche B 2002

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48707

Study title: Vander Borght T, Laloux P, Maes A, Salmon E, Goethals I, Goldman S; Belgian Society for Nuclear Medicine.. Guidelines for brain radionuclide imaging. Perfusion single photon computed tomography (SPECT) using Tc-99m radiopharmaceuticals and brain metabolism positron emission tomography (PET) using F-18 fluorodeoxyglucose. The Belgian Society for Nuclear Medicine. [vander-borght-2001]Acta Neurol Belg. 2001 Dec;101(4):196-209. Vander Borght T 2001

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48708

Study title: A double-blind, placebo-controlled, multicentred study of mizolastine (SL85.0324) (10mg/d) efficacy in patients suffering from perennial allergic rhinoconjunctivitis (RIPERAN study). - Scadding G. Bachert C. Dunmore C. Favennec C. Mathieu G. Steinerstauch P. Weber F.- 06/09/1994

Active substance: MIZOLASTINE

Study summary document link (including results): Mizolastine STUDY 94-00611-EN-00.xls

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Document reference: 32260

Study title: An open-labelled, multicentred study of mizolastine (SL85.0324-00) (10mg and 15mg/d) to assess the long-term safety and long-term efficacy in patients suffering from perennial allergic rhinoconjunctivitis (RIPEREX Study). - Scadding G. Tasman A.J. Dunmore C. Favennec E. Mathieu G. Steinerstauch P. Weber F.- 10/06/1998

Active substance: MIZOLASTINE

Study summary document link (including results): Mizolastine STUDY 94-00939-EN-01.xls

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Document reference: 32261

Study title: Assessment of the therapeutic efficacy and safety of mizolastine in the treatment of chronic idiopathic urticaria. Open-label study of increasing doses (5-10-20mg per day in 2 divided doses) (URTIOC study). -Sayag J. Tudor D. Demontrond V. Narbonne G. Ben-soussen P.- 05/05/1993

Active substance: MIZOLASTINE

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Document reference: 32262

Study title: Comparative safety and efficacy of 3 doses of mizolastine versus placebo in the treatment of seasonnal allergic rhinitis (RHINASE study). - Dry J. Theron M. DEMONTROND V. ATTALI P.- 14/05/1992 STUDY 85.0324.FR.05

Active substance: MIZOLASTINE

Study summary document link (including results): Mizolastine STUDY 85.0324.FR.05.xls

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Document reference: 32263

Study title: Comparative study of the efficacy and safety of 10mg mizolastine and 10mg cetirizine versus placebo in seasonal allergic rhino-conjunctivitis in adults.Double blind placebo-controlled study (MIZOCET study). - Ben-soussen P. Senn N. Tudor D.- 31/09/1994.

Active substance: MIZOLASTINE

Study summary document link (including results): Mizolastine STUDY 94-00672-EN-00.xls

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Document reference: 32264

Study title: Comparative study of the efficacy and safety or mizolastine 10mg and terfenadine 120mg versus placebo in seasonal allergic rhino-conjunctivitis (MIZOTER study). - Broseta V. Murrieta M. Seen N. Tudor D. 13/09/1994

Active substance: MIZOLASTINE

Study summary document link (including results): Mizolastine STUDY 94-00197-EN-00.xls

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Document reference: 32265

Study title: Comparative study to determine the efficacy and safety of mizolastine (15mg/d as a single dose) versus dexchlorpheniramine (12mg/d as two devided doses) in the treatment of chronic rhinitis in adults (POLRIC study). - Haguenauer J.P. Tudor D. Mathieu G. Demontrond V. Guerault E. Soubrane C.- 09/07/1993

Active substance: MIZOLASTINE

Study summary document link (including results): Mizolastine STUDY M.44.04.93.03.xls

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Document reference: 32266

Study title: Comparison of the efficacy, safety and onset of action of mizolastine, cetirizine and placebo in the management of seasonal allergic rhinoconjonctivitis. Sabbah A et al (MIZOCET group). (Ann Allerg Asthm Immunol 1999 ; 83: 319-325) Publication 12 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005 Comparison of the efficacy, safety and onset of action of mizolastine, cetirizine and placebo in the management of seasonal allergic rhinoconjonctivitis. Sabbah A et al (MIZOCET group). (Ann Allerg Asthm Immunol 1999 ; 83: 319-325) Publication 12 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005

Active substance: MIZOLASTINE

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Document reference: 32272

Study title: CStudy to compare the efficacy and safety of 3 doses of mizolastine (SL85.0324) versus placebo in the treatment of perennial allergic rhinitis.

Active substance: MIZOLASTINE

Study summary document link (including results): Mizolastine STUDY M.44.02.93.002.xls

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Document reference: 47994

Study title: Utilisation du Tranxene 5 mg gélules en pédo-psychiatrie - Sauvage D., Psychol. Méd., 1975, 7, 1637-1643Utilisation du Tranxene 5 mg gélules en pédo-psychiatrie - Sauvage D., Psychol. Méd., 1975, 7, 1637-1643

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46083

Study title: A Controlled Trial of Povidone–Iodine to Treat Infectious Conjunctivitis in ChildrenA Controlled Trial of Povidone–Iodine to Treat Infectious Conjunctivitis in Children

Active substance: POVIDONE IODINE

Study summary document link (including results): A controlled trial of povidone-iodine.pdf

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Document reference: 34611

Study title: Yang JS. [Evaluation of 113mIn-DTPMP and 99mTc-MDP for bone scanning] Zhonghua Fang She Xue Za Zhi. 1984 Feb;18(1):58-62. Chinese. No abstract available. Yang JS. [Evaluation of 113mIn-DTPMP and 99mTc-MDP for bone scanning] Zhonghua Fang She Xue Za Zhi. 1984 Feb;18(1):58-62. Chinese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44006

Study title: Evaluation of activity of epiphyseal plates in growing males and females. Yang KT, Yang AD. Calcif Tissue Int. 2006 Jun;78(6):348-56. Epub 2006 Jun 21.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43374

Study title: Yeh SD, Rosen G, Caparros B, Benua RS. Semiquantitative gallium scintigraphy in patients with osteogenic sarcoma. Clin Nucl Med. 1984 Apr;9(4):175-83. Yeh SD, Rosen G, Caparros B, Benua RS. Semiquantitative gallium scintigraphy in patients with osteogenic sarcoma. Clin Nucl Med. 1984 Apr;9(4):175-83.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44003

Study title: Nonfunctioning adrenocortical tumor showing concentration of Tc-99m MDP in a child. Yen TC, Yeh SH. Clin Nucl Med. 1996 Jul;21(7):579-80. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43564

Study title: Technetium-99m-methylene diphosphonate uptake in the fetal skeleton at 30 weeks gestation. McKenzie AF, Budd RS, Yang C, Shapiro B, Hicks RJ. J Nucl Med. 1994 Aug;35(8):1338-41.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43618

Study title: McKillop JH, Etcubanas E, Goris ML. The indications for and limitations of bone scintigraphy in osteogenic sarcoma: a review of 55 patients. Cancer. 1981 Sep 1;48(5):1133-8. McKillop JH, Etcubanas E, Goris ML. The indications for and limitations of bone scintigraphy in osteogenic sarcoma: a review of 55 patients. Cancer. 1981 Sep 1;48(5):1133-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44112

Study title: Role of radionuclide imaging in the diagnosis of chondrosarcoma. McLean RG, Choy D, Höschl R, Nayanar V, Murray IP. Med Pediatr Oncol. 1985;13(1):32-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43972

Study title: McLean RG, Murray IP. Case report 292. Diagnosis: alveolar rhabdomyosarcoma, metastatic to the right femur, primary site undetermined. Skeletal Radiol. 1984;12(4):288-93. No abstract available. McLean RG, Murray IP. Case report 292. Diagnosis: alveolar rhabdomyosarcoma, metastatic to the right femur, primary site undetermined. Skeletal Radiol. 1984;12(4):288-93. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44011

Study title: Meindok H, Rapoport A, Oreopoulos DG, Rabinovich S, Meema HE, Meema S. Quantitative radionuclide scanning in metabolic bone disease. Nucl Med Commun. 1985 Mar;6(3):141-8. Meindok H, Rapoport A, Oreopoulos DG, Rabinovich S, Meema HE, Meema S. Quantitative radionuclide scanning in metabolic bone disease. Nucl Med Commun. 1985 Mar;6(3):141-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43953

Study title: Meire E, Hoogmartens M, De Roo M, Mortelmans L, Nicolai D. The peroperative use of the mobile gamma camera for the localization of spinal osteoid osteoma. Acta Orthop Belg. 1983 May-Jun;49(3):384-90. No abstract available. Meire E, Hoogmartens M, De Roo M, Mortelmans L, Nicolai D. The peroperative use of the mobile gamma camera for the localization of spinal osteoid osteoma. Acta Orthop Belg. 1983 May-Jun;49(3):384-90. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44037

Study title: "Long-term observation of treatment with topical corticosteroid prednicarbate - E.W. Schmitt et al. - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" "Long-term observation of treatment with topical corticosteroid prednicarbate - E.W. Schmitt et al. - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -"

Active substance: PREDNICARBATE

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Document reference: 34673

Study title: AWB-Rei/100797 2 March 1999: Post marketing surveillance for Betaisodona ointment in paediatrics

Active substance: POVIDONE IODINE

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Document reference: 34612

Study title: AWB-TDG/BETA-LSG/220193, 07-Apr-1994, Anwendungsbeobachtung 1992/1993 Betaisodona. (Post marketing surveillance study 1992/1993 Betaisodona.) (Germany)

Active substance: POVIDONE IODINE

Study summary document link (including results): Povidone iodine - Option 1 Mundipharma IACs.xls

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Document reference: 45115

Study title: Pralidoxime safety and toxicity in children; Quail MT & Shannon MW. Prehospital Emergency Care 2007; 11(1): 36-41. Pralidoxime safety and toxicity in children; Quail MT & Shannon MW. Prehospital Emergency Care 2007; 11(1): 36-41.

Active substance: PRALIDOXIME

Study summary document link (including results):

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Document reference: 46084

Study title: Topical pranoprofen 0.1% is as effective anti-inflammatory and analgesic agent as diclofenac sodium 0.1% after strabismus surgery. Akyol-Salman I, Leçe-Sertöz D, Baykal O. J Ocul Pharmacol Ther. 2007 Jun;23(3):280-3.Topical pranoprofen 0.1% is as effective anti-inflammatory and analgesic agent as diclofenac sodium 0.1% after strabismus surgery. Akyol-Salman I, Leçe-Sertöz D, Baykal O. J Ocul Pharmacol Ther. 2007 Jun;23(3):280-3.

Active substance: PRANOPROFEN

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Document reference: 46085

Study title: Use-result surveillance for pranoprofen ophtalmic solution. Clinical data for paediatric use (post marketing surveillance).

Active substance: PRANOPROFEN

Study summary document link (including results):

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Document reference: 46086

Study title: A randomized crossover trial of combination pharmacologic therapy in children with familial hypercholesterolemia

Active substance: PRAVASTATIN

Study summary document link (including results):

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Document reference: 46091

Study title: Dyslipidemia in pediatric renal disease: epidemiology, pathophysiology and management

Active substance: PRAVASTATIN

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Document reference: 46093

Study title: Effects of combination therapy consisting of moderate-dose intravenous immunoglobulin G, pulses methylprednisolone and pravastatin in children with steroid resistant nephrosis

Active substance: PRAVASTATIN

Study summary document link (including results):

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Document reference: 46094

Study title: Effects of pravastatin therapy on steroid hormone levels and pubertal development in children and adolescents with hypercholesterolemia

Active substance: PRAVASTATIN

Study summary document link (including results):

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Document reference: 46095

Study title: Long-term safety of Pravastatin in children with familial hyper-cholesterolaemia

Active substance: PRAVASTATIN

Study summary document link (including results):

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Document reference: 46096

Study title: Pharmacokinetics of Pravastatin in a paediatric population

Active substance: PRAVASTATIN

Study summary document link (including results):

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Document reference: 46097

Study title: Pravastatin ameliorates hypercholesterolemia in pediatric renal transplant recipients

Active substance: PRAVASTATIN

Study summary document link (including results):

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Document reference: 46098

Study title: Indications et resultats obtenus avec le Nootropyl dans les affections de l'oreille interne.

Active substance: PIRACETAM

Study summary document link (including results): DF74J272P - Piracetam.pdf

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Document reference: 45944

Study title: Inefficacy of piracetam in the prevention of painful crises in children and adolescents with sickle cell disease.

Active substance: PIRACETAM

Study summary document link (including results): ADPE05H2932 - Piracetam.pdf

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Document reference: 45917

Study title: Minizide (Brand of Prazosin/Polythiazide) Tablets (0.5 mg/0.25 mg) Clinical Experience in a Non-Comparative, Multicenter Trial

Active substance: PRAZOCIN /POLYTHIAZIDE

Study summary document link (including results): MZ-76-01 and MZ-76-02 EMA Pediatric Web Synopsis.pdf

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Document reference: 46109

Study title: A double- blind study comparing HOE777 fatty ointment with Ibaril fatty ointment in patients with moderate to severe psoriasis - B. Gjertsen et al . - 1985 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" A double- blind study comparing HOE777 fatty ointment with Ibaril fatty ointment in patients with moderate to severe psoriasis - B. Gjertsen et al . - 1985 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -"

Active substance: PREDNICARBATE

Study summary document link (including results):

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Document reference: 34664

Study title: A double-blind multicentre parallel group study comparing HOE777 fatty ointment with betamethasone valerate 0,1% fatty ointment in patients with mild to severe atopic or eczematous contact dermatitis - M. Dietz et al. - 1982 (unpublished report) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Dietz.xls

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Document reference: 34665

Study title: "A double-blind parallel group study comparing HOE777 0,25% emolient cream, HOE777 0,1% emollient cream and vehicle in psoriatic patients - T. Fredriksson - 1983 (Hoeschst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -" "A double-blind parallel group study comparing HOE777 0,25% emolient cream, HOE777 0,1% emollient cream and vehicle in psoriatic patients - T. Fredriksson - 1983 (Hoeschst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -"

Active substance: PREDNICARBATE

Study summary document link (including results):

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Document reference: 34666

Study title: Remarques sur quelques effets therapeutiques du piracetam (1e partie).

Active substance: PIRACETAM

Study summary document link (including results): DF79K121P - Piracetam.pdf

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Document reference: 45959

Study title: Report on the clinical use of Nootropil (UCB 6215) in psychic disorders occurring in severely burnt patients.

Active substance: PIRACETAM

Study summary document link (including results): CE72E041 - Piracetam.pdf

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Document reference: 45911

Study title: Response to prophylactic treatment of benign headache in children.

Active substance: PIRACETAM

Study summary document link (including results): ADPS98J0907 - Piracetam.pdf

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Document reference: 45945

Study title: Restoration of phagocytosis and oxidative metabolism by piracetam in failing human neutrophils: a qualitative assessment.

Active substance: PIRACETAM

Study summary document link (including results): DE84C183P - Piracetam.pdf

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Document reference: 45984

Study title: Results obtained with piracetam in foetal distress during labour.

Active substance: PIRACETAM

Study summary document link (including results): DE83F061P - Piracetam.pdf

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Document reference: 45960

Study title: Rudotel and Nootropil in treatment of pediatric atopic dermatitis: the prove of usage and estimation of clinical efficacy

Active substance: PIRACETAM

Study summary document link (including results): ADPY00J1813 - Piracetam.pdf

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Document reference: 46016

Study title: Specific learning disorders with and without minimal neurological damage. A pharmacologic distinction.

Active substance: PIRACETAM

Study summary document link (including results): PDEJ91F2802 - Piracetam.pdf

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Document reference: 45968

Study title: "Management of scalp psoriasis. Guidelines for corticosteroid use in combination treatment - CJM. Van der Vleuten et al. - 2001 (Drugs vol 61) - Publication in Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005 -" "Management of scalp psoriasis. Guidelines for corticosteroid use in combination treatment - CJM. Van der Vleuten et al. - 2001 (Drugs vol 61) - Publication in Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005 -"

Active substance: PREDNICARBATE

Study summary document link (including results):

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Document reference: 34674

Study title: "Multicentre study (HOE777 5D-402DT) Evaluation of efficacity and tolerance of prednicarbate 0,25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses - No author -1991 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" "Multicentre study (HOE777 5D-402DT) Evaluation of efficacity and tolerance of prednicarbate 0,25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses - No author -1991 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -"

Active substance: PREDNICARBATE

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Document reference: 34675

Study title: Open study with HOE 777 0.1% emollient cream in children suffering from contact dermatitis, atopic dermatitis, seborrhoeic eczema or psoriasis

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Herz dermatitis.xls

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Document reference: 48012

Study title: "Patch testing with HOE777 ointment, 0,1% and 0,25% and non-medicated ointment, with and without preservatives -H. Tronnier - 1984 (unpublished report) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-" "Patch testing with HOE777 ointment, 0,1% and 0,25% and non-medicated ointment, with and without preservatives -H. Tronnier - 1984 (unpublished report) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-"

Active substance: PREDNICARBATE

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Document reference: 34677

Study title: "Prednicarbate embollient cream 0,1% in pedriatric patients with atopic dermatitis - T. Moshang - 2001 (Cutis vol 68) - Publication in Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005 -" "Prednicarbate embollient cream 0,1% in pedriatric patients with atopic dermatitis - T. Moshang - 2001 (Cutis vol 68) - Publication in Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005 -"

Active substance: PREDNICARBATE

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Document reference: 34678

Study title: "RECOR with Dermatop Prednicarbate in the treatment of steroid sensitive skin disorders in children - No author - No date" "RECOR with Dermatop Prednicarbate in the treatment of steroid sensitive skin disorders in children - No author - No date"

Active substance: PREDNICARBATE

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Document reference: 34679

Study title: A COMPARATIVE STUDY OF PRX AND NAPROXEN IN THE TREATMENT OF PRIMARY DYSMENORRHEA

Active substance: PIROXICAM

Study summary document link (including results):

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Document reference: 34352

Study title: A DOUBLE BLIND PLACEBO CONTROLLED STUDY OF THE EFFICACY AND TOLERATION OF PIROXICAM 0.5% TOPICAL GEL IN COMBINATION WITH IONTOPHORESIS IN THE TREATMENT OF TENDINITIS OF THE SHOULDER OR ELBOW.

Active substance: PIROXICAM

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Document reference: 34436

Study title: A DOUBLE-BLIND COMPARATIVE STUDY OF PRX FDDF BY SUBLINGUAL ROUTE VS. PLACEBO IN THE TREATMENT OF PRIMARY HEADACHE

Active substance: PIROXICAM

Study summary document link (including results):

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Document reference: 34404

Study title: La pyrrolidone acetamide dans le traitement des perturbations mentales.

Active substance: PIRACETAM

Study summary document link (including results): PDEF92K2603 - Piracetam.pdf

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Document reference: 45996

Study title: Le piracetam chez les enfants souffrant de troubles fonctionnels? Investigation neuro-psychopharmacologique controlee.

Active substance: PIRACETAM

Study summary document link (including results): DD81C123P - Piracetam.pdf

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Document reference: 45975

Study title: Le syndrome de down. Etude comparative de l'activite therapeutique du Noostan.

Active substance: PIRACETAM

Study summary document link (including results): DS77F021C - Piracetam.pdf

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Document reference: 45942

Study title: Lipid peroxidation and oxidative hemolysis of erythrocytes in healthy children and in small children with iron-deficiency anemia at high altitudes.

Active substance: PIRACETAM

Study summary document link (including results): ADPE91J1101 - Piracetam.pdf

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Document reference: 46021

Study title: Medication psycho-stimulante chez l'enfant.

Active substance: PIRACETAM

Study summary document link (including results): DF79L123P - Piracetam.pdf

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Document reference: 45980

Study title: Memory effects of a group of newly-synthesized pyrolidine derivatives with putative nootropic effect.

Active substance: PIRACETAM

Study summary document link (including results): PDEE92G0605 - Piracetam.pdf

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Document reference: 46039

Study title: Memory performance in dyslexic male juvenile delinquents convicted of severe offences does not differ from that in dyslexic male junior college students.

Active substance: PIRACETAM

Study summary document link (including results): ADPE06E1123 - Piracetam.pdf

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Document reference: 46011

Study title: Migrane und Kopfschmerzen bei Kindern.

Active substance: PIRACETAM

Study summary document link (including results): DD78C061P - Piracetam.pdf

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Document reference: 45921

Study title: Minimal brain dysfunction. III. Treatment (preliminary report).

Active substance: PIRACETAM

Study summary document link (including results): DS87L181P - Piracetam.pdf

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Document reference: 46001

Study title: Movement related potentials of learning disabled children treated with piracetam.

Active substance: PIRACETAM

Study summary document link (including results): PDEE97C1306 - Piracetam.pdf

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Document reference: 45929

Study title: Neuropsychological and pharmacological treatment of dyslexia.

Active substance: PIRACETAM

Study summary document link (including results): ATCE94J1605 - Piracetam.pdf

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Document reference: 46015

Study title: New perspectives for the treatment of bronchial asthma by Nootrop (UCB Pharma).

Active substance: PIRACETAM

Study summary document link (including results): ADPE98C2737 - Piracetam.pdf

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Document reference: 45979

Study title: Objektivierungsmoglichkeiten der therapie kindlicher lernstorungen.

Active substance: PIRACETAM

Study summary document link (including results): DD85G221P - Piracetam.pdf

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Document reference: 45955

Study title: On the effects of nootropic substances on serum biochemical indexes in mentally retarded children.

Active substance: PIRACETAM

Study summary document link (including results): DRU84F041P - Piracetam.pdf

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Document reference: 46023

Study title: Economopoulos T et al. Treatment of intermediate- and high-grade non-Hodgkin's lymphoma using CEOP versus CNOP. Eur J Haematol. 2002 Mar;68(3):135-43.Economopoulos T et al. Treatment of intermediate- and high-grade non-Hodgkin's lymphoma using CEOP versus CNOP. Eur J Haematol. 2002 Mar;68(3):135-43.

Active substance: MITOXANTRONE

Study summary document link (including results):

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Document reference: 32204

Study title: Statistical report of a controlled clinical study regarding the influence of piracetam upon the symptoms presented by children with learning disabilities.

Active substance: PIRACETAM

Study summary document link (including results): CE75F171 - Piracetam.pdf

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Document reference: 45903

Study title: Statistical report of a controlled trial of the effect of Nootropil in epileptic children.

Active substance: PIRACETAM

Study summary document link (including results): CE75F041 - Piracetam.pdf

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Document reference: 45900

Study title: Study on the pediatric use of piracetam in learning disorders.

Active substance: PIRACETAM

Study summary document link (including results): RAE90M071 - Piracetam.pdf

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Document reference: 45913

Study title: Sull' azione terapeutica del piracetam (Nootropil) nelle epilessie.

Active substance: PIRACETAM

Study summary document link (including results): DJ79E281P - Piracetam.pdf

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Document reference: 45922

Study title: Summary of SK&F 38462 retarded children study.

Active substance: PIRACETAM

Study summary document link (including results): RAE90L214 - Piracetam.pdf

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Document reference: 45897

Study title: The action of 2-pyrrolidone acetamide (piracetam) and acetamide as sickling inhibitors and desickling agents of the erythrocytes of patients suffering from sickle cell disease.

Active substance: PIRACETAM

Study summary document link (including results): DE76M292 - Piracetam.pdf

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Document reference: 45933

Study title: The acute and chronic administrations of piracetam affect the movement related brain macropotentials.

Active substance: PIRACETAM

Study summary document link (including results): DE87F222 - Piracetam.pdf

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Document reference: 45893

Study title: The clinical investigation of piracetam (UCB 6215, Nootropil) in treatment of mentally delayed children with hyperactivity.

Active substance: PIRACETAM

Study summary document link (including results): DRU85G241P - Piracetam.pdf

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Document reference: 45920

Study title: Ishii T et al The effects of high-dose ifosfamide in the treatment of bone and soft tissue Sarcomas Gan To Kagaku Ryoho. 1997 Nov;24(14):2123-30. JapaneseIshii T et al The effects of high-dose ifosfamide in the treatment of bone and soft tissue Sarcomas Gan To Kagaku Ryoho. 1997 Nov;24(14):2123-30. Japanese

Active substance: MITOXANTRONE

Study summary document link (including results):

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Document reference: 32161

Study title: Issels RD et al Ifosfamide plus etoposide combined with regional hyperthermia in patients with locally advanced sarcomas: a phase II study J Clin Oncol. 1990 Nov;8(11):1818-29Issels RD et al Ifosfamide plus etoposide combined with regional hyperthermia in patients with locally advanced sarcomas: a phase II study J Clin Oncol. 1990 Nov;8(11):1818-29

Active substance: MITOXANTRONE

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Document reference: 32162

Study title: Jennings MT et al. Preradiation chemotherapy in primary high-risk brainstem tumors: phase II study CCG-9941 of the Children's Cancer Group.J Clin Oncol. 2002 Aug 15;20(16):3431-7Jennings MT et al. Preradiation chemotherapy in primary high-risk brainstem tumors: phase II study CCG-9941 of the Children's Cancer Group.J Clin Oncol. 2002 Aug 15;20(16):3431-7

Active substance: MITOXANTRONE

Study summary document link (including results):

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Document reference: 32238

Study title: Jürgens H et al High-dose ifosfamide with mesna uroprotection in Ewing's sarcoma Cancer Chemother Pharmacol. 1989;24 Suppl 1:S40-4Jürgens H et al High-dose ifosfamide with mesna uroprotection in Ewing's sarcoma Cancer Chemother Pharmacol. 1989;24 Suppl 1:S40-4

Active substance: MITOXANTRONE

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Document reference: 32116

Study title: Jürgens H et al The German Society of Pediatric Oncology Cooperative Ewing Sarcoma Studies CESS 81/86: report after 6 1/2 years Klin Padiatr. 1988 May-Jun;200(3):243-52. GermanJürgens H et al The German Society of Pediatric Oncology Cooperative Ewing Sarcoma Studies CESS 81/86: report after 6 1/2 years Klin Padiatr. 1988 May-Jun;200(3):243-52. German

Active substance: MITOXANTRONE

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Document reference: 32106

Study title: A PARALLEL DOUBLE BLIND STUDY OF THE EFFECT OF FELDENE AS ADJUNCT THERAPY TO PREVENT LUNG DAMAGE IN CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA LUNG INFECTION.

Active substance: PIROXICAM

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Document reference: 34435

Study title: A SINGLE-BLIND COMPARATIVE STUDY OF PIROXICAM FDDF BY SUBLINGUAL ROUTE VS. PLACEBO IN THE TREATMENT OF PRIMARY HEADACHE.

Active substance: PIROXICAM

Study summary document link (including results):

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Document reference: 34403

Study title: AN OPEN COMPARATIVE STUDY OF PARENTERAL PIROXICAM VERSUS PARENTERAL LYSINE ACETYL-SALICYLATE FOR THE TREATMENT OF OSTEO ARTICULAR PAIN (DUE TO SICKLE CRISIS)

Active substance: PIROXICAM

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Document reference: 34495

Study title: AN OPEN COMPARATIVE TRIAL OF PIROXICAM VS. SULINDAC IN THE TREATMENT OF PATIENTS WITH ACUTE LOW BACK PAIN.

Active substance: PIROXICAM

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Document reference: 34365

Study title: AN OPEN NON COMPARATIVE MULTICENTER STUDY ON THE EFFICACY AND SAFETY OF PIROXICAM FAST DISSOLVING DOSAGE FROM (FELDENE FAST) IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS IN INTERNAL MEDICINE.

Active substance: PIROXICAM

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Document reference: 34417

Study title: A COMPARATIVE STUDY OF PARENTERAL PIROXICAM VS. PARENTERAL LYSINE ACETYLSALICYLATE FOR THE TREATMENT OF OSTEOARTICULAR PAINFUL ATTACKS DURING SICKLE CELL DISEASE.

Active substance: PIROXICAM

Study summary document link (including results):

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Document reference: 34461

Study title: AN OPEN NON COMPARATIVE TRAIL WITH PIROXICAM PARENTERAL IN ACUTE MUSCULOSKELETAL DISORDERS.

Active substance: PIROXICAM

Study summary document link (including results):

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Document reference: 34357

Study title: AN OPEN NON-COMPARATIVE OF THE EFFICACY AND SAFETY OF 05% TOPICAL PIROXICAM GEL IN THE TREATMENT OF ACUTE MUSCULOSKELETAL (AMS) DISORDERS

Active substance: PIROXICAM

Study summary document link (including results):

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Document reference: 34454

Study title: AN OPEN NON-COMPARATIVE STUDY OF PIROXICAM BY S.L. ROUTE IN THE TREATMENT OF DENTAL PAIN.

Active substance: PIROXICAM

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Document reference: 34402

Study title: AN OPEN NON-COMPARATIVE STUDY OF PIROXICAM FDDF BY S.L. ROUTE IN THE TREATMENT OF PRIMARY HEADACHE.

Active substance: PIROXICAM

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Document reference: 34401

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF 0.5% TOPICAL FELDENE (PRX) GEL IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS

Active substance: PIROXICAM

Study summary document link (including results):

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Document reference: 34366

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF 0.5% TOPICAL FELDENE (PRX) GEL IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS

Active substance: PIROXICAM

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Document reference: 34469

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF 0.5% TOPICAL PIROXICAM GEL IN THE TREATMENT OF SPORTS INJURIES

Active substance: PIROXICAM

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Document reference: 34455

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF 0.5% TOPICAL PIROXICAM GEL IN THE TREATMENT OF SPORTS INJURIES DUE TO SOCCER OR BASKETBALL.

Active substance: PIROXICAM

Study summary document link (including results):

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Document reference: 34437

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF FELDENE (PIROXICAM) IN SOLUTION IN THE TREATMENT OF PATIENTS WITH POSTOPERATIVE

Active substance: PIROXICAM

Study summary document link (including results):

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Document reference: 34470

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND TOLERATION OF PIROXICAM DISPERSIBLE TABLETS IN THE TREATMENT OF POST-OPERATIVE DENTAL PAIN.

Active substance: PIROXICAM

Study summary document link (including results):

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Document reference: 34456

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND TOLERATION OF 0.5% TOPICAL PIROXICAM GEL IN THE TREATMENT OF SPORTS INJURIES.

Active substance: PIROXICAM

Study summary document link (including results):

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Document reference: 34494

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND TOLERATION OF A PRX FDDF TAB IN THE TREATMENT OF ACUTE LOW BACK PAIN.

Active substance: PIROXICAM

Study summary document link (including results):

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Document reference: 34439

Study title: AN OPEN NON-COMPARATIVE TRIAL WITH PARENTERAL PRX IN THE TREATMENT OF ACUTE DISORDERS

Active substance: PIROXICAM

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Document reference: 34407

Study title: AN OPEN, NON-COMPARATIVE MULTICENTER STUDY OF THE ANALGESIC ACTIVITY OF FELDENE FDDF (PIROXICAM) IN PATIENTS WITH ACUTE MUSCULOSKELETAL POST TRAUMATIC PAIN.

Active substance: PIROXICAM

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Document reference: 34459

Study title: Elomaa I et al Five-year results in Ewing's sarcoma. The Scandinavian Sarcoma Group experience with the SSG IX protocol Eur J Cancer. 2000 May;36(7):875-80Elomaa I et al Five-year results in Ewing's sarcoma. The Scandinavian Sarcoma Group experience with the SSG IX protocol Eur J Cancer. 2000 May;36(7):875-80

Active substance: MITOXANTRONE

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Document reference: 32098

Study title: Entz-Werle N et al Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogenic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group reportLeukemia. 2005 Dec;19(12):2072-81.Entz-Werle N et al Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogenic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group reportLeukemia. 2005 Dec;19(12):2072-81.

Active substance: MITOXANTRONE

Study summary document link (including results):

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Document reference: 32074

Study title: Entz-Werle N et al Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogenic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group reportLeukemia. 2005 Dec;19(12):2072-81.Entz-Werle N et al Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogenic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group reportLeukemia. 2005 Dec;19(12):2072-81.

Active substance: MITOXANTRONE

Study summary document link (including results):

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Document reference: 32084

Study title: Eselgrim M et al Dose intensity of chemotherapy for osteosarcoma and outcome in the Cooperative Osteosarcoma Study Group (COSS) trials Pediatr Blood Cancer. 2006 Jul;47(1):42-50Eselgrim M et al Dose intensity of chemotherapy for osteosarcoma and outcome in the Cooperative Osteosarcoma Study Group (COSS) trials Pediatr Blood Cancer. 2006 Jul;47(1):42-50

Active substance: MITOXANTRONE

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Document reference: 32122

Study title: Felgenhauer J et al Very intensive, short-term chemotherapy for children and adolescents withmetastatic sarcomas Med Pediatr Oncol. 2000 Jan;34(1):29-38Felgenhauer J et al Very intensive, short-term chemotherapy for children and adolescents withmetastatic sarcomas Med Pediatr Oncol. 2000 Jan;34(1):29-38

Active substance: MITOXANTRONE

Study summary document link (including results):

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Document reference: 32160

Study title: Ferrari S et al Ifosfamide and actinomycin-D, added in the induction phase to vincristine,cyclophosphamide and doxorubicin, improve histologic response and prognosis in patients with non metastatic Ewing's sarcoma of the extremity J Chemother. 1998 Dec;10(6):484-91Ferrari S et al Ifosfamide and actinomycin-D, added in the induction phase to vincristine,cyclophosphamide and doxorubicin, improve histologic response and prognosis in patients with non metastatic Ewing's sarcoma of the extremity J Chemother. 1998 Dec;10(6):484-91

Active substance: MITOXANTRONE

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Document reference: 32100

Study title: Ferrari S et al Neoadjuvant chemotherapy with high-dose Ifosfamide, high-dose methotrexate,cisplatin, and doxorubicin for patients with localized osteosarcoma of theextremity: a joint study by the Italian and Scandinavian Sarcoma Groups J Clin Oncol. 2005 Dec 1;23(34):8845-52. Epub 2005 Oct 24Ferrari S et al Neoadjuvant chemotherapy with high-dose Ifosfamide, high-dose methotrexate,cisplatin, and doxorubicin for patients with localized osteosarcoma of theextremity: a joint study by the Italian and Scandinavian Sarcoma Groups J Clin Oncol. 2005 Dec 1;23(34):8845-52. Epub 2005 Oct 24

Active substance: MITOXANTRONE

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Document reference: 32120

Study title: Efficacy and safety of mizolastine in seasonal allergic rhinitis. Leynadier F et al (RHINASE study group). (Ann All Asthm Immunol 1996; 76: 163-168) Publication 10 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005 Efficacy and safety of mizolastine in seasonal allergic rhinitis. Leynadier F et al (RHINASE study group). (Ann All Asthm Immunol 1996; 76: 163-168) Publication 10 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005

Active substance: MIZOLASTINE

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Document reference: 32273

Study title: Five-month open-design extension of the controlled study of mizolastine in treatment of perennial allergic rhinitis in adults (POLRIXT study). - Haguenauer J.P. Tudor D. Mathieu G. Guerault E. Senn N. Soubrane C.- 25/04/1994

Active substance: MIZOLASTINE

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Document reference: 32268

Study title: Kantar M et al Treatment results of osteosarcoma of the extremity in children and adolescents at Ege University Hospital Pediatr Hematol Oncol. 2002 Oct-Nov;19(7):475-82Kantar M et al Treatment results of osteosarcoma of the extremity in children and adolescents at Ege University Hospital Pediatr Hematol Oncol. 2002 Oct-Nov;19(7):475-82

Active substance: MITOXANTRONE

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Document reference: 32125

Study title: Kluin-Nelemans HC et al. Standard chemotherapy with or without high-dose chemotherapy for aggressive non-Hodgkin's lymphoma: randomized phase III EORTC study. J Natl Cancer Inst. 2001 Jan 3;93(1):22-30.Kluin-Nelemans HC et al. Standard chemotherapy with or without high-dose chemotherapy for aggressive non-Hodgkin's lymphoma: randomized phase III EORTC study. J Natl Cancer Inst. 2001 Jan 3;93(1):22-30.

Active substance: MITOXANTRONE

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Document reference: 32210

Study title: Kolb EA et al Long-term event-free survival after intensive chemotherapy for Ewing's family of tumors in children and young adults J Clin Oncol. 2003 Sep 15;21(18):3423-30Kolb EA et al Long-term event-free survival after intensive chemotherapy for Ewing's family of tumors in children and young adults J Clin Oncol. 2003 Sep 15;21(18):3423-30

Active substance: MITOXANTRONE

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Document reference: 32109

Study title: Koscielniak E et al Results of treatment for soft tissue sarcoma in childhood and adolescence: a final report of the German Cooperative Soft Tissue Sarcoma Study CWS-86 J Clin Oncol. 1999 Dec;17(12):3706-19Koscielniak E et al Results of treatment for soft tissue sarcoma in childhood and adolescence: a final report of the German Cooperative Soft Tissue Sarcoma Study CWS-86 J Clin Oncol. 1999 Dec;17(12):3706-19

Active substance: MITOXANTRONE

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Document reference: 32165

Study title: Kushner BH et al Desmoplastic small round-cell tumor: prolonged progression-free survival with aggressive multimodality therapy J Clin Oncol. 1996 May;14(5):1526-31Kushner BH et al Desmoplastic small round-cell tumor: prolonged progression-free survival with aggressive multimodality therapy J Clin Oncol. 1996 May;14(5):1526-31

Active substance: MITOXANTRONE

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Document reference: 32089

Study title: NA

Active substance: PIROXICAM

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Document reference: 34440

Study title: OPEN NON-COMPARATIVE MULTICENTER STUDY ON THE EFFICACY AND TOLERATION OF PIROXICAM FAST DISSOLVING DOSAGE FORM (FDDF) IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS.

Active substance: PIROXICAM

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Document reference: 34339

Study title: OPEN NON-COMPARATIVE STUDY ON THE EFFICACY AND TOLERANCE OF PRX IM 20 MG/ML IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS AGUDIZATION OF CHRONIC RHEUMATIC SITUATIONS

Active substance: PIROXICAM

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Document reference: 34452

Study title: OPEN NON-COMPARATIVE TRIAL ON THE EFFICACY AND TOLERANCE OF PIROXICAM IM 20MG/ML IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS.

Active substance: PIROXICAM

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Document reference: 34451

Study title: OPEN NONCOMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF PIROXICAM FDDF BY S.L. ROUTE IN THE TREATMENT OF PRIMARY DYSMENORRHEA

Active substance: PIROXICAM

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Document reference: 34400

Study title: OPEN, NON-COMPARATIVE STUDY OF EFFICACY AND TOLERATION OF PRX GEL 0.5% IN FENCERS.

Active substance: PIROXICAM

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Document reference: 34368

Study title: OPEN, NON-COMPARATIVE STUDY ON THE EFFICACY AND SAFETY OF FELDENE FAST IN THE TREATMENT OF ACUTE MUSCULO SKELETAL DISORDERS

Active substance: PIROXICAM

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Document reference: 34416

Study title: OPEN, NON-COMPARATIVE STUDY WITH FELDENE 20 MG CAPSULES IN PRIMARY DYSMENORRHEA.

Active substance: PIROXICAM

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Document reference: 34443

Study title: OPEN, NON-COMPARATIVE TRIAL OF THE EFFICACY AND TOLERANCE OF PRX IM 20 MG/ML IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS

Active substance: PIROXICAM

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Document reference: 34449

Study title: OPEN, NON-COMPARATIVE TRIAL ON THE EFFICACY AND TOLERANCE OF PRX IM 20 MG/ML IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS

Active substance: PIROXICAM

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Document reference: 34448

Study title: OPEN, NONCOMPARATIVE STUDY ON THE EFFICACY AND SAFETY OF PIROXICAM TOPICAL GEL 0.5% IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS

Active substance: PIROXICAM

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Document reference: 34446

Study title: OPEN,NON-COMPARATIVE STUDY WITH PIROXICAM IM IN ACUTE MUSCULOSKELETAL DISORDERS.

Active substance: PIROXICAM

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Document reference: 34445

Study title: Radiographic and scintigraphic features of modeling and remodeling in the heterotopic skeleton of patients who have fibrodysplasia ossificans progressiva. Kaplan FS, Strear CM, Zasloff MA. Clin Orthop Relat Res. 1994 Jul;(304):238-47.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43621

Study title: Kaps HP, Georgi P, Becker W. [111-In leukocyte scintigraphy in inflammatory diseases of the support and motor systems--initial results] Z Orthop Ihre Grenzgeb. 1985 Sep-Oct;123(5):880-8. German. Kaps HP, Georgi P, Becker W. [111-In leukocyte scintigraphy in inflammatory diseases of the support and motor systems--initial results] Z Orthop Ihre Grenzgeb. 1985 Sep-Oct;123(5):880-8. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43932

Study title: Spinal cord Ewing's sarcoma metastasis: presentation of one case. Kara G. Ann Nucl Med. 2004 Oct;18(7):623-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43394

Study title: Karanauskas S, Starshak RJ, Sty JR. Heterotopic Tc-99m MDP uptake secondary to phlebitis. Clin Nucl Med. 1991 May;16(5):329-31. Karanauskas S, Starshak RJ, Sty JR. Heterotopic Tc-99m MDP uptake secondary to phlebitis. Clin Nucl Med. 1991 May;16(5):329-31.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43737

Study title: Karanauskas S, Wells RG, Sty JR. Abnormal Tc-99m MDP accumulation in a pyelocaliceal diverticulum. Clin Nucl Med. 1991 Sep;16(9):690-1. No abstract available. Karanauskas S, Wells RG, Sty JR. Abnormal Tc-99m MDP accumulation in a pyelocaliceal diverticulum. Clin Nucl Med. 1991 Sep;16(9):690-1. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43729

Study title: Karayalcin U, Karayalcin B, Yakupoglu G, Yildiz A, Erkilic M. Tc-99m-HMDP bone uptake quantification and plasma osteocalcin levels in hemodialysis patients--a preliminary study. Ann Nucl Med. 1992 Feb;6(1):9-12. Karayalcin U, Karayalcin B, Yakupoglu G, Yildiz A, Erkilic M. Tc-99m-HMDP bone uptake quantification and plasma osteocalcin levels in hemodialysis patients--a preliminary study. Ann Nucl Med. 1992 Feb;6(1):9-12.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43711

Study title: Karimeddini MK, Spencer RP. Bone agent and radiogallium deposition around infiltrated calcium gluconate. Clin Nucl Med. 1993 Sep;18(9):797-8. No abstract available. Karimeddini MK, Spencer RP. Bone agent and radiogallium deposition around infiltrated calcium gluconate. Clin Nucl Med. 1993 Sep;18(9):797-8. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43651

Study title: Limb-sparing procedures: postoperative planar bone scan appearance. Kaste SC, Rao BN, Meyer WM, Lynch M. Pediatr Radiol. 1996 Oct;26(10):750-3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43561

Study title: Bone scans in the diagnosis of bone crisis in patients who have Gaucher disease. Katz K, Mechlis-Frish S, Cohen IJ, Horev G, Zaizov R, Lubin E. J Bone Joint Surg Am. 1991 Apr;73(4):513-7. Erratum in: J Bone Joint Surg Am 1991 Jun;73(5):791.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43741

Study title: MR imaging findings in recurrent primary osseous Ewing sarcoma. Kauffman WM, Fletcher BD, Hanna SL, Meyer WH. Magn Reson Imaging. 1994;12(8):1147-53.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43640

Study title: Simons KS, Pickkers P, Bleeker-Rovers CP, Oyen WJ, van der Hoeven JG.. Epub 2009 Oct 22. F-18-fluorodeoxyglucose positron emission tomography combined with CT in critically ill patients with suspected infection. [simons-2010]Intensive Care Med. 2010 Mar;36(3):504-11. Simons KS 2010

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48699

Study title: Sood S, Chugani HT.. Epub 2006 Jun 24. Functional neuroimaging in the preoperative evaluation of children with drugresistant epilepsy. [sood-2006]Childs Nerv Syst. 2006 Aug;22(8):810-20. Sood S 2006

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48700

Study title: Mizolastine is effective and well-tolerated in the long-term treatment of perennial allergic rhinoconjonctivitis. Scadding GK et al. (RIPEREX study group). (J Int Med Res 1999; 27: 273-285) Publication 14 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005 Mizolastine is effective and well-tolerated in the long-term treatment of perennial allergic rhinoconjonctivitis. Scadding GK et al. (RIPEREX study group). (J Int Med Res 1999; 27: 273-285) Publication 14 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005

Active substance: MIZOLASTINE

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Document reference: 32274

Study title: Mizolastine therapy also has an effect on nasal blockade in perennial allergic rhinoconjonctivitis. Bachert C et al. (RIPERAN study group) (Allergy 1998; 53: 969-975) Publication 13 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005 Mizolastine therapy also has an effect on nasal blockade in perennial allergic rhinoconjonctivitis. Bachert C et al. (RIPERAN study group) (Allergy 1998; 53: 969-975) Publication 13 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005

Active substance: MIZOLASTINE

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Document reference: 32275

Study title: Observational study of patients suffering from seasonal allergic rhinoconjunctivitis treated with mizolastine 10 mg during 14-28 days.

Active substance: MIZOLASTINE

Study summary document link (including results): Mizolastine-Study 2.pdf

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Document reference: 32267

Study title: Observational study of patients suffering from seasonal allergic rhinoconjunctivitis treated with Misolastine 10mg (OD) during 14-28 days (PANEOS study). Murrietta M. 04/10/1999.

Active substance: MIZOLASTINE

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Document reference: 32269

Study title: Optimisation of the experimental design for the population pharmacokinetic analysis of mizolastine solution in children, submitted to J. Pharmacokin. Biopharm - Mentré F, Dubruc C., Thénot J.P.- No date.Optimisation of the experimental design for the population pharmacokinetic analysis of mizolastine solution in children, submitted to J. Pharmacokin. Biopharm - Mentré F, Dubruc C., Thénot J.P.- No date.

Active substance: MIZOLASTINE

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Document reference: 32271

Study title: Pharmacokinetic study of myzolastine paediatric syrup in allergic children aged 6 to 12 years.

Active substance: MIZOLASTINE

Study summary document link (including results): Mizolastine-Study 3.pdf

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Document reference: 32270

Study title: A 1-Year Open-Label, Flexible-Dosage Extension Study to Assess the Safety and Continued Effectiveness of PROVIGIL® (Modafinil) Treatment in Children and Adolescents with Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea/Hyponea Syndrome.

Active substance: MODAFINIL

Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls

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Document reference: 45277

Study title: A 6-Month Open-Label, Flexible-Dosage Study to Assess the Safety and Effectiveness of PROVIGIL® (Modafinil) Treatment in Children and Adolescents with Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea/Hyponea Syndrome.

Active substance: MODAFINIL

Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls

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Document reference: 45278

Study title: A 6-Week, Double-Blind, Placebo-Controlled, Parallel-Group Randomized-Withdrawel Study to Evaluate the Continued Efficacy of Modafinil at Dosages Up to 425 mg/day in Patients with Attention-Defizit/Hyperactivity Disorder who are Resonders to Modafinil Treatment, Followed by a 12-month Open-Label Extension Period.

Active substance: MODAFINIL

Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls

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Document reference: 45280

Study title: Pravastatin in the treatment of secondary hypercholesterolemia in Alagille's syndrome

Active substance: PRAVASTATIN

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Document reference: 46099

Study title: Safety and efficacy of pravastatin in pediatric heart transplant patients

Active substance: PRAVASTATIN

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Document reference: 46101

Study title: PHASE III DOUBLE BLIND CROSSOVER COMPARATIVE TRIAL IN PATIENTS WITH PRIMARY DYSMENORRHEA

Active substance: PIROXICAM

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Document reference: 34322

Study title: PHASE III DOUBLE BLIND PARALLEL COMPARATIVE TIRAL OF PATIENTS WITH POSTOPERATIVE PAIN

Active substance: PIROXICAM

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Document reference: 34313

Study title: PIROXICAM (FELDENE) VS. NAPROXEN (NAPROSYN) IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS IN ATHLETES

Active substance: PIROXICAM

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Document reference: 34324

Study title: PIROXICAM AND FLOCTAFENINA IN PRIMARY DYSMENORRHEA.

Active substance: PIROXICAM

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Document reference: 34481

Study title: PIROXICAM CREAM FOR IONOPHORETIC USE IN REACUTIZED OSTEOARHRITHIS: THE RESULTS OF A COMPARATIVE PLACEBO CONTROLLED STUDY VERSUS KETOPROFEN AND DICLOFENAC

Active substance: PIROXICAM

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Document reference: 34398

Study title: PIROXICAM FLASH IN UPPER RESPIRATORY TRACT INFECTIONS.

Active substance: PIROXICAM

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Document reference: 34374

Study title: PIROXICAM GEL IN PREVENTION OF CANNULA - RELATED THROMBOPHLEBITIS.

Active substance: PIROXICAM

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Document reference: 34477

Study title: PIROXICAM GEL IN THE TREATMENT OF ACUTE POST TRAUMATIC MILD TO MODERATE MUSCULOSKELETAL DISORDERS OPEN NON-COMPARATIVE MULTICENTER STUDY.

Active substance: PIROXICAM

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Document reference: 34364

Study title: PIROXICAM IN THE TREATMENT OF ACUTE LUMBAGO.

Active substance: PIROXICAM

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Document reference: 34426

Study title: PIROXICAM IN THE TREATMENT OF POST-OPERATIVE PAIN FOLLOWING GYN SURGERY.

Active substance: PIROXICAM

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Document reference: 34388

Study title: PIROXICAM IN THE TREATMENT OF PRIMARY DYSMENORRHEA.

Active substance: PIROXICAM

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Document reference: 34372

Study title: PIROXICAM IN THE TREATMENT OF SYMPTOMS ASSOCIATED WITH VIRAL PHARYNGITIS

Active substance: PIROXICAM

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Document reference: 34386

Study title: PROTOCOL FOR THE DOUBLE-BLIND, PARALLE COMPARATIVE STUDY OF PIROXICAM (TWO DOSES), ACETAMINOPHEN/CODEINE AND PLACEBO IN PATIENTSWITH POSTOPERATIVE DENTAL PAIN

Active substance: PIROXICAM

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Document reference: 34312

Study title: A double-blind parallel group study comparing HOE777 0.25% fatty ointment with vehicle in patients with mild to moderate atopic or eczematous contact dermatitis.

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Fredriksson.xls

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Document reference: 34667

Study title: A double-blind three centre parallel group study comparing HOE777 0,25%emollient cream with Ultralan emollent cream in patients with mild to very severe atopic or eczematous contact dermatitis and in psoriasis patients - J. Deschilder et al. - 1982 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Deschilder.xls

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Document reference: 34656

Study title: "A double-blind two centre parallel group study comparing HOE277 0,25% aqueous cream and vehicle patients with mild to very severe contact or atopic dermatitis - A. Lassus et al. - 1984 (Hoechst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -" "A double-blind two centre parallel group study comparing HOE277 0,25% aqueous cream and vehicle patients with mild to very severe contact or atopic dermatitis - A. Lassus et al. - 1984 (Hoechst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -"

Active substance: PREDNICARBATE

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Document reference: 34668

Study title: A double-blind two centre parallel group study comparing HOE777 0.25% aqueous cream, with betamethasone valerate 0.1% aqueous cream in patients with slight to very severe atopic or excematous contact dermatitis

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Pestzoldt.xls

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Document reference: 48014

Study title: Quantitative scintigraphy of sacroiliac joints: effects of age, gender, and laterality. Vyas K, Eklem M, Seto H, Bobba VR, Brown P, Haines J, Krishnamurthy GT. AJR Am J Roentgenol. 1981 Mar;136(3):589-92.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44130

Study title: [Diagnostic evaluation of skeletal scintigraphy in comparison to roentgen studies in histiocytosis X in childhood. Case report] German. Wagenknecht C, Lips H, Nitz I, Hilgenfeld E. Kinderarztl Prax. 1990 Jul;58(7):355-62. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43760

Study title: Wallace AL, Strachan RK, Blane A, Best JJ, Hughes SP. Quantitative early phase scintigraphy in the prediction of healing of tibial fractures. Skeletal Radiol. 1992;21(4):241-5. Wallace AL, Strachan RK, Blane A, Best JJ, Hughes SP. Quantitative early phase scintigraphy in the prediction of healing of tibial fractures. Skeletal Radiol. 1992;21(4):241-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43714

Study title: Positive bone scan in cat-scratch disease. Walterspiel JN, Nimityongskul P. Pediatr Infect Dis J. 1987 Oct;6(10):944-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43843

Study title: Walz D, Craig BM, McGinnis KD. Bone imaging showing shin splints and stress fractures. Clin Nucl Med. 1987 Oct;12(10):822. No abstract available. Walz D, Craig BM, McGinnis KD. Bone imaging showing shin splints and stress fractures. Clin Nucl Med. 1987 Oct;12(10):822. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43844

Study title: Wang K, Allen L, Fung E, Chan CC, Chan JC, Griffith JF. Bone scintigraphy in common tumors with osteolytic components. Clin Nucl Med. 2005 Oct;30(10):655-71. Review. Wang K, Allen L, Fung E, Chan CC, Chan JC, Griffith JF. Bone scintigraphy in common tumors with osteolytic components. Clin Nucl Med. 2005 Oct;30(10):655-71. Review.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43385

Study title: Wardlaw JM, Best JJ, Hughes SP. Dynamic bone imaging in the investigation of local bone pathology--when is it useful? Clin Radiol. 1991 Feb;43(2):107-12. Wardlaw JM, Best JJ, Hughes SP. Dynamic bone imaging in the investigation of local bone pathology--when is it useful? Clin Radiol. 1991 Feb;43(2):107-12.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43748

Study title: Watanabe H, Arita S, Chigira M. Aetiology of a simple bone cyst. A case report. Int Orthop. 1994 Feb;18(1):16-9. Watanabe H, Arita S, Chigira M. Aetiology of a simple bone cyst. A case report. Int Orthop. 1994 Feb;18(1):16-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43635

Study title: Watanabe O, Hashimoto M, Tomura N, Watarai J. [Evaluation of usefulness of bone SPECT for lumbar spondylolysis] Nippon Igaku Hoshasen Gakkai Zasshi. 2002 Jul;62(8):423-9. Japanese. Watanabe O, Hashimoto M, Tomura N, Watarai J. [Evaluation of usefulness of bone SPECT for lumbar spondylolysis] Nippon Igaku Hoshasen Gakkai Zasshi. 2002 Jul;62(8):423-9. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43443

Study title: Stauss J, Franzius C, Pfluger T, Juergens KU, Biassoni L, Begent J, et al..Guidelines for 18F-FDG PET and PET-CT imaging in paediatric oncology. [stauss-2008]Eur J Nucl Med Mol Imaging 2008; 35:1581–1588. Stauss J 2008

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48701

Study title: Stumpe KD, Urbinelli M, Steinert HC, Glanzmann C, Buck A, von Schulthess GK. Whole-body positron emission tomography using fluorodeoxyglucose for staging of lymphoma: effectiveness and comparison with computed tomography. [stumpe-1998]Eur J Nucl Med. 1998 Jul;25(7):721-8. Stumpe KD 1998

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48702

Study title: Tan LT, Ong KL.. Semiquantitative measurements of normal organs with variable metabolic activity on FDG PET imaging. [tan-2004]Ann Acad Med Singapore. 2004 Mar;33(2):183-5. Tan LT 2004

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48703

Study title: Safety and efficacy of pravastatin therapy for the prevention of hyperlipidemia in pediatric and adolescent cardiac transplant patients

Active substance: PRAVASTATIN

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Document reference: 46102

Study title: Short-term efficacy and safety of pravastatin in 72 children with familial hypercholesterolemia

Active substance: PRAVASTATIN

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Document reference: 46103

Study title: Should pediatric patients with hyperlipidemia receive drug therapy?

Active substance: PRAVASTATIN

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Document reference: 46104

Study title: " Kurian-B-T, Ray-W-A, Arbogast-P-G, Fuchs-D-C, Dudley-J-A, Cooper-W-O. Dr. W.O. Cooper, Department of Pediatrics, Vanderbilt University Medical Center, AA-0216 MCN, Nashville, TN 37232, United States e-mail: william.cooper@vanderbilt.edu. Effect of regulatory warnings on antidepressant prescribing for children and adolescents. Archives of Pediatrics and Adolescent Medicine {ARCH-PEDIATR-ADOLESC- MED}, 2007, Vol/Iss/Pg. 161/7 (690-696), eISSN: 1538-3628, ISSN: 1072-4710. " " Kurian-B-T, Ray-W-A, Arbogast-P-G, Fuchs-D-C, Dudley-J-A, Cooper-W-O. Dr. W.O. Cooper, Department of Pediatrics, Vanderbilt University Medical Center, AA-0216 MCN, Nashville, TN 37232, United States e-mail: william.cooper@vanderbilt.edu. Effect of regulatory warnings on antidepr...

Active substance: PRAZEPAM

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Document reference: 34641

Study title: "Le-Heuzey-M-F, Jacqz-Aigrain-E. M.F. Le Heuzey, Serv. Psychopathol. l'Enfant/l'Adol., Hopital Robert Debre, 48, boulevard Serurier, 75019 Paris, France e-mail: marie-france.leheuzey@rdb.ap-hop-paris.fr. Drugs and sleep disorders in children. Archives de Pediatrie {ARCH-PEDIATR}, 2002, Vol/Iss/Pg. 9/SUPPL. 2 (187s-189s), ISSN: 0929-693X." " "Le-Heuzey-M-F, Jacqz-Aigrain-E. M.F. Le Heuzey, Serv. Psychopathol. l'Enfant/l'Adol., Hopital Robert Debre, 48, boulevard Serurier, 75019 Paris, France e-mail: marie-france.leheuzey@rdb.ap-hop-paris.fr. Drugs and sleep disorders in children. Archives de Pediatrie {ARCH-PEDIATR}, 2002, Vol/Iss/Pg. 9/SUPPL. 2 (187s-189s), ISSN: 0929-693X." "

Active substance: PRAZEPAM

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Document reference: 34643

Study title: "Mancini-J, Thirion-X, Masut-A, Saillard-C, Pradel-V, Romain-F, Pastor-M-J-J, Coudert-C, Micallef-J. X. Thirion, Service d'Information Medicale, Hopital Sainte Marguerite, 270 Bd de Sainte Marguerite, Marseille, France e-mail: xavier.thirion@mail.ap.hm.fr. Anxiolytics, hypnotics, and antidepressants dispensed to adolescents in a French region in 2002. Pharmacoepidemiology and Drug Safety {PHARMACOEPIDEMIOL-DRUG-SAF}, 2006, Vol/Iss/Pg. 15/7 (494-503), eISSN: 1099-1557, ISSN: 1053-8569. " "Mancini-J, Thirion-X, Masut-A, Saillard-C, Pradel-V, Romain-F, Pastor-M-J-J, Coudert-C, Micallef-J. X. Thirion, Service d'Information Medicale, Hopital Sainte Marguerite, 270 Bd de Sainte Marguerite, Marseille, France e-mail: xavier.thirion@mail.ap.hm....

Active substance: PRAZEPAM

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Document reference: 34638

Study title: our experience with piracetam (Nootropil UCB) treatment in children from high-risk pregnancies with subsequent minimal brain dysfunction.

Active substance: PIRACETAM

Study summary document link (including results): PDEE92K2736 - Piracetam.pdf

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Document reference: 45993

Study title: Piracetam (UCB 6215) in the reeducation of children with speech disorders.

Active substance: PIRACETAM

Study summary document link (including results): CE71K081 - Piracetam.pdf

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Document reference: 45912

Study title: Piracetam and acetamide in sickle-cell disease.

Active substance: PIRACETAM

Study summary document link (including results): DE77J021P - Piracetam.pdf

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Document reference: 45934

Study title: A double-blind two centre parallel group study comparing HOE777 0.25% fatty ointment with topisolon 0.25% fatty ointment in patients with mild to severe atopic or eczematous contact dermatitis

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Plewig.xls

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Document reference: 48015

Study title: A four-weeks evaluation of HOE777 fatty ointment 0,25%in young patients with severe atopic dermatitis of long duration - G. Rajka - 1987 (unpublished report) Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Rajka.xls

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Document reference: 34657

Study title: An open study with HOE 777 0.25% emollient cream in children aged from 1 to 12 years with contact dermatitis, atopic dermatitis, seborrhoeic eczema or psoriasis

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Herz.xls

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Document reference: 34669

Study title: An open study with HOE 777 0.25% emollient cream in children up to 1 year with seborrhoeic eczema

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Herz 1year.xls

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Document reference: 34676

Study title: "Berlin dermatologists study. Clinical efficacy and tolerance of prednicarbate cream ointment and fatty ointment - C.E Orfanos - 1985 (Hoechst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -" "Berlin dermatologists study. Clinical efficacy and tolerance of prednicarbate cream ointment and fatty ointment - C.E Orfanos - 1985 (Hoechst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -"

Active substance: PREDNICARBATE

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Document reference: 34670

Study title: The effect of piracetam on intellectual abilities and performances in handicapped children.

Active substance: PIRACETAM

Study summary document link (including results): DE85G231P - Piracetam.pdf

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Document reference: 45953

Study title: The migraine: benign paroxysmal vertigo of childhood complex.

Active substance: PIRACETAM

Study summary document link (including results): ADPE99M0703 - Piracetam.pdf

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Document reference: 45958

Study title: The question of correlations between biological and clinical indices in children with mental deficiency.

Active substance: PIRACETAM

Study summary document link (including results): DRU82G141P - Piracetam.pdf

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Document reference: 45940

Study title: The selectivity of action of preparations for metabolic therapy of mentally deficient children.

Active substance: PIRACETAM

Study summary document link (including results): DRU81B233P - Piracetam.pdf

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Document reference: 45919

Study title: The therapeutic value of Nootropil (piracetam-UCB) in pediatric neurosurgery. Preliminary report.

Active substance: PIRACETAM

Study summary document link (including results): DE75L071P - Piracetam.pdf

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Document reference: 46027

Study title: The value of the use of piracetam (UCB 6215) in adjustment disturbances of children

Active substance: PIRACETAM

Study summary document link (including results): CE72B281 - Piracetam.pdf

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Document reference: 45937

Study title: Therapeutic evaluation of Nootropil (piracetam) in pediatric neurosurgery.

Active substance: PIRACETAM

Study summary document link (including results): PDEE92K2608 - Piracetam.pdf

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Document reference: 46028

Study title: Therapeutic monitoring of piracetam in women in childbirth and in neonates.

Active substance: PIRACETAM

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Document reference: 46013

Study title: Evaluation of temporal and facial osteomyelitis by simultaneous In-WBC/Tc-99m-MDP bone SPECT scintigraphy and computed tomography scan. Weber PC, Seabold JE, Graham SM, Hoffmann HH, Simonson TM, Thompson BH. Otolaryngol Head Neck Surg. 1995 Jul;113(1):36-41.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43594

Study title: [Extraosseous tumor uptake of 99m technetium methylendiphosphonate in children with neuroblastoma (author's transl)] Italian Mancini AF, Turba E, Vallicelli R, Vitelli A, Fini A, Rosito P. Pediatr Med Chir. 1981 Nov-Dec;3(6):535-9. Italian. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44189

Study title: Mandell GA, Contreras SJ, Conard K, Harcke HT, Maas KW. Bone scintigraphy in the detection of chronic recurrent multifocal osteomyelitis. J Nucl Med. 1998 Oct;39(10):1778-83. Mandell GA, Contreras SJ, Conard K, Harcke HT, Maas KW. Bone scintigraphy in the detection of chronic recurrent multifocal osteomyelitis. J Nucl Med. 1998 Oct;39(10):1778-83.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43523

Study title: Mandell GA, Harcke HT, Davis N. Accumulation of technetium-99m MDP in an intramuscular hemangioma. Clin Nucl Med. 1986 Jul;11(7):487-90. Mandell GA, Harcke HT, Davis N. Accumulation of technetium-99m MDP in an intramuscular hemangioma. Clin Nucl Med. 1986 Jul;11(7):487-90.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43902

Study title: Uterine blush in multiphase bone imaging.Mandell GA, Harcke HT, Sharkey C, Brooks K J Nucl Med. 1986 Jan;27(1):51-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43919

Study title: Mandell GA, Harcke HT, Sharkey C, Cooley L. Postprandial blush in multiphase bone scanning. J Nucl Med. 1987 Oct;28(10):1550-3. Mandell GA, Harcke HT, Sharkey C, Cooley L. Postprandial blush in multiphase bone scanning. J Nucl Med. 1987 Oct;28(10):1550-3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43845

Study title: Extrinsic causes of vesical filling defects on scintigraphy.Mandell GA, Harcke HT. Clin Nucl Med. 1987 Mar;12(3):204-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43871

Study title: Mandell GA, Harcke HT. Pelvic "doughnut". Sign of incidental pregnancy on bone scintigraphy. Clin Nucl Med. 1987 Feb;12(2):116-7. Mandell GA, Harcke HT. Pelvic "doughnut". Sign of incidental pregnancy on bone scintigraphy. Clin Nucl Med. 1987 Feb;12(2):116-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43874

Study title: Mandell GA, Harcke HT. Scintigraphic manifestations of infraction of the second metatarsal (Freiberg's disease). J Nucl Med. 1987 Feb;28(2):249-51. Mandell GA, Harcke HT. Scintigraphic manifestations of infraction of the second metatarsal (Freiberg's disease). J Nucl Med. 1987 Feb;28(2):249-51.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43875

Study title: Accumulation of MDP in primary childhood hepatic malignancies and their metastases. Mandell GA, Heyman S. Clin Nucl Med. 1983 Dec;8(12):594-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44019

Study title: The Utility of a 3-Dimensional, Large-Field-Of-View, Sodium Iodide Crystal–Based PET Scanner in the Presurgical Evaluation of Partial EpilepsyTHE JOURNAL OF NUCLEAR MEDICINE ,Vol. 42, No. 8, August 2001. Terence J. O’Brien, Rodney J. Hicks, Robert Ware, David S. Binns, Michael Murphy, and Mark J. Cook

Active substance: Steripet

Study summary document link (including results): obrien-2001.pdf

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Document reference: 48740

Study title: The Value of 18F-FDG PET in the Detection of Stage M0 Carcinoma of the NasopharynxJ Nucl Med 2005; 46:405–410 .Tzu-Chen Yen, MD, PhD1; Joseph Tung-Chieh Chang, MD, MHA2; Shu-Hang Ng, MD3; Yu-Chen Chang, MD1; Sheng-Chieh Chan, MD1; Kun-Ju Lin, MD1; Wuu-Jyh Lin, PhD4; Ying-Kai Fu, PhD4; and Chen-Yu Lin2

Active substance: Steripet

Study summary document link (including results): yen-2005-b.pdf

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Document reference: 48748

Study title: Piracetam as a cell communication enhancer: neuroreceptors.

Active substance: PIRACETAM

Study summary document link (including results): ADRE91G1139 - Piracetam.pdf

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Document reference: 46038

Study title: Piracetam effect on rat reproductive function and sexual maturation of the offspring.

Active substance: PIRACETAM

Study summary document link (including results): DRU87H122P - Piracetam.pdf

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Document reference: 46042

Study title: Piracetam for the treatment of breath-holding spells [selected summaries].

Active substance: PIRACETAM

Study summary document link (including results): ADPE99G2323 - Piracetam.pdf

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Document reference: 45946

Study title: Piracetam for the treatment of sickle cell disease in children - a double blind test.

Active substance: PIRACETAM

Study summary document link (including results): ADPE98G1611 - Piracetam.pdf

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Document reference: 45938

Study title: Piracetam in child and adolescent psychiatry.

Active substance: PIRACETAM

Study summary document link (including results): ADPE03J2302-translation - Piracetam.pdf

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Document reference: 45954

Study title: Piracetam in learning and behaviour disorders in children.

Active substance: PIRACETAM

Study summary document link (including results): DE79A153 - Piracetam.pdf

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Document reference: 45892

Study title: Piracetam in learning and behaviour disorders in children.

Active substance: PIRACETAM

Study summary document link (including results): DE79D171 - Piracetam.pdf

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Document reference: 47900

Study title: Piracetam in learning and behaviour disorders in children.

Active substance: PIRACETAM

Study summary document link (including results): DE79D172 - Piracetam.pdf

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Document reference: 47901

Study title: Piracetam in primarily anaemic and cytotoxic hypoxic coma in children.

Active substance: PIRACETAM

Study summary document link (including results): PDEE92K2701 - Piracetam.pdf

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Document reference: 46009

Study title: Piracetam in sickle cell anemia.

Active substance: PIRACETAM

Study summary document link (including results): ARCE92K0801 - Piracetam.pdf

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Document reference: 45894

Study title: Piracetam in the management of spasticity in cerebral palsy.

Active substance: PIRACETAM

Study summary document link (including results): DE78F222P - Piracetam.pdf

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Document reference: 45974

Study title: Piracetam in the treatment of children with acute neuroleptic intoxication.

Active substance: PIRACETAM

Study summary document link (including results): ARCP92F2523 - Piracetam.pdf

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Document reference: 45908

Study title: Piracetam in treatment of children with school problems.

Active substance: PIRACETAM

Study summary document link (including results): DP90J101P - Piracetam.pdf

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Document reference: 46024

Study title: Flamant F et al Treatment of non-metastatic rhabdomyosarcomas in childhood and adolescence.Results of the second study of the International Society of Paediatric Oncology: MMT84 Eur J Cancer. 1998 Jun;34(7):1050-62Flamant F et al Treatment of non-metastatic rhabdomyosarcomas in childhood and adolescence.Results of the second study of the International Society of Paediatric Oncology: MMT84 Eur J Cancer. 1998 Jun;34(7):1050-62

Active substance: MITOXANTRONE

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Document reference: 32150

Study title: Traitement de l'enurese nocturne par la medication associee de la dixyrazine et du piracetam.

Active substance: PIRACETAM

Study summary document link (including results): DE79G022 - Piracetam.pdf

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Document reference: 45898

Study title: Treatment of enuresis: a study with imipramine, amitriptyline, chlordiazepoxide-clidinium and piracetam.

Active substance: PIRACETAM

Study summary document link (including results): DE87G171P - Piracetam.pdf

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Document reference: 46030

Study title: Treatment of nocturnal enuresis: a placebo-controlled trial with piracetam, diphenylhydantoin and psychotherapy

Active substance: PIRACETAM

Study summary document link (including results): PDEE91F0512 - Piracetam.pdf

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Document reference: 45963

Study title: Use of piracetam (2-pyrrolidone acetamide) in sickle cell anaemia.

Active substance: PIRACETAM

Study summary document link (including results): DE82A193P - Piracetam.pdf

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Document reference: 45994

Study title: Use of piracetam in the treatment of children with severe drug poisoning.

Active substance: PIRACETAM

Study summary document link (including results): RAE90K295S - Piracetam.pdf

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Document reference: 46008

Study title: Use of piracetam in the treatment of children with the infantile brain-damage syndrome.

Active substance: PIRACETAM

Study summary document link (including results): DE84D278 - Piracetam.pdf

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Document reference: 46004

Study title: Uso do piracetam (acetamida de pirrolidona) em problemas de escolaridade infantil.

Active substance: PIRACETAM

Study summary document link (including results): DP78D281P - Piracetam.pdf

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Document reference: 45935

Study title: Kushner BH et al How effective is dose-intensive/myeloablative therapy against Ewing'ssarcoma/primitive neuroectodermal tumor metastatic to bone or bone marrow? The Memorial Sloan-Kettering experience and a literature review J Clin Oncol. 2001 Feb 1;19(3):870-80. ReviewKushner BH et al How effective is dose-intensive/myeloablative therapy against Ewing'ssarcoma/primitive neuroectodermal tumor metastatic to bone or bone marrow? The Memorial Sloan-Kettering experience and a literature review J Clin Oncol. 2001 Feb 1;19(3):870-80. Review

Active substance: MITOXANTRONE

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Document reference: 32097

Study title: Laver JH et al. Results of a randomized phase III trial in children and adolescents with advanced stage diffuse large cell non-Hodgkin's lymphoma: a Pediatric Oncology Group study. Leuk Lymphoma. 2002 Jan;43(1):105-9Laver JH et al. Results of a randomized phase III trial in children and adolescents with advanced stage diffuse large cell non-Hodgkin's lymphoma: a Pediatric Oncology Group study. Leuk Lymphoma. 2002 Jan;43(1):105-9

Active substance: MITOXANTRONE

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Document reference: 32205

Study title: Le Deley MC et al SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients Eur J Cancer. 2007 Mar;43(4):752-61. Epub 2007 Jan 30Le Deley MC et al SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients Eur J Cancer. 2007 Mar;43(4):752-61. Epub 2007 Jan 30

Active substance: MITOXANTRONE

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Document reference: 32117

Study title: Link MP et al Treatment of children and young adults with early-stage non-Hodgkin's lymphoma. N Engl J Med. 1997 Oct 30;337(18):1259-66Link MP et al Treatment of children and young adults with early-stage non-Hodgkin's lymphoma. N Engl J Med. 1997 Oct 30;337(18):1259-66

Active substance: MITOXANTRONE

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Document reference: 32213

Study title: Extraosseous uptake of technetium-99m MDP in secondary deposits of neuroblastoma.Mandell GA, Heyman S. Clin Nucl Med. 1986 May;11(5):337-40.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43912

Study title: Mandell GA, Heyman S. Mid-line circular photopenic defects of the sternum. Br J Radiol. 1983 Oct;56(670):761-3. No abstract available. Mandell GA, Heyman S. Mid-line circular photopenic defects of the sternum. Br J Radiol. 1983 Oct;56(670):761-3. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44026

Study title: Rifai A, Nyman R. Scintigraphy and ultrasonography in differentiating osteomyelitis from bone infarction in sickle cell disease. Acta Radiol. 1997 Jan;38(1):139-43. Review. Rifai A, Nyman R. Scintigraphy and ultrasonography in differentiating osteomyelitis from bone infarction in sickle cell disease. Acta Radiol. 1997 Jan;38(1):139-43. Review.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43555

Study title: Ritter G. [Perthes' disease in scintigraphy - early diagnosis, course and therapeutic consequences] Z Orthop Ihre Grenzgeb. 1982 Nov-Dec;120(6):850-9. German. Ritter G. [Perthes' disease in scintigraphy - early diagnosis, course and therapeutic consequences] Z Orthop Ihre Grenzgeb. 1982 Nov-Dec;120(6):850-9. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44067

Study title: Rivera-Rodriguez JE, Rodriguez AA, Turnbull GL, Moreno AJ. Scintigraphic evaluation with Tc-99m MDP and Ga-67 citrate in a case of pediatric T-cell lymphoma. Clin Nucl Med. 1992 Jan;17(1):61-4. No abstract available. Rivera-Rodriguez JE, Rodriguez AA, Turnbull GL, Moreno AJ. Scintigraphic evaluation with Tc-99m MDP and Ga-67 citrate in a case of pediatric T-cell lymphoma. Clin Nucl Med. 1992 Jan;17(1):61-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43715

Study title: Roach J, Höschl R. Diffuse femoral uptake on bone scan after fracture in an infant. Q J Nucl Med. 1996 Jun;40(2):194-6. Roach J, Höschl R. Diffuse femoral uptake on bone scan after fracture in an infant. Q J Nucl Med. 1996 Jun;40(2):194-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43565

Study title: Bowel visualization on bone scan because of protein losing enteropathy. Roach PJ, Itrato D, Treves ST. Clin Nucl Med. 1994 Dec;19(12):1114-6. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43606

Study title: Sympathetic denervation due to neuroblastoma. Roach PJ, Treves ST. Clin Nucl Med. 1994 Nov;19(11):1023-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43611

Study title: Robinson PD, Harris K, Coghlan KC, Altman K. Bone scans and the timing of treatment for condylar hyperplasia. Int J Oral Maxillofac Surg. 1990 Aug;19(4):243-6. Robinson PD, Harris K, Coghlan KC, Altman K. Bone scans and the timing of treatment for condylar hyperplasia. Int J Oral Maxillofac Surg. 1990 Aug;19(4):243-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43758

Study title: Three-phase radionuclide bone imaging in stress injury of the anterior iliac crest. Rockett JF. J Nucl Med. 1990 Sep;31(9):1554-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43754

Study title: Rohlin M. Diagnostic value of bone scintigraphy in osteomyelitis of the mandible. Oral Surg Oral Med Oral Pathol. 1993 May;75(5):650-7. Rohlin M. Diagnostic value of bone scintigraphy in osteomyelitis of the mandible. Oral Surg Oral Med Oral Pathol. 1993 May;75(5):650-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43666

Study title: Fuchs N et al Long-term results of the co-operative German-Austrian-Swiss osteosarcoma study group's protocol COSS-86 of intensive multidrug chemotherapy and surgery for osteosarcoma of the limbs Ann Oncol. 1998 Aug;9(8):893-9Fuchs N et al Long-term results of the co-operative German-Austrian-Swiss osteosarcoma study group's protocol COSS-86 of intensive multidrug chemotherapy and surgery for osteosarcoma of the limbs Ann Oncol. 1998 Aug;9(8):893-9

Active substance: MITOXANTRONE

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Document reference: 32128

Study title: Gentet JC et al Ifosfamide and etoposide in childhood osteosarcoma. A phase II study of the French Society of Paediatric Oncology Eur J Cancer. 1997 Feb;33(2):232-7Gentet JC et al Ifosfamide and etoposide in childhood osteosarcoma. A phase II study of the French Society of Paediatric Oncology Eur J Cancer. 1997 Feb;33(2):232-7

Active substance: MITOXANTRONE

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Document reference: 32140

Study title: Gerhartz HH et al. Randomized, double-blind, placebo-controlled, phase III study of recombinant human granulocyte-macrophage colony-stimulating factor as adjunct to induction treatment of high-grade malignant non-Hodgkin's lymphomas. Blood. 1993 Oct 15;82(8):2329-39.Gerhartz HH et al. Randomized, double-blind, placebo-controlled, phase III study of recombinant human granulocyte-macrophage colony-stimulating factor as adjunct to induction treatment of high-grade malignant non-Hodgkin's lymphomas. Blood. 1993 Oct 15;82(8):2329-39.

Active substance: MITOXANTRONE

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Document reference: 32220

Study title: Geyer JR et al Multiagent chemotherapy and deferred radiotherapy in infants with malignant brain tumors: a report from the Children's Cancer Group. J Clin Oncol. 2005 Oct 20;23(30):7621-31Geyer JR et al Multiagent chemotherapy and deferred radiotherapy in infants with malignant brain tumors: a report from the Children's Cancer Group. J Clin Oncol. 2005 Oct 20;23(30):7621-31

Active substance: MITOXANTRONE

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Document reference: 32233

Study title: Goorin AM et al Phase II/III trial of etoposide and high-dose ifosfamide in newly diagnosed metastatic osteosarcoma: a pediatric oncology group trial J Clin Oncol. 2002 Jan 15;20(2):426-33Goorin AM et al Phase II/III trial of etoposide and high-dose ifosfamide in newly diagnosed metastatic osteosarcoma: a pediatric oncology group trial J Clin Oncol. 2002 Jan 15;20(2):426-33

Active substance: MITOXANTRONE

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Document reference: 32133

Study title: Graham ML et alPhase II trial of mitoxantrone in acute lymphoblastic leukemia of childhood. A Pediatric Oncology Group studyInvest New Drugs. 1991 Aug;9(3):263-7. Erratum in: Invest New Drugs 1991 Nov;9(4):383. Wilkerson RW [corrected to Wilkerson RW].Graham ML et alPhase II trial of mitoxantrone in acute lymphoblastic leukemia of childhood. A Pediatric Oncology Group studyInvest New Drugs. 1991 Aug;9(3):263-7. Erratum in: Invest New Drugs 1991 Nov;9(4):383. Wilkerson RW [corrected to Wilkerson RW].

Active substance: MITOXANTRONE

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Document reference: 32071

Study title: Green DM et al. Treatment of children with clear-cell sarcoma of the kidney: a report from theNational Wilms' Tumor Study Group. J Clin Oncol. 1994 Oct;12(10):2132-7Green DM et al. Treatment of children with clear-cell sarcoma of the kidney: a report from theNational Wilms' Tumor Study Group. J Clin Oncol. 1994 Oct;12(10):2132-7

Active substance: MITOXANTRONE

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Document reference: 32253

Study title: Green DM et al. Treatment of children with stage IV favorable histology Wilms tumor: a report from the National Wilms Tumor Study Group. Med Pediatr Oncol. 1996 Mar;26(3):147-52.Green DM et al. Treatment of children with stage IV favorable histology Wilms tumor: a report from the National Wilms Tumor Study Group. Med Pediatr Oncol. 1996 Mar;26(3):147-52.

Active substance: MITOXANTRONE

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Document reference: 32252

Study title: A 9-Week, Randomized, Double-Blind, Placebo-Controlled, fixed-dosage (340 or 425 mg/day), Parallel-Group Study to Evaluate the Efficacy and Safety of Modafinil (Film-Coated Tablet) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder, Including a 2-Week (Blined) Withdrawel Period.

Active substance: MODAFINIL

Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls

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Document reference: 45282

Study title: Longhi A et al Fertility in male patients treated with neoadjuvant chemotherapy forOsteosarcoma J Pediatr Hematol Oncol. 2003 Apr;25(4):292-6Longhi A et al Fertility in male patients treated with neoadjuvant chemotherapy forOsteosarcoma J Pediatr Hematol Oncol. 2003 Apr;25(4):292-6

Active substance: MITOXANTRONE

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Document reference: 32141

Study title: MacDonald TJ et al. Phase II study of high-dose chemotherapy before radiation in children with newly diagnosed high-grade astrocytoma: final analysis of Children's Cancer Group Study 9933. Cancer. 2005 Dec 15;104(12):2862-71.MacDonald TJ et al. Phase II study of high-dose chemotherapy before radiation in children with newly diagnosed high-grade astrocytoma: final analysis of Children's Cancer Group Study 9933. Cancer. 2005 Dec 15;104(12):2862-71.

Active substance: MITOXANTRONE

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Document reference: 32231

Study title: Magrath I et al A phase II study of ifosfamide in the treatment of recurrent sarcomas in young people Cancer Chemother Pharmacol. 1986;18 Suppl 2:S25-8Magrath I et al A phase II study of ifosfamide in the treatment of recurrent sarcomas in young people Cancer Chemother Pharmacol. 1986;18 Suppl 2:S25-8

Active substance: MITOXANTRONE

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Document reference: 32164

Study title: Magrath I et al. Adults and children with small non-cleaved-cell lymphoma have a similar excellent outcome when treated with the same chemotherapy regimen. J Clin Oncol. 1996 Mar;14(3):925-34.Magrath I et al. Adults and children with small non-cleaved-cell lymphoma have a similar excellent outcome when treated with the same chemotherapy regimen. J Clin Oncol. 1996 Mar;14(3):925-34.

Active substance: MITOXANTRONE

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Document reference: 32250

Study title: Marina NM et al Chemotherapy dose-intensification for pediatric patients with Ewing's family of tumors and desmoplastic small round-cell tumors: a feasibility study at St. Jude Children's Research Hospital J Clin Oncol. 1999 Jan;17(1):180-90Marina NM et al Chemotherapy dose-intensification for pediatric patients with Ewing's family of tumors and desmoplastic small round-cell tumors: a feasibility study at St. Jude Children's Research Hospital J Clin Oncol. 1999 Jan;17(1):180-90

Active substance: MITOXANTRONE

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Document reference: 32112

Study title: PROTOCOL FOR THE DOUBLE-BLIND, PARALLEL COMPARATIVE STUDY OF PIROXICAM (TWO DOSES), ASPIRIN AND PLACEBO IN PATIENTS WITH POSTOPERATIVE DENTAL PAIN

Active substance: PIROXICAM

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Document reference: 34318

Study title: Relazione Clinica sull'uso del preparato Piroxicam FDDF nel trattamento delle affezioni muscoloscheletriche acute

Active substance: PIROXICAM

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Document reference: 34328

Study title: Relazione Clinica Sull'uso del preparato Piroxicam FDDF per via sublinguale vs Diclofenac nel trattamento delle Affezioni mu-scoloscheltriche acute

Active substance: PIROXICAM

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Document reference: 34327

Study title: Relazione Clinical sull'uso del preparato Piroxicam FDDF per via sublinguale nel trattamento della dismenorrea primaria

Active substance: PIROXICAM

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Document reference: 34329

Study title: SINGLE-BLIND COMPARATIVE STUDY ON THE ANALGESIC EFFICACY OF PRX VS. TENOXICAM IN THE TREATMENT OF LOW BACK PAIN WITH A SINGLE ADMINISTRATION

Active substance: PIROXICAM

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Document reference: 34397

Study title: THE EFFICACY AND SAFETY OF 0.5% TOPICAL PIROXICAM GEL IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS

Active substance: PIROXICAM

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Document reference: 34475

Study title: TO ASSESS THE ANALGESIC EFFICACY OF PIROXICAM 20 MG (1 M) IN A VARIETY OF PAINFUL CONDITIONS WITH ACUTE ONSET IN SPORTS MEDICINE WHICH DO NOT INVOLVE ANY INJURY.

Active substance: PIROXICAM

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Document reference: 34331

Study title: TO ASSESS THE EFFECT OF PIROXICAM 0.5% GEL ON THE PAIN AND STIFFNESS IN OSTEOARTHRITIC JOINT AS COMPARED TO PLACEBO.

Active substance: PIROXICAM

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Document reference: 34438

Study title: TO ASSESS THE EFFICACY AND SAFETY OF PIROXICAM COMPARED TO PARACETAMOL WHEN TAKEN AT THE ONSET OF PAIN DUE TO 1 DEGREE DYSMENORRHEA.

Active substance: PIROXICAM

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Document reference: 34427

Study title: TO COMPARE CLINICAL EFFICACY AND TOLERATION OF PIROXICAM DISPERSIBLE TABLETS AND IBUPROFEN TABS IN THE TREATMENT OF AMS DISORDERS.

Active substance: PIROXICAM

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Document reference: 34394

Study title: Unsuspected muscular radionuclide uptake due to chronic muscular injury contracted during sports activity. Roland J, Houben L, Vandevivere J. Clin Nucl Med. 1997 Sep;22(9):632-3. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43544

Study title: Acute epiphyseal osteomyelitis in children. Rosenbaum DM, Blumhagen JD. Radiology. 1985 Jul;156(1):89-92.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43939

Study title: Sato Y, Nakayama C, Kimoto T, Nakata H, Suzuki K. [Appraisal of the clinical value of bone scintigraphy for benign bone tumors and tumor-like lesions] Rinsho Hoshasen. 1987 Jul;32(7):791-6. Japanese. No abstract available. Sato Y, Nakayama C, Kimoto T, Nakata H, Suzuki K. [Appraisal of the clinical value of bone scintigraphy for benign bone tumors and tumor-like lesions] Rinsho Hoshasen. 1987 Jul;32(7):791-6. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43856

Study title: Sato Y, Nakayama C, Nakata H, Suzuki K. [Bone scintigraphy of non-ossifying fibroma] Rinsho Hoshasen. 1988 Feb;33(2):265-9. Japanese. No abstract available. PMID: 3385950 [PubMed - indexed for MEDLINE] Sato Y, Nakayama C, Nakata H, Suzuki K. [Bone scintigraphy of non-ossifying fibroma] Rinsho Hoshasen. 1988 Feb;33(2):265-9. Japanese. No abstract available. PMID: 3385950 [PubMed - indexed for MEDLINE]

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43827

Study title: Sautter-Bihl ML, Bihl H, Heinze HG. [The place of 99mTc-MDP skeletal scintigraphy in neuroblastoma. Is a new assessment necessary?] Nuklearmedizin. 1991 Feb;30(1):7-12. German. Sautter-Bihl ML, Bihl H, Heinze HG. [The place of 99mTc-MDP skeletal scintigraphy in neuroblastoma. Is a new assessment necessary?] Nuklearmedizin. 1991 Feb;30(1):7-12. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43747

Study title: Schallen E, De Odorico I, Shapiro B. Scintigraphy of proximal femoral focal deficiency. Clin Nucl Med. 1997 Oct;22(10):730-2. No abstract available. Schallen E, De Odorico I, Shapiro B. Scintigraphy of proximal femoral focal deficiency. Clin Nucl Med. 1997 Oct;22(10):730-2. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43542

Study title: Schauwecker DS, Park HM, Mock BH, Burt RW, Kernick CB, Ruoff AC 3rd, Sinn HJ, Wellman HN. Evaluation of complicating osteomyelitis with Tc-99m MDP, In-111 granulocytes, and Ga-67 citrate. J Nucl Med. 1984 Aug;25(8):849-53. Schauwecker DS, Park HM, Mock BH, Burt RW, Kernick CB, Ruoff AC 3rd, Sinn HJ, Wellman HN. Evaluation of complicating osteomyelitis with Tc-99m MDP, In-111 granulocytes, and Ga-67 citrate. J Nucl Med. 1984 Aug;25(8):849-53.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43989

Study title: Schauwecker DS. Osteomyelitis: diagnosis with In-111-labeled leukocytes. Radiology. 1989 Apr;171(1):141-6. Schauwecker DS. Osteomyelitis: diagnosis with In-111-labeled leukocytes. Radiology. 1989 Apr;171(1):141-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43787

Study title: Schettini F, Mele M, De Mattia D, Falcone G, D'Addabbo A. Bone metabolism in thalassemia major. J Pediatr. 1987 Jul;111(1):158. No abstract available. Schettini F, Mele M, De Mattia D, Falcone G, D'Addabbo A. Bone metabolism in thalassemia major. J Pediatr. 1987 Jul;111(1):158. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43857

Study title: Radionuclide techniques In: Resnick D and Kransdorf MJ eds. Bone and joint imaging. 3rd Ed. Philidelphia. PA.Schneider R. Chapter 7: Radionuclide techniques In: Resnick D and Kransdorf MJ eds. Bone and joint imaging. 3rd Ed. Philidelphia. PA. Elsevier Saunders; 2005:86-117

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 47923

Study title: A 9-Week, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dosage (up to 425 mg/day), Parallel-Group Study to Evaluate the Efficacy and Safety of Modafinil (Film-Coated Tablet) in Children with Attention-Deficit/Hyperactivity Disorder.

Active substance: MODAFINIL

Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls

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Document reference: 45281

Study title: A 9-Week, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dosage (up to 425 mg/day), Parallel-Group Study to Evaluate the Efficacy and Safety of Modafinil (Film-Coated Tablet) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder.

Active substance: MODAFINIL

Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls

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Document reference: 45283

Study title: EFFICACY AND TOLERATION OF PIROXICAM DISPERSIBLE TABLETS IN PATIENTS WITH ACUTE MUSCULOSKELETAL DISORDERS.

Active substance: PIROXICAM

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Document reference: 34347

Study title: EFFICACY AND TOLERATION OF PIROXICAM IN ACUTE OR DELAYED ANKLE SPRAIN

Active substance: PIROXICAM

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Document reference: 34408

Study title: EFFICACY AND TOLERATION OF PIROXICAM IN AMS PRODUCED DURING SPORTS ACTIVITIES.

Active substance: PIROXICAM

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Document reference: 34421

Study title: EFFICACY AND TOLERATION OF PIROXICAM IN ARTHROSIS AND RHEUMATOID ARTHRITIS.

Active substance: PIROXICAM

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Document reference: 34447

Study title: EFFICACY AND TOLERATION OF PIROXICAM IN PATIENTS FROM DIFFERENT ATHLETIC TEAMS WITH AMS.

Active substance: PIROXICAM

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Document reference: 34422

Study title: EFFICACY AND TOLERATION OF PIROXICAM IN PATIENTS WITH ACUTE MUSCULO-SKELETAL DISORDERS.

Active substance: PIROXICAM

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Document reference: 34345

Study title: EFFICACY AND TOLERATION OF PIROXICAM IN PATIENTS WITH AMS.

Active substance: PIROXICAM

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Document reference: 34420

Study title: EFFICACY AND TOLERATION OF PIROXICAM IN PATIENTS WITH LOW BACK PAIN.

Active substance: PIROXICAM

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Document reference: 34377

Study title: EFFICACY AND TOLERATION OF PIROXICAM IN PATIENTS WITH OSTEOARTHROSIS OF THE KNEE.

Active substance: PIROXICAM

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Document reference: 34326

Study title: EFFICACY AND TOLERATION OF PIROXICAM VS DICLOFENAC IN THE TREATMENT OF ACUTE MUSCULOSKELETAL INJURIES.T

Active substance: PIROXICAM

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Document reference: 34341

Study title: EFFICACY AND TOLERATION OF PIROXICAM WITH ACUTE MUSCULOSKELETAL DISORDERS

Active substance: PIROXICAM

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Document reference: 34442

Study title: EFFICACY OF FELDENE AS AN ANTIPYRETIC ANALGESIC IN ADJUVANT ADMINISTRATION WITH ANTIMALARIAL IN THE MANAGEMENT OF MALARIAL BODY

Active substance: PIROXICAM

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Document reference: 34490

Study title: EFFICACY OF FELDENE IN THE SYMPTOMATIC TREATMENT OF PRIMARY DYSMEUORRHEA.

Active substance: PIROXICAM

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Document reference: 34376

Study title: EFFICACY OF PIROXICAM 20 MG VS. ISOXICAM 200 MG IN PATIENTS WITH ACUTE MUSCULOSKELETAL DISORDERS.

Active substance: PIROXICAM

Study summary document link (including results):

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Document reference: 34390

Study title: EFFICACY OF PIROXICAM IM AFTER ORTHOPEDIC SURGERY.

Active substance: PIROXICAM

Study summary document link (including results):

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Document reference: 34378

Study title: EFFICACY OF PIROXICAM IM VS PLACEBO IN POSTOPERATIVE PAIN AND STUDY OF REVERSE REACTIONS.

Active substance: PIROXICAM

Study summary document link (including results):

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Document reference: 34342

Study title: EFFICACY OF PIROXICAM IN ACUTE LUMBALGIA

Active substance: PIROXICAM

Study summary document link (including results):

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Document reference: 34482

Study title: EFFICACY OF PIROXICAM IN ACUTE MUSCULOSKELETAL DISORDERS AND ADVERSE REACTIONS.

Active substance: PIROXICAM

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Document reference: 34450

Study title: EFFICACY OF PIROXICAM IN ACUTE MUSCULOSKELETAL DISORDERS.

Active substance: PIROXICAM

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Document reference: 34453

Study title: TO COMPARE EFFICACY OF PIROXICAM IM AND NOVALGIN IM IN THE PROMOTION OF ANALGESIA AND WOUND HEALING IN PATIENTS AFTER ABDOMINAL SURGERY.

Active substance: PIROXICAM

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Document reference: 34491

Study title: TO COMPARE THE EFFICACY AND TOLERATION OF PIROXICAM DISPERSAL AND DICLOFENAC IN THE TREATMENT OF ACUTE MUSCULOSKELETAL INJURIES.

Active substance: PIROXICAM

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Document reference: 34343

Study title: TO COMPARE THE EFFICACY, SAFETY AND USEFULNESS OF PIROXICAM SUPPOSITORY WITH THOSE OF DICLOFENAC IN CONTROL OF PATIENTS WITH OSTEOARTHRITIS BY DOUBLE-BLIND COMPARATIVE METHOD.

Active substance: PIROXICAM

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Document reference: 34406

Study title: TO COMPARE THE LOCAL TOLERATION OF THREE FORMULATIONS OF PIROXICAM INJECTED BY IM. ROUTE CONTAINING EACH 20MG OF ACTIVE INGREDIENT.

Active substance: PIROXICAM

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Document reference: 34382

Study title: TO CONFIRM THE EFFICACY AND TOLERATION OF PIROXICAM AS DISPERSIBLE TABLETS IN THE CONTROL OF DYSMENORRHEA PAIN.

Active substance: PIROXICAM

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Document reference: 34411

Study title: TO DETERMINE THE EFFICACY

Active substance: PIROXICAM

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Document reference: 34332

Study title: TO DETERMINE THE EFFICACY AND SAFETY OF FELDENE IM (PIROXICAM) WHEN USED FOR THE TREATMENT OF POST-OPERATIVE PAIN; FOLLOWING SURGERY.

Active substance: PIROXICAM

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Document reference: 34458

Study title: TO EVALUATE CLINICAL EFFICACY AND SAFETY OF PIROXICAM IN THE TREATMENT OF PRIMARY DYSMENORRHEA.

Active substance: PIROXICAM

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Document reference: 34444

Study title: TO EVALUATE PIROXICAM SUPPOSITORIES FOR THE TREATMENT OF OSTEOARTHRITIS COMPARED TO A COMBINATION OF SUPPOSITORIES AND TABLETS OF DICLOFENAC.

Active substance: PIROXICAM

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Document reference: 34478

Study title: TO EVALUATE THE ANALGESIC AND ANTIINFLAMATORY EFFECT OF PIROXICAM IN PATIENTS WITH GONBARTHROSIS.

Active substance: PIROXICAM

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Document reference: 34479

Study title: TO EVALUATE THE EFFECT OF PIROXICAM IN THE COURSE OF TREATMENT ASSOCIATED WITH SYMPTOMATIC VIRAL PHARYNGITIS

Active substance: PIROXICAM

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Document reference: 34480

Study title: TO EVALUATE THE EFFECTIVENESS AND SAFETY OF INJECTABLE PIROXICAM IN THE MANAGEMENT OF POST-OPERATIVE PAIN.

Active substance: PIROXICAM

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Document reference: 34362

Study title: TO EVALUATE THE EFFICACY AND SAFETY OF PIROXICAM IN THE TREATMENT OF JEUVENILE RHEUMATOID ARTHITIS

Active substance: PIROXICAM

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Document reference: 34409

Study title: " Clinical comparison of methylprednisolone aceponate and prednicarbate in chronic eczema - G. Albrecht - 1994 ( J Eur Acad Dermatol Venereol vol 3) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" " Clinical comparison of methylprednisolone aceponate and prednicarbate in chronic eczema - G. Albrecht - 1994 ( J Eur Acad Dermatol Venereol vol 3) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -"

Active substance: PREDNICARBATE

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Document reference: 34658

Study title: Clinical efficacy and tolerance of various regenit preparations

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Orfanos.xls

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Document reference: 48013

Study title: "Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005" "Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005"

Active substance: PREDNICARBATE

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Document reference: 34671

Study title: Schurawitzki H, Wickenhauser J, Fezoulidis I, Sadil V, Fialka V. [Sudeck syndrome--a combined clinico-roentgenologic-nuclear medicine study] Unfallchirurgie. 1988 Oct;14(5):238-46. German. Schurawitzki H, Wickenhauser J, Fezoulidis I, Sadil V, Fialka V. [Sudeck syndrome--a combined clinico-roentgenologic-nuclear medicine study] Unfallchirurgie. 1988 Oct;14(5):238-46. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43809

Study title: Bone scan patterns in acute osteomyelitis. Scoles PV, Hilty MD, Sfakianakis GN. Clin Orthop Relat Res. 1980 Nov-Dec;(153):210-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44136

Study title: A 16-week, randomized, multi-center, parallel- group, pimecrolimus-blinded, controlled study (4 week treatment period followed by a 12 week observational period) to evaluate the safety of concomitant use of ASM981 (pimecrolimus) cream 1% (BID) plus topical corticosteroids (BID) for the treatment of severe atopic dermatitis in patients 2 to 17 years of age

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2439 Art45 listing 2011.xls

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Document reference: 34090

Study title: Lindenschmidt Th, Aleksic D. Der paralytische Ileus in der Chirurgie. Internistische Praxis 1970;10(3):447-58. Lindenschmidt Th, Aleksic D. Der paralytische Ileus in der Chirurgie. Internistische Praxis 1970;10(3):447-58.

Active substance: PYRIDOSTIGMINE

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Document reference: 35226

Study title: Kremens B et al High-dose chemotherapy with autologous stem cell rescue in children with nephroblastoma Bone Marrow Transplant 2002 Dec;30(12):893-8

Active substance: ETOPOSIDE

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Document reference: 26727

Study title: Webster DL, Hurwitz GA, DeVeber LL, Troster M, Driedger AA. Increased activity on immediate phase of bone imaging does not always indicate increased blood volume. Clin Nucl Med. 1986 Nov;11(11):749-50. Webster DL, Hurwitz GA, DeVeber LL, Troster M, Driedger AA. Increased activity on immediate phase of bone imaging does not always indicate increased blood volume. Clin Nucl Med. 1986 Nov;11(11):749-50.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43889

Study title: Extraosseous bone-tracer uptake. Plasma cell granuloma. Wells RG, Sty JR. Clin Nucl Med. 1986 Jul;11(7):527.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43899

Study title: Whallett A, Evans N, Bradley S, Jobanputra P. Isotope bone scans: an assessment of their diagnostic use in polyarticular pain of uncertain origin. Ann Rheum Dis. 2003 Aug;62(8):784-5. No abstract available. Whallett A, Evans N, Bradley S, Jobanputra P. Isotope bone scans: an assessment of their diagnostic use in polyarticular pain of uncertain origin. Ann Rheum Dis. 2003 Aug;62(8):784-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43416

Study title: Esomeprazole Magnesium: A Repeat-Dose Toxicity Study with Up to 3 Months’ Oral (Gavage) Administration in the Neonatal Beagle Dog (with Emphasis on Gastric ECL-Cell Morphology and Toxicokinetics). AstraZeneca R&D Södertälje, Safety Assessment, Sweden (Ch

Active substance: ESOMEPRAZOLE

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Document reference: 26608

Study title: Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans.Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6.Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans.Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6.

Active substance: POLYMYXIN B AND TRIMETHOPRIM

Study summary document link (including results): Clinical evaluation of trimethoprim-containing.pdf

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Document reference: 34584

Study title: Pulce-C, Mollon-P, Pham-E, Frantz-P, Descotes-J. Service de Pharmaco-Toxicovigilance, Hospital E. Herriot, Lyon, France. Acute poisonings with ethyle loflazepate, flunitrazepam, prazepam and triazolam in children. Veterinary and human toxicology, {Vet-Hum-Toxicol}, Apr 1992, vol. 34, no. 2, p. 141-3, ISSN: 0145-6296.Pulce-C, Mollon-P, Pham-E, Frantz-P, Descotes-J. Service de Pharmaco-Toxicovigilance, Hospital E. Herriot, Lyon, France. Acute poisonings with ethyle loflazepate, flunitrazepam, prazepam and triazolam in children. Veterinary and human toxicology, {Vet-Hum-Toxicol}, Apr 1992, vol. 34, no. 2, p. 141-3, ISSN: 0145-6296.

Active substance: PRAZEPAM

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Document reference: 34637

Study title: "Rochet-T, Revol-O, Maillet-J, De-Villard-R. Service de Psychopathologie de, l'Enfant et de l'Adolescent, Hopital Neurologique, 59, Bd Pinel,69003 Lyon, France. Psychoactive drugs in child and adolescent psychiatry. Annales de Pediatrie {ANN-PEDIATR}, 1993, Vol/Iss/Pg. 40/9 (555-563), ISSN: 0066-2097. " "Rochet-T, Revol-O, Maillet-J, De-Villard-R. Service de Psychopathologie de, l'Enfant et de l'Adolescent, Hopital Neurologique, 59, Bd Pinel,69003 Lyon, France. Psychoactive drugs in child and adolescent psychiatry. Annales de Pediatrie {ANN-PEDIATR}, 1993, Vol/Iss/Pg. 40/9 (555-563), ISSN: 0066-2097. "

Active substance: PRAZEPAM

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Document reference: 34639

Study title: "Shader-R-I, Pary-R-J, Harmatz-J-S, Allison-S, Locniskar-A, Greenblatt-D-J. Tufts Univ, New England Med Ctr, Dept Psychiat, Boston, Ma, 02111. Tufts Univ, New England Med Ctr, Div Clin Pharmacol, Boston, Ma, 02111. Plasma-Concentrations And Clinical Effects After Single Oral Doses Of Prazepam, Clorazepate, And Diazepam. Journal-Of-Clinical-Psychiatry, 1984, V45, N10, P411-413." "Shader-R-I, Pary-R-J, Harmatz-J-S, Allison-S, Locniskar-A, Greenblatt-D-J. Tufts Univ, New England Med Ctr, Dept Psychiat, Boston, Ma, 02111. Tufts Univ, New England Med Ctr, Div Clin Pharmacol, Boston, Ma, 02111. Plasma-Concentrations And Clinical Effects After Single Oral Doses Of Prazepam, Clorazepate, And Diazepam. Journal-Of-Clinical-Psychiatry, 1984, V45, N10, ...

Active substance: PRAZEPAM

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Document reference: 34642

Study title: " Stojanovski-S-D, Rasu-R-S, Balkrishnan-R, Nahata-M-C. Prof. M.C. Nahata, Ohio State University College of Pharmacy, 500 W. 12th Avenue, Columbus, OH 43210, United States e-mail: nahata.1@osu.edu. Trends in medication prescribing for pediatric sleep difficulties in US outpatient settings. Sleep {SLEEP}, 01 AUG 2007, Vol/Iss/Pg. 30/8 (1013-1017), ISSN: 0161-8105. " " Stojanovski-S-D, Rasu-R-S, Balkrishnan-R, Nahata-M-C. Prof. M.C. Nahata, Ohio State University College of Pharmacy, 500 W. 12th Avenue, Columbus, OH 43210, United States e-mail: nahata.1@osu.edu. Trends in medication prescribing for pediatric sleep difficulties in US outpatient settings. Sleep {SLEEP}, 01 AUG 2007, Vol/Iss/Pg. 30/8 (1013-1017), ISSN: 0161-8105. "

Active substance: PRAZEPAM

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Document reference: 34640

Study title: Doehring-Schwertfeger E. Ultrasonographical Investigation of Periportal Fibrosis in Children with Schistosoma Mansoni Infection: Reversibility of Morbidity Twenty-Three Months after Treatment with Praziquantel. Am J Trop Med Hyg 1992; 46 (4): 409-415. Doehring-Schwertfeger E. Ultrasonographical Investigation of Periportal Fibrosis in Children with Schistosoma Mansoni Infection: Reversibility of Morbidity Twenty-Three Months after Treatment with Praziquantel. Am J Trop Med Hyg 1992; 46 (4): 409-415.

Active substance: PRAZIQUANTEL

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Document reference: 34647

Study title: Metwally A. Impact of drug dosage and brand on bioavailability and efficacy of Praziquantel. Pharmacol Res 1995; 31 (1): 53-59.Metwally A. Impact of drug dosage and brand on bioavailability and efficacy of Praziquantel. Pharmacol Res 1995; 31 (1): 53-59.

Active substance: PRAZIQUANTEL

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Document reference: 34645

Study title: "Determination of the efficacity and safety of prednicarbate 0,25% solution for dematoses sensitive to topical corticosteroids - K. Drebinger - 1989 (unpublished report) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-" "Determination of the efficacity and safety of prednicarbate 0,25% solution for dematoses sensitive to topical corticosteroids - K. Drebinger - 1989 (unpublished report) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-"

Active substance: PREDNICARBATE

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Document reference: 34672

Study title: Determination of the efficacy and safety of prednicarbate 0.25% solution for dermatoses sensitive to topical corticosteroids

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Drebinger topical 313DT.xls

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Document reference: 34659

Study title: " Eczematous disorders and corticoid-sensitive dermatoses - Treatment with prednicarbate 0,25% solution- S. Nolting et al. - 1994 (Z Allg Med vol 70) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" " Eczematous disorders and corticoid-sensitive dermatoses - Treatment with prednicarbate 0,25% solution- S. Nolting et al. - 1994 (Z Allg Med vol 70) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -"

Active substance: PREDNICARBATE

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Document reference: 34660

Study title: Evaluation of efficacy and tolerance of prednicarbate 0.25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses.

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Drebinger 405DT.xls

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Document reference: 48010

Study title: Evaluation of efficacy and tolerance of prednicarbate 0.25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses.

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Drebinger 402DT.xls

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Document reference: 48011

Study title: Final report on the clinical trial of the substance LS 519 Cl 2.

Active substance: PIRENZEPINE

Study summary document link (including results): Pirenzepine dihydrochloride_U75-0353_synopsis.pdf

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Document reference: 34298

Study title: Study of the drug LS 519.

Active substance: PIRENZEPINE

Study summary document link (including results): Pirenzepine dihydrochloride_U73-0300_synopsis.pdf

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Document reference: 34297

Study title: Study on changes in appetite and body weight after administration of LS 519.

Active substance: PIRENZEPINE

Study summary document link (including results): Pirenzepine dihydrochloride_U73-0298_synopsis.pdf

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Document reference: 34296

Study title: Klinisches gutachten - 3.4 Wirksamkeit nephrotischen syndrome (page 26) - Studie 65: kinder mit lipoid nephrose - Dr. Drebinger - 03/10/1980

Active substance: PIRETANIDE

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Document reference: 34299

Study title: Therapeutisch Erprobung - 2.6.4: Indikation nephrotisches syndrom (pages 1307 to 1380) - Studie 65 : Clinical assessment of HOE118 in children with nephrotic syndrom - Grünberg J - No date

Active substance: PIRETANIDE

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Document reference: 34300

Study title: Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43504

Study title: Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44159

Study title: Mandell GA, Keret D, Harcke HT, Bowen JR. Chondrolysis: detection by bone scintigraphy. J Pediatr Orthop. 1992 Jan;12(1):80-5. Mandell GA, Keret D, Harcke HT, Bowen JR. Chondrolysis: detection by bone scintigraphy. J Pediatr Orthop. 1992 Jan;12(1):80-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43712

Study title: Mandell GA, Morales RW, Harcke HT, Bowen JR. Bone scintigraphy in patients with atypical lumbar Scheuermann disease. J Pediatr Orthop. 1993 Sep-Oct;13(5):622-7. Mandell GA, Morales RW, Harcke HT, Bowen JR. Bone scintigraphy in patients with atypical lumbar Scheuermann disease. J Pediatr Orthop. 1993 Sep-Oct;13(5):622-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43653

Study title: Manfrini M, Rimondi E, Bruno A, Capanna R, Albisinni U, Picci P, Bacci G, Gaiani L, Tarozzi C. Total body bone scan in the evaluation of tumor response to preoperative chemotherapy in the treatment of osteosarcoma. Chir Organi Mov. 1990 Oct-Dec;75(4):325-30. English, Italian. Manfrini M, Rimondi E, Bruno A, Capanna R, Albisinni U, Picci P, Bacci G, Gaiani L, Tarozzi C. Total body bone scan in the evaluation of tumor response to preoperative chemotherapy in the treatment of osteosarcoma. Chir Organi Mov. 1990 Oct-Dec;75(4):325-30. English, Italian.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44175

Study title: Marchandise X, Dhellemmes P, Pellerin P, Dujardin MH. [Evaluation of scintigraphy of the skull. Apropos of 84 cases of craniostenosis] Ann Radiol (Paris). 1983 Sep-Oct;26(6):505-9. French. No abstract available. Marchandise X, Dhellemmes P, Pellerin P, Dujardin MH. [Evaluation of scintigraphy of the skull. Apropos of 84 cases of craniostenosis] Ann Radiol (Paris). 1983 Sep-Oct;26(6):505-9. French. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44029

Study title: Mariconda M, Cozzolino A, Attingenti P, Cozzolino F, Milano C. Osteoarticular tuberculosis in a developed country. J Infect. 2007 Apr;54(4):375-80. Epub 2006 Jul 24. Mariconda M, Cozzolino A, Attingenti P, Cozzolino F, Milano C. Osteoarticular tuberculosis in a developed country. J Infect. 2007 Apr;54(4):375-80. Epub 2006 Jul 24.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43373

Study title: Marks PH, Goldenberg JA, Vezina WC, Chamberlain MJ, Vellet AD, Fowler PJ. Subchondral bone infractions in acute ligamentous knee injuries demonstrated on bone scintigraphy and magnetic resonance imaging. J Nucl Med. 1992 Apr;33(4):516-20. Marks PH, Goldenberg JA, Vezina WC, Chamberlain MJ, Vellet AD, Fowler PJ. Subchondral bone infractions in acute ligamentous knee injuries demonstrated on bone scintigraphy and magnetic resonance imaging. J Nucl Med. 1992 Apr;33(4):516-20.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43701

Study title: Piracetam no controle dos disturbios neurologicos da intoxicacao aguda por anticonvulsivantes. 1. difenilidantoina.

Active substance: PIRACETAM

Study summary document link (including results): ARCP92F2521 - Piracetam.pdf

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Document reference: 45906

Study title: Piracetam no tratamento de intoxicacoes agudas em criancas por HCH e lindane.

Active substance: PIRACETAM

Study summary document link (including results): ARCP92F2522 - Piracetam.pdf

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Document reference: 45907

Study title: Piracetam therapy does not enhance cognitive functioning in children with Down syndrome.

Active substance: PIRACETAM

Study summary document link (including results): ADPE01D1801 - Piracetam.pdf

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Document reference: 45970

Study title: Piracetam-dependent augmentation of phagocytosis and respiratory burst intensity in functionally compromised neutrophils.

Active substance: PIRACETAM

Study summary document link (including results): PDEE92K2618 - Piracetam.pdf

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Document reference: 45983

Study title: Piracetam: effects on reading achievement and evoked potentials in dyslexics.

Active substance: PIRACETAM

Study summary document link (including results): DE88A294P - Piracetam.pdf

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Document reference: 45931

Study title: Preliminary results with piracetam in child and juvenile psychiatry.

Active substance: PIRACETAM

Study summary document link (including results): DE84E031 - Piracetam.pdf

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Document reference: 45952

Study title: Premieres experiences avec piracetam dans la neuropsychiatrie infantile.

Active substance: PIRACETAM

Study summary document link (including results): DF77E101P - Piracetam.pdf

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Document reference: 45949

Study title: Prognostic factors of sudden hearing loss in children.

Active substance: PIRACETAM

Study summary document link (including results): ADPE01K1615 - Piracetam.pdf

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Document reference: 46003

Study title: Prophylaxis of sickle-cell vaso-occlusive crises with oral piracetam.

Active substance: PIRACETAM

Study summary document link (including results): DE82J022P - Piracetam.pdf

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Document reference: 45923

Study title: Psychopathologic analysis of mild forms of mental deficiency.

Active substance: PIRACETAM

Study summary document link (including results): DRU81B231P - Piracetam.pdf

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Document reference: 45973

Study title: Pyramem. treatment of children with minimal brain dysfunction (preliminary data).

Active substance: PIRACETAM

Study summary document link (including results): DE90C052P - Piracetam.pdf

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Document reference: 45930

Study title: Pyramen. Clinical and Reg studies.

Active substance: PIRACETAM

Study summary document link (including results): DE82H313P - Piracetam.pdf

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Document reference: 45988

Study title: Pyramen. effect on the intellectual mnestic activity in mentally retarded schoolchildren in a double blind experiment.

Active substance: PIRACETAM

Study summary document link (including results): DE88H027P - Piracetam.pdf

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Document reference: 46020

Study title: Pyramen. pharmacodynamics.

Active substance: PIRACETAM

Study summary document link (including results): DE85L125P - Piracetam.pdf

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Document reference: 45947

Study title: Pyrrolidone acetamide as an auxiliary drug in the treatment of cerebral palsy.

Active substance: PIRACETAM

Study summary document link (including results): DP76H051P - Piracetam.pdf

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Document reference: 45995

Study title: Pyrrolidone acetamide in the treatment of enuresis nocturna in pedopsychiatry.

Active substance: PIRACETAM

Study summary document link (including results): DE77M122P - Piracetam.pdf

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Document reference: 45997

Study title: Central anticholinergic syndrome in a child underdoing circumcision. Acta Anaethesilogica Scandinavica 46, p.224-226,2002 Central anticholinergic syndrome in a child underdoing circumcision. Acta Anaethesilogica Scandinavica 46, p.224-226,2002

Active substance: PIRITRAMIDE

Study summary document link (including results): schultz_piritramide.pdf

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Document reference: 34304

Study title: Comparison of the visual analogue scale (VAS) and Smiley Analog Scale (SAS) for evaluation of pain in children. Pain World Congress 1984, Seattle. Raven, New York, p.25 Comparison of the visual analogue scale (VAS) and Smiley Analog Scale (SAS) for evaluation of pain in children. Pain World Congress 1984, Seattle. Raven, New York, p.25

Active substance: PIRITRAMIDE

Study summary document link (including results): pothmann_piritramide.pdf

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Document reference: 34302

Study title: On-demand analgesia with piritramide in children. A study on dosage specification and safety. European Journal of Pediatric Surgery 7, p.38-41, 1997 On-demand analgesia with piritramide in children. A study on dosage specification and safety. European Journal of Pediatric Surgery 7, p.38-41, 1997

Active substance: PIRITRAMIDE

Study summary document link (including results): petrat_piritramide.pdf

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Document reference: 34301

Study title: Safe and effective use piritramide following sevoflurane anesthesia in children. Anesthesiology 91 (3A), p.A1280. 1999 Safe and effective use piritramide following sevoflurane anesthesia in children. Anesthesiology 91 (3A), p.A1280. 1999

Active substance: PIRITRAMIDE

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Document reference: 34303

Study title:

Active substance: PIROXICAM

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Document reference: 34306

Study title:

Active substance: PIROXICAM

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Document reference: 34307

Study title:

Active substance: PIROXICAM

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Document reference: 34308

Study title: A CLINICAL EVALUATION OF FELDENE -- SUPPOSITORY IN PATIENTS WITH RHEUMATOID ARTHRITIS

Active substance: PIROXICAM

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Document reference: 34305

Study title: Variant pathogenetic therapy in the acute phase of hypoxic-traumatic brain damage in immature children.

Active substance: PIRACETAM

Study summary document link (including results): DRU87G074P - Piracetam.pdf

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Document reference: 46018

Study title: Martelli H et al Conservative treatment for girls with nonmetastatic rhabdomyosarcoma of thegenital tract: A report from the Study Committee of the International Society of Pediatric Oncology J Clin Oncol. 1999 Jul;17(7):2117-22. ReviewMartelli H et al Conservative treatment for girls with nonmetastatic rhabdomyosarcoma of thegenital tract: A report from the Study Committee of the International Society of Pediatric Oncology J Clin Oncol. 1999 Jul;17(7):2117-22. Review

Active substance: MITOXANTRONE

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Document reference: 32147

Study title: Mastrangelo S et al. Treatment of advanced neuroblastoma: feasibility and therapeutic potential of a novel approach combining 131-I-MIBG and multiple drug chemotherapy. Br J Cancer. 2001 Feb;84(4):460-4Mastrangelo S et al. Treatment of advanced neuroblastoma: feasibility and therapeutic potential of a novel approach combining 131-I-MIBG and multiple drug chemotherapy. Br J Cancer. 2001 Feb;84(4):460-4

Active substance: MITOXANTRONE

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Document reference: 32239

Study title: Maurer HM et al. The Intergroup Rhabdomyosarcoma Study-II. Cancer. 1993 Mar 1;71(5):1904-22Maurer HM et al. The Intergroup Rhabdomyosarcoma Study-II. Cancer. 1993 Mar 1;71(5):1904-22

Active substance: MITOXANTRONE

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Document reference: 32188

Study title: Martin-Simmerman P, Cohen MD, Siddiqui A, Mirkin D, Provisor A. Calcification and uptake of Tc-99m diphosphonates in neuroblastomas: concise communication. J Nucl Med. 1984 Jun;25(6):656-60. Martin-Simmerman P, Cohen MD, Siddiqui A, Mirkin D, Provisor A. Calcification and uptake of Tc-99m diphosphonates in neuroblastomas: concise communication. J Nucl Med. 1984 Jun;25(6):656-60.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43997

Study title: Soft tissue uptake of Tc99m-MDP in acute lymphoblastic leukemia. Marwah A, Kumar R, Dasan J B, Choudhury S, Bandopadhyaya G, Malhotra A. Clin Imaging. 2002 May-Jun;26(3):206-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43448

Study title: Marymont JV. Comparative imaging. Massive osteolysis (Gorham's syndrome, disappearing bone disease). Clin Nucl Med. 1987 Feb;12(2):153-4. No abstract available. Marymont JV. Comparative imaging. Massive osteolysis (Gorham's syndrome, disappearing bone disease). Clin Nucl Med. 1987 Feb;12(2):153-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43873

Study title: [Bone manifestations in non-Hodgkin's lymphoma in childhood and adolescence] German Rosenthal H, Kolb R, Gratz KF, Reiter A, Galanski M. Radiologe. 2000 Aug;40(8):737-44. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43476

Study title: "Cold spots" in pediatric bone imaging. Rosovsky M, Goldfarb CR, Finestone H, Ongseng F. Semin Nucl Med. 1994 Apr;24(2):184-6. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43628

Study title: Rossleigh MA, Smith J, Yeh SD. Scintigraphic features of primary sacral tumors. J Nucl Med. 1986 May;27(5):627-30. Rossleigh MA, Smith J, Yeh SD. Scintigraphic features of primary sacral tumors. J Nucl Med. 1986 May;27(5):627-30.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43909

Study title: The irritable hip. Scintigraphy in 192 children. Royle SG, Galasko CS. Acta Orthop Scand. 1992 Feb;63(1):25-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43706

Study title: Investigation of the irritable hip. Royle SG. J Pediatr Orthop. 1992 May-Jun;12(3):396-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43697

Study title: Three-phase radionuclide bone imaging in sports medicine. Rupani HD, Holder LE, Espinola DA, Engin SI. Radiology. 1985 Jul;156(1):187-96.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43940

Study title: Ryan PJ, Taylor M, Grevitt M, Allen P, Shields J, Clarke SE, Fogelman I. Bone single-photon emission tomography in recent meniscal tears: an assessment of diagnostic criteria. Eur J Nucl Med. 1993 Aug;20(8):703-7. Ryan PJ, Taylor M, Grevitt M, Allen P, Shields J, Clarke SE, Fogelman I. Bone single-photon emission tomography in recent meniscal tears: an assessment of diagnostic criteria. Eur J Nucl Med. 1993 Aug;20(8):703-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43657

Study title: Rypens F, Gevenois PA, Struyven J. Multifocal Ewing's sarcoma. J Belge Radiol. 1994 Oct;77(5):222. No abstract available. Rypens F, Gevenois PA, Struyven J. Multifocal Ewing's sarcoma. J Belge Radiol. 1994 Oct;77(5):222. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43612

Study title: The value of FDG-PET in the detection, grading and response to therapy of soft tissue and bone sarcomas; a systematic review and meta-analysis. CANCER TREATMENT REVIEWS (2004) 30, 83–101. E. Bastiaanneta, H. Groenb, P.L. Jagerc, D.C.P. Cobbenc, W.T.A. van der Graafd, W. Vaalburgc, H.J. Hoekstraa,*

Active substance: Steripet

Study summary document link (including results): bastiaannet-2004.pdf

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Document reference: 48726

Study title: Tian M, Zhang H, Oriuchi N, Higuchi T, Endo K.. Epub 2004 Mar 11. Comparison of 11C-choline PET and FDG PET for the differential diagnosis of malignant tumors. [tian-2004]Eur J Nucl Med Mol Imaging. 2004 Aug;31(8):1064-72. Tian M 2004

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48704

Study title: Green DM et al. Treatment of children with stages II to IV anaplastic Wilms' tumor: a report fromthe National Wilms' Tumor Study Group. J Clin Oncol. 1994 Oct;12(10):2126-31Green DM et al. Treatment of children with stages II to IV anaplastic Wilms' tumor: a report fromthe National Wilms' Tumor Study Group. J Clin Oncol. 1994 Oct;12(10):2126-31

Active substance: MITOXANTRONE

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Document reference: 32254

Study title: Grier HE et al Addition of ifosfamide and etoposide to standard chemotherapy for Ewing's sarcoma and primitive neuroectodermal tumor of bone N Engl J Med. 2003 Feb 20;348(8):694-701Grier HE et al Addition of ifosfamide and etoposide to standard chemotherapy for Ewing's sarcoma and primitive neuroectodermal tumor of bone N Engl J Med. 2003 Feb 20;348(8):694-701

Active substance: MITOXANTRONE

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Document reference: 32091

Study title: Gururangan S et al Primary extracranial rhabdoid tumors. Clinicopathologic features and response to ifosfamide Cancer. 1993 Apr 15;71(8):2653-9Gururangan S et al Primary extracranial rhabdoid tumors. Clinicopathologic features and response to ifosfamide Cancer. 1993 Apr 15;71(8):2653-9

Active substance: MITOXANTRONE

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Document reference: 32142

Study title: Gururangan S et al Treatment of children with peripheral primitive neuroectodermal tumor or extraosseous Ewing's tumor with Ewing's-directed therapy J Pediatr Hematol Oncol. 1998 Jan-Feb;20(1):55-61Gururangan S et al Treatment of children with peripheral primitive neuroectodermal tumor or extraosseous Ewing's tumor with Ewing's-directed therapy J Pediatr Hematol Oncol. 1998 Jan-Feb;20(1):55-61

Active substance: MITOXANTRONE

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Document reference: 32104

Study title: Hachimi-Idrissi S et al Reversible cardiopathy after accidental overdose of mitoxantrone Pediatr Hematol Oncol. 1993 Jan-Mar;10(1):35-40Hachimi-Idrissi S et al Reversible cardiopathy after accidental overdose of mitoxantrone Pediatr Hematol Oncol. 1993 Jan-Mar;10(1):35-40

Active substance: MITOXANTRONE

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Document reference: 32081

Study title: Harris MB et al Treatment of metastatic osteosarcoma at diagnosis: a Pediatric Oncology Group Study J Clin Oncol. 1998 Nov;16(11):3641-8Harris MB et al Treatment of metastatic osteosarcoma at diagnosis: a Pediatric Oncology Group Study J Clin Oncol. 1998 Nov;16(11):3641-8

Active substance: MITOXANTRONE

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Document reference: 32138

Study title: Harris MB et al Treatment of osteosarcoma with ifosfamide: comparison of response in pediatric patients with recurrent disease versus patients previously untreated: a Pediatric Oncology Group study Med Pediatr Oncol. 1995 Feb;24(2):87-92Harris MB et al Treatment of osteosarcoma with ifosfamide: comparison of response in pediatric patients with recurrent disease versus patients previously untreated: a Pediatric Oncology Group study Med Pediatr Oncol. 1995 Feb;24(2):87-92

Active substance: MITOXANTRONE

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Document reference: 32130

Study title: Huber R et al Isolated hyperthermic perfusion with mitoxantrone of melphalan in malignant melanoma of the limb IAmJ Surg. 1995 Oct;170(4):345-52 Huber R et al Isolated hyperthermic perfusion with mitoxantrone of melphalan in malignant melanoma of the limb IAmJ Surg. 1995 Oct;170(4):345-52

Active substance: MITOXANTRONE

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Document reference: 32075

Study title: Hübner G et al. Intensive post-remission therapy in acute myeloid leukemia. Results of a prospective comparative study by the South Germany Hemoblastosis Group Med Klin (Munich). 1996 Apr 12;91 Suppl 3:26-32Hübner G et al. Intensive post-remission therapy in acute myeloid leukemia. Results of a prospective comparative study by the South Germany Hemoblastosis Group Med Klin (Munich). 1996 Apr 12;91 Suppl 3:26-32

Active substance: MITOXANTRONE

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Document reference: 32196

Study title: Intragumtornchai T et al. CHOP versus CHOP plus ESHAP and high-dose therapy with autologous peripheral blood progenitor cell transplantation for high-intermediate-risk and high-risk aggressive non-Hodgkin's lymphoma. Clin Lymphoma. 2000 Dec;1(3):219-25Intragumtornchai T et al. CHOP versus CHOP plus ESHAP and high-dose therapy with autologous peripheral blood progenitor cell transplantation for high-intermediate-risk and high-risk aggressive non-Hodgkin's lymphoma. Clin Lymphoma. 2000 Dec;1(3):219-25

Active substance: MITOXANTRONE

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Document reference: 32209

Study title: McTiernan A et al A phase I/II study of doxorubicin, ifosfamide, etoposide and interval methotrexate in patients with poor prognosis osteosarcoma Pediatr Blood Cancer. 2006 Mar;46(3):345-50McTiernan A et al A phase I/II study of doxorubicin, ifosfamide, etoposide and interval methotrexate in patients with poor prognosis osteosarcoma Pediatr Blood Cancer. 2006 Mar;46(3):345-50

Active substance: MITOXANTRONE

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Document reference: 32131

Study title: McWilliams NB et al.Cyclophosphamide/doxorubicin vs. cisplatin/teniposide in the treatment of children older than 12 months of age with disseminated neuroblastoma: a Pediatric Oncology Group Randomized Phase II study. Med Pediatr Oncol. 1995 Mar;24(3):176-80McWilliams NB et al.Cyclophosphamide/doxorubicin vs. cisplatin/teniposide in the treatment of children older than 12 months of age with disseminated neuroblastoma: a Pediatric Oncology Group Randomized Phase II study. Med Pediatr Oncol. 1995 Mar;24(3):176-80

Active substance: MITOXANTRONE

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Document reference: 32242

Study title: Meyer RM et al. Escalated as compared with standard doses of doxorubicin in BACOP therapy for patients with non-Hodgkin's lymphoma. N Engl J Med. 1993 Dec 9;329(24):1770-6.Meyer RM et al. Escalated as compared with standard doses of doxorubicin in BACOP therapy for patients with non-Hodgkin's lymphoma. N Engl J Med. 1993 Dec 9;329(24):1770-6.

Active substance: MITOXANTRONE

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Document reference: 32216

Study title: Meyer WH et al Carboplatin/ifosfamide window therapy for osteosarcoma: results of the St Jude Children's Research Hospital OS-91 trial J Clin Oncol. 2001 Jan 1;19(1):171-82Meyer WH et al Carboplatin/ifosfamide window therapy for osteosarcoma: results of the St Jude Children's Research Hospital OS-91 trial J Clin Oncol. 2001 Jan 1;19(1):171-82

Active substance: MITOXANTRONE

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Document reference: 32134

Study title: Meyer WH et al Ifosfamide plus etoposide in newly diagnosed Ewing's sarcoma of bone J Clin Oncol. 1992 Nov;10(11):1737-42Meyer WH et al Ifosfamide plus etoposide in newly diagnosed Ewing's sarcoma of bone J Clin Oncol. 1992 Nov;10(11):1737-42

Active substance: MITOXANTRONE

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Document reference: 32115

Study title: Meyers PA et al Osteosarcoma: a randomized, prospective trial of the addition of ifosfamide and/or muramyl tripeptide to cisplatin, doxorubicin, and high-dose methotrexate J Clin Oncol. 2005 Mar 20;23(9):2004-11Meyers PA et al Osteosarcoma: a randomized, prospective trial of the addition of ifosfamide and/or muramyl tripeptide to cisplatin, doxorubicin, and high-dose methotrexate J Clin Oncol. 2005 Mar 20;23(9):2004-11

Active substance: MITOXANTRONE

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Document reference: 32118

Study title: Meyers PA et al. Intensification of preoperative chemotherapy for osteogenic sarcoma: results of the Memorial Sloan-Kettering (T12) protocol. J Clin Oncol. 1998 Jul;16(7):2452-8.Meyers PA et al. Intensification of preoperative chemotherapy for osteogenic sarcoma: results of the Memorial Sloan-Kettering (T12) protocol. J Clin Oncol. 1998 Jul;16(7):2452-8.

Active substance: MITOXANTRONE

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Document reference: 32184

Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF INTRAMUSCULAR PIROXICAM IN ACUTE MUSCULOSKELETAL DISORDERS WHEN ADMINISTERED AS A LOADING DOSE OF 40 MG PER DAY FOR 2 DAYS, FOLLOWED BY 20 MG PER DAY, IM FOR 3 DAYS AND ORAL PIROXICAM ON SUBSEQUENT DAYS.

Active substance: PIROXICAM

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Document reference: 34474

Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF PARENTAL PIROXICAM IN ACUTE MUSCULOSKELETAL DISORDERS WHEN ADMINISTERED AS A LOADING DOSE OF 40 MG STARTING FOR TWO DAYS, FOLLOWED BY 20 MG INTRAMUSCULAR OR ORAL.

Active substance: PIROXICAM

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Document reference: 34492

Study title: TO EVALUATE THE LONG TERM EFFECTS OF TUBAL MORPHOLOGY AND FUNCTION AFTER PUD IN PATIENTS TREATED DURING THE ACUTE EPISODE WITH EITHER DOXYCYCLINE PLUS TINIDAZOLE PLUS PIROXICAM OR PLACEBO.

Active substance: PIROXICAM

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Document reference: 34462

Study title: TO INVESTIGATE THE EFFECT OF A LOADING DOSE OF PIROXICAM 40MG/D FOLLOWED BY 20 MG/D IN THE TREATMENT OF SYMPTOMS ASSOCIATED WITH URTI.

Active substance: PIROXICAM

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Document reference: 34389

Study title: TO MEASURE THE ELIMINATION HALF-LIFE (T1/2) OF PIROXICAM AFTER ITS STEADY KINETIC STATE HAS BEEN ACHIEVED IN CHILDREN WITH JRA. VALUES FOR VOLUME OF DISTRIBUTION AND CLEARANCE CAN THEN BE CALCULATED.

Active substance: PIROXICAM

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Document reference: 34466

Study title: Sahin M, Bernay I, Basoglu T, Canturk F. Comparison of Tc-99m MDP, Tc-99m HSA and Tc-99m HIG uptake in rheumatoid arthritis and its variants. Ann Nucl Med. 1999 Dec;13(6):389-95. Sahin M, Bernay I, Basoglu T, Canturk F. Comparison of Tc-99m MDP, Tc-99m HSA and Tc-99m HIG uptake in rheumatoid arthritis and its variants. Ann Nucl Med. 1999 Dec;13(6):389-95.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43497

Study title: Saito S, Inoue A, Ono K. Intramedullary haemorrhage as a possible cause of avascular necrosis of the femoral head. The histology of 16 femoral heads at the silent stage. J Bone Joint Surg Br. 1987 May;69(3):346-51. Saito S, Inoue A, Ono K. Intramedullary haemorrhage as a possible cause of avascular necrosis of the femoral head. The histology of 16 femoral heads at the silent stage. J Bone Joint Surg Br. 1987 May;69(3):346-51.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43864

Study title: Postoperative bone marrow alterations: potential pitfalls in the diagnosis of osteomyelitis with In-111-labeled leukocyte scintigraphy. Seabold JE, Nepola JV, Marsh JL, Hawes DR, Justin EP, Ponto JA, Pettit WA, el-Khoury GY, Kirchner PT. Radiology. 1991 Sep;180(3):741-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44265

Study title: Cranial osteomyelitis: diagnosis and follow-up with In-111 white blood cell and Tc-99m methylene diphosphonate bone SPECT, CT, and MR imaging. Seabold JE, Simonson TM, Weber PC, Thompson BH, Harris KG, Rezai K, Madsen MT, Hoffman HT. Radiology. 1995 Sep;196(3):779-88.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44260

Study title: Segall GM, Gurevich N. Uterine blush in multiphase imaging. J Nucl Med. 1986 Sep;27(9):1500-1. No abstract available. Segall GM, Gurevich N. Uterine blush in multiphase imaging. J Nucl Med. 1986 Sep;27(9):1500-1. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43896

Study title: Senda K, Itoh S. Evaluation of diffusely high uptake by the calvaria in bone scintigraphy. Ann Nucl Med. 1987 Sep;1(1):23-6. Senda K, Itoh S. Evaluation of diffusely high uptake by the calvaria in bone scintigraphy. Ann Nucl Med. 1987 Sep;1(1):23-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43851

Study title: (99m)Tc-MDP scintigraphic findings in children with leukemia: value of early and delayed whole-body imaging. Shalaby-Rana E, Majd M. J Nucl Med. 2001 Jun;42(6):878-83.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43452

Study title: Shanley DJ, Buckner AB, Alexander HG. Unusual pelvic activity found on bone scan. Clin Nucl Med. 1991 Jun;16(6):453-4. No abstract available. Shanley DJ, Buckner AB, Alexander HG. Unusual pelvic activity found on bone scan. Clin Nucl Med. 1991 Jun;16(6):453-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43735

Study title: Shanley DJ, Vassallo CJ, Buckner AB. Sternoclavicular pyarthrosis demonstrated on bone scan. Correlation with CT and MRI. Clin Nucl Med. 1991 Oct;16(10):786-7. No abstract available. Shanley DJ, Vassallo CJ, Buckner AB. Sternoclavicular pyarthrosis demonstrated on bone scan. Correlation with CT and MRI. Clin Nucl Med. 1991 Oct;16(10):786-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43727

Study title: Turner CD, Chi S, Marcus KJ, MacDonald T, Packer RJ, Poussaint TY, et al.. Epub 2006 Sep 22. Phase II study of thalidomide and radiation in children with newly diagnosed brain stem gliomas and glioblastoma multiforme. [turner-2007]J Neurooncol. 2007 Mar;82(1):95-101. Turner CD 2007

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48705

Study title: Uchida Y, Minoshima S, Kawata T, Motoori K, Nakano K, Kazama T, et al.. Diagnostic value of FDG PET and salivary gland scintigraphy for parotid tumors. [uchida-2005]Clin Nucl Med. 2005 Mar;30(3):170-6. Uchida Y 2005

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48706

Study title: EFFICACY OF PIROXICAM IN COMPARISON WITH NAPROXEN OR PLACEBO IN LARGE PATIENT POPULATION WITH ACUTE M.D.

Active substance: PIROXICAM

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Document reference: 34428

Study title: EFFICACY OF PIROXICAM IN MUSCULOSKELETAL CONDITIONS

Active substance: PIROXICAM

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Document reference: 34464

Study title: EFFICACY OF PIROXICAM IN OUTPATIENTS WITH SPORT-RELATED MUSCULO-SKELETAL INJURIES

Active substance: PIROXICAM

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Document reference: 34473

Study title: EFFICACY OF PIROXICAM IN PATIENTS WITH URTI.

Active substance: PIROXICAM

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Document reference: 34371

Study title: EFFICACY OF PIROXICAM IN RELIEVING MENSTRUAL PAIN.

Active substance: PIROXICAM

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Document reference: 34336

Study title: EFFICACY OF PIROXICAM TO BE EVALUATED IN PATIENTS WITH ARTHROSIS OF KNEW/OR HIP, OR BURSITIS AND /OR TENDINITIS OF ELBOW OR SHOULDER

Active substance: PIROXICAM

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Document reference: 34335

Study title: EFFICACY OF PIROXICAM VS INDOMETHACIN IN ACUTE LOCOMOTOR AFFECTIONS LINKED WITH SPORTS ACTIVITY.

Active substance: PIROXICAM

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Document reference: 34379

Study title: EFFICACY OF PIROXICAM VS MEFANAMIC ACID IN PATIENTS WITH PRIMARY DYSMENORRHEA.

Active substance: PIROXICAM

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Document reference: 34330

Study title: EFFICACY OF PIROXICAM VS TOLFENAMIC ACID IN PRIMARY DYSMENORRHEA

Active substance: PIROXICAM

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Document reference: 34465

Study title: EFFICACY OF PIROXICAM VS. NAPROXEN IN PATIENTS WITH RHEUMATIOD ARTHRITIS.

Active substance: PIROXICAM

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Document reference: 34441

Study title: EFFICACY OF PIROXICAM VS. PLACEBO IN PATIENTS WITH PRIMARY DYSMENORRHEA.

Active substance: PIROXICAM

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Document reference: 34488

Study title: EFFICACY, SAFETY AND TOLERATION OF PIROXICAM IN MODERATE TO SEVERE PRIMARY DYSMENORRHEA.

Active substance: PIROXICAM

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Document reference: 34460

Study title: EFFICACY, TOLERATION AND ACCEPTABILITY OF FELDENE IN A VARIETY OF A.M.S.D. LIKE TENNIS ELBOW, FROZEN SHOULDER, TENDINITIS, BURSITIS, ETC.

Active substance: PIROXICAM

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Document reference: 34483

Study title: EFFICACY, TOLERATION AND ACCEPTABILITY OF FELDENE IN A VARIETY OF AMSD'S LIKE TENNIS ELBOW, TENDINITIS, BURSITIS, GOUT ETC.

Active substance: PIROXICAM

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Document reference: 34489

Study title: EFFICACY, TOLERATION AND ACCEPTABILITY OF FELDENE IN ACUTE GOUT.

Active substance: PIROXICAM

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Document reference: 34485

Study title: EVALUATE EFFICACY AND TOLERATION OF PIROXICAM ON RATE OF SYMPTOMATIC RECOVERY IN ACUTE P. FALCIPARUM MALARIAL ATTACK AGAINST THOSE OF ASA AND TYLENOL.

Active substance: PIROXICAM

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Document reference: 34493

Study title: EVALUATE THE PAIN RELIEVING EFFECT OF PIROXICAM COMBINED WITH EPIDURAL MORPHINE AFTER MAJOR ABDOMINAL SURGERY.

Active substance: PIROXICAM

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Document reference: 34369

Study title: EVALUATION OF THE EFFICACY AND SAFETY OF FELDENE 20 MG INTRAMUSCULAR IN THE OSTEOARTICULAR ACUTE ATTACKS DURING SICKLE CELL DISEASE.

Active substance: PIROXICAM

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Document reference: 34385

Study title: EVALUATION OF THE EFFICACY AND TOLERATION OF PIROXICAM AS ADJUVANT THERAPY IN THE TREATMENT OF THE PAIN-DYSFUNCTION SYNDROME OF THE TEMPOROMANDIBULAR JOINT.

Active substance: PIROXICAM

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Document reference: 34340

Study title: EXTENSIVE WORLDWIDE STUDIES TO DISCOVER EVEN RARE SIDE EFFECTS BY MEANS OF LHIGH PATIENT NUMBERS. ALSO IF ONE CAPSULE OF PIROXICAM 20 MG WOULD BE ADVANTAGIOUS TO 2 CAPS OF 10 MG.

Active substance: PIROXICAM

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Document reference: 34367

Study title: FELDENE (PIROXICAM) VERSUS NAPROXEN IN TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS

Active substance: PIROXICAM

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Document reference: 34323

Study title: INVESTIGATE WHETHER PIROXICAM CREAM AND GEL 1% OR CREAM AND GEL CONTAINING THE SAM EXCIPIENT EXCEPT PIROXICAM INDUCE ANY UNWANTED LOCAL SIDE EFFECTS AS ASSESSED BY A PATCH TEST.

Active substance: PIROXICAM

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Document reference: 34430

Study title: LARGE SCALE MULTICENTRIC EVALUATION OF EFFICACY AND TOLERABILITY OF PRX GEL 0.5% IN THE TREATMENT OF AMEAS

Active substance: PIROXICAM

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Document reference: 34351

Study title: MULTICENTER STUDY - FELDENE DISPERSIBLE 20MG IN TREATMENT OF FLARE-UP OF RHEUMATIC DISEASE.

Active substance: PIROXICAM

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Document reference: 34414

Study title: Topiramate, carbamazepine and valproate monotherapy: double-blind comparison in children with newly diagnosed epilepsy. JM Wheless, J Child Neurol 2004;19:135-141 in CES EXPCRC-CES0296-EN-E01 Topiramate, carbamazepine and valproate monotherapy: double-blind comparison in children with newly diagnosed epilepsy. JM Wheless, J Child Neurol 2004;19:135-141 in CES EXPCRC-CES0296-EN-E01

Active substance: URINARY CONCREMENT SOLVENTS

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Document reference: 39154

Study title: Fibrin clot lysis by thrombolytic agent is impaired in newborns due to a low plasminogen concentration

Active substance: Urokinase

Study summary document link (including results): 1440499.pdf

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Document reference: 48378

Study title: Intrapleural urokinase in the treatment of complicated parapneumonic pleural effusions and empyema

Active substance: Urokinase

Study summary document link (including results): 8866590.pdf

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Document reference: 48379

Study title: Does UDCA improve histological changes in liver disease in cystic fibrosis?

Active substance: URSODEOXYCOLIC ACID

Study summary document link (including results): EUdraCT_reduced_datafields_paediatric data_Ursodeoxycholic acid_Ursofalk capsules_Dr Falk Pharma GmbH.xls

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Document reference: 39159

Study title: Influence of Bile Acids on Postnatal Development im Preterm Infants during the first weeks of life; A controlled study with Ursodeoxycholic acid.

Active substance: URSODEOXYCOLIC ACID

Study summary document link (including results): EUdraCT_reduced_datafields_paediatric data_Ursodeoxycholic acid_Ursofalk suspenion_Dr Falk Pharma GmbH.xls

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Document reference: 39160

Study title: Evaluación del efecto de una vacuna polivalente neumocócica en la incidencia de la carga nasofaríngea de S.pneumoniae y de Otitis media aguda . (U.S)

Active substance: Vacuna conjugada (adsorbida) frente al oligosacárido meningocócico del serogrupo C

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Document reference: 40296

Study title: A Double-blind, Multi-centre Study Comparing Oral Valaciclovir and Aciclovir for the Suppression of CMV Infection and Disease Following Allogeneic Bone Marrow Transplantation

Active substance: VALACICLOVIR

Study summary document link (including results): Valaciclovir-123-016-ICHE3.pdf

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Document reference: 47355

Study title: A multicentre, randomised, double-blind, parallel, placebo controlled study of two dosing regimens of valaciclovir compared to placebo for the prevention/blockage of the progression of the cold sore lesion beyond the papular stage.

Active substance: VALACICLOVIR

Study summary document link (including results): Valaciclovir-HS230028-ICHE3.pdf

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Document reference: 45427

Study title: A multicentre, randomised, double-blind, parallel, placebo-controlled study of two dosing regimens of valaciclovir compared to placebo for the reduction in length of cold sore episodes.

Active substance: VALACICLOVIR

Study summary document link (including results): Valaciclovir-HS230027-ICHE3.pdf

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Document reference: 45426

Study title: A randomised, double-blind, multicentre study to evaluate the efficacy of valaciclovir in episodic treatment of recurrent facial herpes simplex virus (HSV) infection.

Active substance: VALACICLOVIR

Study summary document link (including results): Study HS240011 Valaciclovir.xls

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Document reference: 45428

Study title: A study to investigate the steady state pharmacokinetics of oral Valaciclovir (Valtrex) in immunocompromised children

Active substance: VALACICLOVIR

Study summary document link (including results): Valaciclovir-HS2B4005-ICHE3.pdf

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Document reference: 45429

Study title: An open-label, multiple-dose, multicenter, pharmacokinetic safety and tolerability study of valaciclovir oral suspension in infants and children with HSV infection

Active substance: VALACICLOVIR

Study summary document link (including results): Valaciclovir-HS210915-ICHE3.pdf

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Document reference: 45424

Study title: A multicenter, retrospective, cohort, comparative epidemiologic study of the incidence of pre-specified abnormalities in cranial MRI in pediatric subjects with seizure disorders

Active substance: VIGABATRIN

Study summary document link (including results): Vigabatrin-Study 1.pdf

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Document reference: 47304

Study title: "A parallel group study comparing oral adjuctive vigabatrin with placebo in children with uncontrolled complex partial seizures - Valentine C, Mettert N, Mosier M, Michon AM, and the Vigabatrin protocol 221 investigative cohort - 1998 (Epilepsia In press (abstract) 1998) Publication in Consolidated Responses to Questions raised in Article 12 Referral Procedure - 11/1998"

Active substance: VIGABATRIN

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Document reference: 39386

Study title: A multicenter, open-label, single-dose study to evaluate the pharmacokinetics (i.e. 24 hour pharmacokinetic sampling period) of valsartan given as an oral suspension in pediatric patients 1 year to 16 years of age with hypertension.DOI: 10.1177/0091270008329547 Journal publication: Journal Clinical Pharmacology 2009;49:235-241

Active substance: VALSARTAN

Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2305_2.xls

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Document reference: 47269

Study title: A multicenter, open-label, single-dose study to evaluate the pharmacokinetics (i.e. 24 hour pharmacokinetic sampling period) of valsartan given as an oral suspension in pediatric patients 1 year to 16 years of age with hypertension.

Active substance: VALSARTAN

Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2305_2.xls

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Document reference: 48168

Study title: Burmester M, Mok Q. Randomised controlled trial comparing cisatracurium and vecuronium infusions in a paediatric intensive care unit. Intensive Care Med 2005;31:686-92.Burmester M, Mok Q. Randomised controlled trial comparing cisatracurium and vecuronium infusions in a paediatric intensive care unit. Intensive Care Med 2005;31:686-92.

Active substance: VECURONIUM

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Document reference: 45533

Study title: McEvoy C et al. Acute effects of vecuronium on pulmonary function and hypoxemic episodes in preterm infants. Pediatr Int 2007;49:631-6McEvoy C et al. Acute effects of vecuronium on pulmonary function and hypoxemic episodes in preterm infants. Pediatr Int 2007;49:631-6

Active substance: VECURONIUM

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Document reference: 45532

Study title: A Preliminary Safety, Tolerance, Pharmacokinetic, and Efficacy Study of Venlafaxine in Children and Adolescents with Conduct Disorder

Active substance: Venlafaxine

Study summary document link (including results): 0600A-126-US EMA Pediatrics Web Synopsis.pdf

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Document reference: 47930

Study title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Venlafaxine ER in Pediatric Patients

Active substance: Venlafaxine

Study summary document link (including results): 0600B1-169-US EMA Pediatrics Web Synopsis.pdf

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Document reference: 47931

Study title: Double-Blind, Placebo-Controlled Study of Venlafaxine ER in Children and Adolescents with Generalized Anxiety Disorder

Active substance: Venlafaxine

Study summary document link (including results): 0600B2-396-US EMA Pediatrics Web Synopsis.pdf

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Document reference: 47935

Study title: Double-Blind, Placebo-Controlled Study of Venlafaxine ER in Children and Adolescents With Generalized Anxiety Disorder397

Active substance: Venlafaxine

Study summary document link (including results): 0600B2-397-US EMA Pediatrics Web Synopsis.pdf

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Document reference: 47936

Study title: Double-Blind, Placebo-Controlled Study of Venlafaxine ER in Children and Adolescents With Major Depression

Active substance: Venlafaxine

Study summary document link (including results): 0600B1-382-US EMA Pediatrics Web Synopsis.pdf

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Document reference: 47932

Study title: Double-Blind, Placebo-Controlled Study of Venlafaxine ER in Children and Adolescents with Major Depressive Disorder

Active substance: Venlafaxine

Study summary document link (including results): 0600B1-394-US EMA Pediatrics Web Synopsis.pdf

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Document reference: 47933

Study title: Open-Label Long-Term Safety Study of Venlafaxine ER in Children and Adolescents with Major Depressive Disorder

Active substance: Venlafaxine

Study summary document link (including results): 0600B1-395-US EMA Pediatrics Web Synopsis.pdf

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Document reference: 47934

Study title:

Active substance: SALBUTAMOL

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Document reference: 47690

Study title:

Active substance: SALBUTAMOL

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Document reference: 47691

Study title:

Active substance: SALBUTAMOL

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Document reference: 47692

Study title:

Active substance: SALBUTAMOL

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Document reference: 47693

Study title:

Active substance: SALBUTAMOL

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Document reference: 47694

Study title:

Active substance: SALBUTAMOL

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Document reference: 47695

Study title: A comparative study of the efficacy of and tolerance to 4mg salbutamol controlled release tablets (Volmax) and 1mg ketotifen tablets (Zaditen) administered twice daily in the management of childhood asthma

Active substance: SALBUTAMOL

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Document reference: 35572

Study title: A comparison of intravenous salbutamol, aminophylline and the combination in the treatment of acute severe asthma in children. Report No. GPM/85/008

Active substance: SALBUTAMOL

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Document reference: 35567

Study title: A comparison of Salbutamol and Sodium Cromoglycate in exercise-induced asthma in children. Report No. GPM/84/001

Active substance: SALBUTAMOL

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Document reference: 35547

Study title: A comparison of Salbutamol and Sodium Cromoglycate in exercise-induced asthma in children. Report No. GPM/84/007

Active substance: SALBUTAMOL

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Document reference: 35568

Study title: DIAGNOSTIC ANALYSIS IN PATIENTS WITH CHILDHOOD ONSET GROWTH HORMONE DEFICIENCY DURING TRANSITION FROM ADOLESCENCE TO ADULTHOOD

Active substance: Somatropin

Study summary document link (including results): 307-MET-9002-020 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41650

Study title: Discontinued administration (6 months a year) of growth hormone to children with very short stature and having suffered from intrauterine growth retardation: safety and effect on growth of long-term therapy

Active substance: Somatropin

Study summary document link (including results): GHRETARD-F-2-F_Norditropin.pdf

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Document reference: 41777

Study title: Effet de l'hormone de croissance biosynthétqiue Sanofi sur la croissance de l'enfant présentant un retard de croissance à début intra-utérin.

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41823

Study title: EFFICACY AND SAFETY OF GENOTONORM IN CHILDREN WITH FAMILIAL SHORT STATURE

Active substance: Somatropin

Study summary document link (including results): 90-076 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41715

Study title: Efficacy and Safety of Humatrope® in Patients with Ullrich-Turner Syndrome Turner syndrome

Active substance: Somatropin

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Document reference: 41638

Study title: Efficacy and safety of one year growth hormone therapy in steroid dependent nephrotic syndrome

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41794

Study title: EFFICACY AND SAFETY OF THE AUTHENTIC RECOMBINANT HUMAN SOMATROPIN GENOTROPIN IN CHILDREN WITH FAMILIAL SHORT STATURE

Active substance: Somatropin

Study summary document link (including results): 89-050 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41728

Study title: EFFICACY OF GENOTONORM IN PREPUBERTAL CHILDREN WITH SHORT STATURE SECONDARY TO A NEUROSECRETORY DYSFUNCTION. COMPARISON OF EFFICACY ON GROWTH WITH GROWTH HORMONE DEFICIENT CHILDREN AND CONSTITUTIONAL SHORT STATURE CHILDREN

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41677

Study title: ESKATROPE

Active substance: Somatropin

Study summary document link (including results): 2 10011-86-01 Summary.pdf

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Document reference: 47498

Study title: Hennon DK, Stookey GK, Beiswanger BB. Fluoride-vitamin supplements: effects on dental caries and fluorosis when used in areas with suboptimal fluoride in the water supply. JADA 1977; 95: 965-971Hennon DK, Stookey GK, Beiswanger BB. Fluoride-vitamin supplements: effects on dental caries and fluorosis when used in areas with suboptimal fluoride in the water supply. JADA 1977; 95: 965-971

Active substance: SODIUM FLUORIDE

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Document reference: 42263

Study title: Hennon DK, Stookey GK, Beiswanger BB. Fluoride-vitamin supplements: effects on dental caries and fluorosis when used in areas with suboptimal fluoride in the water supply. JADA 1977; 95: 965-971Hennon DK, Stookey GK, Beiswanger BB. Fluoride-vitamin supplements: effects on dental caries and fluorosis when used in areas with suboptimal fluoride in the water supply. JADA 1977; 95: 965-971

Active substance: SODIUM FLUORIDE

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Document reference: 42295

Study title: Hennon DK, Stookey GK, Beiswanger BB. Fluoride-vitamin supplements: effects on dental caries and fluorosis when used in areas with suboptimal fluoride in the water supply. JADA 1977; 95: 965-971Hennon DK, Stookey GK, Beiswanger BB. Fluoride-vitamin supplements: effects on dental caries and fluorosis when used in areas with suboptimal fluoride in the water supply. JADA 1977; 95: 965-971

Active substance: SODIUM FLUORIDE

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Document reference: 42327

Study title: In vitro fluoride uptake, distribution and retention by human enamel after 1- and 24-hour application of various topical fluoride agents.

Active substance: SODIUM FLUORIDE

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Document reference: 42404

Study title: In vitro fluoride uptake, distribution and retention by human enamel after 1- and 24-hour application of various topical fluoride agents.

Active substance: SODIUM FLUORIDE

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Document reference: 42517

Study title: Influence of F--releasing varnishes on the acid resistance of enamel.

Active substance: SODIUM FLUORIDE

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Document reference: 42337

Study title: A multicentre, randomised, double-blind, parallel group study comparing the efficacy and safety of inhaled salmeterol xinafoate 50mcg bd with that of salbutamol 200mcg to use “as required” from Diskhalers for twelve months in children with asthma.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SLGB3019-ICHE3.pdf

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Document reference: 42050

Study title: A Multicentre, Randomised, Double-Blind, Parallel-Group Study Comparing Pressurised Inhaler and Dry Powder Formulations of Salmeterol Xinafoate 50μg bd in Children With Reversible Airways Obstruction

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SLPT03-ICHE3.pdf

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Document reference: 47697

Study title: A multicentre, randomised. double-blind, crossover study to investigate the efficacy and safety of inhaled salmeterol xinafoate (50mcg twice daily from the diskhaler) compared with placebo (from the diskhaler) with salbutamol (200mcg to use 'as required' from the diskhaler) in children with asthma. Report No. GRP/95/011

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SMS30013-ICHE3.pdf

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Document reference: 42048

Study title: A phase III, multi-centre, double-blind, placebo controlled, parallel group study assessing the efficacy and safety of inhaled salmeterol xinafoate (Serevent™) 50 micrograms BD via the Diskhaler™ when added to the existing treatment of moderate to severe asthmatic children.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SALMP-AH93-J119-ICHE3.pdf

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Document reference: 42041

Study title: Comparative study of corticotrophin vs vigabatrin therapy in infantile spasm - Ahmed R. - 2007 (Pak J Med Sci 2007; 23: 1 141-144) Publication in CES 0759 dated 16 Nov 2007 signed A. Giudicelli

Active substance: VIGABATRIN

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Document reference: 39387

Study title: Dose-modification study of vigabatrin in children with refractory epilepsy.-Farr IN, Beaumont D. , Projekt Report: WIN 90-67, 1990

Active substance: VIGABATRIN

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Document reference: 39395

Study title: Dose-modification study of vigabatrin in children with refractory epilepsy.-Farr IN, Beaumont D. , Projekt Report: WIN 90-67, 1990

Active substance: VIGABATRIN

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Document reference: 39397

Study title: Drug therapy for West's syndrome - Chiron C - 2002 (Adv Exp Med Biol. 2002;497:51-6) Publication in CES dated 14 Nov 2005 signed A. Giudicelli

Active substance: VIGABATRIN

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Document reference: 39388

Study title: Follow-Up Screening to Investigate the Occurrence of Long-Term Retinal Effects in Children Exposed to Vigabatrin Treatment and in Subjects Exposed to Vigabatrin In Utero.

Active substance: VIGABATRIN

Study summary document link (including results): Vigabatrin-Study 3.pdf

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Document reference: 39389

Study title: Infantile spasms and West Syndrome Efficacy of short-term ACTH and vigabatrin treatment - Pintaudi M, Baglietto G, Pessagno A, Gaggero R - 2005 (Boll. Lega Ital. Epilepsia 2005; 169-170) Publication in CES 0741 dated 16 Nov 2006 signed A Giudicelli

Active substance: VIGABATRIN

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Document reference: 39390

Study title: MDL71754 (vigabatrin): 2-week oral range-finding toxicity study in juvenile rats

Active substance: VIGABATRIN

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Document reference: 39391

Study title: MDL71754 (vigabatrin): 4-week oral ocular toxicity study in Sprague Dawley juvenile rats (from postnatal day 4)

Active substance: VIGABATRIN

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Document reference: 39392

Study title: Non-comparative, prospective and observational multicenter study to detect early visual field defects, their frequency and clinical course in first-time vigabatrin (Sabril®) treatment for refractory partial epilepsy (CANADIAN VIGABATRIN STUDY).

Active substance: VIGABATRIN

Study summary document link (including results): Vigabatrin-Study 4.pdf

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Document reference: 39393

Study title: Open, multicentre study of the prevalence, incidence and clinical course of visual field defects in adults and children with refractory partial epilepsy treated with antiepileptic drugs.

Active substance: VIGABATRIN

Study summary document link (including results): Vigabatrin-Study 2.pdf

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Document reference: 47305

Study title: A phase I evaluation of oral and intravenous vinorelbine tartrate in Paediatric Cancer Patients

Active substance: VINORELBINE

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Document reference: 39399

Study title: A phase II study of vinorelbine tartrate in children with Recurrent or Refractory Malignancies.

Active substance: VINORELBINE

Study summary document link (including results): A09705.pdf

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Document reference: 39400

Study title: "Safety of inactivated split-virion influenza vaccine administered by the intradermal route in healthy children"

Active substance: Virus de la gripe fraccionados

Study summary document link (including results):

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Document reference: 45261

Study title: An Open-Label, Multiple-Dose, Multicenter, Pharmacokinetic Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children with VZV Infection

Active substance: VALACICLOVIR

Study summary document link (including results): Valaciclovir-HS210916-ICHE3.pdf

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Document reference: 45425

Study title: An open-label, single-dose, multicenter, pharmacokinetic, safety and tolerability study of valaciclovir oral suspension in infants and children.

Active substance: VALACICLOVIR

Study summary document link (including results): Valaciclovir-HS210914-ICHE3.pdf

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Document reference: 45423

Study title: Etude DEFI. Idiopathic partial GH deficiency. Continuous versus discontinuous GH administration.

Active substance: Somatropin

Study summary document link (including results): GHD-F-5-F_Norditropin.pdf

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Document reference: 41763

Study title: Etude pilote de l'activité de l'hormone de croisance chez les enfants ayant un retard de croissance intra-utérin.

Active substance: Somatropin

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Document reference: 41824

Study title: Evaluation of efficacy and safety of biosynthetic human growth hormone (Norditropin®). An open multicentre study

Active substance: Somatropin

Study summary document link (including results): H-GHV-001-GHD_Norditropin.pdf

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Document reference: 41768

Study title: Evaluation of Growth Promoting Effect and Safety of Growth Hormone in Achondroplasia

Active substance: Somatropin

Study summary document link (including results): Somatropin - B9R-JE-6001 CTR Summary.pdf

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Document reference: 41635

Study title: Evaluation of knee-mometry as a method of growth velocity control in growth retarded children undergoing one year of growth hormone treatment

Active substance: Somatropin

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Document reference: 41782

Study title: EXAMINATION OF EFFECTS ON GROWTH PROMOTING AND SAFETY OF PNU- 180307 IN SHORT CHILDREN BORN SMALL FOR GESTATIONAL AGE WITHOUT EPIPHYSEAL CLOSING

Active substance: Somatropin

Study summary document link (including results): 307-MET-0021-002 PhRMA Web Synopsis.pdf

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Document reference: 41642

Study title: Hruby K et al Pharmacotherapy of Amanita phalloides Poisoning with Silibinin, (Chemotherapy of Amanita phalloides poisoning with intravenous silibinin.)Wiener klin.Wochenschrift (and Human Toxicology); 1983; 7 (and 2 (2): 183-95 )

Active substance: Silibinine dihydrogen succinate, disodium

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Document reference: 40191

Study title: Hruby K et al Pharmacotherapy of Amanita phalloides Poisoning with Silibinin, (Chemotherapy of Amanita phalloides poisoning with intravenous silibinin.). Wiener klin.Wochenschrift (and Human Toxicology); 1983; 7 (and 2 (2): 183-95 )

Active substance: Silibinine dihydrogen succinate, disodium

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Document reference: 39870

Study title: Strenge-Hesse Postmarkting surveillance study (evaluation of 154 Legalon-SIL-case reports,18 children) 1983-1992 Internal Report; Internal Report, Strenge-Hesse, March 1996

Active substance: Silibinine dihydrogen succinate, disodium

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Document reference: 40194

Study title: Von Kleist-Retzow J-C et al Klinik und Therapie der Knollenblätterpilzvergiftung im Kindesalter. Clinical findings and treatment of Amanita phalloides poisoning in childhood); Monatsschrift fur Kinderheilkunde; 143/11 (1118-1127); 1995

Active substance: Silibinine dihydrogen succinate, disodium

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Document reference: 39871

Study title: Von Kleist-Retzow J-C et al Klinik und Therapie der Knollenblätterpilzvergiftung im Kindesalter. Clinical findings and treatment of Amanita phalloides poisoning in childhood)Monatsschrift fur Kinderheilkunde; 143/11 (1118-1127); 1995

Active substance: Silibinine dihydrogen succinate, disodium

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Document reference: 40192

Study title: Nutzen der medikamentösen Lebertherapie in der hausärztlichen Praxis; Die Medizinische Welt 1995; 46(4): 222-227

Active substance: Silimarin (HERB)

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Document reference: 39876

Study title: Nutzen der medikamentösen Lebertherapie in der hausärztlichen Praxis; Die Medizinische Welt 1995; 46(4): 222-227

Active substance: Silimarin (HERB)

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Document reference: 40197

Study title: The Treatment of Toxic Liver Damage with legalon; Z Klin Med; 1992, 47(2): 87-92

Active substance: Silimarin (HERB)

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Document reference: 39874

Study title: The Treatment of Toxic Liver Damage with legalon; Z Klin Med; 1992, 47(2): 87-92

Active substance: Silimarin (HERB)

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Document reference: 40195

Study title: Therapeutische Möglichkeiten mit Legalon in der Pädiatrie; Medica 1983; 4 (11): 3-6

Active substance: Silimarin (HERB)

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Document reference: 39875

Study title: Therapeutische Möglichkeiten mit Legalon in der Pädiatrie; Medica 1983; 4 (11): 3-6

Active substance: Silimarin (HERB)

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Document reference: 40196

Study title: A phase III, multi-centre, double-blind, placebo controlled, parallel group study assessing the efficacy and safety of inhaled salmeterol xinafoate (Serevent™) 50 micrograms BD via the Diskhaler™ when added to the existing treatment of moderate to severe asthmatic children.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SALMP-AH91-D89-ICHE3.pdf

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Document reference: 47699

Study title: A phase IV, multi-centre, double-blind, randomised, parallel group study in general practice to compare the efficacy and tolerability of inhaled salmeterol xinafoate 50 micrograms bd with placebo, both administered via the Diskhaler, in the treatment of episodic asthma induced by upper respiratory tract infection (URTI) in children.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SALMP-AH91-D89-ICHE3.pdf

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Document reference: 42040

Study title: A phase IV, multi-centre, double-blind, randomised, parallel group study in general practice to compare the efficacy and tolerability of inhaled salmeterol xinafoate 50 micrograms bd with placebo, both administered via the Diskhaler, in the treatment of episodic asthma induced by upper respiratory tract infection (URTI) in children.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SALMP-AH93-J119-ICHE3.pdf

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Document reference: 47698

Study title: OPEN-LABELED, MULTI-CENTER, SINGLE ARM STUDY TO DETERMINE PATIENT/CARE GIVER PREFERENCE OF INJEX, THE NEEDLE FREE, AUTOINJECTION DEVICE FOR ADMINISTRATION OF GENOTROPIN.

Active substance: Somatropin

Study summary document link (including results): GENAJT-0029-003 PhRMA Web Synopsis .pdf

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Document reference: 41665

Study title: Pen acceptability Study

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41766

Study title: Placebo controlled trial of growth hormone therapy for short children with steroid dependent nephrotic syndrome

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41795

Study title: Praticability and acceptability study of Stylomaxr in patients with somatropin insufficiency

Active substance: Somatropin

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Document reference: 41821

Study title: Protocol A: The Effects of Biosynthetic Human Growth Hormone Treatment in the Management of Children with Familial Short Stature. Protocol B: A Comparative Evaluation of Growth Hormone, anabolic steroids and a combinationof the two in stimulating the Grow

Active substance: Somatropin

Study summary document link (including results): GHRETARD-BPD-8-9-10-UK_Norditropin.pdf

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Document reference: 41779

Study title: PROTOCOL FOR THE STUDY OF GROWTH HORMONE IN GENETICALLY SHORT CHILDREN

Active substance: Somatropin

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Document reference: 41737

Study title: Randomised study to investigate the effects on growth, on gonadal function and on the safety of recombinant hGH treatment in pubertal children with growth retardation secondary to chronic renal insufficiency

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41793

Study title: Randomised study to investigate the effects on growth, on uraemic toxins profile and on the safety of recombinant human growth hormone treatment in very young children with growth retardation secondary to chronic renal insufficiency (CRI).

Active substance: Somatropin

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Document reference: 41791

Study title: Randomised Study to Investigate the Effects on Growth, on Uremic Toxins Profile and on Renal Function of Recombinant Human Growth Hormone Treatment in Very Young Children With Growth Retardation Secondary To Chronic Renal Insufficiency.

Active substance: Somatropin

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Document reference: 41790

Study title: An Open-Label, Uncontrolled Pharmacokinetic and Clinical Evaluation Study of Valaciclovir Hydrochloride in Children with Chickenpox.

Active substance: VALACICLOVIR

Study summary document link (including results): Valaciclovir-HS2101951-ICHE3.pdf

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Document reference: 45422

Study title: Pharmacokinetics and Safety of valaciclovir in children with Epstein-Barr virus illness; Drugs R&D, 2002: 3(6), SimonPharmacokinetics and Safety of valaciclovir in children with Epstein-Barr virus illness; Drugs R&D, 2002: 3(6), Simon

Active substance: VALACICLOVIR

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Document reference: 45421

Study title: Pharmacokinetics of acyclovir in immunocompromised children with leukopenia and mucositis after chemotherapy: Can intravenous acyclovir be substituted by oral valacyclovir?Med Pediatr Oncol 2002:38:240-246, EksborgPharmacokinetics of acyclovir in immunocompromised children with leukopenia and mucositis after chemotherapy: Can intravenous acyclovir be substituted by oral valacyclovir?Med Pediatr Oncol 2002:38:240-246, Eksborg

Active substance: VALACICLOVIR

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Document reference: 45430

Study title: To estimate the survival of bone marrow transplant (BMT) subjects randomized to receive cytomegalovirus (CMV) prophylaxis with intravenous (IV) acyclovir (ACV) followed by either oral valaciclovir (VACV) or IV ganciclovir (GCV).

Active substance: VALACICLOVIR

Study summary document link (including results): Study 123-039 (HS2A3005) Valaciclovir.xls

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Document reference: 47356

Study title: Clinical Protocol for a Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel Group Study to Compare the Efficacy and Tolerability of Valdecoxib vs. Tramadol in Treatment of Acute Ankle Sprains

Active substance: Valdecoxib

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Document reference: 47444

Study title: Post-marketing surveillance trial evaluating efficacy and tolerability of a valerian root extract in 55 children.

Active substance: Valerian root extract 6.15:1 (HERB)

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Document reference: 40297

Study title: Francis AJ, Dempster RJ. Effect of valerian, Valeriana edulis, on sleep difficulties in children with intellectual deficits: randomised trial. Phytomedicine. 2002 May;9(4):273-9.

Active substance: Valeriana dry extract

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Document reference: 40299

Study title: Müller SF, Klement S. A combination of valerian and lemon balm is effective in the treatment of restlessness and dyssomnia in children. Phytomedicine. 2006 Jun;13(6):383-7. Epub 2006 Feb 17.

Active substance: Valeriana dry extract

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Document reference: 40298

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Valerianaheel (drops) [AWB-AT]

Active substance: Valeriana Heel

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Document reference: 39769

Study title: An open-label, multiple-dose, multicenter, pharmacokinetic safety and tolerability study of valaciclovir oral suspension in infants and children with HSV infection

Active substance: VALGACICLOVIR

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Document reference: 45433

Study title: An Open-Label, Multiple-Dose, Multicenter, Pharmacokinetic Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children with VZV Infection

Active substance: VALGACICLOVIR

Study summary document link (including results):

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Document reference: 45434

Study title: An open-label, single-dose, multicenter, pharmacokinetic, safety and tolerability study of valaciclovir oral suspension in infants and children.

Active substance: VALGACICLOVIR

Study summary document link (including results):

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Document reference: 45432

Study title: An Open-Label, Uncontrolled Pharmacokinetic and Clinical Evaluation Study of Valaciclovir Hydrochloride in Children with Chickenpox.

Active substance: VALGACICLOVIR

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Document reference: 45431

Study title: A clinical study of 57 children with fetal anticonvulsant syndromes. - Moore et al. - J Med Genet 2000;37:489-497.

Active substance: VALPROIC ACID

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Document reference: 45435

Study title: A comparative review of the adverse effects of anticonvulsants in children with epilepsy. - Wallace SJ. - Drug safety 1996; 15(6): 378-393.

Active substance: VALPROIC ACID

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Document reference: 45436

Study title: "Evaluation of safety and immunogenicity of inactivated flu vaccine in children with underlying disease"

Active substance: Virus de la gripe fraccionados, inactivados que contienen antígenos equivalentes a las cepas recomendadas por la OMS (hemisferio Norte) y la decisión de la Unión Europea para cada campaña de vacunación [inactivated influenza split virion vaccine (Triton X 100)]

Study summary document link (including results):

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Document reference: 41459

Study title: Evaluation of safety and immunogenicity of inactivated flu vaccine in children with underlying disease

Active substance: Virus de la gripe fraccionados, inactivados que contienen antígenos equivalentes a las cepas recomendadas por la OMS (hemisferio Norte) y la decisión de la Unión Europea para cada campaña de vacunación [inactivated influenza split virion vaccine (Triton X 100)]

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Document reference: 41460

Study title: A cohort study of childhood hypertrophic cardiomyopathy: improved survival following high−dose beta−adrenoceptor antagonist treatment.Ostman−Smith I, Wettrell G, Riesenfeld T. Journal of the American College of Cardiology, 15 Nov 1999, vol. 34, no. 6, p.1813−22, A cohort study of childhood hypertrophic cardiomyopathy: improved survival following high−dose beta−adrenoceptor antagonist treatment.Ostman−Smith I, Wettrell G, Riesenfeld T. Journal of the American College of Cardiology, 15 Nov 1999, vol. 34, no. 6, p.1813−22,

Active substance: VERAPAMIL

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Document reference: 45540

Study title: Alternatives in drug treatment of chronic paroxysmal hemicrania.Evers S, Husstedt IW. Headache, Jul−Aug 1996, vol. 36, no. 7, p. 429−32, Alternatives in drug treatment of chronic paroxysmal hemicrania.Evers S, Husstedt IW. Headache, Jul−Aug 1996, vol. 36, no. 7, p. 429−32,

Active substance: VERAPAMIL

Study summary document link (including results):

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Document reference: 45546

Study title: Antagonisty kal'tsiia v lechenii nefrogennoi gipertenzii. (Calcium antagonists in the treatment of nephrogenic hypertension).Antonchenko IV, Tareeva IE, Kutyrina IM, Galstian GM, Rogov VA. Klinicheskaia meditsina, Aug 1990, vol. 68, no. 8, p. 52−6,Antagonisty kal'tsiia v lechenii nefrogennoi gipertenzii. (Calcium antagonists in the treatment of nephrogenic hypertension).Antonchenko IV, Tareeva IE, Kutyrina IM, Galstian GM, Rogov VA. Klinicheskaia meditsina, Aug 1990, vol. 68, no. 8, p. 52−6,

Active substance: VERAPAMIL

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Document reference: 45555

Study title: Antihypertensive activity of verapamil: impact of dietary sodium. The VERSAL Study Group.Antihypertensive activity of verapamil: impact of dietary sodium. The VERSAL Study Group.

Active substance: VERAPAMIL

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Document reference: 45550

Study title: Assessment of blindness in the Danish Verapamil Infarction Trial II (DAVIT II). Danish Study Group on Verapamil in Myocardial Infarction.Jespersen CM. European journal of clinical pharmacology, 1990, vol. 39, no. 1, p. 75−6, Assessment of blindness in the Danish Verapamil Infarction Trial II (DAVIT II). Danish Study Group on Verapamil in Myocardial Infarction.Jespersen CM. European journal of clinical pharmacology, 1990, vol. 39, no. 1, p. 75−6,

Active substance: VERAPAMIL

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Document reference: 45556

Study title: Beta−adrenoblokatory i antagonisti kal'tsiia pri gipertroficheskoi kardiomiopatii. (Beta−adrenergic blockers and calcium antagonists in hypertrophic cardiomyopathy).Korovina EP. Klinicheskaia meditsina, 1998, vol. 76, no. 12, p. 30−5, Beta−adrenoblokatory i antagonisti kal'tsiia pri gipertroficheskoi kardiomiopatii. (Beta−adrenergic blockers and calcium antagonists in hypertrophic cardiomyopathy).Korovina EP. Klinicheskaia meditsina, 1998, vol. 76, no. 12, p. 30−5,

Active substance: VERAPAMIL

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Document reference: 45542

Study title: Calcium channel blockers and cardiac mortality in the treatment of hypertension: a report from the Department of Health Hypertension Care Computing Project (DHCCP).Bulpitt CJ, Palmer AJ, Beevers DG, Coles EC, Ledingham JG, Petrie JC, Webster J. Journal of human hypertension, Apr 1997, vol. 11, no. 4, p. 205−11, Calcium channel blockers and cardiac mortality in the treatment of hypertension: a report from the Department of Health Hypertension Care Computing Project (DHCCP).Bulpitt CJ, Palmer AJ, Beevers DG, Coles EC, Ledingham JG, Petrie JC, Webster J. Journal of human hypertension, Apr 1997, vol. 11, no. 4, p. 205−11,

Active substance: VERAPAMIL

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Document reference: 45543

Study title: Calcium channel blockers in cirrhotic patients with portal hypertension.Li D, Lu H, Li X, Quan Q, Li X, Lu W. Chinese medical journal, Nov 1995, vol. 108, no. 11, p. 803−8, Calcium channel blockers in cirrhotic patients with portal hypertension.Li D, Lu H, Li X, Quan Q, Li X, Lu W. Chinese medical journal, Nov 1995, vol. 108, no. 11, p. 803−8,

Active substance: VERAPAMIL

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Document reference: 45547

Study title: Albrecht M./Strenge-Hesse et al. The treatment of Toxic Liver Damage with Legalon. Z Klin Med; 1992, 47(2): 87-92 Albrecht M./Strenge-Hesse et al. The treatment of Toxic Liver Damage with Legalon. Z Klin Med; 1992, 47(2): 87-92

Active substance: SILYMARIN

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Document reference: 42171

Study title: Grüngreiff K./Strenge-Hesse et al. Nutzen der medikamentösen Lebertherpaie in der hausärztlichen Praxis. The value of drug therapy for liver disease in general practice. Die Medizinische Welt 1995; 46(4): 222-227.Grüngreiff K./Strenge-Hesse et al. Nutzen der medikamentösen Lebertherpaie in der hausärztlichen Praxis. The value of drug therapy for liver disease in general practice. Die Medizinische Welt 1995; 46(4): 222-227.

Active substance: SILYMARIN

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Document reference: 42173

Study title: Jdl J et al. Therapeutische M+oglichkeiten mit Legalon in der Pädiatrie. Therapeutic uses of Legalon in paediatrics. Medica 1983; 4 (11): 3-6. Jdl J et al. Therapeutische M+oglichkeiten mit Legalon in der Pädiatrie. Therapeutic uses of Legalon in paediatrics. Medica 1983; 4 (11): 3-6.

Active substance: SILYMARIN

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Document reference: 42172

Study title: Albert J et al. Simethicone for small bowel preparation for capsule endoscopy: a systematic, single-blinded, controlled study. Gastrointest Endosc. 2004 Apr;59(4):487-91 Albert J et al. Simethicone for small bowel preparation for capsule endoscopy: a systematic, single-blinded, controlled study. Gastrointest Endosc. 2004 Apr;59(4):487-91

Active substance: SIMETICONE

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Document reference: 42205

Study title: Fanning EA, Cellier KM, Leadbeater MM, Somerville CM. South Australian kindergarten children: fluoride tablet supplements and dental caries. Aust Dent J 1975: 20: 7-9Fanning EA, Cellier KM, Leadbeater MM, Somerville CM. South Australian kindergarten children: fluoride tablet supplements and dental caries. Aust Dent J 1975: 20: 7-9

Active substance: SODIUM FLUORIDE

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Document reference: 42276

Study title: Fanning EA, Cellier KM, Leadbeater MM, Somerville CM. South Australian kindergarten children: fluoride tablet supplements and dental caries. Aust Dent J 1975: 20: 7-9Fanning EA, Cellier KM, Leadbeater MM, Somerville CM. South Australian kindergarten children: fluoride tablet supplements and dental caries. Aust Dent J 1975: 20: 7-9

Active substance: SODIUM FLUORIDE

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Document reference: 42308

Study title: Feltman R, Kosel G: Prenatal and postnatal ingestion of fluorides – forteen years of investigation - final report. J Dent Med 1961; 16: 190-1999Feltman R, Kosel G: Prenatal and postnatal ingestion of fluorides – forteen years of investigation - final report. J Dent Med 1961; 16: 190-1999

Active substance: SODIUM FLUORIDE

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Document reference: 42245

Study title: Feltman R, Kosel G: Prenatal and postnatal ingestion of fluorides – forteen years of investigation - final report. J Dent Med 1961; 16: 190-1999Feltman R, Kosel G: Prenatal and postnatal ingestion of fluorides – forteen years of investigation - final report. J Dent Med 1961; 16: 190-1999

Active substance: SODIUM FLUORIDE

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Document reference: 42277

Study title: Feltman R, Kosel G: Prenatal and postnatal ingestion of fluorides – forteen years of investigation - final report. J Dent Med 1961; 16: 190-1999Feltman R, Kosel G: Prenatal and postnatal ingestion of fluorides – forteen years of investigation - final report. J Dent Med 1961; 16: 190-1999

Active substance: SODIUM FLUORIDE

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Document reference: 42309

Study title: Fissure sealants versus fluorine varnish on the first permanent molars: economic assessment

Active substance: SODIUM FLUORIDE

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Document reference: 42348

Study title: Fissure sealants versus fluorine varnish on the first permanent molars: economic assessment

Active substance: SODIUM FLUORIDE

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Document reference: 42461

Study title: Fissure sealing of permanent first molars in children receiving a high standard of prophylactic care.

Active substance: SODIUM FLUORIDE

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Document reference: 42400

Study title: Recombinant Growth Hormone (rhGH) in Growth hormone deficient children

Active substance: Somatropin

Study summary document link (including results): 86-001 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41744

Study title: RECOMBINANT SOMATROPIN (GENOTONORM (REGISTERED)) GIVEN SUBCUTANEOUSLY AS DAILY INJECTIONS OR AS CONTINUOUS INFUSION TO GROWTH HORMONE DEFICIENT CHILDREN.

Active substance: Somatropin

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Document reference: 41731

Study title: Safety and efficacy of Growth Hormone treatment of Patients with growth hormone deficiency by means of a pen injector (Nordiject)

Active substance: Somatropin

Study summary document link (including results): YU_GHD_001_GHD_Norditropin.pdf

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Document reference: 41767

Study title: Somatropin: Correlation of Bone Markers and Growth Velocity

Active substance: Somatropin

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Document reference: 41631

Study title: STUDY EVALUATING THE EFFECT OF GENOTROPIN IN PREPUBERTAL SHORT NORMAL CHILDREN

Active substance: Somatropin

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Document reference: 41740

Study title: Study of the effect of subcutaneous administration of two doses of biosynthetic growth hormone (Norditropin) on growth and metabolic parameters in pre-pubertal children with growth hormone deficiency

Active substance: Somatropin

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Document reference: 41755

Study title: Ota FS, Abramo TJ, Maxson RT. Ominous findings in toddlers with increasing abdominal girth: Two unusual cases and a review of the clinical evaluation. Ann Emerg Med. May 1, 2005, 517-23Ota FS, Abramo TJ, Maxson RT. Ominous findings in toddlers with increasing abdominal girth: Two unusual cases and a review of the clinical evaluation. Ann Emerg Med. May 1, 2005, 517-23

Active substance: SIMETICONE

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Document reference: 42182

Study title: Perez A, Scribano PV, Perry H. An intentional opiate intoxication of an infant: When medical toxicology and child maltreatment services merge. Pediatr Emerg Care. November 1, 2004, 769-72Perez A, Scribano PV, Perry H. An intentional opiate intoxication of an infant: When medical toxicology and child maltreatment services merge. Pediatr Emerg Care. November 1, 2004, 769-72

Active substance: SIMETICONE

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Document reference: 42184

Study title: Savino F et al. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics. 2007 Jan;119(1):e124-30 Savino F et al. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics. 2007 Jan;119(1):e124-30

Active substance: SIMETICONE

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Document reference: 42201

Study title: Savino F et al. Reduction of crying episodes owing to infantile colic: A randomized controlled study on the efficacy of a new infant formula. Eur J Clin Nutr. 2006 Nov;60(11):1304-10Savino F et al. Reduction of crying episodes owing to infantile colic: A randomized controlled study on the efficacy of a new infant formula. Eur J Clin Nutr. 2006 Nov;60(11):1304-10

Active substance: SIMETICONE

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Document reference: 42204

Study title: Sethi KS, Sethi JK. Simethicone in the management of infant colic. Practitioner. 1988 May 9;232(1448):508Sethi KS, Sethi JK. Simethicone in the management of infant colic. Practitioner. 1988 May 9;232(1448):508

Active substance: SIMETICONE

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Document reference: 42214

Study title: Final report of the study a double-blind, randomised, controlled, multi-centre safety study of a refrigerator-stable formulation of VARIVAX in healthy 12 to 15 month-old children, X04-VAR-402. :

Active substance: virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella

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Document reference: 45265

Study title: J.A.R. Calderon: Uso de Pantogar en la terapia contra la caida difusa del cabello y danos estructurales del mismo, 2003

Active substance: VITAMIN COMBINATIONS

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Document reference: 39401

Study title: Bates BYC, Evans PH, Sonko BJ, et al. Biochemical indices and neuromuscular function tests in rural Gambian schoolchildren given a riboflavin, or multivitamin plus iron, supplement. British J of Nutr, 1994:72;601-610.Bates BYC, Evans PH, Sonko BJ, et al. Biochemical indices and neuromuscular function tests in rural Gambian schoolchildren given a riboflavin, or multivitamin plus iron, supplement. British J of Nutr, 1994:72;601-610.

Active substance: VITAMINS

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Document reference: 45571

Study title: Benton D, Roberts G. Effect of vitamin and mineral supplementation on intelligence on a sample of schoolchildren. Lancet, 1988:1;140-3.Benton D, Roberts G. Effect of vitamin and mineral supplementation on intelligence on a sample of schoolchildren. Lancet, 1988:1;140-3.

Active substance: VITAMINS

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Document reference: 45576

Study title: Effect of long-acting garlic tablets "allicor" on the incidence of acute respiratory viral infections in children. Andrianova IV, Sobenin IA, Sereda EV, Borodina LI, Studenikin MI. Ter Arkh. 2003;75(3):53-6.Effect of long-acting garlic tablets "allicor" on the incidence of acute respiratory viral infections in children. Andrianova IV, Sobenin IA, Sereda EV, Borodina LI, Studenikin MI. Ter Arkh. 2003;75(3):53-6.

Active substance: VITAMINS

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Document reference: 45569

Study title: Garlic extract therapy in children with hypercholesterolemia. McCrindle BW, Helden E, Conner WT. Arch Pediatr Adolesc Med. 1998 Nov;152(11):1089-94. Garlic extract therapy in children with hypercholesterolemia. McCrindle BW, Helden E, Conner WT. Arch Pediatr Adolesc Med. 1998 Nov;152(11):1089-94.

Active substance: VITAMINS

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Document reference: 45570

Study title: Geltman PL, Meyers AF, Mehta SD, et al. Daily multivitamins with iron to prevent anemia in high-risk infants: A randomized clinical trial. Pediatrics, 2004:114;86-93.Geltman PL, Meyers AF, Mehta SD, et al. Daily multivitamins with iron to prevent anemia in high-risk infants: A randomized clinical trial. Pediatrics, 2004:114;86-93.

Active substance: VITAMINS

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Document reference: 45572

Study title: Immunological and clinical study on therapeutic efficacy of inosine pranobex, Gołebiowska-Wawrzyniak M, Markiewicz K, Kozar A, Derentowicz P, Czerwińska-Kartowicz I, Jastrzebska-Janas K, Wacławek J, Wawrzyniak ZM, Siwińska-Gołebiowska H. Pol Merkur Lekarski. 2005 Sep;19(111):379-82.Immunological and clinical study on therapeutic efficacy of inosine pranobex, Gołebiowska-Wawrzyniak M, Markiewicz K, Kozar A, Derentowicz P, Czerwińska-Kartowicz I, Jastrzebska-Janas K, Wacławek J, Wawrzyniak ZM, Siwińska-Gołebiowska H. Pol Merkur Lekarski. 2005 Sep;19(111):379-82.

Active substance: VITAMINS

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Document reference: 45568

Study title: A multicentre comparative trial of sodium valproate and carbamazepine in paediatric epilepsy. CM Verity Developmental medicine and child neurology,37,97-108, 1995 in CES EXPCRC-CES0002-ENE01

Active substance: VALPROIC ACID

Study summary document link (including results): Valproic Acid STUDY 022-6-133-V1.xls

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Document reference: 45437

Study title: A multicentre comparative trial of sodium valproate and carbamazepine in paediatric epilepsy. CM Verity Developmental medicine and child neurology,37,97-108, 1995 in CES EXPCRC-CES0364-ENE01

Active substance: VALPROIC ACID

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Document reference: 45440

Study title: A multicentre comparative trial of sodium valproate and carbamazepine in paediatric epilepsy. CM Verity Developmental medicine and child neurology,37,97-108, 1995 in CES EXPCRC-CES0368-ENE01

Active substance: VALPROIC ACID

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Document reference: 45441

Study title: Fissure sealing of permanent first molars in children receiving a high standard of prophylactic care.

Active substance: SODIUM FLUORIDE

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Document reference: 42513

Study title: Fluoride clearance of whole saliva in young school children after topical application.

Active substance: SODIUM FLUORIDE

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Document reference: 42397

Study title: Fluoride clearance of whole saliva in young school children after topical application.

Active substance: SODIUM FLUORIDE

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Document reference: 42510

Study title: Fluoride concentration in plaque in adolescents after topical application of different fluoride varnishes.

Active substance: SODIUM FLUORIDE

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Document reference: 42537

Study title: Fluoride concentration in whole saliva and separate gland secretions after topical treatment with three different fluoride varnishes

Active substance: SODIUM FLUORIDE

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Document reference: 42434

Study title: Fluoride concentration in whole saliva and separate gland secretions after topical treatment with three different fluoride varnishes

Active substance: SODIUM FLUORIDE

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Document reference: 42547

Study title: Fluoride content of enamel during treatment and 2 years after discontinuation of treatment with fluoride varnishes.

Active substance: SODIUM FLUORIDE

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Document reference: 42415

Study title: Fluoride content of enamel during treatment and 2 years after discontinuation of treatment with fluoride varnishes.

Active substance: SODIUM FLUORIDE

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Document reference: 42528

Study title: Fluoride deposited topical applications in enamel. KOH-soluble and acquired fluoride.

Active substance: SODIUM FLUORIDE

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Document reference: 42355

Study title: A Four-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multi-Center Study of VENTOLIN™ (albuterol) HFA MDI delivered with facemask and two different holding chambers in Subjects aged 24 to <48 months with asthma symptoms (i.e. wheeze, cough, dyspnea or chest tightness) or consistent with asthma or obstructive airway disease or bronchospasm.

Active substance: SALBUTAMOL

Study summary document link (including results): Salbutamol Sulphate-SB020001-ICHE3.pdf

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Document reference: 47684

Study title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Clinical Trial Assessing the Safety and Efficacy of Albuterol Powder 200mcg QID via the DISKUS versus Albuterol Aerosol 200mcg (180mcg Ex-Actuator) versus Placebo in Pediatric Subjects Aged 4-11 Years with Asthma. Report No. RM1997/00754/00

Active substance: SALBUTAMOL

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Document reference: 35569

Study title: An open cross-over comparison of controlled release salbutamol tablets (4mg bd) with individually titrated slow release theophylline (Theodur) in the management of chronic reversible airways obstruction in children (ST 388). Report No. GRP/88/013

Active substance: SALBUTAMOL

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Document reference: 35573

Study title: - Application and efficacy of the multi-dose powder inhaler, Easyhaler, in children with asthma

Active substance: SALBUTAMOL

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Document reference: 35551

Study title: Combivent vs. salbutamol in patients with metacholine-induced bronchospasm

Active substance: SALBUTAMOL

Study summary document link (including results): Ipratropium bromide_salbutamol sulphate_U00-0040_synopsis.pdf

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Document reference: 30743

Study title: Comparison of the bronchodilating effect of salbutamol inhaled with low inspiratory flow from Easyhaler with that of salbutamol aerosol

Active substance: SALBUTAMOL

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Document reference: 35552

Study title: Easyhaler, Diskus and Turbohaler. A comparison of correct use and acceptability of three devices.

Active substance: SALBUTAMOL

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Document reference: 35550

Study title: T. Orłowski - ,,Clinical evaluation of the preparation Salbutamol tablets and syrup"

Active substance: SALBUTAMOL

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Document reference: 35553

Study title: Sferra TJ, Heitlinger LA. Gastrointestinal gas formation and infantile colic. Pediatr Clin North Am. May 7, 1996, 489-510Sferra TJ, Heitlinger LA. Gastrointestinal gas formation and infantile colic. Pediatr Clin North Am. May 7, 1996, 489-510

Active substance: SIMETICONE

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Document reference: 42192

Study title: Sherbaniuk RW et al. Comparative study of cimetidine and Mylanta II in the 6-week treatment of gastric ulcer. J Clin Gastroenterol. 1985 Jun;7(3):211-5Sherbaniuk RW et al. Comparative study of cimetidine and Mylanta II in the 6-week treatment of gastric ulcer. J Clin Gastroenterol. 1985 Jun;7(3):211-5

Active substance: SIMETICONE

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Document reference: 42216

Study title: Simón A et al. The use of gastric ultrasonography in the evaluation of a new antiflatulent preparation in human volunteers. Methods Find Exp Clin Pharmacol. 1985 Jul;7(7):393-8Simón A et al. The use of gastric ultrasonography in the evaluation of a new antiflatulent preparation in human volunteers. Methods Find Exp Clin Pharmacol. 1985 Jul;7(7):393-8

Active substance: SIMETICONE

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Document reference: 42215

Study title: Sofo L et al. SELG-simeticone vs standard preparation in patients undergoing an endoscopic examination of large bowel. G Ital Endosc Dig. May 29, 1995, 37-42Sofo L et al. SELG-simeticone vs standard preparation in patients undergoing an endoscopic examination of large bowel. G Ital Endosc Dig. May 29, 1995, 37-42

Active substance: SIMETICONE

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Document reference: 42193

Study title: Spiro DM et al. Association between antibiotic use and primary idiopathic intussusception. Arch Pediatr Adolesc Med. January 1, 2003, 54-9Spiro DM et al. Association between antibiotic use and primary idiopathic intussusception. Arch Pediatr Adolesc Med. January 1, 2003, 54-9

Active substance: SIMETICONE

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Document reference: 42187

Study title: Influence of F--releasing varnishes on the acid resistance of enamel.

Active substance: SODIUM FLUORIDE

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Document reference: 42450

Study title: Intensive fluoride varnish program in Swedish adolescents: economic assessment of a 7-year follow-up study on proximal caries incidence.

Active substance: SODIUM FLUORIDE

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Document reference: 42398

Study title: Intensive fluoride varnish program in Swedish adolescents: economic assessment of a 7-year follow-up study on proximal caries incidence.

Active substance: SODIUM FLUORIDE

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Document reference: 42511

Study title: Kinetics of fluorine in deciduous enamel after application of fluoride-containing varnish (Duraphat).

Active substance: SODIUM FLUORIDE

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Document reference: 42375

Study title: Kinetics of fluorine in deciduous enamel after application of fluoride-containing varnish (Duraphat).

Active substance: SODIUM FLUORIDE

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Document reference: 42488

Study title: Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179.Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179.

Active substance: SODIUM FLUORIDE

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Document reference: 42247

Study title: Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179.Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179.

Active substance: SODIUM FLUORIDE

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Document reference: 42279

Study title: Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179.Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179.

Active substance: SODIUM FLUORIDE

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Document reference: 42311

Study title: Long-term use of fluoride lacquer in preventive care of school children in area of basic care.

Active substance: SODIUM FLUORIDE

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Document reference: 42384

Study title: A study of the safety of sodium divalproate (Dépakote®) in adolescents suffering from bipolar disorder in manic, mixed or hypomanic phase

Active substance: VALPROIC ACID

Study summary document link (including results): Sodium Valproate-Study 1.pdf

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Document reference: 47744

Study title: Adab et al. Additional educational needs in children born to mothers with epilepsy. J Neurol Neurosurg Psychiatry 2001;70:15-21.

Active substance: VALPROIC ACID

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Document reference: 45443

Study title: Additional educational needs in children born to mothers with epilepsy. -Adab et al. - J Neurol Neurosurg Psychiatry 2001;70:15-21.

Active substance: VALPROIC ACID

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Document reference: 45444

Study title: American Academy of Pediatrics. Committee on quality improvement, subcommittee on febrile convulsions. Practice parameter: long-term treatment of the child with simple febrile convulsions. Pediatrics 1999; 103: 1307-1309.

Active substance: VALPROIC ACID

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Document reference: 45445

Study title: An open-label trial of divalproex in children and adolescents with bipolar disorder - Wagner KD. - 2002 ( J Am Acad Child Adolesc Psychiatry 2002, 41 (10) : 1224-1230 )

Active substance: VALPROIC ACID

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Document reference: 45446

Study title: Antiepileptic drug-induced worsening of seizures in children. - Guerrini R. et al. - Epilepsia 1998; 39 (suppl. 3): S2-S10

Active substance: VALPROIC ACID

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Document reference: 45448

Study title: Arpino C et al. Teratogenic effects of antiepileptic drugs: use of an international database on malformations and drug exposure (MADRE). Epilepsia 2000;41(11):1436-43.

Active substance: VALPROIC ACID

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Document reference: 45449

Study title: Barnes SE et al. Sodium valproate in the treatment of intractable childhood epilepsy. Develop Med Child Neurol 1975;17:175-81.

Active substance: VALPROIC ACID

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Document reference: 45450

Study title: Baumann RJ. Prevention and management of febrile convulsions. Paedriatr Drugs 2001; 3: 585-592.

Active substance: VALPROIC ACID

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Document reference: 45452

Study title: Baumann RJ. et al. Treatment of children with simple febrile convulsions: the AAP practice parameter. Pediatr Neurol 2000; 23:11-17.

Active substance: VALPROIC ACID

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Document reference: 45451

Study title: Benign epilpesies of infancy - Epilepsy: A compehensive Textbook - 1997, p,2267-76

Active substance: VALPROIC ACID

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Document reference: 45453

Study title: Berg AT et al. Predictors of recurrent febrile convulsions: a metaanalytic review. J Pediatr 1990; 116: 329-337.

Active substance: VALPROIC ACID

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Document reference: 45454

Study title: Camfield PR et al. Febrile seizures. In: epileptic syndromes in infancy, childhood and adolescence. J Roger et al editors. John Libbey and Co Ltd publishers. 3rd edition. 2002; chapter 11: 145-152.

Active substance: VALPROIC ACID

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Document reference: 45455

Study title: Linday LA, Tapia-Mendoza J, Shindledecker, RD, et al. Effect of daily cod liver oil and a mutlivtamin-mineral supplement with selenium on upper respiratory tract pediatric visits by young, inner-city, Latino children: randomized pediatric sites. Ann Otol Rhinol Laryngol, 2004:113;891-901.Linday LA, Tapia-Mendoza J, Shindledecker, RD, et al. Effect of daily cod liver oil and a mutlivtamin-mineral supplement with selenium on upper respiratory tract pediatric visits by young, inner-city, Latino children: randomized pediatric sites. Ann Otol Rhinol Laryngol, 2004:113;891-901.

Active substance: VITAMINS

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Document reference: 45575

Study title: Ozkan B, Bereket A, Turan S. Addition of orlistat to conventional treatment in adolescents with severe obesity. Eur J Pediatr, 2004:163:738-741.Ozkan B, Bereket A, Turan S. Addition of orlistat to conventional treatment in adolescents with severe obesity. Eur J Pediatr, 2004:163:738-741.

Active substance: VITAMINS

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Document reference: 45573

Study title: 30 day oral toxicity study in the young dog - Thien - Aubert and al. - 14/12/94

Active substance: ROXYTHROMYCIN

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Document reference: 35467

Study title: 5 days subchronic oral toxicity study in the young dog - Fournier R. and al. - 19/09/90

Active substance: ROXYTHROMYCIN

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Document reference: 35469

Study title: A multicentre, open, centrally randomised, parallel group study of the evaluation of the efficacy and tolerance of roxithromycin 5 - 8mg/Kg/day bid versus ceflacor 20mg/Kg/day bid in a 5 to 10 days treatment of lower respiratory tract infections in children - Kotze A. - 06/98

Active substance: ROXYTHROMYCIN

Study summary document link (including results): RU28965D3003.pdf

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Document reference: 45230

Study title: A single blind study of the efficacy and tolerance of roxithromycin (25mg bid) and erythromycin ethylsuccinate (1OOmg bid) in children with chlamydia! conjunctivitis

Active substance: ROXYTHROMYCIN

Study summary document link (including results): Roxithromycin STUDY S8796508a.xls

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Document reference: 48008

Study title: AN MULTI-LABELLED, RANDOMIZED MULTI-CENTER STUDY EVLUATING THE EFFICACY OF A LOW DOSE OF RHGH (SOMATOTROPIN) IN SHORT PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY

Active substance: Somatropin

Study summary document link (including results): 91-039 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41703

Study title: AN OPEN FOLLOW-UP TRIAL EVALUATING THE CLINICAL COURSE OF PATIENTS WITH CYSTIC FIBROSIS AFTER GROWTH HORMONE TREATMENT ENDED WITHIN PHARMACIA CLINICAL TRIAL 307- MET-9002-026

Active substance: Somatropin

Study summary document link (including results): GENOT-9002-079 PhRMA Web Synopsis.pdf

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Document reference: 41663

Study title: An Open label, Randomized, Crossover, Patient/Parent Preference Trial of Norditropin® SimpleXx™ versus Humatrope®, Nutropin-AQ® and Genotropin™ in Children with Growth Hormone Deficiency

Active substance: Somatropin

Study summary document link (including results): hGH-2060_Norditropin.pdf

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Document reference: 41819

Study title: An open Multi-center trial evaluating the acceptability and tolerability of a new liquid growth hormone formulation, Norditropin® SimpleXx, by using a new pen system: NordiPenTM with or without NordiPenmateTM

Active substance: Somatropin

Study summary document link (including results): GHLiquid-1227_Norditropin.pdf

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Document reference: 41813

Study title: An open multicenter trial evaluating acceptance of the new liquid Norditropin® formulation

Active substance: Somatropin

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Document reference: 41809

Study title: An open randomised multicenter, 2-period crossover trial evaluating acceptance of the new liquid Norditropin® formulation versus the freeze-dried Norditropin®

Active substance: Somatropin

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Document reference: 41808

Study title: An open randomised multicentre, 2-period crossover trial evaluating acceptance of the new liquid Norditropin® SimpleXx® versus the freeze-dried Norditropin®PenSet®

Active substance: Somatropin

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Document reference: 41810

Study title: An open randomised multicentre, 2-period crossover trial evaluating in GHD children the acceptance of the new liquid Norditropin® Simplexx™ versus the freeze-dried Norditropin® 4 I.U.

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41811

Study title: An open randomized, multicentre,2-period crossover trial evaluating accaptance/ convenience and pain perception of the new liquid formulation versus freeze-dried Norditropin®

Active substance: Somatropin

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Document reference: 41806

Study title: AN OPEN SINGLE CENTRE TRIAL EVALUATING THE EFFICACY AND SAFETY OF GENOTROPIN IN SHORT CHILDREN WITH PRADER-WILLI SYNDROME

Active substance: Somatropin

Study summary document link (including results): 94-8129-007 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41671

Study title: T. Ortowski - "Clinical evaluation of preparation Salbutamol tablets and syrup"

Active substance: SALBUTAMOL

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Document reference: 35554

Study title: Beclometasone Dipropionate inhalation powder in chronic asthma in children. Riv.Ital.Ped., 1981 ,7, 429Grzincich G.L. et al, Riv.Ital.Ped. 1981, Grzincich

Active substance: SALBUTAMOL AND BECLOMETHASONE DIPROPIONATE

Study summary document link (including results): Riv.Ital.Ped. 1981, Grzincich.pdf

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Document reference: 47303

Study title: KlinIsche Studie Kopfwaschsalbe Ichthyol

Active substance: SALICYLIC ACID

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Document reference: 35581

Study title: Koppers B. [Dysplasia epiphysialis multiplex--scintigraphic, roentgenologic and clinical correlation] Rofo. 1982 Sep;137(3):291-305. German. Koppers B. [Dysplasia epiphysialis multiplex--scintigraphic, roentgenologic and clinical correlation] Rofo. 1982 Sep;137(3):291-305. German.

Active substance: SALICYLIC ACID

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Document reference: 44076

Study title: Non-interventional study on the use of Sophtal-POS® N in children

Active substance: SALICYLIC ACID

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Document reference: 35575

Study title: An open trial to evaluate the efficacy and tolerance of Duofilm in the treatment of warts.

Active substance: SALICYLIC ACID AND LACTIC ACID

Study summary document link (including results): Article 45_Ref_C0293_Final for Submission_07Nov2011.xlsx

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Document reference: 48307

Study title: A comparative assessment of contact lens tolerance and a study of possibilities for its improvement.

Active substance: SALICYLIC ACID AND UREA

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Document reference: 35590

Study title: Clinical use of Solcoseryl Eye-Gel in anterior ocular diseases.

Active substance: SALICYLIC ACID AND UREA

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Document reference: 35583

Study title: Evaluation of the effectiveness of Solcoseryl Eye-Gel in the treatment of some corneal diseases.

Active substance: SALICYLIC ACID AND UREA

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Document reference: 35588

Study title: Solcoseryl Eye Gel in pediatric ophtalmology practice.

Active substance: SALICYLIC ACID AND UREA

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Document reference: 35584

Study title: GENOTONORM IN SHORT CHILDREN WITH A BACKGROUND OF INTRAUTERINE GROWTH RETARDATION

Active substance: Somatropin

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Document reference: 41679

Study title: GENOTROPIN IN CHILDREN SHORT FOR GESTATIONAL AGE

Active substance: Somatropin

Study summary document link (including results): CTN 90-079 PhRMA Web Synopsis.pdf

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Document reference: 41716

Study title: GENOTROPIN IN CHILDREN WITH GROWTH HORMONE DEFICIENCY

Active substance: Somatropin

Study summary document link (including results): 90-033 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41722

Study title: GENOTROPIN IN CHILDREN WITH INTRAUTERINE GROWTH RETARDATION. AN OPEN, MULTICENTER, COMPARATIVE, RANDOMISED, NATIONAL STUDY

Active substance: Somatropin

Study summary document link (including results): 93-8122-008 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41678

Study title: GENOTROPIN IN SHORT CHILDREN BORN SMALL FOR GESTATIONAL AGE

Active substance: Somatropin

Study summary document link (including results): 91-045 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41702

Study title: GENOTROPIN IN SHORT CHILDREN BORN SMALL FOR GESTATIONAL AGE (SGA)

Active substance: Somatropin

Study summary document link (including results): 89-070, 89-071 PhRMA Web Synopsis.pdf

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Document reference: 41729

Study title: GENOTROPIN IN SHORT CHILDREN BORN SMALL FOR GESTATIONAL AGE. A LONG TERM STUDY IN BELGIUM

Active substance: Somatropin

Study summary document link (including results): CTN 90-080-98-8122-011 PhRMA Web Synopsis.pdf

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Document reference: 41667

Study title: Long-term use of fluoride lacquer in preventive care of school children in area of basic care.

Active substance: SODIUM FLUORIDE

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Document reference: 42497

Study title: Margolis FJ, Rheames HR, Freshman E et al. Fluoride: ten year prospective study of deciduous teeth and permanent dentition. Am J Dis Child 1975; 129: 794-800.Margolis FJ, Rheames HR, Freshman E et al. Fluoride: ten year prospective study of deciduous teeth and permanent dentition. Am J Dis Child 1975; 129: 794-800.

Active substance: SODIUM FLUORIDE

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Document reference: 42248

Study title: Margolis FJ, Rheames HR, Freshman E et al. Fluoride: ten year prospective study of deciduous teeth and permanent dentition. Am J Dis Child 1975; 129: 794-800.Margolis FJ, Rheames HR, Freshman E et al. Fluoride: ten year prospective study of deciduous teeth and permanent dentition. Am J Dis Child 1975; 129: 794-800.

Active substance: SODIUM FLUORIDE

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Document reference: 42280

Study title: Margolis FJ, Rheames HR, Freshman E et al. Fluoride: ten year prospective study of deciduous teeth and permanent dentition. Am J Dis Child 1975; 129: 794-800.Margolis FJ, Rheames HR, Freshman E et al. Fluoride: ten year prospective study of deciduous teeth and permanent dentition. Am J Dis Child 1975; 129: 794-800.

Active substance: SODIUM FLUORIDE

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Document reference: 42312

Study title: Marthaler TM, König KG. Der Einfluß von Fluoridtablettengaben in der Schule auf den Kariesbefall 6- bis 15-Jähriger Kinder. Schweiz Monatsschr Zahnmed 1967; 77: 539-554Marthaler TM, König KG. Der Einfluß von Fluoridtablettengaben in der Schule auf den Kariesbefall 6- bis 15-Jähriger Kinder. Schweiz Monatsschr Zahnmed 1967; 77: 539-554

Active substance: SODIUM FLUORIDE

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Document reference: 42264

Study title: A Randomized, Double-Blind, Double-Dummy, Five-Way Crossover Comparative Clinical Trial of Single Doses of Salmeterol 25, 50, and 100 mcg via the Diskus (Multidose Powder Inhaler), Albuterol Rotacaps 200 mcg via Rotahaler, and placebo in Pediatirc Subjects Aged 4-11 Years with Asthma. Report No. RM1996/00351/00;

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42021

Study title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparative Clinical Trial of the Effects of Twelve Week Courses of 50mcg and 25mcg Salmeterol Powder Bid via the Diskus Versus Ventolin Rotacaps 200mcg QID Versus Placebo in Pediatric Subjects Aged 4-11 Years with Mild to Moderate Asthma. Report No. RM1997/00414/00;

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42022

Study title: A randomized, double-blind, double-dummy, single-dose, four-way cross-over comparison of salmeterol 25mcg and 50mcg given by the multi-dose powder inhaler (DISKUSTM), albuterol 180mcg given by the metered-dose inhaler, and placebo for the prevention of exercise-induced bronchospasm in pediatric subjects with asthma.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol Xinafoate-SLGA2014-ICHE3.pdf

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Document reference: 42020

Study title: A Randomized, Double-Blind, Double-Dummy, Single-Dose, Three-Way Crossover Comparison of Salmeterol Xinafoate 50mcg and Placebo Given by the Multi-Dose Powder Inhaler and Diskhaler for the Prevention of Exercise-Induced Bronchospasm in Pediatric Patients with Asthma. Report No. UCR/95/014

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42019

Study title: Suntaree, RE. Effects of multivitamin and folic acid supplementation in malnourished children. J Med Assoc Thailand, 2003:86;S537-42.Suntaree, RE. Effects of multivitamin and folic acid supplementation in malnourished children. J Med Assoc Thailand, 2003:86;S537-42.

Active substance: VITAMINS

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Document reference: 45574

Study title: The use of multivitamin-preparations in paediatricsThe use of multivitamin-preparations in paediatrics

Active substance: VITAMINS

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Document reference: 45566

Study title: Wessely P. Klinischer Erfahrungsbericht. 1985. AKH Wien, Neurologische Univ-Klinik Wessely P. Klinischer Erfahrungsbericht. 1985. AKH Wien, Neurologische Univ-Klinik

Active substance: VITAMINS

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Document reference: 45567

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Vomitusheel (drops) [AWB-AT]

Active substance: Vomitusheel

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Document reference: 40309

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Vomitusheel (drops) [AWB-AT]

Active substance: Vomitusheel - Tropfen

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Document reference: 40308

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Vomitusheel S (suppositories) [AWB-AT]

Active substance: Vomitusheel S

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Document reference: 40310

Study title: Clinical study to investigate the efficacy, safety and immunogenicity of Wilate in children < 6 years of age with inherited von willebrand disease.

Active substance: VON WILLEBRAND FACTOR AND COAGULATION FACTOR VIII IN COMBINATION

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Document reference: 45577

Study title: Clinical study to investigate the efficacy, safety and immunogenicity of Wilate in children < 6 years of age with inherited von willebrand disease.

Active substance: VON WILLEBRAND FACTOR AND COAGULATION FACTOR VIII IN COMBINATION

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Document reference: 45580

Study title: International clinical study to investigate the incidence of inhibitors in previously untreated patients with severe haemophilia A treated with Octate (=Wilate).

Active substance: VON WILLEBRAND FACTOR AND COAGULATION FACTOR VIII IN COMBINATION

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Document reference: 45578

Study title: International clinical study to investigate the incidence of inhibitors in previously untreated patients with severe haemophilia A treated with Octate (=Wilate).

Active substance: VON WILLEBRAND FACTOR AND COAGULATION FACTOR VIII IN COMBINATION

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Document reference: 45581

Study title: A randomized, open label, comparative multicenter study of voriconazole versus conventional amphotericin B → fluconazole in the treatment of candidemia in non neutropenic subjects

Active substance: VORICONAZOLE

Study summary document link (including results): 150-608 PhRMA Web Synopsis.pdf

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Document reference: 48051

Study title: A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients with Persistent Fever and Neutropenia

Active substance: VORICONAZOLE

Study summary document link (including results): A1500603 EMA Pediatrics Web Synopsis.pdf

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Document reference: 48053

Study title: An Historical Control Study of the Efficacy of Standard Therapy in Acute Aspergillosis to Allow Comparison with the Efficacy of Voriconazole in Protocol 150-304

Active substance: VORICONAZOLE

Study summary document link (including results): A1501003 EMA Pediatrics Web Synopsis.pdf

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Document reference: 48054

Study title: Camfield PR et al. Treatment of febrile seizures. In: epilepsy: a comprehensive textbook. J Engel and TA Pedley editors. Lippincott-Raven publishers. Philadelphia (USA) 1997; chapter 118: 1305-1309

Active substance: VALPROIC ACID

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Document reference: 45456

Study title: Carbamazepine versus valproate montherapy for epilepsy: a meta-analysis - AG Marson - 2002 (Epilepsia 2002;43:505-513) - Publication in CES EXPCRC-CES0640-EN-E01 -

Active substance: VALPROIC ACID

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Document reference: 45457

Study title: Cerovac-Cosic N et al. Neurological development of infants born to mothers with juvenile myoclonic epilepsy (JME). Epilepsia 1998;39 (Suppl 2):21.

Active substance: VALPROIC ACID

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Document reference: 45459

Study title: An Open-label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10 mg (Recombinant Somatropin) administered by ZomaJet Vision X Children with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner’s

Active substance: Somatropin

Study summary document link (including results): 1 CS-002 Synopsis.pdf

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Document reference: 41753

Study title: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short children with chronic renal insufficiency

Active substance: Somatropin

Study summary document link (including results): 91-003 and 91-004 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41710

Study title: Wound healing in posttraumatic and postoperative oedematous tissue: results of treatment with serrapeptase (G.H. Willital et al., Acta therap. 15: pp. 395-409 (1989)) Wound healing in posttraumatic and postoperative oedematous tissue: results of treatment with serrapeptase (G.H. Willital et al., Acta therap. 15: pp. 395-409 (1989))

Active substance: SERRAPEPTASE

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Document reference: 42123

Study title: A double-Blind, Randomized, Placebo-Controled, Multicenter, Parallel Group Evaluation of the efficacy and Safety of Sertaconazole 2% Cream in Patients with interdigital Tinea Pedis. October 7, 1999

Active substance: SERTACONAZOLE

Study summary document link (including results): Ferrer_ Spain_ Ser-960603.pdf

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Document reference: 42125

Study title: A double-Blind, Randomized, Placebo-Controled, Multicenter, Parallel Group Evaluation of the efficacy and Safety of Sertaconazole 2% Cream in Patients with interdigital Tinea Pedis. January 29, 1999

Active substance: SERTACONAZOLE

Study summary document link (including results): Ferrer_ Spain_ Ser-960602.pdf

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Document reference: 48114

Study title: Van Esso D.; Fajo G.; Losada I., Vilallonga M, Casanovas JM; Clanxet J.; Aliaga A. Clinical Therapeutics 1995; 17:264-269 Sertaconazole in the treatment of paediatric patients with cutaneous dermatophyte infections PMID: 7614526 http://www.ncbi.nlm.nih.gov/pubmed?term=7614526 Van Esso D.; Fajo G.; Losada I., Vilallonga M, Casanovas JM; Clanxet J.; Aliaga A. Clinical Therapeutics 1995; 17:264-269 Sertaconazole in the treatment of paediatric patients with cutaneous dermatophyte infections PMID: 7614526 http://www.ncbi.nlm.nih.gov/pubmed?term=7614526

Active substance: SERTACONAZOLE

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Document reference: 45241

Study title: A multicenter 10-week randomized double-blind, Placebo-controlled flexible dose outpatient study of Sertraline in children and adolescents with major depressive disorder.

Active substance: SERTRALINE

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Document reference: 42130

Study title: A multicenter 10-week randomized double-blind, placebo-controlled flexible dose outpatient study of sertraline in children and adolescents with major depressive disorder. (Strength: 25, 50mg; Pharmaceutical form: tablet)

Active substance: SERTRALINE

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Document reference: 42143

Study title: A multicenter 24-week open-label extension study of Sertraline in children and adolescent outpatients previously diagnosed with major depressive disorder.

Active substance: SERTRALINE

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Document reference: 42131

Study title: A multicenter 24-week open-label extension study of sertraline in children and adolescent putpatients previously diagnosed with major depressive disorder. (Strenght: 50mg; Pharmaceutical form: tablet)

Active substance: SERTRALINE

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Document reference: 42144

Study title: A single-blind comparative study of sertraline in the treatment of depressed patients. (Strength: 25, 50mg; Pharmaceutical form: tablet)

Active substance: SERTRALINE

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Document reference: 42149

Study title: A single-blind comparative study of Sertraline with Imipramine in the treatment of depressed patients.

Active substance: SERTRALINE

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Document reference: 42140

Study title: GENOTROPIN IN SHORT CHILDREN BORN SMALL FOR GESTATIONAL AGE. A TWOYEAR FOLLOW UP TRIAL WITHOUT TREATMENT COMPRISING THE PATIENTS FROM THE FORMER TWO TREATMENT ARMS.

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41714

Study title: GENOTROPIN IN SHORT CHILDREN WITH PRADER-WILLI SYNDROME

Active substance: Somatropin

Study summary document link (including results): 91-019 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41706

Study title: GENOTROPIN IN SHORT CHILDREN WITH SILVER-RUSSELL SYNDROME

Active substance: Somatropin

Study summary document link (including results): 89-070, 89-071 PhRMA Web Synopsis.pdf

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Document reference: 41730

Study title: GENOTROPIN IN THE TREATMENT OF CHILDREN WITH SHORT STATURE

Active substance: Somatropin

Study summary document link (including results): TRN 88-080 PhRMA Web Synopsis.pdf

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Document reference: 41734

Study title: Genetics and Neuroendocrinology in Children with Growth Hormone Deficient

Active substance: Somatropin

Study summary document link (including results): Somatropin - B9R-IT-GDFT CTR Summary.pdf

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Document reference: 41632

Study title: GH IN GHDA

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41691

Study title: GH THERAPY IN PARTIAL GHD ADOLESCENTS: EVALUATION OF EFFICACY BASED ON BODY COMPOSITION AND COMPARISON OF 2 DIFFERENT DOSES OF GENOTONORM(REGISTERED) OPEN LABEL, RANDOMIZED, COMPARATIVE, CONTROLLED, PARALLEL-GROUP, MULTICENTER PHASE IIIB TRIAL

Active substance: Somatropin

Study summary document link (including results): 307-MET-9002-016 (A6281018) PhRMA Web Synopsis.pdf

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Document reference: 41648

Study title: Almeyda JJ et al. "Timodine" cream in the treatment of flexural dermatoses and napkin rash. Practitioner. 1974 Dec;213(1278):864-7Almeyda JJ et al. "Timodine" cream in the treatment of flexural dermatoses and napkin rash. Practitioner. 1974 Dec;213(1278):864-7

Active substance: SIMETICONE

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Document reference: 42223

Study title: Armstrong KL, Fraser DKB, Faoagali JL. Gastrointestinal bleeding with influenza virus. Med J Aust. March 11, 1991, 180-2) Armstrong KL, Fraser DKB, Faoagali JL. Gastrointestinal bleeding with influenza virus. Med J Aust. March 11, 1991, 180-2)

Active substance: SIMETICONE

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Document reference: 42197

Study title: Ball R et al. Stevens-Johnson syndrome and toxic epidermal necrolysis after vaccination: Reports to the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J. March 6, 2001, 219-23Ball R et al. Stevens-Johnson syndrome and toxic epidermal necrolysis after vaccination: Reports to the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J. March 6, 2001, 219-23

Active substance: SIMETICONE

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Document reference: 42188

Study title: Barkun A. Commonly used preparations for colonoscopy: Efficacy, tolerability and safety - A Canadian association of gastroenterology position paper. Can J Gastroenterol, November 1, 2006, 699-710Barkun A. Commonly used preparations for colonoscopy: Efficacy, tolerability and safety - A Canadian association of gastroenterology position paper. Can J Gastroenterol, November 1, 2006, 699-710

Active substance: SIMETICONE

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Document reference: 42176

Study title: Bartel DR et al. Sclerodermalike esophageal disease in children of mothers with silicone breast implants. J Am Med Assoc. September 20, 1994, 767-70Bartel DR et al. Sclerodermalike esophageal disease in children of mothers with silicone breast implants. J Am Med Assoc. September 20, 1994, 767-70

Active substance: SIMETICONE

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Document reference: 42196

Study title: A single centre, double blind, parallel group, placebo controlled study, to evaluate the effect of inhaled Salmeterol xinafoate (50mcg bd from a Diskhaler) on variations in bronchoconstriction induced by methacholine, in paediatric patients with mild to moderate asthma. Report No. VCL/ME/1998/004

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SLMP03-ICHE3.pdf

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Document reference: 42058

Study title: A Randomized, Double-Blind, Comparative Trial of the Effects of Twelve Week Courses of Salmeterol Xinafoate Rotadisks versus Placebo in Pediatric Patients Aged 4 to 11 years with Mild-to-Moderate Asthma. Report No. RD1996/00083/00;

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results):

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Document reference: 42045

Study title: A single centre, open crossover study to compare the duration of protection against exercise-induced bronchoconstriction following single and chronic dosing with salmeterol 50mcg (as xinafoate) twice daily and sodium cromoglycate 20mg four times daily in children with reversible airways' constriction. Report No. GRP/94/046

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42055

Study title: A single centre, randomised, open crossover study to compare the duration of protection against exercise-induced bronchoconstriction following single dosing with salmeterol xinafoate 50mcg delivered via the multi-dose powder inhaler and sodium cromoglycate 20mg delivered via the spinhaler in children aged 6-11 years with reversible airways disease. Report No. GRP/95/025

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Study SMDT08-Salmetrol Xinafoate (Serevent Diskus).xls

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Document reference: 42033

Study title: THE EFFECT OF GENOTROPIN ON GLOMERULAR FILTRATION RATE IN PREPUBERTAL CHILDREN AFTER RENAL TRANSPLANTATION.

Active substance: Somatropin

Study summary document link (including results): 90-054 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41721

Study title: THE EFFECT OF GENOTROPIN ON GLOMERULAR FILTRATION RATE IN PUBERTAL CHILDREN AFTER RENAL TRANSPLANTATION.

Active substance: Somatropin

Study summary document link (including results): 90-055 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41720

Study title: The effects of early postnatal onset recombinant hGH therapy in newborn infants with IUGR

Active substance: Somatropin

Study summary document link (including results): GHRETARD-NL-1-NL_Norditropin.pdf

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Document reference: 41783

Study title: The Efficacy and Safety of Growth Hormone Treatment in Non-growth Hormone Deficient Patients with Short Stature Caused By Turner Syndrome

Active substance: Somatropin

Study summary document link (including results): Somatropin-B9R-JE-T01A.xls

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Document reference: 41633

Study title: The Genet Study

Active substance: Somatropin

Study summary document link (including results): F-GHD-004-GHD_Norditropin.pdf

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Document reference: 41769

Study title: The growth promoting effect of NN-798 in children with chronic renal failure on conservative therapy.

Active substance: Somatropin

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Document reference: 41797

Study title: The growth promoting effect of NN-798 in children with chronic renal failure treated on hemodialysis or peritoneal dialysis.

Active substance: Somatropin

Study summary document link (including results): GHCRF-J-1-J_Norditropin.pdf

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Document reference: 41796

Study title: Clinical comparative assessment of efficacy, tolerance and toxicity of Dipromal and Depakina in the treatment of epilepsy in children

Active substance: VALPROIC ACID

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Document reference: 45460

Study title: Clinical evaluation report - Loiseau - 1980

Active substance: VALPROIC ACID

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Document reference: 45461

Study title: Clinical evaluation report - Loiseau - 25.11.1980

Active substance: VALPROIC ACID

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Document reference: 45462

Study title: Clinical pharmacokinetics of valproic acid - Zaccara G. Messori A. and al. - 1988 (Clin Pharmacokinet, 15 : 367-89) - Publication in expert report on the clinical documentation - Giudicelli A. - 05/2002 -

Active substance: VALPROIC ACID

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Document reference: 45463

Study title: Clinical results obtained during treatment with Depakene conducted in psychiatric hospitals - Beaudouin - No date - Publication 9 in Clinical trials with Depakene - No author - No date -

Active substance: VALPROIC ACID

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Document reference: 45464

Study title: Clinical trials with a new antiepileptic, sodium dipropylacetate - Dereux and al. - 1967 (Congrès de Psychiatrie et de Neurologie de langue française) Publication 4 in Clinical trials with Depakene - No author - No date

Active substance: VALPROIC ACID

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Document reference: 45465

Study title: Committee on quality improvement, subcommittee on febrile convulsions. Practice parameter: long-term treatment of the child with simple febrile convulsions. - American Academy of Pediatrics. - Pediatrics 1999; 103: 1307-1309.

Active substance: VALPROIC ACID

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Document reference: 45466

Study title: Comparative clinical and pharmacokinetic study of a new slow release versus conventional preparations of valproic acid in children with intractable epilepsy - Braisn and Development, 1992, 14 (5), p.304-308 - Imaizumi T., Izumi T., Fukuyama Y.

Active substance: VALPROIC ACID

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Document reference: 45467

Study title: Continuous sodium valproate or pheobarbitone in the prevention of simple febrile-Comparison by a double blind trial - E. Ngwane. - 1980 (Arch Dis Childhood 1980;55:171-174)

Active substance: VALPROIC ACID

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Document reference: 45468

Study title: Dean JCS et al. Long term health and neurodevelopment in children exposed to antiepileptic drugs before birth. J Med Genet 2002;39:251-9.

Active substance: VALPROIC ACID

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Document reference: 45469

Study title: Depacon administration, safety and efficacy in a hospital setting - Short DW. and al. - 1999 ( Epilepsia 1999 - 40 (suppl 7) : 226 (abstract 3.248) ) - Publication in Ergenyl Vial Expert report on the clinical documentation - HUFNAGEL 14/11/2006 -

Active substance: VALPROIC ACID

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Document reference: 45471

Study title: Divalproex sodium treatment in late adolescent and young adult acute mania - Papatheodorou G. Kutcher SP. - 1993 (Psychopharmacol Bull 1993, 29 : 213-19) - Publication in expert report on the clinical documentation - Giudicelli A. -05/2002 -

Active substance: VALPROIC ACID

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Document reference: 45472

Study title: Do seizures in children cause intellectual deterioration ? - Ellenberg JH et al. - N Engl J. Med 1986; 314:1085-88.

Active substance: VALPROIC ACID

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Document reference: 45473

Study title: An Open Label, Non-Comparative Protocol for the Emergency Use of Voriconazole in Patients with Life-threatening, Invasive Mycoses who are failing on currently available antifungal Agents

Active substance: VORICONAZOLE

Study summary document link (including results): A1501050 EMA Pediatrics Web Synopsis.pdf

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Document reference: 48057

Study title: An Open Label, Non-comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections

Active substance: VORICONAZOLE

Study summary document link (including results): 150-309 and 150-604 EMA Pediatrics Web Synopsis.pdf

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Document reference: 48050

Study title: A twelve week double blind multicentre comparaison of sertraline and placebo in patients with obsessive-compulsive disorder. (Strength: 50mg; Pharmaceutical form: capsules)

Active substance: SERTRALINE

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Document reference: 42142

Study title: An open study investigating the efficacy, safety and tolerability of STL in patients with treatment refractory depressive illness.

Active substance: SERTRALINE

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Document reference: 42134

Study title: An open-label, comparative study of sertraline with maprotiline in the treatment of depressed patients.

Active substance: SERTRALINE

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Document reference: 42151

Study title: An open-label, long-term evaluation of Sertraline in children and adolescents with obsessive compulsive disorder or depression.

Active substance: SERTRALINE

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Document reference: 42129

Study title: Drug monitoring program Zoloft.

Active substance: SERTRALINE

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Document reference: 42137

Study title: Early phase II study of Sertraline in Bulimia Nervosa.

Active substance: SERTRALINE

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Document reference: 42138

Study title: Driscoll WS, Heifetz SB, Korts DC. Effect of chewable fluoride tablets on dental caries in schoolchildren: results after six years of use. J Am Dent Assoc. 1978 Nov;97(5):820-4.Driscoll WS, Heifetz SB, Korts DC. Effect of chewable fluoride tablets on dental caries in schoolchildren: results after six years of use. J Am Dent Assoc. 1978 Nov;97(5):820-4.

Active substance: SODIUM FLUORIDE

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Document reference: 42255

Study title: Driscoll WS, Heifetz SB, Korts DC. Effect of chewable fluoride tablets on dental caries in schoolchildren: results after six years of use. J Am Dent Assoc. 1978 Nov;97(5):820-4.Driscoll WS, Heifetz SB, Korts DC. Effect of chewable fluoride tablets on dental caries in schoolchildren: results after six years of use. J Am Dent Assoc. 1978 Nov;97(5):820-4.

Active substance: SODIUM FLUORIDE

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Document reference: 42287

Study title: Driscoll WS, Heifetz SB, Korts DC. Effect of chewable fluoride tablets on dental caries in schoolchildren: results after six years of use. J Am Dent Assoc. 1978 Nov;97(5):820-4.Driscoll WS, Heifetz SB, Korts DC. Effect of chewable fluoride tablets on dental caries in schoolchildren: results after six years of use. J Am Dent Assoc. 1978 Nov;97(5):820-4.

Active substance: SODIUM FLUORIDE

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Document reference: 42319

Study title: Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7.Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7.

Active substance: SODIUM FLUORIDE

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Document reference: 42256

Study title: Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7.Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7.

Active substance: SODIUM FLUORIDE

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Document reference: 42288

Study title: Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7.Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7.

Active substance: SODIUM FLUORIDE

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Document reference: 42320

Study title: Bowring AR, Mackay D, Taylor FR. The treatment of napkin dermatitis: a double-blind comparison of two steroid-antibiotic combinations. Pharmatherapeutica. 1984;3(9):613-7Bowring AR, Mackay D, Taylor FR. The treatment of napkin dermatitis: a double-blind comparison of two steroid-antibiotic combinations. Pharmatherapeutica. 1984;3(9):613-7

Active substance: SIMETICONE

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Document reference: 42218

Study title: Brouwers JR et al. A controlled trial of senna preparations and other laxatives used for bowel cleansing prior to radiological examination. Pharmacology. 1980;20 Suppl 1:58-64Brouwers JR et al. A controlled trial of senna preparations and other laxatives used for bowel cleansing prior to radiological examination. Pharmacology. 1980;20 Suppl 1:58-64

Active substance: SIMETICONE

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Document reference: 42221

Study title: Bruhn C. Diseases of the gastrointestinal tract and the skin in children - Part 7. Dtsch Apoth Ztg. September 13, 2007, 66-76Bruhn C. Diseases of the gastrointestinal tract and the skin in children - Part 7. Dtsch Apoth Ztg. September 13, 2007, 66-76

Active substance: SIMETICONE

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Document reference: 42174

Study title: Chitkara DK et al. Aerophagia in children: Characterization of a functional gastrointestinal disorder. Neurogastroenterol Motil. August 1, 2005, 518-22Chitkara DK et al. Aerophagia in children: Characterization of a functional gastrointestinal disorder. Neurogastroenterol Motil. August 1, 2005, 518-22

Active substance: SIMETICONE

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Document reference: 42179

Study title: Coco TJ, King WD, Slattery AP. Descriptive epidemiology of infant ingestion calls to a regional poison control center. South Med J. August 1, 2005, 779-83)Coco TJ, King WD, Slattery AP. Descriptive epidemiology of infant ingestion calls to a regional poison control center. South Med J. August 1, 2005, 779-83)

Active substance: SIMETICONE

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Document reference: 42178

Study title: Connor F. Gastrointestinal complications of fundoplication. Curr Gastroenterol Rep. June 1, 2005, 219-26Connor F. Gastrointestinal complications of fundoplication. Curr Gastroenterol Rep. June 1, 2005, 219-26

Active substance: SIMETICONE

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Document reference: 42180

Study title: Fluoride deposited topical applications in enamel. KOH-soluble and acquired fluoride.

Active substance: SODIUM FLUORIDE

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Document reference: 42468

Study title: Fluoride retention in sound and demineralized enamel in vivo after treatment with a fluoride varnish (Duraphat).

Active substance: SODIUM FLUORIDE

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Document reference: 42390

Study title: Fluoride retention in sound and demineralized enamel in vivo after treatment with a fluoride varnish (Duraphat).

Active substance: SODIUM FLUORIDE

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Document reference: 42503

Study title: Fluoride uptake in plaque-covered enamel after treatment with the fluoride lacquer Duraphat.

Active substance: SODIUM FLUORIDE

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Document reference: 42368

Study title: Fluoride uptake in plaque-covered enamel after treatment with the fluoride lacquer Duraphat.

Active substance: SODIUM FLUORIDE

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Document reference: 42481

Study title: Fluoride varnish versus acidulated phosphate fluoride for schoolchildren in Manipal.

Active substance: SODIUM FLUORIDE

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Document reference: 42426

Study title: Fluoride varnish versus acidulated phosphate fluoride for schoolchildren in Manipal.

Active substance: SODIUM FLUORIDE

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Document reference: 42539

Study title: Fluoride varnishes (Duraphat): a meta-analysis.

Active substance: SODIUM FLUORIDE

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Document reference: 42367

Study title: Fluoride varnishes (Duraphat): a meta-analysis.

Active substance: SODIUM FLUORIDE

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Document reference: 42480

Study title: Trial to explore efficacy, kinetics and safetyKosmidis et al

Active substance: AMOXICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_7.xlsx

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Document reference: 42447

Study title: Fluoride varnishes in caries prevention.

Active substance: SODIUM FLUORIDE

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Document reference: 42533

Study title: To evaluate the effect of two years of treatment with three different dose regimens of Norditropin® SimpleXx® on height in children with intrauterine growth retardation ages 3 to <8 years at start of treatment; a randomized, parallel, multinational trial

Active substance: Somatropin

Study summary document link (including results): GHLiquid-1424_Norditropin.pdf

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Document reference: 41775

Study title: TO WELL DEFINE IGF-I REFERENCE IN ADOLESCENTS

Active substance: Somatropin

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Document reference: 41747

Study title: Traitement par Hormone biosynthétique MAXOMAT d'enfants en cours de puberté présentant un retard de croissance sévère à début intra-utérin (retard d'au moins -2,5 DS)

Active substance: Somatropin

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Document reference: 41825

Study title: Study of the effect of subcutaneous administration of two doses of biosynthetic growth hormone (Norditropin®) on growth and metabolic parameters in pre-pubertal children with growth hormone deficiency

Active substance: Somatropin

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Document reference: 41756

Study title: TREATMENT OF 94 PATIENTS WITH TURNER SYNDROME WITH RECOMBINANT HUMAN GROWTH HORMONE FOR TWO YEARS. THE RESULT OF A MUNTICENTRIC STUDY IN JAPAN.

Active substance: Somatropin

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Document reference: 41741

Study title: Treatment of Turner's syndrome by administration of Zomacton.

Active substance: Somatropin

Study summary document link (including results): 3 JR-8810ZMJ 003 Tabular summary.pdf

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Document reference: 47497

Study title: TREATMENT WITH ECOMBINANT HUMAN GROWTH HORMONE (GENOTONORM(REGISTERED)) IN PREPUBERTAL CHILDREN WITH SHORT STATURE SECONDARY TO CORTICOID THERAPY.

Active substance: Somatropin

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Document reference: 41673

Study title: TREATMENT WITH GENOTROPIN IN GIRLS WITH TURNER'S SYNDROME AGED 3-9 YEARS. AN OPEN-LABELLED, NONCOMPARATIVE MULTICENTER TRIAL IN SWEDEN.

Active substance: Somatropin

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Document reference: 41735

Study title: Suoranta H, Standertskjöld-Nordenstam CG, Lähde S. The value of simethicone in abdominal preparation. Radiology. 1979 Nov;133(2):307-8Suoranta H, Standertskjöld-Nordenstam CG, Lähde S. The value of simethicone in abdominal preparation. Radiology. 1979 Nov;133(2):307-8

Active substance: SIMETICONE

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Document reference: 42222

Study title: Treem WR. Infant colic: A pediatric gastroenterologist's perspective. Pediatr Clin North Am. November 11, 1994, 1121-38Treem WR. Infant colic: A pediatric gastroenterologist's perspective. Pediatr Clin North Am. November 11, 1994, 1121-38

Active substance: SIMETICONE

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Document reference: 42195

Study title: Tsou VM et al. Multicenter, randomized, double-blind study comparing 20 and 40 mg of pantoprazole for symptom relief in adolescents (12 to 16 years of age) with gastroesophageal reflux disease (GERD). Clin Pediatr (Phila). 2006 Oct;45(8):741-9Tsou VM et al. Multicenter, randomized, double-blind study comparing 20 and 40 mg of pantoprazole for symptom relief in adolescents (12 to 16 years of age) with gastroesophageal reflux disease (GERD). Clin Pediatr (Phila). 2006 Oct;45(8):741-9

Active substance: SIMETICONE

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Document reference: 42203

Study title: Voepel-Lewis TD et al. Evaluation of simethicone for the treatment of postoperative abdominal discomfort in infants. J Clin Anesth. March 1, 1998, 91-4Voepel-Lewis TD et al. Evaluation of simethicone for the treatment of postoperative abdominal discomfort in infants. J Clin Anesth. March 1, 1998, 91-4

Active substance: SIMETICONE

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Document reference: 42190

Study title: Wiberg JM, Nordsteen J, Nilsson N. The short-term effect of spinal manipulation in the treatment of infantile colic: a randomized controlled clinical trial with a blinded observer. J Manipulative Physiol Ther. 1999 Oct;22(8):517-22Wiberg JM, Nordsteen J, Nilsson N. The short-term effect of spinal manipulation in the treatment of infantile colic: a randomized controlled clinical trial with a blinded observer. J Manipulative Physiol Ther. 1999 Oct;22(8):517-22

Active substance: SIMETICONE

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Document reference: 42208

Study title: An Open Label, Non-comparative, Multicentre, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections

Active substance: VORICONAZOLE

Study summary document link (including results): 150-309 and 150-604 EMA Pediatrics Web Synopsis.pdf

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Document reference: 48049

Study title: An Open Multicentre Study of the Efficacy, Safety and Toleration of UK-109,496 (Voriconazole) in the Treatment of Chronic Invasive Aspergillosis and Candidiasis

Active substance: VORICONAZOLE

Study summary document link (including results): A150-303 EMA Pediatrics Web Synopsis.pdf

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Document reference: 48052

Study title: An Open-Label, Intravenous to Oral Switch, Multiple Dose, Multi- Centre Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Hospitalized Children Aged 2 to < 12 Years Who Require Treatment for the Prevention of Systemic Fungal Infection

Active substance: VORICONAZOLE

Study summary document link (including results): A1501037 PhRMA Web Synopsis.pdf

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Document reference: 48056

Study title: An Open, Intravenous Multiple Dose, Multi-Centre Study to Investigate the Pharmacokinetics, Safety and Toleration of Voriconazole in Children Aged 2-12 Years Who Require Treatment for the Prevention of Systemic Fungal Infection

Active substance: VORICONAZOLE

Study summary document link (including results): A1501007 EMA Pediatrics Web Synopsis.pdf

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Document reference: 48055

Study title: An Open, Multicentre, Dose Escalating Study of the Efficacy, Safety and Toleration of UK-109,496 (Voriconazole) in the Treatment of Acute Invasive Aspergillosis

Active substance: VORICONAZOLE

Study summary document link (including results): 150-304 EMA Pediatrics Web Synopsis.pdf

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Document reference: 48048

Study title: An Open, Single Intravenous Dose, Multicentre Study to Investigate the Pharmacokinetics, Safety and Toleration of Voriconazole in Immunocompromised Children Aged 211 Years

Active substance: VORICONAZOLE

Study summary document link (including results): 150-249 EMA Pediatrics Web Synopsis.pdf

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Document reference: 48047

Study title: Oral anticoagulation therapy in children. 2006 Oral anticoagulation therapy in children. 2006

Active substance: WARFARIN

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Document reference: 39419

Study title: B. Romański - ,,Comparative clinical trial of the prep. Xylogel 0.05% and 0.1% in the form of nasal gel and Xylometazolin 0.05% and 0.1% in the form of nasal drops manufactured by WPW Polfa in patients with rhinitis of nose mucous membrane"

Active substance: XYLOMETAZOLINE

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Document reference: 45637

Study title: Bumbalo, T.S. (1960) Xylometazoline HCl, a new nasal medication for paediatric use (an evaluation). West. Med. 1, 9

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Bumbalo_1960.xls

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Document reference: 45638

Study title: De Sa, JV. (1960) Clinical evaluation of a new topical vaso-constrictor in rhinology. Indian Pract. 12, 725-728

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - de Sa_1960.xls

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Document reference: 45639

Study title: Efficacy and tolerability of Otrivin nasal gel vs. Vibrocil nasal gel.19.11.1973

Active substance: XYLOMETAZOLINE

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Document reference: 45640

Study title: Eggenschwiler, E. (1976) Otrivi-Nasen-Gel, eine neue Applikationsform des Xylometazolin-hydrochlorids für die Behandliung acuter Rhinitiden ber Erwachsenen un Kindern. Ars Medici, 1, 11-1

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Eggenschwiler_1976.xls

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Document reference: 45641

Study title: Effect of antiepileptic drugs on psychomotor development in offspring of epileptic mothers. - Ohtsuka Y et al. - Epilepsia 1999;40 (Suppl 2):296

Active substance: VALPROIC ACID

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Document reference: 45474

Study title: Effect size of lithium, divalproex sodium, and carbamazepine in children and adolescents with bipolar disorder - Kowatsch RA. and al. - 2000 ( J Am Acad Child Adolesc Psychiatry 2000, 39 (6) : 713-720 - Publication in expert report on the clinical documentation - Grunze H. - 04/2003 -

Active substance: VALPROIC ACID

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Document reference: 45475

Study title: Driscoll WS, Nowjack-Raymer R, Selwitz RH, Li SH, Heifetz SB. A comparison of the caries-preventive effects of fluoride mouthrinsing, fluoride tablets, and both procedures combined: final results after eight years. J Public Health Dent. 1992 Winter;52(2):111-6.Driscoll WS, Nowjack-Raymer R, Selwitz RH, Li SH, Heifetz SB. A comparison of the caries-preventive effects of fluoride mouthrinsing, fluoride tablets, and both procedures combined: final results after eight years. J Public Health Dent. 1992 Winter;52(2):111-6.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42257

Study title: Driscoll WS, Nowjack-Raymer R, Selwitz RH, Li SH, Heifetz SB. A comparison of the caries-preventive effects of fluoride mouthrinsing, fluoride tablets, and both procedures combined: final results after eight years. J Public Health Dent. 1992 Winter;52(2):111-6.Driscoll WS, Nowjack-Raymer R, Selwitz RH, Li SH, Heifetz SB. A comparison of the caries-preventive effects of fluoride mouthrinsing, fluoride tablets, and both procedures combined: final results after eight years. J Public Health Dent. 1992 Winter;52(2):111-6.

Active substance: SODIUM FLUORIDE

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Document reference: 42289

Study title: An international, multi - center, randomised, open - label, parallel group, observer - blind study of the efficacy and tolerance of roxithromycin 5 - 8mg/Kg/day, administered bid and amoxicillin / clavulanic acid 40/10mg/Kg/day administered tid in the treatmetn of lower respiratory tract infections in children - Rostand A. - 11/86

Active substance: ROXYTHROMYCIN

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Document reference: 35472

Study title: An open, multicenter study of oral Roxithromycin sachet formulation - 2.5mg/kg to 5.Omg/kg bid - in the treatment of pediatrics patients with respiratory and cutaneous infections.

Active substance: ROXYTHROMYCIN

Study summary document link (including results): Roxithromycin STUDY FF8596548.xls

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Document reference: 48004

Study title: Effect of RU 28965 administered orally for 10 days on bone tissue in infant dogs

Active substance: ROXYTHROMYCIN

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Document reference: 35477

Study title: Effects of RU 28 965 (RXM) on toothformation in infant beagle dogs - Sasaki T. - 29/10/94

Active substance: ROXYTHROMYCIN

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Document reference: 35479

Study title: Effects of RU 28 965 administered orally for 10 days on bone tissue in infant dogs - Tateta C. and al. - 22/12/94

Active substance: ROXYTHROMYCIN

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Document reference: 35480

Study title: Efficacy and tolerance study of roxithromycin in the treatment of respiratory and cutaneous infections in children - Astruc J. and al. - 27/03/87 - Publication in RU 28 965-Reference rapport 2.19-50mg paediatric sachet-synthesis of pharmacokinetics and clinical studies in children - Blanc F. - 07/88 -Efficacy and tolerance study of roxithromycin in the treatment of respiratory and cutaneous infections in children - Astruc J. and al. - 27/03/87 - Publication in RU 28 965-Reference rapport 2.19-50mg paediatric sachet-synthesis of pharmacokinetics and clinical studies in children - Blanc F. - 07/88 -

Active substance: ROXYTHROMYCIN

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Document reference: 35481

Study title: An international, multi - center, randomised, open - label, parallel group, observer - blind study of the efficacy and tolerance of roxithromycin 5 - 8mg/Kg/day, administered bid and amoxicillin / clavulanic acid 40/10mg/Kg/day administered tid in the treatment of lower respiratory tract infections in children - Rostand A. - 11/86

Active substance: ROXYTHROMYCIN

Study summary document link (including results): FF9296530.pdf

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Document reference: 35458

Study title: Efficacy and tolerance study of roxithromycin in the treatment of respiratory tract infections in children - Blanc F. and al. - 1987 - Publication in RU 28 965-Reference rapport 2.19-50mg paediatric sachet-synthesis of pharmacokinetics and clinical studies in children - Blanc F. - 07/88 -Efficacy and tolerance study of roxithromycin in the treatment of respiratory tract infections in children - Blanc F. and al. - 1987 - Publication in RU 28 965-Reference rapport 2.19-50mg paediatric sachet-synthesis of pharmacokinetics and clinical studies in children - Blanc F. - 07/88 -

Active substance: ROXYTHROMYCIN

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Document reference: 35482

Study title: Fluoride varnishes in caries prevention].

Active substance: SODIUM FLUORIDE

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Document reference: 42416

Study title: Fluoride varnishes in caries prevention].

Active substance: SODIUM FLUORIDE

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Document reference: 42529

Study title: Fluoride varnishes--a review.

Active substance: SODIUM FLUORIDE

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Document reference: 42349

Study title: Fluoride varnishes--a review.

Active substance: SODIUM FLUORIDE

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Document reference: 42462

Study title: Fluorine gradients in outermost surface enamel after various forms of topical application of fluorides in vivo.

Active substance: SODIUM FLUORIDE

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Document reference: 42395

Study title: Fluorine gradients in outermost surface enamel after various forms of topical application of fluorides in vivo.

Active substance: SODIUM FLUORIDE

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Document reference: 42508

Study title: Friis-Hasché E, Bergamnn J, Wenzel A, Thylstrup A et al. Dental health status and attitudes to dental care in families participating in a Danish fluoride tablet program. Community Dent Oral Epidemiol 1984; 12: 303-307Friis-Hasché E, Bergamnn J, Wenzel A, Thylstrup A et al. Dental health status and attitudes to dental care in families participating in a Danish fluoride tablet program. Community Dent Oral Epidemiol 1984; 12: 303-307

Active substance: SODIUM FLUORIDE

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Document reference: 42246

Study title: Friis-Hasché E, Bergamnn J, Wenzel A, Thylstrup A et al. Dental health status and attitudes to dental care in families participating in a Danish fluoride tablet program. Community Dent Oral Epidemiol 1984; 12: 303-307Friis-Hasché E, Bergamnn J, Wenzel A, Thylstrup A et al. Dental health status and attitudes to dental care in families participating in a Danish fluoride tablet program. Community Dent Oral Epidemiol 1984; 12: 303-307

Active substance: SODIUM FLUORIDE

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Document reference: 42278

Study title: A 2-week, randomized, double-blind, parallel-group study in pediatric subjects with asthma aged 4 to11 years to examine the pharmacokinetics of fluticasone propionate (FP) and salmeterol (SALM) from the FP/SALM combination product administered twice daily via the Diskus (FP 100mcg/SALM 50mcg) and the FP Diskus (FP 100mcg). Report No. RM2004/00114/00

Active substance: SALMETEROL

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Document reference: 35602

Study title: A Multicentre, Randomised, Double-blind, Double-dummy, Parallel Group Comparison of Three Treatments: 1) Seretide (50/100 mcg Strength)bd via Diskus/Accuhaler Inhaler, 2) Fluticasone Propionate 200 mcg bd via Diskus Inhaler, 3) Fluticasone Propionate 100mcg bd via Diskus/Accuhaler Inhaler in Children Aged 4-11 Years with Asthma. Report No. BP1999/00102/00

Active substance: SALMETEROL

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Document reference: 35594

Study title: A pilot single centre, randomised, double-blind crossover study to demonstrate the superiority of Salmeterol/fluticasone propionate combination product 50/100mcg bd versus fluticasone propionate 100mcg bd when treated for two weeks with respect to activity levels in children aged 7 15 years. Report No. GM2003/00237/00;

Active substance: SALMETEROL

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Document reference: 35591

Study title: A Randomized, Double-Blind, 12-Week Trial Evaluating the Safety of the Fluticasone Propionate/Sameterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Sympotmatic Pediatric Subjects (4-11 Years) With Asthma. Report No. RM2002/00268/00;

Active substance: SALMETEROL

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Document reference: 35596

Study title: A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID versus Fluticasone Propionate DISKUS 100/50mcg BID in Pediatric and Adolescent Subjects with Activity-Induced Bronchospasm. Report No. RM2005/00343/00

Active substance: SALMETEROL

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Document reference: 35592

Study title: A Stratified, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial Evaluating the Safety and Efficacy of the Fluticasone Propionate/Salmeterol Diskus Combination Product 100/50mcg Once Daily Versus Fluticasone Propionate Diskus 100mcg Once Daily and Placebo in Symptomatic Pediatric Subjects (4-11 Years) With Asthma. Report No. RM2001/00010/07

Active substance: SALMETEROL

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Document reference: 35595

Study title: Solcoseryl Eye Gel: an effective adjunct in the treatment of chronic ulcers of the cornea.

Active substance: SALICYLIC ACID AND UREA

Study summary document link (including results):

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Document reference: 35586

Study title: Solcoseryl eye-gel preparation in the treatment of selected corneal diseases.

Active substance: SALICYLIC ACID AND UREA

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Document reference: 35589

Study title: Yang JC et al. The role of gastric acid and Helicobacter pylori in the natural course of duodenal ulcer. J Microbiol Immunol Infect. 1999 Sep;32(3):155-62Yang JC et al. The role of gastric acid and Helicobacter pylori in the natural course of duodenal ulcer. J Microbiol Immunol Infect. 1999 Sep;32(3):155-62

Active substance: SIMETICONE

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Document reference: 42207

Study title: De Oliveira Netto N.V. & Diegues A. (1976): Estudo aberto n¿o comparativo do PR-S/109*, no tratamento das broncopatias obstrutivas por secreç¿es. Folha Med. 72(4): 393-7. De Oliveira Netto N.V. & Diegues A. (1976): Estudo aberto n¿o comparativo do PR-S/109*, no tratamento das broncopatias obstrutivas por secreç¿es. Folha Med. 72(4): 393-7.

Active substance: SOBREROL

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Document reference: 42231

Study title: Di Tommaso G. and Mader R. Traitment des hypersecretions bronchiques dans les bronchopneumopathies aigues et chroniques. Di Tommaso G. and Mader R. Traitment des hypersecretions bronchiques dans les bronchopneumopathies aigues et chroniques.

Active substance: SOBREROL

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Document reference: 42226

Study title: Etude contrôlée d¿un nouveau composé à action mucolytique. Acta Therapeutica 7: 243-60. Romano C., Gargani G.F., Cotellessa M. and Rossi C. (1977): Valutazione comparativa del sobrerolo nel trattamento delle broncopneumopatie croniche dell¿età pediatrica. Terzo Congresso Europeo sulle malattie del torace: 52-61. Trombetti E. & Mancino V. (1971) Etude contrôlée d¿un nouveau composé à action mucolytique. Acta Therapeutica 7: 243-60. Romano C., Gargani G.F., Cotellessa M. and Rossi C. (1977): Valutazione comparativa del sobrerolo nel trattamento delle broncopneumopatie croniche dell¿età pediatrica. Terzo Congresso Europeo sulle malattie del torace: 52-61. Trombetti E. & Mancino V. (1971)

Active substance: SOBREROL

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Document reference: 42227

Study title: Marthaler TM, König KG. Der Einfluß von Fluoridtablettengaben in der Schule auf den Kariesbefall 6- bis 15-Jähriger Kinder. Schweiz Monatsschr Zahnmed 1967; 77: 539-554Marthaler TM, König KG. Der Einfluß von Fluoridtablettengaben in der Schule auf den Kariesbefall 6- bis 15-Jähriger Kinder. Schweiz Monatsschr Zahnmed 1967; 77: 539-554

Active substance: SODIUM FLUORIDE

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Document reference: 42296

Study title: Marthaler TM, König KG. Der Einfluß von Fluoridtablettengaben in der Schule auf den Kariesbefall 6- bis 15-Jähriger Kinder. Schweiz Monatsschr Zahnmed 1967; 77: 539-554Marthaler TM, König KG. Der Einfluß von Fluoridtablettengaben in der Schule auf den Kariesbefall 6- bis 15-Jähriger Kinder. Schweiz Monatsschr Zahnmed 1967; 77: 539-554

Active substance: SODIUM FLUORIDE

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Document reference: 42328

Study title: On topical application of fluorides and its inhibiting effect on caries.

Active substance: SODIUM FLUORIDE

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Document reference: 42394

Study title: On topical application of fluorides and its inhibiting effect on caries.

Active substance: SODIUM FLUORIDE

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Document reference: 42507

Study title: Paediatric dentistry discussion paper and case report. Management of small carious lesions in primary teeth: caries removal versus fluoride application and periodic 'observation' until exfoliation.

Active substance: SODIUM FLUORIDE

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Document reference: 42360

Study title: Paediatric dentistry discussion paper and case report. Management of small carious lesions in primary teeth: caries removal versus fluoride application and periodic 'observation' until exfoliation.

Active substance: SODIUM FLUORIDE

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Document reference: 42473

Study title: Petersson LG, Koch G, Rasmusson CG, Stanke H. Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study. Swed Dent J. 1985;9(3):97-104.Petersson LG, Koch G, Rasmusson CG, Stanke H. Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study. Swed Dent J. 1985;9(3):97-104.

Active substance: SODIUM FLUORIDE

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Document reference: 42265

Study title: Effects of valproate in 100 children with special reference to weight. - Egger J et al. - Br Med J 1981;283:577-81.

Active substance: VALPROIC ACID

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Document reference: 45476

Study title: Ellenberg JH et al. Do seizures in children cause intellectual deterioration ? N Engl J. Med 1986; 314:1085-88.

Active substance: VALPROIC ACID

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Document reference: 45477

Study title: Epilepsy in general paediatric practice - Muddiman M.J. and al. - 1983 (Br. J. Clin. Pract., 1983 symposium, suppl. 27, 99-104)

Active substance: VALPROIC ACID

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Document reference: 45478

Study title: Ethosuximide, sodium valproate or lamotrigine for absence seizures in children and adolescents. EB Posner. Cochrane database Syst Rev. 2005;(4):CD003032 in CES EXPCRC-CES733-EN-E01.

Active substance: VALPROIC ACID

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Document reference: 45479

Study title: Expertise clinique. Etude d'activité et de tolérance (Phase II) - Sorel L. - 12/07/1979

Active substance: VALPROIC ACID

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Document reference: 45480

Study title: Febrile seizures. In: epileptic syndromes in infancy, childhood and adolescence. - Camfield PR et al. - J Roger et al editors. John Libbey and Co Ltd publishers. 3rd edition. 2002; chapter 11: 145-152.

Active substance: VALPROIC ACID

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Document reference: 45481

Study title: Fried S et al. Malformation rates in chidren of women with untreated epilepsy. A meta-analysis. Drug Safety 2004;27(3):197-202.

Active substance: VALPROIC ACID

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Document reference: 45482

Study title: Guerrini R. et al. Antiepileptic drug-induced worsening of seizures in children. Epilepsia 1998; 39 (suppl. 3): S2-S10

Active substance: VALPROIC ACID

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Document reference: 45484

Study title: Haigh D et al. The treatment of childhood epilepsy with sodium valproate. Develop Med Child Neurol 1975;17:743-8

Active substance: VALPROIC ACID

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Document reference: 45485

Study title: Herranz JL et al. Side effects of valproate in monotherapy controlled by plasma levels: a study in 88 pediatric patients. Epilepsia 1982;23:203-14.

Active substance: VALPROIC ACID

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Document reference: 45486

Study title: High doses of sodium valproate in refractory childhood epilepsies - F. Viani, 1989, Boll Lega + Epil 66/67 (308-309

Active substance: VALPROIC ACID

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Document reference: 45487

Study title: Importancia de latoma de muestra en la monitorizacion de niveles plasmáticos de ác. Valproic em doentes pediatricos - Quintana, Vergana B. Farmac. Clinica vol 7 n10 (1990)

Active substance: VALPROIC ACID

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Document reference: 45488

Study title: Initiation and tolerance of intravenous valproate in children (abstract), Thomas AB, Wheless JW, Willmore LJ, Galan JA, Curtis VL, Martinez H. Epilepsia 1993; 34 (suppl. 6): 81-2

Active substance: VALPROIC ACID

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Document reference: 45489

Study title: Intravenous valproate : experience in neurosurgery - Proceedings of the fourth International Symposium of Sodium Valproate and Epilepsy - Price D.J and Chadwick D. - 1989 ( International Congress and Symposium Series n° 152 ) ( London : Royal Society of Medecines Services, 1989 - 197-203 ) Publication 5 in Ergenyl Via Expert report on the clinical documentation - Hufnagel A. - 14/11/2006

Active substance: VALPROIC ACID

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Document reference: 45490

Study title: Fradis, M.D. et al. (1987) Treatment of perennial allergic rhinitis by sodium cromoglycate plus 0.025% xylometazoline (a double blind study). J. Laryngol Otology, 101, 666-672.

Active substance: XYLOMETAZOLINE

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Document reference: 45642

Study title: Evaluation of the efficacy and tolerance of roxithromycin 5-8 mg/kg/day taken B.I.D. and clarithromycin 11-21 mg/kg/day taken B.I.D. in a 5 to 10 days treatment of lower respiratory tract infections in children.

Active substance: ROXYTHROMYCIN

Study summary document link (including results): FF9496564.pdf

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Document reference: 45229

Study title: Roxithromycin 1OOmg paediatric tablet - Multicenter clinical trial

Active substance: ROXYTHROMYCIN

Study summary document link (including results): Roxithromycin STUDY FFR8796523.xls

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Document reference: 48007

Study title: Roxithromycin 50 mg paediatric tablet - Multicenter clinical trial.

Active substance: ROXYTHROMYCIN

Study summary document link (including results): Roxithromycin STUDY FFR 87 965 19.xls

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Document reference: 48006

Study title: Study in children and young adults of the diffusion of roxithromycin (RU 28965) into tonsillar tissue following administration of 2 or 3 doses.

Active substance: ROXYTHROMYCIN

Study summary document link (including results): Roxithromycin STUDY Begue &Cotin.xls

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Document reference: 48009

Study title: Study of the diffusion of Roxithromycin (RU 28 965) in the middle ear secretions of children after repeated oral administration

Active substance: ROXYTHROMYCIN

Study summary document link (including results): Roxithromycin STUDY FFR869652.xls

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Document reference: 48005

Study title: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short children with chronic renal insufficiency

Active substance: Somatropin

Study summary document link (including results): 90-127 and 90-128 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41711

Study title: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short children with chronic renal insufficiency

Active substance: Somatropin

Study summary document link (including results): 90-127 and 90-128 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41712

Study title: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short prepubertal and pubertal children on dialysis

Active substance: Somatropin

Study summary document link (including results): 91-005 and 91-006 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41708

Study title: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short prepubertal children with chronic renal insufficiency

Active substance: Somatropin

Study summary document link (including results): TRN 92-8123-003 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41749

Study title: AN OPEN-LABELLED MULTI-CENTRE STUDY EVALUATING THE SAFETY AND EFFICACY OF GROWTH HORMONE THERAPY IN SHORT PUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY

Active substance: Somatropin

Study summary document link (including results): 95-8123-016 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41669

Study title: AN OPEN-LABELLED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE IN SHORT PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFUCUENCY (HUNGARY)

Active substance: Somatropin

Study summary document link (including results): 91-094 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41694

Study title: An Open, Multi-Centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin Simplexx™ in Children with GH Deficiency

Active substance: Somatropin

Study summary document link (including results): GHLiquid-1315_Norditropin.pdf

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Document reference: 41815

Study title: The application of cysteine gel and Solcoseryl eye gel in different corneal diseases.

Active substance: SALICYLIC ACID AND UREA

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Document reference: 35587

Study title: The use of Solcoseryl Eye-Gel in the treatment of certain diseases of cornea and conjunctiva

Active substance: SALICYLIC ACID AND UREA

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Document reference: 35582

Study title: An observational study to assess the health related quality of life impact of treating poorly controlled asthmatic children with SeretideÔ 50/100mcg

Active substance: SALMETEROL

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Document reference: 35600

Study title: Comparison of stepwise treatment of asthmatic children with salmeterol/fluticasone propionate (FP) combination product (Seretide) and/or fluticasone propionate (Flixotide) based on PD20 methacholine plus symptoms or based on symptoms only (Children Asthma Therapy Optimal”

Active substance: SALMETEROL

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Document reference: 35599

Study title: Summary of the efficacy and safety and safety of salmeterol 50mcg and fluticasone propionate 100mcg administered in Diskus Dry Powder Inhaler twice daily in steroid experienced children with reversible airways obstruction

Active substance: SALMETEROL

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Document reference: 35601

Study title: A comparison of salmeterol via diskhalerTM with salmeterol via multi dose powder inhaler in children with exercise-induced asthma. Report No. GRP/95/016

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42026

Study title: A comparison of salmeterol via diskhalerTM with salmeterol via multi dose powder inhaler in children with exercise-induced asthma. Report No. GRP/95/018

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results):

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Document reference: 42034

Study title: GROWTH HORMONE THERAPY IN SHORT CHILDREN AFTER RENAL TRANSPLANTATION FOR CHRONIC RENAL FAILURE IN GERMANY

Active substance: Somatropin

Study summary document link (including results): 94-8123-015 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41672

Study title: Growth hormone treatment in children after renal transplantation.

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41787

Study title: GROWTH HORMONE TREATMENT IN SHORT CHILDREN BORN SMALL FOR DATE (GENOTONORM)

Active substance: Somatropin

Study summary document link (including results): 89-041 PhRMA Web Synopsis.pdf

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Document reference: 41727

Study title: Growth hormone treatment of children after intrauterine growth retardation (IUGR).

Active substance: Somatropin

Study summary document link (including results): GHRETARD-BPD-14-20-21-NL_Norditropin.pdf

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Document reference: 41774

Study title: Growth hormone treatment of prematures with chronic lung disease (CLD) receiving dexamethasone treatment. A double blind, placebo controlled trial, evaluating whether treatment with growth hormone will reduce the negative effects of Dexamethasone treatmen

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41799

Study title: Growth hormone treatment of short stature in children with chronic renal failure

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41784

Study title: Growth hormone treatment of short stature in children with chronic renal failure

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41785

Study title: Growth Velocity of Young Girls with Turner Syndrome

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41634

Study title: Growth-promoting effect of a recombinant Human Growth Hormone NN-798 on Achondroplasia – A 1-year, comparative study between two dose groups.

Active substance: Somatropin

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Document reference: 41803

Study title: Petersson LG, Koch G, Rasmusson CG, Stanke H. Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study. Swed Dent J. 1985;9(3):97-104.Petersson LG, Koch G, Rasmusson CG, Stanke H. Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study. Swed Dent J. 1985;9(3):97-104.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42297

Study title: Petersson LG, Koch G, Rasmusson CG, Stanke H. Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study. Swed Dent J. 1985;9(3):97-104.Petersson LG, Koch G, Rasmusson CG, Stanke H. Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study. Swed Dent J. 1985;9(3):97-104.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42329

Study title: Pharmacokinetics of fluoride gels in children and adults.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42357

Study title: Pharmacokinetics of fluoride gels in children and adults.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42470

Study title: Plasschaert AJM, König KG: Die Wirkung von Zahngesundheitsinformation und von Fluoridtabletten auf den Karieszuwachs bei Schulkindern. I Experimentelle Ergebnisse nach 2 Jahren Versuchsdauer. Schweiz Mschr zahnkeilk 1973; 83: 421-445Plasschaert AJM, König KG: Die Wirkung von Zahngesundheitsinformation und von Fluoridtabletten auf den Karieszuwachs bei Schulkindern. I Experimentelle Ergebnisse nach 2 Jahren Versuchsdauer. Schweiz Mschr zahnkeilk 1973; 83: 421-445

Active substance: SODIUM FLUORIDE

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Document reference: 42266

Study title: Plasschaert AJM, König KG: Die Wirkung von Zahngesundheitsinformation und von Fluoridtabletten auf den Karieszuwachs bei Schulkindern. I Experimentelle Ergebnisse nach 2 Jahren Versuchsdauer. Schweiz Mschr zahnkeilk 1973; 83: 421-445Plasschaert AJM, König KG: Die Wirkung von Zahngesundheitsinformation und von Fluoridtabletten auf den Karieszuwachs bei Schulkindern. I Experimentelle Ergebnisse nach 2 Jahren Versuchsdauer. Schweiz Mschr zahnkeilk 1973; 83: 421-445

Active substance: SODIUM FLUORIDE

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Document reference: 42298

Study title: A single-administration, dose response study of Salmeterol xinafoate in pediatric bronchial asthma

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-102094-ICHE3.pdf

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Document reference: 42017

Study title: A single-administration, dose response study of Salmeterol xinafoate in pediatric bronchial asthma

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-102094-ICHE3.pdf

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Document reference: 42065

Study title: A Single-Centre Study to Determine the Pharmacodynamics and Duration of Action of Single Doses of Salmeterol Xinafoate 50mcg and 100ug as the Dry Powder Formulation Over a 12 Hour Period and to Further Assess the Tolerability of Salmeterol Xinafoate 50mcg BD in Children with Moderate to Severe Asthma. Report No. GRP/95/020

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42052

Study title: A single-centre, cross-over study to compare the duration of protection against exercise-induced bronchoconstriction following single dose Salmeterol 50mcg and Sodium cromoglycate 40mcg in children with reversible airways.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SMS40124-ICHE3.pdf

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Document reference: 42068

Study title: Hagen, W.J. and Trelles, M.G. (1960) A new local decongestant of unusually low toxicity. The eye, ear, nose & throat monthly, 35, 1,56.

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Hagen_1960.xls

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Document reference: 45635

Study title: Hochban, W et al. Nasal decongestion with imidazoline derivatives: acoustic rhinometry measurements. Eur J Clin Pharmacol 1999; 55(1):7-12

Active substance: XYLOMETAZOLINE

Study summary document link (including results):

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Document reference: 45634

Study title: Jacques, A.A. and Fuchs, V.H. (1959) A new topical nasal decongestant. J. Louisiana State Med. Soc. 111(10), 384-386.

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Jacques_1959.xls

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Document reference: 45644

Study title: Jensen, J.H. et al. (1990) Topical application of decongestant in dysfunction of the Eustachian tube: a randomised, double-blind, placebo-controlled trial. Clin. Otolaryngol, 15, 197-201

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Jensen_1990.xls

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Document reference: 45645

Study title: Knoch - ,,Summary report of data of nasal drops activity of Xylometazoline in the ambulatory conditions"

Active substance: XYLOMETAZOLINE

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Document reference: 47909

Study title: Lewison, E. (1970) Comparison of the effectiveness of topical and oral nasal decongestants. Eye, ear, nose & throat monthly, 49:16

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Lewison_1970.xls

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Document reference: 45646

Study title: Maier, A. and Maier, A. (1976) Zur Behandling der akuten Rhinitis. Therapiewoche 26, 4844-4846

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - N OTR A3_Maier_1975.xls

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Document reference: 45647

Study title: McNeill M.D. (1960) A new topical vasoconstrictor, (xylometazoline) n paediatrics. Gen. Pract. 24(4):342-344

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - McNeill_1960.xls

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Document reference: 45648

Study title: Michel O et al. The value of Ems Mineral Salts in the treatment of rhinosinusitis in children: Prospective study on the efficacy of mineral salts versus xylometazoline in the topical nasal treatment of children. Int J Pediatr Otorhinolaryngol 2005; 69(10):1359-1365

Active substance: XYLOMETAZOLINE

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Document reference: 45632

Study title: Otrivin Gel klinksche Bericht

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - N OTR A1_1973.xls

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Document reference: 45650

Study title: Otten and Grote: Otitis media with effusion and chronic upper respiratory tract infection in children: a randomized, placebo-controlled clinical study. Laryngoscope. 1990 Jun;100(6):627-33

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Otten_1990.xls

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Document reference: 47924

Study title: Otten F.W:A. and Grote J.J. (1988) Treatment of chronic maxillary sinusitis in children. Int. J. Pediat. Otorhinolaryngology, 15, 269-278

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Otten_1988.xls

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Document reference: 45651

Study title: Petruson B. et al. (1985) Study in acute infectious rhinitis in children. Larkartidningen 82, 26-27.

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Petruson_1985.xls

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Document reference: 45652

Study title: Intravenous valproic acid administration in status epilepticus - Czapinski P. and al. - 1998 ( Neurol. Neurochir. Pol. 1998 ; 32 : 11-22 ) Publication 3 in Ergenyl Via Expert report on the clinical documentation - Hufnagel A. - 14/11/2006

Active substance: VALPROIC ACID

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Document reference: 45491

Study title: An open, multi-centre trial evaluating acceptance of the new liquid growth hormone formulation - Norditropin® SimpleXx® in children with GH deficiency

Active substance: Somatropin

Study summary document link (including results): GHLiquid-1515_Norditropin.pdf

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Document reference: 41816

Study title: An open, randomised multicentre crossover trial evaluating the acceptance of the new Liquid Norditropin® formulation versus the freeze-dried powder Norditropin® in treatment naïve Turner Syndrome children.

Active substance: Somatropin

Study summary document link (including results): GHLiquid-3338_Norditropin.pdf

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Document reference: 41818

Study title: An open, randomised, mulicenter, 2-period crossover trial, evaluating the acceptance and compliance of Norditropin® SimpleXxTM/NordiPenTM versus Norditropin®/Nordiject®

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41812

Study title: Assessment of satisfaction with growth hormone treatment in children born small for gestational age: benefits of galenic form of the product. Prospective, multi-centre, open, non-randomised trial.

Active substance: Somatropin

Study summary document link (including results): GHLiquid-1670_Norditropin.pdf

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Document reference: 41817

Study title: ASSESSMENT OF TREATMENT WITH GENOTROPIN IN PAEDIATRIC PATIENTS WITH PRADER-WILLI SYNDROME. MULTICENTER, RANDOMIZED, OPEN AND WITH A CONTROL GROUP WITHOUT TREATMENT

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41645

Study title: AUTHENTIC RECOMBINANT SOMATOTROPIN, ALONE OR IN ASSOCIATION WITH ESTROGENS FOR THE TREATMENT OF SHORT STATURE IN TURNER'S SYNDROME

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41733

Study title: Irish post-marketing surveillance study.

Active substance: SERTRALINE

Study summary document link (including results):

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Document reference: 42141

Study title: Late phase II clinical study of Sertraline in Bulimia Nervosa.

Active substance: SERTRALINE

Study summary document link (including results):

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Document reference: 42139

Study title: Open follow-up study of Sertraline in children and adolescents with obsessive compulsive disorder.

Active substance: SERTRALINE

Study summary document link (including results):

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Document reference: 42128

Study title: Sertraline in the treatment of depressed patients. An open non-comparative multicenter study.

Active substance: SERTRALINE

Study summary document link (including results):

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Document reference: 42136

Study title: Sertraline in the treatment of obsessive compulsive disorder (O.C.D) in children and adolescents.

Active substance: SERTRALINE

Study summary document link (including results):

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Document reference: 42132

Study title: Sertraline in the treatment of obsessive disorder (O.C.D) in childrn and adolescents. (Strength: 25, 50mg; Pharmaceutical form: capsules)

Active substance: SERTRALINE

Study summary document link (including results):

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Document reference: 42145

Study title: Sertraline treatment of adolescent depressive and dysthymic disorders and an open trial.

Active substance: SERTRALINE

Study summary document link (including results):

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Document reference: 42135

Study title: Sertraline treatment of adolescent depressive and dysthymic disorders and an open trial. (Strength: 50mg)

Active substance: SERTRALINE

Study summary document link (including results):

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Document reference: 42147

Study title: Sertraline treatment of adolescent outpatients with major depression.

Active substance: SERTRALINE

Study summary document link (including results):

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Document reference: 42133

Study title: Sertraline treatment of adolescent outpatients with major depression. (Strength: 50mg; Pharmaceutical form: tablet)

Active substance: SERTRALINE

Study summary document link (including results):

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Document reference: 42146

Study title: Tolerance and Pharmacokinetics of Sertraline after single and multiple dosing in children and adolescents with obsessive compulsive disorder or depression.

Active substance: SERTRALINE

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Document reference: 42127

Study title: A Phase II, Randomized, Open-Label Study to Compare the Safety and Efficacy of Sevoflurane Versus Halothane Administered with Nitrous Oxide and Oxygen in ASA Class I and II Pediatric Patients

Active substance: SEVOFLURANE

Study summary document link (including results): Sevoflurane-P92-124.pdf

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Document reference: 42160

Study title: High dose growth hormone administration over the first 18 months of treatment in children with GHD

Active substance: Somatropin

Study summary document link (including results): GHD-F-3-F_Norditropin.pdf

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Document reference: 41762

Study title: Human Growth Hormon in Achondroplasia

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41639

Study title: Humatrope® (Somatropin) Drug Monitoring in Patients with Short Stature

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41640

Study title: GROWTH HORMONE THERAPY IN PUBERTAL SHORT CHILDREN, OR PREPUBERTAL ADOLESCENTS OLDER THAN 16 YEARS, WITH RENAL FAILURE.

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41726

Study title: Humatrope® in Short Bowel Syndrome

Active substance: Somatropin

Study summary document link (including results): Somatorpin-B93FPT001.xls

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Document reference: 41636

Study title: Induction of puberty with 17 b-estradiol in girls with Turner syndrome. An open, randomised trial

Active substance: Somatropin

Study summary document link (including results): GHTUR-E-2_Norditropin.pdf

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Document reference: 41773

Study title: INTRODUCTION OF A NEW GENOTROPIN NEEDLE FREE DEVICE - A FUNCTIONALITY AND PATIENT PERCEPTION STUDY OF INJEX

Active substance: Somatropin

Study summary document link (including results): GENAJT-0029-002 PhRMA Web Synopsis.pdf

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Document reference: 41666

Study title: INVESTIGATION OF THE CARDIOVASCULAR EFFECTS OF BIOSYNTHETIC GROWTH HORMONE (GENOTROPIN) IN CHILDREN WITH SHORT STATURE

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41725

Study title: Corazziari E et al. Small volume isosmotic polyethylene glycol electrolyte balanced solution (PMF-100) in treatment of chronic nonorganic constipation. Dig Dis Sci. 1996 Aug;41(8):1636-42Corazziari E et al. Small volume isosmotic polyethylene glycol electrolyte balanced solution (PMF-100) in treatment of chronic nonorganic constipation. Dig Dis Sci. 1996 Aug;41(8):1636-42

Active substance: SIMETICONE

Study summary document link (including results):

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Document reference: 42210

Study title: Danielsson B, Hwang CP. Treatment of infantile colic with surface active substance (Simethicone). Acta Paediatr Scan. October 2, 1985, 446-50Danielsson B, Hwang CP. Treatment of infantile colic with surface active substance (Simethicone). Acta Paediatr Scan. October 2, 1985, 446-50

Active substance: SIMETICONE

Study summary document link (including results):

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Document reference: 42199

Study title: de la Portilla F et al. Improved quality of anorectal endoluminal ultrasonography using emulsion of dimethicone. Dis Colon Rectum. 2003 Oct;46(10):1436-7de la Portilla F et al. Improved quality of anorectal endoluminal ultrasonography using emulsion of dimethicone. Dis Colon Rectum. 2003 Oct;46(10):1436-7

Active substance: SIMETICONE

Study summary document link (including results):

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Document reference: 42206

Study title: Friis H. Dimethicone in lactulose-induced dyspepsia. Effect on H2 production and Symptoms. Ugeskr Laeger. 1993 Oct 18;155(42):3378-80Friis H. Dimethicone in lactulose-induced dyspepsia. Effect on H2 production and Symptoms. Ugeskr Laeger. 1993 Oct 18;155(42):3378-80

Active substance: SIMETICONE

Study summary document link (including results):

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Document reference: 42213

Study title: Gaburro D, Burlina A. Management of acute infectious diarrhea in childhood. Riv Ital Pediatr. December 1, 1985, 122-7Gaburro D, Burlina A. Management of acute infectious diarrhea in childhood. Riv Ital Pediatr. December 1, 1985, 122-7

Active substance: SIMETICONE

Study summary document link (including results):

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Document reference: 42198

Study title: Garg P. Infantile colic – Unfolded. Indian J Pediatr. October 1, 2004, 903-6Garg P. Infantile colic – Unfolded. Indian J Pediatr. October 1, 2004, 903-6

Active substance: SIMETICONE

Study summary document link (including results):

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Document reference: 42183

Study title: A single-centre, randomised, double-blind, placebo controlled, parallel group study to evaluate the efficacy of salmeterol (50mcg BD via the diskhaler) in children aged 6-16 years who have asthma that is difficult to control. Report No. GRP/95/024;

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Study SLPX01- SMS30029-Salmeterol Xinafoate-Serevent Rotadisks.xls

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Document reference: 42062

Study title: A two centre study to assess the ease of handling and efficacy of salmeterol 50mcg twice daily delivered via a multidose powder inhaler compared with terbutaline sulphate 500mcg three times daily delivered via a turbohalerTM in children aged 6-11 years with reversible airways disease. Report No. GRP/95/017

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Study SMDT07-SLGB4005-Salmetrol Xinafoate (Serevent Diskus).xls

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Document reference: 42032

Study title: A two-centre, double-blind, placebo controlled three way cross-over study to determine the duration of action of salmeterol 25mcg and 50mcg administered via Diskhaler against exercise induced bronchoconstriction in children with asthma. Further to compare the effect of salmeterol 50mcg x 2 and salbutamol 200mcg x 2 administered via adiskhaler for 6 weeks, on bronchial hyperreactivity in two parallel groups.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results):

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Document reference: 42057

Study title: Treatment with human recombinant growth hormone of children with chronic renal failure

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41792

Study title: TREATMENT WITH RECOMBIANT HUMAN GROWTH HORMONE(GENOTONORM(REGISTERED)) IN CHILDREN WITH SHORT STATURE SECONDARY TO A LONG TERM CORTICOID THERAPY A STUDY OF EFFICACY AND SAFETY

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41647

Study title: TREATMENT WITH RECOMBINANT HUMAN GROWTH HORMONE (GENOTONORM) IN CHILDREN WITH SHORT STATURE SECONDARY TO A LONG TERM CORTICOID THERAPY

Active substance: Somatropin

Study summary document link (including results): A6281217 (96-8123-018) PhRMA Clinical Study Synopsis.pdf

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Document reference: 41668

Study title: TREATMENT WITH RECOMBINANT HUMAN GROWTH HORMONE IN SHORT CHILDREN AFTER RENAL TRANSPLANTATION FOR CHRONIC RENAL FAILURE IN SPAIN.

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41732

Study title: Use of 17 β-estradiol (Estrofem®) to induce feminisation of girls with Turner syndrome

Active substance: Somatropin

Study summary document link (including results): GHTUR-F-2-F_Norditropin.pdf

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Document reference: 41770

Study title: Use Result Survey of Humatrope® Therapy for Pituitary Drawfism Not Accompanied by Epiphyseal Closure

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41637

Study title: Alpha Therapeutic Corporation. Clinical Report Soyacal 10% TM Study

Active substance: SOYABEAN OIL

Study summary document link (including results):

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Document reference: 27013

Study title: Efficacy of lodoxamide 0.1% versus N-Acetyl Aspartyl Glutamic Acid 6% Ophthalmic solutions in Patients with Vernal KeratoconjunctivitisEfficacy of lodoxamide 0.1% versus N-Acetyl Aspartyl Glutamic Acid 6% Ophthalmic solutions in Patients with Vernal Keratoconjunctivitis

Active substance: SPAGLUMIC ACID

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Document reference: 42575

Study title: Kiszely; 1982

Active substance: VALPROIC ACID

Study summary document link (including results):

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Document reference: 45470

Study title: Lee WL et al. Management of epilepsy in children. In: the treatment of epilepsy. S. Shorvon ed. Blackwell publ. 2004; chapter 15: 190-200.

Active substance: VALPROIC ACID

Study summary document link (including results):

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Document reference: 45492

Study title: Long term health and neurodevelopment in children exposed to antiepileptic drugs before birth. - Dean JCS et al. - J Med Genet 2002;39:251-9.

Active substance: VALPROIC ACID

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Document reference: 45493

Study title: Major malformations in infants exposed to antiepileptic drugs in utero with emphasis on carbamazepine and valproic acid: a nation-wide, population-based register study. - Wide K et al. - Acta Paediatr 2004;93:174-6.

Active substance: VALPROIC ACID

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Document reference: 45494

Study title: Malformation rates in chidren of women with untreated epilepsy. A meta-analysis. - Fried S et al. - Drug Safety 2004;27(3):197-202.

Active substance: VALPROIC ACID

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Document reference: 45495

Study title: Malformations withdrawal manifestations and hypoglycaemia after exposure to valproate in utero. - Thisted et al. - Arch Dis Child 1993;69:288-291.

Active substance: VALPROIC ACID

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Document reference: 45496

Study title: Management of epilepsy in children. In: the treatment of epilepsy. - Lee WL et al. - S. Shorvon ed. Blackwell publ. 2004; chapter 15: 190-200.

Active substance: VALPROIC ACID

Study summary document link (including results):

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Document reference: 45497

Study title: Maternal use of antiepileptic drugs and the risk of major congenital malformations: a joint European prospective study of human teratogenesis associated with maternal epilepsy. - Samren EB et al. - Epilepsia 1997;38(9):981-90.

Active substance: VALPROIC ACID

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Document reference: 45498

Study title: Monotherapie par le valproate de sodium dans les epilepsies de l'enfant - Dulac O. and al. - 1982 (arch. Fr. Pediatr., 1982, 39, (6), 347-352)

Active substance: VALPROIC ACID

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Document reference: 45499

Study title: Monotherapiy in children with epilepsy: a preliminary report advances in epileptology - Mc Gowan and al. - 1983 (XIVth Epilepsy International symposium, 1983, 283-290)

Active substance: VALPROIC ACID

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Document reference: 45500

Study title: Monotherapy with sodium valproate in childhood epilepsy - Jeavons P.M. and al. - 1980 (Symp. Reckitt-labaz: Birmingham, 8-9th, nov. 1979 - Int. Congr. & Simp. Series, 1980, 1, (30), 53-58)

Active substance: VALPROIC ACID

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Document reference: 45501

Study title: Normal intelligence in children with prenatal exposure to carbamazepine. - Gaily E et al. - Neurology 2004;62:28-32.

Active substance: VALPROIC ACID

Study summary document link (including results):

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Document reference: 45502

Study title: Ohtsuka Y et al. Effect of antiepileptic drugs on psychomotor development in offspring of epileptic mothers. Epilepsia 1999;40 (Suppl 2):296

Active substance: VALPROIC ACID

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Document reference: 45503

Study title: Open-study of the efficacy and safety of LA 40220 SRF in the treatment of partial seizure/generalized epilepsy

Active substance: VALPROIC ACID

Study summary document link (including results): Sodium Valproate-Study 2.pdf

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Document reference: 47745

Study title: Overview: Syndromes of Infancy and Early childhood - Epilepsy: A coprehensive Textbook - 1997, p, 2263 - 65

Active substance: VALPROIC ACID

Study summary document link (including results):

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Document reference: 45504

Study title: post-marketing surveillance (once daily in the evening), report 2004

Active substance: VALPROIC ACID

Study summary document link (including results):

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Document reference: 45505

Study title: Prospective, double-blind, randomised, active-controlled multicentre

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - N OTR A2_1973.xls

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Document reference: 48045

Study title: A Phase III, Multicenter, Open-Label Study Evaluating the Effect of Multiple Exposure to Sevoflurane for the Maintenance of Anesthesia in Pediatric ASA Class I, II, and III Inpatients

Active substance: SEVOFLURANE

Study summary document link (including results): Sevoflurane-P92-098.pdf

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Document reference: 42158

Study title: A Phase III, Multicenter, Open-Label, Randomized, Comparative Study Evaluating the Effect of Sevoflurane Versus Halothane in the Induction and Maintenance of Anesthesia in Pediatric ASA Class I and II Outpatients

Active substance: SEVOFLURANE

Study summary document link (including results): Sevoflurane-P92-090.pdf

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Document reference: 42156

Study title: A Phase III, Multicenter, Open-Label, Randomized, Comparative Study Evaluating the Effect of Sevoflurane Versus Halothane in the Induction and Maintenance of Anesthesia in Pediatric ASA Class I and II Inpatients

Active substance: SEVOFLURANE

Study summary document link (including results): Sevoflurane-P92-091.pdf

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Document reference: 42157

Study title: A Phase III, Randomized, Open-Label Study to Compare the Safety, Tolerability and Recovery Characteristics of Sevoflurane Versus Halothane Administered with Nitrous Oxide and Oxygen in ASA Class I and II Pediatric Patients Undergoing Ambulatory Surgery

Active substance: SEVOFLURANE

Study summary document link (including results): Sevoflurane-P92-125.pdf

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Document reference: 42161

Study title: A Phase III, Single Center, Open-Label Study Evaluating the Production of Compound A When Sevoflurane is Administered for the Induction and Maintenance of Anesthesia in Pediatric ASA Class I, II, and III Patients

Active substance: SEVOFLURANE

Study summary document link (including results):

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Document reference: 42162

Study title: Driscoll WS, Nowjack-Raymer R, Selwitz RH, Li SH, Heifetz SB. A comparison of the caries-preventive effects of fluoride mouthrinsing, fluoride tablets, and both procedures combined: final results after eight years. J Public Health Dent. 1992 Winter;52(2):111-6.Driscoll WS, Nowjack-Raymer R, Selwitz RH, Li SH, Heifetz SB. A comparison of the caries-preventive effects of fluoride mouthrinsing, fluoride tablets, and both procedures combined: final results after eight years. J Public Health Dent. 1992 Winter;52(2):111-6.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42321

Study title: Effect of a fluoride varnish on primary dentition. Dental research in Finland 1982.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42392

Study title: Effect of a fluoride varnish on primary dentition. Dental research in Finland 1982.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42505

Study title: Effect of a fluoride-containinglacquer on dental caries.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42362

Study title: Effect of a fluoride-containinglacquer on dental caries.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42475

Study title: Effect of a preventive program based on professional toothcleaning and fluoride application on caries and gingivitis.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42374

Study title: Effect of a preventive program based on professional toothcleaning and fluoride application on caries and gingivitis.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42487

Study title: Effect of annual application of polyurethane lacquer containing silane-fluoride.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42436

Study title: Effect of annual application of polyurethane lacquer containing silane-fluoride.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42549

Study title: Effect of different carriers preventive measures in children highly infected with mutans streptococci.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42381

Study title: Effect of different carriers preventive measures in children highly infected with mutans streptococci.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42494

Study title: Effect of Fluor-Protector varnish on the inhibition of the carious process in milk teeth

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42437

Study title: Garrison MM et al. Early childhood: Colic, child development, and poisoning prevention. A systematic review of treatments for infant colic. Pediatrics. July 1, 2000, 184-90Garrison MM et al. Early childhood: Colic, child development, and poisoning prevention. A systematic review of treatments for infant colic. Pediatrics. July 1, 2000, 184-90

Active substance: SIMETICONE

Study summary document link (including results):

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Document reference: 42189

Study title: Ge ZZ et al. The role of simeticone in small-bowel preparation for capsule endoscopy. Endoscopy. 2006 Aug;38(8):836-40Ge ZZ et al. The role of simeticone in small-bowel preparation for capsule endoscopy. Endoscopy. 2006 Aug;38(8):836-40

Active substance: SIMETICONE

Study summary document link (including results):

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Document reference: 42202

Study title: Gervais AA. Pediatric health: Colic. Can Pharm J. September 1, 1996, 27-8Gervais AA. Pediatric health: Colic. Can Pharm J. September 1, 1996, 27-8

Active substance: SIMETICONE

Study summary document link (including results):

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Document reference: 42191

Study title: Hanauer SB et al. Randomized, double-blind, placebo-controlled clinical trial of loperamide plus simethicone versus loperamide alone and simethicone alone in the treatment of acute diarrhea with gas-related abdominal discomfort. Curr Med Res Opin. 2007 May;23(5):1033-43Hanauer SB et al. Randomized, double-blind, placebo-controlled clinical trial of loperamide plus simethicone versus loperamide alone and simethicone alone in the treatment of acute diarrhea with gas-related abdominal discomfort. Curr Med Res Opin. 2007 May;23(5):1033-43

Active substance: SIMETICONE

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Document reference: 42200

Study title: Hodgkinson R et al. Comparison of cimetidine (Tagamet) with antacid for safety and effectiveness in reducing gastric acidity before elective cesarean section. Anesthesiology. 1983 Aug;59(2):86-90Hodgkinson R et al. Comparison of cimetidine (Tagamet) with antacid for safety and effectiveness in reducing gastric acidity before elective cesarean section. Anesthesiology. 1983 Aug;59(2):86-90

Active substance: SIMETICONE

Study summary document link (including results):

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Document reference: 42219

Study title: Friis-Hasché E, Bergamnn J, Wenzel A, Thylstrup A et al. Dental health status and attitudes to dental care in families participating in a Danish fluoride tablet program. Community Dent Oral Epidemiol 1984; 12: 303-307Friis-Hasché E, Bergamnn J, Wenzel A, Thylstrup A et al. Dental health status and attitudes to dental care in families participating in a Danish fluoride tablet program. Community Dent Oral Epidemiol 1984; 12: 303-307

Active substance: SODIUM FLUORIDE

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Document reference: 42310

Study title: Füchte W. Ergebnisse einer Kariesprophylaxe mit Fluor-Kalktabletten. ZM 3/1971, 1-5Füchte W. Ergebnisse einer Kariesprophylaxe mit Fluor-Kalktabletten. ZM 3/1971, 1-5

Active substance: SODIUM FLUORIDE

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Document reference: 42258

Study title: Füchte W. Ergebnisse einer Kariesprophylaxe mit Fluor-Kalktabletten. ZM 3/1971, 1-5Füchte W. Ergebnisse einer Kariesprophylaxe mit Fluor-Kalktabletten. ZM 3/1971, 1-5

Active substance: SODIUM FLUORIDE

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Document reference: 42290

Study title: Füchte W. Ergebnisse einer Kariesprophylaxe mit Fluor-Kalktabletten. ZM 3/1971, 1-5Füchte W. Ergebnisse einer Kariesprophylaxe mit Fluor-Kalktabletten. ZM 3/1971, 1-5

Active substance: SODIUM FLUORIDE

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Document reference: 42322

Study title: Hamberg L. Controlled trial of fluoride vitamin drops for prevention of caries in children. The Lancet 1971; Feb 27; 441-442Hamberg L. Controlled trial of fluoride vitamin drops for prevention of caries in children. The Lancet 1971; Feb 27; 441-442

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42259

Study title: Hamberg L. Controlled trial of fluoride vitamin drops for prevention of caries in children. The Lancet 1971; Feb 27; 441-442Hamberg L. Controlled trial of fluoride vitamin drops for prevention of caries in children. The Lancet 1971; Feb 27; 441-442

Active substance: SODIUM FLUORIDE

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Document reference: 42291

Study title: Study of the clinical and biological efficacity of NAAXIA SINE® in vernal keratoconjunctivitis

Active substance: SPAGLUMIC ACID

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Document reference: 42574

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spascupreel (ampoules) [AWB-AT]

Active substance: Spascupreel - Ampullen/ Spascupreel S

Study summary document link (including results):

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Document reference: 40205

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spascupreel (injection solution/suppositories/tablets) [AWB-073]

Active substance: Spascupreel - Tabletten/ Spascupreel - Zäpfchen/ Spascupreel S

Study summary document link (including results):

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Document reference: 40207

Study title: Prospective, multicenter, observational study to document therapeutic data in the use of Spascupreel (tablets) in the treatment of spasms of the gastrointestinal tract [AWB-136]

Active substance: Spascupreel - Tabletten/ Spascupreel S

Study summary document link (including results):

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Document reference: 40210

Study title: Treatment with Genotropin in girls with Turner syndrome. A multicentre clinical trial in Belgium.

Active substance: Somatropin

Study summary document link (including results): TRN 87-055 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41659

Study title: Prospective, multicenter, observational study to document therapeutic data relating to the treatment of spasms by children aged up to 11 years old with Spascupreel S tablets [AWB-134]

Active substance: Spascupreel - Tabletten/ Spascupreel S

Study summary document link (including results):

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Document reference: 40209

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spascupreel (tablets) [AWB-034]

Active substance: Spascupreel - Tabletten/ Spascupreel S

Study summary document link (including results):

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Document reference: 40208

Study title: Prospective, multicenter, observational study to document therapeutic data relating to the treatment of spasms by children aged up to 11 years old with Spascupreel S (suppositories) [AWB-135]

Active substance: Spascupreel - Zäpfchen/ Spascupreel S

Study summary document link (including results):

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Document reference: 40212

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spascupreel S (suppositories) [AWB-AT]

Active substance: Spascupreel - Zäpfchen/ Spascupreel S

Study summary document link (including results):

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Document reference: 40211

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spigelon (drops) [AWB-AT]

Active substance: Spigelon

Study summary document link (including results):

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Document reference: 40243

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spigelon (tablets) [AWB-AT]

Active substance: Spigelon

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Document reference: 40244

Study title: Orlandi O., Verzellino A., Bruna S. and Perino A. (1973): Osservazioni cliniche su di un nuovo broncodisostruente di sintesi: il sobrerolo. Gazzetta Medica Italiana 132: 18-23.Orlandi O., Verzellino A., Bruna S. and Perino A. (1973): Osservazioni cliniche su di un nuovo broncodisostruente di sintesi: il sobrerolo. Gazzetta Medica Italiana 132: 18-23.

Active substance: SOBREROL

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Document reference: 42230

Study title: Pellegrini U. Double-blind evaluation of the bronchial cleansing effect of cyclidrol in paediatrics. Report non pubblicato. Milvio C.,Pellegrini U. Double-blind evaluation of the bronchial cleansing effect of cyclidrol in paediatrics. Report non pubblicato. Milvio C.,

Active substance: SOBREROL

Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication - Mucodox (Sobrerol).pdf

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Document reference: 42225

Study title: Seidita F., Deiana M. and Careddu P. (1984): Acute bronchial diseases in paediatrics: therapeutic approach with sobrerol granules. Giornale Italiano Malattie del Torace 38(3): 191-4. Seidita F., Deiana M. and Careddu P. (1984): Acute bronchial diseases in paediatrics: therapeutic approach with sobrerol granules. Giornale Italiano Malattie del Torace 38(3): 191-4.

Active substance: SOBREROL

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Document reference: 42229

Study title: Pubication in well established dossier of hydroxychloroquine: Advanced drug therapy for Juvenile rheumatoid arthritis - Rosenberg AM -1989

Active substance: SODIUM AUROTHIOMALATE

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Document reference: 42232

Study title: BSS Alcon Studies: Clinical Evaluation of the Safety of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Cataract Extraction in Pediatric Patients.

Active substance: SODIUM CHLORIDE

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Document reference: 42233

Study title: Publ. authors & ref: Jamal, T.S. (1995) Avoidance of postoperative blockage of ventilation tubes. Laryngoscope, 105, 833-834

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Jamal_1995.xls

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Document reference: 45653

Study title: Report/protocol/study N°: Testing of Otrivin nasal gel in acute rhinitis Investigator: Dr Maier Report date: 22.05.1975

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - N OTR A3_Kost_1975.xls

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Document reference: 45654

Study title: Sengelmann (1966) What about nose drops in kids? Controlled study of xylometazoline – a new nasal decongestant. Ohio Medical Journal, 62, 141-142.

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Sengelmann_1966.xls

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Document reference: 45655

Study title: Toyoda Y, and Ishikowa K. (1968) Clinical experiences with Otrivin in diseases of the nasal cavity. Jibi Inkoka Rinsho, 61, 319-324

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Toyoda_1968.xls

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Document reference: 45656

Study title: A repeat dose open-label, seafety evaluation of a live yeast cell derivative wound healing ointment in out-patients with minor cuts, scrapes, abrasions, and burns

Active substance: YEAST CELL EXTRACT AND SHARK LIVER OIL

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Document reference: 39447

Study title: Preparation H ointment (WH-66-228) repeated insult patch test

Active substance: YEAST CELL EXTRACT AND SHARK LIVER OIL

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Document reference: 39446

Study title: Coursaget P, Fritzell B, Blondeau C, Saliou P and Diop-Mar I. Simultaneous injection of plasma-derived or recombinant hepatitis B vaccines with yellow fever and killed polio vaccines. Vaccine 1995; 13: 109-111

Active substance: Yellow Fever Vaccine (Live)

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Document reference: 41386

Study title: Lhuillier M, Mazzariol MJ, Zadi S, Le Cam N, Bentejac MC, Adamowicz L, Marie NL and Fritzell B. Study of combined vaccination against yellow fever and measles in infants from six to nine months. J Biol Stand 1989; 17: 9-15.

Active substance: Yellow Fever Vaccine (Live)

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Document reference: 41387

Study title: Mouchon D, Pignon D, Vicens R, Tu-Ha-Tnanh, Tekaia F, Teulières L and Garrigue G. Etude de la vaccination combinée rougeole-fièvre jaune chez l’enfant africain âgé de 6 à 10 mois. [Study of the combined vaccination against measles and yellow fever in African infants aged 6-10 months]. Bull Soc Path Ex 1990; 83: 537-551

Active substance: Yellow Fever Vaccine (Live)

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Document reference: 41388

Study title: 9188IL0138: A Multicenter, Randomized, Double-blind,Placebo-controlled Parallel-group, 15-week Trial of Zafirlukast (ACCOLATE) Versus Low-dose Inhaled Corticosteroids After a 7-day Course of Oral Corticosteroids in Subjects With Asthma

Active substance: ZAFIRLUKAST

Study summary document link (including results): 9188IL0138 CSR Synopsis.pdf

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Document reference: 45604

Study title: A Dose-ranging, Safety, and Efficacy Trial with Zafirlukast (ACCOLATE)in the Treatment of Pediatric Subjects with Mild-to-moderate Asthma; Up toa 52-week Open Label Safety Extension

Active substance: ZAFIRLUKAST

Study summary document link (including results): 9188IL0139 CSR Summary.pdf

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Document reference: 45606

Study title: A Double-Blind, Double-Dummy, Placebo-controlled 13-Week Comparison of ICI 204,219 (20 mg BID) with Sodium Cromoglycate in Patients with Mild to Moderate Asthma

Active substance: ZAFIRLUKAST

Study summary document link (including results): 9188IL0059 Summary.pdf

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Document reference: 45585

Study title: A Double-blind, Parallel Group Trial of Zafirlukast (ACCOLATE) 20 mgbid in Combination With Cetirizine (ZYRTEC) 10 mg at Bedtime VersusCetirizine (ZYRTEC) 10 mg at Bedtime for the Treatment of Subjects WithChronic Idiopathic UrticariaBrief Report

Active substance: ZAFIRLUKAST

Study summary document link (including results): 9188US0024 CSR Summary.pdf

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Document reference: 45609

Study title: post-marketing surveillance (once daily in the evening), report 2006

Active substance: VALPROIC ACID

Study summary document link (including results):

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Document reference: 45506

Study title: post-marketing surveillance, report 2001

Active substance: VALPROIC ACID

Study summary document link (including results):

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Document reference: 45507

Study title: Effect of Fluor-Protector varnish on the inhibition of the carious process in milk teeth

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42550

Study title: Effect of fluoride brushing on the dental treatment requirement in a group of junior elementary school students.

Active substance: SODIUM FLUORIDE

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Document reference: 42413

Study title: Effect of fluoride brushing on the dental treatment requirement in a group of junior elementary school students.

Active substance: SODIUM FLUORIDE

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Document reference: 42526

Study title: Effect of fortnightly rinsing with a 0.2% NaF solution and a fluoride varnish with 5% NaF in dental caries prevention: comparative study in students of the northern region of Sao Paulo city, Brazil, 1992-1993

Active substance: SODIUM FLUORIDE

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Document reference: 42402

Study title: Effect of fortnightly rinsing with a 0.2% NaF solution and a fluoride varnish with 5% NaF in dental caries prevention: comparative study in students of the northern region of Sao Paulo city, Brazil, 1992-1993

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42515

Study title: Effect of schoolbased fluoride varnish programmeson approximal caries in adolescents from different caries risk areas.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42425

Study title: Effect of schoolbased fluoride varnish programmeson approximal caries in adolescents from different caries risk areas.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42538

Study title: Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42396

Study title: Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study.

Active substance: SODIUM FLUORIDE

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Document reference: 42509

Study title: The use of macrolides in the treatment of Paediatric infections - Kafetzis - 14th International Congress of Chemotherapy - 1985, Kyoto The use of macrolides in the treatment of Paediatric infections - Kafetzis - 14th International Congress of Chemotherapy - 1985, Kyoto

Active substance: ROXYTHROMYCIN

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Document reference: 35459

Study title: Results of retrospective Analysis about application of NHO Pollen for hypersensitivity. Age of patients: 6 to79 Years, 104 Patients

Active substance: Rye grass;Velvet grass;Timothy Grass;Dermatophagoides farinae;Dermatophagoides farinae;Dermatophagoides pteronyssinus;Dermatophagoides pteronyssinus;Fescue;Grama;Hazel;Alder;Birch-tree;Rye;Rye;Barley extract;Wheat;Gramineous;Gramineous;

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Document reference: 40155

Study title: Results of retrospective Analysis about hypersensitivity with Novo-Helisen® oral Mites. Age of patients: 2 to 37 Years

Active substance: Rye grass;Velvet grass;Timothy Grass;Dermatophagoides farinae;Dermatophagoides farinae;Dermatophagoides pteronyssinus;Dermatophagoides pteronyssinus;Fescue;Grama;Hazel;Alder;Birch-tree;Rye;Rye;Barley extract;Wheat;Gramineous;Gramineous;

Study summary document link (including results):

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Document reference: 40157

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Sabal-Homaccord (ampoules) [AWB-AT]

Active substance: Sabal-Homaccord - Ampullen

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Document reference: 40161

Study title: 14. Mycoserological study of the treatment of paediatric cystic fibrosis patients with Saccharomyces boulardii (Saccharomyces cerevisiae Hansen CBS 5926).; Mycoses 1995 ; 38 : 119-123.

Active substance: Saccharomyces boulardii

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Document reference: 40168

Study title: 15. Die Therapie der Diarrhöe bei kleinkindern mit Perenterol. Kinder- und Jungendmedizin 2/2001 : 48 – 49

Active substance: Saccharomyces boulardii

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Document reference: 40169

Study title: 16. The probiotic effect of Saccharomyces boulardii in a pediatric age group; Journal of Tropical Pediatrics, 2004 ; 50 (4) :234-236

Active substance: Saccharomyces boulardii

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Document reference: 40170

Study title: 17. Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea in children: a randomized double-blind placebo-controlled trial; Aliment Pharmacol Ther. 2005 ; 21 (5) : 583-590

Active substance: Saccharomyces boulardii

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Document reference: 40171

Study title: 18. Effects of Saccharomyces boulardii in children with acute diarrhoea.; Acta Paediatrica 2005, 94 (1) : 44-47

Active substance: Saccharomyces boulardii

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Document reference: 40172

Study title: Hamberg L. Controlled trial of fluoride vitamin drops for prevention of caries in children. The Lancet 1971; Feb 27; 441-442Hamberg L. Controlled trial of fluoride vitamin drops for prevention of caries in children. The Lancet 1971; Feb 27; 441-442

Active substance: SODIUM FLUORIDE

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Document reference: 42323

Study title: Haugejorgen O, Birkeland JM. Analysis of the ups and downs of caries experience among Norwegian children aged five years between 1997 and 2003. Acta Odonttol Scand 2005; 63 (2): 115-122.Haugejorgen O, Birkeland JM. Analysis of the ups and downs of caries experience among Norwegian children aged five years between 1997 and 2003. Acta Odonttol Scand 2005; 63 (2): 115-122.

Active substance: SODIUM FLUORIDE

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Document reference: 42260

Study title: Haugejorgen O, Birkeland JM. Analysis of the ups and downs of caries experience among Norwegian children aged five years between 1997 and 2003. Acta Odonttol Scand 2005; 63 (2): 115-122.Haugejorgen O, Birkeland JM. Analysis of the ups and downs of caries experience among Norwegian children aged five years between 1997 and 2003. Acta Odonttol Scand 2005; 63 (2): 115-122.

Active substance: SODIUM FLUORIDE

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Document reference: 42292

Study title: Haugejorgen O, Birkeland JM. Analysis of the ups and downs of caries experience among Norwegian children aged five years between 1997 and 2003. Acta Odonttol Scand 2005; 63 (2): 115-122.Haugejorgen O, Birkeland JM. Analysis of the ups and downs of caries experience among Norwegian children aged five years between 1997 and 2003. Acta Odonttol Scand 2005; 63 (2): 115-122.

Active substance: SODIUM FLUORIDE

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Document reference: 42324

Study title: Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315.Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315.

Active substance: SODIUM FLUORIDE

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Document reference: 42261

Study title: A double-blind randomised, placebo controlled, crossover study to evaluate the duration of protection from exercise induced bronchospasm of inhaled salmeterol xinafoate 50μg (from a Diskhaler) after a single dose and after treatment with 50μg twice daily, for 28 days in children and adolescents with asthma.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SLGB4003-ICHE3.pdf

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Document reference: 42046

Study title: A double-blind, double-dummy, placebo-controlled, crossover study to compare the effects of salmeterol 50mcg inhaled from a Diskus inhaler at low and high flow rates in children with exercise induced bronchoconstriction. Report No. GRP/95/041

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42024

Study title: A double-blind, double-dummy, placebo-controlled, crossover study to compare the effects of salmeterol 50mcg inhaled from a Diskus inhaler at low and high flow rates in children with exercise induced bronchoconstriction. Report No. GRP/95/039

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42031

Study title: A double-blind, three-way crossover study assessing the efficacy and safety of inhaled salmeterol xinafoate 50mcg bd and 100mcg bd compared with salbutamol 200mcg qds for the treatment of severe chronic asthma in children 5-16 years old. Report No. GRP/95/019

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42049

Study title: Congenital nonspherocytic haemolytic jaundice due to pyruvate kinase deficiency: splenic destruction of chromium-51 –labeled erythrocytes.Haematologica. 1973;58(11):803-9.

Active substance: SODIUM CHROMATE

Study summary document link (including results): 2011-09 GE response Sodium Chromate List of published articles.doc

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Document reference: 48290

Study title: Erythrocyte Sodium-Lithium Countertransport and Proliferative Diabetic Retinopathy.Invest Ophthalmol Vis Sci. 2000 May;41(6):1482-5.

Active substance: SODIUM CHROMATE

Study summary document link (including results): 2011-09 GE response Sodium Chromate List of published articles.doc

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Document reference: 48285

Study title: Erythrocyte survival in the newborn infant, as measured by chromium 51 and its relation to the postnatal serum bilirubin level.J Pediatr. 1961 Aug;59:194-9.

Active substance: SODIUM CHROMATE

Study summary document link (including results): Vest MF 1961.pdf

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Document reference: 48289

Study title: Impiego di una nuova molecola di sintesi, il sobrerolo, nelle affezioni dell¿albero respiratorio in pediatria. Il Lattante 42: 309-13. Impiego di una nuova molecola di sintesi, il sobrerolo, nelle affezioni dell¿albero respiratorio in pediatria. Il Lattante 42: 309-13.

Active substance: SOBREROL

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Document reference: 42228

Study title: Kinetics, distribution, and sites of destruction of indium-111 oxine labeled red cells in haemolytic anemia.J Clin Pathol 1985;38:128-32.

Active substance: SODIUM CHROMATE

Study summary document link (including results): 2011-09 GE response Sodium Chromate List of published articles.doc

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Document reference: 48287

Study title: Quantitative estimation of hemorrhage in chronic subdural hematoma using the 51Cr erythrocyte labeling method.J Neurosurg. 1987 Jun;66(6):862-4.

Active substance: SODIUM CHROMATE

Study summary document link (including results): 2011-09 GE response Sodium Chromate List of published articles.doc

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Document reference: 48286

Study title: Sequestration studies with chromium-51 labeled red cells as criteria for splenectomy.Isr J Med Sci. 1967 Nov-Dec;3(6):832-7.

Active substance: SODIUM CHROMATE

Study summary document link (including results): 2011-09 GE response Sodium Chromate List of published articles.doc

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Document reference: 48288

Study title: Björklund SI. Miniture enema in children’s practice. The Swedish Medical Journal 1961:58:2763-2766, Björklund SI. Miniture enema in children’s practice. The Swedish Medical Journal 1961:58:2763-2766,

Active substance: SODIUM CITRATE SODIUM LAURYL SULFOACETATE

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Document reference: 42236

Study title: Plasschaert AJM, König KG: Die Wirkung von Zahngesundheitsinformation und von Fluoridtabletten auf den Karieszuwachs bei Schulkindern. I Experimentelle Ergebnisse nach 2 Jahren Versuchsdauer. Schweiz Mschr zahnkeilk 1973; 83: 421-445Plasschaert AJM, König KG: Die Wirkung von Zahngesundheitsinformation und von Fluoridtabletten auf den Karieszuwachs bei Schulkindern. I Experimentelle Ergebnisse nach 2 Jahren Versuchsdauer. Schweiz Mschr zahnkeilk 1973; 83: 421-445

Active substance: SODIUM FLUORIDE

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Document reference: 42330

Study title: Post-treatment effect of fluoride varnishes in children with a high prevalence of dental caries in a community with fluoridated water.

Active substance: SODIUM FLUORIDE

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Document reference: 42534

Study title: Poulsen S, Gadegaard E, Mortensen B. Cariostatic effect of daily use of a fluoride-containing lozenge compared to forthnightly rinses with 0,2% sodium fluoride. Caries Res 1981; 15: 236-242.Poulsen S, Gadegaard E, Mortensen B. Cariostatic effect of daily use of a fluoride-containing lozenge compared to forthnightly rinses with 0,2% sodium fluoride. Caries Res 1981; 15: 236-242.

Active substance: SODIUM FLUORIDE

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Document reference: 42267

Study title: Predictors of recurrent febrile convulsions: a metaanalytic review. - Berg AT et al. - J Pediatr 1990; 116: 329-337.

Active substance: VALPROIC ACID

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Document reference: 45508

Study title: Prevention and management of febrile convulsions. - Baumann RJ. - Paedriatr Drugs 2001; 3: 585-592.

Active substance: VALPROIC ACID

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Document reference: 45509

Study title: Prognosis in children with febrile convulsions. - Nelson KB et al. - Pediatrics 1978; 61: 720-727.

Active substance: VALPROIC ACID

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Document reference: 45510

Study title: Prospective study of development of infants born to mothers with epilepsy. - James FH et al. - J Neurol Neurosurg Psychiatry 2002;72:135.

Active substance: VALPROIC ACID

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Document reference: 45511

Study title: Specific cognitive dysfunction in children with epileptic mothers. - Gaily et al. - Dev Med Child Neurol 1990;32-403-414.

Active substance: VALPROIC ACID

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Document reference: 45512

Study title: Status Epilepticus in children. Experience with intravenous valproate. Update of treatment guidelines - Campistol and al. - 1999 ( Rev. Neurol.1999 - 29 : 359-65 ) Publication 1 in Ergenyl Via Expert report on the clinical documentation - Hufnagel A. - 14/11/2006

Active substance: VALPROIC ACID

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Document reference: 45513

Study title: STUDY OF TOLERANCE OF THE SODIUM DIVALPROATE (DEPAKOTE) AT TEENAGERS SUFFERING FROM BIPOLAR IN PHASE MANIAC, MIXED DISORDER OR HYPOMANIAQUE

Active substance: VALPROIC ACID

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Document reference: 45514

Study title: Teratogenic effects of antiepileptic drugs: use of an international database on malformations and drug exposure (MADRE). - Arpino C et al. - Epilepsia 2000;41(11):1436-43.

Active substance: VALPROIC ACID

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Document reference: 45515

Study title: The epilepsies – febrile convulsions. - Trescher WH et al. - In : WG Bradley et al. Neurology in clinical practice. 4th edition. Elsevier edition 2004; vol II, chapter 73: 1963-64.

Active substance: VALPROIC ACID

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Document reference: 45516

Study title: The longer term outcome of children born to mothers with epilepsy. - Adab et al. - J Neurol Neurosurg Psychiatry 2004;75:1575-83.

Active substance: VALPROIC ACID

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Document reference: 45517

Study title: The safety of intravenous valproate study. - Mattson - 1993 - In the report MAA0461 -

Active substance: VALPROIC ACID

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Document reference: 45518

Study title: The treatment of childhood epilepsy with sodium valproate. - Haigh D et al. - Develop Med Child Neurol 1975;17:743-8

Active substance: VALPROIC ACID

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Document reference: 45519

Study title: Thisted et al. Malformations withdrawal manifestations and hypoglycaemia after exposure to valproate in utero. Arch Dis Child 1993;69:288-291.

Active substance: VALPROIC ACID

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Document reference: 45520

Study title: Treatment of children with simple febrile convulsions: the AAP practice parameter. - Baumann RJ. et al. - Pediatr Neurol 2000; 23:11-17.

Active substance: VALPROIC ACID

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Document reference: 45521

Study title: Treatment of febrile seizures. In: epilepsy: a comprehensive textbook. - Camfield PR et al. - J Engel and TA Pedley editors. Lippincott-Raven publishers. Philadelphia (USA) 1997; chapter 118: 1305-1309

Active substance: VALPROIC ACID

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Document reference: 45522

Study title: Treatment of generalized epilepsies of childhood and adolescence with sodium valproate. - Jeavons PM et al. - Develop Med Child Neurol 1977;19:9-25.

Active substance: VALPROIC ACID

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Document reference: 45523

Study title: A multicenter, double-blind comparison of ACCOLATE (ICI 204,219) with cromolyn sodium (INTAL, Fisons) and placebo in mild to moderate asthmatic patients - 9188/0057

Active substance: ZAFIRLUKAST

Study summary document link (including results): 9188IL0057 Summary.pdf

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Document reference: 45583

Study title: 20. Role of a probiotic (Saccharomyces boulardii) in management and prevention of diarrhoea.; World J Gastroenterol. 2006 ; 12(28) : 4557-60.

Active substance: Saccharomyces boulardii

Study summary document link (including results):

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Document reference: 40174

Study title: 21. Saccharomyces boulardii in acute childhood diarrhoea : a randomized, placebo-controlled study.; Acta Paediatrica, 2007;96(4) : 538-4122. J Int Med Res. 2007 Mar-Apr;35(2):201-

Active substance: Saccharomyces boulardii

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Document reference: 40175

Study title: 22. Effect of Saccharomyces boulardii in children with acute gastroenteritis and its relationship to the immune response.; BMJ. 2007 Aug 18;335:340.

Active substance: Saccharomyces boulardii

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Document reference: 40176

Study title: 23. Probiotics for treatment of acute diarrhoea in children: randomised clinical trial of five different preparations.

Active substance: Saccharomyces boulardii

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Document reference: 40177

Study title: Efecto del Saccharomyces boulardii en ninos con diarreas infecciosas agudas.; Annales de Pédiatrie 1994 ; 41 (6) : 397 - 400.

Active substance: Saccharomyces boulardii

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Document reference: 40166

Study title: Efectos de Saccharomyces boulardii en ninos con diarrea cronica, en especial causada por giardiasis.Revista Mexicana de Puericultura et Pediatria 1995 ; 2 (12) : 5 pages

Active substance: Saccharomyces boulardii

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Document reference: 40165

Study title: Estudio contra placebo del Saccharomyces boulardii en el tratamiento de la diarrea aguda infantil.; Archivos Venezolanos de Puericultura y Pediatria 1992 ; 55 (1) : 27-36.

Active substance: Saccharomyces boulardii

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Document reference: 40167

Study title: Evaluacion clinica de la administracion de Saccharomyces boulardii "vitales" en el tratamiento de la diarrea aguda en ninos. Informe preliminar.; La Semana Medica 1985 ; 167 (9) : 254-262.

Active substance: Saccharomyces boulardii

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Document reference: 40182

Study title: Evaluacion terapeutica de Saccharomyces boulardii en ninos con diarrea aguda.; Tribuna Medica 1989; 56 (2) : 111-115.

Active substance: Saccharomyces boulardii

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Document reference: 40181

Study title: Clinical trial of the efficacy of Genotropin in nephrogenic growth retardation in Germany.

Active substance: Somatropin

Study summary document link (including results): TRN 87-021 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41660

Study title: Clinical trial on growth hormone therapy in short children with chronic renal failure in Belgium.

Active substance: Somatropin

Study summary document link (including results): TRN 88-043 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41657

Study title: Clinical trial on growth hormone therapy in short children with chronic renal failure in France.

Active substance: Somatropin

Study summary document link (including results): TRN 88-047 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41656

Study title: Clinical trial on growth hormone therapy in short children with chronic renal failure in Spain.

Active substance: Somatropin

Study summary document link (including results): TRN 88-158 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41654

Study title: Clinical trial on growth hormone therapy in short children with chronic renal failure in Sweden/Finland.

Active substance: Somatropin

Study summary document link (including results): TRN 88-051 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41655

Study title: Clinical trial on growth hormone therapy in short children with chronic renal failure in UK.

Active substance: Somatropin

Study summary document link (including results): TRN 88-033 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41658

Study title: A multi-centre, double-blind, randomised, parallel group study comparing the addition of inhaled salmeterol with an increase in the dose of inhaled fluticasone propionate in asthmatic patients on a low or intermediate dose of inhaled steroid.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SMS30073-ICHE3.pdf

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Document reference: 42056

Study title: A Multi-centre, Randomised, Double-Blind, 3-Limbed, Parallel-Group Study Comparing the Efficacy and Tolerability of Dry Powder Formulations of Salmeterol Xinafoate 25μg and 50μg Twice Daily With Salbutamol 200μg Twice Daily Given in Children With Reversible Airways Obstruction

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SLPT02-ICHE3.pdf

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Document reference: 42071

Study title: A multicentre, open study to assess the ease of handling and efficacy of salmeterol xinafoate 50mcg twice daily delivered via a multi-dose powder inhaler in both adult and paediatric patients with reversible airways disease. Report No. GRP/94/034

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42023

Study title: A multicentre, open study to assess the ease of handling and efficacy of salmeterol xinafoate 50mcg twice daily delivered via a multi-dose powder inhaler in both adult and paediatric patients with reversible airways disease. Report No. GRP/94/036

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42030

Study title: Linear growth response to treatment with hGH in short children with skeletal dysplasia.

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41801

Study title: Linear growth response to treatment with hGH in short children with skeletal dysplasia.

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41802

Study title: Long term tolerance study in children with renal insufficiency treated with somatropin over 1 year

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41820

Study title: METABOLIC EFFECTS OF GROWTH HORMONE (GENOTONORM) IN GIRLS WITH TURNER SYNDROME.

Active substance: Somatropin

Study summary document link (including results): 95-8121-001 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41670

Study title: Multicentre clinical trial in young girls with Turner's syndrome treated with biosynthetic growth hormone 191 AA. Comparative trial of Genotropin vs Genotropin plus synthetic anabolic drugs

Active substance: Somatropin

Study summary document link (including results): TRN 86-092 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41661

Study title: Multicentre clinical trial on the safety and efficacy of recombinant human growth hormone, Norditropin®, in growth retarded children with chronic renal failure.

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41786

Study title: NN-701 early phase 2 clinical trial – early phase 2 clinical trial in short stature children with intrauterine growth retardation

Active substance: Somatropin

Study summary document link (including results): GHRETARD-J-3-J_Norditropin.pdf

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Document reference: 41778

Study title: No title

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41750

Study title: No title

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41751

Study title: Poulsen S, Gadegaard E, Mortensen B. Cariostatic effect of daily use of a fluoride-containing lozenge compared to forthnightly rinses with 0,2% sodium fluoride. Caries Res 1981; 15: 236-242.Poulsen S, Gadegaard E, Mortensen B. Cariostatic effect of daily use of a fluoride-containing lozenge compared to forthnightly rinses with 0,2% sodium fluoride. Caries Res 1981; 15: 236-242.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42299

Study title: Poulsen S, Gadegaard E, Mortensen B. Cariostatic effect of daily use of a fluoride-containing lozenge compared to forthnightly rinses with 0,2% sodium fluoride. Caries Res 1981; 15: 236-242.Poulsen S, Gadegaard E, Mortensen B. Cariostatic effect of daily use of a fluoride-containing lozenge compared to forthnightly rinses with 0,2% sodium fluoride. Caries Res 1981; 15: 236-242.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42331

Study title: Prediction of root caries in periodontally treated patients maintained with different fluoride programmes.

Active substance: SODIUM FLUORIDE

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Document reference: 42403

Study title: Prediction of root caries in periodontally treated patients maintained with different fluoride programmes.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42516

Study title: Prevention. Part 7: professionally applied topical fluorides for caries prevention.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42366

Study title: Prevention. Part 7: professionally applied topical fluorides for caries prevention.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42479

Study title: Preventive measures and caries progression: an in vitro study on fissures and smooth surfaces of human molars.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42435

Study title: Preventive measures and caries progression: an in vitro study on fissures and smooth surfaces of human molars.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42548

Study title: Professional topical fluoride applications--clinical efficacy and mechanism of action.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42391

Study title: Professional topical fluoride applications--clinical efficacy and mechanism of action.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42504

Study title: Progression of approximal caries in primary molars and the effect of Duraphat treatment.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42399

Study title: Progression of approximal caries in primary molars and the effect of Duraphat treatment.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42512

Study title: Progression of proximal caries in primary teeth in relation to radiographic scoring codes

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42427

Study title: Progression of proximal caries in primary teeth in relation to radiographic scoring codes

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42540

Study title: Clinical assessment of inhaled salmeterol xinafoate Diskus [SN408D] in subjects with paediatric bronchial asthma - Assessment of efficacy and safety of the regimen at 50mcg twice daily in an open-label study

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results):

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Document reference: 42069

Study title: Clinical assessment of inhaled salmeterol xinafoate Diskus [SN408D] in subjects with paediatric bronchial asthma - Assessment of efficacy and safety of the regimen at 50mcg twice daily in an open-label study

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results):

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Document reference: 42072

Study title: Clinical assessment of inhaled salmeterol xinafoate Diskus [SN408D] in subjects with paediatric bronchial asthma - Assessment of efficacy and safety of the regimen at 50mcg twice daily in an open-label study

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results):

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Document reference: 42074

Study title: A Multicenter, Double-blind Comparison of Zafirlukast (ACCOLATE) withPlacebo in Pediatric Subjects with Mild-to-moderate Asthma

Active substance: ZAFIRLUKAST

Study summary document link (including results): 9188IL0150 CSR Summary.pdf

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Document reference: 45607

Study title: A multicenter, double-blind, placebo controlled trial of Accolate TM (ICI 204,219) in mild to moderate asthmatiac patients needing chronic treatment: 13 weeks efficacy and up to a 2-year open label safety extension

Active substance: ZAFIRLUKAST

Study summary document link (including results):

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Document reference: 45582

Study title: A Multicenter, Randomized, Double-blind, Parallel-group, 13-Week TrialComparing Two Doses of Zafirlukast (ACCOLATE) in Combination WithLow-dose Inhaled Corticosteroids Versus High-dose Inhaled CorticosteroidsAlone in Subjects with Mild-to-Moderate Asthma

Active substance: ZAFIRLUKAST

Study summary document link (including results): 9188IL0094 Summary.pdf

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Document reference: 45588

Study title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Zafirlukast (ACCOLATE) In Subjects Who Present to the Emergency Department with Asthma Exacerbations

Active substance: ZAFIRLUKAST

Study summary document link (including results): 9188IL0093 CSR Summary.pdf

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Document reference: 45599

Study title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial ofZafirlukast (ACCOLATE) in Patients with Mild-to-moderate Asthma:3 Weeks Efficacy and up to 104 Weeks Open-label, Safety Extension (12 -79 yrs)

Active substance: ZAFIRLUKAST

Study summary document link (including results): 9188IL0095 COLD Summary1.pdf

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Document reference: 45589

Study title: Trescher WH et al. The epilepsies – febrile convulsions. In : WG Bradley et al. Neurology in clinical practice. 4th edition. Elsevier edition 2004; vol II, chapter 73: 1963-64.

Active substance: VALPROIC ACID

Study summary document link (including results):

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Document reference: 45524

Study title: Clinical trial using Genotropin in diet-treated children with chronic renal failure in Australia.

Active substance: Somatropin

Study summary document link (including results): TRN 89-023 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41653

Study title: Cohorte d'enfants pubères pour l'étude de l'effet du traitement par hormone de croissance biosynthétqiue MAXOMAT sur la taille adulte des enfants présentant un retard de croissance severe a debut intra-utérin (taille inférieure ou égale à 3DS)

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41822

Study title: Comparison of the Effects of Frequency of Growth Hormone Administration on Growth Rate and Biochemical Parameters of Carbohydrate Metabolism

Active substance: Somatropin

Study summary document link (including results): UK-GHD-010-GHD_Norditropin.pdf

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Document reference: 41759

Study title: Concentration control trial of Norditropin SimpleXx in children with growth hormone deficiency: A two year, open-label, randomized, multi-center trial

Active substance: Somatropin

Study summary document link (including results): HGH-2051_Norditropin.pdf

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Document reference: 41758

Study title: Controlled study to evaluate the efficacy and safety of the treatment with liquid Norditropin which will be started randomly at the ages of 2 to 5, in children diagnosed of intrauterine growth retardation

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41780

Study title: DIAGNOSTIC ANALYSIS IN PATIENTS WITH CHILDHOOD ONSET GROWTH HORMONE DEFICIENCY DURING TRANSITION FROM ADOLESCENCE TO ADULTHOOD

Active substance: Somatropin

Study summary document link (including results): 307-MET-9002-019 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41649

Study title: A Phase III, Single Center, Open-Label, Randomized, Comparative Study Evaluating the Effect of Sevoflurane Versus Halothane on Hepatic Metabolism in the Induction and Maintenance of Anesthesia in Pediatric Inpatients

Active substance: SEVOFLURANE

Study summary document link (including results): Sevoflurane-P92-084.pdf

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Document reference: 42155

Study title: An open-label, multi-center, phase IV study to evaluate the efficacy and safety profiles of sevoflurane in pediatric subjects of different ages undergoing inpatient surgery with general anesthesia

Active substance: SEVOFLURANE

Study summary document link (including results): Sevoflurane-CHIN-05-001.pdf

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Document reference: 42152

Study title: Drug Metabolism Report No. 8 - The Minimum Alveolar Concentration (MAC), and Maintenance and Recovery Characteristics of Sevoflurane in Pediatric Patients

Active substance: SEVOFLURANE

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Document reference: 42159

Study title: Evaluation of the Clinical and Consumption Differences between Sevoflurane Innovative Drug and Sevoflurane Similar Drug - Pilot Study

Active substance: SEVOFLURANE

Study summary document link (including results):

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Document reference: 42154

Study title: Sevoflurane versus Halothane in the induction and maintenance of anesthesia in pediatric patients (Abbott Affiliate sponsored study - drug administered)

Active substance: SEVOFLURANE

Study summary document link (including results):

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Document reference: 42153

Study title: The Minimum Alveolar Concentration (MAC), and Maintenance and Recovery Characteristics of Sevoflurane in Pediatric Patients

Active substance: SEVOFLURANE

Study summary document link (including results): sevoflurane-ghba532.pdf

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Document reference: 48115

Study title: A 12-Month Study to Assess the Safety and Efficacy of Meridia® (sibutramine hydrochloride monohydrate) 10 and 15 mg in Obese Adolescents

Active substance: SIBUTRAMINE

Study summary document link (including results): Sibutramine-SB238.pdf

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Document reference: 47621

Study title: A randomised, placebo controlled, doubly blind study of the effect of sibutramine on the treatment of obese adolescents with a recommended diet and exercise plan followed by a sibutramine-free period (SB116)

Active substance: SIBUTRAMINE

Study summary document link (including results): Sibutramine-SB116.pdf

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Document reference: 47620

Study title: No title

Active substance: Somatropin

Study summary document link (including results):

View full study record

Document reference: 41761

Study title: No title

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41764

Study title: No title

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41765

Study title: Norditropin® and Norditropin® cartridges: An open-label, randomized, comparative safety and efficacy trial in children with growth hormone deficiency

Active substance: Somatropin

Study summary document link (including results): HGH-2124_Norditropin.pdf

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Document reference: 41757

Study title: Norditropin® in children with growth failure associated with IGF deficiency: A 12 months open-label, randomized, parallel group study.

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41798

Study title: Linear growth response to treatment with hGH in short children with skeletal dysplasia.

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41800

Study title: Nutritional status of children with chronic renal failure receiving recombinant human growth hormone therapy.

Active substance: Somatropin

Study summary document link (including results): TRN 89-031 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41652

Study title: OPEN-LABEL, MULTI-CENTER, SINGLE ARM STUDY TO DETERMINE PATIENT/CAREGIVER PREFERENCE OF INJEX, THE NEEDLE-FREE, AUTOINJECTION DEVICE FOR THE ADMINISTRATION OF GENOTROPIN IN NEEDLE PHOBIC CHILDREN

Active substance: Somatropin

Study summary document link (including results): GENAJT-0029-005 PhRMA Web Synopsis.pdf

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Document reference: 41664

Study title: Kark W, Krebs-Richter H, Hotz J. Improving the effect of orthograde colonic lavage with golytely solution by adding dimethicone. Z Gastroenterol. 1995 Jan;33(1):20-3Kark W, Krebs-Richter H, Hotz J. Improving the effect of orthograde colonic lavage with golytely solution by adding dimethicone. Z Gastroenterol. 1995 Jan;33(1):20-3

Active substance: SIMETICONE

Study summary document link (including results):

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Document reference: 42211

Study title: Korman MG et al. Influence of smoking on healing rate of duodenal ulcer in response to cimetidine or high-dose antacid. Gastroenterology. 1981 Jun;80(6):1451-3Korman MG et al. Influence of smoking on healing rate of duodenal ulcer in response to cimetidine or high-dose antacid. Gastroenterology. 1981 Jun;80(6):1451-3

Active substance: SIMETICONE

Study summary document link (including results):

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Document reference: 42220

Study title: Lesperance MM. A pediatric otolaryngologist learns to diagnose acute otitis media. Arch Otolaryngol Head Neck Surg. August 1, 2007, 745-6Lesperance MM. A pediatric otolaryngologist learns to diagnose acute otitis media. Arch Otolaryngol Head Neck Surg. August 1, 2007, 745-6

Active substance: SIMETICONE

Study summary document link (including results):

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Document reference: 42175

Study title: Leung AKC, Lemay JF. Infantile colic: A review. J R Soc Promot Health. July 1, 2004, 162-6Leung AKC, Lemay JF. Infantile colic: A review. J R Soc Promot Health. July 1, 2004, 162-6

Active substance: SIMETICONE

Study summary document link (including results):

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Document reference: 42186

Study title: Li BUK, Besedovsky A. Across the developmental continuum of irritable bowel syndrome: Clinical and pathophysiologic considerations. Curr Gastroenterol Rep. June 1, 2004, 247-53Li BUK, Besedovsky A. Across the developmental continuum of irritable bowel syndrome: Clinical and pathophysiologic considerations. Curr Gastroenterol Rep. June 1, 2004, 247-53

Active substance: SIMETICONE

Study summary document link (including results):

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Document reference: 42185

Study title: Lifschitz CH, Irving CS, Smith EO. Effect of a simethicone-containing tablet on colonic gas elimination in breath. Dig Dis Sci. 1985 May;30(5):426-30Lifschitz CH, Irving CS, Smith EO. Effect of a simethicone-containing tablet on colonic gas elimination in breath. Dig Dis Sci. 1985 May;30(5):426-30

Active substance: SIMETICONE

Study summary document link (including results):

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Document reference: 42217

Study title: Clinical assessment of inhaled salmeterol xinafoate Diskus [SN408D] in subjects with pediatric bronchial asthma - Assessment of efficacy and safety of the regimen at 50mcg twice daily in an open-label study-

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-102095-ICHE3.pdf

View full study record

Document reference: 42018

Study title: Clinical study of salmeterol xinafoate (SN408) dry powder. Bioequivalency study between salmeterol xinafoate aerosol in children with bronchial asthma by single dose crossover method. Report No. JJA/93/011;

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Study SMS40086-SD102-Salmeterol Xinafoate-Serevent Rotadisks.xls

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Document reference: 42043

Study title: Clinical study of Salmeterol xinafoate dry powder. Bioequivalency study between Salmeterol xinafoate aerosol in children with bronchial asthma by a single dose, cross-over method. Report No. JJA/93/011

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results):

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Document reference: 42059

Study title: Clinical study of Salmeterol xinafoate dry powder. Study on paediatric patients with bronchial asthma. Report No. JJA/93/007

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Study SMS30009-SD103-Salmeterol Xinafoate-Serevent Rotadisks.xls

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Document reference: 42044

Study title: Effect of four week regular Salmeterol treatment on cardiovascular autonomic balance in asthmatic children.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Study SMS40094-Salmeterol Xinafoate-Serevent Rotadisks.xls

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Document reference: 42060

Study title: Efficacy and safety of long-term inhaled salmeterol and beclomethasone dipropionate in corticosteroid-naïve children with mild to moderate, chronic, stable asthma.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SMS40065-ICHE3.pdf

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Document reference: 42051

Study title: Verapamil plus antiarrhythmic drugs reduce atrial fibrillation recurrences after an electrical cardioversion (VEPARAF Study).De Simone A, De Pasquale M, De Matteis C, Canciello M, Manzo M, Sabino L, Alfano F, Di− Mauro M, Campana A, De−Fabrizio G, Vitale DF, Turco P, Stabile−G. European heart journal, Aug 2003, vol. 24, no. 15, p. 1425−9, Verapamil plus antiarrhythmic drugs reduce atrial fibrillation recurrences after an electrical cardioversion (VEPARAF Study).De Simone A, De Pasquale M, De Matteis C, Canciello M, Manzo M, Sabino L, Alfano F, Di− Mauro M, Campana A, De−Fabrizio G, Vitale DF, Turco P, Stabile−G. European heart journal, Aug 2003, vol. 24, no. 15, p. 1425−9,

Active substance: VERAPAMIL

Study summary document link (including results):

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Document reference: 45537

Study title: Use of injectable valproic acid in status epilepticus - Giroud M. and al. - 1993 ( Drug Invest 1993 ; 5 : 154-9 ) Publication 2 in Ergenyl Via Expert report on the clinical documentation - Hufnagel A. - 14/11/2006

Active substance: VALPROIC ACID

Study summary document link (including results):

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Document reference: 45525

Study title: Verity CM et al. Risk of epilepsy after febrile: a national cohort study. Br. Med J 1991; 303:1373-76.

Active substance: VALPROIC ACID

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Document reference: 45526

Study title: Vit. B6 and valproic acid in treatment of infantile spasms, Masatoshi Ho., pag. 331-336, 1991 - Pediatric Neurol.

Active substance: VALPROIC ACID

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Document reference: 45527

Study title: Wallace SJ. A comparative review of the adverse effects of anticonvulsants in children with epilepsy. Drug safety 1996; 15(6): 378-393.

Active substance: VALPROIC ACID

Study summary document link (including results):

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Document reference: 45528

Study title: Analyse des résultats obtenus avec le DEPAMIDE chez des enfants atteints d'instabilité psychomotrice (hyperkinésie) - F. MAIRLOT - 11/01/77

Active substance: VALPROMIDE

Study summary document link (including results):

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Document reference: 45529

Study title: Etude comparative du DEPAMIDE et du DEPAKINE dans le traitement de l'épilepsie associée à des troubles caractériels - M. SMIDTS - 16/01/78

Active substance: VALPROMIDE

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Document reference: 45530

Study title: Recherche chez les enfants des propriétés anti-convulsiantes et neurotropes, contrôle de la tolérance et de l'innocuité - R. MISES - 19.06.67

Active substance: VALPROMIDE

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Document reference: 45531

Study title: A 4-week, double-blind, randomized, multi-center study followed by 12 months open-label treatment to evaluate the dose-response and safety of valsartan in pediatric hypertensive patients 1-5 years of ageDOI: 10.1161/HYPERTENSIONAHA.108.111054 Journal reference: Hypertension - Journal of the American Heart Association 2008;52:1-7.

Active substance: VALSARTAN

Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2307_2-.xls

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Document reference: 47270

Study title: A 4-week, double-blind, randomized, multi-center study followed by 12 months open-label treatment to evaluate the dose-response and safety of valsartan in pediatric hypertensive patients 1-5 years of age

Active substance: VALSARTAN

Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2307_2-.xls

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Document reference: 48169

Study title: A Double-Blind, Randomized, Multicenter Study followed by 12 Months Open-label Treatment to Evaluate the Dose-response and Safety of Valsartan in Pediatric Hypertensive PatientsDOI: 1111/j.1751-7176.2011.00432.x Journal Clinical Hypertension: 2011;13:357-365

Active substance: VALSARTAN

Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2302_2.xls

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Document reference: 47268

Study title: A Double-Blind, Randomized, Multicenter Study followed by 12 Months Open-label Treatment to Evaluate the Dose-response and Safety of Valsartan in Pediatric Hypertensive Patients

Active substance: VALSARTAN

Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2302_2.xls

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Document reference: 48167

Study title: An open-label, single dose, pharmacokinetic study of sibutramine and its metabolites in obese adolescents.

Active substance: SIBUTRAMINE

Study summary document link (including results): Sibutramine-SB240.pdf

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Document reference: 47622

Study title: Impact Sibutramine Therapy in Children with Hypothalamic Obesity or Obesity with Aggravating Syndromes

Active substance: SIBUTRAMINE

Study summary document link (including results): sibutramine-danielsson.xls

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Document reference: 48136

Study title: Use of Sibutramine in Obese Mexican Adolescents: A 6-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial

Active substance: SIBUTRAMINE

Study summary document link (including results): sibutramine-garciamorales.xls

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Document reference: 48137

Study title: A 7 -Day, Open-Label, Multicenter, Pharmacokinetic study (Part 1) followed by a 7-Day, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study (Part 2) of IV Sildenafil in the treatment of neonates with persistent pulmonary hypertension of the newborn (PPHN) or hypoxic respiratory failure and at risk for PPHN.

Active substance: sildenafil

Study summary document link (including results): A1481157 PhRMA Web Synopsis.pdf

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Document reference: 41606

Study title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study of intravenous Sidenafil in the treatment of children, aged 0 to 17 with pulmonary hypertension.

Active substance: sildenafil

Study summary document link (including results): A1481134 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41605

Study title: Dluholucky S et al Amanita phalloides intoxication - Fully treatable event. 25-Year's experience in children.

Active substance: Silibinine dihydrogen succinate, disodium

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Document reference: 39872

Study title: Dluholucky S et al Amanita phalloides intoxication - Fully treatable event. 25-Year's experience in children.Cesko-Slovenska Pediatrie; VOL: 61 (6); p. 350-356 /2006/

Active substance: Silibinine dihydrogen succinate, disodium

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Document reference: 40193

Study title: Effect on the primary dentition of mouthrinsing with a 0.2 percent neutral NaF solution: results from a demonstration program after four school years.

Active substance: SODIUM FLUORIDE

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Document reference: 42406

Study title: Effect on the primary dentition of mouthrinsing with a 0.2 percent neutral NaF solution: results from a demonstration program after four school years.

Active substance: SODIUM FLUORIDE

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Document reference: 42519

Study title: Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children

Active substance: SODIUM FLUORIDE

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Document reference: 42351

Study title: Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children

Active substance: SODIUM FLUORIDE

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Document reference: 42464

Study title: Effects of fluoride and chlorhexidine on the microflora of dental root surfaces and progression of root-surface caries.

Active substance: SODIUM FLUORIDE

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Document reference: 42410

Study title: Effects of fluoride and chlorhexidine on the microflora of dental root surfaces and progression of root-surface caries.

Active substance: SODIUM FLUORIDE

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Document reference: 42523

Study title: Effects of self-applied topical fluoride preparations in orthodontic patients.

Active substance: SODIUM FLUORIDE

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Document reference: 42448

Study title: Efficacy of preventive agents for dental caries. Systemic fluorides: water fluoridation.

Active substance: SODIUM FLUORIDE

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Document reference: 42388

Study title: Efficacy of preventive agents for dental caries. Systemic fluorides: water fluoridation.

Active substance: SODIUM FLUORIDE

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Document reference: 42501

Study title: Enamel fluoride uptake, distribution and retention from topical fluoride agents.

Active substance: SODIUM FLUORIDE

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Document reference: 42405

Study title: Enamel fluoride uptake, distribution and retention from topical fluoride agents.

Active substance: SODIUM FLUORIDE

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Document reference: 42518

Study title: Erosion caused by gastric reflux in childen. Discussion of etiology, clinical appearance and therapy in two cases.

Active substance: SODIUM FLUORIDE

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Document reference: 42382

Study title: Lucassen PL et al. Effectiveness of treatments for infantile colic: systematic review. BMJ. 1998 May 23;316(7144):1563-9Lucassen PL et al. Effectiveness of treatments for infantile colic: systematic review. BMJ. 1998 May 23;316(7144):1563-9

Active substance: SIMETICONE

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Document reference: 42209

Study title: McCollough M, Sharieff GQ. Abdominal pain in children. Pediatr Clin North Am. February 1, 2006, 107-37McCollough M, Sharieff GQ. Abdominal pain in children. Pediatr Clin North Am. February 1, 2006, 107-37

Active substance: SIMETICONE

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Document reference: 42177

Study title: Metcalf TJ et al. Simethicone in the treatment of infant colic: a randomized, placebo-controlled, multicenter trial. Pediatrics. 1994 Jul;94(1):29-34Metcalf TJ et al. Simethicone in the treatment of infant colic: a randomized, placebo-controlled, multicenter trial. Pediatrics. 1994 Jul;94(1):29-34

Active substance: SIMETICONE

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Document reference: 42212

Study title: Nykamp D. Nonprescription medications in the pediatric population. Am Pharm. May 3, 1995, 10-27Nykamp D. Nonprescription medications in the pediatric population. Am Pharm. May 3, 1995, 10-27

Active substance: SIMETICONE

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Document reference: 42194

Study title: Orenstein SR et al. Nizatidine for the treatment of pediatric gastroesophageal reflux symptoms: An open-label, multiple-dose, randomized, multicenter clinical trial in 210 children. Clin Ther. April 1, 2005, 472-83Orenstein SR et al. Nizatidine for the treatment of pediatric gastroesophageal reflux symptoms: An open-label, multiple-dose, randomized, multicenter clinical trial in 210 children. Clin Ther. April 1, 2005, 472-83

Active substance: SIMETICONE

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Document reference: 42181

Study title: Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315.Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315.

Active substance: SODIUM FLUORIDE

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Document reference: 42293

Study title: Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315.Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315.

Active substance: SODIUM FLUORIDE

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Document reference: 42325

Study title: Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125.Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125.

Active substance: SODIUM FLUORIDE

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Document reference: 42262

Study title: Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125.Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125.

Active substance: SODIUM FLUORIDE

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Document reference: 42294

Study title: Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125.Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125.

Active substance: SODIUM FLUORIDE

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Document reference: 42326

Study title: Verapamil versus flunarizina nella terapia preventiva dell'emicrania. (Verapamil versus flunarizine in the preventive therapy of hemicrania).Lastilla M, Achille P, Savarese MA, Frascella G. La Clinica terapeutica, 31 Mar 1990, vol. 132, no. 6, p. 401−4, Verapamil versus flunarizina nella terapia preventiva dell'emicrania. (Verapamil versus flunarizine in the preventive therapy of hemicrania).Lastilla M, Achille P, Savarese MA, Frascella G. La Clinica terapeutica, 31 Mar 1990, vol. 132, no. 6, p. 401−4,

Active substance: VERAPAMIL

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Document reference: 45559

Study title: Zur antiarrhythmischen Wirksamkeit von Disopyramid bei ventrikulärer Extrasystolie und Vorhofflimmern. (Antiarrhythmic effect of disopyramide in ventricular extrasystole and auricular fibrillation).Breithardt G, Haerten K, Seipel L. Zeitschrift für Kardiologie, Aug 1976, vol. 65, no. 8, p. 713−23,Zur antiarrhythmischen Wirksamkeit von Disopyramid bei ventrikulärer Extrasystolie und Vorhofflimmern. (Antiarrhythmic effect of disopyramide in ventricular extrasystole and auricular fibrillation).Breithardt G, Haerten K, Seipel L. Zeitschrift für Kardiologie, Aug 1976, vol. 65, no. 8, p. 713−23,

Active substance: VERAPAMIL

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Document reference: 45565

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Veratrum-Homaccord (drops) [AWB-AT]

Active substance: Veratrum-Homaccord

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Document reference: 40300

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Vertigoheel (tablets) in children aged up to 11 years old [AWB-089]

Active substance: Vertigoheel

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Document reference: 40303

Study title: Prospective, multicenter, observational study to document therapeutic data in the use of Vertigoheel (tablets) in the treatment vertigo [AWB-114]

Active substance: Vertigoheel

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Document reference: 40304

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Vertigoheel (tablets) [AWB-AT]

Active substance: Vertigoheel

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Document reference: 40302

Study title: Higher frequency of early local side effects with aqueous versus depot immunotherapy for Hymenoptera venom allergy

Active substance: VESPULA SPP

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Document reference: 39384

Study title: Insect sting allergy. A study from 1980 to 2003 of patients who started treatment with venom immunotherapy between 1980 and 1998

Active substance: VESPULA SPP

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Document reference: 39385

Study title: Open, multicentric, post marketing surveillance study of GlaxoSmithKline Biologicals’ Vi polysaccharide typhoid vaccine (TYPHERIXÔ) injected in healthy children and adults according to the Indian prescribing information.

Active substance: Vi polysaccharide of Salmonella typhi

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Document reference: 47496

Study title: Prospective, multicenter, observational study to document therapeutic data relating to the treatment of agitation (with and without fever) by children aged up to 11 years with Viburcol (suppositories) [AWB-097]

Active substance: Viburcol

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Document reference: 40306

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Viburcol (suppositories) [AWB-AT]

Active substance: Viburcol

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Document reference: 40305

Study title: Prospective, multicenter, observational study to document therapeutic data relating to the treatment of acute feverish infects by children aged up to 11 years with Viburcol N (suppositories) [AWB-118]

Active substance: Viburcol N

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Document reference: 40307

Study title:

Active substance: VIGABATRIN

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Document reference: 47306

Study title: Endo et al. The use of GC-120 to children with metabolic acidosis; Shinyaku to Rhinsho 1986;35(8): 8(1804) - 12(1808)

Active substance: URINARY CONCREMENT SOLVENTS

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Document reference: 39157

Study title: Kinugasa Effect of PSC in Preventing Renal Sones in Siblings with Cystinuria; Shinyaku to Rhinsho 1987, 36, 9

Active substance: URINARY CONCREMENT SOLVENTS

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Document reference: 39158

Study title: The use of medicated soap for Pityriasis Versicolor.Thisted et al. Malformations withdrawal manifestations and hypoglycaemia after exposure to valproate in utero. Arch Dis Child 1993;69:288-291.

Active substance: URINARY CONCREMENT SOLVENTS

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Document reference: 39153

Study title: Erosion caused by gastric reflux in childen. Discussion of etiology, clinical appearance and therapy in two cases.

Active substance: SODIUM FLUORIDE

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Document reference: 42495

Study title: Evaluation of a fluoride-containing varnish in children with low caries incidence.

Active substance: SODIUM FLUORIDE

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Document reference: 42377

Study title: Evaluation of a fluoride-containing varnish in children with low caries incidence.

Active substance: SODIUM FLUORIDE

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Document reference: 42490

Study title: Evaluation of a routine for prevention and treatment of fissure caries in permanent first molars.

Active substance: SODIUM FLUORIDE

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Document reference: 42401

Study title: Evaluation of a routine for prevention and treatment of fissure caries in permanent first molars.

Active substance: SODIUM FLUORIDE

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Document reference: 42514

Study title: Evaluation of non-invasive treatment applied to occlusal surfaces.

Active substance: SODIUM FLUORIDE

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Document reference: 42358

Study title: Evaluation of non-invasive treatment applied to occlusal surfaces.

Active substance: SODIUM FLUORIDE

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Document reference: 42471

Study title: Factors governing the use of topical fluorides: time and patient acceptability.

Active substance: SODIUM FLUORIDE

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Document reference: 42338

Study title: Factors governing the use of topical fluorides: time and patient acceptability.

Active substance: SODIUM FLUORIDE

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Document reference: 42451

Study title: Fanning EA, Cellier KM, Leadbeater MM, Somerville CM. South Australian kindergarten children: fluoride tablet supplements and dental caries. Aust Dent J 1975: 20: 7-9Fanning EA, Cellier KM, Leadbeater MM, Somerville CM. South Australian kindergarten children: fluoride tablet supplements and dental caries. Aust Dent J 1975: 20: 7-9

Active substance: SODIUM FLUORIDE

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Document reference: 42244

Study title: Grêle court dysfonctionnel (GCD) compliqué de pullulation bactérienne chez l'enfant : effet de Saccharomyces boulardii.Gastroentérologie Clinique et Biologique 1994 ; 18 : A-101.

Active substance: Saccharomyces boulardii

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Document reference: 40179

Study title: Saccharomyces boulardii for Clostridium difficile-associated enteropathies in infants. Journal of Pediatric Gastroenterology and Nutrition 1993 ; 16 : 419-425.

Active substance: Saccharomyces boulardii

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Document reference: 40180

Study title: Saccharomyces boulardii in the management of toddler diarrhea : a double-blind-placebo controlled study.Journal of Pediatric Gastroenterology and Nutrition 1995 ; 20 (4) : 463.

Active substance: Saccharomyces boulardii

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Document reference: 40164

Study title: Traitement des diarrhées aiguës infantiles : Essai contrôlé de Saccharomyces boulardii. Annales de Pédiatrie 1985 ; 32 (6) : 561-563.

Active substance: Saccharomyces boulardii

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Document reference: 40178

Study title: Treatment of acne with a yeast preparation;Fortschr Med. 1989 Sep 10; 107(26):563-6. German.

Active substance: Saccharomyces boulardii

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Document reference: 40184

Study title: Evaluation thérapeutique de Saccharomyces boulardii chez des enfants souffrant de diarrhée aiguë.Annales de Pédiatrie 1994 ; 41 (6) : 397 - 400.

Active substance: Saccharomyces boulardii

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Document reference: 40163

Study title: Grêle court dysfonctionnel (GCD) compliqué de pullulation bactérienne chez l'enfant : effet de Saccharomyces boulardii.Gastroentérologie Clinique et Biologique 1994 ; 18 : A-101.

Active substance: Saccharomyces boulardii

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Document reference: 40162

Study title: Uma obordagem terapêutica singular das diarréias agudas.Caderno de clinica e terapêutica 1982 ; 11 (3) : 90-94.

Active substance: Saccharomyces boulardii

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Document reference: 40183

Study title:

Active substance: SALBUTAMOL

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Document reference: 47685

Study title:

Active substance: SALBUTAMOL

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Document reference: 47686

Study title:

Active substance: SALBUTAMOL

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Document reference: 47687

Study title:

Active substance: SALBUTAMOL

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Document reference: 47688

Study title:

Active substance: SALBUTAMOL

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Document reference: 47689

Study title: Value of bone scan in the McCune-Albright syndrome. Report of a case. Edeburn GF, Mortensson W. Acta Radiol Diagn (Stockh). 1986 Nov-Dec;27(6):719-21.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43887

Study title: Factor analysis as a means of determining response to chemotherapy in patients with osteogenic sarcoma. Edeline V, Frouin F, Bazin JP, Di Paola M, Kalifa C, Contesso G, Parmentier C, Lumbroso J, Di Paola R. Eur J Nucl Med. 1993 Dec;20(12):1175-85.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43642

Study title: Abnormal whole-body technetium-99m MDP scintigraphy indicating cortical hyperostosis following long-term administration of prostataglandin E-1 in an infant with cyanotic congenital heart disease.Edeling CJ, Frederiksen PB. Clin Nucl Med. 1987 Jan;12(1):74. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44276

Study title: Edeling CJ. 99mTc-methylene diphosphonate uptake in a primary Wilms' tumor. Eur J Nucl Med. 1983;8(1):30. No abstract available. Edeling CJ. 99mTc-methylene diphosphonate uptake in a primary Wilms' tumor. Eur J Nucl Med. 1983;8(1):30. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44055

Study title: Edeling CJ. Bone scintigraphy in hereditary multiple exostoses. Eur J Nucl Med. 1988;14(4):207-8. Edeling CJ. Bone scintigraphy in hereditary multiple exostoses. Eur J Nucl Med. 1988;14(4):207-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43830

Study title: Edeling CJ. Observations on the sequential use of Tc-99m phosphonate and Ga-67 imaging in untreated primary and secondary malignant tumors of the head and neck. Clin Nucl Med. 1983 Mar;8(3):107-111. Edeling CJ. Observations on the sequential use of Tc-99m phosphonate and Ga-67 imaging in untreated primary and secondary malignant tumors of the head and neck. Clin Nucl Med. 1983 Mar;8(3):107-111.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44044

Study title: Egashira K, Ohno M, Uchino A, Hayashi K, Nakayama C, Nakata H. [Bone scintigraphy of decompression sickness] Nippon Igaku Hoshasen Gakkai Zasshi. 1988 Jun 25;48(6):749-58. Japanese. No abstract available. Egashira K, Ohno M, Uchino A, Hayashi K, Nakayama C, Nakata H. [Bone scintigraphy of decompression sickness] Nippon Igaku Hoshasen Gakkai Zasshi. 1988 Jun 25;48(6):749-58. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43814

Study title: Ehara S, Nishida J, Shiraishi H, Tamakawa Y. Pasteurized intercalary autogenous bone graft: radiographic and scintigraphic features. Skeletal Radiol. 2000 Jun;29(6):335-9. Ehara S, Nishida J, Shiraishi H, Tamakawa Y. Pasteurized intercalary autogenous bone graft: radiographic and scintigraphic features. Skeletal Radiol. 2000 Jun;29(6):335-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43479

Study title: Sports-related groin pain: evaluation with MR imaging. Ekberg O, Sjöberg S, Westlin N. Eur Radiol. 1996;6(1):52-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43571

Study title: Wong VC, Sun JG, Yeung DW. Pilot study of efficacy of tongue and body acupuncture in children with visual impairment. [wong-2006-b]J Child Neurol. 2006 Jun;21(6):463-73. Wong VC 2006

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48713

Study title: Wong VC, Sun JG, Yeung DW. Pilot study of positron emission tomography (PET) brain glucose metabolism to assess the efficacy of tongue and body acupuncture in cerebral palsy. [wong-2006-a]J Child Neurol. 2006 Jun;21(6):456-62. Wong VC 2006

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48712

Study title: Wu H, Dimitrakopoulou-Strauss A, Heichel TO, Lehner B, Bernd L, Ewerbeck V, et al.. Quantitative evaluation of skeletal tumours with dynamic FDG PET: SUV in comparison to Patlak analysis. [wu-2001]Eur J Nucl Med. 2001 Jun;28(6):704-10. Wu H 2001

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48714

Study title: The long-term safety and efficacy of Risperdal® in conduct disorder in mild, moderate and borderline mentally retarded children aged 5 to 14 years.

Active substance: RISPERIDONE

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Document reference: 35423

Study title: The long-term safety and efficacy of Risperdal® in conduct disorders in mild, moderate and borderline mentally retarded children- a follow up trial of RIS-INT-41

Active substance: RISPERIDONE

Study summary document link (including results): RIS-INT-41_Interventional_Risperidone.xls

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Document reference: 35424

Study title: The safety and efficacy of open-label risperidone in conduct disorder in mild, moderate and borderline mentally retarded children aged 5 to 12 years.

Active substance: RISPERIDONE

Study summary document link (including results): RIS-USA-97_Interventional_Risperidone.xls

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Document reference: 35431

Study title: A study for investigating the growth in patients with skeletal dysplasia. An extension of wider indications.

Active substance: Somatropin

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Document reference: 41804

Study title: A STUDY OF BIOSYNTHETIC HUMAN GROWTH HORMONE (GENOTROPIN) IN TURNER'S SYNDROME.

Active substance: Somatropin

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Document reference: 41738

Study title: A STUDY OF FACTORS DETERMINING GROWTH IN A POPULATION OF SHORT SLOWLY OR NORMALLY GROWING CHILDREN AND POTENTIAL MANAGEMENT OPTIONS INCLUDING GROWTH HORMONE

Active substance: Somatropin

Study summary document link (including results): 88-007 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41736

Study title: A STUDY OF THE EFFICACY AND SAFETY OF GENOTONORM (REGISTERED) IN SHORT STATURE PATIENTS WITH A HISTORY OF INTRAUTERINE GROWTH RETARDATION. A TWO-YEAR, OPEN RANDOMIZED STUDY. GENETICMOLECULAR AND BIOCHEMICALHORMONONAL EVALUATION

Active substance: Somatropin

Study summary document link (including results): 307-MET-0021-003 PhRMA Web Synopsis .pdf

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Document reference: 41643

Study title: A study to compare Safety and Effect on Final Height of two different models of treating Growth Retardation with Norditropin PenSet 12/24 in Turner´s Syndrome

Active substance: Somatropin

Study summary document link (including results): GHTUR-ROV-2-CRO..MAC_Norditropin.pdf

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Document reference: 41771

Study title: A study to compare Safety and Effect on Final Height of two different models of treating Growth Retardation with Norditropin PenSet 12/24 in Turner´s Syndrome

Active substance: Somatropin

Study summary document link (including results): GHTUR-ROV-2-SK_Norditropin.pdf

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Document reference: 41772

Study title: A study to evaluate the effectivity and safety of introducing biosynthetic human growth hormone (Norditropin PenSet) for treatment of children with growth hormone deficiency in Bulgaria

Active substance: Somatropin

Study summary document link (including results): GHD-ROV-5-BU_Norditropin.pdf

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Document reference: 41760

Study title: A two week convenience study of EcoQuick

Active substance: Somatropin

Study summary document link (including results): 93-0352-001 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41748

Study title: A Two-Week Functionality and Patient Perception Study of Genotropin MiniQuick

Active substance: Somatropin

Study summary document link (including results): 94-0351-003 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41674

Study title: A Two-Week Functionality and Patient Perception Study of Genotropin MiniQuick

Active substance: Somatropin

Study summary document link (including results): 94-0351-001 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41675

Study title: Abschlussbericht über die Prüfung von K41 – KB 227 bei Kindern

Active substance: TECHNETIUM (99m) TETROFOSMIN

Study summary document link (including results): Tramazoline Hydrochloride_U62-0009_synopsis.pdf

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Document reference: 21183

Study title: Fishwick NG, Krarup KC, Belton IP, Finlay DB. An audit of paediatric technetium-99m methylene diphosphonate bone scans. Br J Radiol. 1994 Jun;67(798):552-5. Fishwick NG, Krarup KC, Belton IP, Finlay DB. An audit of paediatric technetium-99m methylene diphosphonate bone scans. Br J Radiol. 1994 Jun;67(798):552-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43624

Study title: Myocardial localization of technetium-99m MDP in an infant. Fleming JC, Pysher TJ, Leonard JC. Clin Nucl Med. 1986 May;11(5):369-70. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43910

Study title: Thallium- 201 uptake in eosinophilic granuloma of the frontal bone: Comparison with Technitium- 99m-MDP imaqinq.Flores LG II, Hoshi H. Nagamachi S, Ohnishi T, Watanabe K, Fukiyama J, et al. J Nucl Med 1995; 36:107-10.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 47918

Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.

Active substance: TAMOXIFEN

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Document reference: 43181

Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.

Active substance: TAMOXIFEN

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Document reference: 43191

Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.

Active substance: TAMOXIFEN

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Document reference: 43201

Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.

Active substance: TAMOXIFEN

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Document reference: 43215

Study title: Cassidy JT; Drugs 1999 Nov; 58 (5): 831-850 Medical Management of Children with Juvenile Rheumatoid ArthritisCassidy JT; Drugs 1999 Nov; 58 (5): 831-850 Medical Management of Children with Juvenile Rheumatoid Arthritis

Active substance: SULFASALAZINE

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Document reference: 42881

Study title: Walter MA, Melzer RA, Schindler C, Müller-Brand J, Tyndall A, Nitzsche EU.. Epub 2005 Mar 4. The value of [18F]FDG-PET in the diagnosis of large-vessel vasculitis and the assessment of activity and extent of disease. [walter-2005]Eur J Nucl Med Mol Imaging. 2005 Jun;32(6):674-81. Walter MA 2005

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48709

Study title: Rett A. Die Obstipaton als Klinisch-terapeutishes Problem hirngeschädigter Kinder. Therapeutische Umschau 1996:23:165-169, Rett A. Die Obstipaton als Klinisch-terapeutishes Problem hirngeschädigter Kinder. Therapeutische Umschau 1996:23:165-169,

Active substance: SODIUM CITRATE SODIUM LAURYL SULFOACETATE

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Document reference: 42234

Study title: Strauss P. Die Behandlung der kindlichen Obstipation unter Verwendung eies neuen Mikroklistiers. Deut Med J 1965:16:476-478 Strauss P. Die Behandlung der kindlichen Obstipation unter Verwendung eies neuen Mikroklistiers. Deut Med J 1965:16:476-478

Active substance: SODIUM CITRATE SODIUM LAURYL SULFOACETATE

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Document reference: 42235

Study title: A 2-year report on caries prevention by fluoride varnishes in a community with fluoridated water.

Active substance: SODIUM FLUORIDE

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Document reference: 42417

Study title: A 2-year report on caries prevention by fluoride varnishes in a community with fluoridated water.

Active substance: SODIUM FLUORIDE

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Document reference: 42419

Study title: A 2-year report on caries prevention by fluoride varnishes in a community with fluoridated water.

Active substance: SODIUM FLUORIDE

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Document reference: 42530

Study title: A 2-year report on caries prevention by fluoride varnishes in a community with fluoridated water.

Active substance: SODIUM FLUORIDE

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Document reference: 42532

Study title: A 24-month study comparing sealant and fluoride varnish in caries reduction on different permanent first molar surfaces.

Active substance: SODIUM FLUORIDE

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Document reference: 42346

Study title: A 24-month study comparing sealant and fluoride varnish in caries reduction on different permanent first molar surfaces.

Active substance: SODIUM FLUORIDE

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Document reference: 42459

Study title: A clinical estimation of the fluoride used during application of a fluoride varnish.

Active substance: SODIUM FLUORIDE

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Document reference: 42408

Study title: A clinical estimation of the fluoride used during application of a fluoride varnish.

Active substance: SODIUM FLUORIDE

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Document reference: 42521

Study title: A cluster randomised controlled trial to evaluate the effectiveness of fluoride varnish as a public health measure to reduce caries in children.

Active substance: SODIUM FLUORIDE

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Document reference: 42363

Study title: A cluster randomised controlled trial to evaluate the effectiveness of fluoride varnish as a public health measure to reduce caries in children.

Active substance: SODIUM FLUORIDE

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Document reference: 42476

Study title: A combined application of ART-fluoride varnish for immigrant junior field-workers: 12-months follow-up field trial in rural Anatolia.

Active substance: SODIUM FLUORIDE

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Document reference: 42356

Study title: Relationship between caries and fluoride uptake by enamel from two fluoride varnishes in a community with fluoridated water.

Active substance: SODIUM FLUORIDE

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Document reference: 42531

Study title: Results of a 32-month fluoride varnish study in Sherbrooke and Lac-Megantic, Canada.

Active substance: SODIUM FLUORIDE

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Document reference: 42353

Study title: Results of a 32-month fluoride varnish study in Sherbrooke and Lac-Megantic, Canada.

Active substance: SODIUM FLUORIDE

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Document reference: 42466

Study title: Results of a promising open trial to prevent baby bottle tooth decay: a fluoride varnish study.

Active substance: SODIUM FLUORIDE

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Document reference: 42439

Study title: Results of a promising open trial to prevent baby bottle tooth decay: a fluoride varnish study.

Active substance: SODIUM FLUORIDE

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Document reference: 42552

Study title: Results of the combined use of remodent and fluorine lacquer for dental caries prevention in preschoolers]

Active substance: SODIUM FLUORIDE

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Document reference: 42433

Study title: Results of the combined use of remodent and fluorine lacquer for dental caries prevention in preschoolers]

Active substance: SODIUM FLUORIDE

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Document reference: 42546

Study title: Review of the anticaries effectiveness of professionally applied and self-applied topical fluoride gels.

Active substance: SODIUM FLUORIDE

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Document reference: 42407

Study title: National Poisons Information Service Center, United Kingdom. Poison Information Monograph: Camphor, 1996

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40230

Study title: Plant-induced seizures: reappearance of an old problem, Burkhard, P.R., J.Neurol. 199; 246 (8): 667-670

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40242

Study title: Reports of Postmarketing Experience, Post Authorisation safety study, Tavipec capsules, Panosch, B., 2007

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40231

Study title: A small risk canot be excluded, but a high risk of congenital anomalies in the children of women who are treated with spiramycin during pregnancy is unlikely (article retrieved from Micromedx online database)

Active substance: SPIRAMYCIN

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Document reference: 42585

Study title: Clinical Expert Report - Rovamycin syrup - J. Paupe - May 22nd, 1980Clinical Expert Report - Rovamycin syrup - J. Paupe - May 22nd, 1980

Active substance: SPIRAMYCIN

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Document reference: 42576

Study title: Clinical view of toxoplasmosis in children - personal observations - Czarnecka-Rudnik D, Stanek-Bazylko F. - Pol Merkuriusz Lek 1997 May; 2(11):237-30Clinical view of toxoplasmosis in children - personal observations - Czarnecka-Rudnik D, Stanek-Bazylko F. - Pol Merkuriusz Lek 1997 May; 2(11):237-30

Active substance: SPIRAMYCIN

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Document reference: 42586

Study title: Compared Biodisponibility in human - Rovamycin Syrup 0,375 MUI - J. Gaillot - August 26, 1976Compared Biodisponibility in human - Rovamycin Syrup 0,375 MUI - J. Gaillot - August 26, 1976

Active substance: SPIRAMYCIN

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Document reference: 42577

Study title: Etude Clinique Nationale de la Rovamycin Sirop - J.R. Paupe - 1980 - RPR FileEtude Clinique Nationale de la Rovamycin Sirop - J.R. Paupe - 1980 - RPR File

Active substance: SPIRAMYCIN

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Document reference: 42578

Study title: Expert Clinical Assessment - Rovamycine 1.5 M.I.U. - Freeze-dried preparation and solution for slow intravenous injection - F. Vachon - March 1985Expert Clinical Assessment - Rovamycine 1.5 M.I.U. - Freeze-dried preparation and solution for slow intravenous injection - F. Vachon - March 1985

Active substance: SPIRAMYCIN

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Document reference: 42579

Study title: Fetal Toxoplasmosis: Outcome of Pregnancy and Infant Follow-Up After In Utero Treatment.Hohlfeld P; Daffos F; Thulliez P; Aufrant C; Couvreur J; MacAleese J J.Pediatr. 115, No. 5, Pt. 1, 765-69, 1989

Active substance: SPIRAMYCIN

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Document reference: 42587

Study title: Intérêt de la Rovamycine Sirop en pédiatrie - H. Batellier, PS Jouk - 1982 (Tome XIII N° 1)

Active substance: SPIRAMYCIN

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Document reference: 42580

Study title: QT interval prolongation and cardiac arrest during antibiotic therapy with spiramycin in a newbron child - Stramba-Badiale et al in American Heart Jounal 1993, vol 126, number 3, part I

Active substance: SPIRAMYCIN

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Document reference: 42588

Study title: A combined application of ART-fluoride varnish for immigrant junior field-workers: 12-months follow-up field trial in rural Anatolia.

Active substance: SODIUM FLUORIDE

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Document reference: 42469

Study title: A polarized light and scanning electron microscope study of the effect of Duraphat treatment on in vivo caries.

Active substance: SODIUM FLUORIDE

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Document reference: 42370

Study title: A polarized light and scanning electron microscope study of the effect of Duraphat treatment on in vivo caries.

Active substance: SODIUM FLUORIDE

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Document reference: 42483

Study title: A review on fluoride varnishes: an alternative topical fluoride treatment.

Active substance: SODIUM FLUORIDE

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Document reference: 42352

Study title: A review on fluoride varnishes: an alternative topical fluoride treatment.

Active substance: SODIUM FLUORIDE

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Document reference: 42465

Study title: Acceptability and tolerability of the new liquid Norditropin® SimpleXx® formulation in combination with the new pen system NordiPenTM, with or without NordiPenmateTM: An open multicentre trial in adults and children with Growth Hormone Deficiency and chi

Active substance: Somatropin

Study summary document link (including results): GHLiquid-1230_Norditropin.pdf

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Document reference: 41814

Study title: A study for investigating the growth in patients with skeletal dysplasia.

Active substance: Somatropin

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Document reference: 41805

Study title: An Exploratory, phase 2, open, two-arm, match-control, randomised and stratified pilot study assessing the prevention of the adverse effects of long-term high-dose glucocorticoid therapy by Growth Hormone (NutropinAq) administered by sub-cutaneous route i

Active substance: Somatropin

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Document reference: 41754

Study title: Etude de la biodisponibilité relative de la suspension à 10 pour cent par rapport au comprimé dose à 500 mg (formulation de référence) chez le sujet jeune en bonne santé - MM. A. Le Liboux, G. Montay, A. Frydman et J. Gaillot - No date

Active substance: SECNIDAZOLE

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Document reference: 42120

Study title: Evaluation de l'efficacité et de la tolérance d'une suspension de secnidazole dans le traitement de la dysentrie ambienne aiguë non compliquée chez l'enfant - Dr F. Djebbar - No date

Active substance: SECNIDAZOLE

Study summary document link (including results): Secnidazole STUDY SZ8002.xls

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Document reference: 42114

Study title: Evaluation of the efficacy and safety of a single dose of secnidazole suspension (30 mg/kg) in the treatment of giardiasis in children - Dr Cimerman, Dr Katz, Dr Zingano - 1988 (registration dossier)

Active substance: SECNIDAZOLE

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Document reference: 42115

Study title: Evaluation of the efficacy and tolerance of a suspension of secnidazole in the treatment of acute uncomplicated amoebic dysentery in children (Study n° SZ 80002) - Dr J.M. Cardo-Salles, Dr Tall, Bobo Di Oulasso, Dr Josseran, Prof R. Lenoble - 1987 to 1988 (registration dossier)

Active substance: SECNIDAZOLE

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Document reference: 42116

Study title: RP 14539 - Comparative acute oral toxicity of secnidazole in juvenil rats aged 4 weeks and in rats aged 8 weeks - André S., Curaudeau A., Caillaud J.M., Boddaert A. Mazuret A. & Cordier A. - 1989 (Rapport ST/CRV/Tox. N° 254)

Active substance: SECNIDAZOLE

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Document reference: 42117

Study title: Secnidazole paediatric granules in amoebiasis / giardiasis

Active substance: SECNIDAZOLE

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Document reference: 42118

Study title: Study of the relative bioavailability of the 10 % suspension in relation to the tablet each containing 500 mg (reference formulation) in the young healthy subject - A. Le Liboux, G. Montay, A. Frydman and J. Gaillot - 1987 (registration dossier)

Active substance: SECNIDAZOLE

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Document reference: 42119

Study title: Prospective multicentric observational study/long term use

Active substance: Sedacur forte; 1 coated tablet contains: 75 mg valerian root dry extract (5-6:1) (extractive agent: ethanol 70% (v/v)), 23 mg hop strobile dry extract (4-8:1) (extractive agent: methanol 40% (v/v)), 45 mg balm leaves dry extract (4-6:1) (extractive agent: purified water) Sedacur forte Beruhigungsdragees; 1 coated tablet contains: 75 mg valerian root dry extract (5-6:1) (extractive agent: et...

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Document reference: 39756

Study title: Prospective observational study

Active substance: Sedacur forte; 1 coated tablet contains: 75 mg valerian root dry extract (5-6:1) (extractive agent: ethanol 70% (v/v)), 23 mg hop strobile dry extract (4-8:1) (extractive agent: methanol 40% (v/v)), 45 mg balm leaves dry extract (4-6:1) (extractive agent: purified water) Sedacur forte Beruhigungsdragees; 1 coated tablet contains: 75 mg valerian root dry extract (5-6:1) (extractive agent: et...

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Document reference: 39757

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Selenium-Homaccord (drops) [AWB-AT]

Active substance: Selenium-Homaccord/Selenium-Homaccord - Tropfen

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Document reference: 40190

Study title: Strauss, Leon Christiaan: The Efficacy of a homeopathic Preparation in the Management of Attention Deficit Hyperactivity Disorder. Biol Ther 2000 (18):197-201 [IIT-publication]

Active substance: Selenium-Homaccord/Selenium-Homaccord - Tropfen

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Document reference: 40189

Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.

Active substance: TAMOXIFEN

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Document reference: 43225

Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.

Active substance: TAMOXIFEN

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Document reference: 43235

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.

Active substance: TAMOXIFEN

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Document reference: 43219

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.

Active substance: TAMOXIFEN

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Document reference: 43229

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.

Active substance: TAMOXIFEN

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Document reference: 43239

Study title: Review of the anticaries effectiveness of professionally applied and self-applied topical fluoride gels.

Active substance: SODIUM FLUORIDE

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Document reference: 42520

Study title: Relationship between caries and fluoride uptake by enamel from two fluoride varnishes in a community with fluoridated water.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42418

Study title: Sealant and fluoride varnish in caries: a randomized trial.

Active substance: SODIUM FLUORIDE

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Document reference: 42347

Study title: Sealant and fluoride varnish in caries: a randomized trial.

Active substance: SODIUM FLUORIDE

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Document reference: 42460

Study title: Stephen KW, Campbell D. Caries reduction and cost benefit after 3 years of sucking fluoride tablets daily at school: a double-blind trail. Br Dent J 1978; 144: 202-206.Stephen KW, Campbell D. Caries reduction and cost benefit after 3 years of sucking fluoride tablets daily at school: a double-blind trail. Br Dent J 1978; 144: 202-206.

Active substance: SODIUM FLUORIDE

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Document reference: 42268

Study title: Stephen KW, Campbell D. Caries reduction and cost benefit after 3 years of sucking fluoride tablets daily at school: a double-blind trail. Br Dent J 1978; 144: 202-206.Stephen KW, Campbell D. Caries reduction and cost benefit after 3 years of sucking fluoride tablets daily at school: a double-blind trail. Br Dent J 1978; 144: 202-206.

Active substance: SODIUM FLUORIDE

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Document reference: 42300

Study title: Stephen KW, Campbell D. Caries reduction and cost benefit after 3 years of sucking fluoride tablets daily at school: a double-blind trail. Br Dent J 1978; 144: 202-206.Stephen KW, Campbell D. Caries reduction and cost benefit after 3 years of sucking fluoride tablets daily at school: a double-blind trail. Br Dent J 1978; 144: 202-206.

Active substance: SODIUM FLUORIDE

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Document reference: 42332

Study title: Strübig W, Aeckerle-Witten B, Lange-v.d. Burchard G. Karies-statische Ergebnisse nach 2-jähriger Tabletten­fluoridierung. Öff Gesundheitswesen 1982; 44: 462-.Strübig W, Aeckerle-Witten B, Lange-v.d. Burchard G. Karies-statische Ergebnisse nach 2-jähriger Tabletten­fluoridierung. Öff Gesundheitswesen 1982; 44: 462-.

Active substance: SODIUM FLUORIDE

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Document reference: 42269

Study title: Strübig W, Aeckerle-Witten B, Lange-v.d. Burchard G. Karies-statische Ergebnisse nach 2-jähriger Tabletten­fluoridierung. Öff Gesundheitswesen 1982; 44: 462-.Strübig W, Aeckerle-Witten B, Lange-v.d. Burchard G. Karies-statische Ergebnisse nach 2-jähriger Tabletten­fluoridierung. Öff Gesundheitswesen 1982; 44: 462-.

Active substance: SODIUM FLUORIDE

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Document reference: 42301

Study title: Widenheim J, Birkhed D, Granath L et al. Pre-eruptive effect of NaF tablets on caries in children from 12 to 17 years of age. Community Dent Oral Epidemiolog 1986, 14: 1-4.Widenheim J, Birkhed D, Granath L et al. Pre-eruptive effect of NaF tablets on caries in children from 12 to 17 years of age. Community Dent Oral Epidemiolog 1986, 14: 1-4.

Active substance: SODIUM FLUORIDE

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Document reference: 42303

Study title: Widenheim J, Birkhed D, Granath L et al. Pre-eruptive effect of NaF tablets on caries in children from 12 to 17 years of age. Community Dent Oral Epidemiolog 1986, 14: 1-4.Widenheim J, Birkhed D, Granath L et al. Pre-eruptive effect of NaF tablets on caries in children from 12 to 17 years of age. Community Dent Oral Epidemiolog 1986, 14: 1-4.

Active substance: SODIUM FLUORIDE

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Document reference: 42335

Study title: Widenheim J, Petersson LG, Koch G. Fluorine concentration in primary tooth enamel in 6-year-olds after 3 years of daily intake of fluoride-containing tablets (Fludent). Swed Dent J. 1984;8(4):203-7.Widenheim J, Petersson LG, Koch G. Fluorine concentration in primary tooth enamel in 6-year-olds after 3 years of daily intake of fluoride-containing tablets (Fludent). Swed Dent J. 1984;8(4):203-7.

Active substance: SODIUM FLUORIDE

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Document reference: 42240

Study title: Aasenden R, Peebles TC. Effects of fluoride supplementation from birth on human deciduous and permanent teeth. Arch Oral Biol 1974; 19: 321-326.Aasenden R, Peebles TC. Effects of fluoride supplementation from birth on human deciduous and permanent teeth. Arch Oral Biol 1974; 19: 321-326.

Active substance: SODIUM FLUORIDE

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Document reference: 42241

Study title: Aasenden R, Peebles TC. Effects of fluoride supplementation from birth on human deciduous and permanent teeth. Arch Oral Biol 1974; 19: 321-326.Aasenden R, Peebles TC. Effects of fluoride supplementation from birth on human deciduous and permanent teeth. Arch Oral Biol 1974; 19: 321-326.

Active substance: SODIUM FLUORIDE

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Document reference: 42273

Study title: Aasenden R, Peebles TC. Effects of fluoride supplementation from birth on human deciduous and permanent teeth. Arch Oral Biol 1974; 19: 321-326.Aasenden R, Peebles TC. Effects of fluoride supplementation from birth on human deciduous and permanent teeth. Arch Oral Biol 1974; 19: 321-326.

Active substance: SODIUM FLUORIDE

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Document reference: 42305

Study title: Allmark C, Green HP, Linney et al. A community study of fluoride tablets for schoolchildren in Portsmouth. Results after six years. Br Dent J 1982; 153: 426-430.Allmark C, Green HP, Linney et al. A community study of fluoride tablets for schoolchildren in Portsmouth. Results after six years. Br Dent J 1982; 153: 426-430.

Active substance: SODIUM FLUORIDE

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Document reference: 42249

Study title: Allmark C, Green HP, Linney et al. A community study of fluoride tablets for schoolchildren in Portsmouth. Results after six years. Br Dent J 1982; 153: 426-430.Allmark C, Green HP, Linney et al. A community study of fluoride tablets for schoolchildren in Portsmouth. Results after six years. Br Dent J 1982; 153: 426-430.

Active substance: SODIUM FLUORIDE

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Document reference: 42281

Study title: Allmark C, Green HP, Linney et al. A community study of fluoride tablets for schoolchildren in Portsmouth. Results after six years. Br Dent J 1982; 153: 426-430.Allmark C, Green HP, Linney et al. A community study of fluoride tablets for schoolchildren in Portsmouth. Results after six years. Br Dent J 1982; 153: 426-430.

Active substance: SODIUM FLUORIDE

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Document reference: 42313

Study title: Andersson R, Grahnen H. Fluoride tablets in pre-school age – effect on primary and permanet teeth. Swed Dent J 1976; 69: 137-143.Andersson R, Grahnen H. Fluoride tablets in pre-school age – effect on primary and permanet teeth. Swed Dent J 1976; 69: 137-143.

Active substance: SODIUM FLUORIDE

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Document reference: 42242

Study title: Andersson R, Grahnen H. Fluoride tablets in pre-school age – effect on primary and permanet teeth. Swed Dent J 1976; 69: 137-143.Andersson R, Grahnen H. Fluoride tablets in pre-school age – effect on primary and permanet teeth. Swed Dent J 1976; 69: 137-143.

Active substance: SODIUM FLUORIDE

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Document reference: 42274

Study title: Andersson R, Grahnen H. Fluoride tablets in pre-school age – effect on primary and permanet teeth. Swed Dent J 1976; 69: 137-143.Andersson R, Grahnen H. Fluoride tablets in pre-school age – effect on primary and permanet teeth. Swed Dent J 1976; 69: 137-143.

Active substance: SODIUM FLUORIDE

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Document reference: 42306

Study title: Strübig W, Aeckerle-Witten B, Lange-v.d. Burchard G. Karies-statische Ergebnisse nach 2-jähriger Tabletten­fluoridierung. Öff Gesundheitswesen 1982; 44: 462-.Strübig W, Aeckerle-Witten B, Lange-v.d. Burchard G. Karies-statische Ergebnisse nach 2-jähriger Tabletten­fluoridierung. Öff Gesundheitswesen 1982; 44: 462-.

Active substance: SODIUM FLUORIDE

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Document reference: 42333

Study title: Strübig W, Gülzow HJ. Die Abhängigkeit des Fluoridgehaltes im Zahnschmelz von regelmäßiger oder unkontrollierter Fluoridaufnahme. Dtsch zahnärztl Z 1979; 34: 172-175Strübig W, Gülzow HJ. Die Abhängigkeit des Fluoridgehaltes im Zahnschmelz von regelmäßiger oder unkontrollierter Fluoridaufnahme. Dtsch zahnärztl Z 1979; 34: 172-175

Active substance: SODIUM FLUORIDE

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Document reference: 42270

Study title: A double blind clinical study of Serrapeptidase enteric coated granule capsule in the treatment of asthmatic bronchitis in children [E. Oka, Y. Kojima, et al., Medical Consultation & New Remedies, Vol 5, 1 (1968)]A double blind clinical study of Serrapeptidase enteric coated granule capsule in the treatment of asthmatic bronchitis in children [E. Oka, Y. Kojima, et al., Medical Consultation & New Remedies, Vol 5, 1 (1968)]

Active substance: SERRAPEPTASE

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Document reference: 42124

Study title: Prophylaxis of postoperative swellings in gnathic surgery: Administration of ice versus serrapeptase

Active substance: SERRAPEPTASE

Study summary document link (including results): 2011-08-30 Serrapeptase AN21 synopsis.pdf

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Document reference: 42122

Study title: Serrapeptase vs. Diclofenac - Postoperative treatment of children. Controlled study. (Comparative study)

Active substance: SERRAPEPTASE

Study summary document link (including results): 2011-08-30 Serrapeptase AN02_89 Synopsis.pdf

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Document reference: 42121

Study title: De Liefde B, Herbison GP. Prevalence of developmental defects of enamel and denatl caries in New Zealand children receiving differing fluoride supplementation. Community Dent Oral Epidemiol 1985; 13: 164-167De Liefde B, Herbison GP. Prevalence of developmental defects of enamel and denatl caries in New Zealand children receiving differing fluoride supplementation. Community Dent Oral Epidemiol 1985; 13: 164-167

Active substance: SODIUM FLUORIDE

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Document reference: 42243

Study title: De Liefde B, Herbison GP. Prevalence of developmental defects of enamel and denatl caries in New Zealand children receiving differing fluoride supplementation. Community Dent Oral Epidemiol 1985; 13: 164-167De Liefde B, Herbison GP. Prevalence of developmental defects of enamel and denatl caries in New Zealand children receiving differing fluoride supplementation. Community Dent Oral Epidemiol 1985; 13: 164-167

Active substance: SODIUM FLUORIDE

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Document reference: 42275

Study title: De Liefde B, Herbison GP. Prevalence of developmental defects of enamel and denatl caries in New Zealand children receiving differing fluoride supplementation. Community Dent Oral Epidemiol 1985; 13: 164-167De Liefde B, Herbison GP. Prevalence of developmental defects of enamel and denatl caries in New Zealand children receiving differing fluoride supplementation. Community Dent Oral Epidemiol 1985; 13: 164-167

Active substance: SODIUM FLUORIDE

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Document reference: 42307

Study title: DePaola PF, Lax M. the caries-inhibiting effect of acidulated phosphate-fluoride chewable tablets: a two-year double-blind study. J Dent Assoc 1968; 76: 554-557.DePaola PF, Lax M. the caries-inhibiting effect of acidulated phosphate-fluoride chewable tablets: a two-year double-blind study. J Dent Assoc 1968; 76: 554-557.

Active substance: SODIUM FLUORIDE

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Document reference: 42253

Study title: DePaola PF, Lax M. the caries-inhibiting effect of acidulated phosphate-fluoride chewable tablets: a two-year double-blind study. J Dent Assoc 1968; 76: 554-557.DePaola PF, Lax M. the caries-inhibiting effect of acidulated phosphate-fluoride chewable tablets: a two-year double-blind study. J Dent Assoc 1968; 76: 554-557.

Active substance: SODIUM FLUORIDE

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Document reference: 42285

Study title: DePaola PF, Lax M. the caries-inhibiting effect of acidulated phosphate-fluoride chewable tablets: a two-year double-blind study. J Dent Assoc 1968; 76: 554-557.DePaola PF, Lax M. the caries-inhibiting effect of acidulated phosphate-fluoride chewable tablets: a two-year double-blind study. J Dent Assoc 1968; 76: 554-557.

Active substance: SODIUM FLUORIDE

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Document reference: 42317

Study title: Discroll WS, Heifetz SB, Brunelle JA. Caries-preventive effects of fluoride tablets in schoolchildren four years after discontinuation of treatments. J Am Dent Assoc 1981; 103: 878-881.Discroll WS, Heifetz SB, Brunelle JA. Caries-preventive effects of fluoride tablets in schoolchildren four years after discontinuation of treatments. J Am Dent Assoc 1981; 103: 878-881.

Active substance: SODIUM FLUORIDE

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Document reference: 42254

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.

Active substance: TAMOXIFEN

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Document reference: 43249

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515.

Active substance: TAMOXIFEN

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Document reference: 43313

Study title: Ben Ami T, Treves ST, Tumeh S, Cox-Bryan J, McCarthy C. Stress fractures after surgery for osteosarcoma: scintigraphic assessment. Radiology. 1987 Apr;163(1):157-62. Ben Ami T, Treves ST, Tumeh S, Cox-Bryan J, McCarthy C. Stress fractures after surgery for osteosarcoma: scintigraphic assessment. Radiology. 1987 Apr;163(1):157-62.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43869

Study title: Bennett RJ, Grennan DM, Johns CW, Taylor L, Brown JD. A comparative evaluation of thermography and scintigraphy in the assessment of sacroiliitis. Int J Nucl Med Biol. 1984;11(1):42-5. No abstract available. Bennett RJ, Grennan DM, Johns CW, Taylor L, Brown JD. A comparative evaluation of thermography and scintigraphy in the assessment of sacroiliitis. Int J Nucl Med Biol. 1984;11(1):42-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44014

Study title: Benz-Bohm G, Georgi P. [Scintigraphic and radiographic findings in eosinophilic granuloma (author's transl)] Radiologe. 1981 Apr;21(4):195-8. German. Benz-Bohm G, Georgi P. [Scintigraphic and radiographic findings in eosinophilic granuloma (author's transl)] Radiologe. 1981 Apr;21(4):195-8. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44128

Study title: Berding G, Schliephake H, Neumann G, Schmelzeisen R, Neukam FW, Meyer GJ, Gratz KF, Hundeshagen H. [Bone SPECT of the jaws after fracture, onlay osteoplasty of insertion of implants] Nuklearmedizin. 1996 Oct;35(5):156-63. German. Berding G, Schliephake H, Neumann G, Schmelzeisen R, Neukam FW, Meyer GJ, Gratz KF, Hundeshagen H. [Bone SPECT of the jaws after fracture, onlay osteoplasty of insertion of implants] Nuklearmedizin. 1996 Oct;35(5):156-63. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43559

Study title: Bereiter H, Hedström SA, Lidgren L. [Skeletal scintigraphy as early diagnostic aid in acute haematogenous osteomyelitis in the iliosacral joint (author's transl)] Z Orthop Ihre Grenzgeb. 1981 Aug;119(4):364-5. German. Bereiter H, Hedström SA, Lidgren L. [Skeletal scintigraphy as early diagnostic aid in acute haematogenous osteomyelitis in the iliosacral joint (author's transl)] Z Orthop Ihre Grenzgeb. 1981 Aug;119(4):364-5. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44114

Study title: Widenheim J, Petersson LG, Koch G. Fluorine concentration in primary tooth enamel in 6-year-olds after 3 years of daily intake of fluoride-containing tablets (Fludent). Swed Dent J. 1984;8(4):203-7.Widenheim J, Petersson LG, Koch G. Fluorine concentration in primary tooth enamel in 6-year-olds after 3 years of daily intake of fluoride-containing tablets (Fludent). Swed Dent J. 1984;8(4):203-7.

Active substance: SODIUM FLUORIDE

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Document reference: 42272

Study title: Widenheim J, Petersson LG, Koch G. Fluorine concentration in primary tooth enamel in 6-year-olds after 3 years of daily intake of fluoride-containing tablets (Fludent). Swed Dent J. 1984;8(4):203-7.Widenheim J, Petersson LG, Koch G. Fluorine concentration in primary tooth enamel in 6-year-olds after 3 years of daily intake of fluoride-containing tablets (Fludent). Swed Dent J. 1984;8(4):203-7.

Active substance: SODIUM FLUORIDE

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Document reference: 42304

Study title: Treatment with sodium oxybate in a child with thalamic lesions suffering from insomnia, sleep fragmentation, and severe attentional and behavioral dysregulation.

Active substance: sodium oxybate

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Document reference: 41613

Study title: Estudio prospectivo para evaluar la seguridad y tolerabilidad del Enema Casen en pacientes pediátricos

Active substance: SODIUM PHOSPHATE

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Document reference: 42561

Study title: Clinical report on Laxoberal for registration Documentation in Italy

Active substance: SODIUM PICOPSULPHATE

Study summary document link (including results): Sodium Picosulfate_U66-0190_synopsis.pdf

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Document reference: 47462

Study title: Effects of sodium picosulfate on pediatric constipation. Judgement of effects by double blind test.

Active substance: SODIUM PICOPSULPHATE

Study summary document link (including results): Sodium Picosulfate_U73-0409_synopsis.pdf

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Document reference: 47463

Study title: Use of Laxoberal in paediatric patients

Active substance: SODIUM PICOPSULPHATE

Study summary document link (including results): Sodium Picosulfate_U80-0501_synopsis.pdf

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Document reference: 47464

Study title: A study to test the efficacy of E45 Cream on nappy rash

Active substance: SOFT PARAFFIN

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Document reference: 42563

Study title: Multicentre open clinical trial, in parallel groups, on the value of Oleatum emollient oil in the treatment of atopic eczema with topical corticosteroid therapy (Betamethasone-17-Valerate).

Active substance: SOFT PARAFFIN

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Document reference: 42564

Study title: Use test Tolerance in use study in children with shower products for dry skin or skin prone to Eczema.

Active substance: SOFT PARAFFIN

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Document reference: 42562

Study title: Holoshina T.V., Opatsa I.A.:Alternative approaches to treat children suffering from nocturnal enuresis. Biological Therapy (Ukraine), 2003, 3: 21-26 [IIT-publication]

Active substance: Solidago compositum-Heel - Ampullen

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Document reference: 40199

Study title: Camphor, Sweetman, S.C., Martindale, The complete drug reference, 33 edition, Pharmaceutical Press, 1589-1590.

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40227

Study title: Camphora (Campher), Monographie BGA/BfArM (Komission E), 1984, Heftnummer 228

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40228

Study title: Clinical effects and management of eucalyptus oil ingestion in infants and young children, Tibballs, J., Med. J. Aust. 1995; 163: 177-180

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40232

Study title: Clinical Toxicology of Commercial Products. 5th ed. Baltimore: Williams and Wilkins, 1984, p.III-85, Gosselin, R.E.

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40238

Study title: Myrtol standardized in the treatment of acute and chronic respiratory infections in children. A multicenter post-marketing surveillance study. Sengespeik HC et al., Arzneimittelforschung, 1998: 990-4.

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40234

Study title: Strübig W, Gülzow HJ. Die Abhängigkeit des Fluoridgehaltes im Zahnschmelz von regelmäßiger oder unkontrollierter Fluoridaufnahme. Dtsch zahnärztl Z 1979; 34: 172-175Strübig W, Gülzow HJ. Die Abhängigkeit des Fluoridgehaltes im Zahnschmelz von regelmäßiger oder unkontrollierter Fluoridaufnahme. Dtsch zahnärztl Z 1979; 34: 172-175

Active substance: SODIUM FLUORIDE

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Document reference: 42302

Study title: Strübig W, Gülzow HJ. Die Abhängigkeit des Fluoridgehaltes im Zahnschmelz von regelmäßiger oder unkontrollierter Fluoridaufnahme. Dtsch zahnärztl Z 1979; 34: 172-175Strübig W, Gülzow HJ. Die Abhängigkeit des Fluoridgehaltes im Zahnschmelz von regelmäßiger oder unkontrollierter Fluoridaufnahme. Dtsch zahnärztl Z 1979; 34: 172-175

Active substance: SODIUM FLUORIDE

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Document reference: 42334

Study title: Studies of fluoride varnishes in Finland.

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42422

Study title: Studies of fluoride varnishes in Finland.

Active substance: SODIUM FLUORIDE

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Document reference: 42535

Study title: The caries-preventive effect of a fluoride varnish in the fissures of the first permanent molar.

Active substance: SODIUM FLUORIDE

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Document reference: 42482

Study title: The caries-protective efficacy of 2 fluoride varnishes in a 2-year controlled clinical trial

Active substance: SODIUM FLUORIDE

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Document reference: 42343

Study title: The caries-protective efficacy of 2 fluoride varnishes in a 2-year controlled clinical trial

Active substance: SODIUM FLUORIDE

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Document reference: 42456

Study title: The clinical effect of application of a urethane lacquer containing silane fluorine. A one-year study.

Active substance: SODIUM FLUORIDE

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Document reference: 42376

Study title: The clinical effect of application of a urethane lacquer containing silane fluorine. A one-year study.

Active substance: SODIUM FLUORIDE

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Document reference: 42489

Study title: The clinical effect of application of fluoride varnish.

Active substance: SODIUM FLUORIDE

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Document reference: 42438

Study title: The clinical effect of application of fluoride varnish.

Active substance: SODIUM FLUORIDE

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Document reference: 42551

Study title: The comparative efficacy of local anticaries agents][Article in Russian

Active substance: SODIUM FLUORIDE

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Document reference: 42371

Study title: The comparative efficacy of local anticaries agents][Article in Russian

Active substance: SODIUM FLUORIDE

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Document reference: 42484

Study title: The effect of Duraphat lacquer on the condition of the permanent teeth in children consuming fluoridated table salt.

Active substance: SODIUM FLUORIDE

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Document reference: 42386

Study title: The effect of Duraphat lacquer on the condition of the permanent teeth in children consuming fluoridated table salt.

Active substance: SODIUM FLUORIDE

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Document reference: 42499

Study title: The effect of five years' implementation of caries-preventive methods in Swedish high-risk adolescents.

Active substance: SODIUM FLUORIDE

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Document reference: 42372

Study title: The effect of five years' implementation of caries-preventive methods in Swedish high-risk adolescents.

Active substance: SODIUM FLUORIDE

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Document reference: 42485

Study title: The effect of prophylactic measures on the gingival health of school children.

Active substance: SODIUM FLUORIDE

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Document reference: 42345

Study title: Kaladze N.N., Titova E.V.: Antihomotoxic preparations in the combined treatment of secondary osteopenia in children suffering from chronic pyelonephritis. Therapy (Ukraine), 2007, 3: 15-19 [IIT-publication]

Active substance: Solidago compositum-Heel - Ampullen

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Document reference: 40198

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Solidago compositum S (ampoules) [AWB-AT]

Active substance: Solidago compositum-Heel - Ampullen

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Document reference: 40200

Study title: Discroll WS, Heifetz SB, Brunelle JA. Caries-preventive effects of fluoride tablets in schoolchildren four years after discontinuation of treatments. J Am Dent Assoc 1981; 103: 878-881.Discroll WS, Heifetz SB, Brunelle JA. Caries-preventive effects of fluoride tablets in schoolchildren four years after discontinuation of treatments. J Am Dent Assoc 1981; 103: 878-881.

Active substance: SODIUM FLUORIDE

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Document reference: 42286

Study title: Discroll WS, Heifetz SB, Brunelle JA. Caries-preventive effects of fluoride tablets in schoolchildren four years after discontinuation of treatments. J Am Dent Assoc 1981; 103: 878-881.Discroll WS, Heifetz SB, Brunelle JA. Caries-preventive effects of fluoride tablets in schoolchildren four years after discontinuation of treatments. J Am Dent Assoc 1981; 103: 878-881.

Active substance: SODIUM FLUORIDE

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Document reference: 42318

Study title: Comparison of intra-examiner reproducibility in scoring caries in primary teeth of two scoring systems used to monitor caries progression.

Active substance: SODIUM FLUORIDE

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Document reference: 42541

Study title: PK in adolescent subjects with rizatriptan 5 mg

Active substance: RIZATRIPTAN

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Document reference: 47417

Study title: Safety and efficacy of rizatriptan in adolescents

Active substance: RIZATRIPTAN

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Document reference: 47418

Study title: Double-blind dose-response study comparing ropivacaine 1 mg/kg, 2 mg/kg and 3 mg/kg (fixed volume of 1 mL/kg of ropivacaine solutions 1 mg/mL, 2 mg/mL and 3 mg/mL, respectively). Single caudal block. 4-12 years.

Active substance: ROPIVACAINE

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Document reference: 35453

Study title: Uncontrolled, pharmacokinetic, efficacy and safety study of ropivacaine 2 mg/kg (1 mL/kg of 2 mg/mL solution). Single caudal block. 1-8 years.

Active substance: ROPIVACAINE

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Document reference: 35452

Study title: Uncontrolled, pharmacokinetic, efficacy and safety study of ropivacaine 2 mg/kg (1 mL/kg of ropivacaine 2 mg/mL). Single caudal block. 0-12 months.

Active substance: ROPIVACAINE

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Document reference: 35455

Study title: Uncontrolled, pharmacokinetic, efficacy and safety study of ropivacaine 3 mg/kg (5 mg/mL solution). Single peripheral nerve block (ilioinguinal block). 1-12 years.

Active substance: ROPIVACAINE

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Document reference: 35454

Study title: The safety and efficacy of risperidone versus placebo in conduct disorder in mild, moderate and borderline mentally retarded children aged 5 to 12 years.

Active substance: RISPERIDONE

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Document reference: 35426

Study title: Long term safety in adolescent patients

Active substance: RIZATRIPTAN

Study summary document link (including results): EMAart45_Rizatripan.pdf

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Document reference: 47419

Study title: Uncontrolled, pharmacokinetic, efficacy and safety study using a dose rate of 0.2 mg/kg/h in 0 to 180-day-old infants and 0.4 mg/kg/h infants over 181 days old. The epidural infusion was preceeded by a bolus injection of 1-2 mg/kg (0.5-1 mL/kg of 2 mg/mL solution). Continuous epidural infusion. 0-12 months.

Active substance: ROPIVACAINE

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Document reference: 35457

Study title: Uncontrolled, pharmacokinetic, efficacy and safety study using a dose rate of 0.4 mg/kg/h preceeded by a bolus dose of 2 mg/kg (1 mL/kg of 2 mg/mL solution). Continuous epidural infusion. 1-12 years.

Active substance: ROPIVACAINE

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Document reference: 35456

Study title: A 30-Week, Forced-titration and Randomised, Crossover, Multicentre, Multinational Trial to Evaluate the Efficacy and Safety of rosuvastatin and Atorvastatin in Subjects with Homozygous Familial Hypercholesterolaemia (4522IL/0054): Full Report of the First 18 Weeks (forced-titration) and Last 12 Weeks of Treatment (crossover period) for Efficacy and for Safety

Active substance: ROSUVASTATIN CALCIUM

Study summary document link (including results): Study 4522IL0054_CSR Synopsis.pdf

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Document reference: 47886

Study title: Pharmacokinetics of Rosuvastatin in Children and Adolescents with Heterozygous Familial Hypercholesterolemia (4522IL/0086)

Active substance: ROSUVASTATIN CALCIUM

Study summary document link (including results): Study 4522IL0086_CSR Synopsis.pdf

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Document reference: 47885

Study title: 10 day oral toxicity study in the young dog - Thien - Aubert and al. - 31/12/95

Active substance: ROXYTHROMYCIN

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Document reference: 35461

Study title: 28 day oral toxicity study and recovery study of RU 28 965 in infant beagle dogs - Moriya A. And al. - 31/07/90

Active substance: ROXYTHROMYCIN

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Document reference: 35463

Study title: Bern G, Brosjö O, Jacobsson H. Uptake of Tc-99m MDP in shoulder muscle caused by the use of elbow crutches. Clin Nucl Med. 1999 Sep;24(9):691-2. No abstract available. Bern G, Brosjö O, Jacobsson H. Uptake of Tc-99m MDP in shoulder muscle caused by the use of elbow crutches. Clin Nucl Med. 1999 Sep;24(9):691-2. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43499

Study title: Bhattacharya A, Prasad V, Thomas EJ, Singh B, Mittal BR. Tc-99m MDP scintigraphy in a case of idiopathic calcinosis cutis. Clin Nucl Med. 2005 Jun;30(6):431-2. No abstract available. Bhattacharya A, Prasad V, Thomas EJ, Singh B, Mittal BR. Tc-99m MDP scintigraphy in a case of idiopathic calcinosis cutis. Clin Nucl Med. 2005 Jun;30(6):431-2. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43387

Study title: Bibbo C, Patel DV, Mackessy RP, Lin SS, Barricella RL. Pyomyositis of the leg with early neurologic compromise. Pediatr Emerg Care. 2000 Oct;16(5):352-4. Bibbo C, Patel DV, Mackessy RP, Lin SS, Barricella RL. Pyomyositis of the leg with early neurologic compromise. Pediatr Emerg Care. 2000 Oct;16(5):352-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43473

Study title: Bielack S, Knop J, Delling G, Winkler K. [Scintigraphic follow-up of osteosarcoma during neoadjuvant chemotherapy. Results of the cooperative osteosarcoma study of the Society for Pediatric Oncology] Nuklearmedizin. 1988 Dec;27(6):237-41. German. Bielack S, Knop J, Delling G, Winkler K. [Scintigraphic follow-up of osteosarcoma during neoadjuvant chemotherapy. Results of the cooperative osteosarcoma study of the Society for Pediatric Oncology] Nuklearmedizin. 1988 Dec;27(6):237-41. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43803

Study title: Chronic recurrent multifocal osteomyelitis involving both jaws: report of a case including magnetic resonance correlation. Flygare L, Norderyd J, Kubista J, Ohlsson J, Vallo-Christiansen J, Magnusson B. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Feb;83(2):300-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43553

Study title: " Topical corticosteroids and adrenal : suppression Special aspects in pediatrics with prednicarbate - G. Herz et al. - 1988 (Raven Press) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" " Topical corticosteroids and adrenal : suppression Special aspects in pediatrics with prednicarbate - G. Herz et al. - 1988 (Raven Press) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -"

Active substance: PREDNICARBATE

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Document reference: 34663

Study title: EFFICACY AND TOLERATION OF PIROXICAM IN PRIMARY DYSMENORRHEA WITH PLACEBO AS CONTROL

Active substance: PIROXICAM

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Document reference: 34423

Study title: TO STUDY THE EFFICACY AND TOLERATION OF PIROXICAM IN TREATMENT OF ACUTE TENDINITIS, AND TO "VISUALIZE" WITH THE ECHOGRAPHY THE IMPROVEMENT OF THESE DISORDERS WITH PIROXICAM.

Active substance: PIROXICAM

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Document reference: 34384

Study title: Effectiveness of piracetam in the treatment of toxic comas.

Active substance: PIRACETAM

Study summary document link (including results): DE75L051 - Piracetam.pdf

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Document reference: 46007

Study title: Use of piracetam improves sickle cell deformability in vitro and in vivo.

Active substance: PIRACETAM

Study summary document link (including results): DE87C173P - Piracetam.pdf

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Document reference: 45948

Study title: 19. Influence of oral intake of Saccharomyces boulardii on Escherichia coli in enteric flora.; Pediatric Nephrology 2006 ; 21 (6) : 807-810

Active substance: Saccharomyces boulardii

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Document reference: 40173

Study title: Irreversible long-term pulmonary functional impairments after adenovirus type-7 pneumonia: assessment with xenon-133 ventilation and Tc-99m MAA perfusion studies. Suga K, Ishikawa Y, Motoyama K, Kume N, Matsunaga N. Eur Radiol. 2000;10(9):1411-5.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48232

Study title: Late pulmonary scintigraphic defects after uneventful recovery from simple focal pneumonia of childhood. Kenney IJ, Lenney W, Lutkin JE, Gordon I. Br J Radiol. 1993 Nov;66(791):1031-4.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48271

Study title: Liver visualization on perfusion scan after umbilical vein catheter administration. Mrhac L, Zakko S. Semin Nucl Med. 1996 Apr;26(2):141-2

Active substance: TECHNETIUM (99m)

Study summary document link (including results): Mrhac L 1996.pdf

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Document reference: 48254

Study title: Lung perfusion scans in patients with congenital heart defects. Tamir A, Melloul M, Berant M, Horev G, Lubin E, Blieden LC, Zeevi B. J Am Coll Cardiol. 1992 Feb;19(2):383-8.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): Tamir A 1992.pdf

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Document reference: 48278

Study title: Lung perfusion scintigraphy in patients with congenital heart disease: sensitivity and important pitfalls. Boothroyd AE, McDonald EA, Carty H. Nucl Med Commun. 1996 Jan;17(1):33-9.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48256

Study title: Massive intestinal albumin loss after Fontan operation. Sano T, Tajiri H, Nakajima T, Matsushita T, Kayatani F, Kanaya-Ida S, Ozaki Y, Nose O, Okada S. Acta Paediatr Jpn. 1991 Jun;33(3):384-8.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): Levin DP 1991.pdf

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Document reference: 48280

Study title: Occult pulmonary artery. Confer R, Burke G, Robinson VJ. Clin Nucl Med. 1996 Dec;21(12):986-8.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48249

Study title: Optimization of aerosol deposition by pressure support in children with cystic fibrosis: an experimental and clinical study. Fauroux B, Itti E, Pigeot J, Isabey D, Meignan M, Ferry G, Lofaso F, Willemot JM, Clément A, Harf A. Am J Respir Crit Care Med. 2000 Dec;162(6):2265-71.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48230

Study title: Preoperative diagnosis of bronchial atresia presenting with recurrent respiratory symptoms in an infant. Yüksel H, Demir E, Tanaç R, Savaş R, Alper H. Turk J Pediatr. 2000 Oct-Dec;42(4):348-51.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48229

Study title: Protein losing enteropathy (PLE) detected by Tc99m-labelled human serum albumin abdominal scintigraphy--case report Hubalewska-Hola A 2003. Przegl Lek. 2003;60(9):606-8 Hubalewska-Hola et al.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE Nanocoll response List of published articles.doc

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Document reference: 48218

Study title: Pseudo pulmonary embolism in complex congenital heart disease. Cook GJ, Fogelman I. J Nucl Med. 1996 Aug;37(8):1359-61.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48251

Study title: Pulmonary arterial lesions in Takayasu arteritis: relationship of inflammatory activity to scintigraphic findings and sequential changes. Ogawa Y, Hayashi K, Sakamoto I, Matsunaga N. Ann Nucl Med. 1996 May;10(2):219-23.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48253

Study title: A MULTICENTER TRIAL OF GENOTROPIN TREATMENT OF CHILDREN BORN SMALL FOR GESTATIONAL AGE (SGA): EVALUATION OF PREDICTORS OF/CORRELATES WITH FIRST YEAR GROWTH RESPONSE

Active substance: Somatropin

Study summary document link (including results): 307-MET-0021-004 PhRMA Clinical Study Synopsis.pdf

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Document reference: 41644

Study title: A CROSSOVER, MULTI-CENTRE, RANDOMISED, MULTIPLE DOSE, SAFETY STUDY OF THE ADMINISTRATION OF GENOTROPIN USING INJEX, A NEEDLE FREE INJECTOR AND A NEEDLE INJECTION DEVICE, IN PEDIATRIC PATIENTS CURRENTLY USING GROWTH HORMONE FOR GROWTH HORMONE DEFICIENCY

Active substance: Somatropin

Study summary document link (including results): 307-MET-0539-003 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41646

Study title:

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41739

Study title: A 104-week, multi-centre, randomised, double-blind, parallel-group, no treatment controlled (open-label) trial investigating the efficacy and safety of two doses of NN-220 in subjects with short stature born small for gestational age.

Active substance: Somatropin

Study summary document link (including results): GHLiquid-1516_Norditropin.pdf

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Document reference: 41776

Study title: A clinical evaluation of the effectiveness and safety of the administration of recombinant human growth hormone in growth hormone deficient children: a multicentre trial conducted in Japan.

Active substance: Somatropin

Study summary document link (including results): TRN 86-042 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41662

Study title: A MULTI CENTRE, OPEN-LABELED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROTH HORMONE THERAPY IN SHORT PUBERTAL AND PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY UNDERGOING DIALYSIS.

Active substance: Somatropin

Study summary document link (including results): 91-032 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41704

Study title: A multi-center open-labeled study evaluating the efficacy and safety of growth hormone therapy in short pubertal and prepubertal children with chronic renal insufficiency undergoing chronic peritoneal dialysis or hemodialysis

Active substance: Somatropin

Study summary document link (including results): 90-059 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41717

Study title: A MULTI-CENTER, OPEN-LABELLED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PUBERTAL AND PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY UNDERGOING DIALYSIS

Active substance: Somatropin

Study summary document link (including results): 91-031 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41705

Study title: A MULTI-CENTRE PILOT STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE IN SHORT CHILDREN WITH CYSTINOSIS

Active substance: Somatropin

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Document reference: 41701

Study title: A MULTI-CENTRE, OPEN-LABELED STUDY EVALUATING THE EFFICACY AND SAFETY OF HUMAN GROWTH HORMONE THERAPY ON THE GROWTH OF INFANTS WITH CHRONIC RENAL FAILURE TREATED CONSERVATIVELY OR BY DIALYSIS

Active substance: Somatropin

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Document reference: 41695

Study title: A MULTI-INDEPENDENT, OPEN LABELLED, STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PREPUBERTAL CHILDREN, WITH CHRONIC RENAL INSUFFICIENCY

Active substance: Somatropin

Study summary document link (including results): 92-8123-009 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41686

Study title: QT interval prolongation and risk of life-threatening arritmias during toxoplasmosis with spiramycin in neonates - Marco Stramba-Badiale, MD, PhD, Filippi Nador, MD, Norberto Porta, MD, Stephano Guffanti, MD (Stramba-Badiale et al) in American Heart Jounal, 1997, vol 133, number 1

Active substance: SPIRAMYCIN

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Document reference: 42589

Study title: Bone mineral density and bone scintigraphy in children and adolescents with osteomalacia. El-Desouki M, Al-Jurayyan N. Eur J Nucl Med. 1997 Feb;24(2):202-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43554

Study title: Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Metzger DL, Kerrigan JR. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Metzger DL, Kerrigan JR. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.

Active substance: TAMOXIFEN

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Document reference: 43303

Study title: Estrogenic activity of tamoxifen on normal mammary parenchyma in the luteal phase of the menstrual cycle. Facina G, Rodrigues De LG, Simoes MJ, Novo NF, Gebrim LH. International Journal of Gynecology and Obstetrics 1997;56(1):19-24 1997;(1):19-24.Estrogenic activity of tamoxifen on normal mammary parenchyma in the luteal phase of the menstrual cycle. Facina G, Rodrigues De LG, Simoes MJ, Novo NF, Gebrim LH. International Journal of Gynecology and Obstetrics 1997;56(1):19-24 1997;(1):19-24.

Active substance: TAMOXIFEN

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Document reference: 43295

Study title: Eugster EA, Rubin SD, Reiter EO, Plourde P, Jou HC, Pecovitz OH. Tamoxifen treatment for precocious puberty in McCune-Albright syndrome: A multicenter trial. Journal of Pediatrics 2003; 143(1):60-6.Eugster EA, Rubin SD, Reiter EO, Plourde P, Jou HC, Pecovitz OH. Tamoxifen treatment for precocious puberty in McCune-Albright syndrome: A multicenter trial. Journal of Pediatrics 2003; 143(1):60-6.

Active substance: TAMOXIFEN

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Document reference: 43140

Study title: Evaluation of monoclonal antibody MIB-1 in the mammary epithelium adjacent to fibroadenomas in premenopausal women treated with Tamoxifen. De Sousa JA, De Seixas MT, De Lima GR, Baracat EC, Gebrim LH. Breast Journal 7(6)()(pp 392-397), 2001 Date of Publication: 2001 2001;(6):392-397.Evaluation of monoclonal antibody MIB-1 in the mammary epithelium adjacent to fibroadenomas in premenopausal women treated with Tamoxifen. De Sousa JA, De Seixas MT, De Lima GR, Baracat EC, Gebrim LH. Breast Journal 7(6)()(pp 392-397), 2001 Date of Publication: 2001 2001;(6):392-397.

Active substance: TAMOXIFEN

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Document reference: 43280

Study title: Evaluation of the ultrasonographic volume of breast fibroadenomas in women treated with tamoxifen. Evaluation of the ultrasonographic volume of breast fibroadenomas in women treated with tamoxifen.

Active substance: TAMOXIFEN

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Document reference: 43278

Study title: Facina G, Rodrigues De LG, Simoes MJ, Novo NF, Gebrim LH. Estrogenic activity of tamoxifen on normal mammary parenchyma in the luteal phase of the menstrual cycle. International Journal of Gynecology and Obstetrics 1997; 56(1):19-24.Facina G, Rodrigues De LG, Simoes MJ, Novo NF, Gebrim LH. Estrogenic activity of tamoxifen on normal mammary parenchyma in the luteal phase of the menstrual cycle. International Journal of Gynecology and Obstetrics 1997; 56(1):19-24.

Active substance: TAMOXIFEN

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Document reference: 43153

Study title: Faulkner LB, Hajdu SI, Kher U, La QM, Exelby PR, Heller G et al. Pediatric desmoid tumor: Retrospective analysis of 63 cases. Journal of Clinical Oncology 13(11)()(pp 2813-2818), 1995 Date of Publication: Nov 1995 1995;(11):2813-2818.Faulkner LB, Hajdu SI, Kher U, La QM, Exelby PR, Heller G et al. Pediatric desmoid tumor: Retrospective analysis of 63 cases. Journal of Clinical Oncology 13(11)()(pp 2813-2818), 1995 Date of Publication: Nov 1995 1995;(11):2813-2818.

Active substance: TAMOXIFEN

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Document reference: 43119

Study title: Diffuse hepatic uptake of technetium-99m methylene diphosphonate in a patient receiving high dose methotrexate. Flynn BM, Treves ST. J Nucl Med. 1987 Apr;28(4):532-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43868

Study title: Clinical assessment of inhaled salmeterol xinafoate Diskus [SN408D] in subjects with paediatric bronchial asthma - Assessment of efficacy and safety of the regimen at 50mcg twice daily in an open-label study

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42063

Study title: Fong W, Haindl W. Bone imaging and congenital hemihypertrophy. Clin Nucl Med. 1992 Aug;17(8):670-1. No abstract available. Fong W, Haindl W. Bone imaging and congenital hemihypertrophy. Clin Nucl Med. 1992 Aug;17(8):670-1. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43692

Study title: Fordyce MJ, Solomon L. Early detection of avascular necrosis of the femoral head by MRI. J Bone Joint Surg Br. 1993 May;75(3):365-7. Fordyce MJ, Solomon L. Early detection of avascular necrosis of the femoral head by MRI. J Bone Joint Surg Br. 1993 May;75(3):365-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43665

Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43245

Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43318

Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43336

Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43346

Study title: Post-treatment effect of fluoride varnishes in children with a high prevalence of dental caries in a community with fluoridated water.

Active substance: SODIUM FLUORIDE

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Document reference: 42421

Study title: Cuarón A, Acero A, Cárdenas M. [Bayesian analysis of myocardial scintigraphy using 99mTc-Sn(II)-methylenediphosphonate and using 99mTc-Sn(II)-pyrophosphate] Arch Inst Cardiol Mex. 1982 Sep-Oct;52(5):365-72. Spanish. Cuarón A, Acero A, Cárdenas M. [Bayesian analysis of myocardial scintigraphy using 99mTc-Sn(II)-methylenediphosphonate and using 99mTc-Sn(II)-pyrophosphate] Arch Inst Cardiol Mex. 1982 Sep-Oct;52(5):365-72. Spanish.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44074

Study title: Chronic recurrent multifocal osteomyelitis. Cyrlak D, Pais MJ Skeletal Radiol. 1986;15(1):32-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43918

Study title: Darsow F, Jaster D, Krüger M. [Scintigraphic studies following Harrington spondylodesis] Beitr Orthop Traumatol. 1986 Jan;33(1):33-7. German. No abstract available. Darsow F, Jaster D, Krüger M. [Scintigraphic studies following Harrington spondylodesis] Beitr Orthop Traumatol. 1986 Jan;33(1):33-7. German. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43917

Study title: Metastatic osteosarcoma to the liver after treatment for synovial sarcoma: a case report. Daw NC, Kaste SC, Hill DA, Kun LE, Pratt CB. Pediatr Hematol Oncol. 2001 Mar;18(2):123-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43456

Study title: De Boeck H, Casteleyn PP, Bossuyt A, Jacobs A. Intraoperative radioactive localization of small bone tumours. Int Orthop. 1992;16(2):172-5. De Boeck H, Casteleyn PP, Bossuyt A, Jacobs A. Intraoperative radioactive localization of small bone tumours. Int Orthop. 1992;16(2):172-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43716

Study title: De Geeter F, Van Steelandt H, Degomme P. Greatly increased humeral uptake as a sign of leukemia. Clin Nucl Med. 1995 Nov;20(11):1022-3. No abstract available. De Geeter F, Van Steelandt H, Degomme P. Greatly increased humeral uptake as a sign of leukemia. Clin Nucl Med. 1995 Nov;20(11):1022-3. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43581

Study title: Declerck P, Schiepers C, Mortelmans L, De Roo M. Stage II reflex sympathetic dystrophy syndrome with unexpected bone changes due to the use of walking crutches. Clin Nucl Med. 1993 Jul;18(7):604-5. No abstract available. Declerck P, Schiepers C, Mortelmans L, De Roo M. Stage II reflex sympathetic dystrophy syndrome with unexpected bone changes due to the use of walking crutches. Clin Nucl Med. 1993 Jul;18(7):604-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43660

Study title: Degrossi OJ, Oliveri P, García del Río H, Labriola R, Artagaveytía D, Degrossi EB. Technetium-99m APD compared with technetium-99m MDP as a bone scanning agent. J Nucl Med. 1985 Oct;26(10):1135-9. Degrossi OJ, Oliveri P, García del Río H, Labriola R, Artagaveytía D, Degrossi EB. Technetium-99m APD compared with technetium-99m MDP as a bone scanning agent. J Nucl Med. 1985 Oct;26(10):1135-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43931

Study title: Transient ureteral dilatation associated with infantile infectious sacroiliitis. Dejter SW, Eggli DF, Gibbons MD. J Urol. 1989 May;141(5):1154-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43785

Study title: Delbem AC, Percinoto C, Cunha RF. Eosinophilic granuloma: report of case. ASDC J Dent Child. 1997 Jul-Aug;64(4):291-3. Delbem AC, Percinoto C, Cunha RF. Eosinophilic granuloma: report of case. ASDC J Dent Child. 1997 Jul-Aug;64(4):291-3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43546

Study title: QT interval prolongation and risk of life-threatening arritmias during toxoplasmosis with spiramycin in neonates - Marco Stramba-Badiale, MD, PhD, Filippi Nador, MD, Norberto Porta, MD, Stephano Guffanti, MD (Stramba-Badiale et al) in American Heart Jounal, 1997, vol 133, number 1QT interval prolongation and risk of life-threatening arritmias during toxoplasmosis with spiramycin in neonates - Marco Stramba-Badiale, MD, PhD, Filippi Nador, MD, Norberto Porta, MD, Stephano Guffanti, MD (Stramba-Badiale et al) in American Heart Jounal, 1997, vol 133, number 1

Active substance: SPIRAMYCIN

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Document reference: 42597

Study title: Rovamycine infant 0.375MIU, children 0.750MIU,older children 1.5 MIU - Spiramycin granules in sachets - part IV A.2.1

Active substance: SPIRAMYCIN

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Document reference: 42591

Study title: Rovamycine nourrissons 0.375 MUI-rovamycine enfants 0.750MUI rovamycine grands enfants 1.5MUI:grnules de spiramycine en sachets (partie IV A.2. etude n°1 du dossier d'AMM) - Mai 1992

Active substance: SPIRAMYCIN

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Document reference: 42592

Study title: Rovamycine sirop - Sirop dosé à 2,5 p.100 (p/v) soit 125 mg ou 0,375 M.U.I. de spiramycine par cuillerée à café - J. Gaillot - 15 mars 1976

Active substance: SPIRAMYCIN

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Document reference: 42593

Study title: Spiramycin and erythromycin in the treatment of acute tonsillopharyngitis : a comparative study. - I. Soekrawinata et al. - 1984 - Curr Med Res Opin (9 (5):296-300) Spiramycin and erythromycin in the treatment of acute tonsillopharyngitis : a comparative study. - I. Soekrawinata et al. - 1984 - Curr Med Res Opin (9 (5):296-300)

Active substance: SPIRAMYCIN

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Document reference: 42581

Study title: Spiramycin and erythromycin in the treatment of acute tonsillopharyngitis in children - D. Soebardja et al. - 1987 - Paediatrica Indonesiana (27: 223-230)Spiramycin and erythromycin in the treatment of acute tonsillopharyngitis in children - D. Soebardja et al. - 1987 - Paediatrica Indonesiana (27: 223-230)

Active substance: SPIRAMYCIN

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Document reference: 42582

Study title: Spiramycin versus penicillin V in the empiric treatment of bacterial tonsillitis - L Manolopoulos et al. - 1989 - BJCP (43 (3): 94-96)Spiramycin versus penicillin V in the empiric treatment of bacterial tonsillitis - L Manolopoulos et al. - 1989 - BJCP (43 (3): 94-96)

Active substance: SPIRAMYCIN

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Document reference: 42583

Study title: Traitement presomptif de première intention des infections cutanées par la spiramycine - H. Meilo - 1993 - Médecine d'Afrique Noire (40(3): 213-215)Traitement presomptif de première intention des infections cutanées par la spiramycine - H. Meilo - 1993 - Médecine d'Afrique Noire (40(3): 213-215)

Active substance: SPIRAMYCIN

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Document reference: 42584

Study title: Treatment of toxoplasmosis during pregnancy: multicenter study of impact on fetal transmission and children's sequelae at age 1 year - Foulon W, Villena I, Stray-Pedersen B., Decoster A, Lappalainen M, Pinon JM, Jenum PA, Hedman K, Naessens A. - Am J Obstet Gynecol 1999 Feb; 180(2Pt1): 410-5 Treatment of toxoplasmosis during pregnancy: multicenter study of impact on fetal transmission and children's sequelae at age 1 year - Foulon W, Villena I, Stray-Pedersen B., Decoster A, Lappalainen M, Pinon JM, Jenum PA, Hedman K, Naessens A. - Am J Obstet Gynecol 1999 Feb; 180(2Pt1): 410-5

Active substance: SPIRAMYCIN

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Document reference: 42594

Study title: Treatment of toxoplasmosis during pregnancy: multicenter study of impact on fetal transmission and children's sequelae at age 1 year - Foulon W, Villena I, Stray-Pedersen B., Decoster A, Lappalainen M, Pinon JM, Jenum PA, Hedman K, Naessens A. - Am J Obstet Gynecol 1999 Feb; 180(2Pt1): 410-5 Treatment of toxoplasmosis during pregnancy: multicenter study of impact on fetal transmission and children's sequelae at age 1 year - Foulon W, Villena I, Stray-Pedersen B., Decoster A, Lappalainen M, Pinon JM, Jenum PA, Hedman K, Naessens A. - Am J Obstet Gynecol 1999 Feb; 180(2Pt1): 410-5

Active substance: SPIRAMYCIN

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Document reference: 42599

Study title: Application of fluoride varnish Duraphat with a cotton carrier respectively a syringe for cartridges--a comparison study.

Active substance: SODIUM FLUORIDE

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Document reference: 42472

Study title: GEMB Group. Tamoxifen therapy for cyclical mastalgia: dose randomized trial. Breast 1997; 6(4):212-213. GEMB Group. Tamoxifen therapy for cyclical mastalgia: dose randomized trial. Breast 1997; 6(4):212-213.

Active substance: TAMOXIFEN

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Document reference: 43154

Study title: The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.

Active substance: TAMOXIFEN

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Document reference: 43301

Study title: The effect of tamoxifen on sex hormone binding globulin in adolescents with pubertal gynecomastia. The effect of tamoxifen on sex hormone binding globulin in adolescents with pubertal gynecomastia.

Active substance: TAMOXIFEN

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Document reference: 43261

Study title: The management of desmoid tumors. The management of desmoid tumors.

Active substance: TAMOXIFEN

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Document reference: 43307

Study title: The use of tamoxifen to improve height potential in short pubertal boys. The use of tamoxifen to improve height potential in short pubertal boys.

Active substance: TAMOXIFEN

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Document reference: 43260

Study title: Tolis G, Karalis K, Kyriakos GM. Gynecomastia. Current Therapy in Endocrinology & Metabolism 1994; 5:370-371.Tolis G, Karalis K, Kyriakos GM. Gynecomastia. Current Therapy in Endocrinology & Metabolism 1994; 5:370-371.

Active substance: TAMOXIFEN

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Document reference: 43121

Study title: Treatment modalities in patients with hepatocellular carcinoma: A retrospective series in a single institution in Mexico. [Spanish]. Treatment modalities in patients with hepatocellular carcinoma: A retrospective series in a single institution in Mexico. [Spanish].

Active substance: TAMOXIFEN

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Document reference: 43268

Study title: Treatment of desmoid tumor. Moral DA, Piulachs CJ, Targarona Soler EM, Combalia AA, Ramon SR, Trias FM. Medicina Clinica 1994;102(7):250-253 1994;(7):250-253.Treatment of desmoid tumor. Moral DA, Piulachs CJ, Targarona Soler EM, Combalia AA, Ramon SR, Trias FM. Medicina Clinica 1994;102(7):250-253 1994;(7):250-253.

Active substance: TAMOXIFEN

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Document reference: 43304

Study title: Tyrrell CJ. Gynaecomastia: aetiology and treatment options [Review]. Prostate Cancer & Prostatic Diseases 1999; 2(4):167-171.Tyrrell CJ. Gynaecomastia: aetiology and treatment options [Review]. Prostate Cancer & Prostatic Diseases 1999; 2(4):167-171.

Active substance: TAMOXIFEN

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Document reference: 43112

Study title: Uehara J, Nazario ACP, Rodrigues De LG, Simoes MJ, Juliano Y, Gebrim LH. Effects of tamoxifen on the breast in the luteal phase of the menstrual cycle. International Journal of Gynecology and Obstetrics 1998; 62(1):77-82.Uehara J, Nazario ACP, Rodrigues De LG, Simoes MJ, Juliano Y, Gebrim LH. Effects of tamoxifen on the breast in the luteal phase of the menstrual cycle. International Journal of Gynecology and Obstetrics 1998; 62(1):77-82.

Active substance: TAMOXIFEN

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Document reference: 43151

Study title: Urban T, Lazor R, Lacronique J, Murris M, Labrune S, Valeyre D et al. Pulmonary lymphangioleiomyomatosis: A study of 69 patients. Medicine 78(5)()(pp 321-337), 1999 Date of Publication: Sep 1999 1999;(5):321-337.Urban T, Lazor R, Lacronique J, Murris M, Labrune S, Valeyre D et al. Pulmonary lymphangioleiomyomatosis: A study of 69 patients. Medicine 78(5)()(pp 321-337), 1999 Date of Publication: Sep 1999 1999;(5):321-337.

Active substance: TAMOXIFEN

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Document reference: 43113

Study title: Lackner H, Urban C, Kerbl R, Schwinger W, Beham A. Noncytotoxic Drug Therapy in Children with Unresectable Desmoid Tumors. Cancer 1997;80(2):334-340 1997;(2):334-340.Lackner H, Urban C, Kerbl R, Schwinger W, Beham A. Noncytotoxic Drug Therapy in Children with Unresectable Desmoid Tumors. Cancer 1997;80(2):334-340 1997;(2):334-340.

Active substance: TAMOXIFEN

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Document reference: 43115

Study title: Lawrence SE, Arnold FK, Vethamuthu J, Lawson ML. Beneficial effects of raloxifene and tamoxifen in the treatment of pubertal gynecomastia. Journal of Pediatrics 145(1)()(pp 71-76), 2004 Date of Publication: Jul 2004 2004;(1):71-76.Lawrence SE, Arnold FK, Vethamuthu J, Lawson ML. Beneficial effects of raloxifene and tamoxifen in the treatment of pubertal gynecomastia. Journal of Pediatrics 145(1)()(pp 71-76), 2004 Date of Publication: Jul 2004 2004;(1):71-76.

Active substance: TAMOXIFEN

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Document reference: 43095

Study title: Lee F. Liver Cancer: New Research. Lee, F [Editor] 2006; Liver Cancer: New Research. , 2006. Series Information: HORIZONS IN CANCER RESEARCH. Vol 11:11111.Lee F. Liver Cancer: New Research. Lee, F [Editor] 2006; Liver Cancer: New Research. , 2006. Series Information: HORIZONS IN CANCER RESEARCH. Vol 11:11111.

Active substance: TAMOXIFEN

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Document reference: 43134

Study title: Liver Cancer: New Research. , 2006. Series Information: Liver Cancer: New Research. , 2006. Series Information:

Active substance: TAMOXIFEN

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Document reference: 43257

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.

Active substance: TAMOXIFEN

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Document reference: 43321

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of thvon Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of th

Active substance: TAMOXIFEN

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Document reference: 43329

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.

Active substance: TAMOXIFEN

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Document reference: 43339

Study title: De Lima GR, Facina G, Shida JY, Chein MB, Tanaka P, Dardes RC et al. Effects of low dose tamoxifen on normal breast tissue from premenopausal women. European Journal of Cancer 2003; 39(7):891-898.De Lima GR, Facina G, Shida JY, Chein MB, Tanaka P, Dardes RC et al. Effects of low dose tamoxifen on normal breast tissue from premenopausal women. European Journal of Cancer 2003; 39(7):891-898.

Active substance: TAMOXIFEN

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Document reference: 43098

Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.

Active substance: TAMOXIFEN

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Document reference: 43118

Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.

Active substance: TAMOXIFEN

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Document reference: 43131

Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.

Active substance: TAMOXIFEN

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Document reference: 43189

Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.

Active substance: TAMOXIFEN

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Document reference: 43199

Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.

Active substance: TAMOXIFEN

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Document reference: 43209

Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.

Active substance: TAMOXIFEN

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Document reference: 43214

Study title: Assessing the effect of fluoride varnish on early enamel carious lesions in the primary dentition

Active substance: SODIUM FLUORIDE

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Document reference: 42336

Study title: Assessing the effect of fluoride varnish on early enamel carious lesions in the primary dentition

Active substance: SODIUM FLUORIDE

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Document reference: 42449

Study title: Bibby BG, Wilkins E, Witol E. A preliminary study of the effects of fluoride lozenges and pills on dental caries. Oral Surg Oral Med Oral Pathol 1955; 8 : 213-216.Bibby BG, Wilkins E, Witol E. A preliminary study of the effects of fluoride lozenges and pills on dental caries. Oral Surg Oral Med Oral Pathol 1955; 8 : 213-216.

Active substance: SODIUM FLUORIDE

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Document reference: 42250

Study title: Bibby BG, Wilkins E, Witol E. A preliminary study of the effects of fluoride lozenges and pills on dental caries. Oral Surg Oral Med Oral Pathol 1955; 8 : 213-216.Bibby BG, Wilkins E, Witol E. A preliminary study of the effects of fluoride lozenges and pills on dental caries. Oral Surg Oral Med Oral Pathol 1955; 8 : 213-216.

Active substance: SODIUM FLUORIDE

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Document reference: 42282

Study title: Bibby BG, Wilkins E, Witol E. A preliminary study of the effects of fluoride lozenges and pills on dental caries. Oral Surg Oral Med Oral Pathol 1955; 8 : 213-216.Bibby BG, Wilkins E, Witol E. A preliminary study of the effects of fluoride lozenges and pills on dental caries. Oral Surg Oral Med Oral Pathol 1955; 8 : 213-216.

Active substance: SODIUM FLUORIDE

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Document reference: 42314

Study title: Busse H, Geiger L. Fluoridierungsmaßnahmen und Kariesprävalenz bei Schülern in der ehemaligen DDR. Oralprophylaxe 1990; 12: 145-153Busse H, Geiger L. Fluoridierungsmaßnahmen und Kariesprävalenz bei Schülern in der ehemaligen DDR. Oralprophylaxe 1990; 12: 145-153

Active substance: SODIUM FLUORIDE

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Document reference: 42251

Study title: Busse H, Geiger L. Fluoridierungsmaßnahmen und Kariesprävalenz bei Schülern in der ehemaligen DDR. Oralprophylaxe 1990; 12: 145-153Busse H, Geiger L. Fluoridierungsmaßnahmen und Kariesprävalenz bei Schülern in der ehemaligen DDR. Oralprophylaxe 1990; 12: 145-153

Active substance: SODIUM FLUORIDE

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Document reference: 42283

Study title: Application of fluoride varnish Duraphat with a cotton carrier respectively a syringe for cartridges--a comparison study.

Active substance: SODIUM FLUORIDE

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Document reference: 42359

Study title: Busse H, Geiger L. Fluoridierungsmaßnahmen und Kariesprävalenz bei Schülern in der ehemaligen DDR. Oralprophylaxe 1990; 12: 145-153Busse H, Geiger L. Fluoridierungsmaßnahmen und Kariesprävalenz bei Schülern in der ehemaligen DDR. Oralprophylaxe 1990; 12: 145-153

Active substance: SODIUM FLUORIDE

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Document reference: 42315

Study title: Caries incidence after topical application of varnishes containing different concentrations of sodium fluoride: 3-year results

Active substance: SODIUM FLUORIDE

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Document reference: 42365

Study title: Caries incidence after topical application of varnishes containing different concentrations of sodium fluoride: 3-year results

Active substance: SODIUM FLUORIDE

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Document reference: 42478

Study title: Caries increment in primary teeth after application of Duraphat fluoride varnish.

Active substance: SODIUM FLUORIDE

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Document reference: 42361

Study title: Caries increment in primary teeth after application of Duraphat fluoride varnish.

Active substance: SODIUM FLUORIDE

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Document reference: 42474

Study title: Caries prevention by means of deep impregnation of the dental enamel with fluoride lacquer] [Article in German]

Active substance: SODIUM FLUORIDE

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Document reference: 42414

Study title: Caries prevention by means of deep impregnation of the dental enamel with fluoride lacquer] [Article in German]

Active substance: SODIUM FLUORIDE

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Document reference: 42527

Study title: Caries prevention with Duraphat in a new application form].

Active substance: SODIUM FLUORIDE

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Document reference: 42412

Study title: The effect of prophylactic measures on the gingival health of school children.

Active substance: SODIUM FLUORIDE

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Document reference: 42458

Study title: Viviani RS, Gebrim LH, Baracat EC, De Lima GR. Evaluation of the ultrasonographic volume of breast fibroadenomas in women treated with tamoxifen. Minerva Ginecologica 2002; 54(6):531-535.Viviani RS, Gebrim LH, Baracat EC, De Lima GR. Evaluation of the ultrasonographic volume of breast fibroadenomas in women treated with tamoxifen. Minerva Ginecologica 2002; 54(6):531-535.

Active substance: TAMOXIFEN

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Document reference: 43103

Study title: Targeting protein kinase C: New therapeutic opportunities against high-grade malignant gliomas? Targeting protein kinase C: New therapeutic opportunities against high-grade malignant gliomas?

Active substance: TAMOXIFEN

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Document reference: 43275

Study title: Al Naeem AN, Powe J, Bakheet S, Elgazzar AH. Displaced urinary bladder creating an unusual pattern on bone scan mimicking disease. Clin Nucl Med. 1999 Feb;24(2):137-8. No abstract available. Al Naeem AN, Powe J, Bakheet S, Elgazzar AH. Displaced urinary bladder creating an unusual pattern on bone scan mimicking disease. Clin Nucl Med. 1999 Feb;24(2):137-8. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43516

Study title: al-Nahhas AM, Jawad AS, Norman A, McCready VR. 99Tcm-MDP blood-pool phase in the assessment of repetitive strain injury. Nucl Med Commun. 1997 Oct;18(10):927-31. al-Nahhas AM, Jawad AS, Norman A, McCready VR. 99Tcm-MDP blood-pool phase in the assessment of repetitive strain injury. Nucl Med Commun. 1997 Oct;18(10):927-31.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43540

Study title: Alexander JE, Seibert JJ, Aronson J, Williamson SL, Glasier CM, Rodgers AB, Corbitt SL. A protocol of plain radiographs, hip ultrasound, and triple phase bone scans in the evaluation of the painful pediatric hip. Clin Pediatr (Phila). 1988 Apr;27(4):175-81. Alexander JE, Seibert JJ, Aronson J, Williamson SL, Glasier CM, Rodgers AB, Corbitt SL. A protocol of plain radiographs, hip ultrasound, and triple phase bone scans in the evaluation of the painful pediatric hip. Clin Pediatr (Phila). 1988 Apr;27(4):175-81.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44271

Study title: Algra PR, Bloem JL, Tissing H, Falke TH, Arndt JW, Verboom LJ. Detection of vertebral metastases: comparison between MR imaging and bone scintigraphy. Radiographics. 1991 Mar;11(2):219-32. Algra PR, Bloem JL, Tissing H, Falke TH, Arndt JW, Verboom LJ. Detection of vertebral metastases: comparison between MR imaging and bone scintigraphy. Radiographics. 1991 Mar;11(2):219-32.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43746

Study title: Amico S, Lucas P, Liehn JC, Valeyre J. Unusual site of extraosseous uptake of Tc 99m-HMDP due to subcutaneous heparin injections. Report of two cases. Eur J Nucl Med. 1989;15(10):670-2. Amico S, Lucas P, Liehn JC, Valeyre J. Unusual site of extraosseous uptake of Tc 99m-HMDP due to subcutaneous heparin injections. Report of two cases. Eur J Nucl Med. 1989;15(10):670-2.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43796

Study title: Amico S, Lucas PG, Chelius P, Ruelle MC, Liehn JC, Valeyre J. Ewing's sarcoma of the thumb. Radiographic, angiographic, CT, and bone scan findings. Clin Nucl Med. 1987 Aug;12(8):671-2. No abstract available. Amico S, Lucas PG, Chelius P, Ruelle MC, Liehn JC, Valeyre J. Ewing's sarcoma of the thumb. Radiographic, angiographic, CT, and bone scan findings. Clin Nucl Med. 1987 Aug;12(8):671-2. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43853

Study title: Andersen BL, Lauver JW, Ross P, Fitzgerald RH. Demonstration of radiation nephritis by computed tomography. Comput Radiol. 1982 Jul-Aug;6(4):187-91. No abstract available. Andersen BL, Lauver JW, Ross P, Fitzgerald RH. Demonstration of radiation nephritis by computed tomography. Comput Radiol. 1982 Jul-Aug;6(4):187-91. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44080

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.

Active substance: TAMOXIFEN

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Document reference: 43349

Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251.

Active substance: TAMOXIFEN

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Document reference: 43107

Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251.

Active substance: TAMOXIFEN

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Document reference: 43128

Study title: Willoughby-M-L-N, Razak-K, Keel-A, Cameron-F-G. R. Hosp. Sick Child., Glasgow, United Kingdom. Alternating chemotherapy for childhood Hodgkin's disease. Lancet {LANCET}, 1982, Vol/Iss/Pg. 2/8301 (763).Willoughby-M-L-N, Razak-K, Keel-A, Cameron-F-G. R. Hosp. Sick Child., Glasgow, United Kingdom. Alternating chemotherapy for childhood Hodgkin's disease. Lancet {LANCET}, 1982, Vol/Iss/Pg. 2/8301 (763).

Active substance: PROCARBAZINE

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Document reference: 34878

Study title: Bilchik TR, Spencer RP. Bladder variants noted on bone and renal imaging. Clin Nucl Med. 1993 Jan;18(1):60-7. No abstract available. Bilchik TR, Spencer RP. Bladder variants noted on bone and renal imaging. Clin Nucl Med. 1993 Jan;18(1):60-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43676

Study title: Binnur K, Firat G, Sukran T, Metin E. Tc-99m HMDP uptake by the kidney in sickle cell disease. Clin Nucl Med. 1992 Mar;17(3):236. No abstract available. Binnur K, Firat G, Sukran T, Metin E. Tc-99m HMDP uptake by the kidney in sickle cell disease. Clin Nucl Med. 1992 Mar;17(3):236. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43703

Study title: Bittini A, Dominguez PL, Martinez Pueyo ML, López Longo FJ, Monteagudo I, Carreño L. Comparison of bone and gallium-67 imaging in heroin users' arthritis. J Nucl Med. 1985 Dec;26(12):1377-81. Bittini A, Dominguez PL, Martinez Pueyo ML, López Longo FJ, Monteagudo I, Carreño L. Comparison of bone and gallium-67 imaging in heroin users' arthritis. J Nucl Med. 1985 Dec;26(12):1377-81.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43926

Study title: Blackmore CC, Perkins A. Lytic bone lesion in a 12-year-old. Acad Radiol. 1995 Jun;2(6):541-3. No abstract available. Blackmore CC, Perkins A. Lytic bone lesion in a 12-year-old. Acad Radiol. 1995 Jun;2(6):541-3. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43598

Study title: Comparative evaluation of the role of NaF, APF & Duraphat topical fluoride applications in the prevention of dental caries--a 2 1/2 years study.

Active substance: SODIUM FLUORIDE

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Document reference: 42431

Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.

Active substance: TAMOXIFEN

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Document reference: 43198

Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.

Active substance: TAMOXIFEN

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Document reference: 43208

Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.

Active substance: TAMOXIFEN

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Document reference: 43218

Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.

Active substance: TAMOXIFEN

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Document reference: 43228

Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.

Active substance: TAMOXIFEN

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Document reference: 43238

Study title: The effect of topical fluoride treatment on enamel fluoride uptake and the tensile bond strength of an orthodontic bonding resin.

Active substance: SODIUM FLUORIDE

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Document reference: 42350

Study title: The effect of topical fluoride treatment on enamel fluoride uptake and the tensile bond strength of an orthodontic bonding resin.

Active substance: SODIUM FLUORIDE

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Document reference: 42463

Study title: The trace efficacy of dental caries prevention in children

Active substance: SODIUM FLUORIDE

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Document reference: 42429

Study title: The trace efficacy of dental caries prevention in children

Active substance: SODIUM FLUORIDE

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Document reference: 42542

Study title: The use of a fluoride varnish and helium-neon laser light in preventing caries of the deciduous teeth] [Article in Russian

Active substance: SODIUM FLUORIDE

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Document reference: 42378

Study title: The use of a fluoride varnish and helium-neon laser light in preventing caries of the deciduous teeth] [Article in Russian

Active substance: SODIUM FLUORIDE

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Document reference: 42491

Study title: Three-year study of the effect of fluoride varnish (Duraphat) on proximal caries progression in teenagers.

Active substance: SODIUM FLUORIDE

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Document reference: 42387

Study title: Three-year study of the effect of fluoride varnish (Duraphat) on proximal caries progression in teenagers.

Active substance: SODIUM FLUORIDE

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Document reference: 42500

Study title: Topical application of fluoride varnish for dental caries prevention in ollectives following a 3-year testing period][Article in German

Active substance: SODIUM FLUORIDE

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Document reference: 42385

Study title: Topical application of fluoride varnish for dental caries prevention in ollectives following a 3-year testing period][Article in German

Active substance: SODIUM FLUORIDE

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Document reference: 42498

Study title: Trials - results - conclusions. Duraphat - Fluor Protector

Active substance: SODIUM FLUORIDE

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Document reference: 42340

Study title: Trials - results - conclusions. Duraphat - Fluor Protector

Active substance: SODIUM FLUORIDE

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Document reference: 42453

Study title: Two-year trial of the fluoride-containing varnishes Duraphat and Carex].

Active substance: SODIUM FLUORIDE

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Document reference: 42389

Study title: Two-year trial of the fluoride-containing varnishes Duraphat and Carex].

Active substance: SODIUM FLUORIDE

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Document reference: 42502

Study title: Uptake of KOH-soluble and KOH-insoluble fluoride in sound human enamel after topical application of a fluoride varnish (Duraphat) or a neutral 2% NaF solution in vitro.

Active substance: SODIUM FLUORIDE

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Document reference: 42354

Study title: Uptake of KOH-soluble and KOH-insoluble fluoride in sound human enamel after topical application of a fluoride varnish (Duraphat) or a neutral 2% NaF solution in vitro.

Active substance: SODIUM FLUORIDE

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Document reference: 42467

Study title: use of a fluoride varnish in caries prevention.

Active substance: SODIUM FLUORIDE

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Document reference: 42383

Study title: use of a fluoride varnish in caries prevention.

Active substance: SODIUM FLUORIDE

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Document reference: 42496

Study title: use of fluoride varnish in the prevention of caries.

Active substance: SODIUM FLUORIDE

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Document reference: 42379

Study title: use of fluoride varnish in the prevention of caries.

Active substance: SODIUM FLUORIDE

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Document reference: 42492

Study title: Widenheim J, Birkhed D, Granath L et al. Pre-eruptive effect of NaF tablets on caries in children from 12 to 17 years of age. Community Dent Oral Epidemiolog 1986, 14: 1-4.Widenheim J, Birkhed D, Granath L et al. Pre-eruptive effect of NaF tablets on caries in children from 12 to 17 years of age. Community Dent Oral Epidemiolog 1986, 14: 1-4.

Active substance: SODIUM FLUORIDE

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Document reference: 42271

Study title: Applegate K, Connolly LP, Treves ST. Neuroblastoma presenting clinically as hip osteomyelitis: a "signature" diagnosis on skeletal scintigraphy. Pediatr Radiol. 1995 Nov;25 Suppl 1:S93-6. Applegate K, Connolly LP, Treves ST. Neuroblastoma presenting clinically as hip osteomyelitis: a "signature" diagnosis on skeletal scintigraphy. Pediatr Radiol. 1995 Nov;25 Suppl 1:S93-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43578

Study title: Arat ZM, Gökalp H, Atasever T, Türkkahraman H. 99mTechnetium-labeled methylene diphosphonate uptake in maxillary bone during and after rapid maxillary expansion. Angle Orthod. 2003 Oct;73(5):545-9. Arat ZM, Gökalp H, Atasever T, Türkkahraman H. 99mTechnetium-labeled methylene diphosphonate uptake in maxillary bone during and after rapid maxillary expansion. Angle Orthod. 2003 Oct;73(5):545-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43411

Study title: Elgazzar AH, Abdel-Dayem HM, Shible O. Brucellosis simulating metastases on Tc-99m MDP bone scan. Clin Nucl Med. 1991 Mar;16(3):189-91. No abstract available. Elgazzar AH, Abdel-Dayem HM, Shible O. Brucellosis simulating metastases on Tc-99m MDP bone scan. Clin Nucl Med. 1991 Mar;16(3):189-91. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43745

Study title: Elgazzar AH, Jahan S, Motawei S, Abdel-Dayem HM. Tc-99m MDP uptake in hepatoblastoma. Clin Nucl Med. 1989 Feb;14(2):143. No abstract available. Elgazzar AH, Jahan S, Motawei S, Abdel-Dayem HM. Tc-99m MDP uptake in hepatoblastoma. Clin Nucl Med. 1989 Feb;14(2):143. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43794

Study title: Bone scintigraphy in the assessment of spondylolysis in patients attending a sports injury clinic. Elliott S, Hutson MA, Wastie ML. Clin Radiol. 1988 May;39(3):269-72.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43815

Study title: Bone scintigraphy in preschool children with lower extremity pain of unknown origin. Englaro EE, Gelfand MJ, Paltiel HJ. J Nucl Med. 1992 Mar;33(3):351-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43702

Study title: Epstein JS, Ganz WI, Lizak M, Grobman L, Goodwin WJ, Dewanjee MK. Indium 111-labeled leukocyte scintigraphy in evaluating head and neck infections. Ann Otol Rhinol Laryngol. 1992 Dec;101(12):961-8. Epstein JS, Ganz WI, Lizak M, Grobman L, Goodwin WJ, Dewanjee MK. Indium 111-labeled leukocyte scintigraphy in evaluating head and neck infections. Ann Otol Rhinol Laryngol. 1992 Dec;101(12):961-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43683

Study title: Acute haematogenous osteomyelitis in children - the reliability of skeletal scintigraphy. Erasmie U, Hirsch G. Z Kinderchir. 1981 Apr;32(4):360-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44127

Study title: Esdaile J, Rosenthall L. Radionuclide joint imaging. Compr Ther. 1983 Sep;9(9):54-63. Esdaile J, Rosenthall L. Radionuclide joint imaging. Compr Ther. 1983 Sep;9(9):54-63.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44028

Study title: Esterhai J, Alavi A, Mandell GA, Brown J. Sequential technetium-99m/gallium-67 scintigraphic evaluation of subclinical osteomyelitis complicating fracture nonunion. J Orthop Res. 1985;3(2):219-25. Esterhai J, Alavi A, Mandell GA, Brown J. Sequential technetium-99m/gallium-67 scintigraphic evaluation of subclinical osteomyelitis complicating fracture nonunion. J Orthop Res. 1985;3(2):219-25.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43965

Study title: Blocklet D, Seret A, Schoutens A. [Bilateral spondylolysis: the value of bone computed scintigraphy] Rev Med Brux. 2000 Feb;21(1):A43-4. French. No abstract available. Blocklet D, Seret A, Schoutens A. [Bilateral spondylolysis: the value of bone computed scintigraphy] Rev Med Brux. 2000 Feb;21(1):A43-4. French. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43488

Study title: Blom J, Pauwels EK, Piso LN, Taminiau AH. Misleading 67Ga uptake and serial bone scintigraphy in osteoid osteoma. Diagn Imaging. 1983;52(5):276-9. Blom J, Pauwels EK, Piso LN, Taminiau AH. Misleading 67Ga uptake and serial bone scintigraphy in osteoid osteoma. Diagn Imaging. 1983;52(5):276-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44057

Study title: Blumenkopf B, Hartshorne MF, Bauman JM, Cawthon MA, Patton JA, Friedman AH. Craniotomy flap osteomyelitis: a diagnostic approach. J Neurosurg. 1987 Jan;66(1):96-101. Blumenkopf B, Hartshorne MF, Bauman JM, Cawthon MA, Patton JA, Friedman AH. Craniotomy flap osteomyelitis: a diagnostic approach. J Neurosurg. 1987 Jan;66(1):96-101.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43878

Study title: Boas SR, Charron M, Ledesma-Medina J, Noyes BE, Kurland G. Hypertrophic osteoarthropathy in a child with follicular bronchiolitis. Clin Nucl Med. 1995 Jan;20(1):49-51. Boas SR, Charron M, Ledesma-Medina J, Noyes BE, Kurland G. Hypertrophic osteoarthropathy in a child with follicular bronchiolitis. Clin Nucl Med. 1995 Jan;20(1):49-51.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43604

Study title: Bockisch A, König R, Wahl G, Hotze A, Biersack HJ. [Scintigraphic panoramic imaging of the jaws] Dtsch Z Mund Kiefer Gesichtschir. 1991 May-Jun;15(3):215-20. German. Bockisch A, König R, Wahl G, Hotze A, Biersack HJ. [Scintigraphic panoramic imaging of the jaws] Dtsch Z Mund Kiefer Gesichtschir. 1991 May-Jun;15(3):215-20. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43739

Study title: Francis IR, Glazer GM, Shapiro B, Sisson JC, Gross BH. Complementary roles of CT and 131I-MIBG scintigraphy in diagnosing pheochromocytoma. AJR Am J Roentgenol. 1983 Oct;141(4):719-25. Francis IR, Glazer GM, Shapiro B, Sisson JC, Gross BH. Complementary roles of CT and 131I-MIBG scintigraphy in diagnosing pheochromocytoma. AJR Am J Roentgenol. 1983 Oct;141(4):719-25.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44027

Study title: Prognostic significance of (18)F-FDG and (99m)Tc-methylene diphosphonate uptake in primary osteosarcoma. Franzius C, Bielack S, Flege S, Sciuk J, Jürgens H, Schober O. J Nucl Med. 2002 Aug;43(8):1012-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43445

Study title: Frater C, Emmett L, van Gaal W, Sungaran J, Devakumar D, Van der Wall H. A critical appraisal of pinhole scintigraphy of the ankle and foot. Clin Nucl Med. 2002 Oct;27(10):707-10. Frater C, Emmett L, van Gaal W, Sungaran J, Devakumar D, Van der Wall H. A critical appraisal of pinhole scintigraphy of the ankle and foot. Clin Nucl Med. 2002 Oct;27(10):707-10.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43436

Study title: Frater C, Van Gaal W, Kannangara S, Van der Wall H. Scintigraphy of injuries to the distal tibiofibular syndesmosis. Clin Nucl Med. 2002 Sep;27(9):625-7. Frater C, Van Gaal W, Kannangara S, Van der Wall H. Scintigraphy of injuries to the distal tibiofibular syndesmosis. Clin Nucl Med. 2002 Sep;27(9):625-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43441

Study title: The bullhead sign: scintigraphic pattern of sternocostoclavicular hyperostosis and pustulotic arthroosteitis. Freyschmidt J, Sternberg A. Eur Radiol. 1998;8(5):807-12.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43532

Study title: Pulmonary arteriovenous malformations in patients with hereditary hemorrhagic telangiectasia. Cottin V, Plauchu H, Bayle JY, Barthelet M, Revel D, Cordier JF. Am J Respir Crit Care Med. 2004 May 1;169(9):994-1000. Epub 2004 Jan 23.Comment in: Am J Respir Crit Care Med. 2004 May 1;169(9):978-9. 2nd reference is published by the same publisher as the first citation.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48224

Study title: Pulmonary arteriovenous malformations: effect of embolization on right-to-left shunt, hypoxemia, and exercise tolerance in 66 patients. Gupta P, Mordin C, Curtis J, Hughes JM, Shovlin CL, Jackson JE. AJR Am J Roentgenol. 2002 Aug;179(2):347-55.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48226

Study title: Pulmonary perfusion after endovascular stenting of pulmonary artery stenosis. Oyen WJ, van Oort AM, Tanke RB, van Mill GJ, Aengevaeren WR, Corstens FH. J Nucl Med. 1995 Nov;36(11):2006-8.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): Oyen WJ 1995.pdf

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Document reference: 48259

Study title: Pulmonary scintigraphic findings in children with pectus excavatum by the comparison of chest radiograph indices. Kao CH, Liao SQ, Wang SJ, Yeh SH. Clin Nucl Med. 1992 Nov;17(11):874-6.

Active substance: TECHNETIUM (99m)

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Document reference: 48274

Study title: Quantification of right to left shunt at rest and during exercise in patients with pulmonary arteriovenous malformations. Whyte MK, Peters AM, Hughes JM, Henderson BL, Bellingan GJ, Jackson JE, Chilvers ER. Thorax. 1992 Oct;47(10):790-6.

Active substance: TECHNETIUM (99m)

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Document reference: 48275

Study title: Quantitative lung perfusion scintigraphy in postoperative evaluation of congenital right ventricular outflow tract obstructive lesions. Kim JH, Lee DS, Chung JK, Lee MC, Kim YW, Yun YS, Yeon KM, Koh CS. Clin Nucl Med. 1996 Jun;21(6):471-6.

Active substance: TECHNETIUM (99m)

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Document reference: 48252

Study title: Reduced effect of inhaled beta 2-adrenergic agonists on lung mucociliary clearance in patients with cystic fibrosis. Mortensen J, Hansen A, Falk M, Nielsen IK, Groth S Chest. 1993 Mar;103(3):805-11.

Active substance: TECHNETIUM (99m)

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Document reference: 48273

Study title: Reversal of intrapulmonary shunting in cirrhosis after liver transplantation demonstrated by perfusion lung scan. Levin DP, Pison CF, Brandt M, Weber A, Paradis K, Laberge JM, Blanchard H. J Nucl Med. 1991 May;32(5):862-4.

Active substance: TECHNETIUM (99m)

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Document reference: 48281

Study title: Reversal of severe hepato-pulmonary syndrome in congenital hepatic fibrosis after living-related liver transplantation. Nagral A, Nabi F, Humar A, Nagral S, Doctor N, Khubchandani SR, Amdekar YK Indian J Gastroenterol. 2007 Mar-Apr;26(2):88-9

Active substance: TECHNETIUM (99m)

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Document reference: 48221

Study title: Reversed ventilation-perfusion mismatch involving a pediatric patient in congestive heart failure. Zucker I, Heyman S, Ozdemir S. J Nucl Med. 1997 Nov;38(11):1681-3.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): Zucker I 1997.pdf

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Document reference: 48245

Study title: Right-to-left pulmonary shunting in pediatric hepatopulmonary syndrome. Murakami JW, Rosenbaum DM. Clin Nucl Med. 1999 Nov;24(11):897.

Active substance: TECHNETIUM (99m)

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Document reference: 48237

Study title: A MULTI-INDEPENDENT, OPEN LABELLED, STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PUBERTAL CHILDREN, WITH CHRONIC RENAL INSUFFICIENCY

Active substance: Somatropin

Study summary document link (including results): 90-057 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41718

Study title: A MULTI-INDEPENDENT, OPEN-LABELED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT PREPUBERTAL CHILDREN WITH

Active substance: Somatropin

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Document reference: 41697

Study title: A MULTI-INDEPENDENT, OPEN-LABELED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT PUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY

Active substance: Somatropin

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Document reference: 41698

Study title: A MULTI-INDEPENDENT, OPEN-LABELED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT PUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY

Active substance: Somatropin

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Document reference: 41699

Study title: A MULTI-INDEPENDENT, OPEN-LABELLED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY

Active substance: Somatropin

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Document reference: 41693

Study title: A MULTI-INDEPENDENT, OPEN-LABELLED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PREPUBERTAL CHILDREN, WITH CHRONIC RENAL INSUFFICIENCY

Active substance: Somatropin

Study summary document link (including results): 90-056 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41719

Study title: A MULTI-INDEPENDENT, OPENLABELLED, STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PREPUBERTAL CHILDREN, WITH CHRONIC RENAL INSUFFICIENCY.

Active substance: Somatropin

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Document reference: 41700

Study title: A MULTI-INDEPENDENT, OPENLABELLED, STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PUBERTAL CHILDREN, WITH CHRONIC RENAL INSUFFICIENCY

Active substance: Somatropin

Study summary document link (including results): TRN 91-009 and 91-010 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41707

Study title: A MULTI-INDEPENDENT,OPENLABELLED, STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY.

Active substance: Somatropin

Study summary document link (including results): TRN 91-109 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41692

Study title: A multi-location clinical study of the effects of biosynthesized 191 AA (rhGH) Growth Hormone in the Treatment of Pituitary Dwarfism

Active substance: Somatropin

Study summary document link (including results): 86-075 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41742

Study title: A MULTICENTER TRIAL EVALUATING THE EFFICACY AND SAFETY OF SOMATROPIN IN SHORT CHILDREN BORN SMALL-FOR GESTATIONAL AGE

Active substance: Somatropin

Study summary document link (including results): 307-MET-0021-001 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41641

Study title: A MULTICENTER, RANDOMIZED, DOUBLEBLIND PLACEBO-CONTROLLED TRIAL EVALUATING THE METABOLIC AND RESPIRATORY EFFECTS OF SOMATROPIN IN CHILDREN WITH CYSTIC FIBROSIS

Active substance: Somatropin

Study summary document link (including results): 307-MET-9002-026 PhRMA Web Synopsis.pdf

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Document reference: 41746

Study title: A multicentre study of the acceptability and convenience of administering growth hormone treatment by means of an injection pen delivery system (NordiJect)

Active substance: Somatropin

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Document reference: 41807

Study title: Etchebehere EC, Caron M, Pereira JA, Lima MC, Santos AO, Ramos CD, Barros FB, Sanches A, Santos-Jesus R, Belangero W, Camargo EE. Activation of the growth plates on three-phase bone scintigraphy: the explanation for the overgrowth of fractured femurs. Eur J Nucl Med. 2001 Jan;28(1):72-80. Etchebehere EC, Caron M, Pereira JA, Lima MC, Santos AO, Ramos CD, Barros FB, Sanches A, Santos-Jesus R, Belangero W, Camargo EE. Activation of the growth plates on three-phase bone scintigraphy: the explanation for the overgrowth of fractured femurs. Eur J Nucl Med. 2001 Jan;28(1):72-80.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43459

Study title: Govrin-Yehudain J, Kogan L, Cohen HI, Falik-Zaccai TC. Familial juvenile hypertrophy of the breast. Journal of Adolescent Health 2004; 35(2):151-155.Govrin-Yehudain J, Kogan L, Cohen HI, Falik-Zaccai TC. Familial juvenile hypertrophy of the breast. Journal of Adolescent Health 2004; 35(2):151-155.

Active substance: TAMOXIFEN

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Document reference: 43092

Study title: Gs alpha-related precocious puberty in females: focus on treatment. Hannon TS. Journal of Pediatric Endocrinology 2006; 19:Suppl-6.Gs alpha-related precocious puberty in females: focus on treatment. Hannon TS. Journal of Pediatric Endocrinology 2006; 19:Suppl-6.

Active substance: TAMOXIFEN

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Document reference: 43256

Study title: Gynaecomastia: aetiology and treatment options [Review]. .Gynaecomastia: aetiology and treatment options [Review]. .

Active substance: TAMOXIFEN

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Document reference: 43290

Study title: Gynecomastia - clinical and therapeutic aspects. [Serbian]. Gynecomastia - clinical and therapeutic aspects. [Serbian].

Active substance: TAMOXIFEN

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Document reference: 43306

Study title: Gynecomastia. Tolis G, Karalis K, Kyriakos GM. Current Therapy in Endocrinology & Metabolism 1994; 5:370-371.Gynecomastia. Tolis G, Karalis K, Kyriakos GM. Current Therapy in Endocrinology & Metabolism 1994; 5:370-371.

Active substance: TAMOXIFEN

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Document reference: 43305

Study title: Gynecomasties pubertaires. Gynecomasties pubertaires.

Active substance: TAMOXIFEN

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Document reference: 43312

Study title: Haddad NARA, E-mail: nhaddad@iupui.edu], Eugster E. An update on the treatment of precocious puberty in McCune-Albright syndrome and testotoxicosis. Journal of Pediatric Endocrinology & Metabolism~ 20(6):653-661, JUN 2007 2007;(6):-661, JUN.Haddad NARA, E-mail: nhaddad@iupui.edu], Eugster E. An update on the treatment of precocious puberty in McCune-Albright syndrome and testotoxicosis. Journal of Pediatric Endocrinology & Metabolism~ 20(6):653-661, JUN 2007 2007;(6):-661, JUN.

Active substance: TAMOXIFEN

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Document reference: 43086

Study title: Hall WA, Doolittle ND, Daman M, Bruns PK, Muldoon L, Fortin D et al. Osmotic blood-brain barrier disruption chemotherapy for diffuse pontine gliomas. Journal of Neuro-Oncology 2006; 77(3):279-284.Hall WA, Doolittle ND, Daman M, Bruns PK, Muldoon L, Fortin D et al. Osmotic blood-brain barrier disruption chemotherapy for diffuse pontine gliomas. Journal of Neuro-Oncology 2006; 77(3):279-284.

Active substance: TAMOXIFEN

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Document reference: 43088

Study title: Hannon TS. Gs alpha-related precocious puberty in females: focus on treatment. Journal of Pediatric Endocrinology 2006; 19:Suppl-6.Hannon TS. Gs alpha-related precocious puberty in females: focus on treatment. Journal of Pediatric Endocrinology 2006; 19:Suppl-6.

Active substance: TAMOXIFEN

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Document reference: 43089

Study title: Hansmann A, Adolph C, Vogel T, Unger A, Moeslein G. High-Dose Tamoxifen and Sulindac as First-Line Treatment for Desmoid Tumors. Cancer 100(3)()(pp 612-620), 2004 Date of Publication: 01 Feb 2004 2004;(3):612-620.Hansmann A, Adolph C, Vogel T, Unger A, Moeslein G. High-Dose Tamoxifen and Sulindac as First-Line Treatment for Desmoid Tumors. Cancer 100(3)()(pp 612-620), 2004 Date of Publication: 01 Feb 2004 2004;(3):612-620.

Active substance: TAMOXIFEN

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Document reference: 43093

Study title: Frier M, Wastie ML. To report or not? Nucl Med Commun. 1997 Jun;18(6):589. No abstract available. Frier M, Wastie ML. To report or not? Nucl Med Commun. 1997 Jun;18(6):589. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43549

Study title: Which diphosphonate for routine bone scintigraphy (MDP, HDP or DPD)?Frühling J, Verbist A, Balikdjian D. Nucl Med Commun. 1986 Jun;7(6):415-25.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43906

Study title: Fujimoto R, Higashi T, Nakamoto Y, Hara T, Lyshchik A, Ishizu K, Kawashima H, Kawase S, Fujita T, Saga T, Togashi K. Diagnostic accuracy of bone metastases detection in cancer patients: comparison between bone scintigraphy and whole-body FDG-PET. Ann Nucl Med. 2006 Jul;20(6):399-408. Fujimoto R, Higashi T, Nakamoto Y, Hara T, Lyshchik A, Ishizu K, Kawashima H, Kawase S, Fujita T, Saga T, Togashi K. Diagnostic accuracy of bone metastases detection in cancer patients: comparison between bone scintigraphy and whole-body FDG-PET. Ann Nucl Med. 2006 Jul;20(6):399-408.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43371

Study title: Fujimoto R, Higashi T, Nakamoto Y, Hara T, Lyshchik A, Ishizu K, Kawashima H, Kawase S, Fujita T, Saga T, Togashi K. Diagnostic accuracy of bone metastases detection in cancer patients: comparison between bone scintigraphy and whole-body FDG-PET. Ann Nucl Med. 2006 Jul;20(6):399-408. Fujimoto R, Higashi T, Nakamoto Y, Hara T, Lyshchik A, Ishizu K, Kawashima H, Kawase S, Fujita T, Saga T, Togashi K. Diagnostic accuracy of bone metastases detection in cancer patients: comparison between bone scintigraphy and whole-body FDG-PET. Ann Nucl Med. 2006 Jul;20(6):399-408.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44146

Study title: Maddalozzo J, Tenta LT, Hutchinson LR, Crawford SE, Morse DS. Juvenile fibromatosis: Hormonal receptors. International Journal of Pediatric Otorhinolaryngology 1993; 25(1-3):191-199.Maddalozzo J, Tenta LT, Hutchinson LR, Crawford SE, Morse DS. Juvenile fibromatosis: Hormonal receptors. International Journal of Pediatric Otorhinolaryngology 1993; 25(1-3):191-199.

Active substance: TAMOXIFEN

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Document reference: 43160

Study title: Male breast disorders in Jordan - Disease patterns and management problems. Male breast disorders in Jordan - Disease patterns and management problems.

Active substance: TAMOXIFEN

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Document reference: 43269

Study title: Management of familial polyposis coli [French]. Management of familial polyposis coli [French].

Active substance: TAMOXIFEN

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Document reference: 43277

Study title: Management of gynaecomastia: an update [Review]. Management of gynaecomastia: an update [Review].

Active substance: TAMOXIFEN

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Document reference: 43251

Study title: Management of recurrent desmoid tumor after surgery and radiation: role of cytotoxic and non-cytotoxic therapies. Management of recurrent desmoid tumor after surgery and radiation: role of cytotoxic and non-cytotoxic therapies.

Active substance: TAMOXIFEN

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Document reference: 43289

Study title: Mastronardi l, Puzzilli F, Ruggeri A. Tamoxifen as a potential treatment of glioma. (Review, 65 refs). Anti-cancer Drugs 1998;9(7):581-586 1998;(7):581-586.Mastronardi l, Puzzilli F, Ruggeri A. Tamoxifen as a potential treatment of glioma. (Review, 65 refs). Anti-cancer Drugs 1998;9(7):581-586 1998;(7):581-586.

Active substance: TAMOXIFEN

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Document reference: 43114

Study title: McAuliffe PF, Cance WG. Preemptive surgery. Surgery (St Louis) 2006 ; 140(1):1-5.McAuliffe PF, Cance WG. Preemptive surgery. Surgery (St Louis) 2006 ; 140(1):1-5.

Active substance: TAMOXIFEN

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Document reference: 43135

Study title: [Left distal femoral diaphysis-metaphyseal injury in a 13-year-old patient] Spanish. Delgado García M, Mitjavila Casanovas M, Balsa Bretón MA, Castillejos Rodríguez L, Alonso García P, Cañamaque García L, Penín González J, Pey Illera C. Rev Esp Med Nucl. 2000 Sep;19(5):356-60. Spanish.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44251

Study title: Bone scintigraphy in calcific discitis of childhood.Delpassand ES, Barron BJ, Gundzik JM. J Nucl Med. 1990 Feb;31(2):234-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43768

Study title: Delpassand ES, Dhekne RD, Barron BJ, Moore WH. Evaluation of soft tissue injury by Tc-99m bone agent scintigraphy. Clin Nucl Med. 1991 May;16(5):309-14. Delpassand ES, Dhekne RD, Barron BJ, Moore WH. Evaluation of soft tissue injury by Tc-99m bone agent scintigraphy. Clin Nucl Med. 1991 May;16(5):309-14.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43740

Study title: Dey HM, Spencer RP. Asymmetrical humeral head activity after therapeutic irradiation. Clin Nucl Med. 1988 Sep;13(9):681. No abstract available. Dey HM, Spencer RP. Asymmetrical humeral head activity after therapeutic irradiation. Clin Nucl Med. 1988 Sep;13(9):681. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43810

Study title: Imaging of non-central nervous system primitive neuroectodermal tumours: diagnostic features and correlation with outcome. Dick EA, McHugh K, Kimber C, Michalski A. Clin Radiol. 2001 Mar;56(3):206-15.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43457

Study title: Discovery of a renal medullary carcinoma in an adolescent male with sickle cell trait by Tc-99m methylene disphosponate bone scintigraphy. Brown JM. Berkey BD, Brooks JA. Clin Nucl Med 2008;33:896-900

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48466

Study title: Djupesland G, Nakken KF, Müller C, Skjørten F, Tøhrt R, Eldevik P. Bone scintigraphy in the diagnosis of fracture and infection of the temporal bone. Acta Otolaryngol. 1983 May-Jun;95(5-6):670-5. Djupesland G, Nakken KF, Müller C, Skjørten F, Tøhrt R, Eldevik P. Bone scintigraphy in the diagnosis of fracture and infection of the temporal bone. Acta Otolaryngol. 1983 May-Jun;95(5-6):670-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44036

Study title: Dodig D, Domljan Z, Popović S, Simonović I. Effect of imaging time on the values of the sacroiliac index. Eur J Nucl Med. 1988;14(9-10):504-6. Dodig D, Domljan Z, Popović S, Simonović I. Effect of imaging time on the values of the sacroiliac index. Eur J Nucl Med. 1988;14(9-10):504-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43834

Study title: Influence of age on quantitative sacro-iliac joint imaging. Dodig D, Popović S, Domljan Z. Eur J Nucl Med. 1984;9(4):177-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44016

Study title: Dolen EG, Berdon WE, Ruzal-Shapiro C. "Cold bone scans" as a sign of hemorrhagic infarcts of the spine in Gaucher's disease. Pediatr Radiol. 1997 Jun;27(6):514-6. Dolen EG, Berdon WE, Ruzal-Shapiro C. "Cold bone scans" as a sign of hemorrhagic infarcts of the spine in Gaucher's disease. Pediatr Radiol. 1997 Jun;27(6):514-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43550

Study title: Warbey VS, Schleyer PJ, Barrington SF, O’Doherty MJ. The new EANM paediatric dosage card – does it conform to ALARA for PET/CT? [warbey-2007]Eur J Nucl Med Mol Imaging 2007; 34 : 1881 - 1882. Schleyer PJ 2007

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48710

Study title: Wickmann L, Lüders H, Dörffel W.. [18- FDG-PET-findings in children and adolescents with Hodgkin's disease: retrospective evaluation of the correlation to other imaging procedures in initial staging and to the predictive value of follow up examinations] [Translated] [wickmann-2003-en]Klin Padiatr. 2003 May-Jun;215(3):146-50. Wickmann L 2003

Active substance: Steripet

Study summary document link (including results): 2011-09 GE response Template List of published articles.doc

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Document reference: 48711

Study title: Treatment of toxoplasmosis in the pregnant mother and newborn child - Stray-Pedersen B. Dept of Gynecology and Obstetrics, Aker Hospital, University of Oslo,0514 Oslo Norway Scandinavian Journal of Infectious Diseases, Supplement ( SCAND. J. INFECT. DIS. SUPPL. ) (Norway) 1992, 23/84 (23-31)Treatment of toxoplasmosis in the pregnant mother and newborn child - Stray-Pedersen B. Dept of Gynecology and Obstetrics, Aker Hospital, University of Oslo,0514 Oslo Norway Scandinavian Journal of Infectious Diseases, Supplement ( SCAND. J. INFECT. DIS. SUPPL. ) (Norway) 1992, 23/84 (23-31)

Active substance: SPIRAMYCIN

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Document reference: 42595

Study title: Treatment of toxoplasmosis in the pregnant mother and newborn child - Stray-Pedersen B. Dept of Gynecology and Obstetrics, Aker Hospital, University of Oslo,0514 Oslo Norway Scandinavian Journal of Infectious Diseases, Supplement ( SCAND. J. INFECT. DIS. SUPPL. ) (Norway) 1992, 23/84 (23-31)Treatment of toxoplasmosis in the pregnant mother and newborn child - Stray-Pedersen B. Dept of Gynecology and Obstetrics, Aker Hospital, University of Oslo,0514 Oslo Norway Scandinavian Journal of Infectious Diseases, Supplement ( SCAND. J. INFECT. DIS. SUPPL. ) (Norway) 1992, 23/84 (23-31)

Active substance: SPIRAMYCIN

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Document reference: 42598

Study title: Use of Spiramycin in the treatmetn of inflammatory diseases of the respiratory tract in children in ambulatory conditions - Otsiians EN, Rziankina MF, D'iachenko VG, Suleimanov SSh, Zakharova EI, Bachaldina OM. - Antiobiot Khimioter 1998; 43(11):34-7.Use of Spiramycin in the treatmetn of inflammatory diseases of the respiratory tract in children in ambulatory conditions - Otsiians EN, Rziankina MF, D'iachenko VG, Suleimanov SSh, Zakharova EI, Bachaldina OM. - Antiobiot Khimioter 1998; 43(11):34-7.

Active substance: SPIRAMYCIN

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Document reference: 42596

Study title: A Multicenter, Double–Blind, Vehicle Controlled Study of Topical 5% Spironolactone Cream in the Treatment of Nodulocystic Acne

Active substance: SPIRONOLACTONE

Study summary document link (including results): S84-89-02-016 EMEA Paediatric Web Synopsis.pdf

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Document reference: 42601

Study title: Relazione clinica sull'impiego dello spironolattone quale agente sodiuretico.

Active substance: SPIRONOLACTONE

Study summary document link (including results): Spironolactone STUDY Dallavolta.xls

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Document reference: 47995

Study title: Multizentrische, nicht-randomisierte offene Anwendungs-beobachtung mit Texx 300

Active substance: (St. John´s wort) dry extract (4,1-7,1:1)

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Document reference: 39752

Study title: ACTG 338 Week 48 Analysis Report, A Phase II Rolling Arm Protocol (PRAM) of Novel Antiretroviral Therapy in Stable Experienced HIV- Infected Children

Active substance: stavudine

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Document reference: 41614

Study title: Blake GM et al. Strontium-89 therapy: strontium kinetics and dosimetry in two patients treated for metastasizing osteosarcoma. Blake GM 1987 Br J Radiol. 1987 Mar; 60(711):253-9

Active substance: STRONTIUM 89

Study summary document link (including results): 2011-09 GE Metastron response List of published articles.doc

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Document reference: 48216

Study title: Bone pain palliation with strontium-89 in children. Giammarile F 1998 Med Pediatr Oncol. 1998 Mar; 30(3):199-200 F Giammarile et al.

Active substance: STRONTIUM 89

Study summary document link (including results): 2011-09 GE Metastron response List of published articles.doc

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Document reference: 48213

Study title: Pain palliation with strontium-89 in children with metastatic disease Charron M 1996 Med Pediatr Oncol. 1996 Jun; 26(6):393-6

Active substance: STRONTIUM 89

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Document reference: 48212

Study title: Strontium-89 for palliation of bone pain. Gompakis N 2003 Med Pediatr Oncol. 2003 Feb;40(2):136 Gompakis N et al

Active substance: STRONTIUM 89

Study summary document link (including results): 2011-09 GE Metastron response List of published articles.doc

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Document reference: 48214

Study title: Caries prevention with fluoride varnish in a socially deprived community

Active substance: SODIUM FLUORIDE

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Document reference: 42444

Study title: Harrison SA, Neuschwander Tetri BA. Nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. Clinics In Liver Disease 2004; 8(4):861-879.Harrison SA, Neuschwander Tetri BA. Nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. Clinics In Liver Disease 2004; 8(4):861-879.

Active substance: TAMOXIFEN

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Document reference: 43137

Study title: Hauffa BP. Pubertal gynecomastia 1992; 101-110.Hauffa BP. Pubertal gynecomastia 1992; 101-110.

Active substance: TAMOXIFEN

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Document reference: 43162

Study title: Vizner B, Vilibic T, Brkic K, Vrkljan M, Smircic L, Sekso M. Gynecomastia - clinical and therapeutic aspects. [Serbian]. Acta Clinica Croatica 33(3-4)()(pp 205-212), 1994 Date of Publication: 1994 1994;(3-4):205-212.Vizner B, Vilibic T, Brkic K, Vrkljan M, Smircic L, Sekso M. Gynecomastia - clinical and therapeutic aspects. [Serbian]. Acta Clinica Croatica 33(3-4)()(pp 205-212), 1994 Date of Publication: 1994 1994;(3-4):205-212.

Active substance: TAMOXIFEN

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Document reference: 43122

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.

Active substance: TAMOXIFEN

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Document reference: 43105

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.

Active substance: TAMOXIFEN

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Document reference: 43126

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515.

Active substance: TAMOXIFEN

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Document reference: 43145

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515.

Active substance: TAMOXIFEN

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Document reference: 43165

Study title: Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.

Active substance: TAMOXIFEN

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Document reference: 43120

Study title: Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.

Active substance: TAMOXIFEN

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Document reference: 43132

Study title: Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994; 79(2):51Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994; 79(2):51

Active substance: TAMOXIFEN

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Document reference: 43156

Study title: Ludemann JP, Hughes CA, Bouzoukis J, Maddalozzo J, Goldman S. Aggressive Fibromatosis of the Neck in Two Brothers: Diagnostic and Therapeutic Implications. Journal of Otolaryngology 1999;28(5):288-292 1999;(5):288-292.Ludemann JP, Hughes CA, Bouzoukis J, Maddalozzo J, Goldman S. Aggressive Fibromatosis of the Neck in Two Brothers: Diagnostic and Therapeutic Implications. Journal of Otolaryngology 1999;28(5):288-292 1999;(5):288-292.

Active substance: TAMOXIFEN

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Document reference: 43109

Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000; 22(3):247.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000; 22(3):247.

Active substance: TAMOXIFEN

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Document reference: 43167

Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000; 22(3):247.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000; 22(3):247.

Active substance: TAMOXIFEN

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Document reference: 43172

Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000; 22(3):247.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000; 22(3):247.

Active substance: TAMOXIFEN

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Document reference: 43178

Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.

Active substance: TAMOXIFEN

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Document reference: 43224

Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.

Active substance: TAMOXIFEN

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Document reference: 43234

Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.

Active substance: TAMOXIFEN

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Document reference: 43244

Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.

Active substance: TAMOXIFEN

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Document reference: 43326

Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137

Active substance: TAMOXIFEN

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Document reference: 43333

Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.

Active substance: TAMOXIFEN

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Document reference: 43344

Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.

Active substance: TAMOXIFEN

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Document reference: 43354

Study title: Caries prevention with fluoride varnish in a socially deprived community

Active substance: SODIUM FLUORIDE

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Document reference: 42557

Study title: Caries prevention with fluoride varnishes among preschool children.

Active substance: SODIUM FLUORIDE

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Document reference: 42344

Study title: Caries prevention with fluoride varnishes among preschool children.

Active substance: SODIUM FLUORIDE

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Document reference: 42457

Study title: Caries prophylaxis by local application of sodium fluoride lacquer

Active substance: SODIUM FLUORIDE

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Document reference: 42441

Study title: Caries prophylaxis by local application of sodium fluoride lacquer

Active substance: SODIUM FLUORIDE

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Document reference: 42554

Study title: Caries prophylaxis by means of local application of sodium fluoride lacquer

Active substance: SODIUM FLUORIDE

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Document reference: 42442

Study title: Caries prophylaxis by means of local application of sodium fluoride lacquer

Active substance: SODIUM FLUORIDE

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Document reference: 42555

Study title: Caries prevention with Duraphat in a new application form].

Active substance: SODIUM FLUORIDE

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Document reference: 42525

Study title: Caries prevention with Duraphat in a new applications form].

Active substance: SODIUM FLUORIDE

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Document reference: 42411

Study title: Caries prophylaxis by topical application of sodium fluoride varnish

Active substance: SODIUM FLUORIDE

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Document reference: 42440

Study title: Caries prophylaxis by topical application of sodium fluoride varnish

Active substance: SODIUM FLUORIDE

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Document reference: 42553

Study title: Caries-preventive effect of a fluoride-containing lacquer, Duraphat, evaluated in a clinical study

Active substance: SODIUM FLUORIDE

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Document reference: 42373

Study title: Caries-preventive effect of a fluoride-containing lacquer, Duraphat, evaluated in a clinical study

Active substance: SODIUM FLUORIDE

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Document reference: 42486

Study title: Caries-preventive effect of fluoride varnish with different fluoride concentrations.

Active substance: SODIUM FLUORIDE

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Document reference: 42423

Study title: Caries-preventive effect of fluoride varnish with different fluoride concentrations.

Active substance: SODIUM FLUORIDE

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Document reference: 42536

Study title: Caries-preventive effects of fluoride products when used in conjunction with fluoride dentifrice.

Active substance: SODIUM FLUORIDE

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Document reference: 42445

Study title: Caries-preventive effects of fluoride products when used in conjunction with fluoride dentifrice.

Active substance: SODIUM FLUORIDE

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Document reference: 42558

Study title: Chemical changes and surface morphology of acid-etching of human enamel treated with topical fluoride agents in vitro.

Active substance: SODIUM FLUORIDE

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Document reference: 42364

Study title: Chemical changes and surface morphology of acid-etching of human enamel treated with topical fluoride agents in vitro.

Active substance: SODIUM FLUORIDE

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Document reference: 42477

Study title: Christen F, Hotz P. [Long-term effect of fluoride prophylaxis: a follow-up study of 151 subjects 13 to 15 years after tablet fluoridation] SSO Schweiz Monatsschr Zahnheilkd. 1981 Nov;91(11):932-9. German.Christen F, Hotz P. [Long-term effect of fluoride prophylaxis: a follow-up study of 151 subjects 13 to 15 years after tablet fluoridation] SSO Schweiz Monatsschr Zahnheilkd. 1981 Nov;91(11):932-9. German.

Active substance: SODIUM FLUORIDE

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Document reference: 42252

Study title: Christen F, Hotz P. [Long-term effect of fluoride prophylaxis: a follow-up study of 151 subjects 13 to 15 years after tablet fluoridation] SSO Schweiz Monatsschr Zahnheilkd. 1981 Nov;91(11):932-9. German.Christen F, Hotz P. [Long-term effect of fluoride prophylaxis: a follow-up study of 151 subjects 13 to 15 years after tablet fluoridation] SSO Schweiz Monatsschr Zahnheilkd. 1981 Nov;91(11):932-9. German.

Active substance: SODIUM FLUORIDE

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Document reference: 42284

Study title: Archer D, Babyn P, Gilday D, Greenberg MA. Potentially misleading bone scan findings in patients with hepatoblastoma. Clin Nucl Med. 1993 Dec;18(12):1026-31. Archer D, Babyn P, Gilday D, Greenberg MA. Potentially misleading bone scan findings in patients with hepatoblastoma. Clin Nucl Med. 1993 Dec;18(12):1026-31.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43643

Study title: Aronson J, Garvin K, Seibert J, Glasier C, Tursky EA. Efficiency of the bone scan for occult limping toddlers. J Pediatr Orthop. 1992 Jan;12(1):38-44. Aronson J, Garvin K, Seibert J, Glasier C, Tursky EA. Efficiency of the bone scan for occult limping toddlers. J Pediatr Orthop. 1992 Jan;12(1):38-44.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43713

Study title: Aso K, Amano M, Sekiya S, Komatani A. [Scintigraphic investigation of the clavicular bone area in patients with psoriasis] Nippon Hifuka Gakkai Zasshi. 1984 Nov;94(13):1515-20. Japanese. No abstract Aso K, Amano M, Sekiya S, Komatani A. [Scintigraphic investigation of the clavicular bone area in patients with psoriasis] Nippon Hifuka Gakkai Zasshi. 1984 Nov;94(13):1515-20. Japanese. No abstract

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43977

Study title: Auringer ST, Sumner TE. Calyceal diverticulum. Focal renal uptake on bone scan. Clin Nucl Med. 1992 Feb;17(2):142. No abstract available. Auringer ST, Sumner TE. Calyceal diverticulum. Focal renal uptake on bone scan. Clin Nucl Med. 1992 Feb;17(2):142. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43708

Study title: Auvert-Colin L, Couret I, Fajon O, Rossi M. [Scintigraphy with radiolabeled granulocytes for the detection of peripheral septic osteoarticular sites] Rev Rhum Ed Fr. 1993 Dec;60(12):871-8. French. Auvert-Colin L, Couret I, Fajon O, Rossi M. [Scintigraphy with radiolabeled granulocytes for the detection of peripheral septic osteoarticular sites] Rev Rhum Ed Fr. 1993 Dec;60(12):871-8. French.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43645

Study title: Ayabe K, Higashi K, Oguchi M, Taniguchi M, Motomura Y, Tonami H, Okimura T, Yamamoto I, Niimura J, Koh E. Photopenic area visualized on bone scintigraphy in a patient with eosinophilic granuloma. Clin Nucl Med. 1999 Mar;24(3):184-5. No abstract available. Ayabe K, Higashi K, Oguchi M, Taniguchi M, Motomura Y, Tonami H, Okimura T, Yamamoto I, Niimura J, Koh E. Photopenic area visualized on bone scintigraphy in a patient with eosinophilic granuloma. Clin Nucl Med. 1999 Mar;24(3):184-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44255

Study title: Ayres R, Curry NS, Gordon L, Bradford BF. Renal metastases from osteogenic sarcoma. Urol Radiol. 1985;7(1):39-41. Ayres R, Curry NS, Gordon L, Bradford BF. Renal metastases from osteogenic sarcoma. Urol Radiol. 1985;7(1):39-41.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43969

Study title: Bahk YW, Kim SH, Chung SK, Kim JH. Dual-head pinhole bone scintigraphy. J Nucl Med. 1998 Aug;39(8):1444-8. Erratum in: J Nucl Med 1998 Dec;39(12):2127. Bahk YW, Kim SH, Chung SK, Kim JH. Dual-head pinhole bone scintigraphy. J Nucl Med. 1998 Aug;39(8):1444-8. Erratum in: J Nucl Med 1998 Dec;39(12):2127.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43529

Study title: Banovac K. The effect of etidronate on late development of heterotopic ossification after spinal cord injury. J Spinal Cord Med. 2000 Spring;23(1):40-4. Banovac K. The effect of etidronate on late development of heterotopic ossification after spinal cord injury. J Spinal Cord Med. 2000 Spring;23(1):40-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43486

Study title: Bar-Sever Z, Connolly LP, Gebhardt MC, Treves ST. Scintigraphy of lower extremity cadaveric bone allografts in osteosarcoma patients. Clin Nucl Med. 1997 Aug;22(8):532-5. Bar-Sever Z, Connolly LP, Gebhardt MC, Treves ST. Scintigraphy of lower extremity cadaveric bone allografts in osteosarcoma patients. Clin Nucl Med. 1997 Aug;22(8):532-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44257

Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251.

Active substance: TAMOXIFEN

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Document reference: 43186

Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251.

Active substance: TAMOXIFEN

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Document reference: 43196

Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251.

Active substance: TAMOXIFEN

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Document reference: 43206

Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000; 22(3):247.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000; 22(3):247.

Active substance: TAMOXIFEN

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Document reference: 43147

Study title: Bomanji J, Nagaraj N, Jewkes R, Fields M, Maini RN. Pachydermoperiostosis: technetium-99m-methylene diphosphonate scintigraphic pattern. J Nucl Med. 1991 Oct;32(10):1907-9. Bomanji J, Nagaraj N, Jewkes R, Fields M, Maini RN. Pachydermoperiostosis: technetium-99m-methylene diphosphonate scintigraphic pattern. J Nucl Med. 1991 Oct;32(10):1907-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43725

Study title: Bone scanning in the adductor insertion avulsion syndrome ("thigh splints"). Charkes ND, Siddhivarn N, Schneck CD. J Nucl Med 1987 Dec;28{12):1835-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48469

Study title: Bone scintigraphy in calcific discitis of childhood.Delpassand ES, Barron BJ, Gundzik JM. J Nucl Med 1990 31{2):234-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48475

Study title: Bonnin F, Buvat I, Benali H, Di Paola R. A comparative study of scatter correction methods for scintigraphic images. Eur J Nucl Med. 1994 May;21(5):388-93. Bonnin F, Buvat I, Benali H, Di Paola R. A comparative study of scatter correction methods for scintigraphic images. Eur J Nucl Med. 1994 May;21(5):388-93.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43626

Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.

Active substance: TAMOXIFEN

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Document reference: 43248

Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin 2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999; 17(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin 2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999; 17(3):968-975.

Active substance: TAMOXIFEN

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Document reference: 43316

Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.

Active substance: TAMOXIFEN

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Document reference: 43325

Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination WiRosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination Wi

Active substance: TAMOXIFEN

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Document reference: 43332

Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination WiRosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination Wi

Active substance: TAMOXIFEN

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Document reference: 43335

Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.

Active substance: TAMOXIFEN

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Document reference: 43343

Study title: An Open Label, Randomized, Multi-center, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Risedronate Administered as a Single Oral Dose of 2.5 mg or 5 mg in Children ≤ 30 kg and 5 mg or 10 mg in Children> 30 kg with Osteogenesis Imperfecta

Active substance: RISEDRONIC ACID

Study summary document link (including results): Risedronate sodium- Study 2.pdf

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Document reference: 35390

Study title: Assessing the safety and efficacy of Actonel in children ages 4-14 with mild Osteogenesis Imperfecta  -F.Glorieux (abstract available)  Assessing the safety and efficacy of Actonel in children ages 4-14 with mild Osteogenesis Imperfecta  -F.Glorieux (abstract available)

Active substance: RISEDRONIC ACID

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Document reference: 35388

Study title: 6 weeks 1st episode psychosis (minimum age 15 years)

Active substance: RISPERIDONE

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Document reference: 35393

Study title: 6-week, prospective, randomized, double-blind, placebo-controlled trial.

Active substance: RISPERIDONE

Study summary document link (including results): RIS-NED-9_Interventional_Risperidone.xls

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Document reference: 47260

Study title: A double-blind , placebo-controlled study of risperidone in children and adolescents with autistic disorder

Active substance: RISPERIDONE

Study summary document link (including results): RIS-USA-150_Interventional_Risperidone.xls

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Document reference: 35418

Study title: "Alpha-Project" Long time Neuroleptic Therapy with Risperidone, age of the patients 14-85. To acquire - modalities of administration of RISPERDAL, mode and frequency of adverse reactions, mode and extent of therapeutic action of RISPERDAL under the routine of daily practice.

Active substance: RISPERIDONE

Study summary document link (including results): AlphaProject_Non-interventional_Risperidone.xls

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Document reference: 35410

Study title: Children and adolescents (5-17 yrs) with Conduct or other DBD

Active substance: RISPERIDONE

Study summary document link (including results): RIS-INT-79_Interventional_Risperidone.xls

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Document reference: 35427

Study title: Children and adolescents (5-17 yrs) with Conduct or other DBD

Active substance: RISPERIDONE

Study summary document link (including results): RIS-INT-84_Interventional_Risperidone.xls

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Document reference: 35433

Study title: Children and adolescents (5-17 yrs) with conduct or other OBD.

Active substance: RISPERIDONE

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Document reference: 35414

Study title: Data of 80 subjects aged between 13 and 17 years of age with schizophrenia and who used risperidone for at least one year are to be collected.

Active substance: RISPERIDONE

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Document reference: 35407

Study title: Determination of the pharmacokinetics and safety of risperidone at steady state in children and adolescents 5 to less than 18 years of age.

Active substance: RISPERIDONE

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Document reference: 35434

Study title: Efficacy and safety of risperidone in the treatment of children with autistic disorder and other pervasive developemental disorders: A canadian, multicenter , double-blind, placebo controlled-study.

Active substance: RISPERIDONE

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Document reference: 35420

Study title: Multicenter, multinational retrospective analysis on the safety of Risperdal in adolescent subjects with schizophrenia (13-17 yrs)

Active substance: RISPERIDONE

Study summary document link (including results): RIS-SCH-4083_Non-interventional_Risperidone.xls

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Document reference: 35391

Study title: Non interventional study for optimisation of ambulant therapy-switch to Risperdal (SWITCH), age of patients 16-100

Active substance: RISPERIDONE

Study summary document link (including results): JC-AWB-RIS-0004_Non-interventional_Risperidone.xls

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Document reference: 35412

Study title: Open label, 6-month, multicenter study in adolescents with schizophrenia. Subjects entered from RIS-USA-231 or RIS-SCH-302 or entered directly.

Active substance: RISPERIDONE

Study summary document link (including results): RIS-SCH-302_Interventional_Risperidone.xls

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Document reference: 35406

Study title: Etchebehere EC, Caron M, Pereira JA, Lima MC, Santos AO, Ramos CD, Barros FB, Sanches A, Santos-Jesus R, Belangero W, Camargo EE. Activation of the growth plates on three-phase bone scintigraphy: the explanation for the overgrowth of fractured femurs. Eur J Nucl Med. 2001 Jan;28(1):72-80. Etchebehere EC, Caron M, Pereira JA, Lima MC, Santos AO, Ramos CD, Barros FB, Sanches A, Santos-Jesus R, Belangero W, Camargo EE. Activation of the growth plates on three-phase bone scintigraphy: the explanation for the overgrowth of fractured femurs. Eur J Nucl Med. 2001 Jan;28(1):72-80.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44153

Study title: Etchebehere EC, Caron M, Pereira JA, Lima MC, Santos AO, Ramos CD, Barros FB, Sanches A, Santos-Jesus R, Belangero W, Camargo EE. Activation of the growth plates on three-phase bone scintigraphy: the explanation for the overgrowth of fractured femurs. Eur J Nucl Med. 2001 Jan;28(1):72-80. Etchebehere EC, Caron M, Pereira JA, Lima MC, Santos AO, Ramos CD, Barros FB, Sanches A, Santos-Jesus R, Belangero W, Camargo EE. Activation of the growth plates on three-phase bone scintigraphy: the explanation for the overgrowth of fractured femurs. Eur J Nucl Med. 2001 Jan;28(1):72-80.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44200

Study title: Etchebehere EC, Caron M, Pereira JA, Lima MC, Santos AO, Ramos CD, Barros FB, Sanches A, Santos-Jesus R, Belangero W, Camargo EE. Activation of the growth plates on three-phase bone scintigraphy: the explanation for the overgrowth of fractured femurs. Eur J Nucl Med. 2001 Jan;28(1):72-80. Etchebehere EC, Caron M, Pereira JA, Lima MC, Santos AO, Ramos CD, Barros FB, Sanches A, Santos-Jesus R, Belangero W, Camargo EE. Activation of the growth plates on three-phase bone scintigraphy: the explanation for the overgrowth of fractured femurs. Eur J Nucl Med. 2001 Jan;28(1):72-80.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44247

Study title: Even-Sapir E, Flusser G, Lerman H, Lievshitz G, Metser U. SPECT/multislice low-dose CT: a clinically relevant constituent in the imaging algorithm of nononcologic patients referred for bone scintigraphy. J Nucl Med. 2007 Feb;48(2):319-24. Even-Sapir E, Flusser G, Lerman H, Lievshitz G, Metser U. SPECT/multislice low-dose CT: a clinically relevant constituent in the imaging algorithm of nononcologic patients referred for bone scintigraphy. J Nucl Med. 2007 Feb;48(2):319-24.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43365

Study title: Fang MA, Reinig JW, Hill SC, Marini J, Zasloff MA. Technetium-99m MDP demonstration of heterotopic ossification in fibrodysplasia ossificans progressiva. Clin Nucl Med. 1986 Jan;11(1):8-9. Fang MA, Reinig JW, Hill SC, Marini J, Zasloff MA. Technetium-99m MDP demonstration of heterotopic ossification in fibrodysplasia ossificans progressiva. Clin Nucl Med. 1986 Jan;11(1):8-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43925

Study title: Fehring TK, Green NE. Negative radionuclide scan in osteoid osteoma. A case report. Clin Orthop Relat Res. 1984 May;(185):245-9. Fehring TK, Green NE. Negative radionuclide scan in osteoid osteoma. A case report. Clin Orthop Relat Res. 1984 May;(185):245-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43999

Study title: Feine U, Ahlemann LM. [Periosteal desmoid of the metaphysis; differential diagnosis from malignant bone tumours by bone scintigrams (author's transl)] Rofo. 1981 Aug;135(2):193-6. German. No abstract available. Feine U, Ahlemann LM. [Periosteal desmoid of the metaphysis; differential diagnosis from malignant bone tumours by bone scintigrams (author's transl)] Rofo. 1981 Aug;135(2):193-6. German. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44117

Study title: Fezoulidis I, Wickenhauser J, Schurawitzki H, Gritzmann N. [Histiocytosis X: scintigraphic and roentgenologic findings] Rontgenblatter. 1987 Jul;40(7):234-9. German. Fezoulidis I, Wickenhauser J, Schurawitzki H, Gritzmann N. [Histiocytosis X: scintigraphic and roentgenologic findings] Rontgenblatter. 1987 Jul;40(7):234-9. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43859

Study title: Bos SD, Piers DA, Mensink HJ. Routine bone scan and serum alkaline phosphatase for staging in patients with renal cell carcinoma is not cost-effective. Eur J Cancer. 1995 Dec;31A(13-14):2422-3. No abstract available. Bos SD, Piers DA, Mensink HJ. Routine bone scan and serum alkaline phosphatase for staging in patients with renal cell carcinoma is not cost-effective. Eur J Cancer. 1995 Dec;31A(13-14):2422-3. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43575

Study title: Bouvier JF, Chassard JL, Brunat-Mentigny M, Bobin JY, Domenach M, Roojee N, Riffat G, Mayer M, Lahneche BE. Radionuclide bone imaging in diaphyseal aclasis with malignant change. Cancer. 1986 Jun 15;57(12):2280-4. Bouvier JF, Chassard JL, Brunat-Mentigny M, Bobin JY, Domenach M, Roojee N, Riffat G, Mayer M, Lahneche BE. Radionuclide bone imaging in diaphyseal aclasis with malignant change. Cancer. 1986 Jun 15;57(12):2280-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43905

Study title: Bouvier JF, Philip T, Chauvot P, Brunat Mentigny M, Ducrettet F, Maïassi N, Lahneche BE. Pitfalls and solutions in neuroblastoma diagnosis using radioiodine MIBG: our experience about 50 cases. Prog Clin Biol Res. 1988;271:707-20. Bouvier JF, Philip T, Chauvot P, Brunat Mentigny M, Ducrettet F, Maïassi N, Lahneche BE. Pitfalls and solutions in neuroblastoma diagnosis using radioiodine MIBG: our experience about 50 cases. Prog Clin Biol Res. 1988;271:707-20.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43831

Study title: Bower GD, Sprague P, Geijsel H, Holt K, Lovegrove FT. Isotope bone scans in the assessment of children with hip pain or limp. Pediatr Radiol. 1985;15(5):319-23. Bower GD, Sprague P, Geijsel H, Holt K, Lovegrove FT. Isotope bone scans in the assessment of children with hip pain or limp. Pediatr Radiol. 1985;15(5):319-23.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43961

Study title: Boyd JB, Mulliken JB, Kaban LB, Upton J 3rd, Murray JE. Skeletal changes associated with vascular malformations. Plast Reconstr Surg. 1984 Dec;74(6):789-97. Boyd JB, Mulliken JB, Kaban LB, Upton J 3rd, Murray JE. Skeletal changes associated with vascular malformations. Plast Reconstr Surg. 1984 Dec;74(6):789-97.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43974

Study title: Fujimoto R, Higashi T, Nakamoto Y, Hara T, Lyshchik A, Ishizu K, Kawashima H, Kawase S, Fujita T, Saga T, Togashi K. Diagnostic accuracy of bone metastases detection in cancer patients: comparison between bone scintigraphy and whole-body FDG-PET. Ann Nucl Med. 2006 Jul;20(6):399-408. Fujimoto R, Higashi T, Nakamoto Y, Hara T, Lyshchik A, Ishizu K, Kawashima H, Kawase S, Fujita T, Saga T, Togashi K. Diagnostic accuracy of bone metastases detection in cancer patients: comparison between bone scintigraphy and whole-body FDG-PET. Ann Nucl Med. 2006 Jul;20(6):399-408.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44193

Study title: Fujimoto R, Higashi T, Nakamoto Y, Hara T, Lyshchik A, Ishizu K, Kawashima H, Kawase S, Fujita T, Saga T, Togashi K. Diagnostic accuracy of bone metastases detection in cancer patients: comparison between bone scintigraphy and whole-body FDG-PET. Ann Nucl Med. 2006 Jul;20(6):399-408. Fujimoto R, Higashi T, Nakamoto Y, Hara T, Lyshchik A, Ishizu K, Kawashima H, Kawase S, Fujita T, Saga T, Togashi K. Diagnostic accuracy of bone metastases detection in cancer patients: comparison between bone scintigraphy and whole-body FDG-PET. Ann Nucl Med. 2006 Jul;20(6):399-408.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44240

Study title: Fuller C, Leonard JC. Extraosseous localization of technetium-99m MDP in benign cystic teratoma. Clin Nucl Med. 1986 Aug;11(8):574-6. Fuller C, Leonard JC. Extraosseous localization of technetium-99m MDP in benign cystic teratoma. Clin Nucl Med. 1986 Aug;11(8):574-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43898

Study title: Successful liver transplantation in a child with biliary atresia and hepatopulmonary syndrome. Liang CD, Chen CL, de Villa VH, Tiao MM, Cheng YF. J Formos Med Assoc. 2001 Jun;100(6):403-6.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): Liang CD 2001.pdf

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Document reference: 48227

Study title: Tc-99m MAA total-body imaging to detect intrapulmonary right-to-left shunts and to evaluate the therapeutic effect in pulmonary arteriovenous shunts. Lu G, Shih WJ, Chou C, Xu JY. Clin Nucl Med. 1996 Mar;21(3):197-202.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48255

Study title: The contribution of perfusion scintigraphy in the evaluation of children suffering from recurrent localized pneumonia. Hardoff R, Rivlin J, Front A. Eur J Nucl Med. 1990;17(3-4):152-5.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48284

Study title: The value of bronchodilator administration in asthmatic patients before lung imaging. Roach PJ, Treves ST. Clin Nucl Med. 1995 Jun;20(6):491-3.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48260

Study title: The value of ventilation-perfusion imaging in pregnancy. Balan KK, Critchley M, Vedavathy KK, Smith ML, Vinjamuri S. Br J Radiol. 1997 Apr;70(832):338-40.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48247

Study title: Unexpected myocardial uptake on perfusion lung scan in the hepatopulmonary syndrome. Demirkale P, Mudun A, Karasulu L, Erelel M, Cantez S. Clin Nucl Med. 1999 Aug;24(8):610-1.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48240

Study title: Unilateral ventilation--perfusion mismatch on pulmonary scintigraphy caused by anomalous origin of a pulmonary artery from the innominate artery. Hung GU, Tsai SC, Fu YC, Kao CH. Clin Nucl Med. 2001 Aug;26(8):719-20.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48228

Study title: Use of Tc-99m MAA in determining the etiology of increasing cyanosis following SVC-PA anastomosis for the hypoplastic left heart syndrome. Glass T, Heyman S, Seliem M, Murphy J, Norwood WI. Clin Nucl Med. 1991 Jun;16(6):410-2.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE response Venticoll List of published articles.doc

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Document reference: 48279

Study title: Usefulness of selective contrast echocardiography and selective scintigraphy for the evaluation of pulmonary arteriovenous fistula in a patient with systemic arterial supply to a normal lung. Masutani S, Senzaki H, Taketazu M, Kobayashi J, Kobayashi T, Asano H, Kyo S, Yokote Y. J Pediatr Surg. 2005 Mar;40(3):E51-4

Active substance: TECHNETIUM (99m)

Study summary document link (including results): Masutani S 2005.pdf

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Document reference: 48223

Study title: Clinical relevance of left ventricular volumes and function assessed by gated SPECT in paediatric patients El-Maghraby TAF 2004 Int J Cardiovasc Imaging. 2004 Apr; 20(2):127-34 El-Maghraby TAF et al.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): 2011-09 GE Myoview response List of published articles.doc

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Document reference: 48217

Study title: 107: Kumar R, Sood A, Marwah A, Sharma R, Padhy AK, Moorthy D. Metaphyseal chondrodysplasia: interesting findings on bone scintigraphy. Clin Nucl Med. 2000 Dec;25(12):1047-9. No abstract available. 107: Kumar R, Sood A, Marwah A, Sharma R, Padhy AK, Moorthy D. Metaphyseal chondrodysplasia: interesting findings on bone scintigraphy. Clin Nucl Med. 2000 Dec;25(12):1047-9. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43468

Study title: A MULTICENTRE STUDY ON GROWTH AND METABOLIC EFFECTS OF HIGH DOSE OF GENOTONORM IN PREPUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY

Active substance: Somatropin

Study summary document link (including results): A6281201 (94-0201-001) PhRMA Clinical Study Synopsis.pdf

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Document reference: 41676

Study title: A MULTICENTRE STUDY ON THE CAPACITY OF THE IGF-I STIMULATION TEST TO PREDICT THE GROWTH PROMOTING EFFECT OF STANDARD AND HIGH DOSES OF GENOTONORM(REGISTERED) IN PREPUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY

Active substance: Somatropin

Study summary document link (including results): A6281023 (307-MET-9002-040) PhRMA Clinical Study Synopsis.pdf

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Document reference: 41745

Study title: A MULTICENTRE TRIAL EVALUATING THE EFFICACY AND SAFETY OF GENOTROPIN IN CHILDREN SHORT FOR GESTATIONAL AGE

Active substance: Somatropin

Study summary document link (including results): 93-8122-003 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41680

Study title: A MULTICENTRE, OPEN RANDOMISED, CROSS-OVER STUDY COMPARING THE CONVENIENCE AND SAFETY OF GENOTROPIN KABIQUICK 2, 3 AND 4 IU WITH GENOTROPIN 12 IU MULTIDOSE VIAL

Active substance: Somatropin

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Document reference: 41723

Study title: A MULTICENTRE, OPEN-LABELLED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PUBERTAL AND PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY UNDERGOING DIALYSIS

Active substance: Somatropin

Study summary document link (including results): 92-8123-010 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41685

Study title: A MULTICENTRE, OPEN-LABELLED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERAPY IN SHORT, PUBERTAL, PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY UNDERGOING DIALYSIS.

Active substance: Somatropin

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Document reference: 41696

Study title: A multicentre, open, clinical trial with duration of 12 months, evaluating the efficacy and safety of Norditropin® SimpleXx®, starting from 4 years of age until onset of puberty in SGA children due to IUGR

Active substance: Somatropin

Study summary document link (including results): GHLiquid-1523_Norditropin.pdf

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Document reference: 41781

Study title: A MULTICENTRE, OPEN, RANDOMISED, CROSS-OVER STUDY, COMPARING THE CONVENIENCE AND SAFETY OF GENOTROPIN 16IU KABIPEN WITH GENOTROPIN 12IU MULTIDOSE VIAL

Active substance: Somatropin

Study summary document link (including results): 90-008 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41724

Study title: A retrospective survey of children being treated with Norditropin® on named patient basis after renal transplantation.

Active substance: Somatropin

Study summary document link (including results): GHCRF-BPD-10-NL_Norditropin.pdf

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Document reference: 41788

Study title: A SINGLE CENTER, OPEN-LABELED, STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE THERPY IN SHORT PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY

Active substance: Somatropin

Study summary document link (including results): 90-109 EMA Pediatrics Web Synopsis.pdf

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Document reference: 41713

Study title: A SIX-MONTH STUDY OF EFFICACY OF GENOTROPIN 36 IU IN PREPUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY

Active substance: Somatropin

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Document reference: 41689

Study title: A STUDY EVALUATING THE EFFECT OF GROWTH HORMONE IN GIRLS WITH TURNER'S SYNDROME

Active substance: Somatropin

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Document reference: 41682

Study title: A STUDY EVALUATING THE EFFECT OF GROWTH HORMONE TREATMENT IN CHILDREN WITH THALASSEMIA MAJOR

Active substance: Somatropin

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Document reference: 41684

Study title: High-dose tamoxifen added to concurrent biochemotherapy with decrescendo interleukin-2 in patients with metastatic melanoma. O'Day SJ, Boasberg PD, Kristedja TS, Martin M, Wang HJ, Fournier P et al. Cancer 2001;92(3):609-19 2001;(3):609-619. High-dose tamoxifen added to concurrent biochemotherapy with decrescendo interleukin-2 in patients with metastatic melanoma. O'Day SJ, Boasberg PD, Kristedja TS, Martin M, Wang HJ, Fournier P et al. Cancer 2001;92(3):609-19 2001;(3):609-619.

Active substance: TAMOXIFEN

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Document reference: 43281

Study title: High-Dose Tamoxifen and Sulindac as First-Line Treatment for Desmoid Tumors. Hansmann A, Adolph C, Vogel T, Unger A, Moeslein G. Cancer 100(3)()(pp 612-620), 2004 Date of Publication: 01 Feb 2004 2004;(3):612-620. High-Dose Tamoxifen and Sulindac as First-Line Treatment for Desmoid Tumors. Hansmann A, Adolph C, Vogel T, Unger A, Moeslein G. Cancer 100(3)()(pp 612-620), 2004 Date of Publication: 01 Feb 2004 2004;(3):612-620.

Active substance: TAMOXIFEN

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Document reference: 43263

Study title: High-dose tamoxifen in the treatment of inoperable hepatocellular carcinoma: A multicenter randomized controlled trial. High-dose tamoxifen in the treatment of inoperable hepatocellular carcinoma: A multicenter randomized controlled trial.

Active substance: TAMOXIFEN

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Document reference: 43274

Study title: Juvenile fibromatosis: Hormonal receptors. Juvenile fibromatosis: Hormonal receptors.

Active substance: TAMOXIFEN

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Document reference: 43308

Study title: Juvenile gigantomastia: Presentation of four cases and review of the literature. Juvenile gigantomastia: Presentation of four cases and review of the literature.

Active substance: TAMOXIFEN

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Document reference: 43279

Study title: Kelly KM. Complementary and alternative medical therapies for children with cancer. European Journal of Cancer 2004; 40(14):2041-2046.Kelly KM. Complementary and alternative medical therapies for children with cancer. European Journal of Cancer 2004; 40(14):2041-2046.

Active substance: TAMOXIFEN

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Document reference: 43138

Study title: Kreher NC, Eugster EA, Shankar RR. The use of tamoxifen to improve height potential in short pubertal boys. Pediatrics 2005; 116(6):1513-1515.Kreher NC, Eugster EA, Shankar RR. The use of tamoxifen to improve height potential in short pubertal boys. Pediatrics 2005; 116(6):1513-1515.

Active substance: TAMOXIFEN

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Document reference: 43090

Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43094

Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.

Active substance: TAMOXIFEN

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Document reference: 43123

Study title: Furuta A, Tanohata K, Itake T, Hashizume T, Kobayashi Y, Nakazima H. [Clinical evaluation of stress fractures using bone scintigraphy] Kaku Igaku. 1984 May;21(5):435-43. Japanese. No abstract available. Furuta A, Tanohata K, Itake T, Hashizume T, Kobayashi Y, Nakazima H. [Clinical evaluation of stress fractures using bone scintigraphy] Kaku Igaku. 1984 May;21(5):435-43. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44000

Study title: [Acute hematogenic osteomyelitis after impetiginized scabies] Gaida G, Töllner U, Krüpe H, Haas JP. Klin Padiatr. 1985 Nov-Dec;197(6):489-91. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43927

Study title: Gandhi SM, Mattox S, Scheiner J, Zuckier LS. Appearance of a common catheter in an uncommon location. Clin Nucl Med. 1996 Dec;21(12):973-4. No abstract available. Gandhi SM, Mattox S, Scheiner J, Zuckier LS. Appearance of a common catheter in an uncommon location. Clin Nucl Med. 1996 Dec;21(12):973-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43556

Study title: Neuroblastoma: imaging evaluation by sequential Tc-99m MDP, I-131 MIBG, and Ga-67 citrate studies. Garty I, Friedman A, Sandler MP, Kedar A. Clin Nucl Med. 1989 Jul;14(7):515-22.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43783

Study title: Bone scintigraphy in two siblings with pulmonary alveolar microlithiasis. Garty I, Giladi N, Flatau E. Br J Radiol. 1985 Aug;58(692):763-6. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43935

Study title: Garty I, Koren A, Garzozi H. Frontal and orbital bone infarctions causing periorbital swelling in patients with sickle cell anemia. Arch Ophthalmol. 1984 Oct;102(10):1486-8. Garty I, Koren A, Garzozi H. Frontal and orbital bone infarctions causing periorbital swelling in patients with sickle cell anemia. Arch Ophthalmol. 1984 Oct;102(10):1486-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43982

Study title: Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994; 79(2):51Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994; 79(2):51

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43169

Study title: Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994; 79(2):51Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994; 79(2):51

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43174

Study title: Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994; 79(2):51Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994; 79(2):51

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43180

Study title: Domstad PA, Coupal JJ, Kim EE, Blake JS, DeLand FH. 99mTc-hydroxymethane diphosphonate: a new bone imaging agent with a low tin content. Radiology. 1980 Jul;136(1):209-11. Domstad PA, Coupal JJ, Kim EE, Blake JS, DeLand FH. 99mTc-hydroxymethane diphosphonate: a new bone imaging agent with a low tin content. Radiology. 1980 Jul;136(1):209-11.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44143

Study title: Dong QR, Wang JX, Dong TH. [Early diagnosis by scintigraphy of segmental collapse of the femur head following femur neck fracture] J Radiol. 1994 Aug-Sep;75(8-9):423-5. French. Dong QR, Wang JX, Dong TH. [Early diagnosis by scintigraphy of segmental collapse of the femur head following femur neck fracture] J Radiol. 1994 Aug-Sep;75(8-9):423-5. French.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43620

Study title: Dong QR, Wang JX, Dong TH. [Prediction of segmental collapse of femoral head after femoral neck fracture by scintimetry] Zhonghua Wai Ke Za Zhi. 1994 Sep;32(9):520-2. Chinese. Dong QR, Wang JX, Dong TH. [Prediction of segmental collapse of femoral head after femoral neck fracture by scintimetry] Zhonghua Wai Ke Za Zhi. 1994 Sep;32(9):520-2. Chinese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43617

Study title: Dorchak JD, Barrack RL, Alexander AH, Dye SF, Dresser TP. Radionuclide imaging of the knee with chronic anterior cruciate ligament tear. Orthop Rev. 1993 Nov;22(11):1233-41. Dorchak JD, Barrack RL, Alexander AH, Dye SF, Dresser TP. Radionuclide imaging of the knee with chronic anterior cruciate ligament tear. Orthop Rev. 1993 Nov;22(11):1233-41.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43646

Study title: Stress fractures in athletes. Dowey KE, Moore GW. Ulster Med J. 1984;53(2):121-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44009

Study title: Dubowitz DJ, Miles KA. Technical note: bone SPECT of the wrist. Br J Radiol. 1994 Sep;67(801):890-3. Dubowitz DJ, Miles KA. Technical note: bone SPECT of the wrist. Br J Radiol. 1994 Sep;67(801):890-3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43616

Study title: Osteoid osteoma of the femoral head. Dunlap H, Martin DJ. Pediatr Radiol. 1985;15(4):262-3. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43964

Study title: Durak H, Aras T, Sungur C, Erbengi G, Bekdik CF. Tl-201 uptake in brown tumors of hyperparathyroidism. Clin Nucl Med. 1991 Dec;16(12):931-5. Durak H, Aras T, Sungur C, Erbengi G, Bekdik CF. Tl-201 uptake in brown tumors of hyperparathyroidism. Clin Nucl Med. 1991 Dec;16(12):931-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43719

Study title: Durak H, Ugur O, Ozgur F. Giant rhabdomyosarcoma with necrosis visualized with Tl-201 chloride. Clin Nucl Med. 1991 Dec;16(12):947-8. No abstract available. Durak H, Ugur O, Ozgur F. Giant rhabdomyosarcoma with necrosis visualized with Tl-201 chloride. Clin Nucl Med. 1991 Dec;16(12):947-8. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43718

Study title: Radionuclide imaging of the patellofemoral joint in young adults with anterior knee pain. Dye SF, Boll DA. Orthop Clin North Am. 1986 Apr;17(2):249-62.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43914

Study title: Ebata K. [Diagnostic imaging of skeletal disorders, with special reference to systemic diagnosis of malignant bone tumors] Nippon Ika Daigaku Zasshi. 1982 Oct;49(5):601-8. Japanese. No abstract available. Ebata K. [Diagnostic imaging of skeletal disorders, with special reference to systemic diagnosis of malignant bone tumors] Nippon Ika Daigaku Zasshi. 1982 Oct;49(5):601-8. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44070

Study title: A STUDY EVALUATING THE EFFECT OF GROWTH HORMONE IN CHILDREN WITH GROWTH HORMONE DEFICIENCY

Active substance: Somatropin

Study summary document link (including results):

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Document reference: 41687

Study title: Salmeterol xinafoate (dry powder) phase II study in paediatric patients with bronchial asthma - single dose crossover comparative study between aerosol and dry powder. Report No. JJA/93/001

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results):

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Document reference: 42042

Study title: Serevent VS Placebo : Paediatric asthma, exercise-induced. A multicentre, double-blind. parallel group study to assesss the efficacy of serevent 50mcg.bd vs placebo.bd (via the accuhaler) on the prevention of exercise induced asthma in children. A real-life situation. Report No. SLGB4021R

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42027

Study title: The effect of salmeterol (50mcg bd) and sustained release theophylline (uniphyllin 200mg bd) on night-time symptoms and sleep quality in children aged 5-16 years with nocturnal asthma. Report No. GRP/95/036

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Study SLPT06- SMS30014-Salmeterol Xinafoate-Serevent Rotadisks.xls

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Document reference: 42047

Study title: The effect of salmeterol (50mcg bd) and sustained release theophylline (uniphyllin 200mg bd) on night-time symptoms and sleep quality in children aged 5-16 years with nocturnal asthma. Report No. GRP/95/036

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results):

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Document reference: 42067

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Schwef-Heel (drops) [AWB-AT]

Active substance: Schwef-Heel

Study summary document link (including results):

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Document reference: 40185

Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Schwef-Heel (drops) [AWB-042]

Active substance: Schwef-Heel

Study summary document link (including results):

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Document reference: 40186

Study title: The efficacy of transdermal therapeutic system (scopolamine) in the prevention of motion sickness in children

Active substance: SCOPOLAMINE

Study summary document link (including results):

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Document reference: 42110

Study title: The efficacy of transdermal therapeutic system (scopolamine) in the prevention of motion sickness in children

Active substance: SCOPOLAMINE

Study summary document link (including results):

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Document reference: 42111

Study title: To determine the efficacy of transdermal therapeutic system (scopolamine) in the prevention of motion sickness in children

Active substance: SCOPOLAMINE

Study summary document link (including results):

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Document reference: 42107

Study title: To determine the efficacy of transdermal therapeutic system (scopolamine) in the prevention of motion sickness in children

Active substance: SCOPOLAMINE

Study summary document link (including results):

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Document reference: 42108

Study title: To determine the efficacy of transdermal therapeutic system (scopolamine) in the prevention of motion sickness in children

Active substance: SCOPOLAMINE

Study summary document link (including results):

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Document reference: 42109

Study title: To establish the pharmacokinetic properties of scopolamine in children

Active substance: SCOPOLAMINE

Study summary document link (including results):

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Document reference: 42112

Study title: LYMPHDIARAL® active tabletta, tablets, observational study

Active substance: Scrophularia nodosa Ø 100.0 mg Echinacea Trit. D3 100.0 mg Mercurius bijodatus Trit. D12 100.0 mg

Study summary document link (including results):

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Document reference: 40187

Study title: LYMPHDIARAL® active tabletta, tablets,experience reports

Active substance: Scrophularia nodosa Ø 100.0 mg Echinacea Trit. D3 100.0 mg Mercurius bijodatus Trit. D12 100.0 mg

Study summary document link (including results):

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Document reference: 40188

Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 2004; 26(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 2004; 26(8):518-522.

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43139

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515.

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43170

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515.

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43176

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43184

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43194

Study title: Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43190

Study title: Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43200

Study title: Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43210

Study title: Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43216

Study title: Efficacy and safety of Salmeterol in patients with asthma controlled with inhaled corticosteroids

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SMS40012-ICHE3.pdf

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Document reference: 42028

Study title: Multicentre, randomised, double-blind, cross-over trial to evaluate the tolerance of Salmeterol protective effect in the asthma of effort.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SMS30078-ICHE3.pdf

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Document reference: 42035

Study title: One year treatment with either inhaled corticosteroid or a long acting beta-2-agonist in asthmatic children. Report No. GM1996/00022/00

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol Xinafoate-SLGB4015-ICHE3.pdf

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Document reference: 42054

Study title: Open-label study of the Efficacy and Safety of salmeterol 50mcg bid in Asthmatic children(4-15y)

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results):

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Document reference: 42038

Study title: Derman O, Kanbur NO, Tokur TE. The effect of tamoxifen on sex hormone binding globulin in adolescents with pubertal gynecomastia. Journal of Pediatric Endocrinology & Metabolism JPEM 2004;17(8):1115-1119 2004;(8):1115-1119.Derman O, Kanbur NO, Tokur TE. The effect of tamoxifen on sex hormone binding globulin in adolescents with pubertal gynecomastia. Journal of Pediatric Endocrinology & Metabolism JPEM 2004;17(8):1115-1119 2004;(8):1115-1119.

Active substance: TAMOXIFEN

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Document reference: 43091

Study title: Derman O, Oksoz KN, Kutluk T. Tamoxifen treatment for pubertal gynecomastia. International Journal of Adolescent Medicine and Health 15(4)()(pp 359-363), 2003 Date of Publication: Oct 2003 2003;(4):359-363.Derman O, Oksoz KN, Kutluk T. Tamoxifen treatment for pubertal gynecomastia. International Journal of Adolescent Medicine and Health 15(4)()(pp 359-363), 2003 Date of Publication: Oct 2003 2003;(4):359-363.

Active substance: TAMOXIFEN

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Document reference: 43099

Study title: Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.

Active substance: TAMOXIFEN

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Document reference: 43282

Study title: Effect of short-term, low-dose treatment with tamoxifen in patients with primary dysmenorrhea. Pierzynski P, Swiatecka J, Oczeretko E, Laudanski P, Batra S, Laudanski T. Gynecological Endocrinology 2006;22(12):698-703 2006;(12):698-703.Effect of short-term, low-dose treatment with tamoxifen in patients with primary dysmenorrhea. Pierzynski P, Swiatecka J, Oczeretko E, Laudanski P, Batra S, Laudanski T. Gynecological Endocrinology 2006;22(12):698-703 2006;(12):698-703.

Active substance: TAMOXIFEN

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Document reference: 43259

Study title: Effects of low dose tamoxifen on normal breast tissue from premenopausal women. De Lima GR, Facina G, Shida JY, Chein MB, Tanaka P, Dardes RC et al. European Journal of Cancer 2003; 39(7):891-898. Effects of low dose tamoxifen on normal breast tissue from premenopausal women. De Lima GR, Facina G, Shida JY, Chein MB, Tanaka P, Dardes RC et al. European Journal of Cancer 2003; 39(7):891-898.

Active substance: TAMOXIFEN

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Document reference: 43270

Study title: Effects of tamoxifen on lipid profile and coagulation parameters in male patients with pubertal gynecomastia. Novoa FJ, Boronat M, Carrillo A, Tapia M, Diaz CJ, Chirino R. Hormone Research 2002;57(5-6):187-91 2002;(5-6):187-191.Effects of tamoxifen on lipid profile and coagulation parameters in male patients with pubertal gynecomastia. Novoa FJ, Boronat M, Carrillo A, Tapia M, Diaz CJ, Chirino R. Hormone Research 2002;57(5-6):187-91 2002;(5-6):187-191.

Active substance: TAMOXIFEN

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Document reference: 43276

Study title: Effects of tamoxifen on the breast in the luteal phase of the menstrual cycle. Uehara J, Nazario ACP, Rodrigues De LG, Simoes MJ, Juliano Y, Gebrim LH. International Journal of Gynecology and Obstetrics 1998;62(1):77-82 1998;(1):77-82.Effects of tamoxifen on the breast in the luteal phase of the menstrual cycle. Uehara J, Nazario ACP, Rodrigues De LG, Simoes MJ, Juliano Y, Gebrim LH. International Journal of Gynecology and Obstetrics 1998;62(1):77-82 1998;(1):77-82.

Active substance: TAMOXIFEN

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Document reference: 43293

Study title: Endometrial carcinoma associated with breast carcinoma: low incidence with tamoxifen use. Cuenca RE, Giachino J, Arredondo MA, Hempling R, Edge SB. Cancer 1996; 77(10):2058-2063.Endometrial carcinoma associated with breast carcinoma: low incidence with tamoxifen use. Cuenca RE, Giachino J, Arredondo MA, Hempling R, Edge SB. Cancer 1996; 77(10):2058-2063.

Active substance: TAMOXIFEN

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Document reference: 43300

Study title: Efficacy and tolerance evaluation of secnidazole suspension single dose (30 mg/kg/day) in the treatment of giardiasis in children - Dr Cimerman, Dr Katz, Dr Zingans - No date

Active substance: SECNIDAZOLE

Study summary document link (including results): Secnidazole STUDY Cimerman.xls

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Document reference: 42113

Study title: Christen F, Hotz P. [Long-term effect of fluoride prophylaxis: a follow-up study of 151 subjects 13 to 15 years after tablet fluoridation] SSO Schweiz Monatsschr Zahnheilkd. 1981 Nov;91(11):932-9. German.Christen F, Hotz P. [Long-term effect of fluoride prophylaxis: a follow-up study of 151 subjects 13 to 15 years after tablet fluoridation] SSO Schweiz Monatsschr Zahnheilkd. 1981 Nov;91(11):932-9. German.

Active substance: SODIUM FLUORIDE

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Document reference: 42316

Study title: Clinical evaluation of Duraphat and Fluor-Protector preparations in caries prevention

Active substance: SODIUM FLUORIDE

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Document reference: 42339

Study title: Clinical evaluation of Duraphat and Fluor-Protector preparations in caries prevention

Active substance: SODIUM FLUORIDE

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Document reference: 42452

Study title: Clinical evaluation of Duraphat varnish in the prevention of dental caries in children and in the control of cervical hypersensitivity in adults.

Active substance: SODIUM FLUORIDE

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Document reference: 42443

Study title: Clinical evaluation of Duraphat varnish in the prevention of dental caries in children and in the control of cervical hypersensitivity in adults.

Active substance: SODIUM FLUORIDE

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Document reference: 42556

Study title: Clinical evaluation of home fluoride-containing varnish.

Active substance: SODIUM FLUORIDE

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Document reference: 42380

Study title: Clinical evaluation of home fluoride-containing varnish.

Active substance: SODIUM FLUORIDE

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Document reference: 42493

Study title: Clinical experience with the use of Duraphat lacquer.

Active substance: SODIUM FLUORIDE

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Document reference: 42341

Study title: Clinical experience with the use of Duraphat lacquer.

Active substance: SODIUM FLUORIDE

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Document reference: 42454

Study title: Clinical experience with the use of Duraphat shellac.

Active substance: SODIUM FLUORIDE

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Document reference: 42446

Study title: Clinical experimental field studies of the caries-preventive effect of a fluoride lacquer]

Active substance: SODIUM FLUORIDE

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Document reference: 42432

Study title: Clinical experimental field studies of the caries-preventive effect of a fluoride lacquer]

Active substance: SODIUM FLUORIDE

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Document reference: 42545

Study title: Collective preschool caries prevention using a fluoride-containing varnish] [Article in German]

Active substance: SODIUM FLUORIDE

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Document reference: 42430

Study title: Comparative assessment of the caries prevention effectiveness of different fluorine preparations] [Article in Russian]

Active substance: SODIUM FLUORIDE

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Document reference: 42393

Study title: Comparative assessment of the caries prevention effectiveness of different fluorine preparations] [Article in Russian]

Active substance: SODIUM FLUORIDE

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Document reference: 42506

Study title: Comparative clinical and radiological studies on Fluor ProtectorR and DuraphatR.

Active substance: SODIUM FLUORIDE

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Document reference: 42342

Study title: Comparative clinical and radiological studies on Fluor ProtectorR and DuraphatR.

Active substance: SODIUM FLUORIDE

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Document reference: 42455

Study title: Comparative evaluation of the role of NaF, APF & Duraphat topical fluoride applications in the prevention of dental caries--a 2 1/2 years study.

Active substance: SODIUM FLUORIDE

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Document reference: 42544

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.

Active substance: TAMOXIFEN

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Document reference: 43204

Study title: Bar-Sever Z, Mukamel M, Harel L, Hardoff R. Scintigraphic evaluation of calcinosis in juvenile dermatomyositis with Tc-99m MDP. Clin Nucl Med. 2000 Dec;25(12):1013-6. Bar-Sever Z, Mukamel M, Harel L, Hardoff R. Scintigraphic evaluation of calcinosis in juvenile dermatomyositis with Tc-99m MDP. Clin Nucl Med. 2000 Dec;25(12):1013-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44249

Study title: Barai S, Bandopadhayaya GP, Chumber S, Gupta DK, Patel CD, Dhanpati H. Role of skeletal scintigraphy in soft tissue sarcoma: Improving the diagnostic yield. J Postgrad Med. 2004 Jul-Sep;50(3):180-3; discussion 183-4. Barai S, Bandopadhayaya GP, Chumber S, Gupta DK, Patel CD, Dhanpati H. Role of skeletal scintigraphy in soft tissue sarcoma: Improving the diagnostic yield. J Postgrad Med. 2004 Jul-Sep;50(3):180-3; discussion 183-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43397

Study title: Barai S, Bandopadhayaya GP, Malhotra A, Agarwal S, Kumar R, Dhanapathi H. Does I-131-MIBG underestimate skeletal disease burden in neuroblastoma? J Postgrad Med. 2004 Oct-Dec;50(4):257-60; discussion 260-1. Barai S, Bandopadhayaya GP, Malhotra A, Agarwal S, Kumar R, Dhanapathi H. Does I-131-MIBG underestimate skeletal disease burden in neuroblastoma? J Postgrad Med. 2004 Oct-Dec;50(4):257-60; discussion 260-1.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43392

Study title: Barron BJ, Tran HD, Lamki LM. Scintigraphic findings of osteomyelitis after intraosseous infusion in a child. Clin Nucl Med. 1994 Apr;19(4):307-8. Barron BJ, Tran HD, Lamki LM. Scintigraphic findings of osteomyelitis after intraosseous infusion in a child. Clin Nucl Med. 1994 Apr;19(4):307-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43630

Study title: Barton D, Allen M, Finlay D, Belton I. Evaluation of whiplash injuries by technetium 99m isotope scanning. Arch Emerg Med. 1993 Sep;10(3):197-202. Barton D, Allen M, Finlay D, Belton I. Evaluation of whiplash injuries by technetium 99m isotope scanning. Arch Emerg Med. 1993 Sep;10(3):197-202.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43656

Study title: Batte WG Jr, Yeh SD, Larson SM. Diffuse lung uptake of Tc-99m MDP associated with pneumocystis carinii pneumonia in a patient with neuroblastoma. Clin Nucl Med. 1991 May;16(5):321-4. No abstract available. Batte WG Jr, Yeh SD, Larson SM. Diffuse lung uptake of Tc-99m MDP associated with pneumocystis carinii pneumonia in a patient with neuroblastoma. Clin Nucl Med. 1991 May;16(5):321-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43738

Study title: Batte WG Jr, Yeh SD, Rosenblum MK, Larson SM. Intense muscle uptake of Ga-67 citrate and Tc-99m MDP in a patient with aplastic anemia. Clin Nucl Med. 1991 Jun;16(6):421-4. Batte WG Jr, Yeh SD, Rosenblum MK, Larson SM. Intense muscle uptake of Ga-67 citrate and Tc-99m MDP in a patient with aplastic anemia. Clin Nucl Med. 1991 Jun;16(6):421-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44268

Study title: Open-label study of the Efficacy and Safety of salmeterol 50mcg bid in Asthmatic children(4-15y)

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-102095-ICHE3.pdf

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Document reference: 42066

Study title: Open-label study of the Efficacy and Safety of salmeterol 50mcg bid in Asthmatic children(4-15y)

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42070

Study title: Open-label study of the Efficacy and Safety of salmeterol 50mcg bid in Asthmatic children(4-15y)

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42073

Study title: Open-label study of the Efficacy and Safety of salmeterol 50mcg bid in Asthmatic children(4-15y)

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42075

Study title: Placebo controlled study during one year comparing the addition of Salmeterol with an increase of the dose of the inhaled corticosteroid in asthmatic children already on treatment with inhaled corticosteroids. Report No. GM1998/00044/00

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol Xinafoate-SLGB4014-ICHE3.pdf

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Document reference: 42053

Study title: Salmeterol dry powder 50mcg bd versus usual treatment in children with moderate asthma.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SMS40069-ICHE3.pdf

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Document reference: 42029

Study title: American Association of Poison Control Centers. Camphor Poisoning: an evidence-based practice guideline for out-of-hospital management, Manoguerra, A.S., Clin.Toxicol. (Phila) 2006; 44 (4): 357-370

Active substance: Spike oil

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Document reference: 40219

Study title: Are one or two dangerous? Camphor exposure in toddlers, Love, JN, J.Emerg.Med. 2004; 27 (1): 49-54

Active substance: Spike oil

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Document reference: 40218

Study title: Camphor hepatotoxicity, Uc, A., South Med.J. 2000; 93 (6): 596-598

Active substance: Spike oil

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Document reference: 40226

Study title: Camphor ingestion for abortion (case report), Rabl, W., Forensic Sci Int. 1997; 89 (1-2): 137-140

Active substance: Spike oil

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Document reference: 40221

Study title: Camphor ingestion in a 10-year-old male, Ragucci, K.R., South Med.J. 2007; 100 (2): 204-207

Active substance: Spike oil

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Document reference: 40222

Study title: Camphor ingestion, Gibson, D.E., Am. J. Emerg. Med. 1989; 7 (1): 41-43

Active substance: Spike oil

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Document reference: 40216

Study title: Camphor toxicity, Emery, D.P., J.Paediatr.Child Health 1999; 35 81): 105-106

Active substance: Spike oil

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Document reference: 40214

Study title: Clinical effects and management of eucalyptus oil ingestion in infants and young children. Tibballs J, Med J Aust., 1995, 163:177-80.

Active substance: Spike oil

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Document reference: 40224

Study title: Clinical Toxicology of Commercial Products. 5th ed. Baltimore: Williams and Wilkins, 1984, p.III-85, Gosselin, R.E.

Active substance: Spike oil

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Document reference: 40217

Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.

Active substance: TAMOXIFEN

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Document reference: 43353

Study title: Samuels BL. Management of recurrent desmoid tumor after surgery and radiation: role of cytotoxic and non-cytotoxic therapies. Surgical Oncology 1999; 8(4):191-196.Samuels BL. Management of recurrent desmoid tumor after surgery and radiation: role of cytotoxic and non-cytotoxic therapies. Surgical Oncology 1999; 8(4):191-196.

Active substance: TAMOXIFEN

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Document reference: 43111

Study title: Study of the action of tamoxifen on the mammary gland epithelium of premenopausal patients by lysosome quantification. Study of the action of tamoxifen on the mammary gland epithelium of premenopausal patients by lysosome quantification.

Active substance: TAMOXIFEN

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Document reference: 43299

Study title: Sultan C. Gynecomasties pubertaires. Revue de Pediatrie 1990; 26(4):155-167.Sultan C. Gynecomasties pubertaires. Revue de Pediatrie 1990; 26(4):155-167.

Active substance: TAMOXIFEN

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Document reference: 43164

Study title: Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital.

Active substance: TAMOXIFEN

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Document reference: 43284

Study title: Tamoxifen as a potential treatment of glioma. (Review, 65 refs). Tolis G, Karalis K, Kyriakos GM. Current Therapy in Endocrinology & Metabolism 1994; 5:370-371Tamoxifen as a potential treatment of glioma. (Review, 65 refs). Tolis G, Karalis K, Kyriakos GM. Current Therapy in Endocrinology & Metabolism 1994; 5:370-371

Active substance: TAMOXIFEN

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Document reference: 43292

Study title: Tamoxifen for treatment of sexual precocity in girls with McCune-Albright syndrome. Tamoxifen for treatment of sexual precocity in girls with McCune-Albright syndrome.

Active substance: TAMOXIFEN

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Document reference: 43309

Study title: Tamoxifen therapy for cyclical mastalgia: dose randomized trial. Tamoxifen therapy for cyclical mastalgia: dose randomized trial.

Active substance: TAMOXIFEN

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Document reference: 43296

Study title: Tamoxifen treatment for precocious puberty in McCune-Albright syndrome: A multicenter trial. Tamoxifen treatment for precocious puberty in McCune-Albright syndrome: A multicenter trial.

Active substance: TAMOXIFEN

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Document reference: 43272

Study title: Tamoxifen treatment for pubertal gynecomastia. Derman O, Oksoz KN, Kutluk T. International Journal of Adolescent Medicine and Health 15(4)()(pp 359-363), 2003 Date of Publication: Oct 2003 2003;(4):359-363.Tamoxifen treatment for pubertal gynecomastia. Derman O, Oksoz KN, Kutluk T. International Journal of Adolescent Medicine and Health 15(4)()(pp 359-363), 2003 Date of Publication: Oct 2003 2003;(4):359-363.

Active substance: TAMOXIFEN

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Document reference: 43271

Study title: Tanaka CI, Gebrim LH, De Lima GR, Simoes MD. Study of the action of tamoxifen on the mammary gland epithelium of premenopausal patients by lysosome quantification. Sao Paulo Medical Journal = Revista Paulista de Medicina 1997; 115(2):1390-1394.Tanaka CI, Gebrim LH, De Lima GR, Simoes MD. Study of the action of tamoxifen on the mammary gland epithelium of premenopausal patients by lysosome quantification. Sao Paulo Medical Journal = Revista Paulista de Medicina 1997; 115(2):1390-1394.

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43116

Study title: Comparative study of the increase in acid solubility resistance of enamel using different fluoride treatments].

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42409

Study title: Comparative study of the increase in acid solubility resistance of enamel using different fluoride treatments].

Active substance: SODIUM FLUORIDE

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Document reference: 42522

Study title: Comparison of intra-examiner reproducibility in scoring caries in primary teeth of two scoring systems used to monitor caries progression.

Active substance: SODIUM FLUORIDE

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Document reference: 42428

Study title: "Organon Risperdal - Non interventional study 2002, age of the patients 15-92. To document efficacy and tolerance of RISPERDAL in psychotic and psychosis-associated symptoms

Active substance: RISPERIDONE

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Document reference: 35411

Study title: "Organon Risperdal -AWB 2002" /(Organon Risperdal - Non Interventional study 2002) age of the patients 15-92

Active substance: RISPERIDONE

Study summary document link (including results): AWB2002_Non-interventional_Risperidone.xls

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Document reference: 35400

Study title: Pharmacokinetics and safety of risperidone in children with autistic disorder after a single oral dose of risperidone. Part I: Pharmackinetics and prolactin response. Part II: Tolerability, cardiovascular safety and laboratory safety.

Active substance: RISPERIDONE

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Document reference: 35422

Study title: Randomized, double-blind, multicenter, 8-week study in adolescents with a DSM-IV diagnosis of schizophreniac and suffering from an acute episode (PANSS total score 60-120)

Active substance: RISPERIDONE

Study summary document link (including results): RIS-USA-231_Interventional_Risperidone.xls

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Document reference: 35394

Study title: Randomized, double-blind, placebo-controlled multicenter 3-week study in children and adolescents (ages 10-17 years) with acute mania in Bipolar I disorder

Active substance: RISPERIDONE

Study summary document link (including results): RIS-BIM-301_Interventional_Risperidone.xls

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Document reference: 35392

Study title: Open-label, 6-month, multicenter study in adolescents with schizophrenia. Subjects entered from RIS-USA-231 or RIS-SCH-302 or entered directly

Active substance: RISPERIDONE

Study summary document link (including results): RIS-USA-231_Interventional_Risperidone.xls

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Document reference: 35395

Study title: Risperidone in adolsecents, effects on tolerability and quality of life, open pilot trial

Active substance: RISPERIDONE

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Document reference: 35409

Study title: Risperidone in the traztment of behavioural disturbances in mentally retarded children and adolescents: a double-blind placebo-controlled pilot trial.

Active substance: RISPERIDONE

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Document reference: 35429

Study title: Risperidone in the treatment of aggressive behavior disorders in adolescents with cognitive abilities in the range from subaverage to mild mental retardation. A double-blind, placebo-controlled trial.

Active substance: RISPERIDONE

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Document reference: 35428

Study title: Risperidone in the treatment of disruptive behavior disorders in children with intellectual limitations. One-year continuation study.

Active substance: RISPERIDONE

Study summary document link (including results): RIS-CAN-20_Interventional_Risperidone.xls

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Document reference: 35430

Study title: Schizophrenia, 1992, RIS-BEL-SLT (1-3 years safety study): Minimum age 17

Active substance: RISPERIDONE

Study summary document link (including results): RIS-BEL-SLT_Interventional_Risperidone.xls

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Document reference: 35403

Study title: Schizophrenia, 1992, Yagi G et al (Japaneses phase II study): Minimum age 16

Active substance: RISPERIDONE

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Document reference: 35397

Study title: Schizophrenia, RIS-INT-2: Minimum age 17,1992

Active substance: RISPERIDONE

Study summary document link (including results):

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Document reference: 35396

Study title: The Efficacy and Safety of Risperidone in the Treatment of Adolescents with Schizophrenia.

Active substance: RISPERIDONE

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Document reference: 35416

Study title: Baydas B, Yavuz I, Uslu H, Dagsuyu IM, Ceylan I. Nonsurgical rapid maxillary expansion effects on craniofacial structures in young adult females. A bone scintigraphy study. Angle Orthod. 2006 Sep;76(5):759-67. Baydas B, Yavuz I, Uslu H, Dagsuyu IM, Ceylan I. Nonsurgical rapid maxillary expansion effects on craniofacial structures in young adult females. A bone scintigraphy study. Angle Orthod. 2006 Sep;76(5):759-67.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43370

Study title: Beatrous TE, Choyke PL, Frank JA. Diagnostic evaluation of cancer patients with pelvic pain: comparison of scintigraphy, CT, and MR imaging. AJR Am J Roentgenol. 1990 Jul;155(1):85-8. Beatrous TE, Choyke PL, Frank JA. Diagnostic evaluation of cancer patients with pelvic pain: comparison of scintigraphy, CT, and MR imaging. AJR Am J Roentgenol. 1990 Jul;155(1):85-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43761

Study title: Belasco J, Watts H. Osteosarcoma of the proximal humerus. Med Pediatr Oncol. 1983;11(1):46-8. No abstract available Belasco J, Watts H. Osteosarcoma of the proximal humerus. Med Pediatr Oncol. 1983;11(1):46-8. No abstract available

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44060

Study title: Fig LM, Shapiro B, Shulkin BL. Uptake of Tc-99m MDP in soft tissue calcific deposits due to the tumor lysis syndrome. Clin Nucl Med. 1988 Oct;13(10):765-7. No abstract available. Fig LM, Shapiro B, Shulkin BL. Uptake of Tc-99m MDP in soft tissue calcific deposits due to the tumor lysis syndrome. Clin Nucl Med. 1988 Oct;13(10):765-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43807

Study title: Fig LM, Shulkin BL. Scintigraphic detection of sinusitis. Eur J Nucl Med. 1988;14(11):552-4. Fig LM, Shulkin BL. Scintigraphic detection of sinusitis. Eur J Nucl Med. 1988;14(11):552-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43835

Study title: Fink-Bennett DM, Benson MT. Unusual exercise-related stress fractures. Two case reports. Clin Nucl Med. 1984 Aug;9(8):430-4. Fink-Bennett DM, Benson MT. Unusual exercise-related stress fractures. Two case reports. Clin Nucl Med. 1984 Aug;9(8):430-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43986

Study title: Fink-Bennett DM, Shapiro EE. The Angle of Louis. A potential pitfall ("Louie's Hot Spot") in bone scan interpretation. Clin Nucl Med. 1984 Jun;9(6):352-4. Fink-Bennett DM, Shapiro EE. The Angle of Louis. A potential pitfall ("Louie's Hot Spot") in bone scan interpretation. Clin Nucl Med. 1984 Jun;9(6):352-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43996

Study title: Firooznia H, Rafii M, Golimbu C, Sokolow J. Computerized tomography of pelvic osteomyelitis in patients with spinal cord injuries. Clin Orthop Relat Res. 1983 Dec;(181):126-31. Firooznia H, Rafii M, Golimbu C, Sokolow J. Computerized tomography of pelvic osteomyelitis in patients with spinal cord injuries. Clin Orthop Relat Res. 1983 Dec;(181):126-31.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44021

Study title: Fischer-Brandies E, Seifert C. Bone scintigraphy: an aid in deciding on the extent of bone resection in malignant oral tumors. J Oral Maxillofac Surg. 1995 Jul;53(7):768-70. Fischer-Brandies E, Seifert C. Bone scintigraphy: an aid in deciding on the extent of bone resection in malignant oral tumors. J Oral Maxillofac Surg. 1995 Jul;53(7):768-70.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43595

Study title: Fisher MC, Gainey MA, Capitanio MA. Atypical radionuclide scan appearance in cellulitis due to group A streptococcus. Clin Nucl Med. 1988 May;13(5):359-62. Fisher MC, Gainey MA, Capitanio MA. Atypical radionuclide scan appearance in cellulitis due to group A streptococcus. Clin Nucl Med. 1988 May;13(5):359-62.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43817

Study title: Myrtol standardized in the treatment of acute and chronic respiratory infections in children. A multicenter post-marketing surveillance study. Sengespeik HC et al., Arzneimittelforschung, 1998: 990-4.

Active substance: Spike oil

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Document reference: 40225

Study title: National Poisons Information Service Center, United Kingdom. Poison Information Monograph: Camphor, 1996

Active substance: Spike oil

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Document reference: 40220

Study title: Plant-induced seizures: reappearance of an old problem, Burkhard, P.R., J.Neurol. 199; 246 (8): 667-670

Active substance: Spike oil

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Document reference: 40213

Study title: Retrospective survey for documentation of appllication and dosage of Spigelon (tablets) in children < 12 years of age [Bef-026]

Active substance: Spigelon

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Document reference: 40245

Study title: Adverse effects of herbal drugs in dermatology, Ernst, E., Br.J.Dermatol. 2000; 143 (5): 923-929

Active substance: Spike oil

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Document reference: 40215

Study title: Reports of Postmarketing experience, Post Authorisation safety study. Panosch B, Montavit, 2007-05-23.

Active substance: Spike oil

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Document reference: 40223

Study title: Adverse effects of herbal drugs in dermatology, Ernst, E., Br.J.Dermatol. 2000; 143 (5): 923-929 Camphor ingestion, Gibson, D.E., Am. J. Emerg. Med. 1989; 7 (1): 41-43

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40239

Study title: American Association of Poison Control Centers. Camphor Poisoning: an evidence-based practice guideline for out-of-hospital management, Manoguerra, A.S., Clin.Toxicol. (Phila) 2006; 44 (4): 357-370

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40229

Study title: Antiobstruktive Wirksamkeit von Cineol bei Atemwegserkrankungen, Grimm, H., Therapiewoche 1987; 37: 4306-4311

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40241

Study title: Are one or two dangerous? Camphor exposure in toddlers, Love, JN, J.Emerg.Med. 2004; 27 (1): 49-54

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40237

Study title: Camphor hepatotoxicity, Uc, A., South Med.J. 2000; 93 (6): 596-598

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40233

Study title: Camphor ingestion for abortion (case report), Rabl, W., Forensic Sci Int. 1997; 89 (1-2): 137-140

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40236

Study title: Camphor ingestion in a 10-year-old male, Ragucci, K.R., South Med.J. 2007; 100 (2): 204-207

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40235

Study title: Camphor toxicity, Emery, D.P., J.Paediatr.Child Health 1999; 35 81): 105-106

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40240

Study title: Devaux j, Bernard JL, Mouly-Bandini a, Raybaud CI. Use of a peptisant gel in a pediatric ward. Méditerranée Médicale 1975:3:65-68 No.67 (English translation), Nolan T, Debelle G, Oberklaid F, Coffey C. Devaux j, Bernard JL, Mouly-Bandini a, Raybaud CI. Use of a peptisant gel in a pediatric ward. Méditerranée Médicale 1975:3:65-68 No.67 (English translation), Nolan T, Debelle G, Oberklaid F, Coffey C.

Active substance: SODIUM CITRATE SODIUM LAURYL SULFOACETATE

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Document reference: 42237

Study title: Pharmacia Consumer Pharma report on the Clinical Documenation on Microlax Enema; Helsingborg May 1995, Jan RundegrenPharmacia Consumer Pharma report on the Clinical Documenation on Microlax Enema; Helsingborg May 1995, Jan Rundegren

Active substance: SODIUM CITRATE SODIUM LAURYL SULFOACETATE

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Document reference: 42239

Study title: Randomised trial of laxatives in treatment of childhood encopresis. Lancet 1991:338:523-527, Grosse K-P, Keller KM, Behrens R, Becker M. Chronische Obstipation im Kindesalter. Monatsschr Kinderheilk 1990:138:231-233 Randomised trial of laxatives in treatment of childhood encopresis. Lancet 1991:338:523-527, Grosse K-P, Keller KM, Behrens R, Becker M. Chronische Obstipation im Kindesalter. Monatsschr Kinderheilk 1990:138:231-233

Active substance: SODIUM CITRATE SODIUM LAURYL SULFOACETATE

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Document reference: 42238

Study title: Abbott GT, Carty H. Pyogenic sacroiliitis, the missed diagnosis? Br J Radiol. 1993 Feb;66(782):120-2. Abbott GT, Carty H. Pyogenic sacroiliitis, the missed diagnosis? Br J Radiol. 1993 Feb;66(782):120-2.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43672

Study title: Abe K, Sasaki M, Kuwabara Y, Koga H, Baba S, Kaneko K, Hayashi K, Shioyama Y, Tajiri T, Suita S, Honda H. Extraosseous accumulation of (99m)Tc-HMDP to radiation nephropathy, mimicking recurrent neuroblastoma. Ann Nucl Med. 2005 Feb;19(1):35-40. Abe K, Sasaki M, Kuwabara Y, Koga H, Baba S, Kaneko K, Hayashi K, Shioyama Y, Tajiri T, Suita S, Honda H. Extraosseous accumulation of (99m)Tc-HMDP to radiation nephropathy, mimicking recurrent neuroblastoma. Ann Nucl Med. 2005 Feb;19(1):35-40.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43389

Study title: Acker R, Leonard JC. Esthesioneuroblastoma imaged with bone scintigraphy. Clin Nucl Med. 1986 Sep;11(9):670-1. Acker R, Leonard JC. Esthesioneuroblastoma imaged with bone scintigraphy. Clin Nucl Med. 1986 Sep;11(9):670-1.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43894

Study title: Acute hematogenous osteomyelitis of children: assessment of skeletal scintigraphy-based diagnosis in the era of MRI. Connolly LP, Connolly SA, Drubach LA, Jaramillo D. Treves ST. J Nucl Med 2002 Oct;43(10):1310-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48472

Study title: Adams BK, Parkar S, Al-Haider ZY. Technetium-99m MDP bone scintigraphy shows multiple abnormalities in sickle cell disease. Arch Dis Child. 2003 Jul;88(7):631. No abstract available. Adams BK, Parkar S, Al-Haider ZY. Technetium-99m MDP bone scintigraphy shows multiple abnormalities in sickle cell disease. Arch Dis Child. 2003 Jul;88(7):631. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43419

Study title: Adams BK. Scintigraphy in benign bone tumours. A report of 4 cases. S Afr Med J. 1989 Aug 5;76(3):112-4. Adams BK. Scintigraphy in benign bone tumours. A report of 4 cases. S Afr Med J. 1989 Aug 5;76(3):112-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43781

Study title: Adatepe MH, Powell OM, Isaacs GH, Nichols K, Cefola R. Hematogenous pyogenic vertebral osteomyelitis: diagnostic value of radionuclide bone imaging. J Nucl Med. 1986 Nov;27(11):1680-5. Adatepe MH, Powell OM, Isaacs GH, Nichols K, Cefola R. Hematogenous pyogenic vertebral osteomyelitis: diagnostic value of radionuclide bone imaging. J Nucl Med. 1986 Nov;27(11):1680-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43890

Study title: Aglietti P, Zaccherotti G, De Biase P, Taddei I. A comparison between medial meniscus repair, partial meniscectomy, and normal meniscus in anterior cruciate ligament reconstructed knees. Clin Orthop Relat Res. 1994 Oct;(307):165-73. Aglietti P, Zaccherotti G, De Biase P, Taddei I. A comparison between medial meniscus repair, partial meniscectomy, and normal meniscus in anterior cruciate ligament reconstructed knees. Clin Orthop Relat Res. 1994 Oct;(307):165-73.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43613

Study title: Aktas A, Elahi N. Bone scan findings in patients with chronic renal failure having symptoms related to bone: correlation with parathyroid hormone levels. Transplant Proc. 1999 Dec;31(8):3309-11. No abstract available. Aktas A, Elahi N. Bone scan findings in patients with chronic renal failure having symptoms related to bone: correlation with parathyroid hormone levels. Transplant Proc. 1999 Dec;31(8):3309-11. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43498

Study title: al Hindawi AY, Qutaishat SA. Survey of 1725 bone scans in patients with malignant disease with particular emphasis on carcinoma of the breast. Nuklearmedizin. 1992 Dec;31(6):239-41. al Hindawi AY, Qutaishat SA. Survey of 1725 bone scans in patients with malignant disease with particular emphasis on carcinoma of the breast. Nuklearmedizin. 1992 Dec;31(6):239-41.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43680