- Trials with a EudraCT protocol (28,833)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (8,635)
Query did not match any clinical trials.
| These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006). | |
| Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records. | |
| 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): |
| View full study record |
| Document reference: 34461 |
| 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): |
| View full study record |
| Document reference: 34454 |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 34494 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32268 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34451 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34416 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34446 |
| Study title: OPEN,NON-COMPARATIVE STUDY WITH PIROXICAM IM IN ACUTE MUSCULOSKELETAL DISORDERS. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34445 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43932 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43741 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 45280 |
| Study title: Pravastatin in the treatment of secondary hypercholesterolemia in Alagille's syndrome |
| Active substance: PRAVASTATIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46099 |
| Study title: Safety and efficacy of pravastatin in pediatric heart transplant patients |
| Active substance: PRAVASTATIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46101 |
| Study title: PIROXICAM (FELDENE) VS. NAPROXEN (NAPROSYN) IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS IN ATHLETES |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34324 |
| Study title: PIROXICAM GEL IN PREVENTION OF CANNULA - RELATED THROMBOPHLEBITIS. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34477 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48014 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43843 |
| Study title: Safety and efficacy of pravastatin therapy for the prevention of hyperlipidemia in pediatric and adolescent cardiac transplant patients |
| Active substance: PRAVASTATIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46102 |
| Study title: Short-term efficacy and safety of pravastatin in 72 children with familial hypercholesterolemia |
| Active substance: PRAVASTATIN |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46103 |
| Study title: Should pediatric patients with hyperlipidemia receive drug therapy? |
| Active substance: PRAVASTATIN |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34638 |
| Study title: Piracetam and acetamide in sickle-cell disease. |
| Active substance: PIRACETAM |
| Study summary document link (including results): DE77J021P - Piracetam.pdf |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34670 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43875 |
| 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 |
| View full study record |
| Document reference: 45938 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44067 |
| 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 |
| View full study record |
| Document reference: 45282 |
| Study title: Relazione Clinica sull'uso del preparato Piroxicam FDDF nel trattamento delle affezioni muscoloscheletriche acute |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34327 |
| Study title: THE EFFICACY AND SAFETY OF 0.5% TOPICAL PIROXICAM GEL IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34475 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34438 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 45283 |
| Study title: EFFICACY AND TOLERATION OF PIROXICAM IN PATIENTS WITH AMS. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34420 |
| Study title: EFFICACY AND TOLERATION OF PIROXICAM IN PATIENTS WITH OSTEOARTHROSIS OF THE KNEE. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34326 |
| Study title: EFFICACY AND TOLERATION OF PIROXICAM WITH ACUTE MUSCULOSKELETAL DISORDERS |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34442 |
| Study title: EFFICACY OF PIROXICAM IN ACUTE MUSCULOSKELETAL DISORDERS AND ADVERSE REACTIONS. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34450 |
| Study title: EFFICACY OF PIROXICAM IN ACUTE MUSCULOSKELETAL DISORDERS. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34453 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34458 |
| Study title: TO EVALUATE PIROXICAM SUPPOSITORIES FOR THE TREATMENT OF OSTEOARTHRITIS COMPARED TO A COMBINATION OF SUPPOSITORIES AND TABLETS OF DICLOFENAC. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34478 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34671 |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35226 |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34300 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43653 |
| Study title: |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34306 |
| Study title: |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34307 |
| Study title: |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34308 |
| Study title: A CLINICAL EVALUATION OF FELDENE -- SUPPOSITORY IN PATIENTS WITH RHEUMATOID ARTHRITIS |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34305 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43873 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 32130 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34462 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34466 |
| Study title: EFFICACY OF PIROXICAM IN MUSCULOSKELETAL CONDITIONS |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34464 |
| Study title: EFFICACY OF PIROXICAM IN OUTPATIENTS WITH SPORT-RELATED MUSCULO-SKELETAL INJURIES |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34473 |
| Study title: EFFICACY OF PIROXICAM VS TOLFENAMIC ACID IN PRIMARY DYSMENORRHEA |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34465 |
| Study title: EFFICACY, SAFETY AND TOLERATION OF PIROXICAM IN MODERATE TO SEVERE PRIMARY DYSMENORRHEA. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34489 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34493 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34385 |
| Study title: MULTICENTER STUDY - FELDENE DISPERSIBLE 20MG IN TREATMENT OF FLARE-UP OF RHEUMATIC DISEASE. |
| Active substance: PIROXICAM |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 39159 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47269 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47934 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41715 |
| Study title: Efficacy and Safety of Humatrope® in Patients with Ullrich-Turner Syndrome Turner syndrome |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| Document reference: 41677 |
| Study title: ESKATROPE |
| Active substance: Somatropin |
| Study summary document link (including results): 2 10011-86-01 Summary.pdf |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42517 |
| Study title: Influence of F--releasing varnishes on the acid resistance of enamel. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39390 |
| Study title: MDL71754 (vigabatrin): 2-week oral range-finding toxicity study in juvenile rats |
| Active substance: VIGABATRIN |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47305 |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41642 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41665 |
| Study title: Pen acceptability Study |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 41795 |
| Study title: Praticability and acceptability study of Stylomaxr in patients with somatropin insufficiency |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41779 |
| Study title: PROTOCOL FOR THE STUDY OF GROWTH HORMONE IN GENETICALLY SHORT CHILDREN |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47356 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 45432 |
| Study title: An Open-Label, Uncontrolled Pharmacokinetic and Clinical Evaluation Study of Valaciclovir Hydrochloride in Children with Chickenpox. |
| Active substance: VALGACICLOVIR |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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)] |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45547 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42173 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42309 |
| Study title: Fissure sealants versus fluorine varnish on the first permanent molars: economic assessment |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42348 |
| Study title: Fissure sealants versus fluorine varnish on the first permanent molars: economic assessment |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42461 |
| Study title: Fissure sealing of permanent first molars in children receiving a high standard of prophylactic care. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41767 |
| Study title: Somatropin: Correlation of Bone Markers and Growth Velocity |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41631 |
| Study title: STUDY EVALUATING THE EFFECT OF GENOTROPIN IN PREPUBERTAL SHORT NORMAL CHILDREN |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42214 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45441 |
| Study title: Fissure sealing of permanent first molars in children receiving a high standard of prophylactic care. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42513 |
| Study title: Fluoride clearance of whole saliva in young school children after topical application. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42397 |
| Study title: Fluoride clearance of whole saliva in young school children after topical application. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42510 |
| Study title: Fluoride concentration in plaque in adolescents after topical application of different fluoride varnishes. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42528 |
| Study title: Fluoride deposited topical applications in enamel. KOH-soluble and acquired fluoride. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35573 |
| Study title: - Application and efficacy of the multi-dose powder inhaler, Easyhaler, in children with asthma |
| Active substance: SALBUTAMOL |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35552 |
| Study title: Easyhaler, Diskus and Turbohaler. A comparison of correct use and acceptability of three devices. |
| Active substance: SALBUTAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35550 |
| Study title: T. Orłowski - ,,Clinical evaluation of the preparation Salbutamol tablets and syrup" |
| Active substance: SALBUTAMOL |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42187 |
| Study title: Influence of F--releasing varnishes on the acid resistance of enamel. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42511 |
| Study title: Kinetics of fluorine in deciduous enamel after application of fluoride-containing varnish (Duraphat). |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42375 |
| Study title: Kinetics of fluorine in deciduous enamel after application of fluoride-containing varnish (Duraphat). |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45450 |
| Study title: Baumann RJ. Prevention and management of febrile convulsions. Paedriatr Drugs 2001; 3: 585-592. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45451 |
| Study title: Benign epilpesies of infancy - Epilepsy: A compehensive Textbook - 1997, p,2267-76 |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45573 |
| Study title: 30 day oral toxicity study in the young dog - Thien - Aubert and al. - 14/12/94 |
| Active substance: ROXYTHROMYCIN |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35469 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41813 |
| Study title: An open multicenter trial evaluating acceptance of the new liquid Norditropin® formulation |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41671 |
| Study title: T. Ortowski - "Clinical evaluation of preparation Salbutamol tablets and syrup" |
| Active substance: SALBUTAMOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35554 |
| Study title: KlinIsche Studie Kopfwaschsalbe Ichthyol |
| Active substance: SALICYLIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35581 |
| Study title: Non-interventional study on the use of Sophtal-POS® N in children |
| Active substance: SALICYLIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35575 |
| Study title: A comparative assessment of contact lens tolerance and a study of possibilities for its improvement. |
| Active substance: SALICYLIC ACID AND UREA |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35590 |
| Study title: Clinical use of Solcoseryl Eye-Gel in anterior ocular diseases. |
| Active substance: SALICYLIC ACID AND UREA |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35588 |
| Study title: Solcoseryl Eye Gel in pediatric ophtalmology practice. |
| Active substance: SALICYLIC ACID AND UREA |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35584 |
| Study title: GENOTONORM IN SHORT CHILDREN WITH A BACKGROUND OF INTRAUTERINE GROWTH RETARDATION |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45574 |
| Study title: The use of multivitamin-preparations in paediatricsThe use of multivitamin-preparations in paediatrics |
| Active substance: VITAMINS |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45567 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45581 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41710 |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41632 |
| Study title: GH IN GHDA |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41633 |
| Study title: The Genet Study |
| Active substance: Somatropin |
| Study summary document link (including results): F-GHD-004-GHD_Norditropin.pdf |
| View full study record |
| Document reference: 41769 |
| Study title: The growth promoting effect of NN-798 in children with chronic renal failure on conservative therapy. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45460 |
| Study title: Clinical evaluation report - Loiseau - 1980 |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45461 |
| Study title: Clinical evaluation report - Loiseau - 25.11.1980 |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45473 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42180 |
| Study title: Fluoride deposited topical applications in enamel. KOH-soluble and acquired fluoride. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42503 |
| Study title: Fluoride uptake in plaque-covered enamel after treatment with the fluoride lacquer Duraphat. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42368 |
| Study title: Fluoride uptake in plaque-covered enamel after treatment with the fluoride lacquer Duraphat. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42481 |
| Study title: Fluoride varnish versus acidulated phosphate fluoride for schoolchildren in Manipal. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42426 |
| Study title: Fluoride varnish versus acidulated phosphate fluoride for schoolchildren in Manipal. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42539 |
| Study title: Fluoride varnishes (Duraphat): a meta-analysis. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42367 |
| Study title: Fluoride varnishes (Duraphat): a meta-analysis. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42480 |
| Study title: Fluoride varnishes in caries prevention. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41775 |
| Study title: TO WELL DEFINE IGF-I REFERENCE IN ADOLESCENTS |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42208 |
| Study title: Oral anticoagulation therapy in children. 2006 Oral anticoagulation therapy in children. 2006 |
| Active substance: WARFARIN |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 45639 |
| Study title: Efficacy and tolerability of Otrivin nasal gel vs. Vibrocil nasal gel.19.11.1973 |
| Active substance: XYLOMETAZOLINE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48004 |
| Study title: Effect of RU 28965 administered orally for 10 days on bone tissue in infant dogs |
| Active substance: ROXYTHROMYCIN |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35481 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35482 |
| Study title: Fluoride varnishes in caries prevention]. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42416 |
| Study title: Fluoride varnishes in caries prevention]. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42529 |
| Study title: Fluoride varnishes--a review. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42349 |
| Study title: Fluoride varnishes--a review. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 35586 |
| Study title: Solcoseryl eye-gel preparation in the treatment of selected corneal diseases. |
| Active substance: SALICYLIC ACID AND UREA |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42328 |
| Study title: On topical application of fluorides and its inhibiting effect on caries. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42394 |
| Study title: On topical application of fluorides and its inhibiting effect on caries. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45479 |
| Study title: Expertise clinique. Etude d'activité et de tolérance (Phase II) - Sorel L. - 12/07/1979 |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45642 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41815 |
| Study title: The application of cysteine gel and Solcoseryl eye gel in different corneal diseases. |
| Active substance: SALICYLIC ACID AND UREA |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41672 |
| Study title: Growth hormone treatment in children after renal transplantation. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 41785 |
| Study title: Growth Velocity of Young Girls with Turner Syndrome |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42329 |
| Study title: Pharmacokinetics of fluoride gels in children and adults. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42357 |
| Study title: Pharmacokinetics of fluoride gels in children and adults. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 45645 |
| Study title: Knoch - ,,Summary report of data of nasal drops activity of Xylometazoline in the ambulatory conditions" |
| Active substance: XYLOMETAZOLINE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 41733 |
| 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 |
| View full study record |
| Document reference: 41762 |
| Study title: Human Growth Hormon in Achondroplasia |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41639 |
| Study title: Humatrope® (Somatropin) Drug Monitoring in Patients with Short Stature |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 41726 |
| Study title: Humatrope® in Short Bowel Syndrome |
| Active substance: Somatropin |
| Study summary document link (including results): Somatorpin-B93FPT001.xls |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| Document reference: 41637 |
| Study title: Alpha Therapeutic Corporation. Clinical Report Soyacal 10% TM Study |
| Active substance: SOYABEAN OIL |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42575 |
| Study title: Kiszely; 1982 |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 48045 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42505 |
| Study title: Effect of a fluoride-containinglacquer on dental caries. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42362 |
| Study title: Effect of a fluoride-containinglacquer on dental caries. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42291 |
| Study title: Study of the clinical and biological efficacity of NAAXIA SINE® in vernal keratoconjunctivitis |
| Active substance: SPAGLUMIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42574 |
| 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 |
| View full study record |
| Document reference: 41659 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39447 |
| Study title: Preparation H ointment (WH-66-228) repeated insult patch test |
| Active substance: YEAST CELL EXTRACT AND SHARK LIVER OIL |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| Document reference: 45506 |
| Study title: post-marketing surveillance, report 2001 |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42509 |
| 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; |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 40157 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42049 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42228 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45508 |
| Study title: Prevention and management of febrile convulsions. - Baumann RJ. - Paedriatr Drugs 2001; 3: 585-592. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45509 |
| Study title: Prognosis in children with febrile convulsions. - Nelson KB et al. - Pediatrics 1978; 61: 720-727. |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45517 |
| Study title: The safety of intravenous valproate study. - Mattson - 1993 - In the report MAA0461 - |
| Active substance: VALPROIC ACID |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41778 |
| Study title: No title |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41750 |
| Study title: No title |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42331 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41649 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| Document reference: 41764 |
| Study title: No title |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45526 |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47270 |
| 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 |
| View full study record |
| Document reference: 47268 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41605 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42523 |
| Study title: Effects of self-applied topical fluoride preparations in orthodontic patients. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42448 |
| Study title: Efficacy of preventive agents for dental caries. Systemic fluorides: water fluoridation. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42388 |
| Study title: Efficacy of preventive agents for dental caries. Systemic fluorides: water fluoridation. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42501 |
| Study title: Enamel fluoride uptake, distribution and retention from topical fluoride agents. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42405 |
| Study title: Enamel fluoride uptake, distribution and retention from topical fluoride agents. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40304 |
| Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Vertigoheel (tablets) [AWB-AT] |
| Active substance: Vertigoheel |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39385 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42495 |
| Study title: Evaluation of a fluoride-containing varnish in children with low caries incidence. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42377 |
| Study title: Evaluation of a fluoride-containing varnish in children with low caries incidence. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42490 |
| Study title: Evaluation of a routine for prevention and treatment of fissure caries in permanent first molars. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42401 |
| Study title: Evaluation of a routine for prevention and treatment of fissure caries in permanent first molars. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42514 |
| Study title: Evaluation of non-invasive treatment applied to occlusal surfaces. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42358 |
| Study title: Evaluation of non-invasive treatment applied to occlusal surfaces. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42471 |
| Study title: Factors governing the use of topical fluorides: time and patient acceptability. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42338 |
| Study title: Factors governing the use of topical fluorides: time and patient acceptability. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40183 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 44276 |
| 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 |
| View full study record |
| Document reference: 35431 |
| Study title: A study for investigating the growth in patients with skeletal dysplasia. An extension of wider indications. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41804 |
| Study title: A STUDY OF BIOSYNTHETIC HUMAN GROWTH HORMONE (GENOTROPIN) IN TURNER'S SYNDROME. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41675 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42459 |
| Study title: A clinical estimation of the fluoride used during application of a fluoride varnish. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42408 |
| Study title: A clinical estimation of the fluoride used during application of a fluoride varnish. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42531 |
| Study title: Results of a 32-month fluoride varnish study in Sherbrooke and Lac-Megantic, Canada. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42353 |
| Study title: Results of a 32-month fluoride varnish study in Sherbrooke and Lac-Megantic, Canada. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42546 |
| Study title: Review of the anticaries effectiveness of professionally applied and self-applied topical fluoride gels. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42407 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42586 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42587 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42483 |
| Study title: A review on fluoride varnishes: an alternative topical fluoride treatment. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42352 |
| Study title: A review on fluoride varnishes: an alternative topical fluoride treatment. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41814 |
| Study title: A study for investigating the growth in patients with skeletal dysplasia. |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42117 |
| Study title: Secnidazole paediatric granules in amoebiasis / giardiasis |
| Active substance: SECNIDAZOLE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42119 |
| Study title: Review of the anticaries effectiveness of professionally applied and self-applied topical fluoride gels. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42418 |
| Study title: Sealant and fluoride varnish in caries: a randomized trial. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42347 |
| Study title: Sealant and fluoride varnish in caries: a randomized trial. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42270 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42254 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41613 |
| Study title: Estudio prospectivo para evaluar la seguridad y tolerabilidad del Enema Casen en pacientes pediátricos |
| Active substance: SODIUM PHOSPHATE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47464 |
| Study title: A study to test the efficacy of E45 Cream on nappy rash |
| Active substance: SOFT PARAFFIN |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40199 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42334 |
| Study title: Studies of fluoride varnishes in Finland. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42422 |
| Study title: Studies of fluoride varnishes in Finland. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42482 |
| Study title: The caries-protective efficacy of 2 fluoride varnishes in a 2-year controlled clinical trial |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42343 |
| Study title: The caries-protective efficacy of 2 fluoride varnishes in a 2-year controlled clinical trial |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42489 |
| Study title: The clinical effect of application of fluoride varnish. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42438 |
| Study title: The clinical effect of application of fluoride varnish. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42551 |
| Study title: The comparative efficacy of local anticaries agents][Article in Russian |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42371 |
| Study title: The comparative efficacy of local anticaries agents][Article in Russian |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42499 |
| Study title: The effect of five years' implementation of caries-preventive methods in Swedish high-risk adolescents. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42372 |
| Study title: The effect of five years' implementation of caries-preventive methods in Swedish high-risk adolescents. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42485 |
| Study title: The effect of prophylactic measures on the gingival health of school children. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40198 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42541 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47885 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34663 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40173 |
| 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 |
| View full study record |
| Document reference: 48256 |
| 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 |
| View full study record |
| Document reference: 48251 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 41646 |
| Study title: |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42589 |
| 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): |
| View full study record |
| Document reference: 42063 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42421 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42593 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42472 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43112 |
| Study title: Assessing the effect of fluoride varnish on early enamel carious lesions in the primary dentition |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42336 |
| Study title: Assessing the effect of fluoride varnish on early enamel carious lesions in the primary dentition |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42478 |
| Study title: Caries increment in primary teeth after application of Duraphat fluoride varnish. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42361 |
| Study title: Caries increment in primary teeth after application of Duraphat fluoride varnish. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42527 |
| Study title: Caries prevention with Duraphat in a new application form]. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42412 |
| Study title: The effect of prophylactic measures on the gingival health of school children. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42458 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43516 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 34878 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43703 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42431 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42463 |
| Study title: The trace efficacy of dental caries prevention in children |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42429 |
| Study title: The trace efficacy of dental caries prevention in children |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42498 |
| Study title: Trials - results - conclusions. Duraphat - Fluor Protector |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42340 |
| Study title: Trials - results - conclusions. Duraphat - Fluor Protector |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42453 |
| Study title: Two-year trial of the fluoride-containing varnishes Duraphat and Carex]. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42389 |
| Study title: Two-year trial of the fluoride-containing varnishes Duraphat and Carex]. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42467 |
| Study title: use of a fluoride varnish in caries prevention. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42383 |
| Study title: use of a fluoride varnish in caries prevention. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42496 |
| Study title: use of fluoride varnish in the prevention of caries. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42379 |
| Study title: use of fluoride varnish in the prevention of caries. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42271 |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41807 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43269 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43550 |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 47995 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41614 |
| 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 |
| Study summary document link (including results): 2011-09 GE Metastron response List of published articles.doc |
| View full study record |
| Document reference: 48212 |
| Study title: Caries prevention with fluoride varnish in a socially deprived community |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43137 |
| Study title: Caries prevention with fluoride varnish in a socially deprived community |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42557 |
| Study title: Caries prevention with fluoride varnishes among preschool children. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42344 |
| Study title: Caries prevention with fluoride varnishes among preschool children. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42457 |
| Study title: Caries prophylaxis by local application of sodium fluoride lacquer |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42441 |
| Study title: Caries prophylaxis by local application of sodium fluoride lacquer |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42554 |
| Study title: Caries prophylaxis by means of local application of sodium fluoride lacquer |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42442 |
| Study title: Caries prophylaxis by means of local application of sodium fluoride lacquer |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42555 |
| Study title: Caries prevention with Duraphat in a new application form]. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42525 |
| Study title: Caries prevention with Duraphat in a new applications form]. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42411 |
| Study title: Caries prophylaxis by topical application of sodium fluoride varnish |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42440 |
| Study title: Caries prophylaxis by topical application of sodium fluoride varnish |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42553 |
| Study title: Caries-preventive effect of a fluoride-containing lacquer, Duraphat, evaluated in a clinical study |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42373 |
| Study title: Caries-preventive effect of a fluoride-containing lacquer, Duraphat, evaluated in a clinical study |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42486 |
| Study title: Caries-preventive effect of fluoride varnish with different fluoride concentrations. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42423 |
| Study title: Caries-preventive effect of fluoride varnish with different fluoride concentrations. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42536 |
| Study title: Caries-preventive effects of fluoride products when used in conjunction with fluoride dentifrice. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42445 |
| Study title: Caries-preventive effects of fluoride products when used in conjunction with fluoride dentifrice. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42284 |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35388 |
| 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 |
| View full study record |
| Document reference: 35433 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 35434 |
| 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 |
| View full study record |
| Document reference: 35391 |
| 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 |
| View full study record |
| Document reference: 35406 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41689 |
| Study title: A STUDY EVALUATING THE EFFECT OF GROWTH HORMONE IN GIRLS WITH TURNER'S SYNDROME |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41682 |
| Study title: A STUDY EVALUATING THE EFFECT OF GROWTH HORMONE TREATMENT IN CHILDREN WITH THALASSEMIA MAJOR |
| Active substance: Somatropin |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41684 |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| 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): |
| View full study record |
| Document reference: 40186 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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): |
| View full study record |
| Document reference: 42038 |
| 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 |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42316 |
| Study title: Clinical evaluation of Duraphat and Fluor-Protector preparations in caries prevention |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42339 |
| Study title: Clinical evaluation of Duraphat and Fluor-Protector preparations in caries prevention |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42556 |
| Study title: Clinical evaluation of home fluoride-containing varnish. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42380 |
| Study title: Clinical evaluation of home fluoride-containing varnish. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42493 |
| Study title: Clinical experience with the use of Duraphat lacquer. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42341 |
| Study title: Clinical experience with the use of Duraphat lacquer. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42454 |
| Study title: Clinical experience with the use of Duraphat shellac. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42446 |
| Study title: Clinical experimental field studies of the caries-preventive effect of a fluoride lacquer] |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42432 |
| Study title: Clinical experimental field studies of the caries-preventive effect of a fluoride lacquer] |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42545 |
| Study title: Collective preschool caries prevention using a fluoride-containing varnish] [Article in German] |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42430 |
| Study title: Comparative assessment of the caries prevention effectiveness of different fluorine preparations] [Article in Russian] |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42393 |
| Study title: Comparative assessment of the caries prevention effectiveness of different fluorine preparations] [Article in Russian] |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42506 |
| Study title: Comparative clinical and radiological studies on Fluor ProtectorR and DuraphatR. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42342 |
| Study title: Comparative clinical and radiological studies on Fluor ProtectorR and DuraphatR. |
| Active substance: SODIUM FLUORIDE |
| Study summary document link (including results): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42544 |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 43392 |
| 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 |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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) |
| Study summary document link (including results): |
| View full study record |
| 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 |
| View full study record |
| 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 |
| View full study record |
| Document reference: 42029 |
| 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): |
| View full study record |
| Document reference: 42409 |
| 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): |
| View full study record |
| 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 |
| Study summary document link (including results): |
| View full study record |
| Document reference: 42428 |
| 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 |
| View full study record |
| Document reference: 35400 |
| 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 |
| View full study record |
| 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 |
| View full study record |
| 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: 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 |
| Study summary document link (including results): |
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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: 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: 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 |
| Study summary document link (including results): |
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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 |
| Study summary document link (including results): |
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| Document reference: 42238 |
| 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: 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 |
| Study summary document link (including results): |
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| Document reference: 43680 |
