Clinical Trials Register

Trials with a EudraCT protocol (30,876)
Paediatric studies in scope of Art45 of the Paediatric Regulation (7,531)

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: To investigate the absorption and excretion of ampicillin from supporitories given to children.Nakazawa et al. (1983-05-16)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_16.xlsx

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Document reference: 49015

Study title: To investigate the absorption of ampicillin from suppositories in children.Motohiro et al. (1983-05-09)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_15.xlsx

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Document reference: 49012

Study title: FLU9705: a multi-centre, parallel group, randomised, double-blind study to investigate the efficacy of fluticasone propionate 100 mcg MDI bd versus placebo MDI bd both via Babyhaler™ spacer in 1 to 5 year old children with asthma or asthma-like symptoms during a 6 months study period.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FMS40256-ICHE3.pdf

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Document reference: 28395

Study title: Nebulised Fluticasone propionate in an upper respiratory tract inflammatory disorder (rhinopharyngitis): a multicentre, randomised, blinded, parallel group study of the efficacy and safety of nebulised fluticasone propionate 0.5mg daily compared with nebulised beclomethasone dipropionate 0.8mg daily in children suffering from acute rhinopharyngitis.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FLIC09-ICHE3.pdf

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Document reference: 28422

Study title: A multi-centre, randomised, open-label, parallel group clinical trial to assess the efficacy and safety of Salmeterol/Fluticasone Propionate combination product (2x 25/125μg/actuation, bd) via a hydrofluoroalkane metereddose inhaler compared with Salmeterol/Fluticasone Propionate Accuhaler™ (50/250μg bd) in adult Chinese patients with mild to moderate asthma.

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAS30021-ICHE3.pdf

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Document reference: 28452

Study title: A 12-week randomized, multicenter, double-blind, placebo controlled, parallel group study in children (aged 5-12, inclusive) with persistent asthma evaluating the safety, efficacy and pharmacokinetics of Foradil (formoterol fumarate) 10 mg bid delivered b

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 0604 Art45 listing 2011.xls

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Document reference: 47797

Study title: Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44086

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44187

Study title: Parker BR. Neuroblastoma with extraosseous uptake of bone-seeking radionuclide. AJR Am J Roentgenol. 1981 May;136(5):1032-4. No abstract available. Parker BR. Neuroblastoma with extraosseous uptake of bone-seeking radionuclide. AJR Am J Roentgenol. 1981 May;136(5):1032-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44124

Study title: Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44223

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44270

Study title: Minoves M, Bassa P, Clemente A, Rivas A, Riera E, Setoain J, Costansa JM. Incidental finding of varicocele detected on a blood-pool image on Tc-99m HMDP bone scintigraphy. Clin Nucl Med. 2000 Nov;25(11):947-8. No abstract available. Minoves M, Bassa P, Clemente A, Rivas A, Riera E, Setoain J, Costansa JM. Incidental finding of varicocele detected on a blood-pool image on Tc-99m HMDP bone scintigraphy. Clin Nucl Med. 2000 Nov;25(11):947-8. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43472

Study title: Becker muscular dystrophy associated with focal myositis on bone scintigraphy. Minshew PT, Silverman ED, Samuels-Botts C. Clin Nucl Med. 2000 Dec;25(12):1010-2.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43470

Study title: Osteomyelitis in the neonate. Clinical aspects and the role of radiography and scintigraphy in diagnosis and management. Mok PM, Reilly BJ, Ash JM. Radiology. 1982 Dec;145(3):677-82.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44066

Study title: Single-blind trial to evaluate the efficacy and safety of ampicillin suppositories in bacterial pneumonia in children using i.v. ampicillin as reference drug.Motohiro et al. (1983-05-09)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_21.xlsx

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Document reference: 49020

Study title: Study plasma concentrations after rectal administration of ampicillin suppositories to children.Movin et al. (1987-06-15)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_23.xlsx

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Document reference: 49022

Study title: LaMont RL, Muz J, Heilbronner D, Bouwhuis JA. Quantitative assessment of femoral head involvement in Legg-Calvé-Perthes disease. J Bone Joint Surg Am. 1981 Jun;63(5):746-52. LaMont RL, Muz J, Heilbronner D, Bouwhuis JA. Quantitative assessment of femoral head involvement in Legg-Calvé-Perthes disease. J Bone Joint Surg Am. 1981 Jun;63(5):746-52.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44122

Study title: Review of spondylolisthesis and spondylolysis in paediatric practice. Oakley RH, Carty H. Br J Radiol. 1984 Oct;57(682):877-85.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43981

Study title: Oesterreich FU, Jend-Rossmann I, Jend HH, Triebel HJ. Semiquantitative SPECT imaging for assessment of bone reactions in internal derangements of the temporomandibular joint. J Oral Maxillofac Surg. 1987 Dec;45(12):1022-8. Oesterreich FU, Jend-Rossmann I, Jend HH, Triebel HJ. Semiquantitative SPECT imaging for assessment of bone reactions in internal derangements of the temporomandibular joint. J Oral Maxillofac Surg. 1987 Dec;45(12):1022-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43840

Study title: Oh SN, Jee WH, Cho SM, Kim SH, Kang HS, Ryu KN, Cho CS. Osteonecrosis in patients with systemic lupus erythematosus: MR imaging and scintigraphic evaluation. Clin Imaging. 2004 Jul-Aug;28(4):305-9. Oh SN, Jee WH, Cho SM, Kim SH, Kang HS, Ryu KN, Cho CS. Osteonecrosis in patients with systemic lupus erythematosus: MR imaging and scintigraphic evaluation. Clin Imaging. 2004 Jul-Aug;28(4):305-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43400

Study title: A 3-month, placebo-controlled efficacy study of formoterol Turbuhaler 4.5μg and 9μg b.i.d. (corresponding to the metered doses 6μg and 12μg, respectively) in asthmatic children aged 6 to 17 years.

Active substance: FORMOTEROL

Study summary document link (including results): SD-037-0003 Study Synopsis.pdf

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Document reference: 47798

Study title: A double-blind, placebo-controlled efficacy study of formoterol Turbuhaler 4.5μg and 9μg (corresponding to the metered doses of 6μg and 12μg, respectively) in asthmatic children.

Active substance: FORMOTEROL

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Document reference: 47803

Study title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTIPLE DOSE (1 WEEK) FINDING, MULTICENTER, CROSSOVER STUDY IN CHILDREN AGED 5 TO 12 WITH PERSISTENT ASTHMA COMPARING 4 DOSES (5, 10, 15 AND 30 UG) OF FORMOTEROL BID ADMINISTERED FROM THE MULTIPLE DOSE DRY

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 0602 Art45 listing 2011.xls

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Document reference: 47808

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44234

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44281

Study title: Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44267

Study title: [Nonspecific osteomyelitis in childhood and adolescence. The contribution of imaging diagnosis] Italian. Urso S, Pacciani E, Fariello G, Colajacomo M, Fassari FM, Randisi F, Certo A, Liberatore M, Pagnotta G. Radiol Med (Torino). 1995 Sep;90(3):212-8. Italian.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43589

Study title: Usui K, Yamamoto W, Shuke N, Aburano T, Yamanaka Y, Tokusashi Y, Miyokawa N. Scintigraphic findings of tibial adamantinoma on a three-phase bone scan. Clin Nucl Med. 2000 Dec;25(12):1057-8. No abstract available. Usui K, Yamamoto W, Shuke N, Aburano T, Yamanaka Y, Tokusashi Y, Miyokawa N. Scintigraphic findings of tibial adamantinoma on a three-phase bone scan. Clin Nucl Med. 2000 Dec;25(12):1057-8. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43467

Study title: Moragas M, Lomeña F, Herranz R, García A, Piera C, Muxí A, Bassa P, Catafau A, Pavía A, Setoain J. 99Tcm-HMPAO leucocyte scintigraphy in the diagnosis of bone infection. Nucl Med Commun. 1991 May;12(5):417-27. Moragas M, Lomeña F, Herranz R, García A, Piera C, Muxí A, Bassa P, Catafau A, Pavía A, Setoain J. 99Tcm-HMPAO leucocyte scintigraphy in the diagnosis of bone infection. Nucl Med Commun. 1991 May;12(5):417-27.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43736

Study title: Age-related changes in the hemodynamics of the femoral head as evaluated by early phase of bone scintigraphy. Hamaguchi H, Fujioka M, Takahashi KA, Hirata T, Ishida M, Sakao K, Ushijima Y, Kubota T, Nishimura T, Kubo T. Ann Nucl Med. 2006 Jan;20(1):35-40.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43378

Study title: Ohta H, Hojo M, Shintaku M, Komibuchi T, Okamoto S. Tc-99m HMDP and Ga-67 imaging along with CT and MRI in fibrous dysplasia of the temporal bone. Clin Nucl Med. 1997 May;22(5):328-30. No abstract available. Ohta H, Hojo M, Shintaku M, Komibuchi T, Okamoto S. Tc-99m HMDP and Ga-67 imaging along with CT and MRI in fibrous dysplasia of the temporal bone. Clin Nucl Med. 1997 May;22(5):328-30. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43551

Study title: Okimura T, Higashi K, Nakagawa T, Kobayashi S, Tohda N. [A case of myositis ossificans with abnormal uptake of 99mTc-MDP and 67Ga-citrate] Rinsho Hoshasen. 1985 Jan;30(1):157-9. Japanese. No abstract available. Okimura T, Higashi K, Nakagawa T, Kobayashi S, Tohda N. [A case of myositis ossificans with abnormal uptake of 99mTc-MDP and 67Ga-citrate] Rinsho Hoshasen. 1985 Jan;30(1):157-9. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43968

Study title: Okuyama T, Suzuki H, Nakamoto K, Suzuki S. [Evaluation of bone scintigraphy in differential diagnosis of benign bone tumors] Kaku Igaku. 1982 Dec;19(10):1519-30. Japanese. No abstract available. Okuyama T, Suzuki H, Nakamoto K, Suzuki S. [Evaluation of bone scintigraphy in differential diagnosis of benign bone tumors] Kaku Igaku. 1982 Dec;19(10):1519-30. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44063

Study title: Holder LE, Michael RH. The specific scintigraphic pattern of "shin splints in the lower leg": concise communication. J Nucl Med. 1984 Aug;25(8):865-9. Holder LE, Michael RH. The specific scintigraphic pattern of "shin splints in the lower leg": concise communication. J Nucl Med. 1984 Aug;25(8):865-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43988

Study title: Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44107

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44188

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44235

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44282

Study title: Open-label, multi-center, non-controlled follow-up study over 3 months on the safety of Formoterol Easyhaler in approximately 35 asthmatic pediatric patients initially treated in study

Active substance: FORMOTEROL

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Document reference: 47855

Study title: Protective effect of single doses of formoterol Turbuhaler 4.5μg and 9μg (corresponding to the metered doses 6μg and 12μg, respectively) compared with terbutaline Turbuhelr 0.5mg and placebo in children with exercise-induced bronchoconstriction (EIB).

Active substance: FORMOTEROL

Study summary document link (including results): SD-037-0149 Study Synopsis.pdf

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Document reference: 47861

Study title: Single dose toxicity of formoterol fumarate (D2522) in young rats after oral administration.

Active substance: FORMOTEROL

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Document reference: 47863

Study title: Behrendt H et alMitoxantrone is effective in treating childhood T-cell lymphoma/T-cell acute lymphoblastic leukemiaCancer. 1995 Jul 15;76(2):339-42.Behrendt H et alMitoxantrone is effective in treating childhood T-cell lymphoma/T-cell acute lymphoblastic leukemiaCancer. 1995 Jul 15;76(2):339-42.

Active substance: MITOXANTRONE

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Document reference: 32083

Study title: Van Campenhout A, Moens P, Fabry G. Serial bone scintigraphy in Legg-Calvé-Perthes disease: correlation with the Catterall and Herring classification. J Pediatr Orthop B. 2006 Jan;15(1):6-10. Van Campenhout A, Moens P, Fabry G. Serial bone scintigraphy in Legg-Calvé-Perthes disease: correlation with the Catterall and Herring classification. J Pediatr Orthop B. 2006 Jan;15(1):6-10.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43382

Study title: van den Oever M, Merrick MV, Scott JH. Bone scintigraphy in symptomatic spondylolysis. J Bone Joint Surg Br. 1987 May;69(3):453-6. van den Oever M, Merrick MV, Scott JH. Bone scintigraphy in symptomatic spondylolysis. J Bone Joint Surg Br. 1987 May;69(3):453-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43865

Study title: Generalized soft tissue calcification in children and adolescents with end stage renal failure. van Diemen-Steenvoorde R, Donckerwolcke RA, de Haas G. Eur J Pediatr. 1986 Sep;145(4):293-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43893

Study title: Liu JX. [Early quantitative detection of vascularity of the reduced femoral head of congenital hip dislocation by scintigraphy] Zhonghua Wai Ke Za Zhi. 1990 May;28(5):292-4, 318. Chinese. Liu JX. [Early quantitative detection of vascularity of the reduced femoral head of congenital hip dislocation by scintigraphy] Zhonghua Wai Ke Za Zhi. 1990 May;28(5):292-4, 318. Chinese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43764

Study title: Hypertrophic pulmonary osteoarthropathy in nasopharyngeal carcinoma: an early sign of pulmonary metastasis. Liu RS, Chen YK, Yen SH, Chu YK, Chu LS, Chen KY, Yeh SH. Nucl Med Commun. 1995 Sep;16(9):785-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43591

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

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43846

Study title: A double blind trial to evaluate the incidence of diarrhea and C. difficile toxin (CDT) folloing therapy with ampicillin (AMP), amoxicillin (AMOX), or trimethoprim-sulfamethoxazole (TMP-SMX) for otitis media.Hyams et al. (Pediatr Infect Dis. 1984 Sep-Oct;3(5):433-6)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_30.xlsx

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Document reference: 49029

Study title: [The age dependence of traumatically induced bone remodeling as studied in the bone scintigram] German Spitz J, Lauer I, Tittel K. Nuklearmedizin. 1991 Oct;30(5):155-60. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43726

Study title: Springorum HW, Bostel F, Puhl W, Georgi P. [Spinal scintigraphy following Harrington's spondylodesis] Z Orthop Ihre Grenzgeb. 1984 May-Jun;122(3):255-9. German. Springorum HW, Bostel F, Puhl W, Georgi P. [Spinal scintigraphy following Harrington's spondylodesis] Z Orthop Ihre Grenzgeb. 1984 May-Jun;122(3):255-9. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44001

Study title: Horne T, Mogle P, Finsterbush A, Gordin M. Increased uptake of 99mTc-MDP in calcified synovial sarcoma. Eur J Nucl Med. 1983;8(2):75-6. No abstract available. Horne T, Mogle P, Finsterbush A, Gordin M. Increased uptake of 99mTc-MDP in calcified synovial sarcoma. Eur J Nucl Med. 1983;8(2):75-6. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44054

Study title: The technetium phosphate bone scan in the diagnosis of osteomyelitis in childhood. Howie DW, Savage JP, Wilson TG, Paterson D. J Bone Joint Surg Am. 1983 Apr;65(4):431-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44041

Study title: Multifocal pyomyositis. Diagnosis on technetium-99m MDP bone scan. Howman-Giles R, McCauley D, Brown J. Clin Nucl Med. 1984 Mar;9(3):149-51.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44004

Study title: Taylor GA, Shea N, O'Brien T, Hall JE, Treves ST. Osteoid osteoma: localization by intraoperative magnification scintigraphy. Pediatr Radiol. 1986;16(4):313-6. PMID: 3725449 [PubMed - indexed for MEDLINE] Taylor GA, Shea N, O'Brien T, Hall JE, Treves ST. Osteoid osteoma: localization by intraoperative magnification scintigraphy. Pediatr Radiol. 1986;16(4):313-6. PMID: 3725449 [PubMed - indexed for MEDLINE]

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43922

Study title: [Osteomyelitis in children: sometimes hard to recognize] Dutch. te Pas AB, Feith SW, Wit JM. Ned Tijdschr Geneeskd. 2002 Aug 17;146(33):1547-50. Dutch.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43438

Study title: Rectus femoris muscle bone-image uptake in a sprinter. Telepak RJ, Hartshorne MF, Bauman JM, Cawthon MA. Clin Nucl Med. 1986 May;11(5):365. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43911

Study title: Thämmig R, Schulze K, Niederle J. [Display of a primary neuroblastoma in the bone scintigram] Rofo. 1981 Aug;135(2):239-40. German. No abstract available. Thämmig R, Schulze K, Niederle J. [Display of a primary neuroblastoma in the bone scintigram] Rofo. 1981 Aug;135(2):239-40. German. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44116

Study title: To investigate the absorption of ampicillin from suppositories.Kida et al. (1983-05-04)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_13.xlsx

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Document reference: 49013

Study title: Intense gallbladder uptake associated with chemotherapy. An unusual finding in pediatric skeletal scintigraphy. Lowry PA, Carstens C. Clin Nucl Med. 1995 Nov;20(11):976-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43579

Study title: Peller PJ, Ho VB, Kransdorf MJ. Extraosseous Tc-99m MDP uptake: a pathophysiologic approach. Radiographics. 1993 Jul;13(4):715-34. Peller PJ, Ho VB, Kransdorf MJ. Extraosseous Tc-99m MDP uptake: a pathophysiologic approach. Radiographics. 1993 Jul;13(4):715-34.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43659

Study title: A Double-blind, Placebo-controlled trial: comparison of the clinical and bacteriological effectiveness of ampicillin and a placebo.Nelson et al. (Ann NY Acad Sci 145 1967)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_6.xlsx

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Document reference: 49006

Study title: A prospective study of rash incidence in 532 patients treated with Amipicillin intravenously is reported.Scioli et al. (Boll 1st Sieroter Milan 1983;62;287-91)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_1.xlsx

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Document reference: 49000

Study title: A Single-blind, randomized trial to Evaluate the efficacy and safety of ampicillin suppositories in the treatment of acute suppurative otitis media by a well controlled method using ampicillin dry syrup as control.Baba et al. (1985-09-27)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_20.xlsx

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Document reference: 49019

Study title: Stauss J, Connolly LP, Perez-Rossello J, Treves ST. Pediatric acute pyelonephritis: diagnosis facilitated by skeletal scintigraphy. Clin Nucl Med. 2003 Oct;28(10):855-7. No abstract available. Stauss J, Connolly LP, Perez-Rossello J, Treves ST. Pediatric acute pyelonephritis: diagnosis facilitated by skeletal scintigraphy. Clin Nucl Med. 2003 Oct;28(10):855-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43413

Study title: Köhnlein S, Brinkmann G, Körner T, Kreusch T, Bohuslavizki KH, Heller M. [Magnetic resonance tomography in the diagnosis of mandibular osteomyelitis] Rofo. 1997 Jul;167(1):52-7. German. Köhnlein S, Brinkmann G, Körner T, Kreusch T, Bohuslavizki KH, Heller M. [Magnetic resonance tomography in the diagnosis of mandibular osteomyelitis] Rofo. 1997 Jul;167(1):52-7. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43547

Study title: Koppers B, Riel K. [3-phase scintigraphy in epicondylitis humeri radialis] Rofo. 1982 Aug;137(2):147-51. German. No abstract available. Koppers B, Riel K. [3-phase scintigraphy in epicondylitis humeri radialis] Rofo. 1982 Aug;137(2):147-51. German. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44077

Study title: [The early diagnosis of Perthes disease: the value of bone scintigraphy and magnetic resonance imaging in comparison with x-ray findings] German. Theissen P, Rütt J, Linden A, Smolarz K, Voth E, Schicha H. Nuklearmedizin. 1991 Dec;30(6):265-71. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43717

Study title: Tiel-van Buul MM, van Beek EJ, Broekhuizen AH, Bakker AJ, Bos KE, van Royen EA. Radiography and scintigraphy of suspected scaphoid fracture. A long-term study in 160 patients. J Bone Joint Surg Br. 1993 Jan;75(1):61-5. Tiel-van Buul MM, van Beek EJ, Broekhuizen AH, Bakker AJ, Bos KE, van Royen EA. Radiography and scintigraphy of suspected scaphoid fracture. A long-term study in 160 patients. J Bone Joint Surg Br. 1993 Jan;75(1):61-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43677

Study title: Lange RH, Lange TA, Rao BK. Correlative radiographic, scintigraphic, and histological evaluation of exostoses. J Bone Joint Surg Am. 1984 Dec;66(9):1454-9. Lange RH, Lange TA, Rao BK. Correlative radiographic, scintigraphic, and histological evaluation of exostoses. J Bone Joint Surg Am. 1984 Dec;66(9):1454-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43975

Study title: Lange W, Wicke A, Stern W, Staudte H. [Osteoid osteoma of the spine. The current differential diagnostic aspects] Rofo. 1991 Apr;154(4):450-2. German. No abstract available. Lange W, Wicke A, Stern W, Staudte H. [Osteoid osteoma of the spine. The current differential diagnostic aspects] Rofo. 1991 Apr;154(4):450-2. German. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43743

Study title: The painful accessory navicular. Lawson JP, Ogden JA, Sella E, Barwick KW. Skeletal Radiol. 1984;12(4):250-62.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44012

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

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43956

Study title: To study the absorption and excretion of the 250 mg ampicillin supporitory in children.Nishimura et al. (1983-05-04)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_18.xlsx

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Document reference: 49017

Study title: To study the pharmacokinetics of ampicillin suppositories in children.Toyonaga et al. (1983-05-06)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_17.xlsx

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Document reference: 49016

Study title: A multicentre, randomised, double-blind, double-dummy, parallel group comparison of three treatments : 1) salmeterol/fluticasone propionate (SFC) (50/100mcg strength) bd via DISKUS/ACCUHALER inhaler, 2) fluticasone propionate 200mcg bd via DISKUS/ACCUHALER inhaler, 3) fluticasone propionate 100mcg bd via DISKUS/ACCUHALER inhaler in children aged 4-11 years with asthma

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAM40012-ICHE3.pdf

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Document reference: 28443

Study title: A pilot single centre, randomised, double-blind, crossover study to demonstrate the superiority of Salmeterol/fluticasone propionate combination product 50/100mcg bd versus fluticasone propionate 100mcg bd when treated for two weeks with respect to activity levels in children aged 7-15 years.

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAM40101-ICHE3.pdf

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Document reference: 28448

Study title: A Randomized, Double-Blind, 12-Week Trial Evaluating the Safety of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Symptomatic Pediatric Subjects (4-11 Years) With Asthma

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAS30031-ICHE3.pdf

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Document reference: 28453

Study title: A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and in Adolescent Subjects with Activity-Induced Bronchospasm

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-SFA100314-ICHE3.pdf

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Document reference: 28454

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-SFA100316-ICHE3.pdf

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Document reference: 47594

Study title: An observational study to assess the health related quality of life impact of treating poorly controlled asthmatic children with Seretide(tm) 50/100mcg

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAM3802-ICHE3.pdf

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Document reference: 28442

Study title: Prospective, parallel-group, randomized, open label study to evaluate the impact of additional guidance from the health professionals team on treatment compliance of children aged between 6 and 14 years old with persistent moderate or severe asthma, receiving the combination salmeterol/fluticasone propionate 50/250 mcg (Seretide) twice a day. ADERE PROJECT (Pediatric)

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-ADERE-PEDIATRIC-1-ICHE3.pdf

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Document reference: 28444

Study title: Randomised, double-blind, comparator study to demonstrate the superiority of salmeterol/fluticasone propionate combination DISKUS™ 50/100mcg bd over fluticasone propionate DISKUS™/ACCUHALER™ 200mcg bd with respect to airway physiology in asthmatic children treated for 6 weeks.

Active substance: FLUTICASONE AND SALMETEROL

Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAM40100-ICHE3.pdf

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Document reference: 28447

Study title: Reduced perfusion and uptake of Tc-99m HDP in the iliac bone. A rare presentation of pelvic osteomyelitis. Pijpers R, Ekkelkamp S, Roos JC, Teule GJ. Clin Nucl Med. 1994 Jun;19(6):516-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43623

Study title: Israel O, Gips S, Jerushalmi J, Frenkel A, Front D. Osteomyelitis and soft-tissue infection: differential diagnosis with 24 hour/4 hour ratio of Tc-99m MDP uptake. Radiology. 1987 Jun;163(3):725-6. Israel O, Gips S, Jerushalmi J, Frenkel A, Front D. Osteomyelitis and soft-tissue infection: differential diagnosis with 24 hour/4 hour ratio of Tc-99m MDP uptake. Radiology. 1987 Jun;163(3):725-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43861

Study title: Bone SPET of symptomatic lumbar spondylolysis. Itoh K, Hashimoto T, Shigenobu K, Yamane S, Tamaki N. Nucl Med Commun. 1996 May;17(5):389-96. Erratum in: Nucl Med Commun 1996 Aug;17(8):732-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43566

Study title: Routine bone scintigraphy in primary staging of soft tissue sarcoma; Is it worthwhile? Jager PL, Hoekstra HJ, Leeuw J, van Der Graaf WT, de Vries EG, Piers D. Cancer. 2000 Oct 15;89(8):1726-31.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43475

Study title: A Single-blinded, Randomized trial to evaluate the efficacy and safety of 125 mg ampicillin suppositories in the treatment of acute respiratory tract infections in pediatric patients using ampicillin dry syrup as control.Nishimura et al. (1983-05-04)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_22.xlsx

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Document reference: 49021

Study title: Clarify the effects of age, dosage, and route of administration on ampicillin-associated diarrhea in pediatric patients.Phillips et al. (PEDIATRICS Vol. 58 No. 6 Dec. 1976)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_5.xlsx

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Document reference: 49004

Study title: Compare ampicillin and choramphenicol, both being given by the parenteral route in the therapyt of typhoid fever.Kaye et al. (Annals Ney York Academy of Sciences 145, 1967)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_3.xlsx

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Document reference: 49002

Study title: [Early diagnosis of bone infarction in children with sickle cell anemia by MDP 99m Tc scanning] Koren A, Fedchteyn S, Katsuni E. Harefuah. 1982 Mar 1;102(5):182-5. Hebrew. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44090

Study title: Knop J, Stritzke P, Montz R, Delling G, Winkler K. [Bone scintigraphy in assessing the success of chemotherapy in osteosarcoma] Nuklearmedizin. 1985 Apr;24(2):75-81. German. Knop J, Stritzke P, Montz R, Delling G, Winkler K. [Bone scintigraphy in assessing the success of chemotherapy in osteosarcoma] Nuklearmedizin. 1985 Apr;24(2):75-81. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43950

Study title: Morrison WB, Schweitzer ME, Bock GW, Mitchell DG, Hume EL, Pathria MN, Resnick D. Diagnosis of osteomyelitis: utility of fat-suppressed contrast-enhanced MR imaging. Radiology. 1993 Oct;189(1):251-7. Morrison WB, Schweitzer ME, Bock GW, Mitchell DG, Hume EL, Pathria MN, Resnick D. Diagnosis of osteomyelitis: utility of fat-suppressed contrast-enhanced MR imaging. Radiology. 1993 Oct;189(1):251-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43650

Study title: Scintigraphy in the diagnosis of occult fractures of the calcaneus. Moss EH, Carty H. Skeletal Radiol. 1990;19(8):575-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43772

Study title: Tc-99m nanocolloid and Tc-99m MDP three-phase bone imaging in osteomyelitis and septic arthritis. A comparative study. Mudun A, Unal S, Aktay R, Akmehmet S, Cantez S. Clin Nucl Med. 1995 Sep;20(9):772-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43587

Study title: Murayama T, Munakata A, Narita K, Fujita K, Fujii K. [Retrospective study of renal images on bone scans] Rinsho Hoshasen. 1989 Mar;34(3):335-8. Japanese. Murayama T, Munakata A, Narita K, Fujita K, Fujii K. [Retrospective study of renal images on bone scans] Rinsho Hoshasen. 1989 Mar;34(3):335-8. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43793

Study title: Murray IP, Ford JC. Tc-99m medronate scintigraphy in mandibular condylar hyperplasia. Clin Nucl Med. 1982 Oct;7(10):474-5. No abstract available. Murray IP, Ford JC. Tc-99m medronate scintigraphy in mandibular condylar hyperplasia. Clin Nucl Med. 1982 Oct;7(10):474-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44072

Study title: Leckie RG, Watabe JT, Shanley DJ, Werner M. Tc-99m HDP bone scintigraphy of ameloblastoma with panorex, CT, MRI, and gross correlation. Clin Nucl Med. 1993 Apr;18(4):350-2. No abstract available. Leckie RG, Watabe JT, Shanley DJ, Werner M. Tc-99m HDP bone scintigraphy of ameloblastoma with panorex, CT, MRI, and gross correlation. Clin Nucl Med. 1993 Apr;18(4):350-2. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43668

Study title: Lee BE, Robinson JL. The use of technetium-99m-labeled white blood cell scan in the management of a case of group A streptococcus necrotizing fasciitis with polymyositis. Clin Infect Dis. 1999 Jan;28(1):153-4. No abstract available. Lee BE, Robinson JL. The use of technetium-99m-labeled white blood cell scan in the management of a case of group A streptococcus necrotizing fasciitis with polymyositis. Clin Infect Dis. 1999 Jan;28(1):153-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43515

Study title: Okuyama T, Suzuki H, Umehara I, Kuwabara Y, Suzuki S, Takagi M. Diagnosis of aneurysmal bone cyst of the mandible. A report of two cases with emphasis on scintigraphic approaches. Clin Nucl Med. 1985 Nov;10(11):786-90. Okuyama T, Suzuki H, Umehara I, Kuwabara Y, Suzuki S, Takagi M. Diagnosis of aneurysmal bone cyst of the mandible. A report of two cases with emphasis on scintigraphic approaches. Clin Nucl Med. 1985 Nov;10(11):786-90.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43928

Study title: Ongolo-Zogo P, Thiesse P, Sau J, Desuzinges C, Blay JY, Bonmartin A, Bochu M, Philip T. Assessment of osteosarcoma response to neoadjuvant chemotherapy: comparative usefulness of dynamic gadolinium-enhanced spin-echo magnetic resonance imaging and technetium-99m skeletal angioscintigraphy. Eur Radiol. 1999;9(5):907-14. Ongolo-Zogo P, Thiesse P, Sau J, Desuzinges C, Blay JY, Bonmartin A, Bochu M, Philip T. Assessment of osteosarcoma response to neoadjuvant chemotherapy: comparative usefulness of dynamic gadolinium-enhanced spin-echo magnetic resonance imaging and technetium-99m skeletal angioscintigraphy. Eur Radiol. 1999;9(5):907-14.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43506

Study title: Oni OO, Graebe A, Pearse M, Gregg PJ. Prediction of the healing potential of closed adult tibial shaft fractures by bone scintigraphy. Clin Orthop Relat Res. 1989 Aug;(245):239-45. Oni OO, Graebe A, Pearse M, Gregg PJ. Prediction of the healing potential of closed adult tibial shaft fractures by bone scintigraphy. Clin Orthop Relat Res. 1989 Aug;(245):239-45.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43782

Study title: Tc-99m MDP uptake secondary to soft tissue extravasation of calcium gluconate in a newborn thought to have osteomyelitis. Orellana P, Velasquez C, Meneses L, Urioste A, Carreño JE, Garcíia CJ, Sabroso F, Cruces P. Clin Nucl Med. 2002 Sep;27(9):653-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44246

Study title: Orzel JA, Rudd TG. Heterotopic bone formation: clinical, laboratory, and imaging correlation. J Nucl Med. 1985 Feb;26(2):125-32. Orzel JA, Rudd TG. Heterotopic bone formation: clinical, laboratory, and imaging correlation. J Nucl Med. 1985 Feb;26(2):125-32.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43958

Study title: A twelve-month, double-blind, between-patient, placebo-controlled trial comparing the safety, tolerability and efficacy of 12 ug and 25 ug twice daily formoterol dry powder capsules for inhalation delivered by a single -dose inhaler (aeroliser) in childre

Active substance: FORMOTEROL

Study summary document link (including results): FOR258 2702049 Art45 listing 2011.xls

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Document reference: 47819

Study title: Sweeney LE Hypophosphataemic rickets after ifosfamide treatment in children Clin Radiol. 1993 May;47(5):345-7Sweeney LE Hypophosphataemic rickets after ifosfamide treatment in children Clin Radiol. 1993 May;47(5):345-7

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 25142

Study title: Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21. Jeffcoat MK, Page R, Reddy M, Wannawisute A, Waite P, Palcanis K, Cogen R, Williams RC, Basch C. Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis. J Periodontal Res. 1991 Sep;26(5):415-21.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43731

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44172

Study title: Velchik MG, Heyman S, Makler PT Jr, Goldstein HA, Alavi A. Bone scintigraphy: differentiating benign cortical irregularity of the distal femur from malignancy. J Nucl Med. 1984 Jan;25(1):72-4. Velchik MG, Heyman S, Makler PT Jr, Goldstein HA, Alavi A. Bone scintigraphy: differentiating benign cortical irregularity of the distal femur from malignancy. J Nucl Med. 1984 Jan;25(1):72-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44015

Study title: Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44141

Study title: Murray IP, Rossleigh MA, Dixon J. Clin Nucl Med. 1995 Jun;20(6):560-1. No abstract available. Murray IP, Rossleigh MA, Dixon J. Clin Nucl Med. 1995 Jun;20(6):560-1. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43599

Study title: Han JS, Kim YG, Kim S, Lee MC, Lee JS, Kim SH. Bone scintigraphy in acute renal failure with severe loin pain and patchy renal vasoconstriction. Nephron. 1991;59(2):254-60. Han JS, Kim YG, Kim S, Lee MC, Lee JS, Kim SH. Bone scintigraphy in acute renal failure with severe loin pain and patchy renal vasoconstriction. Nephron. 1991;59(2):254-60.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43750

Study title: Hanash KA, Bissada NK, Abla A, Esmail D, Dowling A. Predictive value of excretory urography, ultrasonography, computerized tomography, and liver and bone scan in the staging of bilharzial bladder cancer in Saudi Arabia. Cancer. 1984 Jul 1;54(1):172-6. Hanash KA, Bissada NK, Abla A, Esmail D, Dowling A. Predictive value of excretory urography, ultrasonography, computerized tomography, and liver and bone scan in the staging of bilharzial bladder cancer in Saudi Arabia. Cancer. 1984 Jul 1;54(1):172-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43993

Study title: Harcke HT, Conway JJ, Tachdjian MO, Dias LS, Noble HB, MacEwen GD, Weiss S. Scintigraphic localization of bone lesions during surgery. Skeletal Radiol. 1985;13(3):211-6. Harcke HT, Conway JJ, Tachdjian MO, Dias LS, Noble HB, MacEwen GD, Weiss S. Scintigraphic localization of bone lesions during surgery. Skeletal Radiol. 1985;13(3):211-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43966

Study title: Study the antibacterial and clinical efficacy of ampicillin as well as of its side-effects in comparison with penicillin V, our hitherto best peroral penicillin for scarlet fever therapy.Ström (Acta Paediatr Scand. 1968 Jul;57(4):285-8)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_31.xlsx

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Document reference: 49030

Study title: Murray IP, Frater CJ. Prominence of the C2 vertebra on SPECT. A normal variant. Clin Nucl Med. 1994 Oct;19(10):855-9. Murray IP, Frater CJ. Prominence of the C2 vertebra on SPECT. A normal variant. Clin Nucl Med. 1994 Oct;19(10):855-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43614

Study title: Oshiro N, Bito S, Ito H, Morimoto Y, Ikekubo K, Ishihara T, Mori T. [Fundamental and clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Kaku Igaku. 1982 Mar;19(2):305-11. Japanese. No abstract available. Oshiro N, Bito S, Ito H, Morimoto Y, Ikekubo K, Ishihara T, Mori T. [Fundamental and clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Kaku Igaku. 1982 Mar;19(2):305-11. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44091

Study title: Templeton JE, Bauer TW, Lietman SA. Chronic bilateral thigh and knee disconfort in an 18-year-old manTempleton JE, Bauer TW, Lietman SA. Clin Orthop Relat Res 2008;466:507-13

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44205

Study title: Partial growth plate closure: apex view on bone scan. Howman-Giles R, Trochei M, Yeates K, Middleton R, Barrett I, Scougall J, Whiteway D. J Pediatr Orthop. 1985 Jan-Feb;5(1):109-11.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43970

Study title: Hudson TM. Scintigraphy of aneurysmal bone cysts. AJR Am J Roentgenol. 1984 Apr;142(4):761-5. Hudson TM. Scintigraphy of aneurysmal bone cysts. AJR Am J Roentgenol. 1984 Apr;142(4):761-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44002

Study title: Hui C, Lau KK. Intracranial Tc99m MDP uptake in Sturge-Weber syndrome. Australas Radiol. 2003 Mar;47(1):75-7. Hui C, Lau KK. Intracranial Tc99m MDP uptake in Sturge-Weber syndrome. Australas Radiol. 2003 Mar;47(1):75-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43428

Study title: Aoyama R, Nagata K, Clinical results with ampicillin-cloxacillin for intravenous drip (author's transl.) The Japanese Journal of antibiotics, (Jpn-J_Antiot.), Nov.1978, vol. 31, no. 11, p. 681-4Aoyama R, Nagata K, Clinical results with ampicillin-cloxacillin for intravenous drip (author's transl.) The Japanese Journal of antibiotics, (Jpn-J_Antiot.), Nov.1978, vol. 31, no. 11, p. 681-4

Active substance: AMPICILLIN AND CLOXACILLIN

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Document reference: 46646

Study title: Testicular effects of formoterol fumarate (D2522) given orally to young rats for three months, using salbutamol sulphate as a reference compound

Active substance: FORMOTEROL

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Document reference: 47867

Study title: AIDS Clinical Trials Group of the National Institute of Allergy and Infectious diseases. AIDS 8(4), 451-459. 1994.MCGRATH BJ, NEWMAN CL. AIDS Clinical Trials Group of the National Institute of Allergy and Infectious diseases. AIDS 8(4), 451-459. 1994.MCGRATH BJ, NEWMAN CL.

Active substance: FOSCARNET

Study summary document link (including results): MCGRATH BJ and Newman CL 1994.pdf

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Document reference: 28572

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44192

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44239

Study title: Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43828

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44179

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44226

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44273

Study title: Multifocal osteoarticular tuberculosis resembling skeletal metastatic disease. Evaluation with Tc-99m MDP and Ga-67 citrate. Hardoff R, Efrat M, Gips S. Clin Nucl Med. 1995 Mar;20(3):279-81. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43603

Study title: Harris SA, Quayle AA, Testa HJ. Radionuclide bone scanning in the diagnosis and management of condylar hyperplasia. Nucl Med Commun. 1984 Jun;5(6):373-80. Harris SA, Quayle AA, Testa HJ. Radionuclide bone scanning in the diagnosis and management of condylar hyperplasia. Nucl Med Commun. 1984 Jun;5(6):373-80.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43994

Study title: Scintimetry in transient synovitis of the hip in the child.Hasegawa Y, Wingstrand H, Gustafson T. Acta Orthop Scand. 1988 Oct;59(5):520-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43806

Study title: Hasegawa Y. [Quantitative assessment of bone scintigraphy in hip joint disease] Nippon Seikeigeka Gakkai Zasshi. 1985 May;59(5):517-32. Japanese. Hasegawa Y. [Quantitative assessment of bone scintigraphy in hip joint disease] Nippon Seikeigeka Gakkai Zasshi. 1985 May;59(5):517-32. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43944

Study title: Strömqvist B, Hansson LI, Nilsson LT, Thorngren KG. Prognostic precision in postoperative 99mTc-MDP scintimetry after femoral neck fracture. Acta Orthop Scand. 1987 Oct;58(5):494-8. Erratum in: Acta Orthop Scand 1988 Apr;59(2):244. Strömqvist B, Hansson LI, Nilsson LT, Thorngren KG. Prognostic precision in postoperative 99mTc-MDP scintimetry after femoral neck fracture. Acta Orthop Scand. 1987 Oct;58(5):494-8. Erratum in: Acta Orthop Scand 1988 Apr;59(2):244.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43849

Study title: Intraoperative 99m technetium bone imaging in the treatment of benign osteoblastic tumors. Sty J, Simons G. Clin Orthop Relat Res. 1982 May;(165):223-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44085

Study title: Sty JR, Boedecker RA, Babbitt DP. Skull scintigraphy in infantile hypophosphatasia. J Nucl Med. 1979 Apr;20(4):305-6. No abstract available. Sty JR, Boedecker RA, Babbitt DP. Skull scintigraphy in infantile hypophosphatasia. J Nucl Med. 1979 Apr;20(4):305-6. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44145

Study title: Hung GL, Stewart CA, Yeo E, Ansari AN, Wang A, Greenfield L. Incidental demonstration of cerebral infarction on bone scintigraphy in sickle cell disease. Clin Nucl Med. 1990 Oct;15(10):671-2. No abstract available. Hung GL, Stewart CA, Yeo E, Ansari AN, Wang A, Greenfield L. Incidental demonstration of cerebral infarction on bone scintigraphy in sickle cell disease. Clin Nucl Med. 1990 Oct;15(10):671-2. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43752

Study title: Hung WT, Su CT. Diagnosis of atretic prolonged obstructive jaundice; technetium 99m hepatolite excretion study. J Pediatr Surg. 1990 Jul;25(7):797-800. Hung WT, Su CT. Diagnosis of atretic prolonged obstructive jaundice; technetium 99m hepatolite excretion study. J Pediatr Surg. 1990 Jul;25(7):797-800.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43759

Study title: Tindale WB, Martel AL, Barber DC. The use of image registration in the analysis of bone scans for the assessment of temporomandibular joint uptake. Nucl Med Commun. 1999 Jan;20(1):49-59. Tindale WB, Martel AL, Barber DC. The use of image registration in the analysis of bone scans for the assessment of temporomandibular joint uptake. Nucl Med Commun. 1999 Jan;20(1):49-59.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43517

Study title: Accumulation of Tc-99m HMDP in bony structures of immature teratoma in a child. Tohyama J, Ohba S, Sugie C, Ogino H, Hara M, Shibamoto Y. Clin Nucl Med. 2003 Apr;28(4):334-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43424

Study title: Muscular injury in a child diagnosed by 99mTc-MDP bone scan. Tondeur M, Haentjens M, Piepsz A, Ham HR. Eur J Nucl Med. 1989;15(6):328-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43797

Study title: Tondeur M, Sand A, Ham H. Interobserver reproducibility in the interpretation of bone scans from patients suspected of having reflex sympathetic dystrophy. Clin Nucl Med. 2005 Jan;30(1):4-10. Tondeur M, Sand A, Ham H. Interobserver reproducibility in the interpretation of bone scans from patients suspected of having reflex sympathetic dystrophy. Clin Nucl Med. 2005 Jan;30(1):4-10.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43393

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

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44087

Study title: Lusins JO, Elting JJ, Cicoria AD, Goldsmith SJ. SPECT evaluation of lumbar spondylolysis and spondylolisthesis. Spine. 1994 Mar 1;19(5):608-12. Lusins JO, Elting JJ, Cicoria AD, Goldsmith SJ. SPECT evaluation of lumbar spondylolysis and spondylolisthesis. Spine. 1994 Mar 1;19(5):608-12.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43631

Study title: Lusins JO, Elting JJ, Cicoria AD, Goldsmith SJ. SPECT evaluation of unilateral spondylolysis. Clin Nucl Med. 1994 Jan;19(1):1-5. Lusins JO, Elting JJ, Cicoria AD, Goldsmith SJ. SPECT evaluation of unilateral spondylolysis. Clin Nucl Med. 1994 Jan;19(1):1-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43636

Study title: Lytic bone lesion in a 12-year-old. Blackmore CC. Perkins A. Acad Radiol1995 Jun;2(6):541-3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48465

Study title: Pogrel MA, Kopf J, Dodson TB, Hattner R, Kaban LB. A comparison of single-photon emission computed tomography and planar imaging for quantitative skeletal scintigraphy of the mandibular condyle. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1995 Aug;80(2):226-31. Pogrel MA, Kopf J, Dodson TB, Hattner R, Kaban LB. A comparison of single-photon emission computed tomography and planar imaging for quantitative skeletal scintigraphy of the mandibular condyle. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1995 Aug;80(2):226-31.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44261

Study title: Pseudomonas sacroiliac osteomyelitis: diagnosis by gallium citrate Ga 67 scan. Pope TL, Teague WG, Kossack R, Bray ST, Flannery DB. Am J Dis Child. 1982 Jul;136(7):649-50. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44081

Study title: Compare the achieved ampicillin concentrations in CSF following intravenous and intramuscular routes of administration, and to correlate the clinical and laboratory responses in patients treated by the two routes.Wilson et al. (AM J Dis Child/Vol 129, Feb 1975)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_4.xlsx

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Document reference: 49003

Study title: The role of bone scintigraphy in the evaluation of the suspected abused child. Sty JR, Starshak RJ. Radiology. 1983 Feb;146(2):369-75.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44051

Study title: Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44084

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44186

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44233

Study title: Tumeh SS, Aliabadi P, Weissman BN, McNeil BJ. Disease activity in osteomyelitis: role of radiography. Radiology. 1987 Dec;165(3):781-4. Tumeh SS, Aliabadi P, Weissman BN, McNeil BJ. Disease activity in osteomyelitis: role of radiography. Radiology. 1987 Dec;165(3):781-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43838

Study title: Fibrous dysplasia in the spine: prevalence of lesions and association with scoliosis. Leet AI, Magur E, Lee JS, Wientroub S, Robey PG, Collins MT. J Bone Joint Surg Am. 2004 Mar;86-A(3):531-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43405

Study title: Left distal femoral diaphysis metaphyseal injury in a 13-year-old patient.Delgado Garcia M, Mitjavila Casanovas M, Balsa Breton MA, Castillejos Rodriguez L, Alonso Garcia P, Canamaque Garcia L, et al. Rev Esp Med Nucl 2000 Sep;19{5):356-60. [in Spanish]

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48474

Study title: Leslie WD, Reinhold C, Rosenthall L, Tau C, Glorieux FH. Panostotic fibrous dysplasia. A new craniotubular dysplasia. Clin Nucl Med. 1992 Jul;17(7):556-60. Leslie WD, Reinhold C, Rosenthall L, Tau C, Glorieux FH. Panostotic fibrous dysplasia. A new craniotubular dysplasia. Clin Nucl Med. 1992 Jul;17(7):556-60.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43694

Study title: Silva F, Laguna R, Acevedo M, Ruíz C, Orduña E. Clin Nucl Med. 1995 Oct;20(10):913-5. Silva F, Laguna R, Acevedo M, Ruíz C, Orduña E. Clin Nucl Med. 1995 Oct;20(10):913-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43584

Study title: Silvestro L, Bona G, Leonessa M, Giusti M, Mussa GC. [Importance of bone scintigraphy in skeletal diseases] Minerva Pediatr. 1983 Nov 15;35(21):1051-7. Italian. No abstract available. Silvestro L, Bona G, Leonessa M, Giusti M, Mussa GC. [Importance of bone scintigraphy in skeletal diseases] Minerva Pediatr. 1983 Nov 15;35(21):1051-7. Italian. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44022

Study title: Sires BS, Benda PM, Stanley RB Jr, Rosen CE. Orbital osteoid osteoma. Arch Ophthalmol. 1999 Mar;117(3):414-5. No abstract available. Sires BS, Benda PM, Stanley RB Jr, Rosen CE. Orbital osteoid osteoma. Arch Ophthalmol. 1999 Mar;117(3):414-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43510

Study title: "Relationships between amiodarone dosage, drug concentrations, and adverse side effects. Heger J et al. - 1983 (Am. Hearth J., 106: 931-935) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" "Relationships between amiodarone dosage, drug concentrations, and adverse side effects. Heger J et al. - 1983 (Am. Hearth J., 106: 931-935) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -"

Active substance: AMIODARONE

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Document reference: 45156

Study title: Baldini G. et al Controlled clinical study on the activity of a new formulation of Ambroxol in asthma-like bronchitis in children.MinervaPed,1989,Baldini

Active substance: AMBROXOL

Study summary document link (including results): MinervaPed,1989,Baldini.pdf

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Document reference: 48876

Study title: [Articular complications in sickle cell-thalassemia after childhood. Diagnostic problems] Italian. Potente G. Radiol Med (Torino). 1988 Nov;76(5):409-13. Italian.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43805

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

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 47922

Study title: Solitary infantile myofibromatosis of the skull. Queralt JA, Poirier VC. AJNR Am J Neuroradiol. 1995 Mar;16(3):476-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43602

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44219

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44266

Study title: Describing three children, two with meningitis and one with septicemia, from whom ampicillin-resistant Haemophilus influenzae type B were isolated from the CSF, blood or both. At least one case represents ampicillin failure in the treatment of H. influenzae meningitis because of resistence of the organism to the drug.Ousama et al. (JAMA, July 15 1974, Vol 229, No 3)

Active substance: AMPICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_7.xlsx

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Document reference: 49007

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44280

Study title: [Advantages and disadvantages of peroperative isotopic localization in the excision of osteoid osteoma. Considerations apropos of 6 cases] French. Nachin P, Gille P, Aubert D, De La Salle R, Giordan H, Cardot JC. Chir Pediatr. 1986;27(2):65-8. French.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43921

Study title: Nair N, Goyal V, Nair CN. Uptake of Tc-99m MDP by a primitive neuroectodermal tumor of the liver. Clin Nucl Med. 1998 Aug;23(8):548-9. No abstract available. Nair N, Goyal V, Nair CN. Uptake of Tc-99m MDP by a primitive neuroectodermal tumor of the liver. Clin Nucl Med. 1998 Aug;23(8):548-9. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43527

Study title: Nair N. Bone scanning in Ewing's sarcoma. J Nucl Med. 1985 Apr;26(4):349-52. Nair N. Bone scanning in Ewing's sarcoma. J Nucl Med. 1985 Apr;26(4):349-52.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43947

Study title: Otsuka N, Morita R, Yamamoto T, Muranaka A, Tomomitsu T, Yanagimoto S, Sone T, Fukunaga M. A case of synovial sarcoma with bone metastasis identified by bone marrow scintigraphy. Clin Nucl Med. 1985 Apr;10(4):260-3. Otsuka N, Morita R, Yamamoto T, Muranaka A, Tomomitsu T, Yanagimoto S, Sone T, Fukunaga M. A case of synovial sarcoma with bone metastasis identified by bone marrow scintigraphy. Clin Nucl Med. 1985 Apr;10(4):260-3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43949

Study title: Otsuka N, Yoneda M, Sawai M, Saito J, Nagai K, Muranaka A, Terashima H, Yanagimoto S, Ito Y. [Clinical studies on bone deposition of 99mTc-labeled-DPD (dicarboxypropane diphosphonate): a comparison with 99mTc-methylene diphosphonate] Kaku Igaku. 1982 Dec;19(10):1573-8. Japanese. No abstract available. Otsuka N, Yoneda M, Sawai M, Saito J, Nagai K, Muranaka A, Terashima H, Yanagimoto S, Ito Y. [Clinical studies on bone deposition of 99mTc-labeled-DPD (dicarboxypropane diphosphonate): a comparison with 99mTc-methylene diphosphonate] Kaku Igaku. 1982 Dec;19(10):1573-8. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44278

Study title: Primary neuroblastoma uptake of 99mtechnetium methylene diphosphonate. Smith FW, Gilday DL, Ash JM, Reid RH. Radiology. 1980 Nov;137(2):501-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44137

Study title: Smith FW, Gilday DL. Scintigraphic appearances of osteoid osteoma. Radiology. 1980 Oct;137(1 Pt 1):191-5. Smith FW, Gilday DL. Scintigraphic appearances of osteoid osteoma. Radiology. 1980 Oct;137(1 Pt 1):191-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44140

Study title: Detection of adrenal metastasis from osteosarcoma by Tc-99m MDP scintigraphy. Kauffman WM, Winer-Muram H, Sandlund JT. Clin Nucl Med. 1995 Aug;20(8):741. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43592

Study title: Cervical involvement in juvenile-onset ankylosing spondylitis with bone scintigraphy. Kekilli E, Yagmur C, Aydin OM. Rheumatol Int. 2004 May;24(3):164-5. Epub 2003 Sep 20.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43414

Study title: Kerscher A, Fleiner B, Bohuslaviski KH, Clausen M. [Skeletal scintigraphy in the treatment planning for hemimandibular elongation] Nuklearmedizin. 1995 Jun;34(3):110-4. German. Kerscher A, Fleiner B, Bohuslaviski KH, Clausen M. [Skeletal scintigraphy in the treatment planning for hemimandibular elongation] Nuklearmedizin. 1995 Jun;34(3):110-4. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43600

Study title: Kim HC, Alavi A, Russell MO, Schwartz E. Differentiation of bone and bone marrow infarcts from osteomyelitis in sickle cell disorders. Clin Nucl Med. 1989 Apr;14(4):249-54. Kim HC, Alavi A, Russell MO, Schwartz E. Differentiation of bone and bone marrow infarcts from osteomyelitis in sickle cell disorders. Clin Nucl Med. 1989 Apr;14(4):249-54.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43788

Study title: Jonsson K, Jónsson A, Sloth M, Kopylov P, Wingstrand H. CT of the wrist in suspected scaphoid fracture. Acta Radiol. 1992 Sep;33(5):500-1. Jonsson K, Jónsson A, Sloth M, Kopylov P, Wingstrand H. CT of the wrist in suspected scaphoid fracture. Acta Radiol. 1992 Sep;33(5):500-1.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43691

Study title: Joyce JM, Conrad G, Shih WJ, Ryo UY. Arterial thrombosis and insufficiency causing diffusely decreased uptake by skeleton of a limb. Semin Nucl Med. 1991 Apr;21(2):165-6. No abstract available. Joyce JM, Conrad G, Shih WJ, Ryo UY. Arterial thrombosis and insufficiency causing diffusely decreased uptake by skeleton of a limb. Semin Nucl Med. 1991 Apr;21(2):165-6. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43742

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44286

Study title: Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish. Verdú Rico J, Mínguez Vega M, Martínez Caballero A, Antón Leal MA, Jover Díaz R, Riera Ayora M, Muñoz Acosta JM, Caballero Carpena O. [Extraosseous accumulation of 99mTc-HMDP in knees with synovial effusion] Rev Esp Med Nucl. 2004 May-Jun;23(3):162-5. Spanish.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43404

Study title: Malignant fibrous histiocytoma of the mandible. Narvaez JA, Muntane A, Narvaez J, Martin F, Monfort JL, Pons LC. Skeletal Radiol. 1996 Jan;25(1):96-9. Review.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43573

Study title: Ncube BA. Pyogenic sacroiliitis in children. Br J Clin Pract. 1988 Apr;42(4):154-7. No abstract available. Ncube BA. Pyogenic sacroiliitis in children. Br J Clin Pract. 1988 Apr;42(4):154-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43822

Study title: Nepola JV, Seabold JE, Marsh JL, Kirchner PT, el-Khoury GY. Diagnosis of infection in ununited fractures. Combined imaging with indium-111-labeled leukocytes and technetium-99m methylene diphosphonate. J Bone Joint Surg Am. 1993 Dec;75(12):1816-22. Nepola JV, Seabold JE, Marsh JL, Kirchner PT, el-Khoury GY. Diagnosis of infection in ununited fractures. Combined imaging with indium-111-labeled leukocytes and technetium-99m methylene diphosphonate. J Bone Joint Surg Am. 1993 Dec;75(12):1816-22.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43644

Study title: Hashkes PJ, Gorenberg M, Oren V, Friedland O, Uziel Y. "Growing pains" in children are not associated with changes in vascular perfusion patterns in painful regions. Clin Rheumatol. 2005 Aug;24(4):342-5. Epub 2004 Nov 26. Hashkes PJ, Gorenberg M, Oren V, Friedland O, Uziel Y. "Growing pains" in children are not associated with changes in vascular perfusion patterns in painful regions. Clin Rheumatol. 2005 Aug;24(4):342-5. Epub 2004 Nov 26.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43386

Study title: Haskok SN, Konez O. Mixed form lymphatic malformation of the foot simulating acute soft-tissue lesion on 3-phase bone scintigraphy. Clin Nucl Med. 2004 Jan;29(1):48-50. No abstract available. Haskok SN, Konez O. Mixed form lymphatic malformation of the foot simulating acute soft-tissue lesion on 3-phase bone scintigraphy. Clin Nucl Med. 2004 Jan;29(1):48-50. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43406

Study title: Hayasaka K, Sugie H, Saitoh Y, Arakawa K, Amoh K. [Extraosseous tumor uptake of 99m-Tc-MDP] Rinsho Hoshasen. 1985 Jan;30(1):61-5. Japanese. No abstract available. Hayasaka K, Sugie H, Saitoh Y, Arakawa K, Amoh K. [Extraosseous tumor uptake of 99m-Tc-MDP] Rinsho Hoshasen. 1985 Jan;30(1):61-5. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43967

Study title: Pujet−J−C, Keddad−K, Sévenier−F, Jolivet−Landreau−I. Comparative study of two antitussive drugs in the treatment of acute dry cough of infectious origin (prospective, randomized, single blind study). Thérapie, {Therapie}, Sep−Oct 2002, vol. 57, no. 5, p. 457−63.Pujet−J−C, Keddad−K, Sévenier−F, Jolivet−Landreau−I. Comparative study of two antitussive drugs in the treatment of acute dry cough of infectious origin (prospective, randomized, single blind study). Thérapie, {Therapie}, Sep−Oct 2002, vol. 57, no. 5, p. 457−63.

Active substance: GUAIFENESIN AND PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 29053

Study title: Purello−D−Ambrosio−F, Tigano−F, Gallesio−M−T, Chevallier−P, Janssens− M. Astemizole−D compared with triprolidine−D (Actifedregistered trade mark) for acute treatment of perennial allergic rhinitis. Journal of Pharmaceutical Medicine {J−PHARM−MED}, 1994, Vol/Iss/Pg. 4 /1 (15−22). Purello−D−Ambrosio−F, Tigano−F, Gallesio−M−T, Chevallier−P, Janssens− M. Astemizole−D compared with triprolidine−D (Actifedregistered trade mark) for acute treatment of perennial allergic rhinitis. Journal of Pharmaceutical Medicine {J−PHARM−MED}, 1994, Vol/Iss/Pg. 4 /1 (15−22).

Active substance: GUAIFENESIN AND PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 29054

Study title: Parvez−L, Vaidya−M, Sakhardande−A, Subburaj−S, Rajagopalan−T−G. Evaluation of antitussive agents in man. Pulmonary pharmacology, {Pulm−Pharmacol}, Oct−Dec 1996, vol. 9, no. 5−6, p. 299−308.Parvez−L, Vaidya−M, Sakhardande−A, Subburaj−S, Rajagopalan−T−G. Evaluation of antitussive agents in man. Pulmonary pharmacology, {Pulm−Pharmacol}, Oct−Dec 1996, vol. 9, no. 5−6, p. 299−308.

Active substance: GUAIFENESIN OR GUAIFENESIN AND LEVOMENTHOL

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Document reference: 29062

Active substance: GUAIFENESIN OR GUAIFENESIN AND LEVOMENTHOL

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Document reference: 29064

Study title:

Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT)

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Document reference: 41161

Study title: A phase II, double-blind, randomized study to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals¿ Tritanrix¿-HepBlow thio/Hib2.5 Gödöllö to GSK Biologicals¿ Tritanrix¿-HepB/Hiberix¿Gödöllö when administered as a three-dose primary vaccination course to healthy infants at 6, 10 and 14 weeks of age. A dose of unconjugated Hib vaccine (plain PRP booster) will be administered at the age of 10 months to 50% of the subjects. Note: This report presents the results pertaining to the plain PRP challenge at 10 months of age.

Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT)

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Document reference: 41159

Study title: Middendorf PR, Marti RK. [Difficulties and possibilities in the detection and removal of osteoid osteoma] Ned Tijdschr Geneeskd. 1985 May 18;129(20):929-32. Dutch. No abstract available. Middendorf PR, Marti RK. [Difficulties and possibilities in the detection and removal of osteoid osteoma] Ned Tijdschr Geneeskd. 1985 May 18;129(20):929-32. Dutch. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43943

Study title: comparative single blind parallell clinical efficacy and tolerance with amoxicillin suspension 50 mg/mlx2 and compare with amoxicillin suspension 25 mg/ml x3.Olsson et al

Active substance: AMOXICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_12.xlsx

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Document reference: 48994

Study title: Evaluate efficacy in spefic infections and to compare amoxicillin 250 mg qid and 500 mg bd.Andrews et al

Active substance: AMOXICILLIN

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Document reference: 48972

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44150

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44197

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44244

Study title: Unexpected myocardial uptake on bone scintigraphy in an infant with Kawasaki disease. Macdonald WB, Troedson RG. Clin Nucl Med. 2001 May;26(5):455. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43454

Study title: A rare cause of rickets in a young child. Machiels F, De Maeseneer M, Van Snick A, Rayen I, Desprechins B, Osteaux M. J Belge Radiol. 1995 Oct;78(5):276-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43585

Study title: Madsen JL. Scintigraphic detection of clavicular hyperostosis in a patient with fulminant acne. Clin Nucl Med. 1988 May;13(5):345. Madsen JL. Scintigraphic detection of clavicular hyperostosis in a patient with fulminant acne. Clin Nucl Med. 1988 May;13(5):345.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43818

Study title: Helms CA, Hattner RS, Vogler JB 3rd. Osteoid osteoma: radionuclide diagnosis. Radiology. 1984 Jun;151(3):779-84. Helms CA, Hattner RS, Vogler JB 3rd. Osteoid osteoma: radionuclide diagnosis. Radiology. 1984 Jun;151(3):779-84.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43998

Study title: Hematogenous pyogenic vertebral osteomyelitis: diagnostic value of radionuclide bone imaging. Adatepe MH. Powell OM. Isaacs GH. Nichols K. Cefola R. J Nucl Med 1986 Nov;27(11):1680-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48463

Study title: Abnormal Tc-99m MDP renal images associated with hemolytic streptococcal sepsis. Sty JR, Wells RG, Ruiz ME. Clin Nucl Med. 1995 Oct;20(10):944. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43582

Study title: Suematsu T, Yoshida S, Motohara T, Fujiwara H, Nishii H, Komiyama T, Yanase M, Mizutani M. [Diffusely increased uptake in the skull in normal bone scans] Kaku Igaku. 1992 May;29(5):599-605. Japanese. Suematsu T, Yoshida S, Motohara T, Fujiwara H, Nishii H, Komiyama T, Yanase M, Mizutani M. [Diffusely increased uptake in the skull in normal bone scans] Kaku Igaku. 1992 May;29(5):599-605. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43698

Study title: Infantile infectious sacroiliitis. Sueoka BL, Johnson JF, Enzenauer R, Kolina JS. Pediatr Radiol. 1985;15(6):403-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43960

Study title: Sugimura K, Narabayashi I, Yamazaki K, Fukugawa T, Sugimura C, Matsuo M, Nishiyama S, Kimura S. [Bone scintigraphic findings in 2 cases of myositis ossificans progressiva] Kaku Igaku. 1983 Jul;20(6):875-9. Japanese. No abstract available. Sugimura K, Narabayashi I, Yamazaki K, Fukugawa T, Sugimura C, Matsuo M, Nishiyama S, Kimura S. [Bone scintigraphic findings in 2 cases of myositis ossificans progressiva] Kaku Igaku. 1983 Jul;20(6):875-9. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44034

Study title: A Randomized, Double-Blind, Double Dummy, Parallel Group Comparison of Fluticasone Propionate Inhalation Powder (50mcg BID) via DiskusTM with Oral Montelukast (5mg QD) Chewable Tablets in Children 6–12 years of Age with Persistent Asthma

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FPD40012-ICHE3.pdf

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Document reference: 28389

Study title: Minematsu K, Tsuchiya H, Taki J, Tomita K. Blood flow measurement during distraction osteogenesis. Clin Orthop Relat Res. 1998 Feb;(347):229-35. Minematsu K, Tsuchiya H, Taki J, Tomita K. Blood flow measurement during distraction osteogenesis. Clin Orthop Relat Res. 1998 Feb;(347):229-35.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43535

Study title: Sequential radionuclide bone imaging in avascular pediatric hip conditions. Minikel J, Sty J, Simons G. Clin Orthop Relat Res. 1983 May;(175):202-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44038

Study title: Controlled clinical study on the activity of a new mucoregulating drug in obstructive bronchial pathology with a marked hypersecretory feature. Paediatric experience. Min.Ped.1984,36(3),127-138. Romano C. et al. Minerva Pediatrica 1984, Romano

Active substance: AMBROXOL

Study summary document link (including results): Minerva Pediatrica 1984, Romano.pdf

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Document reference: 48874

Study title: An open label, not randomized, age stratified trial to study safety and efficacy of the vaccine in subjects from 6 to 35 months of age.Please see report - study report

Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)

Study summary document link (including results): MEMUFL-95-001.xlsx

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Document reference: 49191

Study title: Controlled study on the efficacy of Flour-Vigantoletten 1000 in prophylaxis of rachitis -Kontrollierte Studie zur rachitisprophylaktischen Wirkung von Flour-Vigantoletten 1000.Ther d Gegenw 1976; 115: 2076-2087 Pohlandt F., 1976

Active substance: COLECALCIFEROL AND SODIUM FLUORIDE

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

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Document reference: 48990

Study title: Casanova M et al Etoposide, cisplatin, epirubicin chemotherapy in the treatment of pediatric liver tumors Pediatr Hematol Oncol 2005 Apr-May;22(3):189-98Casanova M et al Etoposide, cisplatin, epirubicin chemotherapy in the treatment of pediatric liver tumors Pediatr Hematol Oncol 2005 Apr-May;22(3):189-98

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 24816

Study title: open uncontrolled study to evaluate the acceptance and tolerance of flucloxacillin suspension.Lidgren. Clinical trial on flucloxacillin suspension in children.

Active substance: FLUCLOXACILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Flukloxacillin_2.xlsx

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Document reference: 49075

Study title: Anticancer Res. 2003 Jul-Aug;23(4):3513-6. Differentiating recurrent or residual nasopharyngeal carcinomas from post-radiotherapy changes with 18-fluoro-2-deoxyglucose positron emission tomography and thallium-201 single photon emission computed tomography in patients with indeterminate computed tomography findings. Tsai MH, Huang WS, Tsai JJ, Chen YK, Changlai SP, Kao CH.

Active substance: FLUDEOXYGLUCOSE

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Document reference: 28141

Study title: JM Espadaler. Ensayo de la CDPcolina en el tratamiento de los trastornos del aprendizaje del niño. Med Clin (Barc), 71: 357-361, 1978JM Espadaler. Ensayo de la CDPcolina en el tratamiento de los trastornos del aprendizaje del niño. Med Clin (Barc), 71: 357-361, 1978

Active substance: CITICOLINE

Study summary document link (including results): Espadaler CITICOLINE MONOSODIUM_Ferrer Internacional.xls

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Document reference: 24296

Study title: Radionuclide studies in paediatric nephro-urologyPiepsz A. Eur J Radiol. 2002 Aug;43(2):146-53.

Active substance: CHROMIUM 51

Study summary document link (including results): Piepsz A 2002.pdf

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Document reference: 24091

Study title: Guillonneau M, Jacqz Aigrain E, Galliot M, Binet M-H, Darbois Y. Colchicine is excreted at high concentrations in human breast milk. European journal of obstetrics&Gynecology and Reproductive Biology 1995; 61:177-178Guillonneau M, Jacqz Aigrain E, Galliot M, Binet M-H, Darbois Y. Colchicine is excreted at high concentrations in human breast milk. European journal of obstetrics&Gynecology and Reproductive Biology 1995; 61:177-178

Active substance: COLCHICINE

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Document reference: 24588

Study title: Pitsiu−Maria, Hussein−Ziad, Majid−Oneeb, Aarons−Leon, de−Longueville− Marc, Stockis−Armel. Retrospective population pharmacokinetic analysis of cetirizine in children aged 6 months to 12 years. British journal of clinical pharmacology, {Br−J−Clin−Pharmacol}, Apr 2004, vol. 57, no. 4, p. 402−11.Pitsiu−Maria, Hussein−Ziad, Majid−Oneeb, Aarons−Leon, de−Longueville− Marc, Stockis−Armel. Retrospective population pharmacokinetic analysis of cetirizine in children aged 6 months to 12 years. British journal of clinical pharmacology, {Br−J−Clin−Pharmacol}, Apr 2004, vol. 57, no. 4, p. 402−11.

Active substance: CETIRIZINE

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Document reference: 23670

Study title: A report on the method of treatment of chronic osteomyelitis at the Clinic of Infectious Diseases in Lund, which is both general and local in antibiotics administration. Comparisons are made with reports on the same general, but without the local treatment.Hedström (Scand J Infec Dis 1: 175-180, 1969)

Active substance: CLOXACILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Cloxacillin_1.xlsx

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Document reference: 49082

Active substance: CODEINE_AND_PARACETAMOL

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Document reference: 24563

Study title: Forlax in the treatment of childhood constipation: a randomized, controlled, multicenter clinical study. Wang BX, Wang MG, Jiang MZ, Xu CD, Shao CH, Jia LY, Huang ZH, Xu XH. Zhongguo Dang Dai Er Ke Za Zhi. 2007 Oct;9(5):429-32.Forlax in the treatment of childhood constipation: a randomized, controlled, multicenter clinical study. Wang BX, Wang MG, Jiang MZ, Xu CD, Shao CH, Jia LY, Huang ZH, Xu XH. Zhongguo Dang Dai Er Ke Za Zhi. 2007 Oct;9(5):429-32.

Active substance: LACTULOSE

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Document reference: 30993

Study title: A thyroxine dosage of 8 μg/kg per day is appropriate for the initial treatment of the majority of infants with congenital hypothyroidism. Eur J Pediatr 1997; 156: 94-98 Touati G et al., 1997

Active substance: LEVOTHYROXINE

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

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Document reference: 48951

Study title: Children With Congenital Hypothyroidism and Their Siblings: Do They Really Differ?Rovet JF., 2005 Horm Res 2006; 66: 240-248 Pediatrics 2005; 1145 (1): e52-e57

Active substance: LEVOTHYROXINE

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

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Document reference: 48956

Study title: Cognition and Behaviour at School Entry in Children With Congenital Hypothyroidism Treated Early With High-Dose LevothyroxineJ Pediatr 2004; 144: 747-752 Simoneau-Roy J., 2004

Active substance: LEVOTHYROXINE

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

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Document reference: 48980

Study title: Effect of long-term L-thyroxine treatment on bone mineral density in young adults with congenital hypothyroidismEur J Endocrinol 2004; 151: 689-694 Salerno M., 2004

Active substance: LEVOTHYROXINE

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

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Document reference: 48984

Study title: Levothyroxine in Euthyroid Autoimmune Thyroiditis and Type 1 Diabetes: A Randomized, Controlled TrialJ Clin Endocrinol Metab 2007; 92: 1647-1652 Karges B., 2007

Active substance: LEVOTHYROXINE

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

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Document reference: 48983

Study title: Three-Year follow-up of borderline congenital hypothyroidismJ Pediatr 2000; 136: 53-56 Daliva AL., 2000

Active substance: LEVOTHYROXINE

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

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Document reference: 48979

Study title: Treatment for congenital hypothyroidism: Thyroxine alone or thyroxine plus triiodothyronine?Pediatrics 2003, 111, 5: 1055-60 Cassio A., 2003

Active substance: LEVOTHYROXINE

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

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Document reference: 48987

Study title: Submission of result-related information on paediatric studies submitted under Article 45 of the Paediatric Regulation No 1901/2006. Product concerned by this submission: Claritine/Clarityn Syrup and Associated Tradenames (loratadine)Merck Sharp & Dohme (Europe), Inc. Clos du Lynx 5 Lynx Binnenhof B-1200 Brussels

Active substance: LORATADINE

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Document reference: 48848

Study title: Multicentre, randomised, comparative double-blind and double placebo study in two parallel groups, of the efficacy and safety of ketoprofen (0.5 mg/kg/dose), versus paracetamol (15 mg/kg/dose), in repeated doses, in the treatment of febrile conditions in children aged 6 months to 6 years.

Active substance: KETOPROFEN

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

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Document reference: 30864

Study title: [A measurement of V/V distribution by intravenous injection of Kr-81m and Tc-99m-MAA--a comparative study with Xe-133 inhalation method] [Article in Japanese]Kaku Igaku. 1988 Apr;25(4):323-9. Ohtani Y 1988

Active substance: krypton

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

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Document reference: 48542

Study title: A model for assessing bronchial mucus transport.Pediatr Radiol. 1985;15(3):161-4. Ham HR 1985

Active substance: krypton

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

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Document reference: 48549

Study title: Airway responses to repeated exercises detected by krypton-81m in asthmatic children.J Asthma. 1992;29(6):375-81.Obata T 1992

Active substance: krypton

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

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Document reference: 48537

Study title: Can dynamic krypton-81m imaging separate regional ventilation and volume?Lythgoe MF 1992. J Nucl Med. 1992 Nov;33(11):1935-9. Comment in:J Nucl Med. 1992 Nov;33(11):1939-42.

Active substance: krypton

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

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Document reference: 48534

Study title: Donaldson SS et al. A multidisciplinary study investigating radiotherapy in Ewing's sarcoma: end results of POG #8346. Pediatric Oncology Group. Int J Radiat Oncol Biol Phys. 1998 Aug 1;42(1):125-35.Donaldson SS et al. A multidisciplinary study investigating radiotherapy in Ewing's sarcoma: end results of POG #8346. Pediatric Oncology Group. Int J Radiat Oncol Biol Phys. 1998 Aug 1;42(1):125-35.

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 24848

Study title: Medical examiner reports of dextromethorphan exposures in the drug abuse warning network. -McElwee NE. et al.- 1991 (J. Clin. Res. Pharmacoepidemiol.; 5: 167) - Publication of Part IV Dextromethorphan HBr Syrup 1% -

Active substance: DEXTROMETHORPHAN

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Document reference: 25835

Study title: Osborn, D.A., N. Evans, and M. Kluckow, Left ventricular contractility in extremely premature infants in the first day and response to inotropes. Pediatr Res, 2007. 61(3): p. 335-40. Osborn, D.A., N. Evans, and M. Kluckow, Left ventricular contractility in extremely premature infants in the first day and response to inotropes. Pediatr Res, 2007. 61(3): p. 335-40.

Active substance: DOBUTAMINE

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Document reference: 26290

Study title: Denhoff et al.: Treatment of spastic cerebral-palsied children with sodium dantrolene; Dev. Med. Child. Neurol. 17, 736-742 (1975)Denhoff et al.: Treatment of spastic cerebral-palsied children with sodium dantrolene; Dev. Med. Child. Neurol. 17, 736-742 (1975)

Active substance: DANTROLENE

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Document reference: 25533

Study title: AN 15211696 Medline 20070101. TI Cyproheptadine is an effective appetite stimulant in cystic fibrosis. SO Pediatric pulmonology, {Pediatr-Pulmonol}, Aug 2004, vol. 38, no. 2, p. 129-34, ISSN: 8755-6863. AU Homnick-Douglas-N, Homnick-Benjamin-D, Reeves-Andrew-J, Marks-John-H, Pimentel-Ronald-S, Bonnema-Sally-K. IN Division of Pediatric Pulmonology, Department of Pediatrics, Kalamazoo Center for Medical Studies, Michigan State University, 49008, USA. Homnick@kcms.msu.edu. YR 2004.AN 15211696 Medline 20070101. TI Cyproheptadine is an effective appetite stimulant in cystic fibrosis. SO Pediatric pulmonology, {Pediatr-Pulmonol}, Aug 2004, vol. 38, no. 2, p. 129-34, ISSN: 8755-6863. AU Homnick-Douglas-N, Homnick-Benjamin-D, Reeves-Andrew-J, Marks-John-H, Pimentel-Ron...

Active substance: CYPROHEPTADINE

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Document reference: 25235

Study title: Comparative study of angiotensin converting enzyme inhibitor and calcium channel blocker in the treatment of steroid−resistant idiopathic nephrotic syndrome.Kumar NS, Singh A K, Mishra RN, Prakash J. The Journal of the Association of Physicians of India, Jun 2004, vol. 52, p. 454−8, Comparative study of angiotensin converting enzyme inhibitor and calcium channel blocker in the treatment of steroid−resistant idiopathic nephrotic syndrome.Kumar NS, Singh A K, Mishra RN, Prakash J. The Journal of the Association of Physicians of India, Jun 2004, vol. 52, p. 454−8,

Active substance: VERAPAMIL

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Document reference: 45535

Study title: Comparative study of the efficacy of metoprolol and verapamil in patients with syncope and positive head−up tilt test response.Walton SA, Berk M, Brook S. The Journal of clinical psychiatry, Nov 1996, vol. 57, no. 11, p. 543−6, Comparative study of the efficacy of metoprolol and verapamil in patients with syncope and positive head−up tilt test response.Walton SA, Berk M, Brook S. The Journal of clinical psychiatry, Nov 1996, vol. 57, no. 11, p. 543−6,

Active substance: VERAPAMIL

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Document reference: 45545

Study title: Comparison of bisoprolol and verapamil in hypertension: influence on left ventricular mass and function−−a pilot study.Ostman−Smith I, Wettrell G, Riesenfeld T. Journal of the American College of Cardiology, 15 Nov 1999, vol. 34, no. 6, p.1813−22, Comparison of bisoprolol and verapamil in hypertension: influence on left ventricular mass and function−−a pilot study.Ostman−Smith I, Wettrell G, Riesenfeld T. Journal of the American College of Cardiology, 15 Nov 1999, vol. 34, no. 6, p.1813−22,

Active substance: VERAPAMIL

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Document reference: 45541

Study title: Effectiveness of the combination verapamil and chlorpromazine in the treatment of severe manic or mixed patients.Lenzi A, Marazziti D, Raffaelli S, Cassano GB. Progress in neuro−psychopharmacology & biological psychiatry, May 1995, vol. 19, no. 3, p. 519−28, Effectiveness of the combination verapamil and chlorpromazine in the treatment of severe manic or mixed patients.Lenzi A, Marazziti D, Raffaelli S, Cassano GB. Progress in neuro−psychopharmacology & biological psychiatry, May 1995, vol. 19, no. 3, p. 519−28,

Active substance: VERAPAMIL

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Document reference: 45548

Study title: Effects of verapamil on anthracycline−induced cardiomyopathy: preliminary results of a prospective multicenter trial.Kraft J, Grille W, Appelt M, Hossfeld DK, Eichelbaum M, Koslowski B, Quabeck K, Kuse R, Büchner T, Hiddemann W, et al. Haematology and blood transfusion, 1990, vol. 33, p. 566−70,Effects of verapamil on anthracycline−induced cardiomyopathy: preliminary results of a prospective multicenter trial.Kraft J, Grille W, Appelt M, Hossfeld DK, Eichelbaum M, Koslowski B, Quabeck K, Kuse R, Büchner T, Hiddemann W, et al. Haematology and blood transfusion, 1990, vol. 33, p. 566−70,

Active substance: VERAPAMIL

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Document reference: 45560

Study title: Clinical applications of radionuclide lung scanning in infants and children.Br J Radiol. 1981 Jul;54(643):576-85. Gordon I 1981

Active substance: krypton

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

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Document reference: 48553

Study title: Evaluation of esophageal transit in children and in infants by means of Krypton-81m.Pediatr Radiol. 1985;15(3):161-4. Ham HR 1985

Active substance: krypton

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

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Document reference: 48548

Study title: Evaluation of the Accuracy of Steady-State Krypton-Sim Method for Calculating Right Ventricular Ejection FractionHamphrey R. Ham. Philipe R. Franken, Bernard Georges, Eric Delcourt, Marcel Guillaume, and Amnon Piepsz.J NucÃMed 27:593-601, 1986

Active substance: krypton

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Document reference: 48531

Study title: Investigating the small lung: which imaging procedure?Arch Dis Child. 1982 Sep;57(9):696-701. Gordon I 1982

Active substance: krypton

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

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Document reference: 48551

Study title: Provocation test for children with bronchial asthma monitored by 81mKr ventilation and perfusion lung scans.Eur J Nucl Med. 1985;10(1-2):81-3. Uchiyama G 1985

Active substance: krypton

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

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Document reference: 48547

Study title: Pulmonary ventilation and perfusion studies in infants and children.J Thorac Imaging. 1986 Oct;1(4):49-56. Gainey MA 1986

Active substance: krypton

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

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Document reference: 48544

Study title: [Pulmonary ventilation studies of asthmatic children with Kr-81m (author's transl)] [Article in Japanese]Nippon Igaku Hoshasen Gakkai Zasshi. 1979 May 25;39(5):499-505.Uchiyama G 1979

Active substance: krypton

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

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Document reference: 48557

Study title: Quantitative approach to the study of regional lung function in children using krypton 81m.Br J Radiol. 1980 Oct;53(634):950-9. Ciofetta G 1980

Active substance: krypton

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

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Document reference: 48554

Study title: Comparison of Bone and Gallium-67 Imagingin Heroin Users'ArthritisA. Bittini, P L. Dominguez, M. L. Martinez Pueyo, F. J. Lopez Longo, I. Monteagudo, and L. Carreflo. J Nuci Med 26:1377â€”1381, 1985

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48834

Study title: Single-dose versus conventional therapy of urinary tract infections in female adolescents.Fine JS, Jacobson MS. Pediatrics. 1985 May;75(5):916-20.

Active substance: AMOXICILLIN

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Document reference: 48967

Study title: Investigating the neurotoxicity of penicillin G at different serum- and CSF-concentrations.Holloway et al. (The American journal of clinical pathology, 1969 Jun;51(6):705-8)

Active substance: BENZATHINE BENZYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Benzylpenicillin sodium_1.xlsx

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Document reference: 49070

Study title: Investigating the neurotoxicity of penicillin G at different serum- and CSF-concentrations.Lerner et al. (Ann NY Acad Sci 145, 310-8, no 2 1967)

Active substance: BENZATHINE BENZYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Benzylpenicillin sodium_2.xlsx

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Document reference: 49071

Study title: A multicenter, open-label, pharmacokinetic/pharmacodynamic safety, and tolerability study of basiliximab (Simulect) in pediatric de novo renal transplant recipients.Offner G, Broyer M, Niaudet P, Loirat C, Mentser M, Lemire J, Crocker JF, Cochat P, Clark G, Chodoff L, Korn A, Hall M. Transplantation. 2002 Oct 15;74(7):961-6.

Active substance: Azathioprine

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Document reference: 49257

Study title: A randomized multicenter trial of OKT3 mAbs induction compared with intravenous cyclosporine in pediatric renal transplantation.Benfield MR1, Tejani A, Harmon WE, McDonald R, Stablein DM, McIntosh M, Rose S; CCTPT Study Group. Pediatr Transplant. 2005 Jun;9(3):282-92.

Active substance: Azathioprine

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Document reference: 49267

Study title: Adverse events leading to modification of therapy in a large cohort of patients with inflammatory bowel disease.Hindorf U, Lindqvist M, Hildebrand H, Fagerberg U, Almer S. Aliment Pharmacol Ther. 2006 Jul 15;24(2):331-42.

Active substance: Azathioprine

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Document reference: 49272

Study title: Regional ventilation in infancy. Reversal of adult pattern.N Engl J Med. 1985 Dec 26;313(26):1626-8. Davies H, 1985

Active substance: krypton

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

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Document reference: 48546

Study title: Ventilation-perfusion scintigraphy in suspected pulmonary embolism: correlation with pulmonary angiography and refinement of criteria for interpretation.Radiology. 1986 May;159(2):383-90.Spies WG 1986

Active substance: krypton

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

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Document reference: 48545

Study title: Von Kleist-Retzow J-C et al., Klinik und Therapie d.Knollenblätterpilzverg. im Kindesalter. Clinical findings and treatment of Amanita phalloides poisoning in childhood); Monatsschrift fur Kinderheilkunde; 143/11 (1118-1127); 1995

Active substance: (HERB) Milk thistle fruit, dry extract, 36 - 44 : 1 (Silymarin 77.5 %) (Legalon)

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Document reference: 39712

Study title: Comparison of the effect of atropine and cyclopentolate on myopia.Yen MY, Liu JH, Kao SC, Shiao CH. Ann Ophthalmol. 1989 May;21(5):180-2, 187. Comparison of the effect of atropine and cyclopentolate on myopia.Yen MY, Liu JH, Kao SC, Shiao CH. Ann Ophthalmol. 1989 May;21(5):180-2, 187.

Active substance: CYCLOPENTOLATE

Study summary document link (including results): Comparison of the effect of atropine and cyclopentolate on m.pdf

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Document reference: 24707

Study title: Maurer HM et al. The Intergroup Rhabdomyosarcoma Study-II. Cancer. 1993 Mar 1;71(5):1904-22Maurer HM et al. The Intergroup Rhabdomyosarcoma Study-II. Cancer. 1993 Mar 1;71(5):1904-22

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 25011

Study title: Clinical experiences with encephabol -Klinische Erfahrungen mit EncephabolMed Klin 1976; 45: 1958-1961, Glatzel J

Active substance: PYRITINOL

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

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Document reference: 48912

Study title: Schellong-G. University Children's Hospital Muenster, Germany. Pediatric Hodgkin's disease: treatment in the late 1990s. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}, 1998, vol. 9 Suppl 5, p. S115-9, 28 refs, ISSN: 0923-7534.Schellong-G. University Children's Hospital Muenster, Germany. Pediatric Hodgkin's disease: treatment in the late 1990s. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}, 1998, vol. 9 Suppl 5, p. S115-9, 28 refs, ISSN: 0923-7534.

Active substance: PROCARBAZINE

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Document reference: 34836

Study title: To determine if systemic absorption of (pyrvinium pamoate) C1-316 occures in children following single oral doses of 5 mg/kg.Heffelfinger

Active substance: PYRVINIUM

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Pyrvin embonate_1.xls

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Document reference: 49077

Study title: Evaluation of the effects of fixed combinations of sustained−release verapamil/trandolapril versus captopril/hydrochlorothiazide on metabolic and electrolyte parameters in patients with essential hypertension.Cifková R, Nakov R, Novozámská E, Hejl Z, Petrzílková Z, Poledne R, Stávek P, Compagnone D. Journal of human hypertension, Jun 2000, vol. 14, no. 6, p. 347−54, Evaluation of the effects of fixed combinations of sustained−release verapamil/trandolapril versus captopril/hydrochlorothiazide on metabolic and electrolyte parameters in patients with essential hypertension.Cifková R, Nakov R, Novozámská E, Hejl Z, Petrzílková Z, Poledne R, Stávek P, Compagnone D. Journal of human hypertension, Jun 2000, vol. 14, no. 6, p. 347−54,

Active substance: VERAPAMIL

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Document reference: 45539

Study title: Kiowski W, Bühler FR, Fadayomi MO, Erne P, Müller FB, Hulthén UL, Bolli P. The American journal of cardiology, 6 Dec 1985, vol. 56, no. 16, p. 81H−85H, Kiowski W, Bühler FR, Fadayomi MO, Erne P, Müller FB, Hulthén UL, Bolli P. The American journal of cardiology, 6 Dec 1985, vol. 56, no. 16, p. 81H−85H,

Active substance: VERAPAMIL

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Document reference: 45564

Study title: Lechenie sindroma Reino blokatorami vkhoda kal'tsiia. (Treatment of Raynaud's syndrome with calcium entry blockers).Shcherbakov AB, Guseva NG, Mach ES. Terapevticheskii arkhiv, 1987, vol. 59, no. 4, p. 89−92, Lechenie sindroma Reino blokatorami vkhoda kal'tsiia. (Treatment of Raynaud's syndrome with calcium entry blockers).Shcherbakov AB, Guseva NG, Mach ES. Terapevticheskii arkhiv, 1987, vol. 59, no. 4, p. 89−92,

Active substance: VERAPAMIL

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Document reference: 45562

Study title: Otsenka vozmozhnosti individual'nogo podbora antiaritmicheskoi terapii. (Evaluation of the possibility of selection of individual anti− arrhythmia therapy).Antonchenko IV, Gimrikh EO, Popov SV, Chekhov AM, Borisova EV, Savenkova GM, Plekhanov IG. Kardiologiia, Mar 1991, vol. 31, no. 3, p. 43−5, Otsenka vozmozhnosti individual'nogo podbora antiaritmicheskoi terapii. (Evaluation of the possibility of selection of individual anti− arrhythmia therapy).Antonchenko IV, Gimrikh EO, Popov SV, Chekhov AM, Borisova EV, Savenkova GM, Plekhanov IG. Kardiologiia, Mar 1991, vol. 31, no. 3, p. 43−5,

Active substance: VERAPAMIL

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Document reference: 45554

Study title: Betaxolol in the treatment of arterial hypertension: summary of clinical studies - MR95, MR17, MR107 Betaxolol Core Dossier - April 1999 - Part IVB1 Clinical documentation Volume 2

Active substance: BETAXOLOL

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Document reference: 41926

Study title: Azathioprine as a treatment option for uveitis in patients with juvenile idiopathic arthritis.Goebel JC, Roesel M, Heinz C, Michels H, Ganser G, Heiligenhaus A. Br J Ophthalmol. 2011 Feb;95(2):209-13

Active substance: Azathioprine

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Document reference: 49293

Study title: Azathioprine for long-term maintenance of remission in autoimmune hepatitis.Johnson PJ, McFarlane IG, Williams R. N Engl J Med. 1995 Oct 12;333(15):958-63.

Active substance: Azathioprine

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Document reference: 49215

Study title: Azathioprine in patients with juvenile chronic arthritis: a longterm followup study.Savolainen HA1, Kautiainen H, Isomäki H, Aho K, Verronen P. J Rheumatol. 1997 Dec;24(12):2444-50.

Active substance: Azathioprine

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Document reference: 49222

Study title: Basiliximab: efficacy and tolerability in adults and children.Mocarquer A, Pinto V, Buckel E, Lagos E, Pefaur J, Ramirez K, Morales J, Rosatti P, Elberg A; Simulect Multicenter Study Group of Chile. Transplant Proc. 2003 Nov;35(7):2518-9.

Active substance: Azathioprine

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Document reference: 49259

Study title: Childhood-onset lupus nephritis: a single-center experience of pulse intravenous cyclophosphamide therapy.Barbano G, Gusmano R, Damasio B, Alpigiani MG, Buoncompagni A, Gattorno M, Perfumo F. J Nephrol. 2002 Mar-Apr;15(2):123-9.

Active substance: Azathioprine

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Document reference: 49253

Study title: Combined therapy with prednisolone, azathioprine, heparin-warfarin, and dipyridamole for paediatric patients with severe IgA nephropathy--is it relevant for adult patients?Yoshikawa N, Ito H. Nephrol Dial Transplant. 1999 May;14(5):1097-9.

Active substance: Azathioprine

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Document reference: 49227

Study title: Comparison between mycophenolate mofetil and azathioprine based immunosuppression in pediatric renal transplantation from living related donors.Antoniadis A, Papachristou F, Gakis D, Takoudas D, Sotiriou I. Transplant Proc. 1998 Dec;30(8):4085-6.

Active substance: Azathioprine

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Document reference: 49224

Study title: American Association for Respiratory Care (AARC). Clinical practice guideline: Single-breath carbon monoxide diffusing capacity, 1999 update. Resp Care 1999 May;44(5):539-546American Association for Respiratory Care (AARC). Clinical practice guideline: Single-breath carbon monoxide diffusing capacity, 1999 update. Resp Care 1999 May;44(5):539-546

Active substance: HELIUM AND OXYGEN

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Document reference: 29067

Active substance: ETOPOSIDE

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Document reference: 26691

Study title: Uptake pharmacokinetics of the Fentanyl Oralet in children scheduled for central venous access removal: implications for the timing of initiating painful procedures; Paediatr Anaesth 2002, 12(7):594-9

Active substance: FENTANYL

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Document reference: 27190

Study title: Submission of result-related information on paediatric studies submitted under Article 45 of the Paediatric Regulation No 1901/2006. Product concerned by this submission: Cedax Suspension/Keimax and Associated Tradenames (Ceftibuten)Merck Sharp & Dohme (Europe), Inc. Clos du Lynx 5 Lynx Binnenhof B-1200 Brussels

Active substance: CEFTIBUTEN

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Document reference: 48847

Study title: Submission of result-related information on paediatric studies submitted under Article 45 of the Paediatric Regulation No 1901/2006. Product concerned by this submission: Uroced/Cedax and Associated Tradenames (Ceftibuten)Merck Sharp & Dohme (Europe), Inc. Clos du Lynx 5 Lynx Binnenhof B-1200 Brussels

Active substance: CEFTIBUTEN

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Document reference: 48850

Study title: Erfahrungen mit einem Faktor II-, IX- und X-Konzentrat. Laboratoriumsuntersuchungen, In-Vivo-Recovery und klinische Ergebnisse. Global-Druck und Verlag, Heidelberg, (1980).(Vinazzer H, Bergmann H.)

Active substance: FACTOR VIII INHIBITOR BYPASSING ACT

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Document reference: 26997

Study title: 99mTc-HMPAO single photon emission computed tomography (SPECT) in both asphyxiated and epileptic children with or without status epilepticusJ Child Neurol. 2005 Jul; 20(7):560-5. Oner n 2005

Active substance: CERETEC

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

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Document reference: 48618

Study title: Pilot study of pimecrolimus in vitiligo treatment

Active substance: PIMECROLIMUS

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Document reference: 34109

Study title: To study the clinical efficacy of penicillin V given to children as a daily dosage of 50 mg/kg/day divided into two or three doses.Rundcrantz et al

Active substance: PHENOXYMETHYLPENICILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_17.xlsx

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Document reference: 49048

Study title: Treatment of recurrent bacteriuria with mecillinam; Verrier Jones E:R: and Asscher A.W:. 1975, JAC, 1: 193-196 LEO sponsored Treatment of recurrent bacteriuria with mecillinam; Verrier Jones E:R: and Asscher A.W:. 1975, JAC, 1: 193-196 LEO sponsored

Active substance: PIVMECILLINAM

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Document reference: 34526

Study title: Clinical investigator’s report (pediatrics).

Active substance: PHOLCODINE

Study summary document link (including results): Pholcodine_STUDY_640.6.003_Lajouanine.xls

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Document reference: 34034

Study title: Permanent junctional reciprocating tachycardia in children: a multicentre study on clinical profile and outcome.Vaksmann G, D−Hoinne C, Lucet V, Guillaumont S, Lupoglazoff JM, Chantepie A, Heart , Jan 2006 (epub: 14 Apr 2005) , vol. 92, no. 1, p. 101−4, Permanent junctional reciprocating tachycardia in children: a multicentre study on clinical profile and outcome.Vaksmann G, D−Hoinne C, Lucet V, Guillaumont S, Lupoglazoff JM, Chantepie A, Heart , Jan 2006 (epub: 14 Apr 2005) , vol. 92, no. 1, p. 101−4,

Active substance: VERAPAMIL

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Document reference: 45534

Study title: Prevention of atrial fibrillation after cardioversion: results of the PAFAC trial.Fetsch T, Bauer P, Engberding R, Koch−Hans P, Lukl J, Meinertz T, Oeff M, Seipel L, Trappe−Hans J, Treese N , Breithardt G. European heart journal, Aug 2004, vol. 25, no. 16, p. 1385−94, Prevention of atrial fibrillation after cardioversion: results of the PAFAC trial.Fetsch T, Bauer P, Engberding R, Koch−Hans P, Lukl J, Meinertz T, Oeff M, Seipel L, Trappe−Hans J, Treese N , Breithardt G. European heart journal, Aug 2004, vol. 25, no. 16, p. 1385−94,

Active substance: VERAPAMIL

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Document reference: 45536

Study title: Superiority of lithium over verapamil in mania: a randomized, controlled, single−blind trial.Walton SA, Berk M, Brook S. The Journal of clinical psychiatry, Nov 1996, vol. 57, no. 11, p. 543−6, Superiority of lithium over verapamil in mania: a randomized, controlled, single−blind trial.Walton SA, Berk M, Brook S. The Journal of clinical psychiatry, Nov 1996, vol. 57, no. 11, p. 543−6,

Active substance: VERAPAMIL

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Document reference: 45544

Study title: Valutazione degli effetti indotti dall'uso di verapamile, flunarizina, diltiazem, nimodipina e placebo nella profilassi dell'emicrania. Studio a doppio cieco randomizzato cross−over. (Evaluation of the effects of verapamil, flunarizine, diltiazem, nimodipine and placebo in the prevention of hemicrania. A double−blind randomized cross−over study).Paterna S, Martino SG, Campisi D, Cascio IN, Marsala BA. La Clinica terapeutica, 31 Jul 1990, vol. 134, no. 2, p. 119−25, Valutazione degli effetti indotti dall'uso di verapamile, flunarizina, diltiazem, nimodipina e placebo nella profilassi dell'emicrania. Studio a doppio cieco randomizzato cross−over. (Evaluation of the effects of verapamil, flunarizine, diltiazem, nimodipine and placebo in the prevention of hemicrania. A double−blind random...

Active substance: VERAPAMIL

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Document reference: 45557

Study title: Differences between children and adults in thiopurine methyltransferase activity and metabolite formation during thiopurine therapy: possible role of concomitant methotrexate.Pettersson B1, Almer S, Albertioni F, Söderhäll S, Peterson C. Ther Drug Monit. 2002 Jun;24(3):351-8.

Active substance: Azathioprine

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Document reference: 49254

Study title: Effect of early immunomodulator use in moderate to severe pediatric Crohn disease.Punati J, Markowitz J, Lerer T, Hyams J, Kugathasan S, Griffiths A, Otley A, Rosh J, Pfefferkorn M, Mack D, Evans J, Bousvaros A, Moyer MS, Wyllie R, Oliva-Hemker M, Mezoff A, Leleiko N, Keljo D, Crandall W; Pediatric IBD Collaborative Research Group. Inflamm Bowel Dis. 2008 Jul;14(7):949-54

Active substance: Azathioprine

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Document reference: 49284

Study title: Efficacy and tolerability at 3 and 6 months following use of azathioprine for recalcitrant atopic dermatitis in children and young adults.Hon KL, Ching GK, Leung TF, Chow CM, Lee KK, Ng PC. J Dermatolog Treat. 2009;20(3):141-5.

Active substance: Azathioprine

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Document reference: 49287

Study title: Efficacy of methotrexate in pediatric Crohn's disease: a French multicenter study.Uhlen S, Belbouab R, Narebski K, Goulet O, Schmitz J, Cézard JP, Turck D, Ruemmele FM. Inflamm Bowel Dis. 2006 Nov;12(11):1053-7.

Active substance: Azathioprine

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Document reference: 49276

Study title: Favorable effects of immunosuppressive therapy in children with dilated cardiomyopathy and active myocarditis.Camargo PR, Snitcowsky R, da Luz PL, Mazzieri R, Higuchi ML, Rati M, Stolf N, Ebaid M, Pileggi F. Pediatr Cardiol. 1995 Mar-Apr;16(2):61-8.

Active substance: Azathioprine

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Document reference: 49216

Study title: Five-year outcome in pediatric patients with mycophenolate mofetil-based renal transplantation.Jungraithmayr TC, Wiesmayr S, Staskewitz A, Kirste G, Bulla M, Fehrenbach H, Dippell J, Greiner C, Griebel M, Helmchen U, Klaus G, Leichter HE, Mihatsch MJ, Michalk DV, Misselwitz J, Plank C, Tönshoff B, Weber LT, Zimmerhackl LB; German Pediatric Renal Transplantation Study Group. Transplantation. 2007 Apr 15;83(7):900-5.

Active substance: Azathioprine

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Document reference: 49279

Study title: Follow-up of children with autoimmune hepatitis treated with cyclosporine.Cuarterolo M, Ciocca M, Velasco CC, Ramonet M, González T, López S, Garsd A, Alvarez F. J Pediatr Gastroenterol Nutr. 2006 Nov;43(5):635-9.

Active substance: Azathioprine

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Document reference: 49277

Study title: Four-year data after pediatric renal transplantation: a randomized trial of tacrolimus vs. cyclosporin microemulsion. Filler G, Webb NJ, Milford DV, Watson AR, Gellermann J, Tyden G, Grenda R, Vondrak K, Hughes D, Offner G, Griebel M, Brekke IB, McGraw M, Balzar E, Friman S, Trompeter R. Pediatr Transplant. 2005 Aug;9(4):498-503.

Active substance: Azathioprine

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Document reference: 49268

Study title: Heart transplantation in patients with previous Fontan operations.Gamba A1, Merlo M, Fiocchi R, Terzi A, Mammana C, Sebastiani R, Ferrazzi P. J Thorac Cardiovasc Surg. 2004 Feb;127(2):555-62.

Active substance: Azathioprine

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Document reference: 49261

Study title: Al-Kandari et al. Regional cerebral blood flow in patients with sickle cell disease: study with single photon emission computed tomographyAnnals of nuclear medicine (2007), 21(8), 439-45. Al-Kandari fa 2007

Active substance: CERETEC

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

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Document reference: 48604

Study title: Chang et al. Comparison between technetium-99m hexamethylpropylene amineoxide labeled white blood cell abdomen scan and abdominal sonography to detect appendicitis in children with an atypical clinical presentation. Hepatogastroenterology.Hepatogastroenterology. 2003 Mar-Apr;50(50):426-9. Chen-chang c 2003

Active substance: CERETEC

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

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Document reference: 48606

Study title: Charron et al. Temporal correlation of the erythrocyte sedimentation rate with Tc-99m WBC uptake on children with inflammatory bowel diseasesClin Nucl Med. 2003 Nov; 28(11):905-7. charron m 2003

Active substance: CERETEC

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

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Document reference: 48622

Study title: Congenital Middle Fossa Arachnoid Cysts May Cause Global Brain Ischaemia: A Study with 99Tc-Hexamethylpropyleneamineoxime Single Photon Emission Computerised Tomography ScansS. Sgourosa S. Chapmanb. Pediatr Neurosurg 2001;35:188–194

Active substance: CERETEC

Study summary document link (including results): sgouros s 2001.pdf

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Document reference: 48601

Study title: Diagnostic performance of 18F-FDG PET and ictal 99mTc-HMPAO SPET in pediatric temporal lobe epilepsy: Quantitative analysis by statistical parametric mapping, statistical probabilistic anatomical map, and subtraction ictal SPETJong Jin Lee a, Won Jun Kang a, Dong Soo Lee a,*, Jae Sung Lee a, Hee Hwang b, Ki Joong Kim b, Yong-Seung Hwang b, June-Key Chung a, Myung Chul Lee a. Seizure (2005) 14, 213—220

Active substance: CERETEC

Study summary document link (including results): lee jj 2005.pdf

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Document reference: 48595

Study title: Decroix J, et al Oral itraconazole in the treatment of dermatomycosis. A multicenter evaluation of different treatment schedules. Clinical summary on R51211, August 1987. (10-86 years, LMD56447)Decroix J, et al Oral itraconazole in the treatment of dermatomycosis. A multicenter evaluation of different treatment schedules. Clinical summary on R51211, August 1987. (10-86 years, LMD56447)

Active substance: ITRACONAZOLE

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Document reference: 30789

Study title: A 2-year follow up of babies enrolled in a European multicentre trial of porcine surfactant replacement for severe neonatal respiratory distress syndromeEur J Pediatr (1992) 151 : 372-376, B. Robertson

Active substance: PORACTANT ALFA

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

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Document reference: 49240

Active substance: PORACTANT ALFA

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

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Document reference: 49241

Study title: Porcine surfactant replacement therapy in newborns of 25-3 1 weeks' gestation: a randomized, multicentre trial of prophylaxis versus rescue with multiple low dosesActa Paediatr 84: 913-21. 1995, H Walti

Active substance: PORACTANT ALFA

Study summary document link (including results): 50.01-CT-04-93 publication.pdf

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Document reference: 49234

Study title: Prophylactic or Early Selective Surfactant Combined With nCPAP in Very Preterm InfantsPediatrics 2010;125;e1402

Active substance: PORACTANT ALFA

Study summary document link (including results): DM.PR.5000.002.04 publication.pdf

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Document reference: 49239

Study title: Randomised ,multicentre,clinical study on the treatment with natural surfactant of neonatal respiratory distress syndrome in premature infants : comparison between early and late treatmentPediatrics, VOLUME 82 NOVEMBER 1988 NUMBER 5

Active substance: PORACTANT ALFA

Study summary document link (including results): CH-CUR-0003 publication..pdf

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Document reference: 49237

Study title: Surfactant replacement therapy in severe neonatal respiratory distress syndrome (RDS)Pediatrics, VOLUME 82 NOVEMBER 1988 NUMBER 5

Active substance: PORACTANT ALFA

Study summary document link (including results): CH-CUR-001 publication.pdf

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Document reference: 49236

Study title: AN OPEN, NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF 0.5% TOPICAL PIROXICAM GEL IN THE TREATMENT OF ACUTE MUSCULOSKELETAL (AMS) DISORDERS.

Active substance: PIROXICAM

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Document reference: 34457

Study title: Infliximab heals intestinal inflammatory lesions and restores growth in children with Crohn's disease.Borrelli O, Bascietto C, Viola F, Bueno de Mesquita M, Barbato M, Mancini V, Bosco S, Cucchiara S. Dig Liver Dis. 2004 May;36(5):342-7.

Active substance: Azathioprine

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Document reference: 49264

Study title: Initial experience with FK506 (tacrolimus) in pediatric renal transplant recipients.McKee M, Segev D, Wise B, Case B, Neu A, Fivush B, Colombani P. J Pediatr Surg. 1997 May;32(5):688-90.

Active substance: Azathioprine

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Document reference: 49220

Study title: Interventions for idiopathic steroid-resistant nephrotic syndrome in children.Habashy D, Hodson E, Craig J. Cochrane Database Syst Rev. 2004;(2):CD003594.

Active substance: Azathioprine

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Document reference: 49263

Study title: Interventions for idiopathic steroid-resistant nephrotic syndrome in children.Habashy D, Hodson E, Craig J. Cochrane Database Syst Rev. 2004;(2):CD003594.

Active substance: Azathioprine

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Document reference: 49270

Study title: Low bone mineral density in children and adolescents with inflammatory bowel disease: a population-based study from Western Sweden.Schmidt S, Mellström D, Norjavaara E, Sundh SV, Saalman R. Inflamm Bowel Dis. 2009 Dec;15(12):1844-50

Active substance: Azathioprine

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Document reference: 49290

Study title: Methotrexate treatment in pediatric Crohn disease patients intolerant or resistant to purine analogues.Weiss B, Lerner A, Shapiro R, Broide E, Levine A, Fradkin A, Bujanover Y. J Pediatr Gastroenterol Nutr. 2009 May;48(5):526-30

Active substance: Azathioprine

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Document reference: 49292

Study title: Monitoring 6-thioguanine nucleotide concentrations in Japanese children and adolescents with inflammatory bowel disease.Ohtsuka Y, Arai K, Aoyagi Y, Fujii T, Yamakawa Y, Ohtani K, Ikuse T, Baba Y, Inage E, Kudo T, Suzuki R, Nagata S, Shimizu T. J Gastroenterol Hepatol. 2010 Oct;25(10):1626-30

Active substance: Azathioprine

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Document reference: 49294

Study title: Gibson et al. 99Tcm-HMPAO leucocyte labelling in orofacial granulomatosis and gastrointestinal Crohn's disease in childhood and early adulthoodNuclear medicine communications (2000), 21(2), 155-8. gibson j 2000

Active substance: CERETEC

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

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Document reference: 48610

Study title: Hwang et al. Regional cerebral perfusion abnormalities in developmental language disorder. Statistical parametric mapping analysisEur Arch Psychiatry Clin Neurosci. 2006 Apr;256(3):131-7. hwang jw 2006

Active substance: CERETEC

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

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Document reference: 48612

Study title: La gammagrafía con leucocitos marcados con 99mTc-HMPAO en el diagnóstico y seguimiento de la enfermedad inflamatoria intestinalJ. Verdú Ricoa, M. Juste Ruizb, R. Jovera, J. Muñoz Acostaa, J. Muñoza, A. Martínez Caballeroa, A. Antón Leala y O. Caballero Carpenaa. An Pediatr (Barc). 2006;64(5):457-63

Active substance: CERETEC

Study summary document link (including results): verdu j 2006.pdf

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Document reference: 48602

Study title: SPECT FINDINGS IN CHILDREN WITH SPECIFIC LANGUAGE IMPAIRMENTMarianne Ors1, Erik Ryding1, Magnus Lindgren2, Peik Gustafsson3, Gösta Blennow4 and Ingmar Rosén1. Cortex, (2005) 41, 316-326

Active substance: CERETEC

Study summary document link (including results): ors m 2005.pdf

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Document reference: 48598

Study title: Kremens B et al, High-dose consolidation with local radiation and bone marrow rescue in patients with advanced neuroblastoma, Med Pediatr Oncol. 1994;23(6):470-5

Active substance: ETOPOSIDE

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Document reference: 26950

Study title: Diler et al. Pharmacotherapy and regional cerebral blood flow in children with obsessive compulsive disorder.Yonsei Med J. 2004 Feb 29; 45(1):90-9 diler rs 2004

Active substance: CERETEC

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

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Document reference: 48609

Study title: Treatment of severe meconium aspiration syndrome with porcine surfactant: A multicentre, randomized, controlled trialActa Pædiatrica, 2005; 94: 896–902

Active substance: PORACTANT ALFA

Study summary document link (including results): IM.PR.5001.00 publication.pdf

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Document reference: 49245

Study title: A 5-year, multicenter, open-label, parallel group, randomized study to demonstrate the short and long-term safety of Elidel (pimecrolimus, ASM981) cream 1% in the treatment of mild to moderate atopic dermatitis in infants (3 − < 12 months of age)Study report

Active substance: PIMECROLIMUS

Study summary document link (including results): Pimecrolimus Art.45 study.pdf

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Document reference: 49194

Study title: In vitro generation of cytotoxic effectors activated by interleukin 2 (IL-2): Comparison of autologous peripheral blood stem cells (PBSC) from adults and children. Valteau-Couanet D et al. Bone Marrow Transplant June. 13, 2001, 869-75

Active substance: FLUOROURACIL

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Document reference: 28274

Study title: ADHD: new pharmacological treatments on the horizon. FA Lopez, Journal of Developmental and Behavioral Pediatrics - JDBP 2006, 27(5): 410-6 ADHD: new pharmacological treatments on the horizon. FA Lopez, Journal of Developmental and Behavioral Pediatrics - JDBP 2006, 27(5): 410-6

Active substance: MODAFINIL

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Document reference: 45670

Study title: 18F-FDG PET/CT fusion imaging in paediatric solid extracranial tumours Biomedicine & Pharmacotherapy 60 (2006) 593–606. C. Nannia, D. Rubellob,*, P. Castelluccia, M. Farsada, R. Franchia, L. Rampinb M.D. Grossc, A. Al-Nahhasd, S. Fantia

Active substance: Steripet

Study summary document link (including results): nanni-2006.pdf

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Document reference: 48738

Study title: Pediatric renal transplantation with mycophenolate mofetil-based immunosuppression without induction: results after three years.Jungraithmayr T, Staskewitz A, Kirste G, Böswald M, Bulla M, Burghard R, Dippell J, Greiner C, Helmchen U, Klare B, Klaus G, Leichter HE, Mihatsch MJ, Michalk DV, Misselwitz J, Plank C, Querfeld U, Weber LT, Wiesel M, Tönshoff B, Zimmerhackl LB; German Pediatric Renal Transplantation Study Group. Transplantation. 2003 Feb 27;75(4):454-61.

Active substance: Azathioprine

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Document reference: 49258

Study title: Premature atherosclerosis in pediatric systemic lupus erythematosus: risk factors for increased carotid intima-media thickness in the atherosclerosis prevention in pediatric lupus erythematosus cohort.Schanberg LE, Sandborg C, Barnhart HX, Ardoin SP, Yow E, Evans GW, Mieszkalski KL, Ilowite NT, Eberhard A, Levy DM, Kimura Y, von Scheven E, Silverman E, Bowyer SL, Punaro L, Singer NG, Sherry DD, McCurdy D, Klein-Gitelman M, Wallace C, Silver R, Wagner-Weiner L, Higgins GC, Brunner HI, Jung L, Soep JB, Reed A; Atherosclerosis Prevention in Pediatric Lupus Erythematosus Investigators. Arthritis Rheum. 2009 May;60(5):1496-507

Active substance: Azathioprine

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Document reference: 49289

Study title: Severe Henoch-Schönlein nephritis: resolution with azathioprine and steroids.Singh S1, Devidayal, Kumar L, Joshi K, Minz RW, Datta U. Rheumatol Int. 2002 Aug;22(4):133-7. Epub 2002 Jul 5.

Active substance: Azathioprine

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Document reference: 49256

Study title: Transient Posterior Encephalopathy Induced by Chemotherapy in ChildrenRocı´o Sa´nchez-Carpintero, MD, PhD*, Juan Narbona, MD, PhD*, Reyes Lo´pez de Mesa, MD*, Javier Arbizu, MD‡, and Luis Sierrasesu´maga, MD, PhD†. Pediatr Neurol 2001;24:145-148.

Active substance: CERETEC

Study summary document link (including results): Sanchez r 2001.pdf

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Document reference: 48600

Study title: Usefulness of Tc-99m HMPAO-labeled WBC heart scan to predict impaired ventricular function and coronary artery dilation in children with Kawasaki diseaseHsiu-Bao Hsua, Yun-Ching Fub,c,*, Shih-Chuan Tsaid, Ruoh-Fang Yene, Betau Hwangc,f. International Journal of Cardiology 92 (2003) 65– 69

Active substance: CERETEC

Study summary document link (including results): hsiu-bao h 2003.pdf

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Document reference: 48591

Study title: Tc-99m-HMPAO SPECT in the diagnosis of brain death in childrenPediatrics international : official journal of the Japan Pediatric Society (2004), 46(6), 711-4. okuyaz c 2005

Active substance: CERETEC

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

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Document reference: 48617

Study title: Th 1165a metered aerosol: therapy.

Active substance: FENOTEROL

Study summary document link (including results): Fenoterol hydrobromide_U70-0143_synopsis.pdf

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Document reference: 27035

Study title: Evaluation of the efficacy and tolerance of RU51807 (cefpodoxime proxetil) in children with skin and soft tissue infections

Active substance: CEFPODOXIME

Study summary document link (including results): CEFPODOXIME STUDY FF8980740.xls

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Document reference: 47975

Study title: Ciprandi−G, Tosca−M, Ricca−V, Passalacqua−G, Fregonese−L, Fasce−L, Canonica−G−W. Cetirizine treatment of allergic cough in children with pollen allergy. Allergy, Jul 1997, vol. 52, no. 7, p. 752−4.Ciprandi−G, Tosca−M, Ricca−V, Passalacqua−G, Fregonese−L, Fasce−L, Canonica−G−W. Cetirizine treatment of allergic cough in children with pollen allergy. Allergy, Jul 1997, vol. 52, no. 7, p. 752−4.

Active substance: CETIRIZINE

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Document reference: 23659

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A study of the safety and efficacy of RG 5029Y (triamcinolone acetonide) aqueous nasal spray in patients with perennial allergic rhinitis -Procaccini RL -24/02/1994

Active substance: TRIAMCINOLONE

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Document reference: 46853

Study title: Open, phase IIIb multicentric study of the immunogenicity and reactogenicity of the co-administration of Priorix (measles-mumps-rubella) and Infanrix Polio-Hib in each thigh to healthy infants aged 16 to 20 months.

Active substance: trivalent attenuated measles (Schwarz strain) - mumps (RIT 4385 and RIT 4386) - rubella (RA 27/3 strain)

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Document reference: 47872

Study title: Surgery. 1985 Dec;98(6):1189-96. Localization of residual medullary thyroid cancer by thallium/technetium scintigraphy. Talpos GB, Jackson CE, Froelich JW, Kambouris AA, Block MA, Tashjian AH Jr Surgery. 1985 Dec;98(6):1189-96. Localization of residual medullary thyroid cancer by thallium/technetium scintigraphy. Talpos GB, Jackson CE, Froelich JW, Kambouris AA, Block MA, Tashjian AH Jr

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44708

Study title: J Nucl Med. 1987 Jan;28(1):47-52. Thallium-201 brain tumor imaging: a comparative study with pathologic correlation. Kaplan WD, Takvorian T, Morris JH, Rumbaugh CL, Connolly BT, Atkins HL. J Nucl Med. 1987 Jan;28(1):47-52. Thallium-201 brain tumor imaging: a comparative study with pathologic correlation. Kaplan WD, Takvorian T, Morris JH, Rumbaugh CL, Connolly BT, Atkins HL.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44608

Study title: Am J Cardiol. 1996 Jul 15;78(2):175-81. Evaluation of myocardial ischemia and infarction by signal-averaged electrocardiographic late potentials in children with Kawasaki disease. Ogawa S, Nagai Y, Zhang J, Yuge K, Hino Y, Jimbo O, Fukazawa R, Hayashi RAm J Cardiol. 1996 Jul 15;78(2):175-81. Evaluation of myocardial ischemia and infarction by signal-averaged electrocardiographic late potentials in children with Kawasaki disease. Ogawa S, Nagai Y, Zhang J, Yuge K, Hino Y, Jimbo O, Fukazawa R, Hayashi R

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44508

Study title: Undesirable events with radiopharmaceuticals.Santos-Oliveira R. Tohoku J Exp Med 2009;217:251-7

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48757

Study title: Strenge-Hesse Postmarkting surveillance study (evaluation of 154 Legalon-SIL-case reports,18 children) 1983-1992 Internal Report; Cesko-Slovenska Pediatrie; VOL: 61 (6); p. 350-356 /2006/Internal Report, Strenge-Hesse, March 1996

Active substance: Silibinine dihydrogen succinate, disodium

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Document reference: 39873

Study title: Steroid treatment for severe childhood IgA nephropathy: a randomized, controlled trial.Yoshikawa N, Honda M, Iijima K, Awazu M, Hattori S, Nakanishi K, Ito H; Japanese Pediatric IgA Nephropathy Treatment Study Group. Clin J Am Soc Nephrol. 2006 May;1(3):511-7.

Active substance: Azathioprine

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Document reference: 49280

Study title: Tacrolimus and steroids versus ciclosporin microemulsion, steroids, and azathioprine in children undergoing liver transplantation: randomised European multicentre trial.Kelly D1, Jara P, Rodeck B, Lykavieris P, Burdelski M, Becker M, Gridelli B, Boillot O, Manzanares J, Reding R. Lancet. 2004 Sep 18-24;364(9439):1054-61.

Active substance: Azathioprine

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Document reference: 49265

Study title: The effect of long-term calcineurin inhibitor therapy on renal function in children after liver transplantation.Arora-Gupta N, Davies P, McKiernan P, Kelly DA. Pediatr Transplant. 2004 Apr;8(2):145-50.

Active substance: Azathioprine

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Document reference: 49262

Study title: Thiopurine metabolite monitoring in paediatric inflammatory bowel disease.Ooi CY, Bohane TD, Lee D, Naidoo D, Day AS. Aliment Pharmacol Ther. 2007 Apr 15;25(8):941-7.

Active substance: Azathioprine

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Document reference: 49278

Study title: Twelve years experience of juvenile dermatomyositis in North India.Singh S, Bansal A. Rheumatol Int. 2006 Apr;26(6):510-5.

Active substance: Azathioprine

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Document reference: 49269

Study title: produits de contraste et principes d'injection en acquisition helicoidale; DEBELLE L; in : scanner helicoidal ; principes et modalites pratique d'utilisation ; BLUM A. REGENT D. ; Masson Paris 1995 ; p.45 52produits de contraste et principes d'injection en acquisition helicoidale; DEBELLE L; in : scanner helicoidal ; principes et modalites pratique d'utilisation ; BLUM A. REGENT D. ; Masson Paris 1995 ; p.45 52

Active substance: BARIUM SULPHATE

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Document reference: 22197

Study title: Ritzel G. Letter: Ascorbic acid and the common cold.JAMA. 1976 Mar 15;235(11):1108.

Active substance: ASCORBIC ACID

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Document reference: 21878

Study title: Analyse critique des études cliniques Abbott, contains study 75-030 of Depakene syrup in epileptic children - Canlorbe P. - 03/04/1981

Active substance: VALPROIC ACID

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Document reference: 45447

Study title: Efficacy, Safety, and Local Pharmacokinetics of Highly Concentrated Nebulized Tobramycin in Patients with Cystic Fibrosis Colonized with Pseudomonas aeruginosaLenoir et al, Pediatr Drugs 2007; 9 Suppl. 1: 11-20, 1174-5878/07/0001-0011/

Active substance: TOBRAMYCIN

Study summary document link (including results): DM.PR.10000.001.01 publication.pdf

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Document reference: 49195

Study title: Tobramycin sulfate elimination in premature infants. Arbeter AM, Saccar CL, Eisner S, Sarni E, Yaffe SJ. J Pediatr. 1983 Jul;103(1):131-5.

Active substance: TOBRAMYCIN

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Document reference: 48896

Study title: Schmidt LM. Topical dermatologic therapy for the pediatrician. Pediatr Clin North Am. 1978 May;25(2):191-208. Schmidt LM. Topical dermatologic therapy for the pediatrician. Pediatr Clin North Am. 1978 May;25(2):191-208.

Active substance: TOLNAFTATE

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Document reference: 44831

Study title: Final report on clinical trials of K 75 - Rhi and K 76 - Rhi (Rhinospray drops).

Active substance: TRAMAZOLINE

Study summary document link (including results): Tramazoline Hydrochloride_U68-0083_synopsis.pdf

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Document reference: 46698

Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999;17(3):968-975 1999;(3):968-975.

Active substance: TAMOXIFEN

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Document reference: 43110

Study title: Indagine clinica preliminare del trazodone in preanestesia.

Active substance: TRAZODONE

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Document reference: 46728

Study title: Utilidad de la tizanidina. Seguimiento de un ano en el tratamiento de la espasticidad en la paralysis (The usefulness of tizanidine. A one−year follow−up of the treatment of spasticity in infantile cerebral palsy). Vásquez BA, Arellano SME, León HSR, Morales OMG. Revista de neurologia, Aug 1−15 2006, vol. 43, no. 3, p. 132−6Utilidad de la tizanidina. Seguimiento de un ano en el tratamiento de la espasticidad en la paralysis (The usefulness of tizanidine. A one−year follow−up of the treatment of spasticity in infantile cerebral palsy). Vásquez BA, Arellano SME, León HSR, Morales OMG. Revista de neurologia, Aug 1−15 2006, vol. 43, no. 3, p. 132−6

Active substance: TINZANIDINE

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Document reference: 44790

Study title: Pharmacokinetics of teicoplanin in children. - Tarral E, Jehl F, Tarral A et al. (1988) - Journal of Antimicrobial Chematherapy 21, Supplement A, 47-51.

Active substance: TEICOPLANIN

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Document reference: 44306

Study title: Yuen et al. Phenytoin dosage prediction in paediatric patients. Clin Pharmacokinet 1989; 16:254-60Yuen et al. Phenytoin dosage prediction in paediatric patients. Clin Pharmacokinet 1989; 16:254-60

Active substance: PHENYLEPHRINE

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Document reference: 33943

Study title: Assessment of Efficacy and Systemic Safety of a New Chlorofluorocarbon-Free Formulation of Inhaled Beclomethasone Dipropionate in Asthmatic ChildrenPEDIATRIC ASTHMA, ALLERGY & IMMUNOLOGY, Volume 15, Number 3, 2002

Active substance: BECLAMETHASONE

Study summary document link (including results): DM-RS-3303-05-00 pubblication.pdf

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Document reference: 49208

Study title: Comparison of nebulized beclomethasone dipropionate and nebulized budesonide in asthma of infants and children. Multicentre, randomized, controlled, open-label study versus reference product in 2 parallel groups over 14 weeks including a 2-week run-in, in severe or persistent asthma in infants and young children of the equivalent safety and efficacy of the addition, to the usual maintenance treatment, of 800 mg of nebulized beclomethasone dipropionate or 750mg of nebulized Pulmicort® twice a day.study synopsis. Please see report

Active substance: BECLAMETHASONE

Study summary document link (including results): 14.06.CT.01.91 (Synopsis).doc

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Document reference: 49206

Study title: Double-Blind Randomized Parallel Group Design Multicentre Study of the Efficacy and Tolerability of Two Nasal Spray Presentations of Beclomethasone Dipropionate ( Clenil Aqua, Chiesi and Beconase Aqua®, Glaxo) 200 mcg/bid in Patients with Allergic RhinitisMarni Et AL

Active substance: becLAMETHASONE

Study summary document link (including results): R9010291 publication.pdf

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Document reference: 49198

Study title: Hendriksz-C-J, Preece-M-A, Chakrapani-A. Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Steelhouse Lane, Birmingham, B4 6NH, UK. Successful pregnancy in a treated patient with biotinidase deficiency. Journal of inherited metabolic disease, {J-Inherit-Metab-Dis}, 2005, vol. 28, no. 5, p. 791-2, ISSN: 0141-8955.Hendriksz-C-J, Preece-M-A, Chakrapani-A. Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Steelhouse Lane, Birmingham, B4 6NH, UK. Successful pregnancy in a treated patient with biotinidase deficiency. Journal of inherited metabolic disease, {J-Inherit-Metab-Dis}, 2005, vol. 28, no. 5, p. 791-2, ISSN: 0141-8955.

Active substance: BIOTIN

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Document reference: 22596

Study title: An open study to investigate the clinical efficacy of Triamcinolone hexacetonide in diseases of the ear in children.Larras-Martenot (Les Cahier d´O.R.L. 14(4): 415-416, 1979)

Active substance: TRIAMCINOLONE

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Document reference: 48964

Study title: [Injections and local infiltrations of triamcinolone hexacetonide (Lederle) in rheumatology]. [Article in Spanish] De Usobiaga JL. Rev Esp Reum Enferm Osteoartic. 1970 Apr;13(6):349-59.

Active substance: TRIAMCINOLONE

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Document reference: 48960

Study title: "A comparison of once-daily and divided doses of modafinil in children with attention-deficit/hyperactivity disorder: a randomized, double-blind, and placebo-controlled study. J Biederman, et al., Journal of Clinical Psychiatry 2006, 67(5): 727-35.

Active substance: MODAFINIL

Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls

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Document reference: 45291

Study title: "Grinschgl G. Die Kombinationsbehandlung zerebraler Krampfanfälle unter besonderer Berücksichtigung der Epilepsie. Wien Klin Wochenschr 1952; 64/20: 362-365 " "Grinschgl G. Die Kombinationsbehandlung zerebraler Krampfanfälle unter besonderer Berücksichtigung der Epilepsie. Wien Klin Wochenschr 1952; 64/20: 362-365 "

Active substance: MEPHENYTOIN

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Document reference: 31604

Study title: Safety and efficacy comparison of two dosing regimens of MetroGel-Vaginal(R) in the treatment of bacterial vaginosis: a multicenter, randomized, single-blind, parallel comparison.Soper DE1, Livengood C, Sheehan KL, Fenner DE, Martens MG, Nelson AL, Ismail M, Thorp JM, Lappin M, Fleury FJ, Long BJ, Blackwelder T, Sweet RL, Sagov S. Prim Care Update Ob Gyns. 1998 Jul 1;5(4):150.

Active substance: METRONIDAZOLE

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Document reference: 48942

Study title: Submission of result-related information on paediatric studies submitted under Article 45 of the Paediatric Regulation No 1901/2006. Product concerned by this submission: Nasonex and Associated Tradenames (Mometasone Furoate)Merck Sharp & Dohme (Europe), Inc. Clos du Lynx 5 Lynx Binnenhof B-1200 Brussels

Active substance: MOMETAZONE

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Document reference: 48849

Study title: Miser JS et al. Treatment of metastatic Ewing's sarcoma or primitive neuroectodermal tumor of bone: evaluation of combination ifosfamide and etoposide--a Children's Cancer Group and Pediatric Oncology Group study.J Clin Oncol. 2004 Jul 15;22(14):2873-6.Miser JS et al. Treatment of metastatic Ewing's sarcoma or primitive neuroectodermal tumor of bone: evaluation of combination ifosfamide and etoposide--a Children's Cancer Group and Pediatric Oncology Group study.J Clin Oncol. 2004 Jul 15;22(14):2873-6.

Active substance: MITOXANTRONE

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Document reference: 32177

Study title: Neuropathic osteonecrosis of the knee in childhood. Two cases of myelomeningocele. Kjaerulff H, Hejgaard N. Acta Orthop Scand. 1987 Aug;58(4):436-40.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43852

Study title: Lopez Pereira P, Miguelez C, Caffarati J, Estornell F, Anguera A: Trospium chloride for the treatment of detrusor instability in children; J. Urol. 2003; 170(5): 1978-1981Lopez Pereira P, Miguelez C, Caffarati J, Estornell F, Anguera A: Trospium chloride for the treatment of detrusor instability in children; J. Urol. 2003; 170(5): 1978-1981

Active substance: TROSPIUM

Study summary document link (including results): 14532838.pdf

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Document reference: 46886

Study title: Comparative Evaluation of Cefixime versus Amoxicillin-Clavulate Following Ceftriaxone Therapy of PneumoniaClin Pediatr 1996; 35: 629-633, Amir J., 1996

Active substance: CEFIXIME

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

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Document reference: 48974

Study title: Comparative Evaluation of Cefpodoxime Versus Cefixime in children with Lower Respiratory Tract InfectionsIndian J Pediatr 2004; 71: 517-521 Sengupta J.

Active substance: CEFIXIME

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

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Document reference: 48975

Study title: Application of S-CMC to otitis media with effusion. - Yukiko Ito et al.- 1992 (Journal reference not readable, 85:5;815-819) ; Publication M90 French validation registration dossier 05/1995

Active substance: CARBOCYSTEINE

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Document reference: 23308

Study title: emploi d'un nouvel opacifiant triiode en cystographie et pour certains examens digestifs chez l'enfant; COUSSEMENT A; J. Radiol.; 1973 vol.54 n.12 p.67-68emploi d'un nouvel opacifiant triiode en cystographie et pour certains examens digestifs chez l'enfant; COUSSEMENT A; J. Radiol.; 1973 vol.54 n.12 p.67-68

Active substance: BISACODYL

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Document reference: 22725

Study title: Küchle H. J., Busse H., Augenerkrankungen im Kindesalter, Thieme Verlag Stuttgart New York 1985

Active substance: CARBOMER

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Document reference: 23350

Study title: Clinical pharmacokinetics and pharmacodynamics of opioid analgesics in infants and childrenOlkkola KT, Hamunen K, Maunuksela EL., 1995, Clin Pharmacokinet 1995; 5: 385-404

Active substance: MORPHINE

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

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Document reference: 48931

Study title: Single-dose caudal epidural morphine in children: safe, effective, and easy.J Clin Anesth 1991; 5: 386-90, Serlin S., 1991

Active substance: MORPHINE

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

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Document reference: 48932

Study title: Hofmann S, Knoefler R, Lorenz N, et al. Clinical experiences with low molecular weight heparins in pediatric patients. Thrombosis Research 2001;103: 345–53."

Active substance: NADROPARIN

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Document reference: 32450

Study title: A new bowel preparation for elective colon and rectal surgery. A prospective, randomized clinical trial.Wolff BG, Beart RW Jr, Dozois RR, Pemberton JH, Zinsmeister AR, Ready RL, Farnell MB, Washington JA 2nd, Heppell J. Archives of surgery (Chicago Ill. : 1960), Jul 1988, vol. 123, no. 7, p. 895−900

Active substance: ERYTHROMYCIN

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Document reference: 26507

Study title: Lee WT, Leung SS, Wang SH, Xu YC, Zeng WP, Lau J, Oppenheimer SJ, Cheng JC. Double-blind, controlled calcium supplementation and bone mineral accretion in children accustomed to a low-calcium diet. Am J Clin Nutr. 1994 Nov; 60(5):744-50. Lee WT, Leung SS, Wang SH, Xu YC, Zeng WP, Lau J, Oppenheimer SJ, Cheng JC. Double-blind, controlled calcium supplementation and bone mineral accretion in children accustomed to a low-calcium diet. Am J Clin Nutr. 1994 Nov; 60(5):744-50.

Active substance: CALCIUM CARBONATE

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Document reference: 23155

Study title: β-Blocker/thiazide combination for treatment of hypertensive children: a randomized double-blind, placebo-controlled trial.Pediatr Nephrol 2002; 17: 345-350; Sorof JM., 2002

Active substance: BISOPROLOL AND HYDROCHLOROTHIAZIDE

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

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Document reference: 48907

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

Active substance: FLUDEOXYGLUCOSE

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Document reference: 28201

Study title: Corticosteroids administered by nebulization to children with bronchial asthma.Terzano C, Barkai L, Cremonesi G., Adv Ther. 2001 Nov-Dec;18:253-60.

Active substance: FLUNISOLIDE

Study summary document link (including results): MC-PR-3502-001-99 publication.pdf

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Document reference: 49211

Study title: Double-blind evaluation of effectiveness and safety of flunisolide aerosol for treatment of bronchial asthma in children.Piacentini G.L. et al, Allergy 1990,45, 612-616

Active substance: FLUNISOLIDE

Study summary document link (including results): Published paper (Piacentini).pdf

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Document reference: 49212

Study title: Gentamicin in the treatment of acute and chronic pyelonephritis in childrenMed Klinik 1970; 65 (12): 552-557, Kienitz M., 1970

Active substance: GENTAMYCIN

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

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Document reference: 48933

Study title: Doutre MS, Grosshans E, Saiag P. Herpes virus infection in the immunocompetent child and adult. Cutaneous and mucous herpes. Annales de Dermatologie et de Venereologie. 2002; 129(10 Suppl~):2S27-2S35, Octobre.2002.Doutre MS, Grosshans E, Saiag P. Herpes virus infection in the immunocompetent child and adult. Cutaneous and mucous herpes. Annales de Dermatologie et de Venereologie. 2002; 129(10 Suppl~):2S27-2S35, Octobre.2002.

Active substance: Foscarnet

Study summary document link (including results): Doutre MS et al 2002.pdf

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Document reference: 39636

Study title: A Double blind, placebo-controlled trial for further evaluation of the effect of these preparations in migraine and also of their side-effects.Kallós et al. (Translation of a paper from The Swedish Medical journal (Svenska Läkartidningen) 1958:55:1782 No. 24)

Active substance: ergotamine

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ergotamine_1.xlsx

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Document reference: 49073

Study title: Pharmacokinetic and antibacterial activity of daily gentamicinArchives Dis Childhood 1992; 67: 57-61, Skopnik H., 1992.

Active substance: GENTAMYCIN

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Document reference: 48935

Study title: Mitomycin C and 5-fluorouracil antimetabolite therapy for pediatric glaucoma filtration surgery. Snir M et al. Ophthalmic Surg Lasers. January 1, 2000, 31-7

Active substance: FLUOROURACIL

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Document reference: 28277

Study title: Treatment of Neonatal Sepsis with Ceftriaxone/Gentamicin and with Azlocillin/Gentamicin: A Clinical Comparison of Efficacy and Tolerability Chemotherapy1988; 34: 158-163, Wiese G.

Active substance: GENTAMYCIN

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

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Document reference: 48934

Study title: CLINICAL EVALUATION OF FLUCONAZOLE (UK-49,858) IN IV DRIP ENJECTION FROM EFFICACY AND SAFETY IN PEDIATRIC SYSTEMIC MYCOSIS.

Active substance: FLUCONAZOLE

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Document reference: 27933

Study title: Quality of life in a double-blind, randomised, placebo-controlled parallel study comparing the efficacy and safety of three dosage strengths of fexofenadine HCl (15, 30 and 60 mg BID) in paediatric patients (ages 6 to 11 years) in the treatment of Seasonal Allergic Rhinitis, 22 April 1998

Active substance: FEXOFENADINE

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Document reference: 27259

Study title: Once daily aminoglycoside dosing in full term neonatesPediatr Infect Dis J 1995; 14: 71-72, Skopnik H., 1995

Active substance: GENTAMYCIN

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

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Document reference: 48936

Study title: An open uncontrolled study to evaluate the effect of treatment and tolerance of a flucloxacillin nsyrup.Price et al Flucloxacillin in the treatment of infectious conditions in children.

Active substance: FLUCLOXACILLIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Flukloxacillin_1.xlsx

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Document reference: 49076

Study title: Investigate the bioavailability of 2 commercially available pediatric suspensions of erythromycin containing the stearate salt and the ethylsuccinate ester, respectively.Eriksson et al. (Scand J Infcect Dis 13: 211-215, 1981)

Active substance: ERYTHROMYCIN

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_9.xlsx

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Document reference: 49057

Study title: Lack of effect of erythromycin and ketoconazole on the pharmacokinetics and pharmacodynamics of steady state intranasal levocabastine. Tran J Q, Di Cicco R A, Sheth S B, Tucci M, Peng L, Jorkasky D K, Hursting M J, Benincosa L J. Journal of clinical pharmacology, {May 1999, vol. 39, no. 5, p. 513 9.

Active substance: ERYTHROMYCIN

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Document reference: 26441

Study title: Doxapram dosage regimen in apnea of prematurity based on pharmacokinetic data. Jamali F, Barrington KJ, Finer NN, Coutts RT, Torok-Both GA. Dev Pharmacol Ther. 1988;11(5):253-7.

Active substance: Doxapram

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Document reference: 48895

Study title: To determine the apparent bioavailability of Dicloxacillin in children of ages ranging from 6 days to 11,5 years.Smith et al. (Dev Pharmacol Ther 1990;14:35-44)

Active substance: dicloxacillin

Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Dikloxacillin_1.xlsx

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Document reference: 49078

Study title: A phase II, double blind, randomized, double center, controlled study to evaluate the safety and immunogenicity of four formulations of DTwPHib combined vaccine containing different concentrations of Hib conjugate in healthy infants at 3, 4, 5 months of age.Please see report- sturdy report

Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)

Study summary document link (including results): V45P1.xlsx

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Document reference: 49183

Study title: Vecchi-V, Pileri-S, Burnelli-R, Bontempi-N, Comelli-A, Testi-A-M, Carli-M, Sotti-G, Rosati-D, Di-Tullio-M-T, et al. III Department of Pediatrics, Bologna University, Italy. Treatment of pediatric Hodgkin disease tailored to stage, mediastinal mass, and age. An Italian (AIEOP) multicenter study on 215 patients. Cancer, {Cancer}, 15 Sep 1993, vol. 72, no. 6, p. 2049-57, ISSN: 0008-543X.Vecchi-V, Pileri-S, Burnelli-R, Bontempi-N, Comelli-A, Testi-A-M, Carli-M, Sotti-G, Rosati-D, Di-Tullio-M-T, et al. III Department of Pediatrics, Bologna University, Italy. Treatment of pediatric Hodgkin disease tailored to stage, mediastinal mass, and age. An Italian (AIEOP) multicenter study on 215 patients. Cancer, {Cancer}, 15 Sep 1993, vol. 72, no. 6, p. 2049-57, ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34871

Study title: Vietti-T-J, Coulter-D-M. Edward Mallinckrodt Dept. Ped., Washington Univ. Sch. Med., St Louis, Mo., United States. Anticancer agents used in the treatment of childhood leukemias. Cancer Bulletin {CANCER-BULL}, 1978, Vol/Iss/Pg. 30/5 (148-159).Vietti-T-J, Coulter-D-M. Edward Mallinckrodt Dept. Ped., Washington Univ. Sch. Med., St Louis, Mo., United States. Anticancer agents used in the treatment of childhood leukemias. Cancer Bulletin {CANCER-BULL}, 1978, Vol/Iss/Pg. 30/5 (148-159).

Active substance: PROCARBAZINE

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Document reference: 34872

Study title: Walker-R-W, Rosenblum-M-K. Memorial Sloan-Kettering Cancer Cnt., 1275 York Avenue, New York, NY 10021, United States. Childhood medulloblastoma. Revue Neurologique {REV-NEUROL}, 1992, Vol/Iss/Pg. 148/6-7 (467-476), ISSN: 0035-3787.Walker-R-W, Rosenblum-M-K. Memorial Sloan-Kettering Cancer Cnt., 1275 York Avenue, New York, NY 10021, United States. Childhood medulloblastoma. Revue Neurologique {REV-NEUROL}, 1992, Vol/Iss/Pg. 148/6-7 (467-476), ISSN: 0035-3787.

Active substance: PROCARBAZINE

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Document reference: 34873

Study title: Weiner-M-A, Leventhal-B-G, Marcus-R, Brecher-M, Ternberg-J, Behm-F-G, Cantor-A, Wharam-M, Chauvenet-A. Hackensack Medical Center, NJ. Intensive chemotherapy and low-dose radiotherapy for the treatment of advanced-stage Hodgkin's disease in pediatric patients: a Ped iatric Oncology Group study. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Sep 1991, vol. 9, no. 9, p. 1591-8, ISSN: 0732-183X.Weiner-M-A, Leventhal-B-G, Marcus-R, Brecher-M, Ternberg-J, Behm-F-G, Cantor-A, Wharam-M, Chauvenet-A. Hackensack Medical Center, NJ. Intensive chemotherapy and low-dose radiotherapy for the treatment of advanced-stage Hodgkin's disease in pediatric patients: a Ped iatric Oncology Group study. Journal of clinical oncology ...

Active substance: PROCARBAZINE

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Document reference: 34875

Study title: De Haes A et al. Pharmacokinetic/pharmacodynamic modeling of rocuronium in myasthenic patients is improved by taking into account the number of unbound acetylcholine receptors. Anesth Analg. 2002 Sep;95(3):588-96De Haes A et al. Pharmacokinetic/pharmacodynamic modeling of rocuronium in myasthenic patients is improved by taking into account the number of unbound acetylcholine receptors. Anesth Analg. 2002 Sep;95(3):588-96

Active substance: PYRIDOSTIGMINE

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Document reference: 35187

Study title: DeLuca G et al. GH secretion in thalassemia patients with short stature. Horm Res. 1995;44(4):158-63DeLuca G et al. GH secretion in thalassemia patients with short stature. Horm Res. 1995;44(4):158-63

Active substance: PYRIDOSTIGMINE

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Document reference: 35200

Study title: Sellami-M, Auclerc-G, Weil-M, et-al. Service d'Oncologie Medicale, Hopital de la Salpetriere, F 75661 Paris, France. Malignant melanoma of children and adolescents. A report of 37 cases. Bulletin du Cancer {BULL-CANCER}, 1986, Vol/Iss/Pg. 73/1 (2-7).Sellami-M, Auclerc-G, Weil-M, et-al. Service d'Oncologie Medicale, Hopital de la Salpetriere, F 75661 Paris, France. Malignant melanoma of children and adolescents. A report of 37 cases. Bulletin du Cancer {BULL-CANCER}, 1986, Vol/Iss/Pg. 73/1 (2-7).

Active substance: PROCARBAZINE

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Document reference: 34841

Study title: Shalet-S-M, Whitehead-E, Jones-P-H-M. Christie Hosp., Manchester, United Kingdom. Testicular dysfunction ater combination chemotherapy for Hodgkin's disease in childhood. Pediatric Research {PEDIATR-RES}, 1981, Vol/Iss/Pg. 15/12 (No. 165).Shalet-S-M, Whitehead-E, Jones-P-H-M. Christie Hosp., Manchester, United Kingdom. Testicular dysfunction ater combination chemotherapy for Hodgkin's disease in childhood. Pediatric Research {PEDIATR-RES}, 1981, Vol/Iss/Pg. 15/12 (No. 165).

Active substance: PROCARBAZINE

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Document reference: 34842

Study title: Shalet-S-M. Dep. Endocrinol., Christie Hosp., Manchester M20 9BX, United Kingdom. Abnormalities of growth and gonadal function in children treated for malignant disease: A review. Journal of the Royal Society of Medicine {J-R-SOC-MED}, 1982, Vol/Iss/Pg. 75/8 (641-647).Shalet-S-M. Dep. Endocrinol., Christie Hosp., Manchester M20 9BX, United Kingdom. Abnormalities of growth and gonadal function in children treated for malignant disease: A review. Journal of the Royal Society of Medicine {J-R-SOC-MED}, 1982, Vol/Iss/Pg. 75/8 (641-647).

Active substance: PROCARBAZINE

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Document reference: 34843

Study title: Shapiro-W-R. Chemotherapy of primary malignant brain tumors in children. Cancer, {Cancer}, Mar 1975, vol. 35, no. 3 suppl, p. 965-72, ISSN: 0008-543X.Shapiro-W-R. Chemotherapy of primary malignant brain tumors in children. Cancer, {Cancer}, Mar 1975, vol. 35, no. 3 suppl, p. 965-72, ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34844

Study title: Sinniah-D, Lin-H-P. Extrapyramidal tract syndrome following intensive MOPP therapy for stage IV-B Hodgkin's disease in childhood. Cancer, {Cancer}, May 1979, vol. 43, no. 5, p. 1587-9, ISSN: 0008-543X.Sinniah-D, Lin-H-P. Extrapyramidal tract syndrome following intensive MOPP therapy for stage IV-B Hodgkin's disease in childhood. Cancer, {Cancer}, May 1979, vol. 43, no. 5, p. 1587-9, ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34846

Study title: Singer W et al. Acetylcholinesterase inhibition in patients with orthostatic intolerance. J Clin Neurophysiol. 2006 Oct;23(5):476-81Singer W et al. Acetylcholinesterase inhibition in patients with orthostatic intolerance. J Clin Neurophysiol. 2006 Oct;23(5):476-81

Active substance: PYRIDOSTIGMINE

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Document reference: 35182

Study title: Singer W et al. Pyridostigmine treatment trial in neurogenic orthostatic hypotension. Arch Neurol. 2006 Apr;63(4):513-8Singer W et al. Pyridostigmine treatment trial in neurogenic orthostatic hypotension. Arch Neurol. 2006 Apr;63(4):513-8

Active substance: PYRIDOSTIGMINE

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Document reference: 35183

Study title: Somnier FE et al. EMG evidence of myopathy and the occurrence of titin autoantibodies in patients with myasthenia gravis. Eur J Neurol. 1999 Sep;6(5):555-63Somnier FE et al. EMG evidence of myopathy and the occurrence of titin autoantibodies in patients with myasthenia gravis. Eur J Neurol. 1999 Sep;6(5):555-63

Active substance: PYRIDOSTIGMINE

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Document reference: 35191

Study title: Turner GA, Williams JD, Baker DJ. Effect of pretreatment with oral pyridostigmine on subsequent activity of alcuronium in non-anaesthetized subjects. Br J Anaesth. 1991 Mar;66(3):365-9Turner GA, Williams JD, Baker DJ. Effect of pretreatment with oral pyridostigmine on subsequent activity of alcuronium in non-anaesthetized subjects. Br J Anaesth. 1991 Mar;66(3):365-9

Active substance: PYRIDOSTIGMINE

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Document reference: 35208

Study title: Ziv I et al. Prevention of peripheral side-effects of transdermal hyoscine by adjunctive therapy with low dosage of pyridostigmine. Br J Clin Pharmacol. 1992 May;33(5):507-10 Ziv I et al. Prevention of peripheral side-effects of transdermal hyoscine by adjunctive therapy with low dosage of pyridostigmine. Br J Clin Pharmacol. 1992 May;33(5):507-10

Active substance: PYRIDOSTIGMINE

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Document reference: 35203

Study title: Lento G, Tandurella S, Baretti C, Cannata G, Salerno R. G Ital Potol Sci Affin 1982;28(1):9-15. Patients suffering from herpes zoster treated with methisoprinol.Lento G, Tandurella S, Baretti C, Cannata G, Salerno R. G Ital Potol Sci Affin 1982;28(1):9-15. Patients suffering from herpes zoster treated with methisoprinol.

Active substance: INOSINE

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Document reference: 30139

Study title: Litzman J, et al . 1999 Scripta Medca (BRNO) 72 (4) 115 -124. Isoprinosine in the treatment of children with frequent respiratory tract infections and minor T lymphocyte immunodeficiency. Litzman J, et al . 1999 Scripta Medca (BRNO) 72 (4) 115 -124. Isoprinosine in the treatment of children with frequent respiratory tract infections and minor T lymphocyte immunodeficiency.

Active substance: INOSINE

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Document reference: 30140

Study title: Litzman J, Lokaj J, Krejci M, Pesak S, Morgan G. Eur J Pediatr 1999 Jan;158(1):32-7. Isoprinosine does not protect against frequent respiratory tract infections in childhood.Litzman J, Lokaj J, Krejci M, Pesak S, Morgan G. Eur J Pediatr 1999 Jan;158(1):32-7. Isoprinosine does not protect against frequent respiratory tract infections in childhood.

Active substance: INOSINE

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Document reference: 30141

Study title: A multicentre randomised, parallel group, double-blind phase III comparison between iodixanol (VISIPAQUE) 150 mg I/ml and 320 mg I/ml and iohexol (Omnipaque) 140 mg I/ml and 300 mg I/ml Report DXC060 (date Jun 1999)

Active substance: IODIXANOL

Study summary document link (including results): DXC060 Redacted.pdf

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Document reference: 48210

Study title: A phase III, randomised, blinded comparison of Iodixanol (VISIPAQUE; 320 mgI/mL) and OMNIPAQUE 350 (Iohexol) in pediatric patients requiring angiocardiographyStudy Report 1968 (Date May 1996)

Active substance: IODIXANOL

Study summary document link (including results): Study Report 1968 Redacted.pdf

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Document reference: 48204

Study title: A phase III, randomised, double blind comparison of Iodixanol (VISIPAQUE; 270 mgI/mL and 320 mgI/mL) and OMNIPAQUE 300 (Iohexol) in pediatric patients requiring computed tomography (CT) scanning of the bodyStudy Report 1967 (Date Dec 1995)

Active substance: IODIXANOL

Study summary document link (including results): Study Report 1967 Redacted.pdf

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Document reference: 48203

Study title: The safety, efficacy and pharmacokinetics of ZD0859#1 vs. Diprivan (propofol) injection when used for maintenance of anaesthesia in children.

Active substance: PROPOFOL

Study summary document link (including results): 0859IL0058 Study Synopsis.pdf

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Document reference: 46136

Study title: Codispoti M, Mankad PS: Management of anticoagulation and its reversal during paediatric cardiopulmonary bypass: a review of current UK practice. Perfusion 2000; 15: 191-201 Codispoti M, Mankad PS: Management of anticoagulation and its reversal during paediatric cardiopulmonary bypass: a review of current UK practice. Perfusion 2000; 15: 191-201

Active substance: PROTAMINE

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Document reference: 35086

Study title: Slanina-J, Wannenmacher-M, Spratler-J. Abteilung Strahlentherapie, Universitatsklinikum Freiburg i.Br, D 7800 Freiburg i.Br., Germany. Pregnancy and development of the child after treatment of Hodgkin's disease. Strahlentherapie {STRAHLENTHERAPIE}, 1985, Vol/Iss/Pg. 161/9 (558-564).Slanina-J, Wannenmacher-M, Spratler-J. Abteilung Strahlentherapie, Universitatsklinikum Freiburg i.Br, D 7800 Freiburg i.Br., Germany. Pregnancy and development of the child after treatment of Hodgkin's disease. Strahlentherapie {STRAHLENTHERAPIE}, 1985, Vol/Iss/Pg. 161/9 (558-564).

Active substance: PROCARBAZINE

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Document reference: 34847

Study title: Efficacy of sucrose to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Gal P, Kissling GE, Young WO, Dunaway KK, Marsh VA, Jones SM, Shockley DH, Weaver NL, Carlos RQ, Ransom JL. Ann Pharmacother. 2005 Jun;39(6):1029-33;Epub 2005 Apr 26. 2. Efficacy of sucrose to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Gal P, Kissling GE, Young WO, Dunaway KK, Marsh VA, Jones SM, Shockley DH, Weaver NL, Carlos RQ, Ransom JL. Ann Pharmacother. 2005 Jun;39(6):1029-33;Epub 2005 Apr 26. 2.

Active substance: PROXYMETHACAINE

Study summary document link (including results): Efficacy of sucrose to reduce pain in premature infants.pdf

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Document reference: 46139

Study title: Efficacy of topical anesthetics to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Marsh VA, Young WO, Dunaway KK, Kissling GE, Carlos RQ, Jones SM, Shockley DH, Weaver NL, Ransom JL, Gal P. Ann Pharmacother. 2005 May;39(5):829-33;Epub 2005 Mar 29. Efficacy of topical anesthetics to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Marsh VA, Young WO, Dunaway KK, Kissling GE, Carlos RQ, Jones SM, Shockley DH, Weaver NL, Ransom JL, Gal P. Ann Pharmacother. 2005 May;39(5):829-33;Epub 2005 Mar 29.

Active substance: PROXYMETHACAINE

Study summary document link (including results): Efficacy of topical anesthetics to reduce pain in premature .pdf

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Document reference: 46140

Study title: Paediatric cycloplegia: a new approach. Shah P, Jacks AS, Adams GG. Eye. 1997;11 ( Pt 6):845-6. Paediatric cycloplegia: a new approach. Shah P, Jacks AS, Adams GG. Eye. 1997;11 ( Pt 6):845-6.

Active substance: PROXYMETHACAINE

Study summary document link (including results): Paediatric cycloplegia.pdf

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Document reference: 46142

Study title: Topical anesthesia during infant eye examinations: does it reduce stress? Saunders RA, Miller KW, Hunt HH. Ann Ophthalmol. 1993 Dec;25(12):436-9. Topical anesthesia during infant eye examinations: does it reduce stress? Saunders RA, Miller KW, Hunt HH. Ann Ophthalmol. 1993 Dec;25(12):436-9.

Active substance: PROXYMETHACAINE

Study summary document link (including results): Topical anesthesia during infant eye examinations.pdf

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Document reference: 46143

Study title: Ekert-H, Waters-K-D, Smith-P-J, Toogood-I, Mauger-D. Department of Clinical Hematology and Oncology, Royal Children's Hospital, Parkville, Australia. Treatment with MOPP or ChlVPP chemotherapy only for all stages of childhood Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Dec 1988, vol. 6, no. 12, p. 1845-50, ISSN: 0732-183X.Ekert-H, Waters-K-D, Smith-P-J, Toogood-I, Mauger-D. Department of Clinical Hematology and Oncology, Royal Children's Hospital, Parkville, Australia. Treatment with MOPP or ChlVPP chemotherapy only for all stages of childhood Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol},...

Active substance: PROCARBAZINE

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Document reference: 34704

Study title: Ekert-H, Waters-K-D. Results of treatment of 18 children with Hodgkin disease with MOPP chemotherapy as the only treatment modality. Medical and pediatric oncology, {Med-Pediatr-Oncol}, 1983, vol. 11, no. 5, p. 322-6, ISSN: 0098-1532.Ekert-H, Waters-K-D. Results of treatment of 18 children with Hodgkin disease with MOPP chemotherapy as the only treatment modality. Medical and pediatric oncology, {Med-Pediatr-Oncol}, 1983, vol. 11, no. 5, p. 322-6, ISSN: 0098-1532.

Active substance: PROCARBAZINE

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Document reference: 34705

Study title: Ekert-H. Dr. H. Ekert, Department Haematology-Oncology, Royal Children's Hospital, Parkville, Vic, 3052, Australia Massive mediastinal Hodgkin's disease in childhood: Results of treatment from four Australian oncology centres 1972-1993. Cancer Research Therapy and Control {CANCER-RES-THER-CONTROL}, 1996, Vol/Iss/Pg. 5/1 (41-47), ISSN: 1064-0525.Ekert-H. Dr. H. Ekert, Department Haematology-Oncology, Royal Children's Hospital, Parkville, Vic, 3052, Australia Massive mediastinal Hodgkin's disease in childhood: Results of treatment from four Australian oncology centres 1972-1993. Cancer Research Therapy and Control {CANCER-RES-THER-CONTROL}, 1996, Vol/Iss/Pg. 5/1 (41-47), ISSN: 1064-0525.

Active substance: PROCARBAZINE

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Document reference: 34706

Study title: Ekert-H. Treatment of childhood Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Mar 1991, vol. 9, no. 3, p. 528-9, ISSN: 0732-183X.Ekert-H. Treatment of childhood Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Mar 1991, vol. 9, no. 3, p. 528-9, ISSN: 0732-183X.

Active substance: PROCARBAZINE

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Document reference: 34708

Study title: A randomised, parallel, double-blind phase III comparison between iodixanol, 270 mg I/ml and 320 mg I/ml and iohexol (Omnipaque) 300 mg I/ml Trial No. DXV039 (date Dec 1995)

Active substance: IODIXANOL

Study summary document link (including results): DXV039 Redacted.pdf

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Document reference: 48206

Study title: Acad Radiol. 1996 Sep;3 Suppl 3:S524-7. Comparison of iodixanol with iohexol in excretory urography. Siegle RL, Gavant ML. Acad Radiol. 1996 Sep;3 Suppl 3:S524-7. Comparison of iodixanol with iohexol in excretory urography. Siegle RL, Gavant ML.

Active substance: IODIXANOL

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Document reference: 30348

Study title: An open phase II trial with iodixanol 320 mg I/ml and a double-blind, parallel, randomised phase III trial with iodixanol 320 mg I/ml compared to iohexol (Omnipaque) 350 mg I/ml Trial No. DXV036 (date Mar 1996)

Active substance: IODIXANOL

Study summary document link (including results): DXV036 Redacted.pdf

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Document reference: 48209

Study title: An open phase II trial with iodixanol 320 mg I/mL, and a randomised, parallel, double-blind phase III comparison between iodixanol (VISIPAQUE), 270 mg I/ml and 320 mg I/ml, and iohexol (Omnipaque) 300 mg I/ml Trial No. DXV041 (date Dec 1995)

Active substance: IODIXANOL

Study summary document link (including results): DXV041 Redacted.pdf

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Document reference: 48205

Study title: Complications with Outpatient Angiography and Interventional ProceduresYoung N 2002. Cardiovasc Intervent Radiol (2002) 25:123–126

Active substance: IODIXANOL

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

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Document reference: 48199

Study title: A single-blind trial to compare the efficacy, tolerability and safety of levocabastine nasal spray as compared to sodiumcromoglycate nasal spray in children aged 6 months to 5 years with perennial allergic rhinitis. Part I. Clinical Research Report Dated April 1998A single-blind trial to compare the efficacy, tolerability and safety of levocabastine nasal spray as compared to sodiumcromoglycate nasal spray in children aged 6 months to 5 years with perennial allergic rhinitis. Part I. Clinical Research Report Dated April 1998

Active substance: LEVOCABASTINE

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Document reference: 31116

Active substance: LEVOCABASTINE

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Document reference: 31126

Study title: An efficacy and tolerance comparison of emedastine difumarate 0.05% and levocabastine hydrochloride 0.05% reducing chemosis and eyelid swelling in subjects with seasonal allergic conjunctivitis. Acta Ophthalmica Scandinavica 78, p.48-51,2000An efficacy and tolerance comparison of emedastine difumarate 0.05% and levocabastine hydrochloride 0.05% reducing chemosis and eyelid swelling in subjects with seasonal allergic conjunctivitis. Acta Ophthalmica Scandinavica 78, p.48-51,2000

Active substance: LEVOCABASTINE

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Document reference: 31136

Study title: Antihistaminikum als Nasenspray und Augentropfen in der allergologischen Praxis. Allergo Journal 7(5), p.275-277, 1998Antihistaminikum als Nasenspray und Augentropfen in der allergologischen Praxis. Allergo Journal 7(5), p.275-277, 1998

Active substance: LEVOCABASTINE

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Document reference: 31124

Study title: 56. Vazquez, Encarna-cion, Sem Med Mex 1963; 39: 179-181 56. Vazquez, Encarna-cion, Sem Med Mex 1963; 39: 179-181

Active substance: PYRVINIUM

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Document reference: 39585

Study title: 8. Beck et al., Am J Trop Med Hyg 1959; 8: 349-352 8. Beck et al., Am J Trop Med Hyg 1959; 8: 349-352

Active substance: PYRVINIUM

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Document reference: 39537

Study title: 9. Beck, J Am MEd Assoc 1964; 189: 511 9. Beck, J Am MEd Assoc 1964; 189: 511

Active substance: PYRVINIUM

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Document reference: 39538

Study title: Alexander et al., Tijdschr Geneeskd 1970; 26: 333-335 Alexander et al., Tijdschr Geneeskd 1970; 26: 333-335

Active substance: PYRVINIUM

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Document reference: 39532

Study title: A 3-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase IIIb Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL¿) Immediate-release Tablets in Daily Doses of 400 mg and 600 mg Compared with Placebo in the Treatment of Children and Adolescents with Bipolar I Mania

Active substance: QUETIAPINE

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Document reference: 45051

Study title: A Pilot Trial of Quetiapine (SEROQUEL¿) in Adolescents with the Spectrum of Psychotic Disorders (5077US/0018) DRAFT Clinical Study Report Synopsis

Active substance: QUETIAPINE

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Document reference: 45054

Study title: A Study to Characterize the Steady-State Pharmacokinetics, Safety and Tolerability of Quetiapine Fumarate (SEROQUEL¿) in Children and Adolescents with Selected Psychotic Disorders

Active substance: QUETIAPINE

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Document reference: 45055

Study title: Seroquel: "A NON-COMPARATIVE, OPEN-LABEL STUDY TO DEMONSTRATE THE EFFICACY AND TOLERABILITY OF QUETIAPINE IN ADOLESCENT PATIENTS WITH AN ACUTE SCHIZOPHRENIC EPISODE".

Active substance: QUETIAPINE

Study summary document link (including results): D1441C09025 Study Synopsis.pdf

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Document reference: 45052

Study title: Tolerability and Pharmacokinetics of Quetiapine (SEROQUEL¿) in Adolescents with Selected Psychotic Disorders

Active substance: QUETIAPINE

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Document reference: 45053

Study title: Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68)Acceptability and efficacy of intra-rectal Quinine alkaloids as a pre-transfer treatment of non-per os malaria in peripheral health care facilities in Mopti, Mali - Mahamadou A Thera et al. - 22/05/2007 (Malaria Journal, 6:68)

Active substance: QUININE

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Document reference: 45059

Study title: 54. Suzuki, Yamauchi, Jpn J Parasitol 1961; 10: 298-301 54. Suzuki, Yamauchi, Jpn J Parasitol 1961; 10: 298-301

Active substance: PYRVINIUM

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Document reference: 39583

Study title: 55. Turner, Johnson, J Pediatr 1962; 60: 243-251 55. Turner, Johnson, J Pediatr 1962; 60: 243-251

Active substance: PYRVINIUM

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Document reference: 39584

Study title: 50. Lindenschmidt Th, Aleksic D. Der paralytische Ileus in der Chirurgie. Internistische Praxis 1970;10(3):447-58.50. Lindenschmidt Th, Aleksic D. Der paralytische Ileus in der Chirurgie. Internistische Praxis 1970;10(3):447-58.

Active substance: PSEUDOEPHEDRINE/ PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 35142

Study title: Ettinger-L-J, Sinniah-D, Siegel-S-E, Fishman-L-S, Segall-H-D, Soni-D, Bennetts-G-A, Schultz-D-H, Raphael-D. Combination chemotherapy with cyclophosphamide, vincristine, procarbazine, and prednisone (COPP) in children with brain tumors. Journal of neuro-oncology, {J-Neurooncol}, 1985, vol. 3, no. 3, p. 263-9, ISSN: 0167-594X.Ettinger-L-J, Sinniah-D, Siegel-S-E, Fishman-L-S, Segall-H-D, Soni-D, Bennetts-G-A, Schultz-D-H, Raphael-D. Combination chemotherapy with cyclophosphamide, vincristine, procarbazine, and prednisone (COPP) in children with brain tumors. Journal of neuro-oncology, {J-Neurooncol}, 1985, vol. 3, no. 3, p. 263-9, ISSN: 0167-594X.

Active substance: PROCARBAZINE

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Document reference: 34709

Study title: Pakisch-B, Urban-C, Slavc-I, Poier-E, Stucklschweiger-G, Oberbauer-R, Mokry-M, Poschauko-J, Hammer-J, Leitner-H, Hackl-A. Abteilung fur Strahlentherapie, Radiologische Universitatsklinik, Augenbruggerplatz 9, A-8036 Graz, Austria. Hyperfractionated radiotherapy and polychemotherapy in brain stem tumors in children. Child's Nervous System {CHILD-S-NERV-SYST}, 1992, Vol/Iss/Pg. 8/4 (215-218), ISSN: 0256-7040.Pakisch-B, Urban-C, Slavc-I, Poier-E, Stucklschweiger-G, Oberbauer-R, Mokry-M, Poschauko-J, Hammer-J, Leitner-H, Hackl-A. Abteilung fur Strahlentherapie, Radiologische Universitatsklinik, Augenbruggerplatz 9, A-8036 Graz, Austria. Hyperfractionated radiotherapy and polychemotherapy in brain stem tumors in children. Child's Nervous System {CHILD-S-NERV-SYST}, ...

Active substance: PROCARBAZINE

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Document reference: 34801

Study title: Paolucci-G, Vecchi-V, Rosito-P, Paolucci-P, Burnelli-R, Pession-A, Mancini-A-F, Vivarelli-F. Clinica Pediatrica III, Universita degli Studi, Via Massaren11, 40138 Bologna, Italy. New perspectives in pediatric oncology. Rivista Italiana di Pediatria {RIV-ITAL-PEDIATR}, 1991, Vol/Iss/Pg. 17/4 (475-487), ISSN: 0392-5161.Paolucci-G, Vecchi-V, Rosito-P, Paolucci-P, Burnelli-R, Pession-A, Mancini-A-F, Vivarelli-F. Clinica Pediatrica III, Universita degli Studi, Via Massaren11, 40138 Bologna, Italy. New perspectives in pediatric oncology. Rivista Italiana di Pediatria {RIV-ITAL-PEDIATR}, 1991, Vol/Iss/Pg. 17/4 (475-487), ISSN: 0392-5161.

Active substance: PROCARBAZINE

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Document reference: 34802

Study title: Papadakis-V, Vlachopapadopoulou-E, Van-Syckle-K, Ganshaw-L, Kalmanti- M, Tan-C, Sklar-C. Department of Pediatrics, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. Gonadal function in young patients successfully treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, May 1999, vol. 32, no. 5, p. 366-72, ISSN: 0098-1532.Papadakis-V, Vlachopapadopoulou-E, Van-Syckle-K, Ganshaw-L, Kalmanti- M, Tan-C, Sklar-C. Department of Pediatrics, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. Gonadal function in young patients successfully treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, May 1999, vol. 32, no. 5, p. 366-72, ISSN: 0098-1532.

Active substance: PROCARBAZINE

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Document reference: 34803

Study title: Pendergrass-T-W, Milstein-J-M, Geyer-J-R, Mulne-A-F, Kosnik-E-J, Morris-J-D, Heideman-R-L, Ruymann-F-B, Stuntz-J-T, Bleyer-W-A. Eight drugs in one day chemotherapy for brain tumors: experience in 107 children and rationale for preradiation chemotherapy. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Aug 1987, vol. 5, no. 8, p. 1221-31, ISSN: 0732-183X.Pendergrass-T-W, Milstein-J-M, Geyer-J-R, Mulne-A-F, Kosnik-E-J, Morris-J-D, Heideman-R-L, Ruymann-F-B, Stuntz-J-T, Bleyer-W-A. Eight drugs in one day chemotherapy for brain tumors: experience in 107 children and rationale for preradiation chemotherapy. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J...

Active substance: PROCARBAZINE

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Document reference: 34804

Study title: Clinical evaluation of R50547 eye drops on allergic conjunctivitis and vernal conjunctivitis. A sungle masked comparative study with Sodium Cromoglicate eye drops

Active substance: LEVOCABASTINE

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Document reference: 31066

Study title: Clinical laboratory data related to the safety of levocabastine eye drops and nasal spray. An evaluation based on 27 studies in 655 subjects (6-81 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD45257_Interventional_Levocabastine.xls

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Document reference: 31071

Study title: Sackmann-Muriel-F, Zubizarreta-P, Gallo-G, Scopinaro-M, Alderete-D, Alfaro-E, Casak-S, Chantada-G, Felice-M-S, Quinteros-R. Hematology Department, Hospital de Pediatria Prof. Dr. Juan P Garrahan, Buenos Aires, Argentina. Hodgkin disease in children: results of a prospective randomized trial in a single institution in Argentina. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Dec 1997, vol. 29, no. 6, p. 544-52, ISSN: 0098-1532.Sackmann-Muriel-F, Zubizarreta-P, Gallo-G, Scopinaro-M, Alderete-D, Alfaro-E, Casak-S, Chantada-G, Felice-M-S, Quinteros-R. Hematology Department, Hospital de Pediatria Prof. Dr. Juan P Garrahan, Buenos Aires, Argentina. Hodgkin disease in children: results of a prospective randomized trial in a single institution in Argentina....

Active substance: PROCARBAZINE

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Document reference: 34820

Study title: Sackmann-Muriel-F, Diez-B, Schvartzman-E, et-al. Oncology Department, Hospital de Ninos, 1425 Buenos Aires, Argentina. Comparison of two consecutive trials for treatment of childhood non-Hodgkin's lymphoma. Cancer {CANCER}, 1984, Vol/Iss/Pg. 54/12 (2863-2868).Sackmann-Muriel-F, Diez-B, Schvartzman-E, et-al. Oncology Department, Hospital de Ninos, 1425 Buenos Aires, Argentina. Comparison of two consecutive trials for treatment of childhood non-Hodgkin's lymphoma. Cancer {CANCER}, 1984, Vol/Iss/Pg. 54/12 (2863-2868).

Active substance: PROCARBAZINE

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Document reference: 34821

Study title: Sackmann-Muriel-F, Maschio-M, Santarelli-M-T, Pavlovsky-S. Results of therapy for Hodgkin's disease in childhood. The Argentine Group for Treatment of Acute Leukemia. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 271-5, ISSN: 0927-3042.Sackmann-Muriel-F, Maschio-M, Santarelli-M-T, Pavlovsky-S. Results of therapy for Hodgkin's disease in childhood. The Argentine Group for Treatment of Acute Leukemia. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 271-5, ISSN: 0927-3042.

Active substance: PROCARBAZINE

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Document reference: 34822

Study title: Sackmann-Muriel-F. Unid. Hematol., Hosp. Ninos, Buenos Aires, Argentina. Recent advances in treatment of children with non-Hodgkin lymphoma. Revista del Hospital de Ninos {REV-HOSP-NINOS}, 1978, Vol/Iss/Pg. 20 /80 (156-161).Sackmann-Muriel-F. Unid. Hematol., Hosp. Ninos, Buenos Aires, Argentina. Recent advances in treatment of children with non-Hodgkin lymphoma. Revista del Hospital de Ninos {REV-HOSP-NINOS}, 1978, Vol/Iss/Pg. 20 /80 (156-161).

Active substance: PROCARBAZINE

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Document reference: 34823

Study title: Green-D-M, Brecher-M-L, Lindsay-A-N, et-al. Dept. Ped., Roswell Park Mem. Inst., Buffalo, N.Y. 14263, United States. Gonadal function in pediatric patients following treatment for Hodgkin disease. Medical and Pediatric Oncology {MED-PEDIATR-ONCOL}, 1981, Vol/Iss/Pg.9/3 (235-244).Green-D-M, Brecher-M-L, Lindsay-A-N, et-al. Dept. Ped., Roswell Park Mem. Inst., Buffalo, N.Y. 14263, United States. Gonadal function in pediatric patients following treatment for Hodgkin disease. Medical and Pediatric Oncology {MED-PEDIATR-ONCOL}, 1981, Vol/Iss/Pg.9/3 (235-244).

Active substance: PROCARBAZINE

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Document reference: 34726

Study title: Grill-J, Le-Deley-M-C, Gambarelli-D, Raquin-M-A, Couanet-D, Pierre- Kahn-A, Habrand-J-L, Doz-F, Frappaz-D, Gentet-J-C, Edan-C, Chastagner-P, Kalifa-C. Department of Pediatrics, Institut Gustave Roussy, Villejuif, France. Postoperative chemotherapy without irradiation for ependymoma in children under 5 years of age: a multicenter trial of the French Society of Pediatric Oncology. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, 1 Mar 2001, vol. 19, no. 5, p. 1288-96, ISSN: 0732-183X.Grill-J, Le-Deley-M-C, Gambarelli-D, Raquin-M-A, Couanet-D, Pierre- Kahn-A, Habrand-J-L, Doz-F, Frappaz-D, Gentet-J-C, Edan-C, Chastagner-P, Kalifa-C. Department of Pediatrics, Institut Gustave Roussy, ...

Active substance: PROCARBAZINE

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Document reference: 34727

Study title: Gulati-S-C, Vega-R, Gee-T, et-al. Department of Medicine and Pediatrics, Memorial Sloan-Kettering Cancer Center, Cornell University Medical College, New York, NY 10021, United States. Growth and development of children born to patients after cancer therapy. Cancer Investigation {CANCER-INVEST}, 1986, Vol/Iss/Pg. 4/3 (197-205).Gulati-S-C, Vega-R, Gee-T, et-al. Department of Medicine and Pediatrics, Memorial Sloan-Kettering Cancer Center, Cornell University Medical College, New York, NY 10021, United States. Growth and development of children born to patients after cancer therapy. Cancer Investigation {CANCER-INVEST}, 1986, Vol/Iss/Pg. 4/3 (197-205).

Active substance: PROCARBAZINE

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Document reference: 34728

Study title: Gutjahr-P. Universitats-Kinderklinik, 6500 Mainz 1, Germany. Second neoplasms following tumor and leukaemia therapy in childhood: Report on 64 cases. Deutsche Medizinische Wochenschrift {DTSCH-MED-WOCHENSCHR}, 1985, Vol /Iss/Pg. 110/42 (1599-1606).Gutjahr-P. Universitats-Kinderklinik, 6500 Mainz 1, Germany. Second neoplasms following tumor and leukaemia therapy in childhood: Report on 64 cases. Deutsche Medizinische Wochenschrift {DTSCH-MED-WOCHENSCHR}, 1985, Vol /Iss/Pg. 110/42 (1599-1606).

Active substance: PROCARBAZINE

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Document reference: 34729

Study title: Haddad-S-F, Menezes-A-H, Bell-W-E, Godersky-J-C, Afifi-A-K, Bale-J-F. Division of Neurosurgery, Department of Surgery, The University of Iowa, Iowa City, IA 52242, United States. Brain tumors occurring before 1 year of age: A retrospective review of 22 cases in an 11-year period (1977-1987). Neurosurgery {NEUROSURGERY}, 1991, Vol/Iss/Pg. 29/1 (8-13), ISSN: 0148-396X.Haddad-S-F, Menezes-A-H, Bell-W-E, Godersky-J-C, Afifi-A-K, Bale-J-F. Division of Neurosurgery, Department of Surgery, The University of Iowa, Iowa City, IA 52242, United States. Brain tumors occurring before 1 year of age: A retrospective review of 22 cases in an 11-year period (1977-1987). Neurosurgery {NEUROSURGERY}, 1991, Vol/Iss/Pg. 29/1 (8-13), ISSN: 0148-396X.

Active substance: PROCARBAZINE

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Document reference: 34730

Study title: Borowitz SM, et all. Treatment of childhood constipation by primary care physicians: efficacy and predictors of outcome. Pediatrics. 2005 Apr;115(4):873-7.

Active substance: Rabarbar + senna

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Document reference: 40148

Study title: Spiller HA, et all. Skin breakdown and blisters from senna-containing laxatives in young children. Ann Pharmacother. 2003 May;37(5):636-9.

Active substance: Rabarbar + senna

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Document reference: 40149

Study title: Jenkin-D, Doyle-J, Berry-M, Blanchette-V, Chan-H, Doherty-M, Freedman-M, Greenberg-M, Panzarella-T, Saunders-F, et al. Division of Hematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada. Hodgkin's disease in children: treatment with MOPP and low-dose, extended field irradiation without laparotomy. Late results and toxicity. Medical and pediatric oncology, {Med-Pediatr-Oncol}, 1990, vol. 18, no. 4, p. 265-72, ISSN: 0098-1532.Jenkin-D, Doyle-J, Berry-M, Blanchette-V, Chan-H, Doherty-M, Freedman-M, Greenberg-M, Panzarella-T, Saunders-F, et al. Division of Hematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada. Hodgkin's disease in children: treatment with MOPP and low-dose, extended field irradiation without la...

Active substance: PROCARBAZINE

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Document reference: 34748

Study title: Jenkin-D, Chan-H, Freedman-M, Greenberg-M, Gribbin-M, McClure-P, Saunders-F, Sonley-M. Hodgkin's disease in children: treatment results with MOPP and low-dose, extended-field irradiation. Cancer treatment reports, {Cancer-Treat-Rep}, Apr 1982, vol. 66, no. 4, p. 949-59, ISSN: 0361-5960.Jenkin-D, Chan-H, Freedman-M, Greenberg-M, Gribbin-M, McClure-P, Saunders-F, Sonley-M. Hodgkin's disease in children: treatment results with MOPP and low-dose, extended-field irradiation. Cancer treatment reports, {Cancer-Treat-Rep}, Apr 1982, vol. 66, no. 4, p. 949-59, ISSN: 0361-5960.

Active substance: PROCARBAZINE

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Document reference: 34749

Study title: Jenkin-D, Doyle-J. Pediatric Hodgkin's disease. Later results and toxicity--the Toronto experience. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 247-56, ISSN: 0927-3042.Jenkin-D, Doyle-J. Pediatric Hodgkin's disease. Later results and toxicity--the Toronto experience. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 247-56, ISSN: 0927-3042.

Active substance: PROCARBAZINE

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Document reference: 34750

Study title: Jenkin-D, Freedman-M, McClure-P, Peters-V, Saunders-F, Sonley-M. Hodgkin's disease in children: treatment with low dose radiation and MOPP without staging laparotomy: a preliminary report. Cancer, {Cancer}, Jul 1979, vol. 44, no. 1, p. 80-6, ISSN: 0008-543X.Jenkin-D, Freedman-M, McClure-P, Peters-V, Saunders-F, Sonley-M. Hodgkin's disease in children: treatment with low dose radiation and MOPP without staging laparotomy: a preliminary report. Cancer, {Cancer}, Jul 1979, vol. 44, no. 1, p. 80-6, ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34751

Study title: Perrone-L, Sinisi-A-A, Di-Tullio-M-T, Casale-F, Indolfi-P, Manzo-T, Coppola-G, Bellastella-A, Faggiano-M. Department of Pediatrics, University of Naples, Naples, Italy. Endocrine function in subjects treated for childhood Hodgkin's disease. Journal of Pediatric Endocrinology {J-PEDIATR-ENDOCRINOL}, 1989, Vol /Iss/Pg. 3/3 (175-179), ISSN: 0334-018X.Perrone-L, Sinisi-A-A, Di-Tullio-M-T, Casale-F, Indolfi-P, Manzo-T, Coppola-G, Bellastella-A, Faggiano-M. Department of Pediatrics, University of Naples, Naples, Italy. Endocrine function in subjects treated for childhood Hodgkin's disease. Journal of Pediatric Endocrinology {J-PEDIATR-ENDOCRINOL}, 1989, Vol /Iss/Pg. 3/3 (175-179), ISSN: 0334-018X.

Active substance: PROCARBAZINE

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Document reference: 34805

Study title: Nad R_1975Nad R_1975

Active substance: PROMETHAZINE

Study summary document link (including results): Bayer Pharma_Promethazine_Nad R_1975_publication.pdf

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Document reference: 35009

Study title: Promethazine in general anaesthesia - Loyn W.G.G.- (Brit. J. Anaesth. 1956, 28, 126.) - Publication in PHENERGAN therapeutic summary 6th edition May & Baker Ltd.1976 -

Active substance: PROMETHAZINE

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Document reference: 35041

Study title: Publication 8 in PHENERGAN 25mg tablet, 0.1% syrup, 2,5% sol for injection. Clinical documentation. June 1988. Anaesthesia in children. -Anglade G.- (Maroc médical (1970), 50, 545-561.)

Active substance: PROMETHAZINE

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Document reference: 35043

Study title: Compassionate use of SR29142 for prevention or treatment of hyperuricemia at multiple centers in Europe, Australasia, and Asia (LTS3256)

Active substance: rasburicase

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Document reference: 47280

Study title: Compassionate use of SR29142 for prevention or treatment of hyperuricemia at multiple centers in the United States and Canada (LTS3257)

Active substance: rasburicase

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Document reference: 47281

Study title: Lo Iacono F, Agnello D, Malizia R, Balsamo M. Aggiornamento Pediatrico. 1982; 33(1):85-90. Methisoprinol in the treatment of certain diseases of the upper respiratory tract in children .Lo Iacono F, Agnello D, Malizia R, Balsamo M. Aggiornamento Pediatrico. 1982; 33(1):85-90. Methisoprinol in the treatment of certain diseases of the upper respiratory tract in children .

Active substance: INOSINE

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Document reference: 30142

Study title: Lowy M, Ledoux-Corbusier M, Achten G, Wybran J. . J Am Acad Dermatol. Jan 1985;12(1 Pt 1):78-84. Clinical and immunologic response to Isoprinosine in alopecia areata and alopecia universalis: association with autoantibodiesLowy M, Ledoux-Corbusier M, Achten G, Wybran J. . J Am Acad Dermatol. Jan 1985;12(1 Pt 1):78-84. Clinical and immunologic response to Isoprinosine in alopecia areata and alopecia universalis: association with autoantibodies

Active substance: INOSINE

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Document reference: 30144

Study title: A randomized double-blind study evaluating the safety, tolerability and efficacy of SMOF 20% compared to Intralipid in premature infants

Active substance: REFINED SOYBEAN OIL; MEDIUM CHAINED TRIGLYCERIDES; REFINED OLIVE OIL; FISH OIL

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Document reference: 40152

Study title: A randomized double-blind study of safety and efficacy of SMOF 20% vs. Intralipid 20% in infants and children requiring long-term parenteral nutrition

Active substance: REFINED SOYBEAN OIL; MEDIUM CHAINED TRIGLYCERIDES; REFINED OLIVE OIL; FISH OIL

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Document reference: 40151

Study title: Schaison-G-S. Service d'Hematologie Pediatrique, Hopital Saint Louis, 1, Avenue Claude Vellefaux,75475 Parix Cedex 10, France. Current treatment of Hodgkin's disease in children. Pathologie Biologie {PATHOL-BIOL}, 1994, Vol/Iss/Pg. 42/10 (1026-1027), ISSN: 0369-8114.Schaison-G-S. Service d'Hematologie Pediatrique, Hopital Saint Louis, 1, Avenue Claude Vellefaux,75475 Parix Cedex 10, France. Current treatment of Hodgkin's disease in children. Pathologie Biologie {PATHOL-BIOL}, 1994, Vol/Iss/Pg. 42/10 (1026-1027), ISSN: 0369-8114.

Active substance: PROCARBAZINE

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Document reference: 34824

Study title: Schapira-D-V, Chudley-A-E. Successful pregnancy following continuous treatment with combination chemotherapy before conception and throughout pregnancy. Cancer, {Cancer}, 1 Sep 1984, vol. 54, no. 5, p. 800-3, ISSN: 0008-543X.Schapira-D-V, Chudley-A-E. Successful pregnancy following continuous treatment with combination chemotherapy before conception and throughout pregnancy. Cancer, {Cancer}, 1 Sep 1984, vol. 54, no. 5, p. 800-3, ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34825

Study title: Schellong-G, Bramswig-J-H, Hornig-Franz-I, Schwarze-E-W, Potter-R, Wannenmacher-M. Universitat Kinderklinik, Albert Schweitzer Str. 33, D-48149 Munster, Germany. Hodgkin's disease in children: Combined modality treatment for stages IA, IB, and IIA. Annals of Oncology {ANN-ONCOL}, 1994, Vol/Iss/Pg. 5/SUPPL. 2 (113-115), ISSN: 0923-7534.Schellong-G, Bramswig-J-H, Hornig-Franz-I, Schwarze-E-W, Potter-R, Wannenmacher-M. Universitat Kinderklinik, Albert Schweitzer Str. 33, D-48149 Munster, Germany. Hodgkin's disease in children: Combined modality treatment for stages IA, IB, and IIA. Annals of Oncology {ANN-ONCOL}, 1994, Vol/Iss/Pg. 5/SUPPL. 2 (113-115), ISSN: 0923-7534.

Active substance: PROCARBAZINE

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Document reference: 34827

Study title: Pouard P: Review of Efficacy Parameters. Ann Thorac Surg 1998; 65: S40-4 Pouard P: Review of Efficacy Parameters. Ann Thorac Surg 1998; 65: S40-4

Active substance: PROTAMINE

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Document reference: 35085

Study title: Donaubauer J et al. Re-assessment of growth hormone secretion in young adult patients with childhood-onset growth hormone deficiency. Clin Endocrinol. April 1, 2003, 456-63Donaubauer J et al. Re-assessment of growth hormone secretion in young adult patients with childhood-onset growth hormone deficiency. Clin Endocrinol. April 1, 2003, 456-63

Active substance: PYRIDOSTIGMINE

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Document reference: 35179

Study title: Eiermann B, Sommer N, Winne D, Schumm F, Maier U, Breyer-Pfaff U. Renal clearance of pyridostigmine in myasthenic patients and volunteers under the influence of ranitidine and pirenzepine. Xenobiotica. 1993 Nov;23(11):1263-75.Eiermann B, Sommer N, Winne D, Schumm F, Maier U, Breyer-Pfaff U. Renal clearance of pyridostigmine in myasthenic patients and volunteers under the influence of ranitidine and pirenzepine. Xenobiotica. 1993 Nov;23(11):1263-75.

Active substance: PYRIDOSTIGMINE

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Document reference: 35222

Study title: Ghigo E et al. Arginine but not pyridostigmine, a cholinesterase inhibitor, enhances the GHRH-induced GH rise in patients with anorexia nervosa. Biol Psychiatry. 1994 Nov 15;36(10):689-95Ghigo E et al. Arginine but not pyridostigmine, a cholinesterase inhibitor, enhances the GHRH-induced GH rise in patients with anorexia nervosa. Biol Psychiatry. 1994 Nov 15;36(10):689-95

Active substance: PYRIDOSTIGMINE

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Document reference: 35201

Study title: An open label, multicenter, international pilot study evaluating the efficacy and safety of Pegylated interferon alfa-2a in combination with ribavirin in pediatric and teenage patients with CHC virus infection (CHIPS) [100 children adolescents aged 6 – 18 years with CHC (all genotypes)]

Active substance: RIBAVIRIN

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Document reference: 35302

Study title: Pegylated Interferon with and without ribavirin for children with HCV (PEDS – C) [112 children and adolescents aged 5-18 years with CHC (all genotypes) that are able to swallow tablets]

Active substance: RIBAVIRIN

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Document reference: 35303

Study title: Donati F et al. Neostigmine, pyridostigmine and edrophonium as antagonists of deep pancuronium blockade. Can J Anaesth. 1987 Nov;34(6):589-93 Donati F et al. Neostigmine, pyridostigmine and edrophonium as antagonists of deep pancuronium blockade. Can J Anaesth. 1987 Nov;34(6):589-93

Active substance: PYRIDOSTIGMINE

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Document reference: 35218

Study title: EFFICACY AND SAFETY OF RIFABUTIN (AMSAMYCIN LM 427) IN PATIENTS WITH NEWLY DIAGNOSED PULMONARY TUBERCULOSIS. FCE REPORT LM 427/715I NOVEMBER 1990 AGE RANGE 15 -65 YEARSPuri H C et al. Severe hypertension in children with renal

Active substance: RIFABUTIN

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Document reference: 35370

Study title: Abdallah et al., Egypt Med Assoc 1965; 48: 396-398 Abdallah et al., Egypt Med Assoc 1965; 48: 396-398

Active substance: PYRVINIUM

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Document reference: 39530

Study title: Luna Solano JL, Silva Baeza JC.. Ed Medico [Mexico] April 1973;23(1):57- 58,61 Methisporinol in some common infectious viraliseasesLuna Solano JL, Silva Baeza JC.. Ed Medico [Mexico] April 1973;23(1):57- 58,61 Methisporinol in some common infectious viraliseases

Active substance: INOSINE

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Document reference: 30145

Study title: Malfroot A, Wybran J, Duchateau J, Zissus G. (1981). Pediatric Research. January-December,15:1180. Abstract 11. Successful treatment of a systemic CMV infection with IsoprinosineMalfroot A, Wybran J, Duchateau J, Zissus G. (1981). Pediatric Research. January-December,15:1180. Abstract 11. Successful treatment of a systemic CMV infection with Isoprinosine

Active substance: INOSINE

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Document reference: 30146

Study title: Moroni M, Lazzarin A, Galli M.. Presented at the 15th National Congress of the Italian Society of Clinical Allergology and Immunology. October 30-November 1, 1981; Rome, Italy; 73-84. Immunoterapia delle infezioni chroniche e recidivanti. Moroni M, Lazzarin A, Galli M.. Presented at the 15th National Congress of the Italian Society of Clinical Allergology and Immunology. October 30-November 1, 1981; Rome, Italy; 73-84. Immunoterapia delle infezioni chroniche e recidivanti.

Active substance: INOSINE

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Document reference: 30149

Study title: Nunan B, Tonelli E. Jomal de pediatria [Brazil] Nov-Dec 1972;37(11-12):325-328. Therapy of certain acute viral diseases with Isoprinosine Nunan B, Tonelli E. Jomal de pediatria [Brazil] Nov-Dec 1972;37(11-12):325-328. Therapy of certain acute viral diseases with Isoprinosine

Active substance: INOSINE

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Document reference: 30152

Study title: Cytogenetic analysis of peripheral blood lymphocytes after arteriography (exposure to x-rays and contrast medium)Popova L 2005. Radio/ Oncol 2005; 39(2): 153-8.

Active substance: IODIXANOL

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

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Document reference: 48197

Study title: Bedavanija A, Singalavanija A, Kombara M.: Solcoseryl Eye Gel: An Effective Adjunct in the Treatment of Chronic Ulcers of the Cornea. J.med. Assoc. Thailand 68, 415-418 (1985). Bedavanija A, Singalavanija A, Kombara M.: Solcoseryl Eye Gel: An Effective Adjunct in the Treatment of Chronic Ulcers of the Cornea. J.med. Assoc. Thailand 68, 415-418 (1985).

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35104

Study title: Gerkowicz K.; Toczolowski J.; Hamerski W.; Jedrzejewski D.; Gerkowicz M.: Evaluation of the effectiveness of Solcoseryl Eye-Gel in the treatment of some corneal diseases. Klin. Oczna 87: 21-22, 1985. Gerkowicz K.; Toczolowski J.; Hamerski W.; Jedrzejewski D.; Gerkowicz M.: Evaluation of the effectiveness of Solcoseryl Eye-Gel in the treatment of some corneal diseases. Klin. Oczna 87: 21-22, 1985.

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35106

Study title: Krasny J.; Krejci L.; Rezek P.: Solcoseryl eye gel in pediatric ophthalmology practice. Ceskol. Oftalm. 42, 1986, No. 6, 448-453. Krasny J.; Krejci L.; Rezek P.: Solcoseryl eye gel in pediatric ophthalmology practice. Ceskol. Oftalm. 42, 1986, No. 6, 448-453.

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35102

Active substance: QUININE

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Document reference: 45064

Study title: EFFICACY AND SAFETY OF RIFABUTIN (AMSAMYCIN LM 427) IN PATIENTS WITH NEWLY DIAGNOSED PULMONARY TUBERCULOSIS. FCE REPORT LM 427/706I OCTOBER 1990 D93 AGE RANGE 15- 62 YEARS

Active substance: RIFABUTIN

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Document reference: 35372

Study title: RIFABUTIN FOR THE TREATMENT OF NEWLY DIAGNOSIED PULMONARYTUBERCULOIS: A MULTINATIONAL, RANDOMIZED COMPARATIVE STUDY VERUS RIFAMPICIN LUIS JULIO GONZALES-MONTANER AGE RANGE 15-67

Active substance: RIFABUTIN

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Document reference: 35375

Study title: SAFETY OF RIFABUTIN (AMSAMYCIN, LM 427) IN PATIENTS WITH NEWLY DIAGNOSED PULMONARY TUBERCULOSIS. FCE REPORT LM 427/708I OCTOBER 1990 AGE RANGE: 15-68 YRS

Active substance: RIFABUTIN

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Document reference: 35371

Study title: THE COMPASSIONATE USE OF RIFABUTIN FOR THE TREATMENT OF MYCOBACTERIU AVIUM COMPLEX DISEASE IN HIV POSITIVE PATIENTS. FCE REPORTS LM 427/720I JANUARY 1991 AGE RANGE 5 -61

Active substance: RIFABUTIN

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Document reference: 35373

Study title: Clinical Certificate for MA Renewal in Slovenia - Verdoncq B. - 10 July 2007 (0703-CC-RIF+ISO+PYR-SLOVENIA-BV-10.07.07)

Active substance: RIFAMPICIN/ISONIAZID/PYRAZINAMIDE

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Document reference: 35379

Study title: Referenced in Rifater Registration Dossier - Clinical Documentation - Update April 1998 : The use of fixed-dose combinations in antituberculosis chemotherapy. Rationale for their application in daily, intermittant and pediatric regimens. - Acoccella G. - 1990 (Bulletin of the Int. Union Against Tuberculosis and Lung Disease, 65, 2-3: 77-83)

Active substance: RIFAMPICIN/ISONIAZID/PYRAZINAMIDE

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Document reference: 35380

Study title: Spectrophotofluorometric assay for Isoniazid and Acetyl Isoniazid in Plasma adapted tp pediatric studies - Clin. Chem., 23(4), 745 - Olson W.A. Et al (1977) Spectrophotofluorometric assay for Isoniazid and Acetyl Isoniazid in Plasma adapted tp pediatric studies - Clin. Chem., 23(4), 745 - Olson W.A. Et al (1977)

Active substance: RIFAMPICIN/ISONIAZID/PYRAZINAMIDE

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Document reference: 45141

Study title: Matus-Ridley-M, Nicosia-S-V, Meadows-A-T. Children's Cancer Research Center, Children's Hospital of Philadelphia, Philadelphia, PA 19104, United States. Gonadal effects of cancer therapy in boys. Cancer {CANCER}, 1985, Vol/Iss/Pg. 55/10 (2353-2363).Matus-Ridley-M, Nicosia-S-V, Meadows-A-T. Children's Cancer Research Center, Children's Hospital of Philadelphia, Philadelphia, PA 19104, United States. Gonadal effects of cancer therapy in boys. Cancer {CANCER}, 1985, Vol/Iss/Pg. 55/10 (2353-2363).

Active substance: PROCARBAZINE

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Document reference: 34782

Study title: Mauch-P-M, Weinstein-H, Botnick-L, Belli-J, Cassady-J-R. An evaluation of long-term survival and treatment complications in children with Hodgkin's disease. Cancer, {Cancer}, 1 Mar 1983, vol. 51, no. 5, p. 925-32, ISSN: 0008-543X.Mauch-P-M, Weinstein-H, Botnick-L, Belli-J, Cassady-J-R. An evaluation of long-term survival and treatment complications in children with Hodgkin's disease. Cancer, {Cancer}, 1 Mar 1983, vol. 51, no. 5, p. 925-32, ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34783

Study title: 13. Brus et al., Polski Tygodnik Lekarski 1976; 31: 195-197 13. Brus et al., Polski Tygodnik Lekarski 1976; 31: 195-197

Active substance: PYRVINIUM

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Document reference: 39542

Study title: 14. Bumbalo et al., Am J Trop Med Hyg 1958; 7: 212-214 14. Bumbalo et al., Am J Trop Med Hyg 1958; 7: 212-214

Active substance: PYRVINIUM

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Document reference: 39543

Study title: Fernandez-Bouzas-A, Ramirez-Jimenez-H, Vazquez-Zamudio-J, Alonso- Vanegas-M, Mendizabal-Guerra-R. Department of Neuroradiology, Hospital 20 de Noviembre, ISSSTE, Mexico City. Brain calcifications and dementia in children treated with radiotherapy and intrathecal methotrexate. Journal of neurosurgical sciences, {J-Neurosurg-Sci}, Oct-Dec 1992, vol. 36, no. 4, p. 211-4, ISSN: 0390-5616.Fernandez-Bouzas-A, Ramirez-Jimenez-H, Vazquez-Zamudio-J, Alonso- Vanegas-M, Mendizabal-Guerra-R. Department of Neuroradiology, Hospital 20 de Noviembre, ISSSTE, Mexico City. Brain calcifications and dementia in children treated with radiotherapy and intrathecal methotrexate. Journal of neurosurgical sciences, {J-Neurosurg-Sci}, Oct-Dec 1992, vol. 36, no. 4, p...

Active substance: PROCARBAZINE

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Document reference: 34711

Study title: Fink-F-M, Ausserer-B, Dengg-K, Pallua-A-K, Twerdy-K, Frommhold-H, Berger-H. Department of Pediatrics, University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria. Long term remission of intrinsic brainstem gliomas: The case reports of two children. Wiener Klinische Wochenschrift {WIEN-KLIN-WOCHENSCHR}, 1991, Vol/Iss /Pg. 103/13 (392-395), ISSN: 0043-5325.Fink-F-M, Ausserer-B, Dengg-K, Pallua-A-K, Twerdy-K, Frommhold-H, Berger-H. Department of Pediatrics, University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria. Long term remission of intrinsic brainstem gliomas: The case reports of two children. Wiener Klinische Wochenschrift {WIEN-KLIN-WOCHENSCHR}, 1991, Vol/Iss /Pg. 103/13 (392-395), ISSN: 0043-5325.

Active substance: PROCARBAZINE

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Document reference: 34712

Study title: Flamant-F, Rodary-C, Voute-P-A, Otten-J. Pediatric Department, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. Primary chemotherapy in the treatment of rhabdomyosarcoma in children: Trial of the international society of pediatric oncology (SIOP) preliminary results. Radiotherapy and Oncology {RADIOTHER-ONCOL}, 1985, Vol/Iss/Pg. 3/3 (227-236).Flamant-F, Rodary-C, Voute-P-A, Otten-J. Pediatric Department, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. Primary chemotherapy in the treatment of rhabdomyosarcoma in children: Trial of the international society of pediatric oncology (SIOP) preliminary results. Radiotherapy and Oncology {RADIOTHER-ONCOL}, 1985, Vol/Iss/Pg. 3/3 (227-236).

Active substance: PROCARBAZINE

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Document reference: 34713

Study title: 10. Biguet et al., Presse Med 1959; 67: 1739-1740 10. Biguet et al., Presse Med 1959; 67: 1739-1740

Active substance: PYRVINIUM

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Document reference: 39539

Study title: : Eur Radiol. 1997;7 Suppl 4:S123-6 Iopentol (Imagopaque 350) compared with iohexol (Omnipaque 350) in paediatric cardioangiography. A clinical trial assessing adverse events, ECG, blood pressure and diagnostic information. Kunnen M, De Greef D, Skinningsrud K : Eur Radiol. 1997;7 Suppl 4:S123-6 Iopentol (Imagopaque 350) compared with iohexol (Omnipaque 350) in paediatric cardioangiography. A clinical trial assessing adverse events, ECG, blood pressure and diagnostic information. Kunnen M, De Greef D, Skinningsrud K

Active substance: IODIXANOL

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Document reference: 30356

Study title: Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG. Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG.

Active substance: IODIXANOL

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Document reference: 30352

Study title: Experiences with iohexol and iodixanol during cardioangiography in an unselected patient population.Int J Cardiol. 2001 Sep-Oct;80(2-3):143-51. Flinck A, Gottfridsson B.

Active substance: IODIXANOL

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Document reference: 30347

Study title: Frequency, Management, and Outcome of Extravasation of Nonionic Iodinated Contrast Medium in 69 657 Intravenous InjectionsWang CL 2007. Radiology: Volume 243: Number 1-April 2007

Active substance: IODIXANOL

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

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Document reference: 48198

Study title: Lange-B, Littman-P. Div. Oncol., Hosp. Univ. Pennsylvania, Philadelphia, PA 19104, United States. Management of Hodgkin's disease in children and adolescents. Cancer {CANCER}, 1983, Vol/Iss/Pg. 51/8 (1371-1377).Lange-B, Littman-P. Div. Oncol., Hosp. Univ. Pennsylvania, Philadelphia, PA 19104, United States. Management of Hodgkin's disease in children and adolescents. Cancer {CANCER}, 1983, Vol/Iss/Pg. 51/8 (1371-1377).

Active substance: PROCARBAZINE

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Document reference: 34768

Active substance: QUININE

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Document reference: 45069

Active substance: QUININE

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Document reference: 45074

Active substance: QUININE

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Document reference: 45079

Study title: McClain-K-L, Heise-R, Day-D-L, Lee-C-K, Woods-W-G, Aeppli-D. Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis. Hodgkin's disease in children: correlation of clinical characteristics, staging procedures, and treatment at the University of Minnesota. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Summer 1990, vol. 12, no. 2, p. 147-54, 29 refs, ISSN: 0192-8562.McClain-K-L, Heise-R, Day-D-L, Lee-C-K, Woods-W-G, Aeppli-D. Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis. Hodgkin's disease in children: correlation of clinical characteristics, staging procedures, and treatment at the University of Minnesota. The American journal of pediatric hematology/o...

Active substance: PROCARBAZINE

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Document reference: 34785

Study title: McClain-K, Heise-R, Day-D-L, Lee-C-K-K, Woods-G, Aeppli-D. Department of Pediatrics, The University of Minnesota School of Medicine, Minneapolis, MN, United States. Hodgekin's disease in children: Correlation of clinical characteristics, staging procedures, and treatment at the university of Minnesota. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR-HEMATOL-ONCOL}, 1990, Vol/Iss/Pg. 12/2 (147-154), ISSN: 0192-8562.McClain-K, Heise-R, Day-D-L, Lee-C-K-K, Woods-G, Aeppli-D. Department of Pediatrics, The University of Minnesota School of Medicine, Minneapolis, MN, United States. Hodgekin's disease in children: Correlation of clinical characteristics, staging procedures, and treatment at the university of Minnesota. American Jo...

Active substance: PROCARBAZINE

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Document reference: 34784

Study title: Meadows-A-T, Silber-J. Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, United States. Delayed consequences of therapy for childhood cancer. Ca-A Cancer Journal for Clinicians {CA-CANCER-J-CLIN}, 1985, Vol/Iss /Pg. 35/5 (271-286).Meadows-A-T, Silber-J. Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, United States. Delayed consequences of therapy for childhood cancer. Ca-A Cancer Journal for Clinicians {CA-CANCER-J-CLIN}, 1985, Vol/Iss /Pg. 35/5 (271-286).

Active substance: PROCARBAZINE

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Document reference: 34786

Study title: Morgenfeld-M-C, Pavlovsky-A, Suarez-A, Somoza-N, Pavlovsky-S, Palau- M, Barros-C-A. Combined cyclophosphamide vincristine, procarbazine, and prednisone (COPP) therapy of malignant lymphoma. Evaluation of 190 patients. Cancer, {Cancer}, Oct 1975, vol. 36, no. 4, p. 1241-9, ISSN: 0008-543X.Morgenfeld-M-C, Pavlovsky-A, Suarez-A, Somoza-N, Pavlovsky-S, Palau- M, Barros-C-A. Combined cyclophosphamide vincristine, procarbazine, and prednisone (COPP) therapy of malignant lymphoma. Evaluation of 190 patients. Cancer, {Cancer}, Oct 1975, vol. 36, no. 4, p. 1241-9, ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34787

Study title: Weiner-M-A, Leventhal-B, Brecher-M-L, Marcus-R-B, Cantor-A, Gieser-P- W, Ternberg-J-L, Behm-F-G, Wharam-M-D-Jr, Chauvenet-A-R. W, Ternberg-J-L, Behm-F-G, Wharam-M-D-Jr, Chauvenet-A-R College of Physicians and Surgeons of Columbia University, New York, USA. Randomized study of intensive MOPP-ABVD with or without low-dose total-nodal radiation therapy in the treatment of stages IIB, IIIA2, IIIB, and IV Hodgkin's disease in pediatric patients: a Pediatric Oncology Group study. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Aug 1997, vol. 15, no. 8, p. 2769-79, ISSN: 0732-183X.Weiner-M-A, Leventhal-B, Brecher-M-L, Marcus-R-B, Cantor-A, Gieser-P- W, Ternberg-J-L, Behm-F-G, Wharam-M-D-Jr, Chauvenet-A-R. W, Ternb...

Active substance: PROCARBAZINE

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Document reference: 34874

Study title: Petera-J, Macharova-H, Pohankova-R, Malir-A, Coupek-P, Konecný-M, Patera-J, Pecina-J, Drbal-J, Koukalova-H, Vasova-I. Masaryk Memorial Cancer Institute, Brno, Czech Republic. Petera @fuhk.cz. Radiotherapy of early stages Hodgkin's disease. 10 years experience of the Masaryk Memorial Cancer Institute. Neoplasma, {Neoplasma}, 2000, vol. 47, no. 2, p. 129-32, ISSN: 0028-2685.Petera-J, Macharova-H, Pohankova-R, Malir-A, Coupek-P, Konecný-M, Patera-J, Pecina-J, Drbal-J, Koukalova-H, Vasova-I. Masaryk Memorial Cancer Institute, Brno, Czech Republic. Petera @fuhk.cz. Radiotherapy of early stages Hodgkin's disease. 10 years experience of the Masaryk Memorial Cancer Institute. Neoplasma, {Neoplasma}, 2000, vol. 47, no. 2, p. 129-32, ISSN: 0028-2685.

Active substance: PROCARBAZINE

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Document reference: 34806

Study title: Petronio-J, Edwards-M-S-B, Prados-M, Freyberger-S, Rabbitt-J, Silver- P, Levin-V-A. c/o Editorial Office, 1360 Ninth Avenue, San Francisco, CA 94122, United States. Management of chiasmal and hypothalamic gliomas of infancy and childhood with chemotherapy. Journal of Neurosurgery {J-NEUROSURG}, 1991, Vol/Iss/Pg. 74/5 (701-708), ISSN: 0022-3085.Petronio-J, Edwards-M-S-B, Prados-M, Freyberger-S, Rabbitt-J, Silver- P, Levin-V-A. c/o Editorial Office, 1360 Ninth Avenue, San Francisco, CA 94122, United States. Management of chiasmal and hypothalamic gliomas of infancy and childhood with chemotherapy. Journal of Neurosurgery {J-NEUROSURG}, 1991, Vol/Iss/Pg. 74/5 (701-708), ISSN: 0022-3085.

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Document reference: 34807

Study title: Pezzotta-S, Cordero-Di-Montezemolo-L, Knerich-R, Arrigoni-M, Barbara- A, Besenzon-L, Brach-del-Prever-A, Fidani-P, Locatelli-D, Loiacono-G, Magrassi-L, Perilongo-G, Rigobello-L, Urgesi-A, Madon-E. Dept. of Surg., Neurosurgical Clinic, University of Pavia, IRCCS Policlinico San Matteo, Piazzale Golgi, 2, I-27100 Pavia, Italy. CNS-85 trial: A cooperative pediatric CNS tumor study - results of treatment of medulloblastoma patients. Child's Nervous System {CHILD-S-NERV-SYST}, 1996, Vol/Iss/Pg. 12/2 (87-96), ISSN: 0256-7040.Pezzotta-S, Cordero-Di-Montezemolo-L, Knerich-R, Arrigoni-M, Barbara- A, Besenzon-L, Brach-del-Prever-A, Fidani-P, Locatelli-D, Loiacono-G, Magrassi-L, Perilongo-G, Rigobello-L, Urgesi-A, Madon-E. Dept. of Surg., Neurosurgical Clinic, University of Pavia, ...

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Document reference: 34808

Study title: Lemerle-J, Bernard-A, Kalifa-C. Serv. Cancerol. Inf., Inst. Gustave Roussy, Villejuif, France. Management and follow up of antitumoral chemotherapy of the child. Revue du Praticien {REV-PRAT}, 1977, Vol/Iss/Pg. 27/5 (237-247).Lemerle-J, Bernard-A, Kalifa-C. Serv. Cancerol. Inf., Inst. Gustave Roussy, Villejuif, France. Management and follow up of antitumoral chemotherapy of the child. Revue du Praticien {REV-PRAT}, 1977, Vol/Iss/Pg. 27/5 (237-247).

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Document reference: 34770

Study title: Leverger-G, Oberlin-O, Schaison-G, Lemerle-J. (Treatment of Hodgkin's disease in children with chemotherapy and low-dose radiation). Nouvelle revue francaise d'hematologie, {Nouv-Rev-Fr-Hematol}, 1987,vol. 29, no. 1, p. 83-5.vol. 29, no. 1, p. 83-5.Leverger-G, Oberlin-O, Schaison-G, Lemerle-J. (Treatment of Hodgkin's disease in children with chemotherapy and low-dose radiation). Nouvelle revue francaise d'hematologie, {Nouv-Rev-Fr-Hematol}, 1987,vol. 29, no. 1, p. 83-5.vol. 29, no. 1, p. 83-5.

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Document reference: 34773

Study title: Leverger-G, Oberlin-O, Schaison-G, Lemerle-J. ( Treatment of Hodgkin's disease in children with chemotherapy and low-dose radiation). Nouvelle revue francaise d'hematologie {Nouv-Rev-Fr-Hematol} 1987, VOL: 29 (1), P: 83-5.Leverger-G, Oberlin-O, Schaison-G, Lemerle-J. ( Treatment of Hodgkin's disease in children with chemotherapy and low-dose radiation). Nouvelle revue francaise d'hematologie {Nouv-Rev-Fr-Hematol} 1987, VOL: 29 (1), P: 83-5.

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Document reference: 34772

Study title: Loeuille-G-A. Consultation d'Endocrinologie Pediatrique, Hopital Regional, 59037 Lille Cedex, France. Endocrine surveillance of children after antineoplastic radiotherapy and chemotherapy. LARC Medical {LARC-MED}, 1985, Vol/Iss/Pg. 5/10 (562-566).Loeuille-G-A. Consultation d'Endocrinologie Pediatrique, Hopital Regional, 59037 Lille Cedex, France. Endocrine surveillance of children after antineoplastic radiotherapy and chemotherapy. LARC Medical {LARC-MED}, 1985, Vol/Iss/Pg. 5/10 (562-566).

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Document reference: 34774

Study title: Longo-D-L, Russo-A, Duffey-P-L, Hubbard-S-M, Glatstein-E, Hill-J-B, Division of Cancer Treatment, National Cancer Institute, Bethesda, MD. Treatment of advanced-stage massive mediastinal Hodgkin's disease: the case for combined modality treatment. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Feb 1991, vol. 9, no. 2, p. 227-35, ISSN: 0732-183X.Longo-D-L, Russo-A, Duffey-P-L, Hubbard-S-M, Glatstein-E, Hill-J-B, Division of Cancer Treatment, National Cancer Institute, Bethesda, MD. Treatment of advanced-stage massive mediastinal Hodgkin's disease: the case for combined modality treatment. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol...

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Document reference: 34775

Study title: Lawhorn-T-I, Stone-H-H, Martin-J-D-Jr. Chemotherapy in solid tumors of childhood. Oncology, {Oncology}, 1972, vol. 26, no. 2, p. 250-8, 22 refs, ISSN: 0030-2414.Lawhorn-T-I, Stone-H-H, Martin-J-D-Jr. Chemotherapy in solid tumors of childhood. Oncology, {Oncology}, 1972, vol. 26, no. 2, p. 250-8, 22 refs, ISSN: 0030-2414.

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Document reference: 34769

Study title: Hartmann-O, Oberlin-O, Beaujean-F, Brugieres-L, Valteau-D, Vassal-G, Lemerle-J. Departement de Pediatrie, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. High-dose chemotherapy followed by autologous bone marrow transplantation in children's metastatic Ewing sarcoma. Bulletin du Cancer {BULL-CANCER}, 1990, Vol/Iss/Pg. 77/2 (181-187), ISSN: 0007-4551.Hartmann-O, Oberlin-O, Beaujean-F, Brugieres-L, Valteau-D, Vassal-G, Lemerle-J. Departement de Pediatrie, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. High-dose chemotherapy followed by autologous bone marrow transplantation in children's metastatic Ewing sarcoma. Bulletin du Cancer {BULL-CANCER}, 1990, Vol/Iss/Pg. 77/2 (181-187), ISSN: 0007-4551.

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Document reference: 34733

Study title: Hassel-J-U, Braemswig-J-H, Schlegel-W, Schellong-G. Universitaets-Kinderklinik, Muenster. (Testicular function after OPA/COMP chemotherapy without procarbazine in boys with Hodgkin's disease. Results in 25 patients of the DAL-HD-85 study). Klinische Paediatrie {Klin-Padiatr} 1991 Jul-Aug, VOL: 203 (4), P: 268-72, ISSN: 0300-8630.Hassel-J-U, Braemswig-J-H, Schlegel-W, Schellong-G. Universitaets-Kinderklinik, Muenster. (Testicular function after OPA/COMP chemotherapy without procarbazine in boys with Hodgkin's disease. Results in 25 patients of the DAL-HD-85 study). Klinische Paediatrie {Klin-Padiatr} 1991 Jul-Aug, VOL: 203 (4), P: 268-72, ISSN: 0300-8630.

Active substance: PROCARBAZINE

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Document reference: 34734

Study title: Hayani-A, Mahoney-D-H-Jr, Taylor-L-D. Department of Pediatrics, Baylor College of Medicine, Houston, TX. Therapy-related myelodysplastic syndrome in children with medulloblastoma following MOPP chemotherapy. Journal of neuro-oncology, {J-Neurooncol}, Sep 1992, vol. 14, no. 1, p. 57-62, ISSN: 0167-594X.Hayani-A, Mahoney-D-H-Jr, Taylor-L-D. Department of Pediatrics, Baylor College of Medicine, Houston, TX. Therapy-related myelodysplastic syndrome in children with medulloblastoma following MOPP chemotherapy. Journal of neuro-oncology, {J-Neurooncol}, Sep 1992, vol. 14, no. 1, p. 57-62, ISSN: 0167-594X.

Active substance: PROCARBAZINE

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Document reference: 34735

Study title: Heath-John-A, Turner-Christopher-D, Poussaint-Tina-Young, Scott-R- Michael, Goumnerova-Liliana, Kieran-Mark-W. Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. john.heath@rch.org.au. Chemotherapy for progressive low-grade gliomas in children older than ten years: the Dana-Farber experience. Pediatric hematology and oncology, {Pediatr-Hematol-Oncol}, Oct-Nov 2003, vol. 20, no. 7, p. 497-504, ISSN: 0888-0018.Heath-John-A, Turner-Christopher-D, Poussaint-Tina-Young, Scott-R- Michael, Goumnerova-Liliana, Kieran-Mark-W. Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. john.heath@rch.org.au. Chemotherapy for progressive low-grade gliomas in children older than ten years: the Dana-Farber...

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Document reference: 34737

Study title: Whitehead-E, Shalet-S-M, Jones-P-H, Beardwell-C-G, Deakin-D-P. Gonadal function after combination chemotherapy for Hodgkin's disease in childhood. Archives of disease in childhood, {Arch-Dis-Child}, Apr 1982, vol. 57, no. 4, p. 287-91, ISSN: 1468-2044.Whitehead-E, Shalet-S-M, Jones-P-H, Beardwell-C-G, Deakin-D-P. Gonadal function after combination chemotherapy for Hodgkin's disease in childhood. Archives of disease in childhood, {Arch-Dis-Child}, Apr 1982, vol. 57, no. 4, p. 287-91, ISSN: 1468-2044.

Active substance: PROCARBAZINE

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Document reference: 34876

Study title: Wiedrich-T, Keller-D, Arya-S-A, Gilbert-E. Department of Pathology, University of Wisconsin Center for Health Sciences and Medical School, Madison, WI 53792, United States. Adverse histopathologic effects of chemotherapeutic agents in childhood leukemia and lymphoma. Pediatric Pathology {PEDIATR-PATHOL}, 1984, Vol/Iss/Pg. 2/3 (267-283).Wiedrich-T, Keller-D, Arya-S-A, Gilbert-E. Department of Pathology, University of Wisconsin Center for Health Sciences and Medical School, Madison, WI 53792, United States. Adverse histopathologic effects of chemotherapeutic agents in childhood leukemia and lymphoma. Pediatric Pathology {PEDIATR-PATHOL}, 1984, Vol/Iss/Pg. 2/3 (267-283).

Active substance: PROCARBAZINE

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Document reference: 34877

Study title: Woo-S-Y, Donaldson-S-S, Cox-R-S. Department of Therapeutic Radiology, Stanford University Medical Center, Stanford, CA 94305, United States. Astrocytoma in children: 14 years' experience at Stanford University Medical Center. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1988, Vol/Iss/Pg. 6/6 (1001-1007), ISSN: 0732-183X.Woo-S-Y, Donaldson-S-S, Cox-R-S. Department of Therapeutic Radiology, Stanford University Medical Center, Stanford, CA 94305, United States. Astrocytoma in children: 14 years' experience at Stanford University Medical Center. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1988, Vol/Iss/Pg. 6/6 (1001-1007), ISSN: 0732-183X.

Active substance: PROCARBAZINE

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Document reference: 34879

Study title: Ghigo E, Mazza E, Imperiale E, Rizzi G, Benso L, Müller EE, Camanni F, Massara F. Enhancement of cholinergic tone by pyridostigmine promotes both basal and growth hormone (GH)-releasing hormone-induced GH secretion in children of short stature. J Clin Endocrinol Metab. 1987 Sep;65(3):452-6.Ghigo E, Mazza E, Imperiale E, Rizzi G, Benso L, Müller EE, Camanni F, Massara F. Enhancement of cholinergic tone by pyridostigmine promotes both basal and growth hormone (GH)-releasing hormone-induced GH secretion in children of short stature. J Clin Endocrinol Metab. 1987 Sep;65(3):452-6.

Active substance: PYRIDOSTIGMINE

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Document reference: 35221

Study title: Phuphanich-S, Edwards-M-S-B, Levin-V-A, et-al. Neuro-Oncology Service, Brain Tumor Research Center, Department of Neurological Surgery, School of Medicine, University of California, San Francisco, CA, United States. Supratentorial malignant gliomas of childhood. Results of treatment with radiation therapy and chemotherapy. Journal of Neurosurgery {J-NEUROSURG}, 1984, Vol/Iss/Pg. 60/3 (495-499).Phuphanich-S, Edwards-M-S-B, Levin-V-A, et-al. Neuro-Oncology Service, Brain Tumor Research Center, Department of Neurological Surgery, School of Medicine, University of California, San Francisco, CA, United States. Supratentorial malignant gliomas of childhood. Results of treatment with radiation therapy and chemotherapy. Journal of Neurosurgery {J-NEUROSURG}, 1984, V...

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Document reference: 34810

Study title: Urgesi-A, Vasario-E, Monetti-U, et-al. Universita di Torino, Istituto di Radiologia, Divisione di Radioterapia, 10126 Torino, Italy. Treatment of childhood brain stem tumors with irradiation and chemotherapy. Preliminary results. Minerva Pediatrica {MINERVA-PEDIATR}, 1985, Vol/Iss/Pg. 37/20 (779-785).Urgesi-A, Vasario-E, Monetti-U, et-al. Universita di Torino, Istituto di Radiologia, Divisione di Radioterapia, 10126 Torino, Italy. Treatment of childhood brain stem tumors with irradiation and chemotherapy. Preliminary results. Minerva Pediatrica {MINERVA-PEDIATR}, 1985, Vol/Iss/Pg. 37/20 (779-785).

Active substance: PROCARBAZINE

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Document reference: 34862

Study title: Vailati-G, Occhiogrosso-M, Belsanti-M, et-al. Catt. Neurochir., Univ. Bari, Bari, Italy. Medulloblastomas and other intracranial brain tumors in infacy and childhood: Late effects of chemio and radiotherapy. Folia Oncologica {FOLIA-ONCOL}, 1982, Vol/Iss/Pg. 5/3 (523-529).Vailati-G, Occhiogrosso-M, Belsanti-M, et-al. Catt. Neurochir., Univ. Bari, Bari, Italy. Medulloblastomas and other intracranial brain tumors in infacy and childhood: Late effects of chemio and radiotherapy. Folia Oncologica {FOLIA-ONCOL}, 1982, Vol/Iss/Pg. 5/3 (523-529).

Active substance: PROCARBAZINE

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Document reference: 34863

Study title: van-den-Berg-H, Furstner-F, van-den-Bos-C, Behrendt-H. Department of Pediatric Oncology, Emma Children Hospital AMC, University of Amsterdam, Amsterdam; The Netherlands. h.vandenberg@amc.uva.nl. Decreasing the number of MOPP courses reduces gonadal damage in survivors of childhood Hodgkin disease. Pediatric blood & cancer, {Pediatr-Blood-Cancer}, Mar 2004, vol. 42, no. 3, p. 210-5, ISSN: 1545-5009.van-den-Berg-H, Furstner-F, van-den-Bos-C, Behrendt-H. Department of Pediatric Oncology, Emma Children Hospital AMC, University of Amsterdam, Amsterdam; The Netherlands. h.vandenberg@amc.uva.nl. Decreasing the number of MOPP courses reduces gonadal damage in survivors of childhood Hodgkin disease. Pediatric blood & cancer, {Pediatr-Blood-Cancer}, Mar 2004,...

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Document reference: 34864

Study title: van-den-Berg-H, Zsiros-J, Behrendt-H. Emma Kinderziekenhuis AMC, University of Amsterdam, The Netherlands. Treatment of childhood Hodgkin's disease without radiotherapy. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Jun 1997, vol. 15, no. 6, p. 2247-53, ISSN: 0732-183X.van-den-Berg-H, Zsiros-J, Behrendt-H. Emma Kinderziekenhuis AMC, University of Amsterdam, The Netherlands. Treatment of childhood Hodgkin's disease without radiotherapy. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Jun 1997, vol. 15, no. 6, p. 2247-53, ISSN: 0732-183X.

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Document reference: 34865

Study title: van-Eys-J, Cangir-A, Coody-D, Smith-B. MOPP regimen as primary chemotherapy for brain tumors in infants. Journal of neuro-oncology, {J-Neurooncol}, 1985, vol. 3, no. 3, p. 237-43, ISSN: 0167-594X.van-Eys-J, Cangir-A, Coody-D, Smith-B. MOPP regimen as primary chemotherapy for brain tumors in infants. Journal of neuro-oncology, {J-Neurooncol}, 1985, vol. 3, no. 3, p. 237-43, ISSN: 0167-594X.

Active substance: PROCARBAZINE

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Document reference: 34866

Study title: Perani V. Riv Patol Clin Sep/Oct 1978;33(5):1-15. . Clinical evaluation of the efficacy of a new antiviral drug, methisoprinol, in pediatric infectionsPerani V. Riv Patol Clin Sep/Oct 1978;33(5):1-15. . Clinical evaluation of the efficacy of a new antiviral drug, methisoprinol, in pediatric infections

Active substance: INOSINE

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Document reference: 30155

Study title: Perani V. Rivista di Patalogia e Clinica Sept-Oct 1978;33(5):361-372. Clinical evaluation of the efficacy of a new antiviral drug, methisoprinol, in pediatric infections.Perani V. Rivista di Patalogia e Clinica Sept-Oct 1978;33(5):361-372. Clinical evaluation of the efficacy of a new antiviral drug, methisoprinol, in pediatric infections.

Active substance: INOSINE

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Document reference: 30156

Study title: Schellong-G, Braemswig-J-H, Hoernig-Franz-I, Schwarze-E-W, Poetter-R, Wannenmacher-M. Children's Hospital, University of Muenster, Germany. Hodgkin's disease in children: combined modality treatment for stages IA, IB, and IIA. Results in 356 patients of the German/Austrian Pediatric Study Group. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}, 1994, vol. 5 Suppl 2, p. 113-5, ISSN: 0923-7534.Schellong-G, Braemswig-J-H, Hoernig-Franz-I, Schwarze-E-W, Poetter-R, Wannenmacher-M. Children's Hospital, University of Muenster, Germany. Hodgkin's disease in children: combined modality treatment for stages IA, IB, and IIA. Results in 356 patients of the German/Austrian Pediatric Study Group. Annals of oncology : official j...

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Document reference: 34829

Study title: Schellong-G, Braemswig-J-H, Hoernig-Franz-I. University Childrens Hospital, Department of Haematology and Oncology, Muenster, Germany. Pediatric Oncology Group. Treatment of children with Hodgkin's disease-results of the German Pediatric Oncology Group. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}, Sep 1992, vol. 3 Suppl 4, p. 73-6, ISSN: 0923-7534.Schellong-G, Braemswig-J-H, Hoernig-Franz-I. University Childrens Hospital, Department of Haematology and Oncology, Muenster, Germany. Pediatric Oncology Group. Treatment of children with Hodgkin's disease-results of the German Pediatric Oncology Group. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, {Ann-Oncol}...

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Document reference: 34830

Study title: Schellong-G, Braemswig-J-H, Schwarze-E-W, Wannenmacher-M. Children's Hospital University of Muenster, FRG. An approach to reduce treatment and invasive staging in childhood Hodgkin's disease: the sequence of the German DAL multicenter studies. Bulletin du cancer, {Bull-Cancer}, 1988, vol. 75, no. 1, p. 41-51,Schellong-G, Braemswig-J-H, Schwarze-E-W, Wannenmacher-M. Children's Hospital University of Muenster, FRG. An approach to reduce treatment and invasive staging in childhood Hodgkin's disease: the sequence of the German DAL multicenter studies. Bulletin du cancer, {Bull-Cancer}, 1988, vol. 75, no. 1, p. 41-51,

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Document reference: 34831

Study title: Schellong-G, Bramswig-J-H, Schwarze-E-W, Wannenmacher-M. Children's Hospital University of Munster, D-4400 Munster, Germany. An approach to reduce treatment and invasive staging in childhood Hodgkin's disease: The sequence of the German DAL multicenter studies. Bulletin du Cancer {BULL-CANCER}, 1988, Vol/Iss/Pg. 75/1 (41-51), ISSN: 0007-4551.Schellong-G, Bramswig-J-H, Schwarze-E-W, Wannenmacher-M. Children's Hospital University of Munster, D-4400 Munster, Germany. An approach to reduce treatment and invasive staging in childhood Hodgkin's disease: The sequence of the German DAL multicenter studies. Bulletin du Cancer {BULL-CANCER}, 1988, Vol/Iss/Pg. 75/1 (41-51), ISSN: 0007-4551.

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Document reference: 34832

Study title: Schellong-G, Hoernig-I, Schwarze-E-W, Wannenmacher-M. Kinderklinik, Muenster, FRG. Risk factor adapted treatment of Hodgkin's lymphoma in childhood: strategies and results of three consecutive multicenter studies in the Federal Republic of Germany. Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer, {Recent-Results-Cancer-Res}, 1989, vol. 117, p. 205-13, 7 refs, ISSN: 0080-0015.Schellong-G, Hoernig-I, Schwarze-E-W, Wannenmacher-M. Kinderklinik, Muenster, FRG. Risk factor adapted treatment of Hodgkin's lymphoma in childhood: strategies and results of three consecutive multicenter studies in the Federal Republic of Germany. Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les reche...

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Document reference: 34833

Study title: Giustina A et al. Effects of exogenous growth hormone pretreatment on the pituitary growth hormone response to growth hormone-releasing hormone alone or in combination with pyridostigmine in type I diabetic patients. Acta Endocrinol (Copenh). 1991 Nov;125(5):510-7Giustina A et al. Effects of exogenous growth hormone pretreatment on the pituitary growth hormone response to growth hormone-releasing hormone alone or in combination with pyridostigmine in type I diabetic patients. Acta Endocrinol (Copenh). 1991 Nov;125(5):510-7

Active substance: PYRIDOSTIGMINE

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Document reference: 35205

Study title: Giustina A et al. Effects of pyridostigmine on spontaneous and growth hormone-releasing hormone stimulated growth hormone secretion in children on daily glucocorticoid therapy after liver transplantation. Clin Endocrinol (Oxf). 1991 Dec;35(6):491-8Giustina A et al. Effects of pyridostigmine on spontaneous and growth hormone-releasing hormone stimulated growth hormone secretion in children on daily glucocorticoid therapy after liver transplantation. Clin Endocrinol (Oxf). 1991 Dec;35(6):491-8

Active substance: PYRIDOSTIGMINE

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Document reference: 35204

Study title: Gyermek L. Clinical studies on the reversal of the neuromuscular blockade produced by pancuronium bromide. I. The effects of glycopyrrolate and pyridostigmine. Curr Ther Res Clin Exp. 1975 Sep;18(3):377-86Gyermek L. Clinical studies on the reversal of the neuromuscular blockade produced by pancuronium bromide. I. The effects of glycopyrrolate and pyridostigmine. Curr Ther Res Clin Exp. 1975 Sep;18(3):377-86

Active substance: PYRIDOSTIGMINE

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Document reference: 35219

Study title: Intraventricular chemotherapy in neonatal meningitis - E. L. Lee et al - 1977 (J. Pediat., 91. 991 - 995) Intraventricular chemotherapy in neonatal meningitis - E. L. Lee et al - 1977 (J. Pediat., 91. 991 - 995)

Active substance: RIFAMYCIN

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Document reference: 35383

Study title: 17. Carlier, Witry, Rev Med Liege 1965; 20: 461-465 17. Carlier, Witry, Rev Med Liege 1965; 20: 461-465

Active substance: PYRVINIUM

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Document reference: 39546

Study title: 19. Chavarria, Lizano, Indian Pract 1967; 20: 25-29 19. Chavarria, Lizano, Indian Pract 1967; 20: 25-29

Active substance: PYRVINIUM

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Document reference: 39548

Study title: 2. Adiao et al., J Philipp Med Assoc 1961; 37: 485-488 2. Adiao et al., J Philipp Med Assoc 1961; 37: 485-488

Active substance: PYRVINIUM

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Document reference: 39531

Study title: 21. Davis, Am J Dis Child 1966; 112: 49-51 21. Davis, Am J Dis Child 1966; 112: 49-51

Active substance: PYRVINIUM

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Document reference: 39550

Study title: 22. Desai, BMJ 1962; 2: 1583-1585 22. Desai, BMJ 1962; 2: 1583-1585

Active substance: PYRVINIUM

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Document reference: 39551

Study title: 24. Fossati, Minerva Med 1964; 55: 3578-3580 24. Fossati, Minerva Med 1964; 55: 3578-3580

Active substance: PYRVINIUM

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Document reference: 39553

Study title: 25. Fritz, Wiener Med Wochenschrift 1965; 115: 122-124 25. Fritz, Wiener Med Wochenschrift 1965; 115: 122-124

Active substance: PYRVINIUM

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Document reference: 39554

Study title: 26. Garin, Pediatrie 1962; 17: 551-559 26. Garin, Pediatrie 1962; 17: 551-559

Active substance: PYRVINIUM

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Document reference: 39555

Study title: 15. Bumbalo et al., Am J Dis Child 1960; 99: 617-621 15. Bumbalo et al., Am J Dis Child 1960; 99: 617-621

Active substance: PYRVINIUM

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Document reference: 39544

Study title: Precchia et al. Methisoprinol in the therapy of viral diseases: preliminary data relative to a set of diseases Chemioterapia Antimicrobia [Italy] Jan 1981 4 (1): 64 -69, 32 patients, 2 months – 10 years, 500 mg tablet Precchia et al. Methisoprinol in the therapy of viral diseases: preliminary data relative to a set of diseases Chemioterapia Antimicrobia [Italy] Jan 1981 4 (1): 64 -69, 32 patients, 2 months – 10 years, 500 mg tablet

Active substance: INOSINE

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Document reference: 30160

Study title: Robert J, Ghipponi J, Guerrier G, Noiret A, Springer G, Carron R. Gazette Medicale [original in French]. 1987; 94(45):60-62. Prevention of recurrent respiratory infections in children with [use of] Isoprinosine®Robert J, Ghipponi J, Guerrier G, Noiret A, Springer G, Carron R. Gazette Medicale [original in French]. 1987; 94(45):60-62. Prevention of recurrent respiratory infections in children with [use of] Isoprinosine®

Active substance: INOSINE

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Document reference: 30161

Study title: Salas MA, Rossotti N et al. Orient Med 1972;21:551-555. Treatment of some pediatric viral infections with IsoprinosineSalas MA, Rossotti N et al. Orient Med 1972;21:551-555. Treatment of some pediatric viral infections with Isoprinosine

Active substance: INOSINE

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Document reference: 30163

Study title: Serdaroglu A, Gucuyener K, Dursun I, Aydin K, Okuyaz C, Subasi M, Or M, Ozkan B. Ocul Immunol Inflamm. 2005 Sep-Oct;13(5):405-10. Macular retinitis as a first sign of subacute sclerosing panencephalitis: the importance of early diagnosisSerdaroglu A, Gucuyener K, Dursun I, Aydin K, Okuyaz C, Subasi M, Or M, Ozkan B. Ocul Immunol Inflamm. 2005 Sep-Oct;13(5):405-10. Macular retinitis as a first sign of subacute sclerosing panencephalitis: the importance of early diagnosis

Active substance: INOSINE

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Document reference: 30166

Study title: Sobczyk W, Kulczycki J, Pilkowska E, Iwinska B, Milewska D, Szmigielski S. Neurol Neurochir Pol. 1991 Sep-Oct;25(5):626-33. Comparison of the results of the treatment of patients with SSPE using various immunomodulating preparationsSobczyk W, Kulczycki J, Pilkowska E, Iwinska B, Milewska D, Szmigielski S. Neurol Neurochir Pol. 1991 Sep-Oct;25(5):626-33. Comparison of the results of the treatment of patients with SSPE using various immunomodulating preparations

Active substance: INOSINE

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Document reference: 30167

Study title: Sobczyk W, Pilkowska E, Iwinska-Buksowicz B, Jakubowska T. Neurol Neurochir Pol. 1997 Nov-Dec;31(6):1147-56. Polish. Assessment of early treatment results with antineoplaston AS2-1 in subacute sclerosing PanencephalitisSobczyk W, Pilkowska E, Iwinska-Buksowicz B, Jakubowska T. Neurol Neurochir Pol. 1997 Nov-Dec;31(6):1147-56. Polish. Assessment of early treatment results with antineoplaston AS2-1 in subacute sclerosing Panencephalitis

Active substance: INOSINE

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Document reference: 30168

Study title: Krystkowa M. Krystyna; Hydzikowa Marta: Application of Solcoseryl eye-gel in the treatment of certain corneal and conjunctival disease. Transl. from Klin. Ozna (Warszawa) 86, 457-495 (1985) Krystkowa M. Krystyna; Hydzikowa Marta: Application of Solcoseryl eye-gel in the treatment of certain corneal and conjunctival disease. Transl. from Klin. Ozna (Warszawa) 86, 457-495 (1985)

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35101

Study title: Menna F., Napolitano F.: The application of Cysteine gel and Solcoseryl eye gel in different corneal diseases. Proceedings of the IVth World Congress of Ergophtalmology, Italy, May, 1985. Editor: Gennaro G, Naples. Menna F., Napolitano F.: The application of Cysteine gel and Solcoseryl eye gel in different corneal diseases. Proceedings of the IVth World Congress of Ergophtalmology, Italy, May, 1985. Editor: Gennaro G, Naples.

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35105

Study title: Popov N: Solcoseryl Dental Adhesive Paste - Results of a clinical investigation and its use with oral implants. Stomatologija 1988, 6, 47-50 Popov N: Solcoseryl Dental Adhesive Paste - Results of a clinical investigation and its use with oral implants. Stomatologija 1988, 6, 47-50

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35088

Study title: Valoracion de la Rifamicina SV en la practica pediatrica - O. Turro et al - 1965 (Sem. Med., 127. 239 - 241.) Valoracion de la Rifamicina SV en la practica pediatrica - O. Turro et al - 1965 (Sem. Med., 127. 239 - 241.)

Active substance: RIFAMYCIN

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Document reference: 35385

Study title: Curr Med Res Opin. 1997;14(1):39-45. An open, controlled study of two non-absorbable antibiotics for the oral treatment of paediatric infectious diarrhoea. Frisari L, Viggiano V, Pelagalli M. Curr Med Res Opin. 1997;14(1):39-45. An open, controlled study of two non-absorbable antibiotics for the oral treatment of paediatric infectious diarrhoea. Frisari L, Viggiano V, Pelagalli M.

Active substance: RIFAXIMIN

Study summary document link (including results): 2011-05-20-Clin Dat Results-Alfa Wassermann.xls

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Document reference: 47566

Study title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study of One year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate, in Children ≥ 4 to < 16 Years Old with Osteogenesis Imperfecta

Active substance: RISEDRONIC ACID

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

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Document reference: 35389

Study title: 31. Kluska, Tzegota, Wiad Parazytol 1965; 11: 619-620 31. Kluska, Tzegota, Wiad Parazytol 1965; 11: 619-620

Active substance: PYRVINIUM

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Document reference: 39560

Study title: 32. Marzullo, Squadrini, G Mal Infett Parassit 1963; 15: 465-467 32. Marzullo, Squadrini, G Mal Infett Parassit 1963; 15: 465-467

Active substance: PYRVINIUM

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Document reference: 39561

Study title: 33. Milosavljevic, Lambrechts, Rev Med Liege 1964; 19: 449-452 33. Milosavljevic, Lambrechts, Rev Med Liege 1964; 19: 449-452

Active substance: PYRVINIUM

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Document reference: 39562

Study title: 34. Molla, Donald, J Int Med Res 1977; 5: 136-138 34. Molla, Donald, J Int Med Res 1977; 5: 136-138

Active substance: PYRVINIUM

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Document reference: 39563

Study title: Garaventa-A, Haupt-R, Panarello-C, Dodero-P, Gambini-C, Gambaro-M. Department of Pediatric Haematology/Oncology, G. Gaslini Children's Hospital, Genova, Italy. Early occurrence of a secondary thyroid carcinoma in a child treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Mar 2001, vol. 36, no. 3, p. 396-7, ISSN: 0098-1532.Garaventa-A, Haupt-R, Panarello-C, Dodero-P, Gambini-C, Gambaro-M. Department of Pediatric Haematology/Oncology, G. Gaslini Children's Hospital, Genova, Italy. Early occurrence of a secondary thyroid carcinoma in a child treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Mar 2001, vol. 36, no. 3, p. 396-7, ISSN: 0098-1532.

Active substance: PROCARBAZINE

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Document reference: 34715

Study title: Garber-J-E. Dana-Farber Cancer Institute, Boston, MA 02115, United States. Long-term follow-up of children exposed in utero to antineoplastic agents. Seminars in Oncology {SEMIN-ONCOL}, 1989, Vol/Iss/Pg. 16/5 (437-444). ISSN: 0093-7754.Garber-J-E. Dana-Farber Cancer Institute, Boston, MA 02115, United States. Long-term follow-up of children exposed in utero to antineoplastic agents. Seminars in Oncology {SEMIN-ONCOL}, 1989, Vol/Iss/Pg. 16/5 (437-444). ISSN: 0093-7754.

Active substance: PROCARBAZINE

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Document reference: 34716

Study title: Gentet-J-C, Bouffet-E, Doz-F, Tron-P, Roche-H, Thyss-A, Plantaz-D, Stephan-J-L, Mottolese-C, Ponvert-D, Carrie-C, Raybaud-C, Brunat-Mentigny-M, Choux-M, Philip-T, Zucker-J-M, Bernard-J-L. Service d'Oncologie Pediatrique, Hopital d'Enfants de la Timone,13385 Marseille Cedex 5, France. Preirradiation chemotherapy including 'eight drugs in 1 day' regimen and high-dose methotrexate in childhood medulloblastoma: Results of the M7 French Cooperative Study. Journal of Neurosurgery {J-NEUROSURG}, 1995, Vol/Iss/Pg. 82/4 (608-614), ISSN: 0022-3085.Gentet-J-C, Bouffet-E, Doz-F, Tron-P, Roche-H, Thyss-A, Plantaz-D, Stephan-J-L, Mottolese-C, Ponvert-D, Carrie-C, Raybaud-C, Brunat-Mentigny-M, Choux-M, Philip-T, Zucker-J-M, Bernard-J-L. Service d'Oncologie Pediatrique, Hopital...

Active substance: PROCARBAZINE

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Document reference: 34717

Study title: Geyer-J-R, Finlay-J-L, Boyett-J-M, Wisoff-J, Yates-A, Mao-L, Packer-R-J. Publications Office, Childrens Cancer Group, P.O. Box 60012, Arcadia, CA 91066-6012, United States. Survival of infants with malignant astrocytomas: A report from the Childrens Cancer Group. Cancer {CANCER}, 1995, Vol/Iss/Pg. 75/4 (1045-1050), ISSN: 0008-543X.Geyer-J-R, Finlay-J-L, Boyett-J-M, Wisoff-J, Yates-A, Mao-L, Packer-R-J. Publications Office, Childrens Cancer Group, P.O. Box 60012, Arcadia, CA 91066-6012, United States. Survival of infants with malignant astrocytomas: A report from the Childrens Cancer Group. Cancer {CANCER}, 1995, Vol/Iss/Pg. 75/4 (1045-1050), ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34718

Study title: Iodine-supplementation trials;Peter OD Pharoah. Am J Clin Nutr Suppl 1993;57:276S-9S. Iodine-supplementation trials;Peter OD Pharoah. Am J Clin Nutr Suppl 1993;57:276S-9S.

Active substance: IODINE

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Document reference: 30274

Study title: J Nucl Med Technol. 2007 Mar;35(1):21-6.Reproducibility of a standardized quantitative analysis using fixed regions of interest to differentiate movement disorders on 123I-FP-CIT SPECT. Stokkel MP, Dibbets-Schneider P, Koestering E, Dragoiescu C, Blokland KA. J Nucl Med Technol. 2007 Mar;35(1):21-6.Reproducibility of a standardized quantitative analysis using fixed regions of interest to differentiate movement disorders on 123I-FP-CIT SPECT. Stokkel MP, Dibbets-Schneider P, Koestering E, Dragoiescu C, Blokland KA.

Active substance: ioflupane (123l)

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Document reference: 41498

Study title: Neurology. 2001 Jan 23;56(2):266-7. SPECT imaging of the dopamine transporter in juvenile-onset dystonia. O'Sullivan JD, Costa DC, Gacinovic S, Lees AJ.Neurology. 2001 Jan 23;56(2):266-7. SPECT imaging of the dopamine transporter in juvenile-onset dystonia. O'Sullivan JD, Costa DC, Gacinovic S, Lees AJ.

Active substance: ioflupane (123l)

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Document reference: 41501

Study title: Acta Radiol Diagn (Stockh). 1984;25(2):155-8 Iohexol and metrizoate in urography in children. Comparison between a non-ionic and an ionic contrast medium. Bolz KD, Skalpe IO, Gutteberg TJ Acta Radiol Diagn (Stockh). 1984;25(2):155-8 Iohexol and metrizoate in urography in children. Comparison between a non-ionic and an ionic contrast medium. Bolz KD, Skalpe IO, Gutteberg TJ

Active substance: IOHEXOL

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Document reference: 30358

Study title: Acta Radiol Suppl. 1983;366:25-9 Iohexol in urography. Survey and present state. Ekelund L. Acta Radiol Suppl. 1983;366:25-9 Iohexol in urography. Survey and present state. Ekelund L.

Active substance: IOHEXOL

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Document reference: 30360

Study title: Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152)Pilot feasibility study of an emergency paediatric kit for intra-rectal quinine administration used by the personnel of community-based health care units in Senegal - A Ndiaye Jean-Louis - 15/11/2007 (Malaria Journal, 6:152)

Active substance: QUININE

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Document reference: 45061

Active substance: QUININE

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Document reference: 45066

Active substance: QUININE

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Document reference: 45071

Active substance: QUININE

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Document reference: 45076

Active substance: QUININE

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Document reference: 45081

Study title: Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45)Rectal versus intravenous Quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: a randomised, double bind clinical trial - Jane Achan - 1/12/2007 (Clinical Infectious Diseases 45)

Active substance: QUININE

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Document reference: 45062

Active substance: QUININE

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Document reference: 45067

Study title: Muwakkit-S, Geara-F, Nabbout-B, Farah-R-A, Shabb-N-S, Hajjar-T, Khogali-M. Department of Pediatrics, American University of Beirut Medical Center, Lebanon. Treatment of pediatric Hodgkin's disease with chemotherapy alone or combined modality therapy. Radiation oncology investigations, {Radiat-Oncol-Investig}, 1999, vol. 7, no. 6, p. 365-73, ISSN: 1065-7541.Muwakkit-S, Geara-F, Nabbout-B, Farah-R-A, Shabb-N-S, Hajjar-T, Khogali-M. Department of Pediatrics, American University of Beirut Medical Center, Lebanon. Treatment of pediatric Hodgkin's disease with chemotherapy alone or combined modality therapy. Radiation oncology investigations, {Radiat-Oncol-Investig}, 1999, vol. 7, no. 6, p. 365-73, ISSN: 1065-7541.

Active substance: PROCARBAZINE

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Document reference: 34789

Study title: Neidhardt-M-K. I Kinderklinik, Augsburg, Germany. Treatment of medulloblastoma in children: Results and conclusions. Wiener Medizinische Wochenschrift {WIEN-MED-WOCHENSCHR}, 1983, Vol /Iss/Pg. 133/SUPPL. 78 (39-45).Neidhardt-M-K. I Kinderklinik, Augsburg, Germany. Treatment of medulloblastoma in children: Results and conclusions. Wiener Medizinische Wochenschrift {WIEN-MED-WOCHENSCHR}, 1983, Vol /Iss/Pg. 133/SUPPL. 78 (39-45).

Active substance: PROCARBAZINE

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Document reference: 34792

Study title: Neidhardt-M, Habermalz-H-J, Henze-G, Langermann-H-J. (Medulloblastoma study of the German Society for Pediatric Oncology, a first report). Klinische Paediatrie {Klin-Padiatr} 1982 Jul-Aug, VOL: 194 (4), P: 257-61, ISSN: 0300-8630.Neidhardt-M, Habermalz-H-J, Henze-G, Langermann-H-J. (Medulloblastoma study of the German Society for Pediatric Oncology, a first report). Klinische Paediatrie {Klin-Padiatr} 1982 Jul-Aug, VOL: 194 (4), P: 257-61, ISSN: 0300-8630.

Active substance: PROCARBAZINE

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Document reference: 34791

Study title: Oberlin-O, Habrand-J-L, Schaison-G, Leverger-G, Zucker-J-M, Olive-D, Lemerle-J. Departement de pediatrie, Institut Gustave-Roussy, Villejuif, France. (Hodgkin's disease in children. Current therapeutic strategies). Bulletin du cancer {Bull-Cancer} 1988, VOL: 75 (1), P: 53-60, ISSN: 0007-4551.Oberlin-O, Habrand-J-L, Schaison-G, Leverger-G, Zucker-J-M, Olive-D, Lemerle-J. Departement de pediatrie, Institut Gustave-Roussy, Villejuif, France. (Hodgkin's disease in children. Current therapeutic strategies). Bulletin du cancer {Bull-Cancer} 1988, VOL: 75 (1), P: 53-60, ISSN: 0007-4551.

Active substance: PROCARBAZINE

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Document reference: 34793

Study title: Prados-M, Levin-V. Department of Neurological Surgery, Brain Tumor Research Center, University of California, San Francisco, CA 94143-0520, United States. Malignant supratentorial gliomas in childhood. Pediatric Neuroscience {PEDIATR-NEUROSCI}, 1987, Vol/Iss/Pg. 13/3 (144-151), ISSN: 0255-7975.Prados-M, Levin-V. Department of Neurological Surgery, Brain Tumor Research Center, University of California, San Francisco, CA 94143-0520, United States. Malignant supratentorial gliomas in childhood. Pediatric Neuroscience {PEDIATR-NEUROSCI}, 1987, Vol/Iss/Pg. 13/3 (144-151), ISSN: 0255-7975.

Active substance: PROCARBAZINE

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Document reference: 34812

Study title: Ramsay-N-K, Coccia-P-F, Krivit-W, Bloomfield-C-D, Nesbit-M-E. Vinblastine, procarbazine, and cytosine arabinoside in combination for reinduction of childhood acute myelocytic leukemia. Cancer treatment reports, {Cancer-Treat-Rep}, Nov 1976, vol. 60, no. 11, p. 1683-5, ISSN: 0361-5960.Ramsay-N-K, Coccia-P-F, Krivit-W, Bloomfield-C-D, Nesbit-M-E. Vinblastine, procarbazine, and cytosine arabinoside in combination for reinduction of childhood acute myelocytic leukemia. Cancer treatment reports, {Cancer-Treat-Rep}, Nov 1976, vol. 60, no. 11, p. 1683-5, ISSN: 0361-5960.

Active substance: PROCARBAZINE

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Document reference: 34813

Study title: Roettinger-E-M. (Survival of children with primitive neuroectodermal tumors and malignant ependymomas of the central nervous system after treatment with 8 cytostatic agents in one day. A report of the Children's Cancer Group). Strahlentherapie und Onkologie : Organ der Deutschen oentgengesellschaft ... (et al), {Strahlenther-Onkol}, May 1995, vol. 171, no. 5, p. 303-4, ISSN: 0179-7158.Roettinger-E-M. (Survival of children with primitive neuroectodermal tumors and malignant ependymomas of the central nervous system after treatment with 8 cytostatic agents in one day. A report of the Children's Cancer Group). Strahlentherapie und Onkologie : Organ der Deutschen oentgengesellschaft ... (et al), {Strahlenther-Onkol}, May ...

Active substance: PROCARBAZINE

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Document reference: 34815

Study title: Rosenberg-S-A, Kaplan-H-S. The evolution and summary results of the Stanford randomized clinical trials of the management of Hodgkin's disease: 1962-1984. International journal of radiation oncology biology physics, {Int-J-Radiat-Oncol-Biol-Phys}, Jan 1985, vol. 11, no. 1, p. 5-22, ISSN: 0360-3016.Rosenberg-S-A, Kaplan-H-S. The evolution and summary results of the Stanford randomized clinical trials of the management of Hodgkin's disease: 1962-1984. International journal of radiation oncology biology physics, {Int-J-Radiat-Oncol-Biol-Phys}, Jan 1985, vol. 11, no. 1, p. 5-22, ISSN: 0360-3016.

Active substance: PROCARBAZINE

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Document reference: 34816

Study title: van-Eys-J, Cangir-A, Pack-R, Baram-T. Department of Pediatrics, University of Texas System Cancer Center, M. D. Anderson Hospital and Tumor Institute, Houston 77030.. Phase I trial of procarbazine as a 5-day continuous infusion in children with central nervous system tumors. Cancer treatment reports, {Cancer-Treat-Rep}, Oct 1987, vol. 71, no. 10, p. 973-4, ISSN: 0361-5960. van-Eys-J, Cangir-A, Pack-R, Baram-T. Department of Pediatrics, University of Texas System Cancer Center, M. D. Anderson Hospital and Tumor Institute, Houston 77030.. Phase I trial of procarbazine as a 5-day continuous infusion in children with central nervous system tumors. Cancer treatment reports, {Cancer-Treat-Rep}, Oct 1987, vol. 71, no. 10, p. 973-4, ISSN: 0361-5960.

Active substance: PROCARBAZINE

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Document reference: 34867

Study title: Andersen M et al. Evaluation of growth hormone assays using ratio plots. Clin Chem. 1998 May;44(5):1032-8 Andersen M et al. Evaluation of growth hormone assays using ratio plots. Clin Chem. 1998 May;44(5):1032-8

Active substance: PYRIDOSTIGMINE

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Document reference: 35193

Study title: Arvat E et al. The enhancing effect of pyridostigmine on the GH response to GHRH undergoes an accelerated age-related reduction in Down syndrome. Dementia. 1996 Sep-Oct;7(5):288-92Arvat E et al. The enhancing effect of pyridostigmine on the GH response to GHRH undergoes an accelerated age-related reduction in Down syndrome. Dementia. 1996 Sep-Oct;7(5):288-92

Active substance: PYRIDOSTIGMINE

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Document reference: 35194

Study title: Burke G et al. Distinct phenotypes of congenital acetylcholine receptor deficiency. Neuromuscul Disord. 2004 Jun;14(6):356-64Burke G et al. Distinct phenotypes of congenital acetylcholine receptor deficiency. Neuromuscul Disord. 2004 Jun;14(6):356-64

Active substance: PYRIDOSTIGMINE

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Document reference: 35185

Study title: Cappa M et al. The growth hormone response to pyridostigmine plus growth hormone releasing hormone is not influenced by pubertal maturation. J Endocrinol Invest. 1991 Jan;14(1):41-5Cappa M et al. The growth hormone response to pyridostigmine plus growth hormone releasing hormone is not influenced by pubertal maturation. J Endocrinol Invest. 1991 Jan;14(1):41-5

Active substance: PYRIDOSTIGMINE

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Document reference: 35210

Study title: Cook JE, Kolka MA, Wenger CB. Chronic pyridostigmine bromide administration: side effects among soldiers working in a desert environment. Mil Med. 1992 May;157(5):250-4 Cook JE, Kolka MA, Wenger CB. Chronic pyridostigmine bromide administration: side effects among soldiers working in a desert environment. Mil Med. 1992 May;157(5):250-4

Active substance: PYRIDOSTIGMINE

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Document reference: 35202

Study title: Hegewald-G, Reddemann-H, Barenwald-G, Schwanengel-H. Pathol. Inst., Ernst-Moritz-Arndt-Univ., 2200 Greifswald, Germany. Ultrastructural findings in the liver of children survived a long time after antineoplatic polychemotherapy. Archiv fur Geschwulstforschung {ARCH-GESCHWULSTFORSCH}, 1982, Vol/Iss /Pg. 52/5 (397-405).Hegewald-G, Reddemann-H, Barenwald-G, Schwanengel-H. Pathol. Inst., Ernst-Moritz-Arndt-Univ., 2200 Greifswald, Germany. Ultrastructural findings in the liver of children survived a long time after antineoplatic polychemotherapy. Archiv fur Geschwulstforschung {ARCH-GESCHWULSTFORSCH}, 1982, Vol/Iss /Pg. 52/5 (397-405).

Active substance: PROCARBAZINE

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Document reference: 34738

Study title: Heikens-J, Behrendt-H, Adriaanse-R, Berghout-A. Department of Internal Medicine, University of Amsterdam, The Netherlands. Irreversible gonadal damage in male survivors of pediatric Hodgkin's disease. Cancer, {Cancer}, 1 Nov 1996, vol. 78, no. 9, p. 2020-4, ISSN 0008-543X.Heikens-J, Behrendt-H, Adriaanse-R, Berghout-A. Department of Internal Medicine, University of Amsterdam, The Netherlands. Irreversible gonadal damage in male survivors of pediatric Hodgkin's disease. Cancer, {Cancer}, 1 Nov 1996, vol. 78, no. 9, p. 2020-4, ISSN 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34739

Study title: Horowitz-M-E, Mulhern-R-K, Kun-L-E, Kovnar-E, Sanford-R-A, Simmons-J, Hayes-F-A, Jenkins-III-J-J. Department of Hematology-Oncology, St. Jude Children's Research Hospital, Memphis, TN, United States. Brain tumors in the very young child. Postoperative chemotherapy in combined-modality treatment. Cancer {CANCER}, 1988, Vol/Iss/Pg. 61/3 (428-434), ISSN: 0008-543X.Horowitz-M-E, Mulhern-R-K, Kun-L-E, Kovnar-E, Sanford-R-A, Simmons-J, Hayes-F-A, Jenkins-III-J-J. Department of Hematology-Oncology, St. Jude Children's Research Hospital, Memphis, TN, United States. Brain tumors in the very young child. Postoperative chemotherapy in combined-modality treatment. Cancer {CANCER}, 1988, Vol/Iss/Pg. 61/3 (428-434), ISSN: 0008-543X.

Active substance: PROCARBAZINE

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Document reference: 34740

Study title: Huma-Z, Boulad-F, Black-P, Heller-G, Sklar-C. Department of Pediatrics, Memorial Sloan-Kettering Cancer Ctr., 1275 York Ave, New York, NY 10021, United States. Growth in children after bone marrow transplantation for acute leukemia. Blood {BLOOD}, 1995, Vol/Iss/Pg. 86/2 (819-824), ISSN: 0006-4971.Huma-Z, Boulad-F, Black-P, Heller-G, Sklar-C. Department of Pediatrics, Memorial Sloan-Kettering Cancer Ctr., 1275 York Ave, New York, NY 10021, United States. Growth in children after bone marrow transplantation for acute leukemia. Blood {BLOOD}, 1995, Vol/Iss/Pg. 86/2 (819-824), ISSN: 0006-4971.

Active substance: PROCARBAZINE

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Document reference: 34742

Study title: Zeltzer-L-K, LeBaron-S, Zeltzer-P-M. Department of Pediatrics, The University of Texas Health Science Center, San Antonio, TX 78284, United States. A prospective assessment of chemotherapy-related nausea and vomiting in children with cancer. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR-HEMATOL-ONCOL}, 1984, Vol/Iss/Pg. 6/1 (5-16).Zeltzer-L-K, LeBaron-S, Zeltzer-P-M. Department of Pediatrics, The University of Texas Health Science Center, San Antonio, TX 78284, United States. A prospective assessment of chemotherapy-related nausea and vomiting in children with cancer. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR-HEMATOL-ONCOL}, 1984, Vol/Iss/Pg. 6/1 (5-16).

Active substance: PROCARBAZINE

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Document reference: 34882

Study title: "Publication mentioned in CES made available in 2007 for national renewals: Options for the prevention and management of acute chemotherapy-induced nausea and vomiting in children. L.L. Dupuis, P.C. Nathan, Paediatric drugs 2003; 5(9): 597-613." "Publication mentioned in CES made available in 2007 for national renewals: Options for the prevention and management of acute chemotherapy-induced nausea and vomiting in children. L.L. Dupuis, P.C. Nathan, Paediatric drugs 2003; 5(9): 597-613."

Active substance: PROCHLOPERAZINE

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Document reference: 34969

Study title: Clinical Report - Ph. VERIN - 06.11.1973

Active substance: PROCYANIDOLIC OLIGOMERS

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Document reference: 40140

Study title: Efficacité et tolérance du progabide (SL 76.002) dans les syndromes spastiques d'origine cérébrale chez des enfants, adolescents, jeunes adultes - Ferriere G. - 04/1981

Active substance: PROGABIDE

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Document reference: 34972

Study title: Double-blind randomized comparison of proglumetacin and naproxen sodium in the treatment of patients with ankle sprains [Current Therapeutic Research 1995, 56(7): 639-48].Double-blind randomized comparison of proglumetacin and naproxen sodium in the treatment of patients with ankle sprains [Current Therapeutic Research 1995, 56(7): 639-48].

Active substance: PROGLUMETACIN

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Document reference: 34995

Study title: Rosenthal-J, Arush-M-W-B, Kuten-A, Arie-J-B, Shahar-M-B, Robinson-E. Pediatric Oncology Unit, Rambam Medical Center, Haifa 31096, Israel. Hodgkin's disease in childhood: Treatment modalities, outcome and epidemiological aspects: The Northern Israel Cancer Center experience. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR- HEMATOL-ONCOL}, 1994, Vol/Iss/Pg. 16/2 (138-142), ISSN: 0192-8562.Rosenthal-J, Arush-M-W-B, Kuten-A, Arie-J-B, Shahar-M-B, Robinson-E. Pediatric Oncology Unit, Rambam Medical Center, Haifa 31096, Israel. Hodgkin's disease in childhood: Treatment modalities, outcome and epidemiological aspects: The Northern Israel Cancer Center experience. American Journal of Pediatric Hematology/Oncology {AM-J-PEDIATR- HEMATOL-ONC...

Active substance: PROCARBAZINE

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Document reference: 34817

Study title: Küchle H. J., Busse H., Augenerkrankungen im Kindesalter, Thieme Verlag Stuttgart New York 1985 Küchle H. J., Busse H., Augenerkrankungen im Kindesalter, Thieme Verlag Stuttgart New York 1985

Active substance: RETINOL

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Document reference: 35292

Study title: Sobczyk W, Pilkowska E, Iwinska-Buksowicz B. Neurol Neurochir Pol. 1999 Jul-Aug;33(4):797-805. The evaluation of the use of antineoplaston AS2-1 treatment in subacute sclerosing panencephalitisSobczyk W, Pilkowska E, Iwinska-Buksowicz B. Neurol Neurochir Pol. 1999 Jul-Aug;33(4):797-805. The evaluation of the use of antineoplaston AS2-1 treatment in subacute sclerosing panencephalitis

Active substance: INOSINE

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Document reference: 30169

Study title: Dr Martinez (publication 20-30 years ago in neonates) 15 infants aged from 9 days to 1 year old 1973Dr Martinez (publication 20-30 years ago in neonates) 15 infants aged from 9 days to 1 year old 1973

Active substance: RHUBARB AND SALICYLIC ACID

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Document reference: 35293

Study title: Schellong-G. Department of Haematology and Oncology, University Children's Hospital, Muenster, Germany. Treatment of children and adolescents with Hodgkin's disease: the experience of the German-Austrian Paediatric Study Group. Bailliere's clinical haematology, {Baillieres-Clin-Haematol}, Sep 1996, vol. 9, no. 3, p. 619-34, ISSN: 0950-3536.Schellong-G. Department of Haematology and Oncology, University Children's Hospital, Muenster, Germany. Treatment of children and adolescents with Hodgkin's disease: the experience of the German-Austrian Paediatric Study Group. Bailliere's clinical haematology, {Baillieres-Clin-Haematol}, Sep 1996, vol. 9, no. 3, p. 619-34, ISSN: 0950-3536.

Active substance: PROCARBAZINE

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Document reference: 34835

Study title: Schmitt-C, Bordigoni-P, Chastagner-P, Galloy-M-A, Bey-P, Sommelet-D. Service de Medecine Infantile II, Hopital d'Enfants, C.H.U., Nancy, France. Hodgkin's disease in childhood. Annales Medicales de Nancy et de l'Est {ANN-MED-NANCY-EST}, 1992, Vol /Iss/Pg. 31/1 (75-78), ISSN: 0221-3796.Schmitt-C, Bordigoni-P, Chastagner-P, Galloy-M-A, Bey-P, Sommelet-D. Service de Medecine Infantile II, Hopital d'Enfants, C.H.U., Nancy, France. Hodgkin's disease in childhood. Annales Medicales de Nancy et de l'Est {ANN-MED-NANCY-EST}, 1992, Vol /Iss/Pg. 31/1 (75-78), ISSN: 0221-3796.

Active substance: PROCARBAZINE

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Document reference: 34837

Study title: Schut-L, Rosenstock-J-G. Neurosurg. Serv.Child. Hosp.PhiladelphiaPa. 19146, United States. Treatment of intracranial neoplasms in children. Seminars in Oncology {SEMIN-ONCOL}, 1974, Vol/Iss/Pg. 1/1 (9-15).Schut-L, Rosenstock-J-G. Neurosurg. Serv.Child. Hosp.PhiladelphiaPa. 19146, United States. Treatment of intracranial neoplasms in children. Seminars in Oncology {SEMIN-ONCOL}, 1974, Vol/Iss/Pg. 1/1 (9-15).

Active substance: PROCARBAZINE

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Document reference: 34838

Study title: Seiler-R-W, Bernasconi-S, Berchtold-W, Feldges-A, Imbach-P, Luethi-A, Pluess-H-J, Vassella-F, Wyss-M, Wagner-H-P. Adjuvant chemotherapy with procarbazine, vincristine and prednisone for medulloblastomas. A preliminary report. Helvetica paediatrica acta, {Helv-Paediatr-Acta}, Jul 1981, vol. 36, no. 3, p. 249-54, ISSN: 0018-022X.Seiler-R-W, Bernasconi-S, Berchtold-W, Feldges-A, Imbach-P, Luethi-A, Pluess-H-J, Vassella-F, Wyss-M, Wagner-H-P. Adjuvant chemotherapy with procarbazine, vincristine and prednisone for medulloblastomas. A preliminary report. Helvetica paediatrica acta, {Helv-Paediatr-Acta}, Jul 1981, vol. 36, no. 3, p. 249-54, ISSN: 0018-022X.

Active substance: PROCARBAZINE

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Document reference: 34840

Study title: Kirk JM et al. Pyridostigmine fails to increase either spontaneous or GHRH-stimulated GH secretion during day or night in growth hormone-insufficient children. Clin Endocrinol (Oxf). 1991 May;34(5):407-11Kirk JM et al. Pyridostigmine fails to increase either spontaneous or GHRH-stimulated GH secretion during day or night in growth hormone-insufficient children. Clin Endocrinol (Oxf). 1991 May;34(5):407-11

Active substance: PYRIDOSTIGMINE

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Document reference: 35207

Study title: Loche S et al. Evidence for involvement of endogenous somatostatin in the galanin-induced growth hormone secretion in children. Pediatr Res. 1990 Apr;27(4 Pt 1):405-7Loche S et al. Evidence for involvement of endogenous somatostatin in the galanin-induced growth hormone secretion in children. Pediatr Res. 1990 Apr;27(4 Pt 1):405-7

Active substance: PYRIDOSTIGMINE

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Document reference: 35214

Study title: Morita M, Gabbai AA, Oliveira ASB, Penn AS: Myasthenia gravis in children. Arq Neuropsiquiatr 2001, 59 (3-B): 681-685 Morita M, Gabbai AA, Oliveira ASB, Penn AS: Myasthenia gravis in children. Arq Neuropsiquiatr 2001, 59 (3-B): 681-685

Active substance: PYRIDOSTIGMINE

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Document reference: 35220

Study title: Oh AY, Kim SD, Kim CS. Early and late reversal of rocuronium with pyridostigmine during sevoflurane anaesthesia in children. Anaesth Intensive Care. 2004 Oct;32(5):649-52Oh AY, Kim SD, Kim CS. Early and late reversal of rocuronium with pyridostigmine during sevoflurane anaesthesia in children. Anaesth Intensive Care. 2004 Oct;32(5):649-52

Active substance: PYRIDOSTIGMINE

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Document reference: 35184

Study title: Procopio M et al. Effect of arginine and pyridostigmine on the GHRH-induced GH rise in obesity and Cushing's syndrome. Int J Obes Relat Metab Disord. 1995 Feb;19(2):108-12Procopio M et al. Effect of arginine and pyridostigmine on the GHRH-induced GH rise in obesity and Cushing's syndrome. Int J Obes Relat Metab Disord. 1995 Feb;19(2):108-12

Active substance: PYRIDOSTIGMINE

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Document reference: 35199

Study title: 35. do Nascimento et al., Hosp Rio de Brasilia 1962; 61: 117-121 35. do Nascimento et al., Hosp Rio de Brasilia 1962; 61: 117-121

Active substance: PYRVINIUM

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Document reference: 39564

Study title: 38. Padelt, Flentje, childrenärztl Prax 1967; 35: 93-97 38. Padelt, Flentje, childrenärztl Prax 1967; 35: 93-97

Active substance: PYRVINIUM

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Document reference: 39567

Study title: 39. Palicka, Cesk Pediatr 1971; 26: 563-565 39. Palicka, Cesk Pediatr 1971; 26: 563-565

Active substance: PYRVINIUM

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Document reference: 39568

Study title: 4. Asmera et al., Ceskoslovenska pediatrie 1971; 26: 456-458 4. Asmera et al., Ceskoslovenska pediatrie 1971; 26: 456-458

Active substance: PYRVINIUM

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Document reference: 39533

Study title: 41. Pazdziora, Cesk Epidemiol Mikrobiol Immunol 1976; 25: 50-55 41. Pazdziora, Cesk Epidemiol Mikrobiol Immunol 1976; 25: 50-55

Active substance: PYRVINIUM

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Document reference: 39570

Study title: 42. Pistoletti, Igiene Sania Publ 1962; 18: 42-45 42. Pistoletti, Igiene Sania Publ 1962; 18: 42-45

Active substance: PYRVINIUM

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Document reference: 39571

Study title: 45. Reitano, Pane, Riv Pediatr Seciliana 1960; 15: 270-288 45. Reitano, Pane, Riv Pediatr Seciliana 1960; 15: 270-288

Active substance: PYRVINIUM

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Document reference: 39574

Study title: 46. Rodriguez et al., J Pediatr 1960; 25: 324-330 46. Rodriguez et al., J Pediatr 1960; 25: 324-330

Active substance: PYRVINIUM

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Document reference: 39575

Study title: 47. Salem et al., J Egypt Pub Health Assoc 1961; 26: 225-233 47. Salem et al., J Egypt Pub Health Assoc 1961; 26: 225-233

Active substance: PYRVINIUM

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Document reference: 39576

Study title: 48. Sandars, Med J Aust 1963; 1: 722-725 48. Sandars, Med J Aust 1963; 1: 722-725

Active substance: PYRVINIUM

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Document reference: 39577

Study title: Spicak V, Polackova M, Tlaskalova H, Kacirek E. Presented at the 8th European Immunology Meeting; August 30 - September 5, 1987; Zagreb, Yugoslavia. (Abstract only). Modimunal®/Isoprinosine® in the treatment of asthmatic children.Spicak V, Polackova M, Tlaskalova H, Kacirek E. Presented at the 8th European Immunology Meeting; August 30 - September 5, 1987; Zagreb, Yugoslavia. (Abstract only). Modimunal®/Isoprinosine® in the treatment of asthmatic children.

Active substance: INOSINE

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Document reference: 30170

Study title: Tepebasili I, Caksen H, Odabas D, Atas B, Akbayram S. J Emerg Med. 2004 Apr;26(3):356-9. Report of two children with subacute sclerosing panencephalitis displaying an atypical clinical course.Tepebasili I, Caksen H, Odabas D, Atas B, Akbayram S. J Emerg Med. 2004 Apr;26(3):356-9. Report of two children with subacute sclerosing panencephalitis displaying an atypical clinical course.

Active substance: INOSINE

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Document reference: 30174

Study title: Wiedermann D, Widermannova D, Lokaj J. Scripta Medica [Czech edition from Brno]. 1986; 59(7):415-424. Several parameters of cellular and humoral immune function in children with recurrent respiratory infections treated with Isoprinosine®.Wiedermann D, Widermannova D, Lokaj J. Scripta Medica [Czech edition from Brno]. 1986; 59(7):415-424. Several parameters of cellular and humoral immune function in children with recurrent respiratory infections treated with Isoprinosine®.

Active substance: INOSINE

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Document reference: 30177

Study title: Acta Radiol. 1992 Nov;33(6):592-5 Comparison of intravenous contrast agents for CT studies in children. Cohen MD, Herman E, Herron D, White SJ, Smith JA Acta Radiol. 1992 Nov;33(6):592-5 Comparison of intravenous contrast agents for CT studies in children. Cohen MD, Herman E, Herron D, White SJ, Smith JA

Active substance: IOHEXOL

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Document reference: 30363

Study title: Sato Y, Takashima A, Oka S: A double-blind study of the clinical efficacy of Solcoseryl in childblains. Kis to Rinsho,. Clin Rep 1975; 9 2453-2489 Sato Y, Takashima A, Oka S: A double-blind study of the clinical efficacy of Solcoseryl in childblains. Kis to Rinsho,. Clin Rep 1975; 9 2453-2489

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35096

Study title: "Behandlung einer Hemmkörperhämophilie B mit hochdosierter Factor IX-Substitution. In: Landbeck,G., Marx R. (Hrsg.): 15 Hämophilie-Symposium Hamburg, 1984, Springer-Verlag, Berlin, Heidelberg, New York, Tokyo: 251-254 (1986).(Kraus B et al.) " "Behandlung einer Hemmkörperhämophilie B mit hochdosierter Factor IX-Substitution. In: Landbeck,G., Marx R. (Hrsg.): 15 Hämophilie-Symposium Hamburg, 1984, Springer-Verlag, Berlin, Heidelberg, New York, Tokyo: 251-254 (1986).(Kraus B et al.) "

Active substance: PROTHROMBIN

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Document reference: 35111

Study title: "Factor X survival and therapeutic factor X levels in the abnormal factor X (factor X FRIULI) COAGULATION DISORDER. Acta Haematol (1974) 52: 223-231.(Girolami A et al.) " "Factor X survival and therapeutic factor X levels in the abnormal factor X (factor X FRIULI) COAGULATION DISORDER. Acta Haematol (1974) 52: 223-231.(Girolami A et al.) "

Active substance: PROTHROMBIN

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Document reference: 35110

Study title: "Laboratory and clinical evaluation of concentrates for treatment of haemophilia. Acta Clin Belg (1975) 30: 437-448. (Verstraete M, Vermylen J. ) " "Laboratory and clinical evaluation of concentrates for treatment of haemophilia. Acta Clin Belg (1975) 30: 437-448. (Verstraete M, Vermylen J. ) "

Active substance: PROTHROMBIN

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Document reference: 35108

Study title: Donaldson-S-S, Berberich-F-R, Kaplan-H-S. Stanford Univ. Sch. Med., Stanford, Calif. 94305, United States. A program of low dose radiation and MOPP chemotherapy for pediatric Hodgkin's disease. Proceedings of the American Association for Cancer Research {PROC-AM-ASSOC-CANCER-RES}, 1981, Vol/Iss/Pg. Vol. 22/- (C-730).Donaldson-S-S, Berberich-F-R, Kaplan-H-S. Stanford Univ. Sch. Med., Stanford, Calif. 94305, United States. A program of low dose radiation and MOPP chemotherapy for pediatric Hodgkin's disease. Proceedings of the American Association for Cancer Research {PROC-AM-ASSOC-CANCER-RES}, 1981, Vol/Iss/Pg. Vol. 22/- (C-730).

Active substance: PROCARBAZINE

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Document reference: 34698

Study title: Donaldson-S-S, Kaplan-H-S. Div. Radiat. Ther., Dept. Radiol., Stanford Univ. Med. Cent., Stanford, CA 94305, United States. Complications of treatment of Hodgkin's disease in children. Cancer Treatment Reports {CANCER-TREAT-REP}, 1982, Vol/Iss/Pg. 66/4 (977-989).Donaldson-S-S, Kaplan-H-S. Div. Radiat. Ther., Dept. Radiol., Stanford Univ. Med. Cent., Stanford, CA 94305, United States. Complications of treatment of Hodgkin's disease in children. Cancer Treatment Reports {CANCER-TREAT-REP}, 1982, Vol/Iss/Pg. 66/4 (977-989).

Active substance: PROCARBAZINE

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Document reference: 34699

Study title: Donaldson-S-S, Link-M-P, McDougall-I-R, Parker-B-R, Shochat-S-J. Clinical investigations of children with Hodgkin's disease at Stanford University Medical Center. A preliminary overview using low- dose irradiation and alternating ABVD/MOPP chemotherapy. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 307-15, ISSN: 0927-3042.Donaldson-S-S, Link-M-P, McDougall-I-R, Parker-B-R, Shochat-S-J. Clinical investigations of children with Hodgkin's disease at Stanford University Medical Center. A preliminary overview using low- dose irradiation and alternating ABVD/MOPP chemotherapy. Cancer treatment and research, {Cancer-Treat-Res}, 1989, vol. 41, p. 307-15, ISSN: 0927-3042.

Active substance: PROCARBAZINE

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Document reference: 34700

Study title: Donaldson-S-S, Link-M-P. Combined modality treatment with low-dose radiation and MOPP chemotherapy for children with Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, May 1987, vol. 5, no. 5, p. 742-9, ISSN: 0732-183X.Donaldson-S-S, Link-M-P. Combined modality treatment with low-dose radiation and MOPP chemotherapy for children with Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, May 1987, vol. 5, no. 5, p. 742-9, ISSN: 0732-183X.

Active substance: PROCARBAZINE

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Document reference: 34701

Study title: Duffner-P-K, Cohen-M-E, Anderson-S-W, et-al. Department of Neurology, Buffalo Children's Hospital, Buffalo, NY 14222, United States. Long-term effects of treatment on endocrine function in children with brain tumors. Annals of Neurology {ANN-NEUROL}, 1983, Vol/Iss/Pg. 14/5 (528-532).Duffner-P-K, Cohen-M-E, Anderson-S-W, et-al. Department of Neurology, Buffalo Children's Hospital, Buffalo, NY 14222, United States. Long-term effects of treatment on endocrine function in children with brain tumors. Annals of Neurology {ANN-NEUROL}, 1983, Vol/Iss/Pg. 14/5 (528-532).

Active substance: PROCARBAZINE

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Document reference: 34702

Study title: Duffner-P-K, Cohen-M-E. Department of Neurology, Children's Hospital of Buffalo, 219 Bryant Street, Buffalo, NY 14222, United States. Changes in the approach to central nervous system tumors in childhood. Pediatric Clinics of North America {PEDIATR-CLIN-NORTH-AM}, 1992, Vol /Iss/Pg. 39/4 (859-877), ISSN: 0031-3955.Duffner-P-K, Cohen-M-E. Department of Neurology, Children's Hospital of Buffalo, 219 Bryant Street, Buffalo, NY 14222, United States. Changes in the approach to central nervous system tumors in childhood. Pediatric Clinics of North America {PEDIATR-CLIN-NORTH-AM}, 1992, Vol /Iss/Pg. 39/4 (859-877), ISSN: 0031-3955.

Active substance: PROCARBAZINE

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Document reference: 34703

Study title: 49. Sanders, Hall, J Lab Clin Med 1960; 56: 413-416 49. Sanders, Hall, J Lab Clin Med 1960; 56: 413-416

Active substance: PYRVINIUM

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Document reference: 39578

Study title: 5. Bandyopadhyay, Chowdhury, Bull Calcutta Scool Trop Med 1961; 2: 125 5. Bandyopadhyay, Chowdhury, Bull Calcutta Scool Trop Med 1961; 2: 125

Active substance: PYRVINIUM

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Document reference: 39534

Study title: 50. Seth, J Indian Med Assoc 1962; 38: 528-530 50. Seth, J Indian Med Assoc 1962; 38: 528-530

Active substance: PYRVINIUM

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Document reference: 39579

Study title: 51. Silli, Riv Clin Pediatr 1968; 81: 1331-1334 51. Silli, Riv Clin Pediatr 1968; 81: 1331-1334

Active substance: PYRVINIUM

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Document reference: 39580

Study title: 52. Suarez, Domingo, Rev Esp Pediatr 1961; 17: 557-561 52. Suarez, Domingo, Rev Esp Pediatr 1961; 17: 557-561

Active substance: PYRVINIUM

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Document reference: 39581

Study title: 53. Sudigbia, et al., Paediatr Indon 1970; 10: 125-130 53. Sudigbia, et al., Paediatr Indon 1970; 10: 125-130

Active substance: PYRVINIUM

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Document reference: 39582

Study title: Geyer-J-R, Zeltzer-P-M, Boyett-J-M, Rorke-L-B, Stanley-P, Albright-A- L, Wisoff-J-H, Milstein-J-M, Allen-J-C, Finlay-J-L, et al. Children's Hospital and Medical Center, Seattle, WA. Survival of infants with primitive neuroectodermal tumors or malignant ependymomas of the CNS treated with eight drugs in 1 day: a report from the Childrens Cancer Group. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Aug 1994, vol. 12, no. 8, p. 1607-15, ISSN: 0732-183X.Geyer-J-R, Zeltzer-P-M, Boyett-J-M, Rorke-L-B, Stanley-P, Albright-A- L, Wisoff-J-H, Milstein-J-M, Allen-J-C, Finlay-J-L, et al. Children's Hospital and Medical Center, Seattle, WA. Survival of infants with primitive neuroectodermal tumors or malignan...

Active substance: PROCARBAZINE

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Document reference: 34720

Study title: Geyer-R, Levy-M, Berger-M-S, Milstein-J, Griffin-B, Bleyer-W-A. Depts. Ped./Neuro Surg./Radia., Children's Hos./Medical Care, University of Washington, Seattle, WA, United States. Infants with medulloblastoma: a single institution review of survival. Neurosurgery {NEUROSURGERY}, 1991, Vol/Iss/Pg. 29/5 (707-711), ISSN: 0148-396X.Geyer-R, Levy-M, Berger-M-S, Milstein-J, Griffin-B, Bleyer-W-A. Depts. Ped./Neuro Surg./Radia., Children's Hos./Medical Care, University of Washington, Seattle, WA, United States. Infants with medulloblastoma: a single institution review of survival. Neurosurgery {NEUROSURGERY}, 1991, Vol/Iss/Pg. 29/5 (707-711), ISSN: 0148-396X.

Active substance: PROCARBAZINE

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Document reference: 34721

Study title: Glynne-Jones-R, Whitaker-S-J, Plowman-P-N. Department of Radiotherapy, St Bartholomew's Hospital, London. The 'urn' portal; an alternative to the 'mantle' portal in the chemoradiotherapy management of paediatric Hodgkin's disease. Clinical oncology (Royal College of Radiologists (Great Britain)), {Clin-Oncol-R-Coll-Radiol}, Jul 1990, vol. 2, no. 4, p. 235-40, ISSN: 0936-6555.Glynne-Jones-R, Whitaker-S-J, Plowman-P-N. Department of Radiotherapy, St Bartholomew's Hospital, London. The 'urn' portal; an alternative to the 'mantle' portal in the chemoradiotherapy management of paediatric Hodgkin's disease. Clinical oncology (Royal College of Radiologists (Great Britain)), {Clin-Oncol-R-Coll-Radiol}, Jul 1990, vol. 2, no. 4, p. 235-40, ISSN: 0936-6555.

Active substance: PROCARBAZINE

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Document reference: 34722

Study title: Acta Radiol. 1994 Mar;35(2):186-90 Nonionic contrast media in pediatric CT. A comparative study of intravenous use of iopentol and iohexol. Wiklund LM, Brolin I, Sjöholm K Acta Radiol. 1994 Mar;35(2):186-90 Nonionic contrast media in pediatric CT. A comparative study of intravenous use of iopentol and iohexol. Wiklund LM, Brolin I, Sjöholm K

Active substance: IOHEXOL

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Document reference: 30364

Study title: Br J Radiol. 1987 Feb;60(710):133-5. Comparison of low-osmolar contrast media in paediatric cardiac angiography. Rubin CM, Ogilvie BC, Keeton BR Br J Radiol. 1987 Feb;60(710):133-5. Comparison of low-osmolar contrast media in paediatric cardiac angiography. Rubin CM, Ogilvie BC, Keeton BR

Active substance: IOHEXOL

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Document reference: 30366

Study title: Cent Afr J Med. 1996 Jul;42(7):192-5 Myelography with Omnipaque (Iohexol) using basic radiographic facilities: the main adverse effects. Ndosi BN, Ndosi NK, Kazema RR Cent Afr J Med. 1996 Jul;42(7):192-5 Myelography with Omnipaque (Iohexol) using basic radiographic facilities: the main adverse effects. Ndosi BN, Ndosi NK, Kazema RR

Active substance: IOHEXOL

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Document reference: 30367

Study title: Double-blind comparative study of Ultravist, Solutrast and Omnipaque in excretory urography in childrenAJR Am J Roentgenol. 1991 Feb;156(2):345-50 Comparison of iohexol with barium in gastrointestinal studies of infants and children. Cohen MD, Towbin R, Baker S, Davis S, Becker C, Eggleston DE, Kehler M, Smith JA, Cory DA, White SJ.

Active substance: IOHEXOL

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Document reference: 30365

Study title: Double-blind comparative study of Ultravist, Solutrast and Omnipaque in excretory urography in childrenJ Invasive Cardiol. 2003 Mar;15(3):133-8. Early and late reactions following the use of iopamidol 340, iomeprol 350 and iodixanol 320 in cardiac catheterization. Sutton AG, Finn P, Campbell PG, Price DJ, Hall JA, Stewart MJ, Davies A, Linker NJ, De Belder MA.

Active substance: IOHEXOL

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Document reference: 30379

Active substance: IOHEXOL

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Document reference: 30372

Study title: Int J Cardiol. 2001 Sep-Oct;80(2-3):143-51. Experiences with iohexol and iodixanol during cardioangiography in an unselected patient population. Flinck A, Gottfridsson B. Int J Cardiol. 2001 Sep-Oct;80(2-3):143-51. Experiences with iohexol and iodixanol during cardioangiography in an unselected patient population. Flinck A, Gottfridsson B.

Active substance: IOHEXOL

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Document reference: 30374

Study title: Anesthetic effects from low concentrations of proparacaine and benoxinate. Jauregui MJ, Sanders TJ, Polse KA. J Am Optom Assoc. 1980 Jan;51(1):37-41.Anesthetic effects from low concentrations of proparacaine and benoxinate. Jauregui MJ, Sanders TJ, Polse KA. J Am Optom Assoc. 1980 Jan;51(1):37-41.

Active substance: PROXYMETHACAINE

Study summary document link (including results): Anesthetic effects from low concentrations of proparacaine a.pdf

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Document reference: 46144

Active substance: QUININE

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Document reference: 45077

Active substance: QUININE

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Document reference: 45082

Study title: Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059)Safety and Efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children : randomised clinical trial - Hubert Barennes et al. - 15/11/2007 (BMJ;332:1055-1059)

Active substance: QUININE

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Document reference: 45063

Active substance: QUININE

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Document reference: 45068

Active substance: QUININE

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Document reference: 45073

Active substance: QUININE

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Document reference: 45078

Active substance: QUININE

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Document reference: 45072

Study title: Oberlin-O, Boilletot-A, Leverger-G, et-al. Institut Gustave-Roussy 94800, Villejuif, France. Clinical staging, primary chemotherapy and involved field radiotherapy in childhood Hodgkin's disease. European Paediatric Haematology and Oncology {EUR-PAEDIATR-HAEMATOL-ONCOL}, 1985, Vol/Iss/Pg. 2/2 (65-70).Oberlin-O, Boilletot-A, Leverger-G, et-al. Institut Gustave-Roussy 94800, Villejuif, France. Clinical staging, primary chemotherapy and involved field radiotherapy in childhood Hodgkin's disease. European Paediatric Haematology and Oncology {EUR-PAEDIATR-HAEMATOL-ONCOL}, 1985, Vol/Iss/Pg. 2/2 (65-70).

Active substance: PROCARBAZINE

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Document reference: 34795

Study title: Oberlin-O. Department of Pediatricts, Institut Gustave Roussy,94805 Villejuif Cedex, France. Present and future strategies of treatment in childhood Hodgkin's lymphomas. Annals of Oncology {ANN-ONCOL}, 1996, Vol/Iss/Pg. 7/SUPPL. 4 (S73- S78), ISSN: 0923-7534.Oberlin-O. Department of Pediatricts, Institut Gustave Roussy,94805 Villejuif Cedex, France. Present and future strategies of treatment in childhood Hodgkin's lymphomas. Annals of Oncology {ANN-ONCOL}, 1996, Vol/Iss/Pg. 7/SUPPL. 4 (S73- S78), ISSN: 0923-7534.

Active substance: PROCARBAZINE

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Document reference: 34797

Study title: Olive-D, Philip-T, Zucker-J-M, et-al. Service de Medicine Infantile II, Hopital d'Enfants, 54511 Vandoeuvre Cedex 11, France. Efficacy of '8 drugs in 1 day' regimen in the treatment of poor risk childhood brain tumors. European Paediatric Haematology and Oncology {EUR-PAEDIATR-HAEMATOL-ONCOL}, 1985, Vol/Iss/Pg. 2/1 (57-58).Olive-D, Philip-T, Zucker-J-M, et-al. Service de Medicine Infantile II, Hopital d'Enfants, 54511 Vandoeuvre Cedex 11, France. Efficacy of '8 drugs in 1 day' regimen in the treatment of poor risk childhood brain tumors. European Paediatric Haematology and Oncology {EUR-PAEDIATR-HAEMATOL-ONCOL}, 1985, Vol/Iss/Pg. 2/1 (57-58).

Active substance: PROCARBAZINE

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Document reference: 34798

Study title: Ortin-T-T, Shostak-C-A, Donaldson-S-S. CA 94305. Gonadal status and reproductive function following treatment for Hodgkin's disease in childhood: the Stanford experience. International journal of radiation oncology biology physics, {Int-J- Radiat-Oncol-Biol-Phys}, Oct 1990, vol. 19, no. 4, p. 873-80, ISSN: 0360-3016.Ortin-T-T, Shostak-C-A, Donaldson-S-S. CA 94305. Gonadal status and reproductive function following treatment for Hodgkin's disease in childhood: the Stanford experience. International journal of radiation oncology biology physics, {Int-J- Radiat-Oncol-Biol-Phys}, Oct 1990, vol. 19, no. 4, p. 873-80, ISSN: 0360-3016.

Active substance: PROCARBAZINE

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Document reference: 34800

Study title: A Study to Compare the Efficacy and Safety of 0.25% Levobupivacaine to 0.25% Bupivacaine when Administered as a Caudal Extradural for PostOperative Analgesia in Paediatric In-Patients Undergoing Elective Orthopaedic or Major Urological Surgery

Active substance: LEVOBUVICAINE HCL

Study summary document link (including results): Levobupivacaine-30590.pdf

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Document reference: 47650

Study title: Astudy to assess the efficacy and safety of 0.25% levobupivacaine when administered as a caudal injection in paediatric patients undergoing hernia repair, circumcision or orchidopexy.

Active substance: LEVOBUVICAINE HCL

Study summary document link (including results): Levobupivacaine-30585.pdf

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Document reference: 47649

Study title: Double-Blind Randomized Controlled Trial of05% L.evobupivacaine for Post-Operative Pain Control in Pediatric Patients Foliowing Hernia Repair Surgery

Active substance: LEVOBUVICAINE HCL

Study summary document link (including results): Levobupivacaine-CS007.pdf

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Document reference: 47648

Study title: A double-blind, placebo-controlled comparison of treatment with fluticasone propionate and levocabastine in patients with seasonal allergic rhinitis. Allergy 54, p.1173-1180, 1999A double-blind, placebo-controlled comparison of treatment with fluticasone propionate and levocabastine in patients with seasonal allergic rhinitis. Allergy 54, p.1173-1180, 1999

Active substance: LEVOCABASTINE

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Document reference: 31138

Study title: A placebo-controlled trial of the therapeutic value of levocabastine eye drops used as required in the treatment of seasonal allergic conjunctivitis (13.1-56.7 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62493_Interventional_Levocabastine.xls

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Document reference: 31105

Active substance: LEVOCABASTINE

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Document reference: 31059

Study title: Micromedex. Diphenhydramine Hydrochloride. Thomson Healthcare. 1974-2005 medizinishes Informationssystem Vol.125 expires 9/2005, 2005Micromedex. Diphenhydramine Hydrochloride. Thomson Healthcare. 1974-2005 medizinishes Informationssystem Vol.125 expires 9/2005, 2005

Active substance: DEXAMETHASONE AND DIPHENHYDRAMINE

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Document reference: 25712

Study title: Vorberg, G. Erfolgreiche Behandlung von entzündlichen Veränderungen der Mund- und Rachenschleimhaut sowie des Zahnfleisches mit Pyralves. 1982, 28:2972-2973 aged 15 - 72 years, 60 patientsVorberg, G. Erfolgreiche Behandlung von entzündlichen Veränderungen der Mund- und Rachenschleimhaut sowie des Zahnfleisches mit Pyralves. 1982, 28:2972-2973 aged 15 - 72 years, 60 patients

Active substance: RHUBARB AND SALICYLIC ACID

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Document reference: 35296

Study title: Placebo-controlled comparison of levamisole, pyrantel pamoate, thiabendazole, piperazine citrate, and varlaus dosages of mebendazole in the treatment of ascariasis and trichuriasis in children. 1975

Active substance: MEBENDAZOLE

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Document reference: 31539

Study title: Longo-D-L, Young-R-C, Wesley-M, Hubbard-S-M, Duffey-P-L, Jaffe-E-S, DeVita-V-T-Jr. Twenty years of MOPP therapy for Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Sep 1986, vol. 4, no. 9, p. 1295-306, ISSN: 0732-183X.Longo-D-L, Young-R-C, Wesley-M, Hubbard-S-M, Duffey-P-L, Jaffe-E-S, DeVita-V-T-Jr. Twenty years of MOPP therapy for Hodgkin's disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Sep 1986, vol. 4, no. 9, p. 1295-306, ISSN: 0732-183X.

Active substance: PROCARBAZINE

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Document reference: 34776

Study title: Luker-G-D, Siegel-M-J. Department of Radiology, Mallinckrodt Institute of Radiology, Washington Univ. School of Medicine, 510 S Kingshighway Blvd, St Louis, MO 63110, United States. Mediastinal Hodgkin disease in children: Response to therapy. Radiology {RADIOLOGY}, 1993, Vol/Iss/Pg. 189/3 (737-740), ISSN: 0033-8419.Luker-G-D, Siegel-M-J. Department of Radiology, Mallinckrodt Institute of Radiology, Washington Univ. School of Medicine, 510 S Kingshighway Blvd, St Louis, MO 63110, United States. Mediastinal Hodgkin disease in children: Response to therapy. Radiology {RADIOLOGY}, 1993, Vol/Iss/Pg. 189/3 (737-740), ISSN: 0033-8419.

Active substance: PROCARBAZINE

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Document reference: 34777

Study title: A therapeutic trial of the use of penicillin V or erythromycin with or without rifampin in the treatment of psoriasis. Vincent F, Ross JB, Dalton M, Wort AJ. Journal of the American Academy of Dermatology, Mar 1992, vol. 26, no. 3 Pt 2, p. 458−61.

Active substance: ERYTHROMYCIN

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Document reference: 26479

Study title: Th 1165a metered aerosol: pediatrics / therapeutic observations.

Active substance: FENOTEROL

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Document reference: 27033

Study title: Liberal use of antibiotics and its effect in neonatal staphylococcal infection, with particular reference to erythromycin.Forfar J O, Keay A J, Maccabe A F, Gould J C, Bain A D. Lancet, {Lancet}, 6 Aug 1966, vol. 2, no. 7458, p. 295−300, ISSN: 0140−6736.

Active substance: ERYTHROMYCIN

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Document reference: 26564

Active substance: QUININE

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Document reference: 45083

Study title: Hunger-S-P, Link-M-P, Donaldson-S-S. Department of Pediatrics, Stanford University School of Medicine, CA 94305. ABVD/MOPP and low-dose involved-field radiotherapy in pediatric Hodgkin's disease: the Stanford experience. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Oct 1994, vol. 12, no. 10, p. 2160-6, ISSN: 0732-183X.Hunger-S-P, Link-M-P, Donaldson-S-S. Department of Pediatrics, Stanford University School of Medicine, CA 94305. ABVD/MOPP and low-dose involved-field radiotherapy in pediatric Hodgkin's disease: the Stanford experience. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Oct 1994, vol. 12, no. 10, p. 2160-6, ISSN: 0732-183X.

Active substance: PROCARBAZINE

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Document reference: 34743

Study title: Ilveskoski-I, Saarinen-U-M, Wiklund-T, Perkkioe-M, Salmi-T-T, Lanning-M, Maekipernaa-A, Pihko-H. Children's Hospital, University of Helsinki, Finland. Ototoxicity in children with malignant brain tumors treated with the 8 in 1 chemotherapy protocol. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Jul 1996, vol. 27, no. 1, p. 26-31, ISSN: 0098-1532.Ilveskoski-I, Saarinen-U-M, Wiklund-T, Perkkioe-M, Salmi-T-T, Lanning-M, Maekipernaa-A, Pihko-H. Children's Hospital, University of Helsinki, Finland. Ototoxicity in children with malignant brain tumors treated with the 8 in 1 chemotherapy protocol. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Jul 1996, vol. 27, no. 1, p. 26-31, ISSN: 0098-1532.

Active substance: PROCARBAZINE

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Document reference: 34745

Study title: Jacobi-G. Abt. Pad. Neurol., Zent. Kinderheilk., 6000 Frankfurt am M. 70, Germany. Intracranial tumors in children. Aktuelle Neurologie {AKTUEL-NEUROL}, 1982, Vol/Iss/Pg. 9/1 (42-50).Jacobi-G. Abt. Pad. Neurol., Zent. Kinderheilk., 6000 Frankfurt am M. 70, Germany. Intracranial tumors in children. Aktuelle Neurologie {AKTUEL-NEUROL}, 1982, Vol/Iss/Pg. 9/1 (42-50).

Active substance: PROCARBAZINE

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Document reference: 34746

Study title: A controled surgical series treated with promethazine before inducation. - Smith A.H.- (N.Y. State J. Med. 19/03/1959, 1024-9). - Publication in PROMETHAZINE Safety and efficacy review of medicines following UK authorities review of psychotropic and centrally acting drugs. May&Baker Ltd. Company April 1980 -

Active substance: PROMETHAZINE

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Document reference: 34996

Study title: Clinical observations with promethazine hydrochloride (PHERNERGAN ELIXIR), in paediatric practice. - Sarma D.N. Dass C.S.- (Indian Med. J., 1978, 72 (9), 156-157.) - Publication in PHENERGAN Tableelt 25mg, Syrup 1%, Sol inj 2,5%. Syndthesis documentation. French validation dossier 17/06

Active substance: PROMETHAZINE

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Document reference: 35011

Study title: Randomized,double-blind study of the efficacy and tolerability of proglumetacin versus diclofenac in sports trauma [Current Therapeutic Research 1993, 53(6):630-4]. Randomized,double-blind study of the efficacy and tolerability of proglumetacin versus diclofenac in sports trauma [Current Therapeutic Research 1993, 53(6):630-4].

Active substance: PROGLUMETACIN

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Document reference: 34994

Study title: Goldman-A, Pritchard-J. Hospital For Sick Children, London WC1N 3JH, United Kingdom. Current management of children with cancer. Prescribers' Journal {PRESCR-J}, 1985, Vol/Iss/Pg. 25/1 (2-11).Goldman-A, Pritchard-J. Hospital For Sick Children, London WC1N 3JH, United Kingdom. Current management of children with cancer. Prescribers' Journal {PRESCR-J}, 1985, Vol/Iss/Pg. 25/1 (2-11).

Active substance: PROCARBAZINE

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Document reference: 34725

Study title: Rousseau-P, Habrand-J-L, Sarrazin-D, Kalifa-C, Terrier-Lacombe-M-J, Rekacewicz-C, Rey-A. Department of Radiation Oncology, Montreal General Hospital, 1650 Cedar Ave, Montreal, Que. H3G 1A4, Canada. Treatment of intracranial ependymomas of children: Review of a 15- year experience. International Journal of Radiation Oncology Biology Physics {INT-J- RADIAT-ONCOL-BIOL-PHYS}, 1994, Vol/Iss/Pg. 28/2 (381-386), ISSN: 0360-3016.Rousseau-P, Habrand-J-L, Sarrazin-D, Kalifa-C, Terrier-Lacombe-M-J, Rekacewicz-C, Rey-A. Department of Radiation Oncology, Montreal General Hospital, 1650 Cedar Ave, Montreal, Que. H3G 1A4, Canada. Treatment of intracranial ependymomas of children: Review of a 15- year experience. International Journal of Radiation Oncology Biology Physics {...

Active substance: PROCARBAZINE

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Document reference: 34818

Study title: Sackmann-Muriel-F, Bonesana-A-C, Pavlovsky-S, Papendieck-C, Morgenfeld-M, Penchansky-L, Schwartz-L, Kvicala-R, Sica-M, Ojeda-F. Hodgkin's disease in childhood: therapy results in Argentina. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Fall 1981, vol. 3, no. 3, p. 247-54, ISSN: 0192-8562.Sackmann-Muriel-F, Bonesana-A-C, Pavlovsky-S, Papendieck-C, Morgenfeld-M, Penchansky-L, Schwartz-L, Kvicala-R, Sica-M, Ojeda-F. Hodgkin's disease in childhood: therapy results in Argentina. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Fall 1981, vol. 3, no. 3, p. 247-54, ISSN: 0192-8562.

Active substance: PROCARBAZINE

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Document reference: 34819

Study title: Kowalik-Mikolajewska B. Polski Tygodnik Lekarski. 1993; 48(11-13):258-260. The course of chronic hepatitis B in children and attempts at modifying its treatment. Kowalik-Mikolajewska B. Polski Tygodnik Lekarski. 1993; 48(11-13):258-260. The course of chronic hepatitis B in children and attempts at modifying its treatment.

Active substance: INOSINE

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Document reference: 30133

Study title: Maity-A, Goldwein-J-W, Lange-B, D-Angio-G-J. Department of Radiation Oncology, Hospital of the University of Department of Radiation Oncology, Hospital of the University of Pennsylvania, Philadelphia 19104. Mediastinal masses in children with Hodgkin's disease. An analysis of the Children's Hospital of Philadelphia and the Hospital of the University of Pennsylvania experience. University of Pennsylvania experience. Cancer, {Cancer}, 1 Jun 1992, vol. 69, no. 11, p. 2755-60, ISSN: 0008-543X.Maity-A, Goldwein-J-W, Lange-B, D-Angio-G-J. Department of Radiation Oncology, Hospital of the University of Department of Radiation Oncology, Hospital of the University of Pennsylvania, Philadelphia 19104. Mediastinal masses in children with Hodgkin's disease. An ...

Active substance: PROCARBAZINE

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Document reference: 34779

Study title: Mamelak-A-N, Prados-M-D, Obana-W-G, Cogen-P-H, Edwards-M-S-B. Department of Neurological Surgery, c/o The Editorial Office, 1360 Ninth Avenue, San Francisco, CA 94122, United States. Treatment options and prognosis for multicentric juvenile pilocytic astrocytoma. Journal of Neurosurgery {J-NEUROSURG}, 1994, Vol/Iss/Pg. 81/1 (24-30) , ISSN: 0022-3085. Mamelak-A-N, Prados-M-D, Obana-W-G, Cogen-P-H, Edwards-M-S-B. Department of Neurological Surgery, c/o The Editorial Office, 1360 Ninth Avenue, San Francisco, CA 94122, United States. Treatment options and prognosis for multicentric juvenile pilocytic astrocytoma. Journal of Neurosurgery {J-NEUROSURG}, 1994, Vol/Iss/Pg. 81/1 (24-30) , ISSN: 0022-3085.

Active substance: PROCARBAZINE

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Document reference: 34781

Study title: Van-Eys-J, Cangir-A. Dept. Ped., M.D. Anderson Hosp., Houston, Tex. 77030, United States. Chemotherapy for childhood brain tumors. Journal of Pediatrics {J-PEDIATR}, 1978, Vol/Iss/Pg. 93/3 (544-546).Van-Eys-J, Cangir-A. Dept. Ped., M.D. Anderson Hosp., Houston, Tex. 77030, United States. Chemotherapy for childhood brain tumors. Journal of Pediatrics {J-PEDIATR}, 1978, Vol/Iss/Pg. 93/3 (544-546).

Active substance: PROCARBAZINE

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Document reference: 34868

Study title: Van-Eys-J. Dept. Ped., Univ. Texas Syst. Cancer Cent., M.D. Anderson Hosp. Tum. Inst., Houston, Tex., United States. Chemotherapy for gliomas in children. Cancer Bulletin {CANCER-BULL}, 1975, Vol/Iss/Pg. 27/1 (16-19).Van-Eys-J. Dept. Ped., Univ. Texas Syst. Cancer Cent., M.D. Anderson Hosp. Tum. Inst., Houston, Tex., United States. Chemotherapy for gliomas in children. Cancer Bulletin {CANCER-BULL}, 1975, Vol/Iss/Pg. 27/1 (16-19).

Active substance: PROCARBAZINE

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Document reference: 34869

Study title: Report in Clinical documentation for Marketing Authorisation Application (June 1987): Efficacy and tolerability of teicoplanin in infections caused by Gram-positive organisms - Del Favero A. - 28 November 1985Report in Clinical documentation for Marketing Authorisation Application (June 1987): Efficacy and tolerability of teicoplanin in infections caused by Gram-positive organisms - Del Favero A. - 28 November 1985

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY Gram positive - Del Favero.xls

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Document reference: 44318

Study title: Report in Clinical documentation for Marketing Authorisation Application (June 1987): Evaluation of therapeutic efficacy and tolerability of teicoplanin in serious infections caused by Gram-positive micro-organisms - Martino - 28 November 1985Report in Clinical documentation for Marketing Authorisation Application (June 1987): Evaluation of therapeutic efficacy and tolerability of teicoplanin in serious infections caused by Gram-positive micro-organisms - Martino - 28 November 1985

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY Serious infections - Martino.xls

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Document reference: 44320

Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Clinical Pharmacology of teicoplanin in children - Milner R.D.G., Whincup G. - 1985Report in Clinical documentation for Marketing Autorisation Application (June 1987): Clinical Pharmacology of teicoplanin in children - Milner R.D.G., Whincup G. - 1985

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY pharmacological.xls

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Document reference: 44315

Study title: A multi-center, 6-week, open label study to document the visual treatment characteristics of Elidel (pimecrolimus) cream 1% (twice daily application) by photography in patients >2 years old in the treatment of mild to moderate atopic dermatitis.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2314 Art45 listing 2011.xls

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Document reference: 34089

Study title: A multicenter , non-interventional study about pimecrolimus 1 % cream, to measure the drug consumption and cosmetical tolerability in the treatment of mild or moderate atopic dermatitis

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CHU03 Art45 listing 2011.xls

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Document reference: 34113

Study title: A prospective, open label proof of concept study

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CBE01 Art45 listing 2011.xls

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Document reference: 48117

Study title: A randomized, double-blind, multicenter study of the blood concentrations, safety and efficacy of 1% SDZ ASM981 cream administered up to four times daily in adolescents and adults with atopic dermatitis

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CUS01 Art45 listing 2011.xls

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Document reference: 34138

Study title: A randomized, multi-center, parallel-group, double-blind, vehicle-controlled study to evaluate the time of pruritus improvement during the first week of pimecrolimus cream 1% treatment in patients >2 years old with mild to moderate atopic dermatitis.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CUS08 Art45 listing 2011.xls

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Document reference: 34104

Study title: A Retrospective Analysis of Elidel (pimecrolimus cream 1%) for the Treatment of Facial Vitiligo.

Active substance: PIMECROLIMUS

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Document reference: 47708

Study title: A single-centre, randomised, double-blind, placebo-controlled pilot study of cross-over design testing nifedipine in patients with cystic fibrosis.

Active substance: NIFEPIDINE

Study summary document link (including results): Bayer Pharma_Nifedipine_1123_study_synopsis.pdf

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Document reference: 32631

Study title: A study to determine the effect of nifedipine (Adalat Retard) on early renal allograft function and cyclosoprin nephrotoxicity.

Active substance: NIFEPIDINE

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Document reference: 32633

Study title: "DRUCKSENKUNG DER PULMONALEN HYPERTENSION DURCH BAYA1040, SUBLINGUAL, IM RAHMEN VON BRONCHOPULMONALER DYSPLASIE BEI KINDERN UNTER 2 JAHRE"

Active substance: NIFEPIDINE

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Document reference: 32635

Study title: Open, non controlled, non randomised, unicenter pilot study to investigate the long-term efficacy of Adalat® drops and Adalat® retard 10 mg tablets in children with pulmonary hypertension and with peripheral pulmonary stenosis

Active substance: NIFEPIDINE

Study summary document link (including results): Bayer Pharma_Nifedipine_1555_study_synopsis.pdf

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Document reference: 32632

Study title: "PILOTSTUDIE: LANGZEITWIRKUNG VON ADALAT TROPFEN UND ADALAT RETARD BEI KINDERN MIT PULMONALER HYPERTONIE UND PERIPHEREN PULMONALSTENOSEN."

Active substance: NIFEPIDINE

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Document reference: 32636

Study title: Dr. Benezis Essai contrôle en double aveugle etablissant l'efficacité et la tolerance de l'acide niflumique gélule par rapport au placébo et au diclofenac dans les tendinites du membre inférieur.

Active substance: NIFLUMIC ACID

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Document reference: 32637

Study title: Dr. M. Chelly.Essai controle en ouvert evaluant l'efficacitè et la tolèrance du morniflumate suppositoire enfant versus alpha-amylase sirop dans les angines.

Active substance: NIFLUMIC ACID

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Document reference: 32638

Study title: A propos du traitement des diarrhées aiguës du nourrisson.Essai d’un nouvel antiseptique intestinal : le 27.109 R.C - Riedweg M, Herlier M. - 1964 (J. Méd. Lyon, 5 Mai 1964) - Publication in Clinical Expert Report - Lassale C. - July 1998 -

Active substance: NIFUROXAZIDE

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Document reference: 47065

Study title: Clinical Expert Statement - Renewal of the MA for Nifuroxazide Capsules - Guigen S. & Verdoncq B. - 15/11/2007

Active substance: NIFUROXAZIDE

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Document reference: 47067

Study title: Recherche d'une éventuelle absorption digestive du nifuroxazide au cours des gastro-entérites aigues infantiles - Colle M. Battin J. Guinebault P. - 16/07/85

Active substance: NIFUROXAZIDE

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Document reference: 47070

Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Efficacy and tolerability of teicoplanin in infections caused by Gram-positive organisms - Martinetto P. - 22 November 1985Report in Clinical documentation for Marketing Autorisation Application (June 1987): Efficacy and tolerability of teicoplanin in infections caused by Gram-positive organisms - Martinetto P. - 22 November 1985

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY Gram positive - Martinetto.xls

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Document reference: 44319

Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Evaluation of therapeutic efficacy and tolerability of teicoplanin in serious infections caused by Gram-positive micro-organisms - Terragna A. - 28 November 1985Report in Clinical documentation for Marketing Autorisation Application (June 1987): Evaluation of therapeutic efficacy and tolerability of teicoplanin in serious infections caused by Gram-positive micro-organisms - Terragna A. - 28 November 1985

Active substance: TEICOPLANIN

Study summary document link (including results): Teicoplanin STUDY Serious infections - Terragna.xls

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Document reference: 44321

Study title: AD on face: A 6-month study with 3 week randomized, multicenter, double blind, vehicle-controlled, parallel phase followed by 23 week open-label phase to study the safety and efficacy of 1% SDS ASM981 cream in pediatric subjects with atopic dermatitis

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CES01 Art45 listing 2011.xls

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Document reference: 34102

Study title: An investigator initiated study to explore the effectiveness of pimecrolimus cream 1% used twice daily (BID) for the treatment of facial vitiligo

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CUS28 Art45 listing 2011.xls

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Document reference: 48121

Study title: Graf et al. Ten days' Use of Oxymetazoline Nasal Spray With or Without Benzalkonium Chloride in Patients With Vasomotor Rhinits. Arch Otolaryngol Head Neck Surg 1999; 125: 1128-1132Graf et al. Ten days' Use of Oxymetazoline Nasal Spray With or Without Benzalkonium Chloride in Patients With Vasomotor Rhinits. Arch Otolaryngol Head Neck Surg 1999; 125: 1128-1132

Active substance: OXYMETAZOLINE

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Document reference: 33042

Study title: Graf, Hallén. Effect on the Nasal Mucosa of Long-Term Treatment With Oxymetazoline, Benzalkonium Chloride, and Placebo Nasal Sprays. Laryngoscope 1996; 106:605-609Graf, Hallén. Effect on the Nasal Mucosa of Long-Term Treatment With Oxymetazoline, Benzalkonium Chloride, and Placebo Nasal Sprays. Laryngoscope 1996; 106:605-609

Active substance: OXYMETAZOLINE

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Document reference: 33041

Study title: Semmelmayer 1972Semmelmayer 1972

Active substance: OXYMETAZOLINE

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Document reference: 33040

Study title: Treatment of trachoma in the West Bank. Chumbley LC, Viswalingam ND, Thomson IM, Zeidan MA. Eye. 1988;2 ( Pt 5):471-5.Treatment of trachoma in the West Bank. Chumbley LC, Viswalingam ND, Thomson IM, Zeidan MA. Eye. 1988;2 ( Pt 5):471-5.

Active substance: OXYTETRACYCLINE

Study summary document link (including results): Treatment of trachoma in the West Bank. Chumbley LC, Viswalingam ND, Thomson IM, Zeidan MA. Eye. 1988;2 ( Pt 5)471-5.pdf

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Document reference: 33043

Study title: Study of a 3-hour paclitaxel infusion in children with refractory solid tumours: a SFOP study.Doz F; Gentet J C et al. British journal of cancer Mar 2 2001, 84 (5) p604-10 , Study of a 3-hour paclitaxel infusion in children with refractory solid tumours: a SFOP study.Doz F; Gentet J C et al. British journal of cancer Mar 2 2001, 84 (5) p604-10 ,

Active substance: PACLITAXEL

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Document reference: 33044

Study title: Study PALIOROS-PSZ-1001 is a multicenter, open-label, single- and multiple-dose study in subjects aged 10 to 17 years, inclusive, diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder to evaluate pharmcokinetics and tolerability.

Active substance: PALIPERIDONE

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Document reference: 45719

Study title: Infantile spasms. A retrospective study of 105 cases.

Active substance: NITRAZEPAM

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Document reference: 32658

Study title: Short-term nonhormonal and nonsteroid treatment in West syndrome. Short-term nonhormonal and nonsteroid treatment in West syndrome.

Active substance: NITRAZEPAM

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Document reference: 32650

Study title: Bortone L, Picetti E, Mergoni M. Anaesthesia with sevoflurane in children: Nitrous oxide does not increase postoperative vomiting. Paediatric Anaesthesia. 2002; 12(9):775-9. Bortone L, Picetti E, Mergoni M. Anaesthesia with sevoflurane in children: Nitrous oxide does not increase postoperative vomiting. Paediatric Anaesthesia. 2002; 12(9):775-9.

Active substance: NITROUS OXIDE

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Document reference: 32663

Study title: Byhahn C, Strouhal U, Westphal K. The anaesthesiologist's occupational exposure to sevoflurane and nitrous oxide during inhalation mask induction and general anaesthesia in paediatric anaesthesia. Anaesthesiologie und Reanimation. 2000; 25(1):12-6. Byhahn C, Strouhal U, Westphal K. The anaesthesiologist's occupational exposure to sevoflurane and nitrous oxide during inhalation mask induction and general anaesthesia in paediatric anaesthesia. Anaesthesiologie und Reanimation. 2000; 25(1):12-6.

Active substance: NITROUS OXIDE

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Document reference: 32664

Study title: Teicoplanin in the treatment of gram positive infections in paediatric patients. (Abstract) In: Abstracts of the 7th mediterranean congress of chemotherapy. - Becker L, Fell JJ, Dieterich HA. -Barcelona, 20-25 May 1990: 183.Teicoplanin in the treatment of gram positive infections in paediatric patients. (Abstract) In: Abstracts of the 7th mediterranean congress of chemotherapy. - Becker L, Fell JJ, Dieterich HA. -Barcelona, 20-25 May 1990: 183.

Active substance: TEICOPLANIN

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Document reference: 44326

Study title: A 4-week repeated dose toxicity study of HMR3647 administered orally to young Beagle dogs followed by a 4-weeek recovery period

Active substance: telithromycin

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Document reference: 41545

Study title: A 4-week repeated dose toxicity study of HMR3647 administered to young rats

Active substance: telithromycin

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Document reference: 41544

Study title: Activity of telithromycin against erythromycin susceptible and resistant Streptococcus pyogenes and Streptococcus pneumoniae isolates from paediatric origin

Active substance: telithromycin

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Document reference: 41554

Study title: Activity of telithromycin and comparators against paediatric respiratory tract infection (RTI) isolates collected across Canada over the past 3 years (1997-1998, 1998-1999, and 1999-2000)

Active substance: telithromycin

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Document reference: 41558

Study title: Activity of telithromycin on clinical isolates of Streptococcus pyogenes and Streptococcus pneumoniae from paediatric patients in different regions of Italy

Active substance: telithromycin

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Document reference: 41553

Study title: Determination of the susceptibility of isolates of Streptococcus pneumoniae and Streptococcus pyogenes, from paediatric patients, to telithromycin and comparator compounds and identification of the mechanism of resistance in erythromycin A-resistant strains

Active substance: telithromycin

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Document reference: 41551

Study title: Evaluation of pharmacokinetics, safety, efficacy and acceptability of HMR3647 (20mg/kg and 30mg/kg q.d.) in pediatric patients with infection (a non-blind, randomised, parallel-group comparative study)

Active substance: telithromycin

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Document reference: 41572

Study title: Evaluation of telithromycin on acute otitis media in an experimental animal model (chinchilla)

Active substance: telithromycin

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Document reference: 41563

Study title: Evaluation of the Safety, Efficacy, Pharmacokinetics and Acceptability of HMR 3647 20 mg/kg QD for 5 Days with Acute Otitis Media in Children(Multicenter, open label, non comparative study)

Active substance: telithromycin

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Document reference: 41574

Study title: Evaluation of the Safety, Pharmacokinetics, Efficacy and Acceptability of HMR 3647 20mg/kg QD for 5-7 Days with Community Acquired Pneumonia (CAP) in children. (Multicenter, open label, non comparative study)

Active substance: telithromycin

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Document reference: 41573

Study title: Experimental studies of otitis media due to Streptococcus pneumoniae treated with HMR3647

Active substance: telithromycin

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Document reference: 41562

Study title: HMR3647: Exploratory 7-day oral toxicity study in Sprague Dawley juvenile rats (from postnatal day 5)

Active substance: telithromycin

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Document reference: 41546

Study title: HMR3647: Single-dose toxicokinetic study in neonatal Sprague Dawley rats

Active substance: telithromycin

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Document reference: 41543

Study title: In vitro actibity of telithromycin (HMR3647) against Streptococcus pyogenes and Streptococcus pneumoniae clinical isolates from paediatric patients in Greece

Active substance: telithromycin

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Document reference: 41552

Study title: In vitro activity of antimicrobial agents against Streptococcus pyogenes in paediatrics : a Belgian multicenter study

Active substance: telithromycin

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Document reference: 41560

Study title: In vitro activity of telithromycin (HMR3647) against strains of S.pneumoniae and S. pyogenes isolated in Iceland and comparison with other antimicrobials

Active substance: telithromycin

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Document reference: 41556

Study title: In vitro activity of telithromycin and multiple comparison antibiotics against recent clinical isolates from children

Active substance: telithromycin

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Document reference: 41559

Study title: In vitro activity of telithromycin, including well characterized erythromycin. A - resistant clinical isolates of S. pneumoniae and S.pyogenes in paediatrics

Active substance: telithromycin

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Document reference: 41549

Study title: McNeely JK, Buczulinski B, Rosner DR. Severe neurological impairment in an infant after nitrous oxide anesthesia. Anesthesiology. 2000; 93(6):1549-50. McNeely JK, Buczulinski B, Rosner DR. Severe neurological impairment in an infant after nitrous oxide anesthesia. Anesthesiology. 2000; 93(6):1549-50.

Active substance: NITROUS OXIDE

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Document reference: 32667

Study title: PA Averley, NM Girdler, S Bond, N Steen, J Steele. A randomised controlled trial of paediatric conscious sedation for dental treatment using intravenous midazolam combined with inhaled nitrous oxide or nitrous oxide⁄sevoflurane. Anaesthesia, 2004, 59, pages 844–852 PA Averley, NM Girdler, S Bond, N Steen, J Steele. A randomised controlled trial of paediatric conscious sedation for dental treatment using intravenous midazolam combined with inhaled nitrous oxide or nitrous oxide⁄sevoflurane. Anaesthesia, 2004, 59, pages 844–852

Active substance: NITROUS OXIDE

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Document reference: 32669

Study title: Selzer RR, Rosenblatt DS, Laxova R, Hogan K. Adverse effect of nitrous oxide in a child with 5,10-methylenetetrahydrofolate reductase deficiency. New England Journal of Medicine. 2003; 349(1):45-50. Selzer RR, Rosenblatt DS, Laxova R, Hogan K. Adverse effect of nitrous oxide in a child with 5,10-methylenetetrahydrofolate reductase deficiency. New England Journal of Medicine. 2003; 349(1):45-50.

Active substance: NITROUS OXIDE

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Document reference: 32671

Study title: Abdelkefi A, Abdennebi YB, Mellouli F, Othman TB, Torjman L, Ladeb S, Aouf S, Béjaoui M, Abdeladhim AB. Effectiveness of fixed 50% nitrous oxide oxygen mixture and EMLA cream for insertion of central venous catheters in children. Pediatr Blood Cancer 2004;43;777-779

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32673

Study title: Annequin D, Carbajal R, Chauvin P, Gall O, Tourniaire B, Murat I. Fixed 50% nitrous oxide oxygen mixture for painful procedures: A French survey. Pediatrics 2000 Apr;105(4):E47.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32675

Study title: Baskett PJF, Hyland J, Deane M, Wray G. Analgesia for burns dressing in children. A dose-finding study for phenoperidine and droperidol with and without 50 per cent nitrous oxide and oxygen. Br J Anaesth 1969 Aug;41(8):684-8.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32676

Study title: Berge TI. Acceptance and side effects of nitrous oxide oxygen sedation for oral surgical procedures. Acta Odontol Scand 1999 Aug;57(4):201-6.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32678

Study title: Burton JH, Auble TE, Fuchs SM. Effectiveness of 50% nitrous oxide/50% oxygen during laceration repair in children. Acad Emerg Med 1998 Feb;5(2):112-7.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32681

Study title: Investigation of the efficacy, safety and acceptability of HMR 3647 (1-g divided 20% fine granule packets) in paediatric patients with infections ( a multi-center collaborative single-group non blinded study)

Active substance: telithromycin

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Document reference: 41575

Study title: macrolide-resistant streptococci among pediatric patients in Denmark, Luxemburg, The Netherlands and Turkey

Active substance: telithromycin

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Document reference: 41548

Study title: Minimal inhibittory concentrations of telithromycin (Ketek) against Streptococcus pneumoniae, Heamophilus influenzae and Moraxella catarrhalis strains isolated from specimen of young patients (17 years old or less) and from specimen of adults (18 years old and older)

Active substance: telithromycin

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Document reference: 41557

Study title: Multicenter, Phase II, open-label study of the efficacy, safety, acceptability, and pharmacokinetics of telithromycin, after repeated oral administration of either of two doses, once daily, for 5 days or 7 to 10 days, in the treatment of respiratory tracts infections in children of 6 months to 12 years

Active substance: telithromycin

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Document reference: 41569

Study title: Multicenter, Phase II, open-label study of the efficacy, safety, acceptability, and pharmacokinetics of telithromycin, following administration of 20mg/kg once daily, for 5 days in the treatment of acute otitis media in children

Active substance: telithromycin

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Document reference: 41570

Study title: Multicenter, Phase II, open-label study of the efficacy, safety, acceptability, and pharmacokinetics of telithromycin, following administration of 15mg/kg twice daily, for 5 days in the treatment of acute otitis media in children

Active substance: telithromycin

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Document reference: 41571

Study title: Open Study to determine the concentration of telithromycin in middle ear fluid and plasma in infants/children with otitis media with effusion after multiple oral administration of 20mg/kg, once daily for 5 days or 15mg/kg twice daily for 4.5/5 days of telithromycin pediatric suspension

Active substance: telithromycin

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Document reference: 41568

Study title: Open Study to determine the concentration of telithromycin in the extracellular and intracellular compartments of middle ear fluid in children with acute otitis media or otitis media with spontaneous effusion after single oral administration of a telithromycin pediatric suspension

Active substance: telithromycin

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Document reference: 41567

Study title: Pattern of killing of telithromycin and azithromycin against various strains of Streptococcus pneumoniae

Active substance: telithromycin

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Document reference: 41561

Study title: Pharmacokinetics of Telithromycin (HMR3647) in infants and children suffering from bacterial lower respiratory tract infections after single oral administration of 30mg/kg of a telithromyucin suspension (50mg/ml)

Active substance: telithromycin

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Document reference: 41565

Study title: Susceptibility of 1034 Streptococcus pneumoniae and 1039 Streptococcus pyogenes strains from paediatric patients in ten central and eastern European contries to telithromycin, erythromycin A, azithromycin, clarithromycin, clindamycin, levofloxacin, quinupristin/dalfopristin, and penicillin G

Active substance: telithromycin

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Document reference: 41555

Study title: Telithromycin : epidemiological multicenter study on macrolide resistance of S.pneumoniae and S.pyogenes in the pediatric population in Germany, 2000- 2001

Active substance: telithromycin

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Document reference: 41550

Study title: Telithromycin epidemiological survey in Austria isolates from paediatric patients

Active substance: telithromycin

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Document reference: 41547

Study title: U.S Survey of Telithromycin Activity against Streptococcus pyogenes

Active substance: telithromycin

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Document reference: 41564

Study title: A double blind, parallel, multicenter comparison of tenoxicam with naproxene in the treatment of children and adolescents suffering from Juvenile Chronic Arthritis (JCA).

Active substance: TENOXICAM

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Document reference: 44339

Study title: Open-label 40 weeks extension of study S-12159 to follow-up the long-term tolerability and efficacy of tenoxicam in children and adolescents suffering from juvenile rheumatoid arthritis (JRA) treated for up to one year.

Active substance: TENOXICAM

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Document reference: 44338

Study title: Open-label short-term study to find the adequate dosage tenoxicam for the treatment of children and adolescents suffering from juvenile rheumatoid arthritis.

Active substance: TENOXICAM

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Document reference: 44337

Study title: A randomized, investigator-blinded, parallel, single dose, multicenter study to compare for eight hours the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets (20-30 mg/kg) compared to regular strength, conventional release acetaminophen pediatric chewable tablets (10-25 mg/kg) in the treatment of febrile children. Jan 1990.A randomized, investigator-blinded, parallel, single dose, multicenter study to compare for eight hours the efficacy and side effects profile of sustained release acetaminophen pediatric chewable tablets (20-30 mg/kg) compared to regular strength, conventional release acetaminophen pediatric chewable tablets (10-25 mg/kg) in the treatment of febrile children. Jan 1990.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33338

Study title: A single dose study to compare the efficacy of acetaminophen elixir dosed at 10-15 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Feb 1992.A single dose study to compare the efficacy of acetaminophen elixir dosed at 10-15 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Feb 1992.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33325

Study title: Burow et al. Kopflausbefall in Deutschland: Korrelation zwischen Häufigkeit des "Resistenz-Gens" und klinischer Wirksamkeit von 0,5 % Permethrin-Lösung. Kinder- und Jugendarzt 2010;41(3):224-228Burow et al. Kopflausbefall in Deutschland: Korrelation zwischen Häufigkeit des "Resistenz-Gens" und klinischer Wirksamkeit von 0,5 % Permethrin-Lösung. Kinder- und Jugendarzt 2010;41(3):224-228

Active substance: PERMETHRIN

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Document reference: 33897

Study title: Hamm et al. Treatment of scabies with 5 % permethrin cream: results of a German multicenter study. J Dtsch Dermatol Ges 2006;4(5): 407-413Hamm et al. Treatment of scabies with 5 % permethrin cream: results of a German multicenter study. J Dtsch Dermatol Ges 2006;4(5): 407-413

Active substance: PERMETHRIN

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Document reference: 33896

Study title: Fujii Y. Anti-emetic efficacy of prophylactic granisetron compared with perphenazine for the prevention of post-operative vomiting in children (Eur J Anesthesiol 1999; 16: 304-307)Fujii Y. Anti-emetic efficacy of prophylactic granisetron compared with perphenazine for the prevention of post-operative vomiting in children (Eur J Anesthesiol 1999; 16: 304-307)

Active substance: PERPHENAZINE

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Document reference: 33898

Study title: Splinter W. Prophylaxis for vomiting by children after tonsillectomy: dexamethasone versus perphenazine (Anest Analg 19976; 85: 534-537Splinter W. Prophylaxis for vomiting by children after tonsillectomy: dexamethasone versus perphenazine (Anest Analg 19976; 85: 534-537

Active substance: PERPHENAZINE

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Document reference: 33900

Study title: Splinter WM. Perphenazine decreases vomiting by children after tonsillectomy (Can J Anesth 1997; 44 /12): 1308-1310)Splinter WM. Perphenazine decreases vomiting by children after tonsillectomy (Can J Anesth 1997; 44 /12): 1308-1310)

Active substance: PERPHENAZINE

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Document reference: 33899

Study title: Splinter WM. Prophylaxis for vomiting by children after tonsillectomy: ondansetron versus perphenazine (Br J Anesthesia 1998; 80: 155-158)Splinter WM. Prophylaxis for vomiting by children after tonsillectomy: ondansetron versus perphenazine (Br J Anesthesia 1998; 80: 155-158)

Active substance: PERPHENAZINE

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Document reference: 33901

Study title: Abdeladhim AB. Effectiveness of fixed 50% nitrous oxide oxygen mixture and EMLA cream for insertion of central venous catheters in children. Pediatr Blood Cancer 2004;43;777-779

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32674

Study title: Constant I, Abbas M, Boucheseiche S, Laude D, Murat I. Non-invasive assessment of cardiovascular autonomic activity induced by brief exposure to 50% nitrous oxide in children. Br J Anaesth 2002;88(5):637-43.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32683

Study title: Dunn-Russell T, Adair SM, Sams DR, Russell CM, Barenie JT. Oxygen saturation and diffusion hypoxia in children following nitrous oxide sedation. Pediatr Dent 1993 Mar-Apr;15(2):88-92.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32684

Study title: Ekbom K, Jakobsson J, Marcus C. Nitrous oxide inhalation is a safe and effective way to facilitate procedures in paediatric outpatient departments. Arch Dis Child 2005;90:1073-1076.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32685

Study title: Erbe RW, Salis RJ. Severe methylenetetrahydrofolate reductase deficiency, methionine synthase, and nitrous oxide – A cautionary tale. N Engl J Med 2003;349(1):5-6.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32686

Study title: Evans JK, Buckley SL, Alexander AH, Gilpin AT. Analgesia for the reduction of fractures in children: A comparison of nitrous oxide with intramuscular sedation. J Pediatr Orthop 1995 Jan-Feb;15(1):73-7.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32687

Study title: Fauroux B, Onody P, Gall O, Tourniaire B, Koscielny S, Clément A. The efficacy of premixed nitrous oxide and oxygen for fiberoptic bronchoscopy in paediatric patients: A randomised, double-blind, controlled study. Chest 2004 Jan;125(1):315-21.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32688

Study title: Fishman G, Botzer E, Marouani N, DeRowe A. Nitrous oxide-oxygen inhalation for outpatient otologic examination and minor procedures performed on the uncooperative child. International Journal of Pediatric Otorhinolaryngology 2005;69:501-504.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32690

Study title: Gall O, Annequin D, Benoit G, Van Glabeke E, Vrancea F, Murat I. Adverse events of premixed nitrous oxide and oxygen for procedural sedation in children. Lancet 2001;358:1514-15.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32692

Study title: Griffin GC, Campbell VD, Jones R. Nitrous oxide-oxygen sedation for minor surgery. JAMA 1981 June 19;245(23):2411-2413.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32695

Study title: Hennrikus WL, Shin AY, Klingelberger CE. Self-administered nitrous oxide and a haematoma block for analgesia in the Outpatient reduction of fractures in children. J Bone Joint Surg 1995;77A(3);335-339

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32698

Study title: Hennrikus WL, Simpson RB, Klingelberger CE, Reis MT. Self-administered nitrous oxide analgesia for pediatric fracture reductions. J Pediatr Orthoped 1994;14:538-542.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32699

Study title: Single dose pharmacokinetic study of tenoxicam in children and adolescents ruffering from Juvenile Rheumathoid Arthritis (JRA).

Active substance: TENOXICAM

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Document reference: 44340

Study title: Jones, 1995: overview of six clinical studies, 152 children were evaluated for efficacy, 196 for tolerability.

Active substance: TERBINAFINE

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Document reference: 44342

Study title: Nejjam et al, 1996: 12 children 5-11 years old

Active substance: TERBINAFINE

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Document reference: 44343

Study title: OPEN STUDY TO DETERMINE THE EFFICACY OF 62.5 MG/D TERBINAFINE IN THE TREATMENT OF CHILDREN WITH TINEA CAPITIS.

Active substance: TERBINAFINE

Study summary document link (including results): SFE302 E-00 001MR.xls

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Document reference: 44352

Study title: Study 2 - Jones, 1995: overview of six clinical studies, 152 children were evaluated for efficacy, 196 for tolerability.

Active substance: TERBINAFINE

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Document reference: 44345

Study title: Study 3 - Nejjam et al, 1996: 12 children 5-11 years old.

Active substance: TERBINAFINE

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Document reference: 44346

Study title: TO EVALUATE THE EFFICACY AND SAFETY OF A SINGLE ORAL DOSE OF 2.25 GM OF STM & PRABENECID 1 GM WITH AND WITHOUT PROBENECIDE IN THE TREATMENT OF GONORRHEA.

Active substance: SULTAMICILLIN

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Document reference: 43062

Study title: "Ospolot bei Kindern mit BNS. Prüferinitiierte Studie". Publication: Debus EM, Kurlemann G., Epilepsia 2004; 45/2: 103 - 108

Active substance: SULTIAME

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Document reference: 43065

Study title: Experimentation clinique du 1403RD chez l'enfant - Delagrange - 10/08/68

Active substance: SULTOPRIDE

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Document reference: 43066

Study title: Sultopiride study in paediatric psychiatry - Delagrange - 02/08/89

Active substance: SULTOPRIDE

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Document reference: 43067

Study title: GCV/93/006 A Double-Blind study to compare the efficacy & safety of oral sumatriptan (50mg-100mg)

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-S2CT40-ICHE3.pdf

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Document reference: 43071

Study title: A multicentre randomised, parallel group, double-blind phase III comparison between iodixanol (VISIPAQUE) 270 mg I/ml and 320 mg I/ml, and iohexol (Omnipaque) 300 mg I/ml Trial No. DXV037 (date Dec 1995)

Active substance: IODIXANOL

Study summary document link (including results): DXV037 Redacted.pdf

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Document reference: 48208

Study title: Jackson D. A trial of premixed nitrous oxide and oxygen in dental anaesthesia in children. Brit J Anaesth 1975;39;161-164

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32701

Study title: Kanagasundaram SA, Lane LJ, Cavalletto BP, Keneally JP, Cooper MG. Efficacy and safety of nitrous oxide in alleviating pain and anxiety during painful procedures. Arch Dis Child 2001;84:492-495.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32702

Study title: Lassen HCA, Henriksen E, Neukirch F, Kristensen HS. Severe bone marrow depression after prolonged nitrous oxide anaesthesia. Lancet 1956;April;527-530

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32704

Study title: Luhmann JD, Kennedy RM, Jaffe DM, McAllister JD. Continuous-flow delivery of nitrous oxide and oxygen: A safe and cost-effective technique for inhalation analgesia and sedation of pediatric patients. Pediatric Emergency Care 1999;15(6):388-392.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32706

Study title: McNeely JK, Buczulinski B, Rosner D. Severe neurological impairment in an infant after nitrous oxide anesthesia. Anesthesiology 2000;93(6);1549-1550

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32708

Study title: Selzer RR, Rosenblatt DS, Laxova R, Hogan K. Adverse effect of nitrous oxide in a child with 5,10-methylenetetrahydrofolate reductase deficiency. N Engl J Med 2003;349:45-50.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32709

Study title: Vetter TR. A comparison of EMLA cream versus nitrous oxide for pediatric venous cannulation. J Clin Anesth 1995;7;486-490

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32710

Study title: Wilson KE, Girdler NM, Welbury RR. Randomized, controlled, crossover clinical trial comparing intravenous midazolam sedation with nitrous oxide sedation in children undergoing dental extractions. British Journal of Anaesthesia 2003 Dec;91(6):850-856.

Active substance: NITROUS OXIDE AND OXYGEN

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Document reference: 32711

Study title: A Prospective Registry of European Hemophilia B Patients Receiving BeneFIX (Nonacog Alfa, Recombinant Human Factor IX) for Usual Use

Active substance: NONACOG ALFA

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Document reference: 41494

Study title: In Vitro Evaluation of Allergic Reactions in hemophilia B Subjects who have Exhibited a Systemic Allergic Response after Exposure to BeneFIX (Nonacog Alfa; recombinant Factor IX)

Active substance: NONACOG ALFA

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Document reference: 41496

Study title: A. Huber: Which contraceptive for adolescents? Sexualmedizin 9; 154-157 (1980)

Active substance: NONOXINOL-9

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Document reference: 32719

Study title: H. Brehm, W. Haase: The alternative to hormonal contraception?, Med. Welt 26 (N.F.; 1610-1617 (1975)

Active substance: NONOXINOL-9

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Document reference: 32717

Study title: J. Dimpfl, W. Salomon, K.-H. Schicketanz: The sperizidal barrier. Sexualmedizin 13; 95-98 (1984) J.Balmer, P.Hartmann, K.-H Schicketanz: Sexual behaviour during intravaginal contraception. Sexualmedizin 15: 244-248 (1986)

Active substance: NONOXINOL-9

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Document reference: 32720

Study title: A Multicenter, Open‑Label Study to Compare On‑Demand Treatment With 2 Prophylaxis Regimens of Recombinant Coagulation Factor IX (BeneFIX) Reformulated Drug Product (rFIX‑R) in Subjects With Severe Hemophilia B

Active substance: NONACOG ALFA

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Document reference: 41495

Study title: Comparison of Bricanyl depot tablets 5 mg and ordinary tablets 2.5 mg in children with bronchial asthma.

Active substance: TERBUTALINE

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Document reference: 44395

Study title: GCV/93/008 A Double-Blind study to compare the efficacy & safety of oral Sumartriptan (50mg or 100mg) in the treatment of migraine in adolescents

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-S2CT37-ICHE3.pdf

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Document reference: 43070

Study title: GCV/96/007 A double-blind,randomised,placebo-controlled study to compare the safety & efficacy of oral sumatriptan (25mg,50mg, &100mg) in the acute treatment of migraine in adolescents.

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-SUMB2003-ICHE3.pdf

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Document reference: 43080

Study title: GM1997/00059/00 An open design study to evalute repeat dose oral sumatriptan 100mg in the acute treatment of adolescent migraine during a six month period.

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-SUMB3005-ICHE3.pdf

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Document reference: 43081

Study title: RM1998/00017/00 A double blind placebo controlled parallel group study to evaluate three dose levels (5mg, 10mg and 20mg) of sumatripaten nasal spray in the acute treatment of a single migraine attack in adolescent migraineurs (12-17 yrs of age).

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-SUMA3005-ICHE3.pdf

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Document reference: 43078

Study title: RM2003/00271/00 A double blind placebo controlled, parallel group study to evaluate two dose levels (5mg and 20mg) of sumatriptan nasal spray in the acute treatment of a single migraine attack in adolescent migraineurs (12-17 yrs).

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-SUM30045-ICHE3.pdf

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Document reference: 43073

Study title: UCR/96/001 A randomised,double-blind,placebo-controlled study of the safety & efficacy of 25mg,50mg, &100mg oral sumatriptan in adolescent migraine subjects.

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-SUMA2002-ICHE3.pdf

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Document reference: 43077

Study title: Lecha M, 2005: Tacalcitol in the treatment of psoriasis vulgaris: the Spanish experience. (556 patients aged 6-86 years; 6 % <18 years)

Active substance: TACALCITOL

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Document reference: 43083

Study title: publication : Golnick (1998) German study on 5205 patients including 153 children between 5 and 18 years

Active substance: TACALCITOL

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Document reference: 43082

Study title: GCV/92/005 An in-clinical pilot study to examine the safety & efficacy of oral GR43175 (50mg or 100mg)

Active substance: SUMATRIPTAN

Study summary document link (including results): Sumatriptan-S2CP46-ICHE3.pdf

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Document reference: 43069

Study title: Norfloxacin interferes with cyclosporine disposition in pediatric patients undergoing renal transplantation; Clin. Pharmacol. Ther. 1995 Sep. 58(3): 322-327

Active substance: NORFLOXACIN

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Document reference: 32721

Study title: Post-marketing surveillance study 2006-2007 on specific immunotherapy with NHD Mites/Pollen preparations in a Cluster-doseescalationregimen. Age of patients: 4-65 Years

Active substance: NovoHelisenDepot Mites/Pollen

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Document reference: 47787

Study title: A 24-week open – label randomized cross-over study to monitor the plasma phenylalanine concentrations of subjects with phenylketonuria, aged 8 to 30 years, using Aminogran 1g tablets supplement to manage at least 50% of their protein substitute requirements or using standard diet supplement (Aminogran 1g tablets excluded)

Active substance: NUTRIENTS WITHOUT PHENYLALANINE

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Document reference: 32722

Study title: Alban J.Current therapeutic research 1972; 14(4):158-161 Efficacy of nystatin topical cream in the management of cutaneous candidiasis in infants PMID: 4623594 http://www.ncbi.nlm.nih.gov/pubmed?term=4623594 Alban J.Current therapeutic research 1972; 14(4):158-161 Efficacy of nystatin topical cream in the management of cutaneous candidiasis in infants PMID: 4623594 http://www.ncbi.nlm.nih.gov/pubmed?term=4623594

Active substance: Nystatin

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Document reference: 45239

Study title: Kozinn PJ. et al.: Treatment of cutaneous candidiasis in infancy and childhood with nystatin and amphotericin B. Antibiotics Annual 1956/57:128-13Kozinn PJ. et al.: Treatment of cutaneous candidiasis in infancy and childhood with nystatin and amphotericin B. Antibiotics Annual 1956/57:128-13

Active substance: NYSTATIN

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Document reference: 32727

Study title: Munz D, Powell KR, Pai CH: Treatment of candidal diaper dermatitis: double blind placebo controlled com¬parison of topical nystatin with topical plus oral nystatin. J Pediatr 101 1022 – 1025 (1982)Munz D, Powell KR, Pai CH: Treatment of candidal diaper dermatitis: double blind placebo controlled com¬parison of topical nystatin with topical plus oral nystatin. J Pediatr 101 1022 – 1025 (1982)

Active substance: NYSTATIN

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Document reference: 32729

Study title: Comparison of Bricanyl depot tablets 5 mg b.i.d. and ordinary tablets 2.5 mg t.i.d. in children with bronchial asthma.

Active substance: TERBUTALINE

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Document reference: 44394

Study title: Comparison of Bricanyl depot tablets 5 mg b.i.d. and ordinary tablets 2.5 mg t.i.d. in children with bronchial asthma.

Active substance: TERBUTALINE

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Document reference: 44432

Study title: Comparison of Bricanyl(R) depot tablets 5 mg b.i.d. with ordinary oral ß-agonist treatment b.i.d. in children with bronchial asthma.

Active substance: TERBUTALINE

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Document reference: 44396

Study title: Treatment of Pneumocystis carinii pneumonitis. Siegel, S.E., Wolff, L.J., Baehner, R.L. and Hammond D. (1984) American Journal of Disease of Children 138:1051-1054Treatment of Pneumocystis carinii pneumonitis. Siegel, S.E., Wolff, L.J., Baehner, R.L. and Hammond D. (1984) American Journal of Disease of Children 138:1051-1054

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45837

Study title: A Phase 3, Randomized, Double-Blind Study Comparing Twice Daily FK506 Cream 0.03% Versus Cream Vehicle in the Treatment of Atopic Dermatitis in Pediatric Subjects

Active substance: Tacrolimus

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Document reference: 47773

Study title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Once Daily 0.3% FK506 Gel Versus Gel Vehicle in the Treatment of Psoriasis -

Active substance: Tacrolimus

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Document reference: 41601

Study title: Tacrolimus ointment is effective for facial and intertriginous psoriasis ( J Am Acad Dermatol 2004;51:723-30.) -

Active substance: Tacrolimus

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Document reference: 41602

Study title: Golnick (1998) German study on 5205 patients including 153 children between 5 and 18 years

Active substance: TALCACITOL MONOHYDRATE (EFALIZUMAB)

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Document reference: 36704

Study title: Acker JC, Bossen EH, Halperin EC. The management of desmoid tumors. International Journal of Radiation Oncology Biology Physics 1993; 26(5) 851-858.Acker JC, Bossen EH, Halperin EC. The management of desmoid tumors. International Journal of Radiation Oncology Biology Physics 1993; 26(5) 851-858.

Active substance: TAMOXIFEN

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Document reference: 43158

Study title: Observational use study of the tolerability of Octenisept in premature infants with a gestational age of less than 27 weeks, at the Department of Neonatology of the Charite Campus Virchow Clinic.(Director: Prof. Dr. med. Michael Obladen.2002.

Active substance: OCTENIDINE

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Document reference: 32734

Study title: Use of 2% 2-phenoxyethanol and 0.1% octenidine as antiseptic in premature newborn infants of 23-26 weeks gestation. C. Buhrer, S. Bahr, J. Siebert, R. Wettstein, C. Geffers and M. Obladen. Journal of Hospital Infection (2002) 51: 305-307.Use of 2% 2-phenoxyethanol and 0.1% octenidine as antiseptic in premature newborn infants of 23-26 weeks gestation. C. Buhrer, S. Bahr, J. Siebert, R. Wettstein, C. Geffers and M. Obladen. Journal of Hospital Infection (2002) 51: 305-307.

Active substance: OCTENIDINE

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Document reference: 41626

Study title: Use of Octenisept for pre-operative skin and mucous membrane antisepsis and for supportive wound and suture treatment in small children and babies. UNIV-KLINIK FUR CHIRURGIE.1998.

Active substance: OCTENIDINE

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Document reference: 32737

Study title: Schendekehl TK. Therapie und Verlauf der Juvenilen Hyperthyreose, Schweiz Med Wochenschr 1997; 127 (Suppl 87): Abstract 51 Schendekehl TK. Therapie und Verlauf der Juvenilen Hyperthyreose, Schweiz Med Wochenschr 1997; 127 (Suppl 87): Abstract 51

Active substance: OBIDOXIME

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Document reference: 32733

Study title: "Addendum to the clinical expert report, Local and systemic tolerability in babies and premature infants. Author: Priv. Doz. Dr. med. E. Sebastian Debus.2003. "

Active substance: OCTENIDINE

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Document reference: 32735

Study title: Bereston ES: Nystatin in the treatment of Candida albicans infections South Med J 50 547-550. (1957)Bereston ES: Nystatin in the treatment of Candida albicans infections South Med J 50 547-550. (1957)

Active substance: NYSTATIN

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Document reference: 29021

Study title: Observational study of the use of Octenisept on babies and neonates at the Pediatric Clinic of Gera Hospital.1996.

Active substance: OCTENIDINE

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Document reference: 32738

Study title: Optimal inhalation flow rate for Bricanyl(R) Turbuhaler powder inhaler 0.25 mg/dose in asthmatic children.

Active substance: TERBUTALINE

Study summary document link (including results): Terbutaline Bricanyl 01-2110 interventional.xls

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Document reference: 44406

Study title: Hemoclar-rapport final d'étude : essai pilote del'hémoclar (CB 8061) dans la néphrose de l'enfant.C 327A - Kieffer G. - 23/06/1987

Active substance: PENTOSAN

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Document reference: 45841

Study title: Blood radioactivity profile and whole body autoradiography in infant and adult rats following oral administration of 14C-BL 191 - Wheatley-Brown - 31/05/1985

Active substance: PENTOXYFILLINE

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Document reference: 45842

Study title: Disposition of pentoxifylline in neonatal rats in relation to its pharmacological effect - Tabata - 2/05/1988

Active substance: PENTOXYFILLINE

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Document reference: 45843

Study title: Group B strepto-coccus induces tumor necrosis factor in neonatal piglets: Effect of the tumor necrosis factor inhibitor pentoxifylline on haemodynamics and gas exchange. Am. Rev. Respir. Dis. 143:598-604 - Gibson - 1991 - Publication in pharmacological-toxicological expert reportGroup B strepto-coccus induces tumor necrosis factor in neonatal piglets: Effect of the tumor necrosis factor inhibitor pentoxifylline on haemodynamics and gas exchange. Am. Rev. Respir. Dis. 143:598-604 - Gibson - 1991 - Publication in pharmacological-toxicological expert report

Active substance: PENTOXYFILLINE

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Document reference: 45844

Study title: Pentoxifylline reduces ventilatory disturbances in experimental meconium aspiration. Annual meeting of the pediatric societies, Balimore. Ped Research. 51, n°4 Part 2: 394A - Kohonen - April 2002 - Publication in NDA Annual Report -Pentoxifylline reduces ventilatory disturbances in experimental meconium aspiration. Annual meeting of the pediatric societies, Balimore. Ped Research. 51, n°4 Part 2: 394A - Kohonen - April 2002 - Publication in NDA Annual Report -

Active substance: PENTOXYFILLINE

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Document reference: 45845

Study title: Pharmacokinetic and tolerability assessment of a pediatric oral formulation of pentoxifylline in Kawasaki disease. Current-Ther-research,64;2:96-115 - Best-Brookie - February 2003 - Publication in NDA Annual Report -Pharmacokinetic and tolerability assessment of a pediatric oral formulation of pentoxifylline in Kawasaki disease. Current-Ther-research,64;2:96-115 - Best-Brookie - February 2003 - Publication in NDA Annual Report -

Active substance: PENTOXYFILLINE

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Document reference: 45846

Study title: Progressive hearing loss in hearing impaired children: immediate results of antiphlogistic-rheologic infusion therapy. Michael Streppel, Claus Wittekindt, Hasso von Wedel, Martin Walger, Hans Jakob Schondorf, Olaf Michel, Eberhard Stennert. International Journal of Pediatric Otorhinolaryngology 57 (2001) 129-136

Active substance: PENTOXYFILLINE

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Document reference: 45848

Study title: A 12 week multi-center study consisting of a 6 week double-blind, randomized, vehicle controlled, parallel group phase, followed by a 6 week open label phase, to assess the efficacy and safety of Elidel Cream 1% in mild to moderate head and neck atopic dermatitis patients (2-11 years of age, inclusive) intolerant of topical corticosteroids.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2440 Art45 listing 2011.xls

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Document reference: 34091

Study title: Etude de l'efficacité et de la tolérance de l'ofloxacine en solution auriculaire dans le traitement des otorrhées purulentes de l'enfant sur aérateur transtympanique, sur cavité d'évidement et sur otite chronique à tympan ouvert. - Dr Narcy - Fev. 1995

Active substance: OFLOXACIN

Study summary document link (including results): Ofloxacin STUDY FD.93.280.04.xls

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Document reference: 32745

Study title: John W.Warren et al., Guidelines fro Antimicrobial Treatment of Uncomplicated Acute Bacterial Cystitis and Acute Pyelonephritis in Women, Clinical Infectious Diseases, 1999; 29:745-58

Active substance: OFLOXACIN

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Document reference: 32757

Study title: John W.Warren et al., Guidelines fro Antimicrobial Treatment of Uncomplicated Acute Bacterial Cystitis and Acute Pyelonephritis in Women, Clinical Infectious Diseases, 1999; 29:745-58

Active substance: Ofloxacin

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Document reference: 32767

Study title: Metabolic fate of DL 8280. Distribution of DL-8280 to articular cartilage in immature dog after multiple administration. - TACHIZAWA - 26 March 1985 (ofloxacin Daiichi Dossier)

Active substance: OFLOXACIN

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Document reference: 32746

Study title: Special Toxicity : Effects of orally administered DL-8280 on diarthric joints of immature dogs (no effect dose level and reversibility of arthropathy). - 0N0 - 6 Apr. 1984 (ofloxacin Daiichi Dossier)

Active substance: OFLOXACIN

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Document reference: 32752

Study title: Special Toxicity : Effects of orally administered DL-8280 on the knee and elbow joints of immature rats. - ONO - 26 Jul. 1982 (ofloxacin Daiichi Dossier)

Active substance: OFLOXACIN

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Document reference: 32754

Study title: Special Toxicity : Joint toxicity of DR-3355 in Juvenile Rats: Comparison with DR-3354 and Ofloxacin. - Michiyuki Kato - 1990 (Levofloxacin MAA Initial - MRP Dossier - Vol. 46: 167-183)

Active substance: OFLOXACIN

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Document reference: 32755

Study title: Ofloxacin Auricular Solution : Clinical Expert Report - Dr Ichou - Fev. 1995

Active substance: OFLOXACIN

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Document reference: 32748

Study title: A 12 week multicenter study consisting of a 6 week double blind, randomized, vehicle controlled, parallel group phase, followed by a 6 week open label phase, to assess the safety and efficacy of Elidel® Cream 1% in mild to moderate head and neck atopic dermatitis of patients intolerant of topical corticosteroids

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2442 Art45 listing 2011.xls

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Document reference: 34092

Study title: A 12-week open-label, multicenter, effectiveness and safety study of Elidel (pimecrolimus) cream 1% in subjects with atopic dermatitis.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CEG01 Art45 listing 2011.xls

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Document reference: 34098

Study title: A 20-week study with a 4 week randomized, multi-center, double-blind, vehicle-controlled, parallel-group phase followed by a 12 week open label phase and a 4 week follow-up phase to study the efficacy and safety of 1% SDZ ASM981 cream in pediatric subjects with atopic dermatitis and to collect information about the time and extent of relapse.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CDE04 Art45 listing 2011.xls

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Document reference: 34093

Study title: A 26-week, randomized, multicenter, parallel-group, double-blind, vehicle-controlled study to evaluate the incidence of atopic dermatitis flares when ASM981 (pimecrolimus) cream 1% is used at the first signs and/or symptoms of atopic dermatitis and its safety and tolerability in children and adolescents 2 - 17 years of age

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2406 Art45 listing 2011.xls

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Document reference: 34132

Study title: A 27 week study, 3 week randomized, multicenter, double blind, parallel group, vehicle control and 24 week open label phase, to evaluate efficacy , tolerability and safety, of ASM 981 (pimecrolimus) cream 1% in pediatric patients with mild to moderate atopic dermatitis in face

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981MX01 Art45 listing 2011.xls

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Document reference: 34099

Study title: Prevention of early otorrhea in ventilation tubes Epstein JS, Beane J, Hubbell R. Otolaryngol Head Neck Surg. 1992 Dec;107(6 Pt 1): 758-62 "This prospective randomized study of 430 children, ages 6 months to 15 years, examined the efficacy of sulfacetamide/prednisolone otic drops used for 3 days postoperatively in reducing the incidence of otorrhea at 1 week after the placement of Donaldson tubes" Prevention of early otorrhea in ventilation tubes Epstein JS, Beane J, Hubbell R. Otolaryngol Head Neck Surg. 1992 Dec;107(6 Pt 1): 758-62 "This prospective randomized study of 430 children, ages 6 months to 15 years, examined the efficacy of sulfacetamide/prednisolone otic drops used for 3 days postoperatively in reducing the incidence of otorrhea at 1 week after the placement of Donaldson t...

Active substance: SULFACETAMIDE

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Document reference: 42875

Study title: Efficacy and Safety of Olanzapine in Patients with Borderline Personality Disorder: A Randomized, Flexible-Dose, Double-Blind Comparison with Placebo

Active substance: OLANZAPINE

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Document reference: 32759

Study title: The Use of Remestyp in the Paediatric Gynecology treating Juvenile MetrorrhagiaJ. Hořejší, Československá gynekologie 1980, 45 (5): 292-294The Use of Remestyp in the Paediatric Gynecology treating Juvenile MetrorrhagiaJ. Hořejší, Československá gynekologie 1980, 45 (5): 292-294

Active substance: TERLIPRESSIN

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Document reference: 44439

Study title: Briet, E et al. The prophylactiv treatment of hemophilia B Leyden with anabolic steroids. Ann. Intern. Med. 1985; 103: 225-226.Ann. Intern. Med. 1985; 103: 225-226Briet, E et al. The prophylactiv treatment of hemophilia B Leyden with anabolic steroids. Ann. Intern. Med. 1985; 103: 225-226.Ann. Intern. Med. 1985; 103: 225-226

Active substance: TESTOSTERONE UNDECANOATE

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Document reference: 44441

Study title: Endres W, et al. Priapism in Fabry's disease during testosterone treatment. Klin Wochenschr 1987;65:925; Klin Wochenschr 1987;65:925Endres W, et al. Priapism in Fabry's disease during testosterone treatment. Klin Wochenschr 1987;65:925; Klin Wochenschr 1987;65:925

Active substance: TESTOSTERONE UNDECANOATE

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Document reference: 44440

Study title: Arch.Dis.Child 2007;92:585-588.Arch.Dis.Child 2007;92:585-588.

Active substance: TETRACOSACTIDE

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Document reference: 44460

Study title: Brain Dev. 1996;18:456-460.Brain Dev. 1996;18:456-460.

Active substance: TETRACOSACTIDE

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Document reference: 44479

Study title: Kinsey VE. Cooperative study of retrolental fibroplasia and the use of oxygen. Arch Ophthalmol 1956;56:481-543. Kinsey VE. Cooperative study of retrolental fibroplasia and the use of oxygen. Arch Ophthalmol 1956;56:481-543.

Active substance: OXYGEN

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Document reference: 45405

Study title: Macey PM, Woo MA, Harper RM. Hyperoxic brain effects are normalized by addition of CO2. PLoS Med. 2007 May;4(5):e173Macey PM, Woo MA, Harper RM. Hyperoxic brain effects are normalized by addition of CO2. PLoS Med. 2007 May;4(5):e173

Active substance: OXYGEN

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Document reference: 45420

Study title: Neonatal inhaled nitric oxide study group. Inhaled nitric oxide in full term and nearly full term infants with hypoxic respiratory failure. NEJM 1997 Feb 27; 336(9):597-604.Neonatal inhaled nitric oxide study group. Inhaled nitric oxide in full term and nearly full term infants with hypoxic respiratory failure. NEJM 1997 Feb 27; 336(9):597-604.

Active substance: OXYGEN

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Document reference: 45406

Study title: Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968; 42:565-589Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968; 42:565-589

Active substance: OXYGEN

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Document reference: 45409

Study title: Christensen LA, Fallingborg J, Jacobson BA, " Bioavailability of 5-aminosalicylic acid from slow release 5-aminosalicylic acid drug and sulfasalasine in normal children." Did Dis Sci 38 (1993) 1831-1836Christensen LA, Fallingborg J, Jacobson BA, " Bioavailability of 5-aminosalicylic acid from slow release 5-aminosalicylic acid drug and sulfasalasine in normal children." Did Dis Sci 38 (1993) 1831-1836

Active substance: SULFASALAZINE

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Document reference: 42877

Study title: Emery HM; Curr Opin Rheumatol (United States), Sep 1993, 5(5) p629-33 Treatment of juvenile rheumatoid arthritis.Emery HM; Curr Opin Rheumatol (United States), Sep 1993, 5(5) p629-33 Treatment of juvenile rheumatoid arthritis.

Active substance: SULFASALAZINE

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Document reference: 42883

Study title: Gedalia A, Barash J, Press J, et al. Clin Rheumatol (Belgium), Dec 1993, 12(4) p511-4; Sulphasalazine in the treatment of pauciarticular-onset juvenile chronic arthritis. Gedalia A, Barash J, Press J, et al. Clin Rheumatol (Belgium), Dec 1993, 12(4) p511-4; Sulphasalazine in the treatment of pauciarticular-onset juvenile chronic arthritis.

Active substance: SULFASALAZINE

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Document reference: 42884

Study title: Hertzberger-ten Cate R, Cats A ; Clin Exp Rheumatol (Italy), Jan-Feb 1991, 9(1) p85-8; Toxicity of sulfasalazine in systemic juvenile chronic arthritis.Hertzberger-ten Cate R, Cats A ; Clin Exp Rheumatol (Italy), Jan-Feb 1991, 9(1) p85-8; Toxicity of sulfasalazine in systemic juvenile chronic arthritis.

Active substance: SULFASALAZINE

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Document reference: 42885

Study title: Huang JL, Chen LC.; Clin Rheumatol 1998;17(5):359-63; Sulphasalazine in the treatment of children with chronic arthritis.Huang JL, Chen LC.; Clin Rheumatol 1998;17(5):359-63; Sulphasalazine in the treatment of children with chronic arthritis.

Active substance: SULFASALAZINE

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Document reference: 42886

Study title: Huang JL, Hung IJ, Hsieh KH.; Asian Pac J Allergy Immunol 1997 Jun;15(2):71-5; Sulphasalazine therapy in chronic uveitis of children with chronic arthritis.Huang JL, Hung IJ, Hsieh KH.; Asian Pac J Allergy Immunol 1997 Jun;15(2):71-5; Sulphasalazine therapy in chronic uveitis of children with chronic arthritis.

Active substance: SULFASALAZINE

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Document reference: 42887

Study title: Ilowite NT; Pediatrics (United States), Jan 2002, 109(1) p109-15. Current treatment of juvenile rheumatoid arthritis.Ilowite NT; Pediatrics (United States), Jan 2002, 109(1) p109-15. Current treatment of juvenile rheumatoid arthritis.

Active substance: SULFASALAZINE

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Document reference: 42888

Study title: Neuroimmunomodulation. 2006;13:56-62.Neuroimmunomodulation. 2006;13:56-62.

Active substance: TETRACOSACTIDE

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Document reference: 44464

Study title: Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6Cedrato−A−E et al. (Comparison of the antipyretic effect of a single dose of dipyrone, paracetamol and diclofenac resinate. A multicenter clinical trial). {Medicina−B−Aires}, 1989, vol. 49, no. 6, p. 635−6

Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID

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Document reference: 33249

Study title: Gehri−Mario et al. When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm−World−Sci}, Jun 2005, vol. 27, no. 3, p. 254−7Gehri−Mario et al. When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm−World−Sci}, Jun 2005, vol. 27, no. 3, p. 254−7

Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID

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Document reference: 33270

Study title: Braunsteiner A*,Habermacher B: Clinical acceptability, tolerability and efficacy of BACTRIM syrup (Ro 06-2580/103) in children. An open uncontrolled study. Final study report. Dr. Eggenberger, Yverdon, Switzerland. 16.04.1985

Active substance: Sulfamethoxazole trimethoprim

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Document reference: 45243

Active substance: Sulfamethoxazole trimethoprim

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Document reference: 45244

Active substance: Sulfamethoxazole trimethoprim

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Document reference: 45245

Active substance: Sulfamethoxazole trimethoprim

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Document reference: 45246

Study title: Braunsteiner A*,Habermacher B: Clinical acceptability, tolerability and efficacy of BACTRIM syrup (Ro 06-2580/103) in children. An open uncontrolled study. Final study report by Dr. D'Aruzzo, Mendrisio/Switzerland. 10.05.1985

Active substance: Sulfamethoxazole trimethoprim

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Document reference: 45247

Study title: Havas L: DOSAGE OF PHARMACEUTICALS IN CHILDREN B-0054340

Active substance: Sulfamethoxazole trimethoprim

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Document reference: 45251

Study title: Bondesen S, Nielsen OH, Schou JB, Jensen PH, Lassen LB, Binder V, Krasilnikoff PA, Dano P, Honore Hansen S, Norby Rasmussen S, Hvidberg EF. Steady-state kinetics of 5-aminosalicylic acid and sulphapyridine during sulfasalazine prophylaxis in ulcerative colitis. Scan J Gastroent 21 (1986) 693-700.Bondesen S, Nielsen OH, Schou JB, Jensen PH, Lassen LB, Binder V, Krasilnikoff PA, Dano P, Honore Hansen S, Norby Rasmussen S, Hvidberg EF. Steady-state kinetics of 5-aminosalicylic acid and sulphapyridine during sulfasalazine prophylaxis in ulcerative colitis. Scan J Gastroent 21 (1986) 693-700.

Active substance: SULFASALAZINE

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Document reference: 42897

Study title: Cromolyn sodium in the treatment of children with severe, perennial asthma - BA. Berman et al. - 1975 (Pediatrics vol 55) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 -

Active substance: NEDOCROMIL

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Document reference: 47028

Study title: Effects of nedocromil sodium on exercise induced bronchoconstriction exacerbated by inhalation of cold air - S. Oseid et al. - 1995 (Scand J Med Sci Sports vol 5) - Publication in Nedocromil sodium HFA- 227- metered dose inhaler-Part IV clinical Documentation - no author- 26/03/1998 -

Active substance: NEDOCROMIL

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Document reference: 47003

Study title: Randomised prospective masked study comparing patient comfort following the instillation of topical proxymetacaine and amethocaine. Shafi T, Koay P. Br J Ophthalmol. 1998 Nov;82(11):1285-7. Randomised prospective masked study comparing patient comfort following the instillation of topical proxymetacaine and amethocaine. Shafi T, Koay P. Br J Ophthalmol. 1998 Nov;82(11):1285-7.

Active substance: TETRACAINE

Study summary document link (including results): Randomised prospective masked study comparing patient comfort following the instillation of topical proxymetacaine and amethocaine. Shafi T.pdf

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Document reference: 44445

Study title: Subconjunctival bupivacaine versus topical amethocaine in strabismus surgery. Habib NE, el-Kasaby HT, Marczak AM, Hsuan J. Eye. 1993;7 ( Pt 6):757-9. Subconjunctival bupivacaine versus topical amethocaine in strabismus surgery. Habib NE, el-Kasaby HT, Marczak AM, Hsuan J. Eye. 1993;7 ( Pt 6):757-9.

Active substance: TETRACAINE

Study summary document link (including results): Subconjunctival bupivacaine versus topical amethocaine in strabismus surgery. Habib NE, el-Kasaby HT, Marczak AM, Hsuan J. Eye. 1993;7.pdf

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Document reference: 44447

Study title: Topical amethocaine in strabismus surgery. Watson DM. Anaesthesia. 1991 May;46(5):368-70.Topical amethocaine in strabismus surgery. Watson DM. Anaesthesia. 1991 May;46(5):368-70.

Active substance: TETRACAINE

Study summary document link (including results): Topical amethocaine in strabismus surgery. Watson DM. Anaesthesia. 1991 May;46(5)368-70.pdf

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Document reference: 44448

Study title: Yeo E, Miller JH. Pulmonary gallium-67 uptake in diffuse pulmonary calcinosis. Pediatr Radiol. 1996 Nov;26(11):825-6. Yeo E, Miller JH. Pulmonary gallium-67 uptake in diffuse pulmonary calcinosis. Pediatr Radiol. 1996 Nov;26(11):825-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43557

Study title: Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43391

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44148

Study title: Publication in NDA Annual Report: Inhibition of meconium induced activation of granulocytes from neonates and adults by pentoxifylline. - Klin -Padiatr. 214(6): 347-52 - Tegtmeyer - Nov-Dec 2002Publication in NDA Annual Report: Inhibition of meconium induced activation of granulocytes from neonates and adults by pentoxifylline. - Klin -Padiatr. 214(6): 347-52 - Tegtmeyer - Nov-Dec 2002

Active substance: PENTOXYFILLINE

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Document reference: 45847

Study title: Antitussive effect of carbetapentane (toclase) to infantile respiratory tract disturbances.

Active substance: PENTOXYVERINE

Study summary document link (including results): ARCE92G0601 - Pentoxyverine.pdf

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Document reference: 45854

Study title: Antitussive wirkung von pentoxyverin. eine randomisierte kontrollierte doppelblindstudie.

Active substance: PENTOXYVERINE

Study summary document link (including results): ARCD94F2701 - Pentoxyverine.pdf

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Document reference: 45850

Study title: Anwendung von Sedotussin Suppositorien (8 mg) bei Sauglingen und Kleinkindern mit Husten verschiedener genese. integrieter Abschlussbericht.

Active substance: PENTOXYVERINE

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Document reference: 45855

Study title: Clinical study;Administration of Sedotussin to infants and young children. Final evaluation and expert report involving 5,024 patients.

Active substance: PENTOXYVERINE

Study summary document link (including results): ARCE94C1701(2) - Pentoxyverine.pdf

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Document reference: 47360

Study title: Experimentation du sirop ucb 2543 expectorant chez l'enfant.

Active substance: PENTOXYVERINE

Study summary document link (including results): DF68B006 - Pentoxyverine.pdf

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Document reference: 45856

Study title: Expertise clinique du sirop "uc 2543" des laboratoire ucepha.

Active substance: PENTOXYVERINE

Study summary document link (including results): ARCF92G0616 - Pentoxyverine.pdf

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Document reference: 45851

Study title: Expertise clinique du sirop "uc-2543 - expectorant" des laboratoires UCEPHA.

Active substance: PENTOXYVERINE

Study summary document link (including results): ARCF99D1205 - Pentoxyverine.pdf

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Document reference: 45849

Study title: Final report of the study of the possible relation between pentoxyverin dispensing and respiratory depression in children.

Active substance: PENTOXYVERINE

Study summary document link (including results): DE85C261 - Pentoxyverine.pdf

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Document reference: 45852

Study title: Hustenbehandlung bei akuten und chronisch entzundlichen Erkrankungen der Atemwege im sauglings- und kindesalter mit Sedotussin Expectorans Sauglingszapfchen.

Active substance: PENTOXYVERINE

Study summary document link (including results): DID88H112.pdf

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Document reference: 45858

Study title: Open, single-dose, phase i study to evaluate the pharmacokinetic parameters of pentoxyverine and its major metabolites in plasma and urine of children with upper respiratory tract infection.

Active substance: PENTOXYVERINE

Study summary document link (including results): 9738 - Pentoxyverine - MRCE99K0801.pdf

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Document reference: 45861

Study title: Pentoxyverine effectively controls irritating cough in preschool children.

Active substance: PENTOXYVERINE

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Document reference: 45853

Study title: Tableau synoptique des essais avec le produit : "sirop expectoclase".

Active substance: PENTOXYVERINE

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Document reference: 45857

Study title: Besedovsky A, Li BUK. Across the developmental continuum of irritable bowel syndrome: Clinical and pathophysiologic considerations. CURR GASTROENTEROL REP 2004; 6(3): 247−253

Active substance: Peppermint Oil 0.200 ml

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Document reference: 40115

Study title: Brooks CD; J Rheumatol (Canada), Apr 2001, 28(4) p845-53; Sulfasalazine for the management of juvenile rheumatoid arthritis.Brooks CD; J Rheumatol (Canada), Apr 2001, 28(4) p845-53; Sulfasalazine for the management of juvenile rheumatoid arthritis.

Active substance: SULFASALAZINE

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Document reference: 42880

Study title: Chiang. Chronic duodenal ulcer in children: clinical observation and response to treatment. J Pediatr Gastroenterol Nutr 1989; 8: 161-165. Chiang. Chronic duodenal ulcer in children: clinical observation and response to treatment. J Pediatr Gastroenterol Nutr 1989; 8: 161-165.

Active substance: SUCRALFATE

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Document reference: 42607

Study title: Dr. Nagita's study reported in 1986 14 Children (9 boys and 5 girls, from 1-year-old to 13-year-old) Gastric ulcer or duodenal ulcer treated by Ulcerlmin (Sucralfate)Dr. Nagita's study reported in 1986 14 Children (9 boys and 5 girls, from 1-year-old to 13-year-old) Gastric ulcer or duodenal ulcer treated by Ulcerlmin (Sucralfate)

Active substance: SUCRALFATE

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Document reference: 42611

Study title: Hermans . Primary duodenogastric reflux in children and adolescents. Eur J Pediatr 2003; 162: 598-602. Hermans . Primary duodenogastric reflux in children and adolescents. Eur J Pediatr 2003; 162: 598-602.

Active substance: SUCRALFATE

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Document reference: 42604

Study title: Shenep JL. Efficacy of oral sucralfate suspension in prevention and treatment of chemotherapy-induced mycositis. J Pediatr 1988; 113: 758-763. Shenep JL. Efficacy of oral sucralfate suspension in prevention and treatment of chemotherapy-induced mycositis. J Pediatr 1988; 113: 758-763.

Active substance: SUCRALFATE

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Document reference: 42603

Study title: Long -term effects of budesonide or nedocromil in children with asthma. The Childhood Asthma Management Program Research Group - no author -2000 ( N-Engl-J-Med) - Publication in Clinical Expert Statement - Renewal application for : Nedocromil-Sodium (all formulations) - DR. Rolf Ohlrogge - 08/12/2005 -

Active substance: NEDOCROMIL

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Document reference: 47034

Study title: Nedocromil sodium (FPL 59002KP) Safety evaluation - Summary of safety evaluation studies SE 5660/7, January 1987

Active substance: NEDOCROMIL

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Document reference: 47020

Study title: Nedocromil sodium for chronic asthma in children. - A-V. Sridhar et al. - 2006 (Cochrane database of systematics review vol 3) - Publication in Nedocromil Sodium CFC-free Inhaler Corporate Data Sheet - no author - 25/06/2003 -

Active substance: NEDOCROMIL

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Document reference: 47039

Study title: Nedocromil sodium in adults with asthma dependent on inhaled corticosteroids - MF. Bone et al. - 1989 ( Thorax vol 44) - Publication in Product licence application TILADE MINT AEROSOL (nedocromil sodium) -Clinical documentation -29/08/1995 -

Active substance: NEDOCROMIL

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Document reference: 47040

Study title: Nedocromil sodium Safety evaluation- Summary of safety evaluation studies- B. Clark- 01/ 1987 - Publication in Product licence application TILADE MINT AEROSOL (nedocromil sodium) - Pre Clinical documentation -29/08/1995 -

Active substance: NEDOCROMIL

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Document reference: 47007

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

Study summary document link (including results):

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Document reference: 44195

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44242

Study title: Yilmaz M, Yilmaz K, Celen Z, Sirikci A, Ozkiliç S, Zincirkeser S. Bilateral symmetrically increased Tc-99m MDP cranial uptake in Hurler syndrome. Clin Nucl Med. 2002 Dec;27(12):915. No abstract available. Yilmaz M, Yilmaz K, Celen Z, Sirikci A, Ozkiliç S, Zincirkeser S. Bilateral symmetrically increased Tc-99m MDP cranial uptake in Hurler syndrome. Clin Nucl Med. 2002 Dec;27(12):915. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43427

Study title: Yoffe N, Besser MI, Sobel JD, Front D. [Early diagnosis of pyogenic sacroiliac infection using 67-gallium scintigram] Harefuah. 1983 Jan 16;104(2):55-6. Hebrew. No abstract available. Yoffe N, Besser MI, Sobel JD, Front D. [Early diagnosis of pyogenic sacroiliac infection using 67-gallium scintigram] Harefuah. 1983 Jan 16;104(2):55-6. Hebrew. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44052

Study title: Two cases of pediatric bone disease (eosinophilic granuloma and Brodie's abscess) showing similar scintigraphic and radiographic findings. Yoshikawa M, Sugawara Y, Kikuchi T, Nakata S, Mochizuki T, Ikezoe J, Sakayama K. Clin Nucl Med. 2000 Dec;25(12):986-90.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43466

Study title: A 3 week randomized, multicenter, double blind, vehicle-controlled, parallel-group study to evaluate the efficacy and safety of Pimecrolimus cream 1% in children between 2-12 years with mild to moderate atopic dermatitis (Speed Study)

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CES02 Art45 listing 2011.xls

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Document reference: 34103

Study title: A 3-month open label study assessing the efficacy and tolerability of Elidel (pimecrolimus) cream 1% in patients with mild or moderate atopic dermatitis

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CSA01 Art45 listing 2011.xls

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Document reference: 34116

Study title: A 3-month open label, national, Quality of Life and safety study with Elidel (pimecrolimus) cream 1% in children (2-12 years) with atopic dermatitis

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CZA01 Art45 listing 2011.xls

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Document reference: 34119

Study title: A 6-month open label, multi-national, effectiveness, and safety study of Elidel® (pimecrolimus) Cream, 1% in subjects with atopic dermatitis

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2405 Art45 listing 2011.xls

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Document reference: 34133

Study title: A 6-month open label, multi-national, effectiveness, and safety study of Elidel® (pimecrolimus) Cream, 1% in subjects with atopic dermatitis

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2405 Art45 listing 2011.xls

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Document reference: 34134

Study title: A 6-month study of the utility of Elidel cream 1% in the long-term management of pediatric patients with severe AD

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CDE10 Art45 listing 2011.xls

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Document reference: 34095

Study title: A 6-week open label, national, post-marketing surveillance program to obtain photographic documentation of mild to moderate atopic eczema lesions before and after treatment with Elidel (pimecrolimus) cream 1% in children from 2 years and above and adults with atopic ezcema

Active substance: PIMECROLIMUS

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Document reference: 34120

Study title: Yildizdas D. Occurrence of ventilator-associated pneumonia in mechanically ventilated pediatric intensive care patients during stress ulcer prophylaxis with Sucralfate, ranitidine, and omeprazole. J Crit Care 2002; 17: 240-245. Yildizdas D. Occurrence of ventilator-associated pneumonia in mechanically ventilated pediatric intensive care patients during stress ulcer prophylaxis with Sucralfate, ranitidine, and omeprazole. J Crit Care 2002; 17: 240-245.

Active substance: SUCRALFATE

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Document reference: 42606

Study title: Comparison of intranasal midazolam and sufentanil premedication pediatric outpatients. Clinical Pharmacology and Therapeutics 59, p. 314-348, 1996Comparison of intranasal midazolam and sufentanil premedication pediatric outpatients. Clinical Pharmacology and Therapeutics 59, p. 314-348, 1996

Active substance: SUFENTANYL

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Document reference: 42622

Study title: Fentanly versus sufentanil: plasma concentrations during continuous epidural postoerative infusion in children. British Journal of Anaethesia 85, p.615-617, 2000Fentanly versus sufentanil: plasma concentrations during continuous epidural postoerative infusion in children. British Journal of Anaethesia 85, p.615-617, 2000

Active substance: SUFENTANYL

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Document reference: 42621

Study title: Safety evaluation - Dentomint : Summary of toxicité - Publication in Product licence application TILADE MINT AEROSOL (nedocromil sodium) - Pre Clinical documentation -29/08/1995 -

Active substance: NEDOCROMIL

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Document reference: 47013

Study title: The addition of nedocromil sodium to maintenance therapy in the management of patients with bronchial ashma - AJ. Williams et al. - 1986 (Eur J Resp Dis vol 69) - Publication in Product licence application TILADE MINT AEROSOL (nedocromil sodium) -Clinical documentation -29/08/1995 -

Active substance: NEDOCROMIL

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Document reference: 47045

Study title: Yu JQ, Zhuang H, Posteraro A, Reddy S, Alavi A. Transiently increased MDP activity in the soft tissue of lower extremity caused by iliofemoral venous thrombosis. Clin Nucl Med. 2005 Nov;30(11):742-3. No abstract available. Yu JQ, Zhuang H, Posteraro A, Reddy S, Alavi A. Transiently increased MDP activity in the soft tissue of lower extremity caused by iliofemoral venous thrombosis. Clin Nucl Med. 2005 Nov;30(11):742-3. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43383

Study title: Yui N, Kinoshita F, Akiyama Y, Koakutsu M, Umeda T. [Clinical evaluation of transaxial bone imaging with 99mTc-phosphate compounds] Radioisotopes. 1982 Oct;31(10):521-8. Japanese. Yui N, Kinoshita F, Akiyama Y, Koakutsu M, Umeda T. [Clinical evaluation of transaxial bone imaging with 99mTc-phosphate compounds] Radioisotopes. 1982 Oct;31(10):521-8. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44069

Study title: Unusual bone scan of a child with osteogenesis imperfecta. Yurekli Y, Erdogan S, Cullu E. Clin Nucl Med. 2003 Feb;28(2):156. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43429

Study title: Yurtkuran M, Yurtkuran M, Alp A, Sivrioglu K, Dilek K, Tamgaç F, Alper E, Tunali S, Saricaoğlu H, Nasircilar A. Hand involvement in Behçet's disease. Joint Bone Spine. 2006 Dec;73(6):679-83. Epub 2006 Mar 15. Yurtkuran M, Yurtkuran M, Alp A, Sivrioglu K, Dilek K, Tamgaç F, Alper E, Tunali S, Saricaoğlu H, Nasircilar A. Hand involvement in Behçet's disease. Joint Bone Spine. 2006 Dec;73(6):679-83. Epub 2006 Mar 15.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43377

Study title: Zebedin D, Fotter R, Reittner P, Preidler KW, Mache C, Szolar DH. [Chronic recurrent multifocal osteomyelitis of the lower jaw] Rofo. 1998 Nov;169(5):551-4. German. No abstract available. Zebedin D, Fotter R, Reittner P, Preidler KW, Mache C, Szolar DH. [Chronic recurrent multifocal osteomyelitis of the lower jaw] Rofo. 1998 Nov;169(5):551-4. German. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43521

Study title: A dermal embryo-fetal development study in rats

Active substance: PIMECROLIMUS

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Document reference: 34126

Study title: Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968;42:565-589Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968;42:565-589

Active substance: OXYGEN

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Document reference: 45415

Study title: Tay-Uyboco JS, Kwiatkowski K, Cates DB, Kavanagh L, Rigatto H. Hypoxic airway constriction in infants of very low birth weight recovering from moderate to severe bronchopulmonary dysplasia. J Pediatr. 1989; 115:456–459.Tay-Uyboco JS, Kwiatkowski K, Cates DB, Kavanagh L, Rigatto H. Hypoxic airway constriction in infants of very low birth weight recovering from moderate to severe bronchopulmonary dysplasia. J Pediatr. 1989; 115:456–459.

Active substance: OXYGEN

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Document reference: 45411

Study title: The British guidelines on management of asthma. Thorax 2003; 58(suppl)S1:1-83The British guidelines on management of asthma. Thorax 2003; 58(suppl)S1:1-83

Active substance: OXYGEN

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Document reference: 45416

Study title: The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000; 105;295-310The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000; 105;295-310

Active substance: OXYGEN

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Document reference: 45412

Study title: The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000;105;295-310The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000;105;295-310

Active substance: OXYGEN

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Document reference: 45418

Study title: UK Collaborative ECMO Trial Group. UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation. Lancet 1996; 348: 75-82UK Collaborative ECMO Trial Group. UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation. Lancet 1996; 348: 75-82

Active substance: OXYGEN

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Document reference: 45413

Study title: Kumar P et al.: Caudal additives in pediatrics: A comparison among midazolam, ketamine, and neostigmine coadministered with bupivacaine. Anesthesia and Analgesia ( Anesth. Analg. ) (United States) , July 1, 2005 , 101/1 (69-73) Kumar P et al.: Caudal additives in pediatrics: A comparison among midazolam, ketamine, and neostigmine coadministered with bupivacaine. Anesthesia and Analgesia ( Anesth. Analg. ) (United States) , July 1, 2005 , 101/1 (69-73)

Active substance: NEOSTIGMINE

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Document reference: 47055

Study title: Mahajan R.; Grover V.K.; Chari P.: Caudal neostigmine with bupivacaine produces a dose-independent analgesic effect in children. Canadian Journal of Anesthesia ( Can. J. Anesth. ) (Canada), August 1, 2004 , 51/7 (702-706) Mahajan R.; Grover V.K.; Chari P.: Caudal neostigmine with bupivacaine produces a dose-independent analgesic effect in children. Canadian Journal of Anesthesia ( Can. J. Anesth. ) (Canada), August 1, 2004 , 51/7 (702-706)

Active substance: NEOSTIGMINE

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Document reference: 47056

Study title: Early bisphosphonate treatment in infants with severe osteogenesis imperfecta.(study published in 2006)

Active substance: NERIDRONIC ACID

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Document reference: 47061

Study title: [A case of Maffucci's syndrome] German. Zöller A, Hör G, Köbrich U. Nuklearmedizin. 1993 Jun;32(3):156-8. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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

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Document reference: 43663

Study title: Zompatori M, Gavelli G, Bernasconi A, Fabbri M, Sturani C, Galavotti V. [Pulmonary eosinophilic granuloma in adults. Case histories and a review of the literature] Radiol Med (Torino). 1989 Apr;77(4):347-53. Review. Italian. Zompatori M, Gavelli G, Bernasconi A, Fabbri M, Sturani C, Galavotti V. [Pulmonary eosinophilic granuloma in adults. Case histories and a review of the literature] Radiol Med (Torino). 1989 Apr;77(4):347-53. Review. Italian.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43791

Study title: Mora S. Longitudinal Changes of Bone Density and Bone Resorption in Hyperthyroid Girls During Treatment, J Bone Miner Res 1999; 14: 1971-77Mora S. Longitudinal Changes of Bone Density and Bone Resorption in Hyperthyroid Girls During Treatment, J Bone Miner Res 1999; 14: 1971-77

Active substance: TEGAFUR/URACIL

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Document reference: 44287

Study title: Schendekehl TK. Therapie und Verlauf der Juvenilen Hyperthyreose, Schweiz Med Wochenschr 1997; 127 (Suppl 87): Abstract 51Schendekehl TK. Therapie und Verlauf der Juvenilen Hyperthyreose, Schweiz Med Wochenschr 1997; 127 (Suppl 87): Abstract 51

Active substance: TEGAFUR/URACIL

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Document reference: 44289

Study title: Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396

Active substance: TEGAFUR/URACIL

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Document reference: 44288

Study title: Clinical and pharmacokinetic study of teicoplanin in children. - Kafetsis DA, Tspra H, Gianacopoulou C, Karamitsos S. -(Abstract) In: Abstract book of the 15th international congress of chemotherapy. Istanbul, 19-24 July 1987:322.

Active substance: TEICOPLANIN

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Document reference: 44304

Study title: Lal−A et al. Antipyretic effects of nimesulide, paracetamol and ibuprofen− paracetamol. {INDIAN−J−PEDIATR}, 2000, Vol/Iss/Pg. 67 /12 (865−870)Lal−A et al. Antipyretic effects of nimesulide, paracetamol and ibuprofen− paracetamol. {INDIAN−J−PEDIATR}, 2000, Vol/Iss/Pg. 67 /12 (865−870)

Active substance: PARACETAMOL AND CAFFEINE AND CHLORPHENAMINE AND DEXTROMETHORPHAN AND ASCORBIC ACID

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Document reference: 33283

Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992.A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. Dec 1992.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33317

Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with sore throat pain. Dec 1992.A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with sore throat pain. Dec 1992.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33332

Study title: Intravenous neridronate in children with osteogenesis imperfecta: a randomized controlled study. (study published in 2005)

Active substance: NERIDRONIC ACID

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Document reference: 47062

Study title: Reduction of plasma taurine level in children affected by osteogenesis imperfecta during bisphosphonate therapy. (study published in 2007)

Active substance: NERIDRONIC ACID

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Document reference: 47060

Study title: Bacopoulou, 2009;Netilmicin in the neonate: pharmacokinetic analysis and influence of parenteral nutrition Pharm World Sci (2009) 31:365–368 DOI 10.1007/s11096-009-9278-z

Active substance: NETILMICIN

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Document reference: 32622

Study title: Bouissou, 2008; PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).Prospective, Randomized Trial Comparing Short and Long Intravenous Antibiotic Treatment of Acute Pyelonephritis in Children: Dimercaptosuccinic Acid Scintigraphic Evaluation at 9 Months

Active substance: NETILMICIN

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Document reference: 32619

Study title: Comparison of 5 milligrams of netilmicin per kilogram of body weight once daily versus 2 milligrams per kilogram thrice daily for treatment of gram-negative pyelonephritis in children; publication from american society for microbiology "antimicrobial agents and chemotherapy, july 1992, p 1499-1503, vol 36, No 7.

Active substance: NETILMICIN

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Document reference: 32618

Study title: Optimalisation of Netilmicin dosage based on therapeutic drug monitoring during the first days of life in very pre-term neonates (gestational age 23-32 weeks); MED.WIEKU ROZWOJ.,2009, XIII,4,252-259

Active substance: NETILMICIN

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Document reference: 32621

Study title: Sherwin, 2008;Individualising netilmicin dosing in neonates. Eur J Clin Pharmacol (2008) 64:1201–1208 DOI 10.1007/s00228-008-0536-0

Active substance: NETILMICIN

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Document reference: 32620

Study title: High levels of serum prostaglandin e2 in children with osteogenesis imperfecta are reduced by neridronate treatment. Not Available (study published in 2008)

Active substance: NERIDRONIC ACID

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Document reference: 47059

Study title: Post-marketing study 2001-2005 with NHD Pollen in patients with saisonal allergic rhinitis, conjunctivitis and possibly asthmatic disorders, so far only statistical analysis. Age of patients: 5-67 Years

Active substance: NHD POLLEN

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Document reference: 47786

Study title: Hurt RD et al. Nicotine patch therapy in 101 adolescent smokers: efficacy, withdrawal symptom relief, and carbon monoxide and plasma cotinine levels. Arch Pediatr Adolesc med 2000; 154: 31-37

Active substance: NICOTINE

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Document reference: 32628

Study title: Killen JD et al. Randomised clinical trial of the effiacy of bupropion combined with nicotine patch in the treatment of adolescent smokers. J Consult Clin Psychol 2004; 72: 729-735

Active substance: NICOTINE

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Document reference: 32627

Study title: Kleges LM et al. Use in nicotine replacement therapy in adolescent smokers and nonsmokers. Arch Pediatr Adolesc Med 2003; 157: 517-522

Active substance: NICOTINE

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Document reference: 32630

Study title: Moolchan ET et al. Safety and efficacy of the nicotine patch and gum for the treatment of adolescent tobacco addiction.Pediatrics 2005; 115: 407-414

Active substance: NICOTINE

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Document reference: 32625

Study title: Smith TA et al. Nicotine patch therapy in adolescent smokers. Pediatrics 1996; 98: 659-667

Active substance: NICOTINE

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Document reference: 32629

Study title: Open Study on teicoplanin efficacy and tolerability for the treatment of gram-positive infection in children. (Abstract) In: Abstracts of the 17th international congress of chemotherapy.- Careddu P, Boccazzi A, Mosconi G. - Berlin, 23-28 June 1991; Abstract: No. 1259.Open Study on teicoplanin efficacy and tolerability for the treatment of gram-positive infection in children. (Abstract) In: Abstracts of the 17th international congress of chemotherapy.- Careddu P, Boccazzi A, Mosconi G. - Berlin, 23-28 June 1991; Abstract: No. 1259.

Active substance: TEICOPLANIN

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Document reference: 44327

Study title: Kline RM et al. Enteric−coated, pH−dependent peppermint oil capsules for the treatment of irritable bowel syndrome in children. J PEDIATR 2001; 138(1): 125−128

Active substance: Peppermint Oil 0.200 ml

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Document reference: 40117

Study title: Liu JH et al. Enteric−coated peppermint−oil capsules in the treatment of irritable bowel syndrome: a prospective, randomized trial. J Gastroenterol 1997; 32(6): 765−8

Active substance: Peppermint Oil 0.200 ml

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Document reference: 40116

Study title: Miranda A, Sood M. Treatment options for chronic abdominal pain in children and adolescents. CURR TREAT OPTIONS GASTROENTEROL 2006; 9(5): 409−415

Active substance: Peppermint Oil 0.200 ml

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Document reference: 21225

Study title: Miranda A, Sood M. Treatment options for chronic abdominal pain in children and adolescents. CURR TREAT OPTIONS GASTROENTEROL 2006; 9(5): 409−415

Active substance: Peppermint Oil 0.200 ml

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Document reference: 40113

Study title: Verträglichkeit und Wirksamkeit von Pinimenthol® Erkältungssalbe bei Patienten mit Erkältungskrankheiten der Luftwege.

Active substance: per 100g: Kampfer (raz.) 7g Eukalyptusöl 11g Kiefernnadelöl 9,5g Latschenkiefernöl 1,5g Terpentinöl ger. 1g Guajazulen 0,005g/ per 100g: Kampfer (raz.) 7g Eukalyptusöl 11g Kiefernnadelöl 9,5g Latschenkiefernöl 1,5g Terpentinöl ger. 1g Guajazulen 0,005g

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Document reference: 40118

Study title: Efficacy of Tonsiotren for acute angina catarrhalis.

Active substance: Per tablet: Atropinum sulfuricum D5 12,5 mg Hepar sulfuris D3 10,0 mg Kalium bichromicum D4 50,0 mg Silicea D2 5,0 mg Mercurius bijodatus D8 25,0 mg

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Document reference: 39744

Study title: Clinical Expertise - Study N° ERI 175 - Pr. Bouletreau - Nov 83

Active substance: PERFLOXACIN

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Document reference: 45862

Study title: Campo JV. Coping with ignorance: Exploring pharmacologic management for pediatric functional abdominal pain. J PEDIATR GASTROENTEROL NUTR 2005; 41(5): 569−574

Active substance: Peppermint Oil 0.200 ml

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Document reference: 40114

Study title: Study of high doses in infant psychiatry: neuroses, psychoses, evolving dysharmony, behaviour disorders. Dr R. Mises, fondation Vallee (Gentilly), 01/1970 - Study mentioned in the summary report - Doc. 000632

Active substance: PERICIAZINE

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Document reference: 33893

Study title: Study of the efficacy of the oral drop formulation in children and adolescents. Dr F. Larbre, Hopital Debrousse (Lyon), 05/1964 - Study mentioned in the summary report -

Active substance: PERICIAZINE

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Document reference: 33894

Study title: Acceptability, safety, pharmacokinetics and effects on blood pressure of a paediatric formulation of perindopril S 90652 (daily dose 0.025 to 0.135 mg/kg) in hypertensive children -an open, non comparative, 3-month then at least 24-months duration multicentre study.

Active substance: PERINDOPRIL

Study summary document link (including results): perindopril_CL2-90652-002_synopsis.pdf

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Document reference: 45867

Study title: Jürgens H et al The German Society of Pediatric Oncology Cooperative Ewing Sarcoma Studies CESS 81/86: report after 6 1/2 years Klin Padiatr. 1988 May-Jun;200(3):243-52. GermanJürgens H et al The German Society of Pediatric Oncology Cooperative Ewing Sarcoma Studies CESS 81/86: report after 6 1/2 years Klin Padiatr. 1988 May-Jun;200(3):243-52. German

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 24944

Study title: Final Summary of Japanese Retrospective Surveillance and Prospective Studies in Children Less than 1 Year of Age.

Active substance: oseltamivir

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Document reference: 47896

Study title: - The Completed NIH Chart Review - CASG 113 FSR

Active substance: oseltamivir

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Document reference: 47898

Study title: "Contribution to recalcification therapy in pediatric medicine", Talavera R., Acta Pediatrica Espanola, 1962, 1-25 "Contribution to recalcification therapy in pediatric medicine", Talavera R., Acta Pediatrica Espanola, 1962, 1-25

Active substance: OSSEIN HYDROXYAPATITE COMPOUND

Study summary document link (including results): Ossopan nr5.xls

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Document reference: 47718

Study title: 11.) Systemic en- zyme therapy in the treatement of supra- condylar fractures of the humerus in Children

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40103

Study title: Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9.Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9.

Active substance: TOBRAMYCIN

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Document reference: 25751

Study title: Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9.Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9.

Active substance: TOBRAMYCIN

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Document reference: 44821

Study title: Tolerability and acceptability of Ro 01-4065/342, EPHYNAL effervescent tablets

Active substance: TOCOPHEROL

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Document reference: 47790

Study title: 4. Robinson HM, Jr., Raskin J. Tolnaftate, a potent topical antifungal agent. Arch Dermatol. 1965 Apr;91(4):372-6. 4. Robinson HM, Jr., Raskin J. Tolnaftate, a potent topical antifungal agent. Arch Dermatol. 1965 Apr;91(4):372-6.

Active substance: TOLNAFTATE

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Document reference: 44827

Study title: Carpenter WE. Tolnaftate, its effectiveness in pedal mycosis. A preliminary report. J Am Podiatry Assoc. 1966 Dec;56(12):541-6.Jun;57(6):275 Carpenter WE. Tolnaftate, its effectiveness in pedal mycosis. A preliminary report. J Am Podiatry Assoc. 1966 Dec;56(12):541-6.Jun;57(6):275

Active substance: TOLNAFTATE

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Document reference: 44824

Study title: Jacobs PH. Fungal infections in childhood. Pediatr Clin North Am. 1978 May;25(2):357-70. Jacobs PH. Fungal infections in childhood. Pediatr Clin North Am. 1978 May;25(2):357-70.

Active substance: TOLNAFTATE

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Document reference: 44829

Study title: A study comparing the efficacy and safety of acetaminophen sustained release 1300 mg to acetaminophen regular release 650 mg in the treatment of post-operative dental pain.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol 88-856.pdf

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Document reference: 47509

Study title: A Study Comparing the Efficacy and Safety of Acetaminophen Sustained Release 1300 mg to Acetaminophen Regular Release 650 mg in the Treatment of Post-Operative Episiotomy Pain.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol 88-857.pdf

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Document reference: 47510

Study title: An open trial to investigate pharmacokinetics as well as efficacy and safety of 0.25 mg/kg meloxicam suspension administered once daily in children with juvenile rheumatoid arthritis over a treatment period of up to 52 weeks (3 months results).

Active substance: PARACETAMOL

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Document reference: 45776

Active substance: PARACETAMOL

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Document reference: 45777

Study title: Nasal decongestant activity of pseudoephedrine. Ann Otol Rhinol Laryngol 1977; 86(2 pt. 1):235-42Nasal decongestant activity of pseudoephedrine. Ann Otol Rhinol Laryngol 1977; 86(2 pt. 1):235-42

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33639

Study title: Sperber SJ et al. Effectiveness of pseudoephedrine plus acetaminophen for treatment of symptoms attributed to the paranasal sinuses associated with the common cold. Arch Fam Med 2000; 9(10):979-85 Sperber SJ et al. Effectiveness of pseudoephedrine plus acetaminophen for treatment of symptoms attributed to the paranasal sinuses associated with the common cold. Arch Fam Med 2000; 9(10):979-85

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 25781

Study title: Study of the pharmacokinetic linearity of three paediatric doses of paracetamol (50, 125, and 250mg) administered as a new Synthelabo formulation, and their bioequivlence with a standard formulation of DOLIPRANE dosed at 16mg healthy male young volunteers. Open, randomised, cross-over and single-center study.

Active substance: PARACETAMOL

Study summary document link (including results): 2890 98 FR 001.pdf

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Document reference: 47077

Study title: The antipyretic use of acetaminophen versus ibuprofen in a pediatric care setting. {P T}, 2000, Vol/Iss/Pg. 25/8 (395 397) The antipyretic use of acetaminophen versus ibuprofen in a pediatric care setting. {P T}, 2000, Vol/Iss/Pg. 25/8 (395 397)

Active substance: PARACETAMOL

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Document reference: 45754

Study title: Ulukol−B et al. Assessment of the efficacy and safety of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections. {EUR−J−CLIN−PHARMACOL}, 1999, Vol/Iss/Pg. 55/9 (615−618Ulukol−B et al. Assessment of the efficacy and safety of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections. {EUR−J−CLIN−PHARMACOL}, 1999, Vol/Iss/Pg. 55/9 (615−618

Active substance: PARACETAMOL

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Document reference: 45757

Study title: Shannon, M. W. and Townsend, M. K. The Pediatric Environmental Health Center, Children's Hospital, Harvard Medical School, Boston, MA 02115, USA. Adverse effects of reduced-dose d-penicillamine in children with mild-to-moderate lead poisoning Ann.Pharmacother. 2000;34:15-18. Shannon, M. W. and Townsend, M. K. The Pediatric Environmental Health Center, Children's Hospital, Harvard Medical School, Boston, MA 02115, USA. Adverse effects of reduced-dose d-penicillamine in children with mild-to-moderate lead poisoning Ann.Pharmacother. 2000;34:15-18.

Active substance: PENICILLAMINE

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Document reference: 33838

Study title: "Medical Treatment of Essential Enuresis with Oxybutynin Hydrochloride and Imipramine - Laurenti C et al. - Min Urol Nefr - 1987 (39: 195-200) - Publication in UK registration file - " "Medical Treatment of Essential Enuresis with Oxybutynin Hydrochloride and Imipramine - Laurenti C et al. - Min Urol Nefr - 1987 (39: 195-200) - Publication in UK registration file - "

Active substance: OXYBUTYNIN

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Document reference: 32984

Study title: "Oxybutynin Chloride in enuresis/Randomized clinical study - Marconi A M et al - Urologia - 1984 (51(2): 262-263) - Publication in UK registration file -" "Oxybutynin Chloride in enuresis/Randomized clinical study - Marconi A M et al - Urologia - 1984 (51(2): 262-263) - Publication in UK registration file -"

Active substance: OXYBUTYNIN

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Document reference: 32985

Study title: "Oxybutynin and the Prevention of Urinary Incontinence in Spina bifida - M. Hehir, J.M. Fitzpatrick - Eur. Urol. - 1985 (11: 254-256) - Publication in UK registration file - " "Oxybutynin and the Prevention of Urinary Incontinence in Spina bifida - M. Hehir, J.M. Fitzpatrick - Eur. Urol. - 1985 (11: 254-256) - Publication in UK registration file - "

Active substance: OXYBUTYNIN

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Document reference: 32986

Study title: Oxybutynin does not affect cyclosporin blood levels - Springate JE - J Drug Monit - 2001; 23(2):155-156 Oxybutynin does not affect cyclosporin blood levels - Springate JE - J Drug Monit - 2001; 23(2):155-156

Active substance: OXYBUTYNIN

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Document reference: 32995

Study title: "Oxybutynin in Bladder Spasm, Neurogenic Bladder and Enuresis - Thompson I M and Lauvetz R. - Urology - 1976 (8: 452-454) - Publication in UK registration file - " "Oxybutynin in Bladder Spasm, Neurogenic Bladder and Enuresis - Thompson I M and Lauvetz R. - Urology - 1976 (8: 452-454) - Publication in UK registration file - "

Active substance: OXYBUTYNIN

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Document reference: 32991

Study title: Plasma levels of Oxybutynin chloride in children - Autret E, Jonville AP, Dutertre JP, Bertiere MC, Robert M, Averous M. Couet W - Eur J Clin Pharmacol - 1994; 46:83-85 Plasma levels of Oxybutynin chloride in children - Autret E, Jonville AP, Dutertre JP, Bertiere MC, Robert M, Averous M. Couet W - Eur J Clin Pharmacol - 1994; 46:83-85

Active substance: OXYBUTYNIN

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Document reference: 32996

Study title: 5. Phase 3, randomized, double-blind, parallel group, multicenter, PBO- and active-controlled, dose-response study to evaluate the efficacy and safety of 2 doses of TPM vs. PBO and PROP in migraine prophylaxis (plus blinded Ext)

Active substance: TOPIRAMATE

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Document reference: 44838

Study title: 5. Topiramate clinical trial in primary generalized tonic-clonic seizures (long-term extension).

Active substance: TOPIRAMATE

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Document reference: 44939

Study title: Publication in CES0506 - Lavin B - 30/06/2006 Comparative efficacy, safety, and effect on quality of life of triamcinolone acetonide and fluticasone propionate aqueous nasal sprays in patients with fall seeasonal allergic rhinitis - Gross - 2002 (Annals of allergy asthma & immunology 89; 1: 56-62, 2002)

Active substance: TRIAMCINOLONE

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Document reference: 46833

Study title: Yoder−K−E, Shaffer−M−L, La−Tournous−S−J, Paul−I−M. Child assessment of dextromethorphan, diphenhydramine, and placebo for nocturnal cough due to upper respiratory infection. Clinical Pediatrics {CLIN−PEDIATR}, 2006, Vol/Iss/Pg. 45/7 (633−640).Yoder−K−E, Shaffer−M−L, La−Tournous−S−J, Paul−I−M. Child assessment of dextromethorphan, diphenhydramine, and placebo for nocturnal cough due to upper respiratory infection. Clinical Pediatrics {CLIN−PEDIATR}, 2006, Vol/Iss/Pg. 45/7 (633−640).

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33624

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE AND TRIPTOLIDINE

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Document reference: 33725

Study title: A multinational, multicentre, prospective, Zaldiar post marketing surveillance observation to assess the safety of Zaldiar (tramadol/paracetamol 37.5 mg/325 mg) and patient satisfaction in the routine Latin American clinical setting

Active substance: PARACETAMOL AND TRAMADOL

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Document reference: 44977

Study title: Fritsch G. Bioverfügbarkeit von Diphenylhydantoin - Freie Säure - Serumspiegeluntersuchungen eines Präparates mit Laktose als Tablettenbasis. Monatsschr. Kinderheilkd. 1980; 128: 648-650Fritsch G. Bioverfügbarkeit von Diphenylhydantoin - Freie Säure - Serumspiegeluntersuchungen eines Präparates mit Laktose als Tablettenbasis. Monatsschr. Kinderheilkd. 1980; 128: 648-650

Active substance: PHENYTOIN

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Document reference: 33968

Study title: Grinschgl G. Die Kombinationsbehandlung zerebraler Krampfanfälle unter besonderer Berücksichtigung der Epilepsie. Wien Klin Wochenschr 1952; 64/20: 362-365Grinschgl G. Die Kombinationsbehandlung zerebraler Krampfanfälle unter besonderer Berücksichtigung der Epilepsie. Wien Klin Wochenschr 1952; 64/20: 362-365

Active substance: PHENYTOIN

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Document reference: 33967

Study title: Comparison of pentamdine isethionate abd trimethoprim-sulfametoxazole in the treatment of Pneumocystis carinii pneumonia. Walter T. Hughes M.D., Sandor Feldman M.D, Subhash C. Chaudary M.D., Michael J. Ossi M.D., Frederick Cox M.D. and S.K. Sanyal MBBS, Memphis-Tenn. The Journal of Pediatrics Vol 92 N° 2 p. 285-291Comparison of pentamdine isethionate abd trimethoprim-sulfametoxazole in the treatment of Pneumocystis carinii pneumonia. Walter T. Hughes M.D., Sandor Feldman M.D, Subhash C. Chaudary M.D., Michael J. Ossi M.D., Frederick Cox M.D. and S.K. Sanyal MBBS, Memphis-Tenn. The Journal of Pediatrics Vol 92 N° 2 p. 285-291

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45823

Study title: Pentamidine isethionate in the treatment of Pneumocystis carinii pneumonia. Karl A. Western, M.D., David R., Perera, M.D. and Myrong G. Schultz, D.V.M, M.D. Annals of Internal Medicine 73 : 695-702, 1970Pentamidine isethionate in the treatment of Pneumocystis carinii pneumonia. Karl A. Western, M.D., David R., Perera, M.D. and Myrong G. Schultz, D.V.M, M.D. Annals of Internal Medicine 73 : 695-702, 1970

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45826

Study title: J Asthma. 2004;41(3):285-7. Immune modulator pidotimod decreases the in vitro expression of CD30 in peripheral blood mononuclear cells of atopic asthmatic and normal children. Gourgiotis D, Papadopoulos NG, Bossios A, Zamanis P, Saxoni-Papageorgiou PJ Asthma. 2004;41(3):285-7. Immune modulator pidotimod decreases the in vitro expression of CD30 in peripheral blood mononuclear cells of atopic asthmatic and normal children. Gourgiotis D, Papadopoulos NG, Bossios A, Zamanis P, Saxoni-Papageorgiou P

Active substance: PIDOTIMOD

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Document reference: 34074

Study title: Walson−P−D et al. Comparison of multidose ibuprofen and acetaminophen therapy in febrile children. {AM−J−DIS−CHILD}, 1992, Vol /Iss/Pg. 146/5 (626−632)Walson−P−D et al. Comparison of multidose ibuprofen and acetaminophen therapy in febrile children. {AM−J−DIS−CHILD}, 1992, Vol /Iss/Pg. 146/5 (626−632)

Active substance: PARACETAMOL

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Document reference: 45762

Study title: When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm World Sci}, Jun 2005, vol. 27, no. 3, p. 254-7 When fever, paracetamol? Theory and practice in a paediatric outpatient clinic. {Pharm World Sci}, Jun 2005, vol. 27, no. 3, p. 254-7

Active substance: PARACETAMOL

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Document reference: 45766

Study title: Publication in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 Short-term growth in children with allergic rhinitis treated with oral antihistamine, depot and intranasal glucocorticoids - Wolthers OD - 1993 (Acta Paediatr 82:635-640)

Active substance: TRIAMCINOLONE

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Document reference: 46836

Study title: Publication in Rapport d'Expert sur la documentation clinique - Staudinger H - Update Dossier 24/03/1997 International Rhinitis Management Working Group. International Consensus Report on the Diagnosis and Management of Rhinitis - No Author - 1994 (Allergy 19:5-34)

Active substance: TRIAMCINOLONE

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Document reference: 46837

Study title: Publication in Rapport d'Expert sur la documentation pharmaco-toxicologique - Roquet F - 15/08/1995 A thirty day comparison of the oral toxicity of CL 30,980 : 1,4-Pregnadiene-3,20-dione, 9a-fluoro-11b-hydroxy-16a,17a-(isopropylidenedioxy)-21-(tetrahydropyran-2-yloxy)- and CL 22,353 : 1,4-Pregnadiene-3,20-dione, 9a-fluoro-11b,21-dihydroxy-16a,17a-(isopropylidenedioxy)- in rats - Kanegis LA - 26/09/1960 (Safety Evaluation.studies. PR Volume 6, 2694-2726)

Active substance: TRIAMCINOLONE

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Document reference: 46838

Study title: Publication in Response Document of MRP type II variation - Banerji D - 16/05/2000 A long-term (1 year) safety study of triamcinolone acetonide (TAA) HFA oral inhaler in asthmatic children - Weinberg EG - 1999 (European Respiratory Journal 14 (S30) abstract P361, p42s)

Active substance: TRIAMCINOLONE

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Document reference: 46839

Study title: Report in Expert Report - Critical Evaluation - Banerji DD - 06/12/1999 A phase III, single center, randomised, cross-over paediatric trial with Nasacort AQ nasal spray assessing short term growth in patients with allergic rhinitis - Kane R- 15/08/2007

Active substance: TRIAMCINOLONE

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Document reference: 46840

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in patients with perennial allergic rhinitis - No Author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46841

Active substance: TRIAMCINOLONE

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Document reference: 46842

Active substance: TRIAMCINOLONE

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Document reference: 46843

Active substance: TRIAMCINOLONE

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Document reference: 46844

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in pediatric patients with perennial allergic rhinitis - No Author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46845

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in pediatric patients with perennial allergic rhinitis - No Author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46846

Study title: Strotzka H. Die Kombinationsbehandlung der behandlungsresistenten Epilepsie. Wien Med Wochenschr 1951; 101/24-25: 465-468Strotzka H. Die Kombinationsbehandlung der behandlungsresistenten Epilepsie. Wien Med Wochenschr 1951; 101/24-25: 465-468

Active substance: PHENYTOIN

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Document reference: 33966

Study title: A randomised, double-blind, placebo-controlled, multi-centre, Phase I trial investigating the safety of Grazax® in children aged 5-12 years with grass pollen induced rhinoconjunctivitis (with/without asthma)

Active substance: Phleum pratense

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Document reference: 40130

Active substance: OXITRIPTAN

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Document reference: 32946

Study title: J Chemother. 1999 Apr;11(2):126-30. Prophylaxis with the novel immunomodulator pidotimod reduces the frequency and severity of upper respiratory tract infections in children with Down's syndrome. La Mantia I, Grillo C, Mattina T, Zaccone P, Xiang M, Di Mauro M, Meroni PL, Nicoletti F.J Chemother. 1999 Apr;11(2):126-30. Prophylaxis with the novel immunomodulator pidotimod reduces the frequency and severity of upper respiratory tract infections in children with Down's syndrome. La Mantia I, Grillo C, Mattina T, Zaccone P, Xiang M, Di Mauro M, Meroni PL, Nicoletti F.

Active substance: PIDOTIMOD

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Document reference: 34075

Study title: Namazova Baranova, Kharit, Tuzankina et al 2010; Results of a multicentre study of pidotimod therapy in the prevention of acute respiratory infections in ailing children.Namazova Baranova, Kharit, Tuzankina et al 2010; Results of a multicentre study of pidotimod therapy in the prevention of acute respiratory infections in ailing children.

Active substance: PIDOTIMOD

Study summary document link (including results): Namazova_VSP_2-2010_pidotimod+ENG transl.pdf

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Document reference: 34071

Study title: Rev Alerg Mex. 2005 Jan-Feb;52(1):25-38. Comparative meta-analysis of immunoestimulant agents used in pediatric patients in Mexico. de la Torre González C, Pacheco Ríos A, Escalante Domínguez AJ, del Río Navarro BE.Rev Alerg Mex. 2005 Jan-Feb;52(1):25-38. Comparative meta-analysis of immunoestimulant agents used in pediatric patients in Mexico. de la Torre González C, Pacheco Ríos A, Escalante Domínguez AJ, del Río Navarro BE.

Active substance: PIDOTIMOD

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Document reference: 34069

Study title: Vargas Correa JB, Espinosa Morales S, Bolanos Ancona JC, Farfan Ale JA. “Pidotimod in recurring respiratory infection in children with allergic rhinitis, asthma, or both conditions.” Publication: Rev Alerg Mex 2002; 49: 27-32, (Polichem Ref. N. 0680).Vargas Correa JB, Espinosa Morales S, Bolanos Ancona JC, Farfan Ale JA. “Pidotimod in recurring respiratory infection in children with allergic rhinitis, asthma, or both conditions.” Publication: Rev Alerg Mex 2002; 49: 27-32, (Polichem Ref. N. 0680).

Active substance: PIDOTIMOD

Study summary document link (including results): Vargas Correa_2002_pidotimod.pdf

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Document reference: 34078

Study title: Eyedrop instillation for reluctant children. Smith SE. Br J Ophthalmol. 1991 Aug;75(8):480-1.Eyedrop instillation for reluctant children. Smith SE. Br J Ophthalmol. 1991 Aug;75(8):480-1.

Active substance: PILOCARPINE

Study summary document link (including results): Eyedrop instillation for reluctant children.pdf

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Document reference: 34079

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981 0301-0301E1 Art45 listing 2011.xls

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Document reference: 34081

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981 0315E1 Art45 listing 2011.xls

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Document reference: 34082

Study title: Pneumocystis carinii pneumonia in an adopted vietnamese infant. Redman, J.C. (1974) Journal of the American Medical association 230 : 1561-1563Pneumocystis carinii pneumonia in an adopted vietnamese infant. Redman, J.C. (1974) Journal of the American Medical association 230 : 1561-1563

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45831

Study title: Successful treatment of Pneumocystis carinii pneumonitis in a patient with congenital hypogammaglobulinaemia. Robbins, J.B., Miller, R.H.; Arean, V.M. and Pearson , H.A. (1965). New England Journal of Medicine 272:708-713Successful treatment of Pneumocystis carinii pneumonitis in a patient with congenital hypogammaglobulinaemia. Robbins, J.B., Miller, R.H.; Arean, V.M. and Pearson , H.A. (1965). New England Journal of Medicine 272:708-713

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45834

Study title: Treatment of Pneumocystis carinii in children. Lipson, A., Marshall, W.C., and Hayward, A.R. (1977) Archives of disease in childhood 52 : 314-319Treatment of Pneumocystis carinii in children. Lipson, A., Marshall, W.C., and Hayward, A.R. (1977) Archives of disease in childhood 52 : 314-319

Active substance: PENTAMIDINE ISETHIONATE

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Document reference: 45835

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C1301 Art45 listing 2011.xls

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Document reference: 34083

Study title: 271/87: Steady-state pharmcokinetics and phamacodynamics of theophylline, in asthmatic children of 9 - 13 years, after unequal twice-daily dosing of the oral sustained-release formulation BY158K

Active substance: THEOPHYLLINE

Study summary document link (including results): Study report 271-87 Theopyhlline -synopsis.pdf

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Document reference: 44730

Study title: 84/83: Theophylline retard (250 mg): Clinical efficacy / tolerability and pharmacokinetics

Active substance: THEOPHYLLINE

Study summary document link (including results): Study report 84-83 Theophylline - synopsis English.pdf

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Document reference: 44728

Study title: Dose-dependent kinetics for theophylline obersvations among ambulatory asthmatic children Sarrazin J Pediatr 19801 97(5) 825-8 in Annual Report 02Dose-dependent kinetics for theophylline obersvations among ambulatory asthmatic children Sarrazin J Pediatr 19801 97(5) 825-8 in Annual Report 02

Active substance: THEOPHYLLINE

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Document reference: 44722

Study title: Effect of age on patients of theophylline metabolism Grygiel - No author - 1980 (Clin Pharmacol Therp 1980 28(4) 456-62 in Annual report 02)Effect of age on patients of theophylline metabolism Grygiel - No author - 1980 (Clin Pharmacol Therp 1980 28(4) 456-62 in Annual report 02)

Active substance: THEOPHYLLINE

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Document reference: 44727

Study title: Laursen et al. Effects of Enprofylline and Theofylline on Exercise-Induced Asthma. Allergy 1985; 40: 506-509Laursen et al. Effects of Enprofylline and Theofylline on Exercise-Induced Asthma. Allergy 1985; 40: 506-509

Active substance: THEOPHYLLINE

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Document reference: 44716

Study title: Laursen et al. Long-term oral therapy of asthma with terbutaline and theofyllin, alone and combined. Eur J Respir Dis 1985; 66: 82-90Laursen et al. Long-term oral therapy of asthma with terbutaline and theofyllin, alone and combined. Eur J Respir Dis 1985; 66: 82-90

Active substance: THEOPHYLLINE

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Document reference: 44717

Study title: Metaproterenol and theophylline in asthmatic children Rachelefsky Ann Allergy 1980, 45(4) 207-12 in Annual Report 02Metaproterenol and theophylline in asthmatic children Rachelefsky Ann Allergy 1980, 45(4) 207-12 in Annual Report 02

Active substance: THEOPHYLLINE

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Document reference: 44724

Study title: Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968;42:565-589Sinclair JC, Engel K, Silverman WA. Early correction of hypoxemia and acidemia in infants of low birth weight. A controlled trial of oxygen breathing, rapid alkali infusion and assisted ventilation. Pediatrics 1968;42:565-589

Active substance: OXITRIPTAN

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Document reference: 32952

Study title: Study of a 3-hour paclitaxel infusion in children with refractory solid tumours: a SFOP study.Doz F; Gentet J C et al. British journal of cancer Mar 2 2001, 84 (5) p604-10 ,Study of a 3-hour paclitaxel infusion in children with refractory solid tumours: a SFOP study.Doz F; Gentet J C et al. British journal of cancer Mar 2 2001, 84 (5) p604-10 ,

Active substance: OXITRIPTAN

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Document reference: 32962

Study title: Successful Treatment of Nocturnal Enuresis: A Practical Approach - Maizels M and Rosenbaum D. - Primary Care - 1985 (12(4): 621-635) - Publication in UK registration file - Successful Treatment of Nocturnal Enuresis: A Practical Approach - Maizels M and Rosenbaum D. - Primary Care - 1985 (12(4): 621-635) - Publication in UK registration file -

Active substance: OXITRIPTAN

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Document reference: 32916

Active substance: OXITRIPTAN

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Document reference: 32948

Study title: The British guidelines on management of asthma. Thorax 2003; 58(suppl)S1:1-83The British guidelines on management of asthma. Thorax 2003; 58(suppl)S1:1-83

Active substance: OXITRIPTAN

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Document reference: 32953

Study title: Demonstration of the Analgesic Efficacy and Safety of Liquid Formulations of Ibuprofen (10mg/kg), Acetaminophen (15mg/kg), and Placebo in the relief of Orthodontic Pain in Children

Active substance: PARACETAMOL

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Document reference: 45792

Study title: Demonstration of the Analgesic Efficacy and Safety of Liquid Formulations of Ibuprofen (10mg/kg), Acetaminophen (15mg/kg), and Placebo in the relief of Orthodontic Pain in Children

Active substance: PARACETAMOL

Study summary document link (including results): Paracetamol Clinical Trial Summaries.pdf

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Document reference: 45798

Study title: Essai comparatif en double aveugle évaluant l’efficacité et la tolérance d’une dose de charge de 30 mg/kg de paracétamol versus 15 mg/kg dans la fièvre de l’enfant pesant entre 4 et 26 kg. Essai en double aveugle, comparatif sur deux groupes parallèles, multicentrique, phase III.Publication = Treluyer JM. Et al : Antipyretic efficacy of an initial 30 mg/kg loading dose of acetaminophen versus a 15 mg/kg maintenance dose.

Active substance: PARACETAMOL

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Document reference: 45780

Study title: Comparison of IM pethidine, diazepam and flunitrazepam as premedicants in children undergoing otolaryngological surgery - L Lindgren Br J. - 1979 (Anaesth 1979, 51 321-327) - Publication in expert report DOL01VOL2 -

Active substance: PETHIDINE

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Document reference: 45868

Study title: Urinary excretion and metabolism of pethidine and norpethidine in the newborn - M Hogg Br - 1977 ( J. Anaesth 1977, 45:891-898) - Publication in expert report DOL01VOL2 -Urinary excretion and metabolism of pethidine and norpethidine in the newborn - M Hogg Br - 1977 ( J. Anaesth 1977, 45:891-898) - Publication in expert report DOL01VOL2 -

Active substance: PETHIDINE

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Document reference: 45870

Study title: An observational study collecting data on the efficacy and tolerability of Elidel® (pimecrolimus) cream 1% in patients with mild or moderate atopic dermatitis after one and six weeks in real life practice.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CSA02 Art45 listing 2011.xls

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Document reference: 34117

Study title: An open-label, single-arm study to determine the efficacy of 1% Elidel (pimecrolimus) cream in the treatment of pityriasis alba.

Active substance: PIMECROLIMUS

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Document reference: 34105

Study title: An oral fertility and early embryonic development study in rats

Active substance: PIMECROLIMUS

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Document reference: 34124

Study title: EFFECTIVE ELI – Evaluation of EFFECTIVEness of ELIdel in prevention of flares

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CSI01 Art45 listing 2011.xls

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Document reference: 34118

Study title: Efficacy of Elidel in vitiligo vulgaris

Active substance: PIMECROLIMUS

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Document reference: 34108

Study title: Elidel (pimecrolimus) cream 1% on drug consumption and drug utilization in subjects >2 years of age with mild to moderate atopic dermatitis using Elidel cream 1% in routine daily treatment practice

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CBE03 Art45 listing 2011.xls

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Document reference: 34110

Study title: Elidel PMS trial with Elidel in patients with AD.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CDE07 Art45 listing 2011.xls

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Document reference: 34094

Study title: Elidel Tolerability, Safety and Efficacy in Dermatitis Atopic Patients (El-Tosca)

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CID01 Art45 listing 2011.xls

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Document reference: 34114

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C1302 Art45 listing 2011.xls

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Document reference: 34085

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C1303 Art45 listing 2011.xls

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Document reference: 34086

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C1304 Art45 listing 2011.xls

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Document reference: 34087

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2313 Art45 listing 2011.xls

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Document reference: 34088

Study title:

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2314 Art45 listing 2011.xls

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Document reference: 34121

Study title: 12-week, open-label, uncontrolled, non blinded, non randomized, single-arm, single-center, investigator-initiated study

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CUS11 Art45 listing 2011.xls

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Document reference: 48119

Study title: A 12 month open label non-controlled extension to a randomized multicenter, parallel-group, double-blind, vehicle controlled study to evaluate the efficacy and safety of 1% SDZ ASM981 cream in the long-term management of atopic dermatitis in children from 3 months to 23 months

Active substance: PIMECROLIMUS

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Document reference: 34129

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33612

Study title: A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991.A single dose study to compare the efficacy of acetaminophen elixir dosed at 12.5 mg/kg and 25 mg/kg and ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg in febrile children. Oct 1991.

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33600

Study title: Amdekar−Y−K, Desai−R−Z. Antipyretic activity of ibuprofen and paracetamol in children with pyrexia. {Br−J−Clin−Pract}, Apr 1985, vol. 39, no. 4, p. 140−3Amdekar−Y−K, Desai−R−Z. Antipyretic activity of ibuprofen and paracetamol in children with pyrexia. {Br−J−Clin−Pract}, Apr 1985, vol. 39, no. 4, p. 140−3

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33577

Study title: Essai comparative en double aveugle évaluant l’efficacité et la tolérance d’une dose de charge 30 mg/kg de paracétamol versus 15 mg/kg dans la fièvre de l’entant pesant entre 4 et 26 kg

Active substance: PARACETAMOL

Study summary document link (including results): DO 428.pdf

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Document reference: 47080

Study title: Etude multicentrique, ouverte, non comparative, de l'acceptabilite et de la tolerance du paracetamol suspension buvable pediatrique a 4,8% - J. Lalau Keraky, C. Leblond-Joly, V. Dubourg, M. Kabir-Ahmadi, C. Kempf - May 25th, 2007.

Active substance: PARACETAMOL

Study summary document link (including results):

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Document reference: 45779

Study title: Etude multicentrique, randomisée en 2 groupes parallèles, en double aveugle, comparant l’effet antalgique du paracétamol oral en doses répétées, après une dose initiale de 30 mg/kg ou de 15 mg/kg, chez l’enfant âgé de 1 à 6 ans.

Active substance: PARACETAMOL

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Document reference: 45782

Study title: Etude multicentrique, randomisée en 2 groupes parallèles, en double aveugle, comparant l’effet antalgique du paracétamol oral en doses répétées, après une dose initiale de 30mg/kg ou de 15mg/kg, chez l’enfant âgé de 1 à 6 ans

Active substance: PARACETAMOL

Study summary document link (including results): DO466.pdf

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Document reference: 47079

Study title: ETUDE MULTICENTRIQUE, RANDOMISEE, EN DOUBLE AVEUGLE, COMPARANT L EFFET ANTIPYRETIQUE DU PARACETAMOL EN DOSES REPETEES, APRES UNE DOSE INITIALE DE 15 MG/KG OU DE 30 MG/KG CHEZ L ENFANT PESANT ENTRE 4 ET 26 KG ET AGE D AU MOINS 1 MOIS

Active substance: PARACETAMOL

Study summary document link (including results): DO465.pdf

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Document reference: 47078

Study title: Etude multicentrique, randomisée, en double aveugle, comparant l’effet antipyrétique du paracétamol en doses répétées, après une dose initiale de 15 mg/kg ou de 30 mg/kg, chez l’enfant pesant entre 4 et 26 kg et âgé d’au moins 1 mois.

Active substance: PARACETAMOL

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Document reference: 45781

Study title: Gehri M, Guignard E, et al. (2005) When fever, paracetamol ? Theory and practice in a paediatric outpatient clinic. Pharmacy World &Science 27: 254-7Gehri M, Guignard E, et al. (2005) When fever, paracetamol ? Theory and practice in a paediatric outpatient clinic. Pharmacy World &Science 27: 254-7

Active substance: PARACETAMOL

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Document reference: 45772

Study title: Evaluation of the safety profile and clinical effectiveness of oral tramadol hydrochloride tablets for the treatment of postsurgical pain in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-005; Phase 2)

Active substance: PARACETAMOL AND TRAMADOL

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Document reference: 45806

Study title: ELPASO-Elidel Patient Self-observation

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CDE11 Art45 listing 2011.xls

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Document reference: 34096

Study title: An observation post-marketing surveillance (PMS) study evaluating efficacy and safety of Elidel (pimecrolimus) cream 1% in patients >=3 months of age with mild to moderate dermatitis.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CPH01 Art45 listing 2011.xls

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Document reference: 34100

Study title: Exploratory, 2-week, double-blind, randomized

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CUS22 Art45 listing 2011.xls

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Document reference: 48120

Study title: A Phase I Study of the Safety, Tolerance and Phannacokinetics of Reconstituted Lyophilized MEDI-493, a Humanized Monoclonal Antibody to Respiratory Syncytial Virus, Administered Intravenously at 15 mg/kg and 30 mg/kg in Children with a History of Prematurity or Bronchopulmonary Dysplasia

Active substance: palivizumab

Study summary document link (including results): palivizumab-mi-cp045.pdf

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Document reference: 48104

Study title: "Successful Treatment of Nocturnal Enuresis: A Practical Approach - Maizels M and Rosenbaum D. - Primary Care - 1985 (12(4): 621-635) - Publication in UK registration file - " "Successful Treatment of Nocturnal Enuresis: A Practical Approach - Maizels M and Rosenbaum D. - Primary Care - 1985 (12(4): 621-635) - Publication in UK registration file - "

Active substance: OXYBUTYNIN

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Document reference: 32992

Study title: "Use of Oxybutynin Chloride (Ditropan) in Treatment of Enuresis - R. De Castro, E. Casolari, and S. Ricci - Riv Ital Ped - 1985 (11: 208-211) - Publication in UK registration file - " "Use of Oxybutynin Chloride (Ditropan) in Treatment of Enuresis - R. De Castro, E. Casolari, and S. Ricci - Riv Ital Ped - 1985 (11: 208-211) - Publication in UK registration file - "

Active substance: OXYBUTYNIN

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Document reference: 32993

Study title: A Multi-center, Inpatient, Open-Label, Dose-Ranging Study to Characterize the Pharmacokinetics and Safety of an Oral Liquid Formulation of Oxycodone in Patients from Birth to 4 Years of Age, Who Require Opioid Analgesia

Active substance: OXYCODONE

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Document reference: 45393

Study title: MF-OXY-010898 Oxycodone in post-operative pain

Active substance: OXYCODONE

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Document reference: 45396

Study title: Multi-center, double-blind, randomised, dose ranging study, in pediatric patients 5 to ≤ 16 years of age receiving morphine as standard supplementary pain medication to evaluate pharmacokinetics, efficacy and safety of oxy pediatric liquid (1 mg/ml) versus placebo in the treatment of acute moderate to severe pain. (USA & EU)

Active substance: OXYCODONE

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Document reference: 45394

Study title: Multiple dose, open-label, multicentric study for the conversion of immediate release Oxycodone (OxyIR) dose to controlled release Oxycodone (OxyContin) in order to assess the pharmacokinetics and characterize the efficacy and safety in pediatric patients from 6 to 16 years old. (USA & EU)

Active substance: OXYCODONE

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Document reference: 45395

Study title: OXN9002 safety and efficacy of Targin in patients with pain

Active substance: OXYCODONE

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Document reference: 45398

Study title: OXY4407 Pain controlling with Oxygesic

Active substance: OXYCODONE

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Document reference: 45397

Study title: Oxycodone in post-operative pain

Active substance: OXYCODONE

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Document reference: 45390

Study title: Pain controlling with Oxygesic

Active substance: OXYCODONE

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Document reference: 45391

Study title: safety and efficacy of Targin in patients with pain

Active substance: OXYCODONE

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Document reference: 45392

Study title: Askie LM, Henderson-Smart DJ, Lirwig L, Simpson JM. Oxygen-saturation targets and outcomes in extremely preterm infants. N Engl J Med 2003; 349:959-67Askie LM, Henderson-Smart DJ, Lirwig L, Simpson JM. Oxygen-saturation targets and outcomes in extremely preterm infants. N Engl J Med 2003; 349:959-67

Active substance: OXYGEN

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Document reference: 45399

Study title: Bakwin H. Oxygen therapy in premature babies with anoxemia. Am J Dis Child. 1923; 25:157–192.Bakwin H. Oxygen therapy in premature babies with anoxemia. Am J Dis Child. 1923; 25:157–192.

Active substance: OXYGEN

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Document reference: 45400

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33570

Study title: Blennow G, Heijbel J, Sandstedt P, Tonnby B. Discontinuation of antiepileptic drugs in children who have outgrown epilepsy: effects on cognitive function. Epilepsia. 1990;31 Suppl 4:S50-3Blennow G, Heijbel J, Sandstedt P, Tonnby B. Discontinuation of antiepileptic drugs in children who have outgrown epilepsy: effects on cognitive function. Epilepsia. 1990;31 Suppl 4:S50-3

Active substance: PHENYLEPHRINE

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Document reference: 33930

Study title: Bowe JC, Cornish EJ,Dawson M. Evaluation of folic acid supplements in children taking phenytoin. Dev Med Child Neurol. 1971 Jun;13(3):343-54.Bowe JC, Cornish EJ,Dawson M. Evaluation of folic acid supplements in children taking phenytoin. Dev Med Child Neurol. 1971 Jun;13(3):343-54.

Active substance: PHENYLEPHRINE

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Document reference: 33940

Study title: Connell JT. Effectiveness of topical nasal decongestants. Ann Allergy 1969; 27(11):541-6 Connell JT. Effectiveness of topical nasal decongestants. Ann Allergy 1969; 27(11):541-6

Active substance: PHENYLEPHRINE

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Document reference: 45103

Study title: Conners CK, Kramer R, Rothschild GH, Schwartz L, Stone A. Treatment of young delinquent boys with diphenylhydantoin sodium and methyphenidate. A controlled comparison. Arch Gen Psychiatry. 1971 Feb;24(2):156- 60.Conners CK, Kramer R, Rothschild GH, Schwartz L, Stone A. Treatment of young delinquent boys with diphenylhydantoin sodium and methyphenidate. A controlled comparison. Arch Gen Psychiatry. 1971 Feb;24(2):156- 60.

Active substance: PHENYLEPHRINE

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Document reference: 33941

Study title: A Phase IV Double-Blind Single Dose Study of the Relative Efficacy and Safety of Acetaminophen 650 mg, Acetaminophen 650 mg With Phenyltoloxamine Citrate 60 mg, Phenyltoloxamine Citrate 60 mg, and Placebo in the Treatment of Postoperative Pain Following Oral Surgery.

Active substance: PARACETAMOL PHENYLTOXOLAMINE

Study summary document link (including results): paracetamol 0-235.pdf

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Document reference: 47506

Study title: Open label safety evaluation of specific immunotherapy in subjects aged 5-17 years suffering from seasonal allergic rhinoconjunctivitis due to grass pollen not responding to pharmacotherapy

Active substance: PHLEUM PRATENSE

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Document reference: 34027

Active substance: Phleum pratense

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Document reference: 40125

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33326

Study title: A single-dose, randomized, investigator-blinded trial to compare the efficacy and safety of ibuprofen suspension 7.5 mg/kg with acetaminophen suspension 12.5 mg/kg for the treatment of febrile patients. Aug 1996.A single-dose, randomized, investigator-blinded trial to compare the efficacy and safety of ibuprofen suspension 7.5 mg/kg with acetaminophen suspension 12.5 mg/kg for the treatment of febrile patients. Aug 1996.

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33323

Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID

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Document reference: 33300

Study title: Diagnostik und Therapie der Sensibilierung gegen Derm. pter. und Derm. farinae bei Kindern.Allergologie 1988, 11, 12, S503 - 508

Active substance: HOUSE DUST

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Document reference: 29124

Study title: Double-blind comparative clinical study of iopromide (SHL414A) versus amidotrizoate (Visotrast-370Ò) in angiocardiography in 50 newborns and infants

Active substance: IOPROMIDE

Study summary document link (including results): Bayer Pharma_Iopromide_86058_study_synopsis.pdf

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Document reference: 46901

Study title: Indomethacin prophylaxis for patent ductus arteriosus (PDA) in infants with a birth weight of less than 1250 grams.

Active substance: INDOMETHACIN

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Document reference: 29934

Study title: Elibol O., Alcelik T., Yüksel N., Caglar Y., Acta Ophthalmol Scand 1997, 75: 178-180; Rosales T., Isenberg S., Leake R., Everett S., J Ped Opht & Strab 1981; 18, 6: 42-44 Elibol O., Alcelik T., Yüksel N., Caglar Y., Acta Ophthalmol Scand 1997, 75: 178-180; Rosales T., Isenberg S., Leake R., Everett S., J Ped Opht & Strab 1981; 18, 6: 42-44

Active substance: PHENYLEPHRINE

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Document reference: 26156

Study title: Loughnan PM, Greenwald A et al. Pharmacokinetic observations of phenytoin disposition in the newborn and young infant. Archives of Disease in Childhood, 1977, 52: 302-209Loughnan PM, Greenwald A et al. Pharmacokinetic observations of phenytoin disposition in the newborn and young infant. Archives of Disease in Childhood, 1977, 52: 302-209

Active substance: PHENYLEPHRINE

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Document reference: 33937

Study title: Shope JT. Intervention to improve compliance with pediatric anticonvulsant therapy. Patient Couns Health Educ. 1980 3d Quart;2(3):135-41.Shope JT. Intervention to improve compliance with pediatric anticonvulsant therapy. Patient Couns Health Educ. 1980 3d Quart;2(3):135-41.

Active substance: PHENYLEPHRINE

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Document reference: 33936

Study title: "Pediatric use of a whole-bone preparation", D'Oelsnitz M. & Embriaco J.P., Gazette Medicale de France, 1966, 73 : 603-605"Pediatric use of a whole-bone preparation", D'Oelsnitz M. & Embriaco J.P., Gazette Medicale de France, 1966, 73 : 603-605

Active substance: OSSEIN HYDROXYAPATITE COMPOUND

Study summary document link (including results): Ossopan nr2..xls

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Document reference: 47715

Study title: "Symmetrical Transformation zones in infant rickets (Milkman syndrome?)", Kosenow W., Zeitschrift fur kinderheilkunde, 1951, 69 : 191-206"Symmetrical Transformation zones in infant rickets (Milkman syndrome?)", Kosenow W., Zeitschrift fur kinderheilkunde, 1951, 69 : 191-206

Active substance: OSSEIN HYDROXYAPATITE COMPOUND

Study summary document link (including results): Ossopan nr8.xls

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Document reference: 47721

Study title: "The influence of a whole-bone preparation on the growth of dystrophic children", Gotti D. & Nicolaj P., La clinica Pediatrica, 1951, N°5, 33 "The influence of a whole-bone preparation on the growth of dystrophic children", Gotti D. & Nicolaj P., La clinica Pediatrica, 1951, N°5, 33

Active substance: OSSEIN HYDROXYAPATITE COMPOUND

Study summary document link (including results): Ossopan nr7.xls

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Document reference: 47720

Study title: "The use of powdered raw bone of young animals in children", Cornet-Jacquemoud C., Moderne Probleme der Pediatrie, 1954, 1 : 245-251"The use of powdered raw bone of young animals in children", Cornet-Jacquemoud C., Moderne Probleme der Pediatrie, 1954, 1 : 245-251

Active substance: OSSEIN HYDROXYAPATITE COMPOUND

Study summary document link (including results): Ossopan nr6.xls

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Document reference: 47719

Study title: Efficacy and safety of phloroglucinol versus hyoscine-n-butylbromide for the treatment of dysmenorrheic pain. a clinical trial. Deligeoroglou E. et col. XI worl congress paediatric & adolescent gynaecology 1995. book of abstract Efficacy and safety of phloroglucinol versus hyoscine-n-butylbromide for the treatment of dysmenorrheic pain. a clinical trial. Deligeoroglou E. et col. XI worl congress paediatric & adolescent gynaecology 1995. book of abstract

Active substance: PHLOROGLUCINOL

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Document reference: 34032

Study title: Clinical evaluation in pediatrics

Active substance: PHOLCODINE

Study summary document link (including results): Pholcodine_STUDY_640.6.002_Lafargues.xls

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Document reference: 34033

Study title: Clinical evaluation in pediatrics.

Active substance: PHOLCODINE

Study summary document link (including results): Pholcodine_STUDY__640.6.005_Polonovski.xls

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Document reference: 34035

Study title: Dal Monte A, Leonardi LM, Figura F, Cappozzo A, Marchetti M, De Santis AM. Effects of phosphocreatine administration on muscle strength in man. Gazz. Med. Ital. 1976; 135 (9): 439-448

Active substance: PHOSPHOCREATINE

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Document reference: 34037

Study title: Radu H, Keresztes L, Stenzel K. Effects of administration of phosphocreatine on the clinical, biochemical and electromyographic evolution of Duchenne's progressive muscular dystrophy. Minerva Med. 1968; 59 (99): 5524-29

Active substance: PHOSPHOCREATINE

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Document reference: 34038

Study title: Simonazzi-P, Tedeschi-C, Lombardi-F, Camurri-G-B. Valutazione isocinetica dell'efficacia della creatina fosfato nel trattamento dell'ipotrofia muscolare da non uso. Il ruolo di farmaci nella medicina riabilitativa 1992; Vol. 2: 262-265

Active substance: PHOSPHOCREATINE

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Document reference: 34036

Study title: The clinical efficacy of oxybutynin - Malone-Lee J - Rev. Contemp. Pharmacother. - 1994; 5:195-202The clinical efficacy of oxybutynin - Malone-Lee J - Rev. Contemp. Pharmacother. - 1994; 5:195-202

Active substance: OXITRIPTAN

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Document reference: 32925

Study title: The role of Oxybutynin Chloride as adjuctive therapy for Intermittent Catheterization in children with neurogenic bladder: results on continence - De Castro R., Casolari E, Ricci S. - Ped. Med. Chir. (Med. Surg. Ped.) - 1984 (6: 795-804) - Publication in UK registration file - The role of Oxybutynin Chloride as adjuctive therapy for Intermittent Catheterization in children with neurogenic bladder: results on continence - De Castro R., Casolari E, Ricci S. - Ped. Med. Chir. (Med. Surg. Ped.) - 1984 (6: 795-804) - Publication in UK registration file -

Active substance: OXITRIPTAN

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Document reference: 32917

Active substance: PARACETAMOL AND DIPHENHYDRAMINE

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Document reference: 33430

Active substance: PARACETAMOL AND DIPHENHYDRAMINE

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Document reference: 33439

Study title: Antibiotherapie prophylactique de l'enfant - Herrault A. - 1966 (Ann. Pédiatr., 13 (5) 368 - 371)Antibiotherapie prophylactique de l'enfant - Herrault A. - 1966 (Ann. Pédiatr., 13 (5) 368 - 371)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45873

Study title: Comment je traite un R.A.A. de l'enfant - 1973 (Gaz. Méd., 80, (3), 345 - 352)Comment je traite un R.A.A. de l'enfant - 1973 (Gaz. Méd., 80, (3), 345 - 352)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45874

Study title: Evaluer l'acceptabilité et la tolérance clinique de la nouvelle formule d'Oracilline suspension buvable, dosée à 250.000 Unités par cuillère-doseuse de 5 ml, auprès d'une population de nourrissons et de jeunes enfants - Pr Y. Castel, Dr Y. Fryda - 1985 à 1986 (résumé du compte-rendu d'essai clinique)Evaluer l'acceptabilité et la tolérance clinique de la nouvelle formule d'Oracilline suspension buvable, dosée à 250.000 Unités par cuillère-doseuse de 5 ml, auprès d'une population de nourrissons et de jeunes enfants - Pr Y. Castel, Dr Y. Fryda - 1985 à 1986 (résumé du compte-rendu d'essai clinique)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45877

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45889

Study title: An open randomised study to compare efficacy and safety of Fucithalmic® with neosporin.Yacinto U Dy, Llacco Int. J. of clinical practices, Vol 7., No. 3., 1991 82 pts (4-75)

Active substance: FUSIDIC ACID

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Document reference: 48461

Study title: Gentamicin in paediatrics - McAllister TA. - 1974 (Postgraduate Med. J., 50, Suppl 7: 45-52) - Publication in Gentamicin Registration Dossier - 1978 -

Active substance: GENTAMYCIN

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Document reference: 28912

Study title: 9.) Clinical efficacy of orally applied enzyme medicine Wobenzym in pa- tients with first time diagnosed diabetes mellitus

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40101

Study title: Efficacy and Safety of Woben- zym as Antidema- tous Therapy in Meniscectomies

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40097

Study title: Efficacy and Safety of Woben- zym/Wobenzym N in the post trau- matic treatment after sport injuries and surgery

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40099

Active substance: OXITRIPTAN

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Document reference: 32928

Active substance: OXITRIPTAN

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Document reference: 32930

Active substance: OXITRIPTAN

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Document reference: 32949

Study title: The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000;105;295-310The STOP-ROP Multicenter Study Group Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes. Pediatrics 2000;105;295-310

Active substance: OXITRIPTAN

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Document reference: 32955

Study title: L'antibiotherapie dans le rhumatisme de l'enfant. 4ème Conférence internationale des maladies rhumatismales - Mozziconacci P. & Gautier M. - 1964 (Les Thérapeutiques médicales des affections rhumatismales. Grenoble, Edit. Imprimerie générale pp. 157 - 176)L'antibiotherapie dans le rhumatisme de l'enfant. 4ème Conférence internationale des maladies rhumatismales - Mozziconacci P. & Gautier M. - 1964 (Les Thérapeutiques médicales des affections rhumatismales. Grenoble, Edit. Imprimerie générale pp. 157 - 176)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45880

Study title: A comparison of oral ondansetron syrup or intravenous ondansetron loading dose regimens given in combination with dexamethasone for the prevention of nausea and emesis in pediatric and adolescent patients receiving moderately/highly emetogenic chemotherapy. White L, Daly SA, McKenna CJ, Zhestkova N, Leal C, Breatnach F, Smelhaus V, Hung IJ, Kowalczyk J, Ninane J, Mitchell T, Haigh C. Pediatr Hematol Oncol. 2000 Sep; 17(6):445-55.A comparison of oral ondansetron syrup or intravenous ondansetron loading dose regimens given in combination with dexamethasone for the prevention of nausea and emesis in pediatric and adolescent patients receiving moderately/highly emetogenic chemotherapy. White L, Daly SA, McKenna CJ, Zhestkova N, Leal C, Breatnach F, Smelhaus V, Hung IJ, Kowalczyk J, Ninane J...

Active substance: ONDASETRON

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Document reference: 32804

Study title: Assessment of chemotherapy-induced emesis and evaluation of a reduced-dose intravenous ondansetron regimen in pediatric outpatients with leukemia.Holdsworth MT, Raisch DW, Duncan MH, Chavez CM, Leasure MM.Ann Pharmacother. 1995 Jan; 29(1):16-21. Assessment of chemotherapy-induced emesis and evaluation of a reduced-dose intravenous ondansetron regimen in pediatric outpatients with leukemia.Holdsworth MT, Raisch DW, Duncan MH, Chavez CM, Leasure MM.Ann Pharmacother. 1995 Jan; 29(1):16-21.

Active substance: ONDASETRON

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Document reference: 32807

Study title: Bolton, C.M., et al., Randomized, double-blind study comparing the efficacy of moderate-dose metoclopramide and ondansetron for the prophylactic control of postoperative vomiting in children after tonsillectomy. Br J Anaesth, 2007. 99(5): p. 699-703.Bolton, C.M., et al., Randomized, double-blind study comparing the efficacy of moderate-dose metoclopramide and ondansetron for the prophylactic control of postoperative vomiting in children after tonsillectomy. Br J Anaesth, 2007. 99(5): p. 699-703.

Active substance: ONDASETRON

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Document reference: 32805

Study title: Fucithalmic in acute conjunctivitis. Open, randomized comparison of fusidic acid, chloramphenicol and framycetin eye drops.Dirdal M. Acta Ophthalmol 1987; 65: 129-133.

Active substance: FUSIDIC ACID

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Document reference: 48456

Study title: Fusidic acid in infections of the external eye.Bijsterveld O.P. van 1987, Infection, 15: 16-19

Active substance: FUSIDIC ACID

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Document reference: 48457

Study title: Non-interventional study on the use of Kanamycin-POS® in children; Küchle H. J., Busse H., Augenerkrankungen im Kindesalter, Thieme Verlag Stuttgart New York 1985Non-interventional study on the use of Kanamycin-POS® in children; Küchle H. J., Busse H., Augenerkrankungen im Kindesalter, Thieme Verlag Stuttgart New York 1985

Active substance: KETOPROFEN AND SUCRALFATE

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Document reference: 30892

Study title: Levron JC, Chwetzoff E, Stephan P, Gluckman DR. Etude des concentrations plasmatiques de L'itraconazole en traitement prophylactique des greffes de moelle, pendant 5 semaines.Rapport de recherche clinique, May 1986. (12-42 years, LMD51161)Levron JC, Chwetzoff E, Stephan P, Gluckman DR. Etude des concentrations plasmatiques de L'itraconazole en traitement prophylactique des greffes de moelle, pendant 5 semaines.Rapport de recherche clinique, May 1986. (12-42 years, LMD51161)

Active substance: ITRACONAZOLE

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Document reference: 30810

Study title: J Am Acad Dermatol. 1981 Dec;5(6):670-2. A new noninvasive evaluation of muscular lesions in dermatomyositis: thallium 201 muscle scans. Guillet GY, Guillet JA, Blanquet P, Maleville J. J Am Acad Dermatol. 1981 Dec;5(6):670-2. A new noninvasive evaluation of muscular lesions in dermatomyositis: thallium 201 muscle scans. Guillet GY, Guillet JA, Blanquet P, Maleville J.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44587

Study title: Clinical outcomes of treatment with oral pantoprazole in patients aged 5 to 11 years with symptomatic GERD ; safety and tolerability. Out patient,randomized, double-blind, parallel-group.

Active substance: PANTOPRAZOLE

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Document reference: 45720

Study title: Efficacy and tolerabilty in items of pHmetry of pantoprazole 20 mg (0,5-1,0 mg/kg/day) in pediatrics patients aged 6 to 16 years.

Active substance: PANTOPRAZOLE

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Document reference: 45721

Study title: Pharmacokinetics of a sigle oral dose of pantoprazole 20 mg or 40 mg in pediatric patients aged 5 to 16 years ; safety an tolarability. Open label, randomized, age-stratified, parallel-group study.

Active substance: PANTOPRAZOLE

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Document reference: 45722

Study title: Kapoor−S−K et al. Comparison of antipyretic effect of nimesulide and paracetamol in children attending a secondary level hospital. {INDIAN−PEDIATR}, 2002, Vol/Iss/Pg. 39/5 (473−477)Kapoor−S−K et al. Comparison of antipyretic effect of nimesulide and paracetamol in children attending a secondary level hospital. {INDIAN−PEDIATR}, 2002, Vol/Iss/Pg. 39/5 (473−477)

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33546

Study title: The use of an antihistamine-decongestant in conjunction with an anti-infective drug in the treatment of acute otitis media. Moran DM, Mutchie KD, Higbee MD, Paul LD. J Pediatr. 1982 Jul;101(1):132-6.The use of an antihistamine-decongestant in conjunction with an anti-infective drug in the treatment of acute otitis media. Moran DM, Mutchie KD, Higbee MD, Paul LD. J Pediatr. 1982 Jul;101(1):132-6.

Active substance: PARACETAMOL AND PHENYLPROPANOLAMINE AND PHENYLTOLOXAMINE

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Document reference: 33616

Study title: Prophylactic Treatment with Wobenzym after Sport Injuries in Karate Fighters

Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase

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Document reference: 40095

Study title: Nabulsi−M et al. Equal antipyretic effectiveness of oral and rectal acetaminophen: A randomized controlled trial (ISRCTNI 1886401). {BMC−PEDIATR}, 06 SEP 2005, Vol/Iss/Pg. 5/− (7p)Nabulsi−M et al. Equal antipyretic effectiveness of oral and rectal acetaminophen: A randomized controlled trial (ISRCTNI 1886401). {BMC−PEDIATR}, 06 SEP 2005, Vol/Iss/Pg. 5/− (7p)

Active substance: PARACETAMOL

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Document reference: 45730

Study title: Nabulsi−Mona et al. Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial (ISRCTN11886401). {BMC−Pediatr}, 2005 (epub), vol. 5, p. 35Nabulsi−Mona et al. Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial (ISRCTN11886401). {BMC−Pediatr}, 2005 (epub), vol. 5, p. 35

Active substance: PARACETAMOL

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Document reference: 45731

Study title: Obata H et al Clinical outcome of patients with Ewing sarcoma family of tumors of bone in Japan: the Japanese Musculoskeletal Oncology Group cooperative study Cancer. 2007 Feb 15;109(4):767-75Obata H et al Clinical outcome of patients with Ewing sarcoma family of tumors of bone in Japan: the Japanese Musculoskeletal Oncology Group cooperative study Cancer. 2007 Feb 15;109(4):767-75

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 25043

Study title: PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trialW Voskuijl BMJ Gut 2004

Active substance: PEG 3350

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Document reference: 48370

Study title: Once-per-cycle pegfilgrastim versus daily filgrastim in pediatric patients with Ewing sarcoma. Wendelin, G. et al. Journal of Pediatric Hematology/Oncology 27(8): 449-51.Once-per-cycle pegfilgrastim versus daily filgrastim in pediatric patients with Ewing sarcoma. Wendelin, G. et al. Journal of Pediatric Hematology/Oncology 27(8): 449-51.

Active substance: pegfilgrastim

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Document reference: 41579

Study title: The effects of ondansetron and granisetron on electrocardiography in children receiving chemotherapy for acute leukemia. Buyukavci M, Olgun H, Ceviz N. Am J Clin Oncol. 2005 Apr; 28(2):201-4.The effects of ondansetron and granisetron on electrocardiography in children receiving chemotherapy for acute leukemia. Buyukavci M, Olgun H, Ceviz N. Am J Clin Oncol. 2005 Apr; 28(2):201-4.

Active substance: ONDASETRON

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Document reference: 32809

Study title: Effectiveness of Mass Oral Cholera Vaccination in Beira, Mozambique, published in New England Journal Med in Feb 2005

Active substance: oral cholera vaccine

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Document reference: 41502

Study title: A phase II, randomised, double-blind, placebo-controlled study to evaluate the immunogenicity, reactogenicity and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine when given concomitantly with OPV versus when given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh.

Active substance: oral live attenuated human rotavirus

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Document reference: 45712

Study title: Double-blind Pediatric Study to Assess the Safety, Pharmacokinetics and Efficacy of Single IV Doses of Palonosetron, 3.0 μg/kg or 10.0 μg/kg, in the Prevention of Chemotherapy- Induced Nausea and Vomiting

Active substance: PALONOSETRON HYDROCHLORIDE

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Document reference: 47743

Study title: J Am Coll Cardiol. 1985 Jan;5(1 Suppl):128S-139S. Thallium-201 myocardial imaging in children. Sty JR, Starshak RJ. J Am Coll Cardiol. 1985 Jan;5(1 Suppl):128S-139S. Thallium-201 myocardial imaging in children. Sty JR, Starshak RJ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44589

Study title: J Bone Joint Surg Am. 1993 Apr;75(4):526-31. Comment in: J Bone Joint Surg Am. 1993 Dec;75(12):1880-1. Thallium-201 scanning for the evaluation of osteosarcoma and soft-tissue sarcoma. A study of the evaluation and predictability of the histologicalJ Bone Joint Surg Am. 1993 Apr;75(4):526-31. Comment in: J Bone Joint Surg Am. 1993 Dec;75(12):1880-1. Thallium-201 scanning for the evaluation of osteosarcoma and soft-tissue sarcoma. A study of the evaluation and predictability of the histological

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44592

Study title: J Cardiogr. 1981 Mar;11(1):105-14. [Myocardial imaging with thallium -201 in the patients with coronary involvement after Kawasaki disease (author's transl)] [Article in Japanese] J Cardiogr. 1981 Mar;11(1):105-14. [Myocardial imaging with thallium -201 in the patients with coronary involvement after Kawasaki disease (author's transl)] [Article in Japanese]

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44593

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33540

Study title: Wilson JT, Höjer B, Tomson G, Rane A, Sjöqvist F High incidence of contration-dependent skin reaction in children treated with phenytoin B M J, 1978, 1: 1583- 1586Wilson JT, Höjer B, Tomson G, Rane A, Sjöqvist F High incidence of contration-dependent skin reaction in children treated with phenytoin B M J, 1978, 1: 1583- 1586

Active substance: PHENYLEPHRINE

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Document reference: 33938

Study title: Young B, Rapp RP, Norton JA, Haack D, Walsh JW. Failure of prophylactically administered phenytoin to prevent posttraumatic seizures in children. Childs Brain. 1983;10(3):185-92.Young B, Rapp RP, Norton JA, Haack D, Walsh JW. Failure of prophylactically administered phenytoin to prevent posttraumatic seizures in children. Childs Brain. 1983;10(3):185-92.

Active substance: PHENYLEPHRINE

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Document reference: 33932

Study title: Zumpft CW. Double-blind comparison of metizoline hydrochloride (Ellsyl) and phenylephrine in allergic and vasomotor rhinitis. Curr Ther Res Clin Exp 1975; 17(1):40-6 Zumpft CW. Double-blind comparison of metizoline hydrochloride (Ellsyl) and phenylephrine in allergic and vasomotor rhinitis. Curr Ther Res Clin Exp 1975; 17(1):40-6

Active substance: PHENYLEPHRINE

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Document reference: 45102

Study title: Bavdekar, A. R., Bhave, S. A., Pradhan, A. M., Pandit, A. N., and Tanner, M. S. Department of Paediatrics, King Edward Memorial Hospital, Pune, India Long term survival in Indian childhood cirrhosis treated with D-penicillamine Arch.Dis.Child 1996;74:32-35. Bavdekar, A. R., Bhave, S. A., Pradhan, A. M., Pandit, A. N., and Tanner, M. S. Department of Paediatrics, King Edward Memorial Hospital, Pune, India Long term survival in Indian childhood cirrhosis treated with D-penicillamine Arch.Dis.Child 1996;74:32-35.

Active substance: PENICILLAMINE

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Document reference: 33839

Study title: Bhave, S. and Pandit, A. D-penicillamine in the therapy of Indian childhood cirrhosis Indian J.Pediatr. 1987;54:587-590. Bhave, S. and Pandit, A. D-penicillamine in the therapy of Indian childhood cirrhosis Indian J.Pediatr. 1987;54:587-590.

Active substance: PENICILLAMINE

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Document reference: 33847

Study title: Giannini, E. H., Brewer, E. J., Kuzmina, N., Alekseev, L., and Shokh, B. P. Baylor College of Medicine, Houston, Texas Characteristics of responders and nonresponders to slow-acting antirheumatic drugs in juvenile rheumatoid arthritis Arthritis Rheum. 1988;31:15-20. Giannini, E. H., Brewer, E. J., Kuzmina, N., Alekseev, L., and Shokh, B. P. Baylor College of Medicine, Houston, Texas Characteristics of responders and nonresponders to slow-acting antirheumatic drugs in juvenile rheumatoid arthritis Arthritis Rheum. 1988;31:15-20.

Active substance: PENICILLAMINE

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Document reference: 33850

Study title: Vashev EA. Some aspects of virus hepatitis B treatment in children. Mikrobiol epidemiol i klinika infeksionnykh boleznei 1988, 46-8 (currently only summary available) Vashev EA. Some aspects of virus hepatitis B treatment in children. Mikrobiol epidemiol i klinika infeksionnykh boleznei 1988, 46-8 (currently only summary available)

Active substance: PHOSPHOLIPIDS AND VITAMINS

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Document reference: 34045

Active substance: PARACETAMOL AND DIPHENHYDRAMINE

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Document reference: 33406

Active substance: PARACETAMOL AND DIPHENHYDRAMINE

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Document reference: 33375

Study title: Goyal−P−K et al. Double blind randomized comparative evaluation of nimesulide and paracetamol as antipyretics. {Indian−Pediatr}, Jun 1998, vol. 35, no. 6, p. 519−22Goyal−P−K et al. Double blind randomized comparative evaluation of nimesulide and paracetamol as antipyretics. {Indian−Pediatr}, Jun 1998, vol. 35, no. 6, p. 519−22

Active substance: PARACETAMOL AND DIPHENHYDRAMINE

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Document reference: 33385

Study title: Greene−S−L, Reed−C−E, Schroeter−A−L. Double−blind crossover study comparing doxepin with diphenhydramine for the treatment of chronic urticaria. Journal of the American Academy of Dermatology, {J−Am−Acad−Dermatol}, Apr 1985, vol. 12, no. 4, p. 669−75.Greene−S−L, Reed−C−E, Schroeter−A−L. Double−blind crossover study comparing doxepin with diphenhydramine for the treatment of chronic urticaria. Journal of the American Academy of Dermatology, {J−Am−Acad−Dermatol}, Apr 1985, vol. 12, no. 4, p. 669−75.

Active substance: PARACETAMOL AND DIPHENHYDRAMINE

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Document reference: 33628

Study title: Kramer−M−S et al. Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. {Lancet}, 9 Mar 1991, vol. 337, no. 8741, p. 591−4Kramer−M−S et al. Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. {Lancet}, 9 Mar 1991, vol. 337, no. 8741, p. 591−4

Active substance: PARACETAMOL AND DIPHENHYDRAMINE

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Document reference: 33361

Study title: Efficacy and Safety by Children and Adolescents (5-17 yrs and 2 months) with Autictic Disorders

Active substance: TRETINOIN

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Document reference: 46730

Study title: Etude d'efficacité et tolérance biologique ouverte multicentrique 320 patients dont 31 de 15 ans et moins

Active substance: TRETINOIN

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Document reference: 46731

Study title: Topical isotretinoin vs. topical retinoic acid in the treatment of acne vulgaris Dominguez J, Hojyo MT, Celayo JL, Dominguez-Soto L, Teixeira F. Int J Dermatol. 1998 Jan;37 (1) : 54-5 "This is a clinical, prospective, and longitudinal study comparing the efficacy and incidence of averse effects of topical isotretinoin against those of topical retinoic acid in the treatment of acne vulgaris" Topical isotretinoin vs. topical retinoic acid in the treatment of acne vulgaris Dominguez J, Hojyo MT, Celayo JL, Dominguez-Soto L, Teixeira F. Int J Dermatol. 1998 Jan;37 (1) : 54-5 "This is a clinical, prospective, and longitudinal study comparing the efficacy and incidence of averse effects of topical isotretinoin against those of topical retinoic acid in the treatment of acne vulgaris"

Active substance: TRETINOIN

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Document reference: 46732

Study title: A Phase III multicenter, open-label, long term safety study of Triamcinolone acetonide forte HFA-134a oral inhaler treatment in moderate to severe asthmatic children, involving 250 patients - No author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46822

Study title: Rev Esp Med Nucl. 1998;17(2):112-5. [False positive with Tl-201 in the study of Ewing's sarcoma of the astragalus caused by reflex sympathetic dystrophy] [Article in Spanish] Serrano Vicente J, Caballero Carpena O, VerdÃº Rico J, AlcalÃ¡ Santaella R, MRev Esp Med Nucl. 1998;17(2):112-5. [False positive with Tl-201 in the study of Ewing's sarcoma of the astragalus caused by reflex sympathetic dystrophy] [Article in Spanish] Serrano Vicente J, Caballero Carpena O, VerdÃº Rico J, AlcalÃ¡ Santaella R, M

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44698

Study title: Treatment of rhinitis: not at the cost of mucosal injury! Ärzt. Praxis 34 (5), 102-103Gunther 1982

Active substance: PHENYLEPHRINE AND DEMETHINDENE MALEATE

Study summary document link (including results): 2011-EMA spreadsheet - Vibrocil - Gunther_1982.xls

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Document reference: 48027

Study title: Wilson JT, Höjer B, Rane A. Loading and conventional dose therapy with phenytoin in children: kinetic profile of parent drug and main metabolite in plasma. Clin Pharmacol Ther. 1976 Jul;20(1):48-58Wilson JT, Höjer B, Rane A. Loading and conventional dose therapy with phenytoin in children: kinetic profile of parent drug and main metabolite in plasma. Clin Pharmacol Ther. 1976 Jul;20(1):48-58

Active substance: PHENYLEPHRINE

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Document reference: 33939

Study title: Clinical study of Adumbran" syrup of Boehringer Ingelheim (generic name "oxazepam")."

Active substance: OXAZEPAM

Study summary document link (including results): Oxazepam_U76-0287_SYNOPSIS.pdf

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Document reference: 45387

Study title: Final report on the study of the product Z 10-TR at the university eye hospital in Mainz.

Active substance: OXAZEPAM

Study summary document link (including results): Oxazepam_U64-0066_SYNOPSIS.pdf

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Document reference: 45388

Study title: Investigations into the effect of Adumbran suppositories in children

Active substance: OXAZEPAM

Study summary document link (including results): Oxazepam_U70-0340_SYNOPSIS.pdf

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Document reference: 45389

Study title: Report on the experience with the use of Adumbran.

Active substance: OXAZEPAM

Study summary document link (including results): Oxazepam_U70-0342_SYNOPSIS.pdf

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Document reference: 45386

Study title: Bioavailability and efficacy of Konakion MM Ro 01-6722/130, 1.5mg vitamin K1 i.m. versus 3.0mg vitamin K1 oral in healthy newborn breast-fed babies

Active substance: PHYTOMENADION

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Document reference: 34058

Study title: Comparative tolerability of Ro 01-6722/120 (Konakion MM) and Ro 01-6722/092 (Konakion commercial form with Cremophor) 5 mg/0.5 ml i.m. in healthy new-born and premature babies.

Active substance: PHYTOMENADION

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Document reference: 34064

Study title: Efficacy and tolerability of Konakion MM Ro 01-6722/135, 1mg vitamin K1 i.v. and 2mg vitamin K1 p.o. in the prophylactic treatment against hemorrhagic disease in premature infants

Active substance: PHYTOMENADION

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Document reference: 34065

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33591

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45890

Study title: Pharmacologic evaluation of orally administered antibiotics in infants and children: effect of feeding on bioavailability - Mc Cracken G. H, Jr, Ginsburb Ch. M., Clahsen J.C. & Thomas M. L. - 1978 (Pediatrics, 62 (5) 738 - 743, 10 réf.)Pharmacologic evaluation of orally administered antibiotics in infants and children: effect of feeding on bioavailability - Mc Cracken G. H, Jr, Ginsburb Ch. M., Clahsen J.C. & Thomas M. L. - 1978 (Pediatrics, 62 (5) 738 - 743, 10 réf.)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45881

Study title: Prophylaxie de la scarlatine dans les collectivités - Vilde J. C. - 1978 (Gaz. Méd. Fr., 85 (35) 4103)Prophylaxie de la scarlatine dans les collectivités - Vilde J. C. - 1978 (Gaz. Méd. Fr., 85 (35) 4103)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45882

Study title: Randomized, multicenter open study comparing the efficacy of potassium-phenoxymethylpenicillin V three times daily for 10 days versus benzathine penicillin V twice daily for 5 days in the treatment of acute group A ß-hemolytic streptococcal tonsillopharyngitis in children

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45891

Study title: Randomized, multicenter pilot study comparing the efficacy of potassium-phenoxymethylpenicillin granules for oral suspension 100.000 IU /kg/day tid for 10 days versus benzathine-phenoxymethylpenicillin suspension 100.000 IU /kg/day bid for 7 days versus benzathine-phenoxymethylpenicillin suspension 100.000 IU /kg/day bid for 5 days in the treatment of acute group A ß-hemolytic streptococcal tonsillopharyngitis in children

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45872

Study title: Rev Esp Med Nucl. 2004 Sep-Oct;23(5):330-7. [Value of thallium 201-SPECT in typing brain space-occupying lesions] [Article in Spanish] MartÃnez del Valle Torres MD, GÃ³mez Rio M, RodrÃguez FernÃ¡ndez A, Sabatel Hernandez G, Ortega Lozano S, Ramos FonRev Esp Med Nucl. 2004 Sep-Oct;23(5):330-7. [Value of thallium 201-SPECT in typing brain space-occupying lesions] [Article in Spanish] MartÃnez del Valle Torres MD, GÃ³mez Rio M, RodrÃguez FernÃ¡ndez A, Sabatel Hernandez G, Ortega Lozano S, Ramos Fon

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44700

Study title: Rinsho Hoshasen. 1990 Feb;35(2):253-7. [The role and clinical value of thallium-201 myocardial scintigraphy in ischemic heart disease] [Article in Japanese] Shimada T, Nakamori H, Kurimoto T, Karakawa M, Matsuura T, Iwasaka T, Inada M, Nishiyama Y. Rinsho Hoshasen. 1990 Feb;35(2):253-7. [The role and clinical value of thallium-201 myocardial scintigraphy in ischemic heart disease] [Article in Japanese] Shimada T, Nakamori H, Kurimoto T, Karakawa M, Matsuura T, Iwasaka T, Inada M, Nishiyama Y.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44701

Study title: Semin Nucl Med. 1993 Jul;23(3):243-54. Thallium-201 for oncological imaging in children. Nadel HR. Semin Nucl Med. 1993 Jul;23(3):243-54. Thallium-201 for oncological imaging in children. Nadel HR.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44703

Study title: Anticholinergic therapy for primary enuresis efficacy of oxybutynin chloride in a controlled clinical trial in 58 patients - Marconi A.M., Felici E., Roggia A., Torelli F. - Ped. Med. Chir - Med. Surg. Ped. - 1985 (7:573-576) - Publication in UK registration file - Anticholinergic therapy for primary enuresis efficacy of oxybutynin chloride in a controlled clinical trial in 58 patients - Marconi A.M., Felici E., Roggia A., Torelli F. - Ped. Med. Chir - Med. Surg. Ped. - 1985 (7:573-576) - Publication in UK registration file -

Active substance: OXITRIPTAN

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Document reference: 32927

Active substance: OXITRIPTAN

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Document reference: 32936

Active substance: OXITRIPTAN

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Document reference: 32937

Study title: A Combined Analysis of the Data Provided by Drs. J. Hopkinson, W. Bare, and R. Posatko's Tylenol 500 (Acetaminophen) Studies. Unpublished Report TA8A2, Nov 1972 and Teal TW. Dr. John Hopkinson's Tylenol 500 (Acetaminophen) Study. Unpublished Report TA8A3.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol TA8A2 and TA8A3.pdf

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Document reference: 47518

Study title: A double-blind comparison of the safety and efficacy of a single dose of Children's Advil ibuprofen suspension (10mg/kg), acetaminophen (15mg/kg), and a control vehicle in the relief of sore throat pain in children.

Active substance: PARACETAMOL

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Document reference: 45791

Active substance: PARACETAMOL

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Document reference: 45797

Study title: A double-blind comparison of the safety and efficacy of a single dose of Children's Advil Suspension (10 mg/kg), acetaminophen (15 mg/kg), and a vehicle control in the relief of sore throat pain in children

Active substance: PARACETAMOL

Study summary document link (including results): Ibuprofen-WM-375A.pdf

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Document reference: 45790

Active substance: OXITRIPTAN

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Document reference: 32950

Study title: Use of Oxybutynin Chloride (Ditropan) in Treatment of Enuresis - R. De Castro, E. Casolari, and S. Ricci - Riv Ital Ped - 1985 (11: 208-211) - Publication in UK registration file - Use of Oxybutynin Chloride (Ditropan) in Treatment of Enuresis - R. De Castro, E. Casolari, and S. Ricci - Riv Ital Ped - 1985 (11: 208-211) - Publication in UK registration file -

Active substance: OXITRIPTAN

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Document reference: 32920

Study title: Wiklund et al. The Efficacy of oxymetasoline Administered with a Nasal Bellows Container and Combined with Oral Phenoxymethyl-penicillin in the Treatment of Acute Maxillary Sinusitis. Acta Otolaryngol (Stockh) 1994; 515: 57-64Wiklund et al. The Efficacy of oxymetasoline Administered with a Nasal Bellows Container and Combined with Oral Phenoxymethyl-penicillin in the Treatment of Acute Maxillary Sinusitis. Acta Otolaryngol (Stockh) 1994; 515: 57-64

Active substance: OXITRIPTAN

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Document reference: 32958

Study title: Expertise clinique du produit C1491 oxolamine phosphate sirop adulte -prilon-

Active substance: OXOLAMINE

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Document reference: 45106

Study title: Expertise clinique du produit C1491 oxolamine phosphate sirop adulte -prilon-

Active substance: OXOLAMINE AND PROPYLPHENAZONE

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Document reference: 32971

Study title: A phase III randomized multi-center study to assess the immunogenicity of three doses of Pediarix®, Prevnar® and ActHIB® given to healthy infants at 2, 4 and 6 months of age when administered with GlaxoSmithKline (GSK) Biologicals’ two-dose oral live attenuated human rotavirus (HRV) vaccine given during the same vaccination visit (at 2 and 4 months of age) or given separately (at 3 and 5 months of age).

Active substance: oral live attenuated human rotavirus

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Document reference: 45713

Study title: Rehydratation von Säuglingen und Kleinkindern mit einer neuen oralen Rehydrierungslösung; Guggenbichler et al; Dt. Apo. Zeitg. 130/35, 1912 - 1913 (1990)Rehydratation von Säuglingen und Kleinkindern mit einer neuen oralen Rehydrierungslösung; Guggenbichler et al; Dt. Apo. Zeitg. 130/35, 1912 - 1913 (1990)

Active substance: ORAL REHYDRATION SALT FORMULATIONS

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Document reference: 32810

Study title: An open−label dose−titration study of the efficacy and tolerability of tizanidine hydrochloride tablets in the prophylaxis of chronic daily headache.Saper JR, Winner PK, Lake AE−3rd. Headache, Apr 2001, vol. 41, no. 4, p. 357−68An open−label dose−titration study of the efficacy and tolerability of tizanidine hydrochloride tablets in the prophylaxis of chronic daily headache.Saper JR, Winner PK, Lake AE−3rd. Headache, Apr 2001, vol. 41, no. 4, p. 357−68

Active substance: TIZANIDINE

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Document reference: 38511

Study title: (Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia). Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60(Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia). Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60

Active substance: TIZANIDINE

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Document reference: 38508

Study title: Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2. Granfors MT, Backman JT, Laitila J, Neuvonen PJ. Clinical pharmacology and therapeutics, Oct 2005, vol. 78, no. 4, p. 400−11Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2. Granfors MT, Backman JT, Laitila J, Neuvonen PJ. Clinical pharmacology and therapeutics, Oct 2005, vol. 78, no. 4, p. 400−11

Active substance: TIZANIDINE

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Document reference: 38507

Study title: Tizanidine treatment of spasticity: a meta−analysis of controlled, double−blind, comparative studies with baclofen and diazepam.Groves L, Shellenberger MK, Davis CS. Advances in therapy, Jul−Aug 1998, vol. 15, no. 4, p. 241−51.Tizanidine treatment of spasticity: a meta−analysis of controlled, double−blind, comparative studies with baclofen and diazepam.Groves L, Shellenberger MK, Davis CS. Advances in therapy, Jul−Aug 1998, vol. 15, no. 4, p. 241−51.

Active substance: TIZANIDINE

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Document reference: 38512

Study title: A double-blind, single dose evaluation comparing the analgesic efficacy and adverse effect liability of acetaminophen 650 mg, acetaminophen 1000 mg and placebo in the treatment of postoperative pain following oral surgery.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol 0-223.pdf

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Document reference: 47505

Study title: A double-blind, single dose evaluation of the relative analgesia and safety of acetaminophen 2000 mg, 1500 mg, 1000 mg, 500 mg, and placebo in the treatment of pain following oral or periodontal surgery.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol 1-221.pdf

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Document reference: 47507

Study title: A double-dose, single dose evaluation comparing the analgesic efficacy and adverse effect liability of acetaminophen 650 mg, acetaminophen 1000 mg and placebo in the treatment of postoperative pain following oral surgery.

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol 0-214.pdf

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Document reference: 47504

Study title: Antipyretic effectiveness of ibuprofen and paracetamol. An Pediatr Barc , Feb 2005, vol. 62, no. 2, p. 117-22 Antipyretic effectiveness of ibuprofen and paracetamol. An Pediatr Barc , Feb 2005, vol. 62, no. 2, p. 117-22

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33657

Study title: Antipyretic effects of nimesulide, paracetamol and ibuprofen paracetamol. {INDIAN J PEDIATR}, 2000, Vol/Iss/Pg. 67 /12 (865-870) Antipyretic effects of nimesulide, paracetamol and ibuprofen paracetamol. {INDIAN J PEDIATR}, 2000, Vol/Iss/Pg. 67 /12 (865-870)

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33659

Study title: Clinical trial of 3 days of treatment with oral pseudoephedrine for the common cold in the southern hemisphere. Am J Rhinol 2007; 21(4):452-5 Clinical trial of 3 days of treatment with oral pseudoephedrine for the common cold in the southern hemisphere. Am J Rhinol 2007; 21(4):452-5

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33631

Study title: Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. {Lancet}, 9 Mar 1991, vol. 337, no. 8741, p. 591-4 Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. {Lancet}, 9 Mar 1991, vol. 337, no. 8741, p. 591-4

Active substance: PARACETAMOL

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Document reference: 45743

Study title: Russell−Fiona−M et al. Evidence on the use of paracetamol in febrile children. {Bull−World−Health−Organ}, 2003 (epub: 07 Jul 2003), vol. 81, no. 5, p. 367−72Russell−Fiona−M et al. Evidence on the use of paracetamol in febrile children. {Bull−World−Health−Organ}, 2003 (epub: 07 Jul 2003), vol. 81, no. 5, p. 367−72

Active substance: PARACETAMOL

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Document reference: 45744

Study title: Scolnik−D et al. Comparison of oral versus normal and high−dose rectal acetaminophen in the treatment of febrile children. {PEDIATRICS}, 2002, Vol/Iss/Pg. 110/3 (553−556)Scolnik−D et al. Comparison of oral versus normal and high−dose rectal acetaminophen in the treatment of febrile children. {PEDIATRICS}, 2002, Vol/Iss/Pg. 110/3 (553−556)

Active substance: PARACETAMOL

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Document reference: 45746

Study title: Sidler−J et al. A double−blind comparison of ibuprofen and paracetamol in juvenile pyrexia. {Br−J−Clin−Pract− Suppl}, Aug 1990, vol. 70, p. 22−5Sidler−J et al. A double−blind comparison of ibuprofen and paracetamol in juvenile pyrexia. {Br−J−Clin−Pract− Suppl}, Aug 1990, vol. 70, p. 22−5

Active substance: PARACETAMOL

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Document reference: 45747

Study title: Simila S. et Kylmamaa T. : Antipyretic effect of tenoxicam and paracetamol in febrile children. Drugs Exp. Clin. Res. 1985Simila S. et Kylmamaa T. : Antipyretic effect of tenoxicam and paracetamol in febrile children. Drugs Exp. Clin. Res. 1985

Active substance: PARACETAMOL

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Document reference: 45748

Study title: Kvien, T. K., Larheim, T. A., Hoyeraal, H. M., and Sandstad, B. Radiographic temporomandibular joint abnormalities in patients with juvenile chronic arthritis during a controlled study of sodium aurothiomalate and D-penicillamine Br.J.Rheumatol. 1986;25:59-66. Kvien, T. K., Larheim, T. A., Hoyeraal, H. M., and Sandstad, B. Radiographic temporomandibular joint abnormalities in patients with juvenile chronic arthritis during a controlled study of sodium aurothiomalate and D-penicillamine Br.J.Rheumatol. 1986;25:59-66.

Active substance: PENICILLAMINE

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Document reference: 33842

Study title: Clinical Trial of High Lipase Pancreatic Enzyme Supplementation in Cystic Fibrosis: Evaluation of Creon® 25 000

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-K224-5006.pdf

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Document reference: 47654

Study title: Creon 8000 vs Creon 25: An Open Label Comparative Study

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-223-8-01.pdf

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Document reference: 47652

Study title: Double-blind, multicenter, crossover study comparing the efficacy and tolerance of Creon® 25 000 versus Panzytrat® in patients with pancreatic exocrine insufficiency caused by cystic fibrosis.

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-K224-5001.pdf

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Document reference: 47653

Study title: 25. Open-label monocenter study to investigate the tolerability, safety and efficacy of topamax in disabled or mentally handicapped patients aged 14 or older.

Active substance: TOPIRAMATE

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Document reference: 44959

Study title: Effectiveness of pseudoephedrine plus acetaminophen for treatment of symptoms attributed to the paranasal sinuses associated with the common cold. Arch Fam Med 2000; 9(10):979-85 Effectiveness of pseudoephedrine plus acetaminophen for treatment of symptoms attributed to the paranasal sinuses associated with the common cold. Arch Fam Med 2000; 9(10):979-85

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33634

Study title: Effects of semprex-D and diphenhydramine on learning in young adults with seasonal allergic rhinitis. Vuurman EF, van Veggel LM, Sanders RL, Muntjewerff ND, O'Hanlon, JF. Ann Allergy Asthma Immunol. 1996 Mar;76(3):247-52.Effects of semprex-D and diphenhydramine on learning in young adults with seasonal allergic rhinitis. Vuurman EF, van Veggel LM, Sanders RL, Muntjewerff ND, O'Hanlon, JF. Ann Allergy Asthma Immunol. 1996 Mar;76(3):247-52.

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33641

Study title: Efficacy of acrivastine plus pseudoephedrine for symptomatic relief of seasonal allergic rhinitis due to mountain cedar. Ann Allergy Asthma Immunol 1996; 76(5):432-438Efficacy of acrivastine plus pseudoephedrine for symptomatic relief of seasonal allergic rhinitis due to mountain cedar. Ann Allergy Asthma Immunol 1996; 76(5):432-438

Active substance: PARACETAMOL AND PSEUDOEPHEDRINE

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Document reference: 33637

Study title: Borgmann et al.Cystine Stones in a Tree-Year Old Boy; Zeitschr-Kinderderchirurgie 1978; 25Borgmann et al.Cystine Stones in a Tree-Year Old Boy; Zeitschr-Kinderderchirurgie 1978; 25

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33963

Study title: Breitwieser et al.Conservative treatment of uric acid sone diathesis; Med. Welt 1967, 8: 2130-2135Breitwieser et al.Conservative treatment of uric acid sone diathesis; Med. Welt 1967, 8: 2130-2135

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33964

Study title: Cossolini M, Sonzogni V, Di Dedda G, Fruga F, Pansera C, Pirola C, et al. Paediatric cold heart surgery: experience with creatine phosphate added to cardioplegic solution heart surgery. Acts of 5th International Symposium on Cardiac Surgery - Rome (Italy), May 25-28, 1993: 442-443Cossolini M, Sonzogni V, Di Dedda G, Fruga F, Pansera C, Pirola C, et al. Paediatric cold heart surgery: experience with creatine phosphate added to cardioplegic solution heart surgery. Acts of 5th International Symposium on Cardiac Surgery - Rome (Italy), May 25-28, 1993: 442-443

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33959

Study title: Lakatos, L., Hatvani, I., Oroszlan, G., Balla, G., Karmazsin, L., Alaka, O., Kincses, E., Szabo, I., and Lakatos, Z. Controlled trial of D-penicillamine to prevent retinopathy of prematurity Acta Paediatr.Hung. 1986;27:47-56. Lakatos, L., Hatvani, I., Oroszlan, G., Balla, G., Karmazsin, L., Alaka, O., Kincses, E., Szabo, I., and Lakatos, Z. Controlled trial of D-penicillamine to prevent retinopathy of prematurity Acta Paediatr.Hung. 1986;27:47-56.

Active substance: PENICILLAMINE

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Document reference: 33843

Study title: Lakatos, L., Kover, B., and Peter, F. D-penicillamine therapy of neonatal hyperbilirubinaemia Acta Paediatr.Acad.Sci.Hung. 1974;15:77-85. Lakatos, L., Kover, B., and Peter, F. D-penicillamine therapy of neonatal hyperbilirubinaemia Acta Paediatr.Acad.Sci.Hung. 1974;15:77-85.

Active substance: PENICILLAMINE

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Document reference: 33846

Study title: Pradhan, A. M., Bhave, S. A., Joshi, V. V., Bavdekar, A. R., Pandit, A. N., and Tanner, M. S. Department of Paediatrics, K.E.M. Hospital, Pune, India Reversal of Indian childhood cirrhosis by D-penicillamine therapy J.Pediatr.Gastroenterol.Nutr. 1995;20:28-35. Pradhan, A. M., Bhave, S. A., Joshi, V. V., Bavdekar, A. R., Pandit, A. N., and Tanner, M. S. Department of Paediatrics, K.E.M. Hospital, Pune, India Reversal of Indian childhood cirrhosis by D-penicillamine therapy J.Pediatr.Gastroenterol.Nutr. 1995;20:28-35.

Active substance: PENICILLAMINE

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Document reference: 33840

Study title: Prieur, A. M., Piussan, C., Manigne, P., Bordigoni, P., and Griscelli, C. Evaluation of D-penicillamine in juvenile chronic arthritis. A double-blind, multicenter study Arthritis Rheum. 1985;28:376-382. Prieur, A. M., Piussan, C., Manigne, P., Bordigoni, P., and Griscelli, C. Evaluation of D-penicillamine in juvenile chronic arthritis. A double-blind, multicenter study Arthritis Rheum. 1985;28:376-382.

Active substance: PENICILLAMINE

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Document reference: 33844

Study title: Final Study report: Influence of intravenous, Intramuscular and oral administration of Konakion MM Paediatric on Bilirubin Binding to albumin in Full-Term Neonates (BK15055)

Active substance: PHYTOMENADION

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Document reference: 34048

Study title: Plasma levels of vitamin K1 and PIVKA levels in breast fed infants after repeated oral administration of 0.5 mg vitamin K1.

Active substance: PHYTOMENADION

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Document reference: 34051

Study title: Plasma Vitamin K1 and PIVKA-II Levels in Breast Fed Infants after Oral Administration of Ro 01-6722/141 (0.25 mg Vitamin K1) at Birth.

Active substance: PHYTOMENADION

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Document reference: 34052

Study title: Double~blind, bicenter, randomized, crossover study to prove equivalent efficacy and tolerance of Creon® 25 000 Minimicrospheres™ versus Creon® 25 000 Microspheres (Pankreon® forte) in patients with pancreatic exocrine insufficiency caused by cystic fibrosis.

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-S248-3002.pdf

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Document reference: 47672

Study title: Open single-center study to investigate the pharmacodynamics of Creon® 25 000 minimicrospheres measured by 13C.triglyceride breath test and gastric emptying measured by 13C_octanoate breath test in cystic fibrosis patients using healthy children not receiving Creon® 25 000 minimicrospheres as controls

Active substance: Pancreatin

Study summary document link (including results): Pancreatin-S248-2001.pdf

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Document reference: 47671

Active substance: PARACETAMOL AND PHENYLEPHRINE

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Document reference: 33606

Study title: A randomized, double-blind, parallel group, placebo-controlled, four-week efficacy and safety evaluation of Nasacort AQ 110 μg QD, followed by six-month open-label safety in children ages 2-5 years with perennial allergic rhinitis

Active substance: TRIAMCINOLONE

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

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Document reference: 46825

Study title: A randomized, placebo-controlled, parallel-group, multiple dose study of RG 5029Y on Hypotalamic-pituitary-Adrenal (HPA) function and pharmacokinetic profile in pediatric patients with allergic rhinitis - Rom D - 22/12/1995 - Report in Rapport d'Expert sur la documentation clinique - Staudinger H - Update Dossier 24/03/1997 -

Active substance: TRIAMCINOLONE

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

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Document reference: 46826

Study title: An open-label long term study of the safety of Nasacort 134a Nasal Inhaler in patients with perennial allergic rhinitis - Simpson BE - 15/11/1996

Active substance: TRIAMCINOLONE

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Document reference: 46828

Study title: An open-label, long-term study of WHR 5029 NasacortTM) in patients with perennial rhinitis - No Author - No date - Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 -

Active substance: TRIAMCINOLONE

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Document reference: 46829

Study title: An Open-Label, Repeat Dose, Multicenter Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Intranasally Administered Triamcinolone Acetonide (Nasacort AQ) in Pediatric Allergic Rhinitis Patients 2 to 5 Years of Age Compared to Adult Patients 18 to 50 Years of Age

Active substance: TRIAMCINOLONE

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

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Document reference: 46830

Study title: A Phase III multicenter, parallel group, randomized, open study of Triamcinolone acetonide HFA 75µg oral inhaler, compared to Beclomethasone dipropionate in mild symptomatic to moderate asthmatic children, involving 280 patients - No author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46823

Study title: Publication in CES - Ruuth E - 19/10/2001 Triamcinolone acetonide aqueous nasal inhaler and fluticasone propionate have no effect on short-term growth in children with allergic rhinitis - Skoner D - 2000 ( Allergy 2000; 55(Suppl 63): 184)

Active substance: TRIAMCINOLONE

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Document reference: 46832

Study title: Dal Monte A, Leonardi LM, Figura F, Cappozzo A, Marchetti M, De Santis AM. Effects of phosphocreatine administration on muscle strength in man. Gazz. Med. Ital. 1976; 135 (9): 439-448Dal Monte A, Leonardi LM, Figura F, Cappozzo A, Marchetti M, De Santis AM. Effects of phosphocreatine administration on muscle strength in man. Gazz. Med. Ital. 1976; 135 (9): 439-448

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33960

Study title: Efficacy and safety of phloroglucinol versus hyoscine-n-butylbromide for the treatment of dysmenorrheic pain. a clinical trial. Deligeoroglou E. et col. XI worl congress paediatric & adolescent gynaecology 1995. book of abstractEfficacy and safety of phloroglucinol versus hyoscine-n-butylbromide for the treatment of dysmenorrheic pain. a clinical trial. Deligeoroglou E. et col. XI worl congress paediatric & adolescent gynaecology 1995. book of abstract

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33956

Study title: Endo et al.The use of GC-120 to children with metabolic acidosis; Shinyaku to Rhinsho 1986;35(8): 8(1804) - 12(1808)Endo et al.The use of GC-120 to children with metabolic acidosis; Shinyaku to Rhinsho 1986;35(8): 8(1804) - 12(1808)

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33965

Study title: Hussain et al Aetiology, course and outcome of children admitted to paediatric intensive care with convulsive status epilepticus: a retrospective 5-year review. Seizure 2007, Jun; 16(4):305-12Hussain et al Aetiology, course and outcome of children admitted to paediatric intensive care with convulsive status epilepticus: a retrospective 5-year review. Seizure 2007, Jun; 16(4):305-12

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33955

Study title: Principi N. et al. Fosfomycin Trometamol versus Netilmicin in Children's Lower Urinary Tract Infections. Chemotherapy, 36 suppl. 1 pp 41-45 1990 Principi N. et al. Fosfomycin Trometamol versus Netilmicin in Children's Lower Urinary Tract Infections. Chemotherapy, 36 suppl. 1 pp 41-45 1990

Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE

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Document reference: 33962

Active substance: OXITRIPTAN

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Document reference: 32960

Active substance: OXITRIPTAN

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Document reference: 32959

Study title: Plasma vitamin K1 and PIVKA-II levels in breast fed infants after repeated oral administration of Ro 01-6722/141 (2x0.25 mg vitamin K1).

Active substance: PHYTOMENADION

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Document reference: 34050

Study title: Randomized comparative trial to evaluate efficacy and tolerability of Konakion MM, Ro 01-6722/135, Konakion drops Ro 01-6722/119 intramuscularly in the prophylaxis of hemorrhagic disease in newbord, breastfed infants

Active substance: PHYTOMENADION

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Document reference: 34062

Study title: Aivazis V, Hatzimichail A, Papachristou A, Valeri R, Iuga-Donca G. "Clinical evaluation and changes of the respiratory epithelium function after administration of Pidotimod in Greek children with recurrent respiratory tract infections."Publication: Minerva Pediatr 2002; 54: 315-319Aivazis V, Hatzimichail A, Papachristou A, Valeri R, Iuga-Donca G. "Clinical evaluation and changes of the respiratory epithelium function after administration of Pidotimod in Greek children with recurrent respiratory tract infections."Publication: Minerva Pediatr 2002; 54: 315-319

Active substance: PIDOTIMOD

Study summary document link (including results): Aivazis_2002_pidotimod.pdf

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Document reference: 34077

Study title: Arzneimittelforschung. 1994 Dec;44(12A):1490-4. Therapeutic efficacy and safety of pidotimod in the treatment of urinary tract infections in children. Clemente E, Solli R, Mei V, Cera R, Caramia G, Carnelli V, Ruffini E, Venturoli V, Corsini A.Arzneimittelforschung. 1994 Dec;44(12A):1490-4. Therapeutic efficacy and safety of pidotimod in the treatment of urinary tract infections in children. Clemente E, Solli R, Mei V, Cera R, Caramia G, Carnelli V, Ruffini E, Venturoli V, Corsini A.

Active substance: PIDOTIMOD

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Document reference: 34070

Study title: Arzneimittelforschung. 1994 Dec;44(12A):1506-11. Role of immunoactivation with pidotimod in recurrent respiratory infections in childhood. Careddu P. Arzneimittelforschung. 1994 Dec;44(12A):1506-11. Role of immunoactivation with pidotimod in recurrent respiratory infections in childhood. Careddu P.

Active substance: PIDOTIMOD

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Document reference: 34072

Study title: Arzneimittelforschung. 1994 Dec;44(12A):1525-9 Immunoactivation by pidotimod in children with recurrent respiratory infections. Burgio GR, Marseglia GL, Severi F, De Benedetti F, Masarone M, Ottolenghi A, Pagliano L, Serra U, Nespoli LArzneimittelforschung. 1994 Dec;44(12A):1525-9 Immunoactivation by pidotimod in children with recurrent respiratory infections. Burgio GR, Marseglia GL, Severi F, De Benedetti F, Masarone M, Ottolenghi A, Pagliano L, Serra U, Nespoli L

Active substance: PIDOTIMOD

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Document reference: 34076

Study title: Clin Evid. 2005 Jun;(13):444-57. Review Urinary tract infection in children. Larcombe J.Clin Evid. 2005 Jun;(13):444-57. Review Urinary tract infection in children. Larcombe J.

Active substance: PIDOTIMOD

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Document reference: 34073

Study title: Studio clinico dell'Uniplus. Rapporto sperimentale

Active substance: OXOLAMINE AND PROPYLPHENAZONE

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Document reference: 32972

Study title: DOXERGAN (OXOMEMAZINE)- Tablet 10mg, Syrup 01%.. Summary document. France validation dossier 17/06/1988. Clinical information. Reference to clinical Expert report from LARBRE F., Lyon 12/07/1962. Children 5months-13 years treated from 4 to 21 days. (French language)

Active substance: OXOMEMAZINE

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Document reference: 32974

Study title: Traitement des angines aiguës de l'enfant - De Paillerets F., Rivron M. & Boussangant Y. - 1977 (Rev. Prat., 27 (59) 4129 - 4132)Traitement des angines aiguës de l'enfant - De Paillerets F., Rivron M. & Boussangant Y. - 1977 (Rev. Prat., 27 (59) 4129 - 4132)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45886

Study title: Un R.A.A. de l'enfant. Hambourg M. - 1973 (Gaz. Méd. France, 80 (3) 345 - 352)Un R.A.A. de l'enfant. Hambourg M. - 1973 (Gaz. Méd. France, 80 (3) 345 - 352)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45887

Study title: Utilisation de l'Oricilline en pédiatrie - Pennaforte F. & Pennaforte M. - 1970 (Ann. Méd. Reims, 159 - 165)Utilisation de l'Oricilline en pédiatrie - Pennaforte F. & Pennaforte M. - 1970 (Ann. Méd. Reims, 159 - 165)

Active substance: PHENOXYMETHYLPENICILLIN

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Document reference: 45888

Study title: Abernathy RS. A survey of 156 seizure patients in a general pediatric clinic. J Lancet. 1966 Mar;86(3):115-20.Abernathy RS. A survey of 156 seizure patients in a general pediatric clinic. J Lancet. 1966 Mar;86(3):115-20.

Active substance: PHENYLEPHRINE

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Document reference: 33942

Study title: Tokai J Exp Clin Med. 1982 Jan;7(1):69-75. Thallium--201 myocardial imaging in Kawasaki disease. Kato S, Ohta T, Suzuki Y, Matsuyama S. Tokai J Exp Clin Med. 1982 Jan;7(1):69-75. Thallium--201 myocardial imaging in Kawasaki disease. Kato S, Ohta T, Suzuki Y, Matsuyama S.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44710

Study title: Z Gesamte Inn Med. 1989 Jan 15;44(2):54-7. [Hyperthyroidism and its relation to heart function] [Article in German] Marek H, Kellner K, Duck HJ, Neumann G, Krosse B, Machill K. Z Gesamte Inn Med. 1989 Jan 15;44(2):54-7. [Hyperthyroidism and its relation to heart function] [Article in German] Marek H, Kellner K, Duck HJ, Neumann G, Krosse B, Machill K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44712

Study title: Z Kardiol. 1988 Aug;77(8):503-7. [Disorders of myocardial perfusion in Kawasaki syndrome: noninvasive detection by 201 thallium tomography] [Article in German] Nienaber CA, Hausdorf G, Spielmann RP. Z Kardiol. 1988 Aug;77(8):503-7. [Disorders of myocardial perfusion in Kawasaki syndrome: noninvasive detection by 201 thallium tomography] [Article in German] Nienaber CA, Hausdorf G, Spielmann RP.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44713

Study title: Zhonghua Nei Ke Za Zhi. 1985 Dec;24(12):715-8, 767-8. [Clinical evaluation of thallium-201 myocardial imaging] [Article in Chinese] Liu XJ, Shi RF, Guo XZ. Zhonghua Nei Ke Za Zhi. 1985 Dec;24(12):715-8, 767-8. [Clinical evaluation of thallium-201 myocardial imaging] [Article in Chinese] Liu XJ, Shi RF, Guo XZ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44714

Study title: Surg Clin North Am. 1987 Apr;67(2):343-57. How to recognize and treat parathyroid carcinoma. Fujimoto Y, Obara T. Surg Clin North Am. 1987 Apr;67(2):343-57. How to recognize and treat parathyroid carcinoma. Fujimoto Y, Obara T.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44706

Study title: 214/92: Efficacy of BY158K vs. terbutaline on the oscillatory resistance in children aged 2 to 5 years suffering from bronchial asthma

Active substance: THEOPHYLLINE

Study summary document link (including results): Study report 214-92 Theopyhlline - synopsis.pdf

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Document reference: 44731

Active substance: OXITRIPTAN

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Document reference: 32942

Active substance: OXITRIPTAN

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Document reference: 32957

Active substance: OXITRIPTAN

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Document reference: 32943

Study title: Oxybutynin does not affect cyclosporin blood levels - Springate JE - J Drug Monit - 2001; 23(2):155-156Oxybutynin does not affect cyclosporin blood levels - Springate JE - J Drug Monit - 2001; 23(2):155-156

Active substance: OXITRIPTAN

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Document reference: 32922

Study title: Plasma levels of Oxybutynin chloride in children - Autret E, Jonville AP, Dutertre JP, Bertiere MC, Robert M, Averous M. Couet W - Eur J Clin Pharmacol - 1994; 46:83-85Plasma levels of Oxybutynin chloride in children - Autret E, Jonville AP, Dutertre JP, Bertiere MC, Robert M, Averous M. Couet W - Eur J Clin Pharmacol - 1994; 46:83-85

Active substance: OXITRIPTAN

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Document reference: 32923

Study title: A Single-Dose, Double-Blind, Placebo-Controlled Study of the Relative Efficacy and Safety of Acetaminophen at Doses of 500 mg and 1000 mg in Postoperative Dental Pain

Active substance: PARACETAMOL

Study summary document link (including results): paracetamol 02-156.pdf

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Document reference: 47508

Study title: "An Aetiopathogenic and Therapeutic Study with Oxybutynin Chloride - Grassetti F et al. - Ped Oggi - 1986 (6(1): 47-51) - Publication in UK registration file - Enuresis -" "An Aetiopathogenic and Therapeutic Study with Oxybutynin Chloride - Grassetti F et al. - Ped Oggi - 1986 (6(1): 47-51) - Publication in UK registration file - Enuresis -"

Active substance: OXYBUTYNIN

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Document reference: 32981

Study title: "Anticholinergic therapy for primary enuresis efficacy of oxybutynin chloride in a controlled clinical trial in 58 patients - Marconi A.M., Felici E., Roggia A., Torelli F. - Ped. Med. Chir - Med. Surg. Ped. - 1985 (7:573-576) - Publication in UK registration file - " "Anticholinergic therapy for primary enuresis efficacy of oxybutynin chloride in a controlled clinical trial in 58 patients - Marconi A.M., Felici E., Roggia A., Torelli F. - Ped. Med. Chir - Med. Surg. Ped. - 1985 (7:573-576) - Publication in UK registration file - "

Active substance: OXYBUTYNIN

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Document reference: 32982

Study title: Similä−S, Kylmämaa−T. Antipyretic effect of tenoxicam and paracetamol in febrile children. {Drugs−Exp−Clin−Res}, 1985, vol. 11, no. 10, p. 731−4Similä−S, Kylmämaa−T. Antipyretic effect of tenoxicam and paracetamol in febrile children. {Drugs−Exp−Clin−Res}, 1985, vol. 11, no. 10, p. 731−4

Active substance: PARACETAMOL

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Document reference: 45749

Study title: Single dose, placebo controlled comparative study of ibuprofen and acetaminophen antipyresis in children. {J Pediatr}, Nov 1991, vol. 119, no. 5, p. 803-11Single dose, placebo controlled comparative study of ibuprofen and acetaminophen antipyresis in children. {J Pediatr}, Nov 1991, vol. 119, no. 5, p. 803-11

Active substance: PARACETAMOL

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Document reference: 45750

Study title: Bacon CJ, Cranage JD, Hierons AM, Rawlins MD, Webb JK. Behavioural effects of phenobarbitone and phenytoin in small children. Arch Dis Child. 1981 Nov;56(11):836-40.Bacon CJ, Cranage JD, Hierons AM, Rawlins MD, Webb JK. Behavioural effects of phenobarbitone and phenytoin in small children. Arch Dis Child. 1981 Nov;56(11):836-40.

Active substance: PHENYLEPHRINE

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Document reference: 33934

Study title: Oberbaum et al: Experimental treatment of Chemotherapy-Induced Stomatitis Using a Homeopathic Complex Preparation. Biol Ther 1998;(4):261-265 [IIT-publication]

Active substance: Traumeel - Ampullen

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Document reference: 40282

Study title: Bannikov, Mihail Y.; Vasilenko, Inna V.: Anwendung von homöopathischen Komplexmitteln in der Behandlungakuter kindlicher Speiseröhrenverätzungen. Biol Med 2000 (29):253-254 [IIT-publication]

Active substance: Traumeel S

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Document reference: 40270

Study title: Oberbaum et al: Experimental treatment of Chemotherapy-Induced Stomatitis Using a Homeopathic Complex Preparation. Biol Ther 1998;(4):261-265 [IIT-publication

Active substance: Traumeel S

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Document reference: 40269

Study title: Tsymbal, I.N.; Plahuta, T.G.; Vdovin, V.V. u.a.: Traumeel S in treatment of intramuscular hematomas in children with hemophilia. Thromb Haemostasis 1997;(suppl246):PS-1007 [IIT-publication]

Active substance: Traumeel S

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Document reference: 40263

Study title: High - dose pyridoxine and magnesium administration in children with autistic disorder : an absence of salutary effect in a double-blind, placebo-controlled study - R.L Finding et al. - 1997 (Journal of Autism and Developmental Disorders vol 27) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -High - dose pyridoxine and magnesium administration in children with autistic disorder : an absence of salutary effect in a double-blind, placebo-controlled study - R.L Finding et al. - 1997 (Journal of Autism and Developmental Disorders vol 27) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Eston...

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31488

Study title:

Active substance: TIAGABINE

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Document reference: 38475

Study title: AJR Am J Roentgenol. 2007 Feb;188(2):572-8. The cause and clinical significance of central tumor photopenia on thallium scintigraphy of pediatric osteosarcoma of the extremity. McCarville MB, Barton EH, Cameron JR, Xiong X, Daw NC, Kaste SC, Wu S, GlassAJR Am J Roentgenol. 2007 Feb;188(2):572-8. The cause and clinical significance of central tumor photopenia on thallium scintigraphy of pediatric osteosarcoma of the extremity. McCarville MB, Barton EH, Cameron JR, Xiong X, Daw NC, Kaste SC, Wu S, Glass

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44494

Study title: Am Heart J. 1984 Apr;107(4):718-25. The cardiokymography exercise test compared to the thallium-201 perfusion exercise test in the diagnosis of coronary artery disease. Burke JF, Morganroth J, Soffer J, Panidis I, Chen CC, David D. Am Heart J. 1984 Apr;107(4):718-25. The cardiokymography exercise test compared to the thallium-201 perfusion exercise test in the diagnosis of coronary artery disease. Burke JF, Morganroth J, Soffer J, Panidis I, Chen CC, David D.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44495

Study title: Am Heart J. 1988 Dec;116(6 Pt 1):1575-9. Dipyridamole-thallium-201 tomography documenting improved myocardial perfusion with therapy in Kawasaki disease. Nienaber CA, Spielmann RP, Hausdorf G Am Heart J. 1988 Dec;116(6 Pt 1):1575-9. Dipyridamole-thallium-201 tomography documenting improved myocardial perfusion with therapy in Kawasaki disease. Nienaber CA, Spielmann RP, Hausdorf G

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44497

Study title: Kaku Igaku. 1983 Jun;20(5):633-40. [ECG-gated single photon emission computed tomography for thallium-201 myocardial imaging in patients with hypertrophic cardiomyophathy.] [Article in Japanese] Futagami Y, Hamada M, Ichikawa T, Konishi T, Nakano T, TaKaku Igaku. 1983 Jun;20(5):633-40. [ECG-gated single photon emission computed tomography for thallium-201 myocardial imaging in patients with hypertrophic cardiomyophathy.] [Article in Japanese] Futagami Y, Hamada M, Ichikawa T, Konishi T, Nakano T, Ta

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44640

Study title: Kaku Igaku. 1985 Sep;22(9):1353-9. [Evaluation of cardiomyopathy in Duchenne muscular dystrophy by Tl-201 myocardial SPECT] [Article in Japanese] Jinnouchi S, Asai J, Inoue K, Hoshi H, Watanabe K. Kaku Igaku. 1985 Sep;22(9):1353-9. [Evaluation of cardiomyopathy in Duchenne muscular dystrophy by Tl-201 myocardial SPECT] [Article in Japanese] Jinnouchi S, Asai J, Inoue K, Hoshi H, Watanabe K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44642

Study title: Clinical trial. Drops. Infants and Children - Larbre F. - 23/06/1973

Active substance: TIAPRIDE

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Document reference: 44750

Study title: Die behandlung extrapyramidaler bewegungsstorungen im kindes alter mit tiapridal R - Klepel H. Gebelt H. - 04/86 Traitement par le tiapridal des troubles moteurs extra-pyramidaux chez l'enfant - Klepel H. Gebelt H. - 04/86

Active substance: TIAPRIDE

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Document reference: 44751

Study title: Die behandlung extrapyramidaler hyperkinesen im kindes alter mit tiapridal R - Klepel H - 16/12/85

Active substance: TIAPRIDE

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Document reference: 44752

Study title: Expertise en pédiatrie du FLO 1347 soluté injectable - Fontaine G. - 02/02/73

Active substance: TIAPRIDE

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Document reference: 44744

Study title: Nippon Igaku Hoshasen Gakkai Zasshi. 1994 Jul 25;54(8):789-97. [Diffuse slow washout pattern (DSWO) on exercise stress thallium-201 myocardial SPECT: correlative study with coronary arteriography and the related clinical factors] [Article in Japanese] Nippon Igaku Hoshasen Gakkai Zasshi. 1994 Jul 25;54(8):789-97. [Diffuse slow washout pattern (DSWO) on exercise stress thallium-201 myocardial SPECT: correlative study with coronary arteriography and the related clinical factors] [Article in Japanese]

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44670

Study title: Nippon Naika Gakkai Zasshi. 1986 Sep;75(9):1234-42. [Evaluation of myocardial and skeletal muscular involvement with thallium-201 myocardial emission computed tomography and whole body scintigraphy] [Article in Japanese] Yamamoto S, Matsushima H, SotobNippon Naika Gakkai Zasshi. 1986 Sep;75(9):1234-42. [Evaluation of myocardial and skeletal muscular involvement with thallium-201 myocardial emission computed tomography and whole body scintigraphy] [Article in Japanese] Yamamoto S, Matsushima H, Sotob

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44672

Study title: Nucl Med Commun. 1985 Dec;6(12):753-62. Idiopathic hypertrophic sub-aortic stenosis (IHSS): a new diagnostic method using ECG-gated thallium-201 myocardial scintigraphy. Garty I, Flatau E, Bloch L. Nucl Med Commun. 1985 Dec;6(12):753-62. Idiopathic hypertrophic sub-aortic stenosis (IHSS): a new diagnostic method using ECG-gated thallium-201 myocardial scintigraphy. Garty I, Flatau E, Bloch L.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44673

Study title: Nucl Med Commun. 1989 Jul;10(7):477-85. Role of thallium-201 in the diagnosis of solitary bone lesions. Elgazzar AH, Malki AA, Abdel-Dayem HM, Mahmoud A, Sahweil A, Razzak S, Jahan S, el-Sayed M, Omar YT. Nucl Med Commun. 1989 Jul;10(7):477-85. Role of thallium-201 in the diagnosis of solitary bone lesions. Elgazzar AH, Malki AA, Abdel-Dayem HM, Mahmoud A, Sahweil A, Razzak S, Jahan S, el-Sayed M, Omar YT.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44674

Study title: Nucl Med Commun. 2001 Sep;22(9):1015-9. Inhomogeneity of myocardial perfusion in heart transplant recipients: evaluation with dobutamine thallium-201 SPECT. Yen RF, Ho YL, Chou NK, Hsu RB, Huang PJ Nucl Med Commun. 2001 Sep;22(9):1015-9. Inhomogeneity of myocardial perfusion in heart transplant recipients: evaluation with dobutamine thallium-201 SPECT. Yen RF, Ho YL, Chou NK, Hsu RB, Huang PJ

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44676

Study title: A. Griffiths. et al. Slow-release 5-Aminosalicylic acid therapy in children with small intestinal Crohn’s Disease. Journal of Pediatric Gastroenterology and Nutrition 1993; 17: 186-92A. Griffiths. et al. Slow-release 5-Aminosalicylic acid therapy in children with small intestinal Crohn’s Disease. Journal of Pediatric Gastroenterology and Nutrition 1993; 17: 186-92

Active substance: MESALAZINE

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Document reference: 31635

Study title: Bioavailibility of 5-ASA from slow release 5-ASA drug and sulfasalazine in normal children; Christensen LA et al, Dig. Diseases and Sci., 1993, 38(10):1831-6

Active substance: MESALAZINE

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Document reference: 31628

Study title: Case-controlled, open study on the pharmacokinetics and treatment effect of 5-aminosalicylic acid in children with ulcerative colitis

Active substance: MESALAZINE

Study summary document link (including results): EUdraCT_reduced_datafields_paediatric data_Mesalazine_Salofallk enema_Dr Falk Pharma GmbH.xls

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Document reference: 31626

Study title: Efficacy of mesalazine 500 mg tablets in preventing relapses of quiescent Crohn’s disease in children

Active substance: MESALAZINE

Study summary document link (including results): Pentacomp9001_mesalazine_synopsis_EMA.pdf

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Document reference: 47387

Study title: Am Heart J. 1998 Mar;135(3):482-7. Noninvasive evaluation of myocardial ischemia in Kawasaki disease: comparison between dipyridamole stress thallium imaging and exercise stress testing. Fukuda T, Akagi T, Ishibashi M, Inoue O, Sugimura T, Kato H. Am Heart J. 1998 Mar;135(3):482-7. Noninvasive evaluation of myocardial ischemia in Kawasaki disease: comparison between dipyridamole stress thallium imaging and exercise stress testing. Fukuda T, Akagi T, Ishibashi M, Inoue O, Sugimura T, Kato H.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44499

Study title: Am J Cardiol. 1978 Oct;42(4):675-80. Thallium-201 myocardial imaging in anomalous left coronary artery arising from the pulmonary artery. Applications before and after medical and surgical treatment. Finley JP, Howman-Giles R, Gilday DL, Olley PM, Rowe Am J Cardiol. 1978 Oct;42(4):675-80. Thallium-201 myocardial imaging in anomalous left coronary artery arising from the pulmonary artery. Applications before and after medical and surgical treatment. Finley JP, Howman-Giles R, Gilday DL, Olley PM, Rowe

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44500

Study title: Huntington's Chorea: current concepts and improvement in one case after tiapride - G. Serratrice, G. Cremieux.

Active substance: TIAPRIDE

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Document reference: 44754

Study title: Le tiapridal dans la maladie des tics de l'enfant - Herbaut M. - 02/08/82

Active substance: TIAPRIDE

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Document reference: 44753

Study title: Paediatric clinical trial of FLO 1347 Drops - Fontaine G. - 02/02/73

Active substance: TIAPRIDE

Study summary document link (including results): Tiapride STUDY 73-00079-EN-00.xls

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Document reference: 44745

Study title: Relevance of tiapride in treatment of certain abnormal movements of the encephalopathic child - Gardisseaux J.F., Maloteaux J.M., Ferriere G. - neuropsych. Enf. Adolesc., 1985, 33, 139-143Relevance of tiapride in treatment of certain abnormal movements of the encephalopathic child - Gardisseaux J.F., Maloteaux J.M., Ferriere G. - neuropsych. Enf. Adolesc., 1985, 33, 139-143

Active substance: TIAPRIDE

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Document reference: 38472

Study title: Studie tiapridex bei stotternden kindern - Prof. Dr. A. Rothenberger - No date

Active substance: TIAPRIDE

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Document reference: 44746

Study title: Tiapridal treatment of extrapyramidal motor disorders in children - Klepel H. Gebelt H. - 04/1986

Active substance: TIAPRIDE

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Document reference: 44747

Study title: Tiapridal treatment of tic disease in children - Herbaut M. - No date

Active substance: TIAPRIDE

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Document reference: 44748

Study title: Traitement des hyperkinésiens de type exrtapyramidal chez l'enfant à l'aide du tiapridal - Klepel H. - 16/12/85

Active substance: TIAPRIDE

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Document reference: 44749

Study title: Aust Paediatr J. 1983 Mar;19(1):47-50. Congenital left coronary artery - right ventricular fistula. Adams P, Morris L, Ross I. Aust Paediatr J. 1983 Mar;19(1):47-50. Congenital left coronary artery - right ventricular fistula. Adams P, Morris L, Ross I.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44525

Study title: Br Heart J. 1981 Feb;45(2):198-205. Quantitative thallium-201 myocardial imaging in assessing right ventricular pressure in patients with congenital heart defects. Rabinovitch M, Fischer KC, Treves S. Br Heart J. 1981 Feb;45(2):198-205. Quantitative thallium-201 myocardial imaging in assessing right ventricular pressure in patients with congenital heart defects. Rabinovitch M, Fischer KC, Treves S.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44526

Study title: (Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia).Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60.(Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia).Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60.

Active substance: TINZANIDINE

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Document reference: 44792

Study title: (Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia).Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60.(Effects of tizanidine for refractory sleep disturbance in disabled children with spastic quadriplegia).Tanaka H, Fukuda I, Miyamoto A, Oka R, Cho K, Fujieda K. No to hattatsu. Brain and development, Nov 2004, vol. 36, no. 6, p. 455−60.

Active substance: TINZANIDINE

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Document reference: 44804

Study title: Efficacy of neuroprotectors in patients with tension headaches.Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6Efficacy of neuroprotectors in patients with tension headaches.Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6

Active substance: TINZANIDINE

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Document reference: 44788

Active substance: TINZANIDINE

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Document reference: 44800

Study title: Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2.Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2.

Active substance: TINZANIDINE

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Document reference: 44787

Study title: F. Hadziselimovic. Therapie der chronisch entzündlichen Darmkrankheiten im Kindesalter. Pädiat Prax 1991;42:443-51. F. Hadziselimovic. Therapie der chronisch entzündlichen Darmkrankheiten im Kindesalter. Pädiat Prax 1991;42:443-51.

Active substance: MESALAZINE

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Document reference: 31642

Study title: Intravenous milrinone following cardiac surgery: effect of bolus infusion followed by variable dose maintenance infusion - Feneck RO. Et al. - 1992 (J Cardiothorac Anthes 1992, 6, 554-562)Intravenous milrinone following cardiac surgery: effect of bolus infusion followed by variable dose maintenance infusion - Feneck RO. Et al. - 1992 (J Cardiothorac Anthes 1992, 6, 554-562)

Active substance: MILRINONE

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Document reference: 32026

Study title: Milrinone in the treatment of low output states following cardiac surgery - Wright EM et al. - 1992 (Eur J Anaesthesiol 1992, 5 21-26)Milrinone in the treatment of low output states following cardiac surgery - Wright EM et al. - 1992 (Eur J Anaesthesiol 1992, 5 21-26)

Active substance: MILRINONE

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Document reference: 32027

Study title: Milrinone: systemic and pulmonary hemodynamic effects in neonates after cardiac surgery - Chang AC et al. - 1995 (Crit. Care Med. 1995, 23, 1907-14)Milrinone: systemic and pulmonary hemodynamic effects in neonates after cardiac surgery - Chang AC et al. - 1995 (Crit. Care Med. 1995, 23, 1907-14)

Active substance: MILRINONE

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Document reference: 32028

Study title: Platelet activation and aggregation during cardiopulmonary bypass - Rinder CS et al. - 1991 (Anesthesiology, 1991, 75, 388-393)Platelet activation and aggregation during cardiopulmonary bypass - Rinder CS et al. - 1991 (Anesthesiology, 1991, 75, 388-393)

Active substance: MILRINONE

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Document reference: 32031

Study title: Anesthesiologic and surgical problems of adenotonsillectomy in paediatric patients. Our current approach - Palmieri AM, Meglio M, Testa D, Salafia M, Lasiello A - 1998 (Minerva Anesthesiol 1998; 64: 545-552)Anesthesiologic and surgical problems of adenotonsillectomy in paediatric patients. Our current approach - Palmieri AM, Meglio M, Testa D, Salafia M, Lasiello A - 1998 (Minerva Anesthesiol 1998; 64: 545-552)

Active substance: TRAMADOL

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Document reference: 45020

Study title: J Nucl Med. 1991 Dec;32(12):2215-20. Assessment of right ventricular overload by a thallium-201 SPECT study in children with congenital heart disease. Nakajima K, Taki J, Ohno T, Taniguchi M, Taniguchi M, Bunko H, Hisada K. J Nucl Med. 1991 Dec;32(12):2215-20. Assessment of right ventricular overload by a thallium-201 SPECT study in children with congenital heart disease. Nakajima K, Taki J, Ohno T, Taniguchi M, Taniguchi M, Bunko H, Hisada K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44610

Study title: J Nucl Med. 1993 Dec;34(12):2053-61. Comment in: J Nucl Med. 1993 Dec;34(12):2061-3. J Nucl Med. 1994 Dec;35(12):2055. Safety and clinical utility of combined intravenous dipyridamole/symptom-limited exercise stress test with thallium-201 imaginJ Nucl Med. 1993 Dec;34(12):2053-61. Comment in: J Nucl Med. 1993 Dec;34(12):2061-3. J Nucl Med. 1994 Dec;35(12):2055. Safety and clinical utility of combined intravenous dipyridamole/symptom-limited exercise stress test with thallium-201 imagin

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44613

Study title: J Nucl Med. 1993 Dec;34(12):2085-9. Comment in: J Nucl Med. 1993 Dec;34(12):2089-90. Clinical evaluation of thallium-201 SPECT in supratentorial gliomas: relationship to histologic grade, prognosis and proliferative activities. Oriuchi N, Tamura M,J Nucl Med. 1993 Dec;34(12):2085-9. Comment in: J Nucl Med. 1993 Dec;34(12):2089-90. Clinical evaluation of thallium-201 SPECT in supratentorial gliomas: relationship to histologic grade, prognosis and proliferative activities. Oriuchi N, Tamura M,

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44614

Study title: Can J Neurol Sci. 1984 Nov;11(4 Suppl):588-91. The cardiomyopathy in Friedreich's ataxia: isotopic ventriculography and myocardial imaging with thallium-201. Therriault L, Lamoureux G, CÃ´tÃ© M, Plourde G, Lemieux B. Can J Neurol Sci. 1984 Nov;11(4 Suppl):588-91. The cardiomyopathy in Friedreich's ataxia: isotopic ventriculography and myocardial imaging with thallium-201. Therriault L, Lamoureux G, CÃ´tÃ© M, Plourde G, Lemieux B.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44527

Study title: Cancer J. 2002 Nov-Dec;8(6):469-75. Thallium-201 imaging in evaluation of Hodgkin's disease. Dadparvar S, Hussain R, Esteves F, Yu JQ, Grewal RK, Arif S, Cruz R, Barbaria CJ, Woods K, Styler MJ. Cancer J. 2002 Nov-Dec;8(6):469-75. Thallium-201 imaging in evaluation of Hodgkin's disease. Dadparvar S, Hussain R, Esteves F, Yu JQ, Grewal RK, Arif S, Cruz R, Barbaria CJ, Woods K, Styler MJ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44528

Study title: Cancer. 1997 Oct 15;80(8):1507-12. Thallium-201 scintigraphy for the evaluation of tumor response to preoperative chemotherapy in patients with osteosarcoma. Imbriaco M, Yeh SD, Yeung H, Zhang JJ, Healey JH, Meyers P, Huvos AG, Larson SM. Cancer. 1997 Oct 15;80(8):1507-12. Thallium-201 scintigraphy for the evaluation of tumor response to preoperative chemotherapy in patients with osteosarcoma. Imbriaco M, Yeh SD, Yeung H, Zhang JJ, Healey JH, Meyers P, Huvos AG, Larson SM.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44530

Study title: Chest. 1995 Feb;107(2):440-6. Comparison of thallium-201 and gallium-67 citrate scintigraphy in the diagnosis of pulmonary disease. Miller JA, Lee S, Lao R, Karetzky M. Chest. 1995 Feb;107(2):440-6. Comparison of thallium-201 and gallium-67 citrate scintigraphy in the diagnosis of pulmonary disease. Miller JA, Lee S, Lao R, Karetzky M.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44532

Study title: Endocr J. 2002 Feb;49(1):55-60. Quantitative estimation and clinical significance of accumulation and washout of thallium-201 chloride in follicular thyroid neoplasm. Yada H, Hozumi Y, Kanazawa K, Nagai H Endocr J. 2002 Feb;49(1):55-60. Quantitative estimation and clinical significance of accumulation and washout of thallium-201 chloride in follicular thyroid neoplasm. Yada H, Hozumi Y, Kanazawa K, Nagai H

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44562

Study title: Eur Heart J. 1996 Jul;17(7):1056-64. Comment in: Eur Heart J. 1996 Jul;17(7):982-4. Chest pain during daily life in patients with hypertrophic cardiomyopathy: an ambulatory electrocardiographic study. Elliott PM, Kaski JC, Prasad K, Seo H, Slade AKEur Heart J. 1996 Jul;17(7):1056-64. Comment in: Eur Heart J. 1996 Jul;17(7):982-4. Chest pain during daily life in patients with hypertrophic cardiomyopathy: an ambulatory electrocardiographic study. Elliott PM, Kaski JC, Prasad K, Seo H, Slade AK

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44565

Study title: Eur Heart J. 1998 Mar;19(3):500-7. Dipyridamole stress thallium-201 perfusion abnormalities in patients with hypertrophic cardiomyopathy. Relationship to clinical presentation and outcome. Yamada M, Elliott PM, Kaski JC, Prasad K, Gane JN, Lowe CM, Doi Eur Heart J. 1998 Mar;19(3):500-7. Dipyridamole stress thallium-201 perfusion abnormalities in patients with hypertrophic cardiomyopathy. Relationship to clinical presentation and outcome. Yamada M, Elliott PM, Kaski JC, Prasad K, Gane JN, Lowe CM, Doi

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44566

Study title: Eur J Nucl Med. 1984;9(3):99-105. Segmental analysis of stress thallium myocardial emission tomography for localization of coronary artery disease. Tamaki N, Yonekura Y, Mukai T, Fujita T, Nohara R, Kadota K, Kambara H, Kawai C, Torizuka K, Ishii Y.Eur J Nucl Med. 1984;9(3):99-105. Segmental analysis of stress thallium myocardial emission tomography for localization of coronary artery disease. Tamaki N, Yonekura Y, Mukai T, Fujita T, Nohara R, Kadota K, Kambara H, Kawai C, Torizuka K, Ishii Y.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44567

Study title: Eur J Nucl Med. 1984;9(3):99-105. Segmental analysis of stress thallium myocardial emission tomography for localization of coronary artery disease. Tamaki N, Yonekura Y, Mukai T, Fujita T, Nohara R, Kadota K, Kambara H, Kawai C, Torizuka K, Ishii Y. Eur J Nucl Med. 1984;9(3):99-105. Segmental analysis of stress thallium myocardial emission tomography for localization of coronary artery disease. Tamaki N, Yonekura Y, Mukai T, Fujita T, Nohara R, Kadota K, Kambara H, Kawai C, Torizuka K, Ishii Y.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44568

Study title: Postoperative course and hemodynamic profile after the arterial switch operation in neonates and infants: a comparison of low-flow ardiopulmonary bypass and circulatory arrest - Wernovsky G et al. - 1995 (Circulation, 1995, 92, 2226-2235)Postoperative course and hemodynamic profile after the arterial switch operation in neonates and infants: a comparison of low-flow ardiopulmonary bypass and circulatory arrest - Wernovsky G et al. - 1995 (Circulation, 1995, 92, 2226-2235)

Active substance: MILRINONE

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Document reference: 32032

Study title: Study of the live attenuated Rubella vaccine among adults (≥ 15 years old)

Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN)

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Document reference: 47473

Study title: A repeat dose, open-label, safety evaluation of a live yeast cell derivative wound healing ointment in out-patients with minor cuts, scrapes, abrasions, and burns

Active substance: Live Yeast Cell Derivative , Shark Liver Oil

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Document reference: 40031

Study title: Preparation H ointment (WH-66-228) repeated insult patch test

Active substance: Live Yeast Cell Derivative , Shark Liver Oil

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Document reference: 40030

Study title: C8559 - November 15, 1989; C8569 (011:37150:0688) - June 30, 1988; C8569 (016:38610:0490) - March 14, 1994; C8569 (010:34350:1287) - April 21, 1988; C8569 (015:38610:0490) - November 5, 1990; C8569 (017:38610:0490) - June 16, 1994; C8569 (02:38610:0194) - July 6, 1994; C8569 (009:34350:1287) - April 21, 1988; C8569 (008:34350:1287) - April 21, 1988; C8569A (055:38610:1189) - November 13, 1989; C8569A (022:38610:0490) - November 6, 1990; C8569A (024:38610:0490) - May 27, 1994; C8881 - June 2, 1994; C9126 - April 21, 1995; C9144 - June 30, 1993; C9151 - August 3, 1994; C9165 - March 8, 1994; C9171 - June 29, 1993; C9274 - October 3, 1995

Active substance: LODOXAMIDE

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Document reference: 46926

Study title: Efficacy and safety evaluation of Lodoxamide Ophthalmic Solution versus OPTICROM Ophthalmic Solution in patients with vernal conjunctivitis, giant papillary conjunctivitis and allergic/atopic conjunctivitis (C8559)

Active substance: LODOXAMIDE

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Document reference: 46925

Study title: Clarke I, Uchida Y, Jauch A, Fsadni M, Ikeda M. Combined analysis report. The combined experience of the safety of lomefloxacin 0.3% and lomefloxacin 0.5% and the efficacy of lomefloxacin 0.3% compared with ofloxacin 0.3% in the treatment of acute bacterial conjunctivitis and other infections of the eye in children under 15 years old reported upon in three previous studies of lomefloxacin in Japan. May 1996. Meta-analysis of Refs 2-20, Part IV of BIRD October 1993 (Refs 3, 14, 18-34, Part IV of BIRD November 1997)Clarke I, Uchida Y, Jauch A, Fsadni M, Ikeda M. Combined analysis report. The combined experience of the safety of lomefloxacin 0.3% and lomefloxacin 0.5% and the efficacy of lomefloxacin 0.3% compared with ofloxacin 0.3% in the treatment of acute bacterial conjunctivitis and o...

Active substance: LOMEFLOXACIN

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Document reference: 31380

Study title: J Nucl Med. 1995 Apr;36(4):537-41. Indium-111-pentetreotide imaging in intra-axial brain tumors: comparison with thallium-201 SPECT and MRI. Lee JD, Kim DI, Lee JT, Chang JW, Park CY. J Nucl Med. 1995 Apr;36(4):537-41. Indium-111-pentetreotide imaging in intra-axial brain tumors: comparison with thallium-201 SPECT and MRI. Lee JD, Kim DI, Lee JT, Chang JW, Park CY.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44615

Study title: J Nucl Med. 1995 Aug;36(8):1372-6. Thallium-201 scintigraphy in pediatric soft-tissue tumors. Howman-Giles R, Uren RF, Shaw PJ. J Nucl Med. 1995 Aug;36(8):1372-6. Thallium-201 scintigraphy in pediatric soft-tissue tumors. Howman-Giles R, Uren RF, Shaw PJ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44616

Study title: J Nucl Med. 1995 Jan;36(1):107-10. Thallium-201 uptake in eosinophilic granuloma of the frontal bone: comparison with technetium-99m-MDP imaging. Flores LG 2nd, Hoshi H, Nagamachi S, Ohnishi T, Watanabe K, Fukiyama J, Nao-i N, Sawada A. J Nucl Med. 1995 Jan;36(1):107-10. Thallium-201 uptake in eosinophilic granuloma of the frontal bone: comparison with technetium-99m-MDP imaging. Flores LG 2nd, Hoshi H, Nagamachi S, Ohnishi T, Watanabe K, Fukiyama J, Nao-i N, Sawada A.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44617

Study title: A randomized trial assessing dorzolamide in patients with glaucoma who are younger than 6 years. Ott EZ, Mills MD, Arango S, Getson AJ, Assaid CA, Adamsons IA. Arch Ophthalmol. 2005 Sep;123(9):1177-86. A randomized trial assessing dorzolamide in patients with glaucoma who are younger than 6 years. Ott EZ, Mills MD, Arango S, Getson AJ, Assaid CA, Adamsons IA. Arch Ophthalmol. 2005 Sep;123(9):1177-86.

Active substance: TIAGABINE

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Document reference: 38481

Study title: A single-blind, tolerability and preliminary efficacy study of tiagabine in children with epilepsyPhase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9.

Active substance: TIAGABINE

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Document reference: 38527

Study title: An open-label study of the safety and efficacy of long-term tiagabine administration in patients with epilepsy3-day treatment with azithromycin 1.5% eye drops versus 7-day treatment with tobramycin 0.3% for purulent bacterial conjunctivitis: multicentre, randomised and controlled trial in adults and children. Cochereau I, Meddeb-Ouertani A, Khairallah M, Amraoui A, Zaghloul K, Pop M, Delval L, Pouliquen P, Tandon R, Garg P, Goldschmidt P, Bourcier T. Br J Ophthalmol. 2007 Apr;91(4):465-9;Epub 2006 Oct 18.

Active substance: TIAGABINE

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Document reference: 38528

Study title: The respiratory effects of tramadol in children under halothane anaesthesia - Bösenberg AT, Ratcliffe S - 1998 (Anaesthesia 1998; 53: 960-964)The respiratory effects of tramadol in children under halothane anaesthesia - Bösenberg AT, Ratcliffe S - 1998 (Anaesthesia 1998; 53: 960-964)

Active substance: TRAMADOL

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Document reference: 45036

Study title: Tramadol hydrochloride: analgesic pharmacodynamics-pharmacokinetics in dental-extraction pain

Active substance: TRAMADOL

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Document reference: 44991

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, acetaminophen with dextropropoxyphene and placebo in dental-extraction pain

Active substance: TRAMADOL

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Document reference: 44989

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, acetaminophen with propoxyphene napsylate and placebo in dental-extraction pain

Active substance: TRAMADOL

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Document reference: 44987

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine phosphate and placebo in dental-extraction pain

Active substance: TRAMADOL

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Document reference: 44986

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine phosphate and placebo in dental-extraction pain

Active substance: TRAMADOL

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Document reference: 44988

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine sulfate and placebo in pain following cesarean section

Active substance: TRAMADOL

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Document reference: 44984

Study title: Tramadol hydrochloride: efficacy compared to codeine sulfate, aspirin with codeine sulfate and placebo in dental extraction pain

Active substance: TRAMADOL

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Document reference: 44985

Study title: Kaku Igaku. 1994 Aug;31(8):951-6. [Thallium-201 single photon emission computed tomography in the evaluation of therapeutic response for brain tumors] [Article in Japanese] Tomura N, Kobayashi M, Oyama Y, Satoh K, Kato K, Kusaka K, Watarai J, Sasaki K.Kaku Igaku. 1994 Aug;31(8):951-6. [Thallium-201 single photon emission computed tomography in the evaluation of therapeutic response for brain tumors] [Article in Japanese] Tomura N, Kobayashi M, Oyama Y, Satoh K, Kato K, Kusaka K, Watarai J, Sasaki K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44645

Study title: Effect of tranexamic acid on postoperative bleeding in pediatric heart surgery. Rev Esp Anestesiol Reanim. 2007 Mar;54(3):155-61.Effect of tranexamic acid on postoperative bleeding in pediatric heart surgery. Rev Esp Anestesiol Reanim. 2007 Mar;54(3):155-61.

Active substance: TRAXENAMIC ACID

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Document reference: 46708

Study title: Hemostatic parameters and platelet activation marker expression in cyanotic and acyanotic pediatric patients undergoing cardiac surgery in the presence of tranexamic acid. Thromb Haemost. 2000 Jan;83(1):54-9Hemostatic parameters and platelet activation marker expression in cyanotic and acyanotic pediatric patients undergoing cardiac surgery in the presence of tranexamic acid. Thromb Haemost. 2000 Jan;83(1):54-9

Active substance: TRAXENAMIC ACID

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Document reference: 46716

Study title: Local antifibrinolytic treatment with tranexamic acid in hemophilic children undergoing dental extractions. Egypt Dent J. 1995 Jan;41(1):961-8.Local antifibrinolytic treatment with tranexamic acid in hemophilic children undergoing dental extractions. Egypt Dent J. 1995 Jan;41(1):961-8.

Active substance: TRAXENAMIC ACID

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Document reference: 46720

Study title: Surgical repair of congenital diaphragmatic hernia during extracorporeal membrane oxygenation: hemorrhagic complications and the effect of tranexamic acid. J Pediatr Surg. 1997 Apr;32(4):594-9Surgical repair of congenital diaphragmatic hernia during extracorporeal membrane oxygenation: hemorrhagic complications and the effect of tranexamic acid. J Pediatr Surg. 1997 Apr;32(4):594-9

Active substance: TRAXENAMIC ACID

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Document reference: 46718

Study title: Meenan FO. A clinical trial of Tolnaftate in fungus infection of the skin. J Ir Med Assoc. 1967 Dec;60(366):450-2. Meenan FO. A clinical trial of Tolnaftate in fungus infection of the skin. J Ir Med Assoc. 1967 Dec;60(366):450-2.

Active substance: TOLNAFTATE

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Document reference: 44825

Study title: O'Brien JM. Common skin problems of infancy, childhood, and adolescence. Prim Care. 1995 Mar;22(1):99-115. O'Brien JM. Common skin problems of infancy, childhood, and adolescence. Prim Care. 1995 Mar;22(1):99-115.

Active substance: TOLNAFTATE

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Document reference: 44830

Study title: Schwartz RA, Janniger CK. Tinea capitis. Cutis. 1995 Jan;55(1):29-33. Schwartz RA, Janniger CK. Tinea capitis. Cutis. 1995 Jan;55(1):29-33.

Active substance: TOLNAFTATE

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Document reference: 44832

Study title: Theos A. Diagnosis and management of superficial cutaneous fungal infections in children. Pediatr Ann. 2007 Jan;36(1):46-54. Theos A. Diagnosis and management of superficial cutaneous fungal infections in children. Pediatr Ann. 2007 Jan;36(1):46-54.

Active substance: TOLNAFTATE

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Document reference: 44833

Study title: Tong MM, Altman PM, Barnetson RS. Tea tree oil in the treatment of tinea pedis. Friedlander SF, Suarez S. Pediatric antifungal therapy. Dermatol Clin. 1998 Jul;16(3):527-37. Tong MM, Altman PM, Barnetson RS. Tea tree oil in the treatment of tinea pedis. Friedlander SF, Suarez S. Pediatric antifungal therapy. Dermatol Clin. 1998 Jul;16(3):527-37.

Active substance: TOLNAFTATE

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Document reference: 44828

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

Active substance: Tonico-Injeel

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Document reference: 40261

Study title: 15. Open-label extension study of the safety and efficacy of RWJ-17021-001 in subjects with bipolar i disorder who completed protocol TOPMAT-PDMD-002.

Active substance: TOPIRAMATE

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Document reference: 44949

Study title: Cognitive effects of the new antiepileptic drugs ; KJ Meador, KJ Meador, Neurologist 1998, 4(5): S35-S39Cognitive effects of the new antiepileptic drugs ; KJ Meador, KJ Meador, Neurologist 1998, 4(5): S35-S39

Active substance: TIAGABINE

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Document reference: 38434

Study title: Am J Cardiol. 1979 Nov;44(6):1040-5. Idiopathic hypertrophic subaortic stenosis: evaluation of anginal symptoms with thallium-201 myocardial imaging. Rubin KA, Morrison J, Padnick MB, Binder AJ, Chiaramida S, Margouleff D, Padmanabhan VT, Gulotta SJ. Am J Cardiol. 1979 Nov;44(6):1040-5. Idiopathic hypertrophic subaortic stenosis: evaluation of anginal symptoms with thallium-201 myocardial imaging. Rubin KA, Morrison J, Padnick MB, Binder AJ, Chiaramida S, Margouleff D, Padmanabhan VT, Gulotta SJ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44501

Study title: Am J Cardiol. 1980 May;45(5):1013-8. Radionuclide assessment of right and left ventricular exercise reserve after total correction of tetralogy of Fallot. Reduto LA, Berger HJ, Johnstone DE, Hellenbrand W, Wackers FJ, Whittemore R, Cohen LS, Gottschalk Am J Cardiol. 1980 May;45(5):1013-8. Radionuclide assessment of right and left ventricular exercise reserve after total correction of tetralogy of Fallot. Reduto LA, Berger HJ, Johnstone DE, Hellenbrand W, Wackers FJ, Whittemore R, Cohen LS, Gottschalk

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44502

Study title: Am J Cardiol. 1982 Apr 1;49(5):1197-207. Noninvasive assessment of coronary stenoses by myocardial imaging during pharmacologic coronary vasodilation. VI. Detection of coronary artery disease in human beings with intravenous N-13 ammonia and positron coAm J Cardiol. 1982 Apr 1;49(5):1197-207. Noninvasive assessment of coronary stenoses by myocardial imaging during pharmacologic coronary vasodilation. VI. Detection of coronary artery disease in human beings with intravenous N-13 ammonia and positron co

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44503

Study title: Kaku Igaku. 1994 Jan;31(1):53-61. [Clinical usefulness of thallium-201 chloride in the diagnosis of tumors (I)--Evaluation in brain tumors] [Article in Japanese] Endo K, Yui N, Suzuki K, Torizuka K. Kaku Igaku. 1994 Jan;31(1):53-61. [Clinical usefulness of thallium-201 chloride in the diagnosis of tumors (I)--Evaluation in brain tumors] [Article in Japanese] Endo K, Yui N, Suzuki K, Torizuka K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44647

Study title: Kaku Igaku. 1994 May;31(5):441-9. [Detection and localization of parathyroid adenomas and hyperplasias in patients with hyperparathyroidism using thallium-201/technetium-99m parathyroid subtraction scintigraphy] [Article in Japanese] Kanegae K, Itoh KKaku Igaku. 1994 May;31(5):441-9. [Detection and localization of parathyroid adenomas and hyperplasias in patients with hyperparathyroidism using thallium-201/technetium-99m parathyroid subtraction scintigraphy] [Article in Japanese] Kanegae K, Itoh K

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44649

Study title: Pediatr Hematol Oncol. 2005 Mar;22(2):153-62. Quantitative thallium-201 scintigraphy in childhood osteosarcoma: Comparison with technetuim-99m MDP and magnetic resonance imaging in the evaluation of chemotherapeutic response. Ilhan IE, Vural G, BerberogPediatr Hematol Oncol. 2005 Mar;22(2):153-62. Quantitative thallium-201 scintigraphy in childhood osteosarcoma: Comparison with technetuim-99m MDP and magnetic resonance imaging in the evaluation of chemotherapeutic response. Ilhan IE, Vural G, Berberog

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44681

Study title: Pediatr Neurol. 1991 Jul-Aug;7(4):249-57. 201Tl/99mTc-HMPAO SPECT imaging of treated childhood brain tumors. O'Tuama LA, Janicek MJ, Barnes PD, Scott RM, Black PM, Sallan SE, Tarbell NJ, Kupsky WJ, Wagenaar D, Ulanski JS, et al. Pediatr Neurol. 1991 Jul-Aug;7(4):249-57. 201Tl/99mTc-HMPAO SPECT imaging of treated childhood brain tumors. O'Tuama LA, Janicek MJ, Barnes PD, Scott RM, Black PM, Sallan SE, Tarbell NJ, Kupsky WJ, Wagenaar D, Ulanski JS, et al.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44682

Study title: Pediatr Neurol. 1998 Nov;19(5):351-7. Comparative value of thallium and glucose SPECT imaging in childhood brain tumors. Maria BL, Drane WE, Mastin ST, Jimenez LA. Pediatr Neurol. 1998 Nov;19(5):351-7. Comparative value of thallium and glucose SPECT imaging in childhood brain tumors. Maria BL, Drane WE, Mastin ST, Jimenez LA.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44683

Study title: Pediatr Neurol. 1998 Oct;19(4):259-62. Childhood brain tumor: neuroimaging correlated with disease outcome. O'Tuama LA, Poussaint TY, Anthony DC, Treves ST. Pediatr Neurol. 1998 Oct;19(4):259-62. Childhood brain tumor: neuroimaging correlated with disease outcome. O'Tuama LA, Poussaint TY, Anthony DC, Treves ST.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44684

Study title: Pediatr Neurosurg. 1991-1992;17(2):95-7. Thallium-201 single-photon emission computed tomography imaging in a pediatric brain tumor. A case report. Bhargava S, Coel M, Wilkinson R. Pediatr Neurosurg. 1991-1992;17(2):95-7. Thallium-201 single-photon emission computed tomography imaging in a pediatric brain tumor. A case report. Bhargava S, Coel M, Wilkinson R.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44685

Study title: Am J Cardiol. 1990 May 1;65(16):1134-9. Decreased coronary vasodilatory capacity in hypertrophic cardiomyopathy determined by split-dose thallium-dipyridamole myocardial scintigraphy. Koga Y, Yamaguchi R, Ogata M, Kihara K, Toshima H. Am J Cardiol. 1990 May 1;65(16):1134-9. Decreased coronary vasodilatory capacity in hypertrophic cardiomyopathy determined by split-dose thallium-dipyridamole myocardial scintigraphy. Koga Y, Yamaguchi R, Ogata M, Kihara K, Toshima H.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44505

Study title: Caudal bupivacaine-tramadol combination for postoperative analgesia in paediatric herniorrhaphy - Senel AC, Akyol A, Dohman D, Solak M, - 2001 (Acta. Anaesthesiologiol. Scand, 2001; 45: 786-789)Caudal bupivacaine-tramadol combination for postoperative analgesia in paediatric herniorrhaphy - Senel AC, Akyol A, Dohman D, Solak M, - 2001 (Acta. Anaesthesiologiol. Scand, 2001; 45: 786-789)

Active substance: TRAMADOL

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Document reference: 45021

Study title: Comparaison of caudal morphine and tramadol for postoperative pain control in children undergoing inguinal herniorrhapy - Ozcengiz D, Gunduz H, Ozbek H, Isik G, - 2001 (Paediatric Anaesthesia 2001, 11: 459-464)Comparaison of caudal morphine and tramadol for postoperative pain control in children undergoing inguinal herniorrhapy - Ozcengiz D, Gunduz H, Ozbek H, Isik G, - 2001 (Paediatric Anaesthesia 2001, 11: 459-464)

Active substance: TRAMADOL

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Document reference: 45023

Study title: Treatment of neuroblastoma with 131I-metaiodobenzylguanidine: experience of the Munster/Kassel GroupMedical and pediatric oncology (1987), 15(4), 196-8

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48314

Study title: Investigator's study (Dr. Rudolf Schosser): Post-authorisation observation Study, Booster Vaccination with FSME-IMMUN Adult und FSME-IMMUN 0,25ml Junior to achieve Protection if Irregular Vaccination scheme have occured in the vaccination history (duration: May 2005 - December 2006)

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 41102

Study title: Multicenter Phase IV Study to Investigate the Seropersistence of TBE Virus Antibodies Approximately Three Years After a Booster Vaccination with FSME-Immun 0.25 ml Junior in Children (Follow-up to Study 146A and 180)

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 41103

Study title: Multizentrische offene Studie zur Untersuchung der FSME-Antikörper 1 Jahr nach Impfung mit 0,25 oder 0,50 ml TicoVac - Anschlußstudie an die FSME-Kinderstudie 146

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 21214

Study title: Multizentrische offene Studie zur Untersuchung der FSME-Antikörper 1 Jahr nach Impfung mit 0,25 oder 0,50 ml TicoVac - Anschlußstudie an die FSME-Kinderstudie 146

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 41105

Study title: Single-blind, randomized, multicenter comparison of FSME IMMUN NEW and ENCEPUR: safety and tolerability of two vaccinations in healthy volunteers aged 16 to 65 years

Active substance: Tick-Borne Encephalitis Virus

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Document reference: 21204

Study title: Acute oral toxicity in the baboon (LSR report n°76/CAS4/176) - Lightowler - 28 July 1976

Active substance: TICLOPIDINE

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Document reference: 44755

Study title: Pharmacocinetique de la ticlopidine à dose unique et doses répétées chez des volontaires sains jeunes et agés. Rapport final. ICM 1161/ CL 3690 - Gabuzda G. - 01/12/86

Active substance: TICLOPIDINE

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Document reference: 44759

Study title: Publication: Effect of vitamin E and ticlopidine on platelet aggregation in Fabry's disease. Clin Gen; 31:349-54 - Sakuraba - 4 January 1987

Active substance: TICLOPIDINE

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Document reference: 44756

Study title: Publication: Treatment of angiomas with associated thrombocytopenia (Kasabach-Merrit syndrome) by ticlopidine-aspirin combination - Drouet - No date

Active substance: TICLOPIDINE

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Document reference: 44757

Study title: Studies on platelet functions and the protection of platelet consumption during extracorporeal circulation -Isomura - No date

Active substance: TICLOPIDINE

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Document reference: 44758

Study title: Circulation. 1980 Mar;61(3):596-9. Thallium-201 myocardial perfusion imaging in infants and children. Value in distinguishing anomalous left coronary artery from congestive cardiomyopathy. Gutgesell HP, Pinsky WW, DePuey EG. Circulation. 1980 Mar;61(3):596-9. Thallium-201 myocardial perfusion imaging in infants and children. Value in distinguishing anomalous left coronary artery from congestive cardiomyopathy. Gutgesell HP, Pinsky WW, DePuey EG.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44534

Active substance: TINZANIDINE

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Document reference: 44791

Active substance: TINZANIDINE

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Document reference: 44803

Study title: (The impact of diltiazem on aminophylline serum concentration−−a clinical study). Li X, Zhao JP, Chen BG. Zhonghua nei ke za zhi (Chinese journal of internal medicine),Nov 1994, vol. 33, no. 11, p. 773−5(The impact of diltiazem on aminophylline serum concentration−−a clinical study). Li X, Zhao JP, Chen BG. Zhonghua nei ke za zhi (Chinese journal of internal medicine),Nov 1994, vol. 33, no. 11, p. 773−5

Active substance: DILTIAZEM

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Document reference: 26131

Active substance: TINZANIDINE

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Document reference: 44802

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A placebo-controlled, double-blind study of Nasacort® (triamcinolone acetonide nasal aerosol) in pediatric patients with seasonal allergic rhinitis - No Author - 31/07/1992

Active substance: TRIAMCINOLONE

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Document reference: 46848

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A placebo-controlled, double-blind study of NasacortTM (triamcinolone acetonide nasal aerosol) in pediatric patients with perennial allergic rhinitis - No Author - 15/04/1991

Active substance: TRIAMCINOLONE

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Document reference: 46849

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A placebo-controlled, double-blind study of RG 5029Y aqueous nasal spray in pediatric patients with spring grass seasonal allergic rhinitis - Simpson BE - 31/08/1995

Active substance: TRIAMCINOLONE

Study summary document link (including results): Triamcinolone acetonide STUDY RG5029Y-312 CSR.xls

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Document reference: 46850

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A placebo-controlled, double-blind study of the safety and efficacy of RG5029Y (triamcinolone acetonide) aqueous nasal spray in adolescent patients with ragweed allergic rhinitis - Procaccini RL - 25/02/1994

Active substance: TRIAMCINOLONE

Study summary document link (including results): Triamcinolone acetonide STUDY RG5029Y-302 CSR.xls

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Document reference: 46851

Active substance: TRIAMCINOLONE

Study summary document link (including results): Triamcinolone acetonide STUDY RG5029Y-305 CSR.xls

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Document reference: 46852

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 An open-label, long-term safety of WHR 5029 (triamcinolone acetonide nasal aerosol) in patients with perennial allergic rhinitis - No Author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46854

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 An open-label, long-term study of WHR 5029 (triamcinolone acetonide nasal aerosol) in patients with perennial allergic rhinitis - No Author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46855

Study title: Wilson disease in children: serum aminotransferases and urinary copper on triethylene tetramine dihydrochloride (trientine) treatmentArnon R et al. J Pediatr Gastroenterol Nutr 2007; 44:596-602.Wilson disease in children: serum aminotransferases and urinary copper on triethylene tetramine dihydrochloride (trientine) treatmentArnon R et al. J Pediatr Gastroenterol Nutr 2007; 44:596-602.

Active substance: TRIENTINE

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Document reference: 46734

Study title: DiMario FJ Jr. Childhood head tremor. J Child Neurol 2000 Jan; 15(1): 22-5.DiMario FJ Jr. Childhood head tremor. J Child Neurol 2000 Jan; 15(1): 22-5.

Active substance: TRIHEXYPHENIDYL

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Document reference: 46738

Study title: Fahn Systemic Therapy of Dystonia Can J Neurol Sci 1987;14:528-532Fahn Systemic Therapy of Dystonia Can J Neurol Sci 1987;14:528-532

Active substance: TRIHEXYPHENIDYL

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Document reference: 46743

Study title: Report in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 A controlled, double-blind study of WHR 5029 (triamcinolone acetonide nasal aerosol) and placebo in pediatric patients with seasonal allergic rhinitis - No Author - No date

Active substance: TRIAMCINOLONE

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Document reference: 46847

Study title: Fahn S. High dosage anticholinergic therapy in dystonia. Neurology 1983 Oct; 33(10): 1255-61.Fahn S. High dosage anticholinergic therapy in dystonia. Neurology 1983 Oct; 33(10): 1255-61.

Active substance: TRIHEXYPHENIDYL

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Document reference: 46745

Study title: Comparison of caudal tramadol versus bupivacaine for postoperative analgesia in children undergoing hypospadis surgery - Batra YK, Prasad MK, Arya VK, Chari P, Yaddnapudi LN - 1999 (Int J Clin Pharmacol Ther. 1999; 37(5): 238-242)Comparison of caudal tramadol versus bupivacaine for postoperative analgesia in children undergoing hypospadis surgery - Batra YK, Prasad MK, Arya VK, Chari P, Yaddnapudi LN - 1999 (Int J Clin Pharmacol Ther. 1999; 37(5): 238-242)

Active substance: TRAMADOL

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Document reference: 45024

Study title: Comparison of the efficacy and tolerability of tramadol, pethidine and nalbuphine in children with postoperative pain. An open randomised study - Barsoum MW - 1995 (Clin Drug Invest 1995; 9(4): 183-190)Comparison of the efficacy and tolerability of tramadol, pethidine and nalbuphine in children with postoperative pain. An open randomised study - Barsoum MW - 1995 (Clin Drug Invest 1995; 9(4): 183-190)

Active substance: TRAMADOL

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Document reference: 45025

Study title: Control of postoperative pain with tramadol in paediatric and adolescent patients with neurological lesions: our experience - Girotto T, Padovan L, Muraretto P, Marazza D, Marzeolini M, De Nobili E - 1998 (Acta Anaesth Italica 1998; 49: 257-262)Control of postoperative pain with tramadol in paediatric and adolescent patients with neurological lesions: our experience - Girotto T, Padovan L, Muraretto P, Marazza D, Marzeolini M, De Nobili E - 1998 (Acta Anaesth Italica 1998; 49: 257-262)

Active substance: TRAMADOL

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Document reference: 45026

Study title: Double-blind randomised study of tramadol vs. Paracetamol in analgeia afetr day-case tonsillectomy in children - Pendeville PE, Von Montigny S, Dort JP, Veyckemans F - 2000 (Eur. J Anaesthesiol 2000; 17: 576-582)Double-blind randomised study of tramadol vs. Paracetamol in analgeia afetr day-case tonsillectomy in children - Pendeville PE, Von Montigny S, Dort JP, Veyckemans F - 2000 (Eur. J Anaesthesiol 2000; 17: 576-582)

Active substance: TRAMADOL

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Document reference: 45027

Study title: Circulation. 1991 May;83(5):1660-7. Myocardial metabolic, hemodynamic, and electrocardiographic significance of reversible thallium-201 abnormalities in hypertrophic cardiomyopathy. Cannon RO 3rd, Dilsizian V, O'Gara PT, Udelson JE, Schenke WH, Quyyumi Circulation. 1991 May;83(5):1660-7. Myocardial metabolic, hemodynamic, and electrocardiographic significance of reversible thallium-201 abnormalities in hypertrophic cardiomyopathy. Cannon RO 3rd, Dilsizian V, O'Gara PT, Udelson JE, Schenke WH, Quyyumi

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44536

Study title: Clin Neurol Neurosurg. 2007 Sep;109(7):607-12. Epub 2007 Jun 6. Cerebral necrosis after 25Gy radiotherapy in childhood followed 28 years later by 54Gy radiotherapy. Koot RW, Stalpers LJ, Aronica E, Andries Bosch D Clin Neurol Neurosurg. 2007 Sep;109(7):607-12. Epub 2007 Jun 6. Cerebral necrosis after 25Gy radiotherapy in childhood followed 28 years later by 54Gy radiotherapy. Koot RW, Stalpers LJ, Aronica E, Andries Bosch D

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44539

Study title: Clin Nucl Med. 1985 Aug;10(8):562-6. Thallium-201 myocardial perfusion imaging in myocarditis. Tamaki N, Yonekura Y, Kadota K, Kambara H, Torizuka K. Clin Nucl Med. 1985 Aug;10(8):562-6. Thallium-201 myocardial perfusion imaging in myocarditis. Tamaki N, Yonekura Y, Kadota K, Kambara H, Torizuka K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44540

Study title: Clin Nucl Med. 1988 Mar;13(3):155-8. The reliability of thallium-201 myocardial tomography in a clinical setting without exclusions for drugs or suboptimal exercise. Coel M, Gushiken B. Clin Nucl Med. 1988 Mar;13(3):155-8. The reliability of thallium-201 myocardial tomography in a clinical setting without exclusions for drugs or suboptimal exercise. Coel M, Gushiken B.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44542

Study title: A CLINICAL STUDY ENTITLED TIOCONAZOL 6,5% SINGLE DOSE VAGINAL OINTMENT IN THE TREATMENT OF VAGINAL CANDIDASIS (DR. GRIGORIU ET ALL) (MULTICENTER STUDY)

Active substance: TIOCONAZOLE

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Document reference: 44807

Study title: Eur J Nucl Med. 1995 Jun;22(6):553-5. Quantitative evaluation of thallium-201 uptake in predicting chemotherapeutic response of osteosarcoma. Lin J, Leung WT, Ho SK, Ho KC, Kumta SM, Metreweli C, Johnson PJ. Eur J Nucl Med. 1995 Jun;22(6):553-5. Quantitative evaluation of thallium-201 uptake in predicting chemotherapeutic response of osteosarcoma. Lin J, Leung WT, Ho SK, Ho KC, Kumta SM, Metreweli C, Johnson PJ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44570

Study title: Eur J Nucl Med. 1995 May;22(5):419-26. Quantitative studies of monoclonal antibody targeting to disialoganglioside GD2 in human brain tumors. Arbit E, Cheung NK, Yeh SD, Daghighian F, Zhang JJ, Cordon-Cardo C, Pentlow K, Canete A, Finn R, Larson SM. Eur J Nucl Med. 1995 May;22(5):419-26. Quantitative studies of monoclonal antibody targeting to disialoganglioside GD2 in human brain tumors. Arbit E, Cheung NK, Yeh SD, Daghighian F, Zhang JJ, Cordon-Cardo C, Pentlow K, Canete A, Finn R, Larson SM.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44571

Study title: Eur J Nucl Med. 1995 Nov;22(11):1232-7. Erratum in: Eur J Nucl Med. 1996 Nov;23(11):1558. Correlation of the findings of thallium-201 chloride scans with those of other imaging modalities and histology following therapy in patients with bone and sofEur J Nucl Med. 1995 Nov;22(11):1232-7. Erratum in: Eur J Nucl Med. 1996 Nov;23(11):1558. Correlation of the findings of thallium-201 chloride scans with those of other imaging modalities and histology following therapy in patients with bone and sof

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44572

Study title: Eur J Nucl Med. 1996 May;23(5):504-10. Early and delayed thallium-201 scintigraphy in thyroid nodules: the relationship between early thallium-201 uptake and perfusion. Derebek E, Biberoglu S, Kut O, Yesil S, Saydam S, Yilmaz M, Yenici O, Igci E, GokceEur J Nucl Med. 1996 May;23(5):504-10. Early and delayed thallium-201 scintigraphy in thyroid nodules: the relationship between early thallium-201 uptake and perfusion. Derebek E, Biberoglu S, Kut O, Yesil S, Saydam S, Yilmaz M, Yenici O, Igci E, Gokce

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44573

Study title: Eur J Surg Oncol. 2003 Dec;29(10):908-15. Thallium-201 scintigraphy--a predictor of tumour necrosis in soft tissue sarcoma following preoperative radiotherapy? Choong PF, Nizam I, Ngan SY, Schlict S, Powell G, Slavin J, Smith P, Toner G, Hicks R. Eur J Surg Oncol. 2003 Dec;29(10):908-15. Thallium-201 scintigraphy--a predictor of tumour necrosis in soft tissue sarcoma following preoperative radiotherapy? Choong PF, Nizam I, Ngan SY, Schlict S, Powell G, Slavin J, Smith P, Toner G, Hicks R.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44576

Study title: Hoon AH Jr, et al. Agedependent effects of trihexyphenidyl in extrapyramidal celebral palsy. Pediatric Neurol 2001; 25(1): 55-8.Hoon AH Jr, et al. Agedependent effects of trihexyphenidyl in extrapyramidal celebral palsy. Pediatric Neurol 2001; 25(1): 55-8.

Active substance: TRIHEXYPHENIDYL

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Document reference: 46737

Study title: Study of theophylline metabolism in premature human newborns using stable isotope labelling Brazier Bioomed Mass Spectrom 1980 May 7(5) 189-92 in Annual Report 02Study of theophylline metabolism in premature human newborns using stable isotope labelling Brazier Bioomed Mass Spectrom 1980 May 7(5) 189-92 in Annual Report 02

Active substance: THEOPHYLLINE

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Document reference: 44725

Study title: Theophylline-modulation of bronchial hyper-reactivity (direct and indirect) and T-cell subsets in atopic asthmatic children; Zarkovic J. et al. (1995); XVI European congress of allergology and clinical immunology; Basomba A. and Hernandez F. de Rojas M.D. Theophylline-modulation of bronchial hyper-reactivity (direct and indirect) and T-cell subsets in atopic asthmatic children; Zarkovic J. et al. (1995); XVI European congress of allergology and clinical immunology; Basomba A. and Hernandez F. de Rojas M.D.

Active substance: THEOPHYLLINE

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Document reference: 44720

Study title: Uncontrolled study of serum theophylline concentrations and lung function parameters in 18 children with bronchial asthma between 5 and 9 years of age after four days’administration of 450 mg theophylline (BY158K) per day.

Active substance: THEOPHYLLINE

Study summary document link (including results): Study report 13-89 Theophylline - synopsis.pdf

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Document reference: 21676

Study title: Uncontrolled study of serum theophylline concentrations and lung function parameters in 18 children with bronchial asthma between 5 and 9 years of age after four days` administration of 450 mg theophylline (BY158K) per day

Active substance: THEOPHYLLINE

Study summary document link (including results): Study report 13-89 Theophylline - synopsis.pdf

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Document reference: 44729

Study title: AWB-BL /UNI-300-400/151092, 22-Jan-1997, Wirksamkeit und Verträglichkeit einer individuelle angepassten Theophyllintherapie mit Uniphyllin/Uniphyllin 300 bei Patienten mit chronisch obstruktiver Bronchitis. Efficacy and safety of an individually adopted therapy with Theophyllin (Uniphyllin/Uniphyllin 300) in patient with chronic obstructive bronchitis (Germany)

Active substance: Theophylline anhydrous

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Document reference: 40255

Study title: Emrich D. et al., Dtsch. Med. Wochenschr. 35, 1261 1977Emrich D. et al., Dtsch. Med. Wochenschr. 35, 1261 1977

Active substance: THIAMAZOLE

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Document reference: 44733

Study title: J Pediatr. 1990 Jan;116(1):52-6. Myocardial performance and perfusion during exercise in patients with coronary artery disease caused by Kawasaki disease. Paridon SM, Ross RD, Kuhns LR, Pinsky WW. J Pediatr. 1990 Jan;116(1):52-6. Myocardial performance and perfusion during exercise in patients with coronary artery disease caused by Kawasaki disease. Paridon SM, Ross RD, Kuhns LR, Pinsky WW.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44626

Study title: J Surg Oncol. 1990 Dec;45(4):282-8. Multiple endocrine neoplasia type IIb: a clinicopathological report. Van Zyl JA, Muller GS, Rossouw DJ, Van Velden DJ. J Surg Oncol. 1990 Dec;45(4):282-8. Multiple endocrine neoplasia type IIb: a clinicopathological report. Van Zyl JA, Muller GS, Rossouw DJ, Van Velden DJ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44627

Study title: J Thorac Cardiovasc Surg. 1984 Jan;87(1):59-65. Single-trunk anomalous origin of both coronary arteries from the pulmonary artery. Diagnosis and surgical management. J Thorac Cardiovasc Surg. 1984 Jan;87(1):59-65. Single-trunk anomalous origin of both coronary arteries from the pulmonary artery. Diagnosis and surgical management.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44628

Study title: Efficacy of neuroprotectors in patients with tension headaches. Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6Efficacy of neuroprotectors in patients with tension headaches. Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6

Active substance: TIAGABINE

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Document reference: 38504

Study title: Follmann P., Wix K., Kenyeres A., Folia Ophthalmol 1990; 15: 167-171Follmann P., Wix K., Kenyeres A., Folia Ophthalmol 1990; 15: 167-171

Active substance: TIAGABINE

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Document reference: 38482

Study title: Four years later: a clinical update on latanoprost. Ravinet E, Mermoud A, Brignoli R. Eur J Ophthalmol. 2003 Mar;13(2):162-75. Four years later: a clinical update on latanoprost. Ravinet E, Mermoud A, Brignoli R. Eur J Ophthalmol. 2003 Mar;13(2):162-75.

Active substance: TIAGABINE

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Document reference: 38484

Study title: Tramadol infusion for pain therapy after major bladder surgery in paediatric wards - Griessinger N, Rösch W, Schott G - 1997 (Der Urologe 1997; 38: 552-556)Tramadol infusion for pain therapy after major bladder surgery in paediatric wards - Griessinger N, Rösch W, Schott G - 1997 (Der Urologe 1997; 38: 552-556)

Active substance: TRAMADOL

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Document reference: 45037

Study title: Tramal for pain control in children-continuous infusion versus repeated bolus administration: effectiveness and adverse effects - Kralinski K, Dluholucky S, Laho L - 1995 (Anesteziologie a Neonadkladne Pece 1995; 1: 19-21)Tramal for pain control in children-continuous infusion versus repeated bolus administration: effectiveness and adverse effects - Kralinski K, Dluholucky S, Laho L - 1995 (Anesteziologie a Neonadkladne Pece 1995; 1: 19-21)

Active substance: TRAMADOL

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Document reference: 45038

Study title: Tramal in the treatment of pain in children with malignancies - Kralinski K, Dluholucky S, Bajciova V, LahoL, Drobova Z - 1994 (Klinicka Onkologie 1994; 6: 182-185)Tramal in the treatment of pain in children with malignancies - Kralinski K, Dluholucky S, Bajciova V, LahoL, Drobova Z - 1994 (Klinicka Onkologie 1994; 6: 182-185)

Active substance: TRAMADOL

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Document reference: 45039

Study title: Tramal long 100 mg and Tramal long 100/150/200 mg Two multicentric post-marketing surveillance studies of an analgesic in the treatment of moderate to severe pain

Active substance: TRAMADOL

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Document reference: 44996

Study title: Tramal long 100 mg and Tramal long 100/150/200 mg Two multicentric post-marketing surveillance studies of an analgesic in the treatment of moderate to severe pain

Active substance: TRAMADOL

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Document reference: 45012

Study title: The efficacy of tranexamic acid versus placebo in decreasing blood loss in pediatric patients undergoing repeat cardiac surgery. Anesth Analg. 1997 May;84(5):990-6.The efficacy of tranexamic acid versus placebo in decreasing blood loss in pediatric patients undergoing repeat cardiac surgery. Anesth Analg. 1997 May;84(5):990-6.

Active substance: TRAXENAMIC ACID

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Document reference: 46717

Study title: Tranexamic acid as a means of reducing the need for blood and blood component therapy in children undergoing open heart surgery for congenital cyanotic heart disease. J Med Assoc Thai. 2002 Sep;85 Suppl 3:S904-9.Tranexamic acid as a means of reducing the need for blood and blood component therapy in children undergoing open heart surgery for congenital cyanotic heart disease. J Med Assoc Thai. 2002 Sep;85 Suppl 3:S904-9.

Active substance: TRAXENAMIC ACID

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Document reference: 46714

Study title: Tranexamic acid for control of haemorrhage in acute promyelocytic leukaemia. Lancet. 1989 Jul 15;2(8655):122-4.Tranexamic acid for control of haemorrhage in acute promyelocytic leukaemia. Lancet. 1989 Jul 15;2(8655):122-4.

Active substance: TRAXENAMIC ACID

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Document reference: 46721

Study title: Tranexamic acid in the prevention of periventricular haemorrhage. Arch Dis Child. 1984 Aug;59(8):719-21.Tranexamic acid in the prevention of periventricular haemorrhage. Arch Dis Child. 1984 Aug;59(8):719-21.

Active substance: TRAXENAMIC ACID

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Document reference: 46722

Study title: Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery. Anesthesiology. 2005 Apr;102(4):727-32.Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery. Anesthesiology. 2005 Apr;102(4):727-32.

Active substance: TRAXENAMIC ACID

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Document reference: 46709

Study title: Tranexamic acid. A review of its use in surgery and other indications. Dunn CJ et al. Drugs 1999; 57: 1005-1037 - Publication in CES0406 for MA renewal in UK -

Active substance: TRAXENAMIC ACID

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Document reference: 46706

Study title: The effect of preoperative tranexamic acid on blood loss after cardiac operations in children. J Thorac Cardiovasc Surg. 1996 May;111(5):982-7.The effect of preoperative tranexamic acid on blood loss after cardiac operations in children. J Thorac Cardiovasc Surg. 1996 May;111(5):982-7.

Active substance: TRAXENAMIC ACID

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Document reference: 46719

Study title: Treatment by tranexamic acid in menorrhagia in women using intrauterine devices. Lakartidningen. 1971 Aug 11;68(33):3685-91. Swedish.Treatment by tranexamic acid in menorrhagia in women using intrauterine devices. Lakartidningen. 1971 Aug 11;68(33):3685-91. Swedish.

Active substance: TRAXENAMIC ACID

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Document reference: 46724

Study title: Which may be effective to reduce blood loss after cardiac operations in cyanotic children: tranexamic acid, aprotinin or a combination? Paediatr Anaesth. 2005 Jan;15(1):41-6.Which may be effective to reduce blood loss after cardiac operations in cyanotic children: tranexamic acid, aprotinin or a combination? Paediatr Anaesth. 2005 Jan;15(1):41-6.

Active substance: TRAXENAMIC ACID

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Document reference: 46710

Study title: Health Phys. 1989 Apr;56(4):539-41. Thallium-201 in human milk: observations and radiological consequences. Murphy PH, Beasley CW, Moore WH, Stabin MG. Health Phys. 1989 Apr;56(4):539-41. Thallium-201 in human milk: observations and radiological consequences. Murphy PH, Beasley CW, Moore WH, Stabin MG.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44577

Active substance: THIAMAZOLE

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Document reference: 44736

Study title: Neurology 2002;58:110-114.Neurology 2002;58:110-114.

Active substance: TETRACOSACTIDE

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Document reference: 44456

Study title: Seizure. 2005;14:552-556.Seizure. 2005;14:552-556.

Active substance: TETRACOSACTIDE

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Document reference: 44471

Study title: Fechner P. U., Teichmann, K. D., 4th ed., Enke Verlag Stuttgart New York 2000; Küchle H. J., Busse H., Augenerkrankungen im Kindesalter, Thieme Verlag Stuttgart New York 1985Fechner P. U., Teichmann, K. D., 4th ed., Enke Verlag Stuttgart New York 2000; Küchle H. J., Busse H., Augenerkrankungen im Kindesalter, Thieme Verlag Stuttgart New York 1985

Active substance: TETRYZOLINE

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Document reference: 44481

Study title: Acta Med Austriaca. 1990;17(2-3):55-8. [Clinical significance of Tl-201/Tc-99m subtraction scintigraphy as a parameter for surgical indication of cold struma nodules] [Article in German] Binter G, Lind P, Langsteger W, Klima G, KÃltringer P, Beham A, EActa Med Austriaca. 1990;17(2-3):55-8. [Clinical significance of Tl-201/Tc-99m subtraction scintigraphy as a parameter for surgical indication of cold struma nodules] [Article in German] Binter G, Lind P, Langsteger W, Klima G, KÃltringer P, Beham A, E

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44482

Study title: Pharmacocinetique de la ticlopidine à dose unique et doses répétées chez des volontaires sains jeunes et agés. Rapport final. ICM 1161/ CL 3690 - Gabuzda G. - 01/12/86Pharmacocinetique de la ticlopidine à dose unique et doses répétées chez des volontaires sains jeunes et agés. Rapport final. ICM 1161/ CL 3690 - Gabuzda G. - 01/12/86

Active substance: TIAGABINE

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Document reference: 38479

Study title: Publication: Effect of vitamin E and ticlopidine on platelet aggregation in Fabry's disease. Clin Gen; 31:349-54 - Sakuraba - 4 January 1987Publication: Effect of vitamin E and ticlopidine on platelet aggregation in Fabry's disease. Clin Gen; 31:349-54 - Sakuraba - 4 January 1987

Active substance: TIAGABINE

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Document reference: 38476

Study title: Publication: Treatment of angiomas with associated thrombocytopenia (Kasabach-Merrit syndrome) by ticlopidine-aspirin combination - Drouet - No datePublication: Treatment of angiomas with associated thrombocytopenia (Kasabach-Merrit syndrome) by ticlopidine-aspirin combination - Drouet - No date

Active substance: TIAGABINE

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Document reference: 38477

Study title: Quelques réflexions sur les tics de l'enfant. A propos d'un éssai clinique. - C. Pasquier, F. Pouplard -revue de neuropsychiatrie infantile, 1977, 25 (10) 645-651Quelques réflexions sur les tics de l'enfant. A propos d'un éssai clinique. - C. Pasquier, F. Pouplard -revue de neuropsychiatrie infantile, 1977, 25 (10) 645-651

Active substance: TIAGABINE

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Document reference: 38471

Study title: Ann Endocrinol (Paris). 1993;54(4):248-54. [Can benign and malignant thyroid nodules be differentiated with thallium 201?] [Article in French] Hermans J, Schmitz A, Merlo P, Bodart F, Beauduin M. Ann Endocrinol (Paris). 1993;54(4):248-54. [Can benign and malignant thyroid nodules be differentiated with thallium 201?] [Article in French] Hermans J, Schmitz A, Merlo P, Bodart F, Beauduin M.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44510

Study title: Ann Nucl Med. 1990 Jul;4(2):59-65. Evaluation of viral myocarditis in children by radionuclide method. Kawamura Y, Morishita T, Yamazaki J, Okuzumi I, Wakakura M, Muto T, Saji T, Matsuura H, Matsuo N, Yabe Y. Ann Nucl Med. 1990 Jul;4(2):59-65. Evaluation of viral myocarditis in children by radionuclide method. Kawamura Y, Morishita T, Yamazaki J, Okuzumi I, Wakakura M, Muto T, Saji T, Matsuura H, Matsuo N, Yabe Y.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44511

Study title: Kokyu To Junkan. 1985 Feb;33(2):191-7. [Thallium-201 myocardial imaging in children with heart disease; quantitative assessment of right ventricular pressure] [Article in Japanese] Mitomori T, Ono Y, Kamiya T, Nishimura T, Kozuka T, Kohata T, Tanimoto Kokyu To Junkan. 1985 Feb;33(2):191-7. [Thallium-201 myocardial imaging in children with heart disease; quantitative assessment of right ventricular pressure] [Article in Japanese] Mitomori T, Ono Y, Kamiya T, Nishimura T, Kozuka T, Kohata T, Tanimoto

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44653

Study title: Kokyu To Junkan. 1987 Jan;35(1):59-64. [Clinical evaluation of thallium-201 myocardial scintigram in myocarditis] [Article in Japanese] Shimonagata T, Nishimura T, Hayashida K, Uehara T, Takamiya M. Kokyu To Junkan. 1987 Jan;35(1):59-64. [Clinical evaluation of thallium-201 myocardial scintigram in myocarditis] [Article in Japanese] Shimonagata T, Nishimura T, Hayashida K, Uehara T, Takamiya M.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44654

Study title: Kokyu To Junkan. 1987 Jan;35(1):97-103. [Decreased coronary reserve in patients with hypertrophic cardiomyopathy--a study using split dose thallium-201 dipyridamole myocardial imaging] [Article in Japanese] Yamaguchi R. Kokyu To Junkan. 1987 Jan;35(1):97-103. [Decreased coronary reserve in patients with hypertrophic cardiomyopathy--a study using split dose thallium-201 dipyridamole myocardial imaging] [Article in Japanese] Yamaguchi R.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44655

Study title: Kokyu To Junkan. 1990 Dec;38(12):1247-51. [Usefulness for evaluation of the left ventricular disorders by apexcardiographic A-wave ratio in patients with hypertrophic cardiomyopathy] [Article in Japanese] Yada T, Nezuo S, Sawayama T, Hasegawa K, TadaokKokyu To Junkan. 1990 Dec;38(12):1247-51. [Usefulness for evaluation of the left ventricular disorders by apexcardiographic A-wave ratio in patients with hypertrophic cardiomyopathy] [Article in Japanese] Yada T, Nezuo S, Sawayama T, Hasegawa K, Tadaok

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44657

Study title: Kokyu To Junkan. 1991 Apr;39(4):355-60. [Evaluation of myocarditis using T1-201 myocardial scintigraphy with bull's eye functional map] [Article in Japanese] Satoh K, Utsumi J, Satoh H, Kasuya H, Mitsuyama H, Nakata Y, Yamaguchi H, Kawai Y, Okada R, KaKokyu To Junkan. 1991 Apr;39(4):355-60. [Evaluation of myocarditis using T1-201 myocardial scintigraphy with bull's eye functional map] [Article in Japanese] Satoh K, Utsumi J, Satoh H, Kasuya H, Mitsuyama H, Nakata Y, Yamaguchi H, Kawai Y, Okada R, Ka

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44658

Study title: Kokyu To Junkan. 1992 May;40(5):485-90. [Thallium-201 myocardial imaging in cases involving transposition of the great arteries after arterial switch operation] [Article in Japanese] Fukushima H, Satou S, Satou I, Iwatani H, Tsuda E, Nakamura H, Ono Y,Kokyu To Junkan. 1992 May;40(5):485-90. [Thallium-201 myocardial imaging in cases involving transposition of the great arteries after arterial switch operation] [Article in Japanese] Fukushima H, Satou S, Satou I, Iwatani H, Tsuda E, Nakamura H, Ono Y,

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44659

Study title: Kurume Med J. 1992;39(4):245-55. Myocardial ischemia in Kawasaki disease; evaluation by dipyridamole stress thallium-201 (Tl-201) myocardial imaging and exercise stress test. Fukuda T. Kurume Med J. 1992;39(4):245-55. Myocardial ischemia in Kawasaki disease; evaluation by dipyridamole stress thallium-201 (Tl-201) myocardial imaging and exercise stress test. Fukuda T.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44660

Study title: Ticlopidine. Chronic glomeruloneprhitis (pilot study) - Narita - 21 June 1977

Active substance: TICLOPIDINE

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Document reference: 44761

Study title: Relazione clinica sull'uso del trazodone nella medicazione pre-anestetica.

Active substance: TRAZODONE

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Document reference: 46727

Study title: Sperimentazione clinica del prodotto AF 1161 (Trazodone) usato come neurolettico nell'endoscopia urologica.

Active substance: TRAZODONE

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Document reference: 46726

Study title: Trazodon in der kinder-und jugendpsychiatrie

Active substance: TRAZODONE

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Document reference: 46725

Study title: Pediatr Neurosurg. 1995;22(1):8-14. Comparison of gadolinium-enhanced MR and thallium-201 single photon emission computed tomography in pediatric brain tumors. Rollins NK, Lowry PA, Shapiro KN. Pediatr Neurosurg. 1995;22(1):8-14. Comparison of gadolinium-enhanced MR and thallium-201 single photon emission computed tomography in pediatric brain tumors. Rollins NK, Lowry PA, Shapiro KN.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44687

Study title: Pediatr Radiol. 1980 Apr;9(3):183-5. Thallium 201 scintigraphy in an infant with myocardial infarction following mucocutaneous lymph node syndrome. Ueda K, Saito A, Nakano H, Yano M. Pediatr Radiol. 1980 Apr;9(3):183-5. Thallium 201 scintigraphy in an infant with myocardial infarction following mucocutaneous lymph node syndrome. Ueda K, Saito A, Nakano H, Yano M.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44688

Study title: Pediatr Radiol. 2000 May;30(5):352-4. Myocardial perfusion in children with sickle cell anaemia. Acar P, SÃ©bahoun S, de Pontual L, Maunoury C. Pediatr Radiol. 2000 May;30(5):352-4. Myocardial perfusion in children with sickle cell anaemia. Acar P, SÃ©bahoun S, de Pontual L, Maunoury C.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44690

Study title: Radioisotopes. 1977 Jul;26(7):458-64. [Whole body autoradiography with 201Tl and clinical results] [Article in Japanese] Ishii K, Kobayashi T, Matsubayashi T, Nakazawa K, Yoda K. Radioisotopes. 1977 Jul;26(7):458-64. [Whole body autoradiography with 201Tl and clinical results] [Article in Japanese] Ishii K, Kobayashi T, Matsubayashi T, Nakazawa K, Yoda K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44691

Study title: Acta Med Okayama. 2004 Apr;58(2):75-83. Differentiation of thyroid nodules using Tl-201 scintigraphy quantitative analysis and fine-needle aspiration biopsy. Yamamoto Y, Okumura Y, Sato S, Maki K, Mukai T, Mifune H, Akaki S, Takeda Y, Kanazawa S, HirakiActa Med Okayama. 2004 Apr;58(2):75-83. Differentiation of thyroid nodules using Tl-201 scintigraphy quantitative analysis and fine-needle aspiration biopsy. Yamamoto Y, Okumura Y, Sato S, Maki K, Mukai T, Mifune H, Akaki S, Takeda Y, Kanazawa S, Hiraki

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44483

Study title: Acta Med Scand. 1977;202(5):349-56. Myocardial scintigraphy as a supplementary diagnostic tool in heart disease. Gustafson A, Larsson I, Olsson L, Svensson SE, Westling H. Acta Med Scand. 1977;202(5):349-56. Myocardial scintigraphy as a supplementary diagnostic tool in heart disease. Gustafson A, Larsson I, Olsson L, Svensson SE, Westling H.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44484

Study title: Ann Nucl Med. 1993 Aug;7(3):147-52. Thallium-201 scintigraphy in the evaluation of thyroid nodules. A retrospective study of 246 cases. Koizumi M, Taguchi H, Goto M, Nomura T, Watari T. Ann Nucl Med. 1993 Aug;7(3):147-52. Thallium-201 scintigraphy in the evaluation of thyroid nodules. A retrospective study of 246 cases. Koizumi M, Taguchi H, Goto M, Nomura T, Watari T.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44512

Study title: Ann Nucl Med. 2002 Apr;16(2):95-101. The usefulness of serum thyroglobulin levels and Tl-201 scintigraphy in differentiating between benign and malignant thyroid follicular lesions. Tamizu A, Okumura Y, Sato S, Takeda Y, Maki K, Hiraki T, Akaki S, KurodAnn Nucl Med. 2002 Apr;16(2):95-101. The usefulness of serum thyroglobulin levels and Tl-201 scintigraphy in differentiating between benign and malignant thyroid follicular lesions. Tamizu A, Okumura Y, Sato S, Takeda Y, Maki K, Hiraki T, Akaki S, Kurod

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44514

Study title: Ann Nucl Med. 2005 Sep;19(6):461-8. Thallium-201 scintigraphy in bone and soft-tissue tumors: a comparison of dynamic, early and delayed scans. Sugawara Y, Kikuchi T, Kajihara M, Semba T, Ochi T, Fujii T, Mochizuki T, Sakayama K, Nakata S Ann Nucl Med. 2005 Sep;19(6):461-8. Thallium-201 scintigraphy in bone and soft-tissue tumors: a comparison of dynamic, early and delayed scans. Sugawara Y, Kikuchi T, Kajihara M, Semba T, Ochi T, Fujii T, Mochizuki T, Sakayama K, Nakata S

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44515

Active substance: TRAMADOL

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Document reference: 44979

Study title: Evaluation of the Safety Profile and Clinical Effectiveness of Two Dosing Levels of Oral Tramadol Hydrochloride with Acetaminophen for the Treatment of Postsurgical Pain in Children and Adolescents Aged Seven to Sixteen Years

Active substance: TRAMADOL

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Document reference: 44976

Study title: Publication #21 A double-blind, placebo-controlled trial of fexofenadine HCl in the treatment of CIU - Finn A et al - 1999 (J Allergy Clin Immunol 1999; 104(5):1071-78)

Active substance: FEXOFENADINE

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Document reference: 27251

Study title: Interventions to retard myopia progression in children: an evidence-based update. Saw SM, Shih-Yen EC, Koh A, Tan D. Ophthalmology. 2002 Mar;109(3):415-21; discussion 422-4; quiz 425-6, 443. Interventions to retard myopia progression in children: an evidence-based update. Saw SM, Shih-Yen EC, Koh A, Tan D. Ophthalmology. 2002 Mar;109(3):415-21; discussion 422-4; quiz 425-6, 443.

Active substance: TIMOLOL

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Document reference: 44765

Study title: Medical Therapy of Pediatric Glaucoma and Glaucoma in Pregnancy; Ophthalmol Clin N Am 18 (2005) 461 – 468

Active substance: TIMOLOL

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Document reference: 47681

Study title: Tclid. Acute and chronic pharmacokinetic study of ticlopidine hydrochloride in young and old normal subjects. Final report. ICM 1161/ CL 3690 - Gabuzda G. - 01/12/86

Active substance: TICLOPIDINE

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Document reference: 44760

Study title: Timolol and pediatric glaucomas. McMahon CD, Hetherington J Jr, Hoskins HD Jr, Shaffer RN. Ophthalmology. 1981 Mar;88(3):249-52. Timolol and pediatric glaucomas. McMahon CD, Hetherington J Jr, Hoskins HD Jr, Shaffer RN. Ophthalmology. 1981 Mar;88(3):249-52.

Active substance: TIMOLOL

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Document reference: 44767

Study title: Timolol in uncontrolled childhood glaucomas. Boger WP 3rd, Walton DS. Ophthalmology. 1981 Mar;88(3):253-8.Timolol in uncontrolled childhood glaucomas. Boger WP 3rd, Walton DS. Ophthalmology. 1981 Mar;88(3):253-8.

Active substance: TIMOLOL

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Document reference: 44768

Study title: Radiology. 1995 Sep;196(3):851-5. Use of Tl-201 to detect untreated pediatric Hodgkin disease. Fletcher BD, Kauffman WM, Kaste SC, Winer-Muram HT, Fang L, Chen G, Hudson M. Radiology. 1995 Sep;196(3):851-5. Use of Tl-201 to detect untreated pediatric Hodgkin disease. Fletcher BD, Kauffman WM, Kaste SC, Winer-Muram HT, Fang L, Chen G, Hudson M.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44695

Study title: Radiology. 1998 Nov;209(2):471-5. Hodgkin disease: use of Tl-201 to monitor mediastinal involvement after treatment. Fletcher BD, Xiong X, Kauffman WM, Kaste SC, Hudson MM. Radiology. 1998 Nov;209(2):471-5. Hodgkin disease: use of Tl-201 to monitor mediastinal involvement after treatment. Fletcher BD, Xiong X, Kauffman WM, Kaste SC, Hudson MM.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44696

Study title: A CLINICAL STUDY ENTITLED TROSID (TIOCONAZOL) SOLUTION. A EFFICACY OPEN LABEL STUDY IN THE TREATMENT OF ONYCHOMYCOSIS (ST. JOHAN´S HOSPITAL FOR DISEASE OF SKIN (LONDON) AND DEPARTMENT OF DERMATOLOGY-UNIVERSITY OF GRALGOW. CLINICAL AND EXPERIMENTAL DERMATOLOGY, 10, 11-115, 1985)

Active substance: TIOCONAZOLE

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Document reference: 44808

Study title: J Cardiogr. 1984 Jun;14(1):59-73. [Diagnosis of myocardial ischemia in Kawasaki disease: thallium-201 myocardial imagings at rest, with exercise and with dipyridamole administration] [Article in Japanese] Mitomori T, Ono Y, Sugiyama H, Suzuki A, KamiyaJ Cardiogr. 1984 Jun;14(1):59-73. [Diagnosis of myocardial ischemia in Kawasaki disease: thallium-201 myocardial imagings at rest, with exercise and with dipyridamole administration] [Article in Japanese] Mitomori T, Ono Y, Sugiyama H, Suzuki A, Kamiya

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44596

Study title: J Cardiogr. 1984 Oct;14(3):565-75. [Thallium-201 myocardial imaging in patients with congenital heart disease following open-heart surgery] [Article in Japanese] Ono Y, Mitomori T, Watanabe K, Echigo S, Ryujin Y, Kamiya T, Nishimura T, Kozuka T, NaitoJ Cardiogr. 1984 Oct;14(3):565-75. [Thallium-201 myocardial imaging in patients with congenital heart disease following open-heart surgery] [Article in Japanese] Ono Y, Mitomori T, Watanabe K, Echigo S, Ryujin Y, Kamiya T, Nishimura T, Kozuka T, Naito

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44597

Study title: J Cardiogr. 1986 Jun;16(2):373-85. [Myocardial involvement in muscular dystrophy evaluated by thallium-201 emission computed tomography] [Article in Japanese] Yamamoto S, Matsushima H, Kawai N, Sotobata I. J Cardiogr. 1986 Jun;16(2):373-85. [Myocardial involvement in muscular dystrophy evaluated by thallium-201 emission computed tomography] [Article in Japanese] Yamamoto S, Matsushima H, Kawai N, Sotobata I.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44598

Study title: Influences of tramadol on emergence characteristics from sevoflurane anaesthesia in pediatric ambulatory surgery - Fan KT, Lee TH, Yu KL, Tang CS, Lu DV, Chen PY, Soo LY - 2000 (Kaohsiung J Med Sci, 2000; 16: 255-260)Influences of tramadol on emergence characteristics from sevoflurane anaesthesia in pediatric ambulatory surgery - Fan KT, Lee TH, Yu KL, Tang CS, Lu DV, Chen PY, Soo LY - 2000 (Kaohsiung J Med Sci, 2000; 16: 255-260)

Active substance: TRAMADOL

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Document reference: 45029

Study title: Investigation of paediatric postoperative analgesia with tramadol - Schaeffer J, Hageman H, holzapfel S, Panning B, Piepenbrock S - 1989 (Fortschr Anästh 1989; 3: 42-45)Investigation of paediatric postoperative analgesia with tramadol - Schaeffer J, Hageman H, holzapfel S, Panning B, Piepenbrock S - 1989 (Fortschr Anästh 1989; 3: 42-45)

Active substance: TRAMADOL

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Document reference: 45030

Study title: Nalbuphine and tramadol for the control of postoperative pain in children - Schaeffer J, Piepenbrock S, Kretz FJ, Schoenfeld C - 1986 (Anaesthesist 1986; 35: 408-413)Nalbuphine and tramadol for the control of postoperative pain in children - Schaeffer J, Piepenbrock S, Kretz FJ, Schoenfeld C - 1986 (Anaesthesist 1986; 35: 408-413)

Active substance: TRAMADOL

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Document reference: 45031

Study title: J Thorac Cardiovasc Surg. 1997 May;113(5):942-8. Comment in: J Thorac Cardiovasc Surg. 1997 Dec;114(6):1127-8. Effect of preoperative supplementation with alpha-tocopherol and ascorbic acid on myocardial injury in patients undergoing cardiac operatiJ Thorac Cardiovasc Surg. 1997 May;113(5):942-8. Comment in: J Thorac Cardiovasc Surg. 1997 Dec;114(6):1127-8. Effect of preoperative supplementation with alpha-tocopherol and ascorbic acid on myocardial injury in patients undergoing cardiac operati

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44629

Study title: J Thorac Cardiovasc Surg. 1999 Feb;117(2):352-7. Surgical angioplasty of the main coronary arteries in children. Bonnet D, Bonhoeffer P, Sidi D, Kachaner J, Acar P, Villain E, VouhÃ© PR. J Thorac Cardiovasc Surg. 1999 Feb;117(2):352-7. Surgical angioplasty of the main coronary arteries in children. Bonnet D, Bonhoeffer P, Sidi D, Kachaner J, Acar P, Villain E, VouhÃ© PR.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44630

Study title: Jpn Circ J. 1981 Jan;45(1):148-58. The quantitative diagnosis of thallium-201 myocardial perfusion images and vectorcardiograms in myocardial infarction and hypertrophic cardiomyopathy. Watanabe Y, Yasui S, Inagaki H, Kawai N, Sotobata I. Jpn Circ J. 1981 Jan;45(1):148-58. The quantitative diagnosis of thallium-201 myocardial perfusion images and vectorcardiograms in myocardial infarction and hypertrophic cardiomyopathy. Watanabe Y, Yasui S, Inagaki H, Kawai N, Sotobata I.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44631

Study title: Clin Nucl Med. 1990 Sep;15(9):636-9. Cardiac sarcoidosis demonstrated by Tl-201 and Ga-67 SPECT imaging. Taki J, Nakajima K, Bunko H, Ohguchi M, Tonami N, Hisada K. Clin Nucl Med. 1990 Sep;15(9):636-9. Cardiac sarcoidosis demonstrated by Tl-201 and Ga-67 SPECT imaging. Taki J, Nakajima K, Bunko H, Ohguchi M, Tonami N, Hisada K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44546

Study title: Clin Nucl Med. 1991 Dec;16(12):931-5. Tl-201 uptake in brown tumors of hyperparathyroidism. Durak H, Aras T, Sungur C, Erbengi G, Bekdik CF. Clin Nucl Med. 1991 Dec;16(12):931-5. Tl-201 uptake in brown tumors of hyperparathyroidism. Durak H, Aras T, Sungur C, Erbengi G, Bekdik CF.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44547

Study title: Clin Nucl Med. 1993 Jul;18(7):551-7. The role of thallium scintigraphy in excluding malignancy in bone. Van der Wall H, Murray IP, Huckstep RL, Philips RL. Clin Nucl Med. 1993 Jul;18(7):551-7. The role of thallium scintigraphy in excluding malignancy in bone. Van der Wall H, Murray IP, Huckstep RL, Philips RL.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44551

Study title: Heart Vessels Suppl. 1985;1:111-5. Myocardial bioptic findings in correlation with TL-201 imaging and hemodynamic parameters in patients with latent cardiomyopathies suspected of having myocarditis. MÃ¼ller S, MÃ¼ller P, Meyer R, Volkmann H, Gottschild Heart Vessels Suppl. 1985;1:111-5. Myocardial bioptic findings in correlation with TL-201 imaging and hemodynamic parameters in patients with latent cardiomyopathies suspected of having myocarditis. MÃ¼ller S, MÃ¼ller P, Meyer R, Volkmann H, Gottschild

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44579

Study title: Heart Vessels. 1989;5(1):47-51. Long-term prognosis of Kawasaki disease patients with coronary artery obstruction. Tatara K, Kusakawa S, Itoh K, Kazuma N, Lee K, Hashimoto K, Shinohara T, Kondoh C, Hiroe M. Heart Vessels. 1989;5(1):47-51. Long-term prognosis of Kawasaki disease patients with coronary artery obstruction. Tatara K, Kusakawa S, Itoh K, Kazuma N, Lee K, Hashimoto K, Shinohara T, Kondoh C, Hiroe M.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44580

Study title: Efficacy of Thiobactin in the treatment of acute non tuberculosis lower respiratory tract infections in children

Active substance: THIAMPHENICOL

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Document reference: 44737

Study title: A multicentre, double-blind, placebo-controlled clinical trial with Muscoril® capsules and ampoules in orthopedic and post-traumatic disorders (PHX 89 00 101)

Active substance: THIOCOLCHICOSIDE

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

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Document reference: 44742

Study title: Clinical study (phase IV) in dossier MAA0051: A multicentre, randomised, double bind, placebo-controlled clinical trial with Muscoril® Capsules and Ampoulesin orthopedic and post-traumatic disorders (protocol PHX 89 00 101) - Blondin P, Derde MP- 1989

Active substance: THIOCOLCHICOSIDE

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Document reference: 44741

Study title: Comparative Efficacy and Safety of Muscoril® 4 mg BID Ampoules versus Placebo in Orthopedo-Traumatologic Pathologies : a Monocentre Double-Blind Randomised Clinical Trial

Active substance: THIOCOLCHICOSIDE

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

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Document reference: 44740

Study title: Controlled clinical researches on the activity and tolerability of different preparations of Muscoril (ampoules, capsules, cream, ointment) for the comparison with other active injectable preparation or with placebo per os and for local application, in patients with painful contractures of different origin STUDY MARIANI

Active substance: THIOCOLCHICOSIDE

Study summary document link (including results): Thiocolchicoside STUDY Mariani.xls

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Document reference: 47996

Study title: Jpn Circ J. 1982 Jul;46(7):715-24. Quantitative estimation of the right ventricular overloading by thallium-201 myocardial scintigraphy. Owada K, Machii K, Tsukahara Y, Awano N, Kijima M, Miyazaki Y, Ono K, Ebitani S, Muroi S, Ikeda K, Uchida T, KariyoJpn Circ J. 1982 Jul;46(7):715-24. Quantitative estimation of the right ventricular overloading by thallium-201 myocardial scintigraphy. Owada K, Machii K, Tsukahara Y, Awano N, Kijima M, Miyazaki Y, Ono K, Ebitani S, Muroi S, Ikeda K, Uchida T, Kariyo

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44632

Study title: Jpn Circ J. 1986 Dec;50(12):1275-9. Myocarditis with myocardial infarction like findings in a 3-year old girl. Tsukada K, Takemura N, Itoh K, Tatara K, Tahara K, Lee K, Kiguchi H, Kusakawa S. Jpn Circ J. 1986 Dec;50(12):1275-9. Myocarditis with myocardial infarction like findings in a 3-year old girl. Tsukada K, Takemura N, Itoh K, Tatara K, Tahara K, Lee K, Kiguchi H, Kusakawa S.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44633

Study title: Jpn Circ J. 2001 Feb;65(2):99-105. Thallium-201 single photon emission computed tomography (SPECT) in patients with duchenne's progressive muscular dystrophy: a histopathologic correlation study. Nishimura T, Yanagisawa A, Sakata H, Sakata K, ShimoyamaJpn Circ J. 2001 Feb;65(2):99-105. Thallium-201 single photon emission computed tomography (SPECT) in patients with duchenne's progressive muscular dystrophy: a histopathologic correlation study. Nishimura T, Yanagisawa A, Sakata H, Sakata K, Shimoyama

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44634

Study title: Jpn Heart J. 1985 May;26(3):413-23. Radionuclide imaging for assessment of myocarditis and postmyocarditic state in infant and children. Thallium-201 myocardial imaging and technetium-99m-HSA gated equilibrium ventriculography. Saji T, Matsuo N, HashiguJpn Heart J. 1985 May;26(3):413-23. Radionuclide imaging for assessment of myocarditis and postmyocarditic state in infant and children. Thallium-201 myocardial imaging and technetium-99m-HSA gated equilibrium ventriculography. Saji T, Matsuo N, Hashigu

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44635

Study title: Jpn Heart J. 1985 Sep;26(5):767-75. Evaluation of myocardial involvement in Duchenne's progressive muscular dystrophy with thallium-201 myocardial perfusion imaging. Kawai N, Sotobata I, Okada M, Iwase M, Yamamoto S, Matsushima H, Miyakoda H, Yokota M, Jpn Heart J. 1985 Sep;26(5):767-75. Evaluation of myocardial involvement in Duchenne's progressive muscular dystrophy with thallium-201 myocardial perfusion imaging. Kawai N, Sotobata I, Okada M, Iwase M, Yamamoto S, Matsushima H, Miyakoda H, Yokota M,

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44636

Study title: Safety of tiagabine: Summary of 53 trials ; IEGram LDeaton RSommerville KW Leppik, IE Leppik, Epilepsy Research 1999, 33(2-3): 235-246Safety of tiagabine: Summary of 53 trials ; IEGram LDeaton RSommerville KW Leppik, IE Leppik, Epilepsy Research 1999, 33(2-3): 235-246

Active substance: TIAGABINE

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Document reference: 38433

Study title: Studies on platelet functions and the protection of platelet consumption during extracorporeal circulation -Isomura - No dateStudies on platelet functions and the protection of platelet consumption during extracorporeal circulation -Isomura - No date

Active substance: TIAGABINE

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Document reference: 38478

Study title: Tclid. Acute and chronic pharmacokinetic study of ticlopidine hydrochloride in young and old normal subjects. Final report. ICM 1161/ CL 3690 - Gabuzda G. - 01/12/86Tclid. Acute and chronic pharmacokinetic study of ticlopidine hydrochloride in young and old normal subjects. Final report. ICM 1161/ CL 3690 - Gabuzda G. - 01/12/86

Active substance: TIAGABINE

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Document reference: 38480

Study title: Evaluation of the effects of L.A.N.D., phenylephrine, and vehicle control nasal sprays in children with acute and chronic rhinitis due to coryza or allergy.

Active substance: TRAMAZOLINE

Study summary document link (including results): Tramazoline Hydrochloride_U70-0222_synopsis.pdf

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Document reference: 46700

Study title: ULTRAM® tramadol HCl: Safety and efficacy in dental-extraction pain

Active substance: TRAMADOL

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Document reference: 44983

Study title: Int J Radiat Oncol Biol Phys. 1991 Mar;20(3):593-7. Blood flow of human soft tissue sarcomas measured by thallium-201 scanning: prediction of tumor response to radiation. Nishizawa K, Okunieff P, Elmaleh D, McKusick KA, Strauss HW, Suit HD. Int J Radiat Oncol Biol Phys. 1991 Mar;20(3):593-7. Blood flow of human soft tissue sarcomas measured by thallium-201 scanning: prediction of tumor response to radiation. Nishizawa K, Okunieff P, Elmaleh D, McKusick KA, Strauss HW, Suit HD.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44584

Study title: Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1503-6. Thallium-201 scintigraphy is not predictive of late cardiac complications in patients with Hodgkin's disease treated with mediastinal radiation. Girinsky T, Cordova A, Rey A, Cosset JM, Tertian G, PInt J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1503-6. Thallium-201 scintigraphy is not predictive of late cardiac complications in patients with Hodgkin's disease treated with mediastinal radiation. Girinsky T, Cordova A, Rey A, Cosset JM, Tertian G, P

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44585

Study title: Levocabastina contra cetirizina en ninBs con rinitis alCrgica perenne. Revista Alergia Mexico 45(3), p.7-11, 1998Levocabastina contra cetirizina en ninBs con rinitis alCrgica perenne. Revista Alergia Mexico 45(3), p.7-11, 1998

Active substance: LEVOCABASTINE

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Document reference: 31131

Study title: Levocabastine eye drops and nasal spray in seasonal allergic rhino conjunctivitis: a single-blind comparison with antazolineaphazoline eye drops and flunisolide nasal spray (17-54 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD43871_Interventional_Levocabastine.xls

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Document reference: 31094

Study title: Levocabastine eye drops in the treatment of vernal conjunctivitis: a double-blind comparison with placebo (5-59 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62491_Interventional_Levocabastine.xls

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Document reference: 31104

Study title: Data collection for observational study (AWB) on tolerability of thyme preparations in children up to 12 years

Active substance: Thyme , liquid extract (1:2-2,5)

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Document reference: 40256

Study title: Wirkung und Verträglichkeit von Tussamag Hustensaft bei Kindern mit akuter Bronchitis

Active substance: Thymi Extractum Fluidum

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Document reference: 40257

Study title: Acta Neurochir (Wien). 2005 Jul;147(7):795-9; discussion 799. Epub 2005 May 23. Incidentally detected parafalcine chondrosarcoma. Tosaka M, Fukasawa Y, Takahashi A, Sasaki A, Saito N Acta Neurochir (Wien). 2005 Jul;147(7):795-9; discussion 799. Epub 2005 May 23. Incidentally detected parafalcine chondrosarcoma. Tosaka M, Fukasawa Y, Takahashi A, Sasaki A, Saito N

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44485

Study title: Acta Radiol Suppl. 1992;378 ( Pt 3):51-70. Polar presentation of coronary angiography and thallium-201 single photon emission computed tomography. Studies of patients examined for heart disease. Svane B. Acta Radiol Suppl. 1992;378 ( Pt 3):51-70. Polar presentation of coronary angiography and thallium-201 single photon emission computed tomography. Studies of patients examined for heart disease. Svane B.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44486

Study title: Acta Radiol. 1989 Nov-Dec;30(6):561-74. Polar presentation of coronary angiography and thallium-201 single photon emission computed tomography. A method for comparing anatomic and pathologic findings in coronary angiography with isotope distribution in tActa Radiol. 1989 Nov-Dec;30(6):561-74. Polar presentation of coronary angiography and thallium-201 single photon emission computed tomography. A method for comparing anatomic and pathologic findings in coronary angiography with isotope distribution in t

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44487

Study title: Acta Radiol. 2001 Nov;42(6):548-54. Pre-operative grading of intracranial glioma. Lam WW, Chan KW, Wong WL, Poon WS, Metreweli C. Acta Radiol. 2001 Nov;42(6):548-54. Pre-operative grading of intracranial glioma. Lam WW, Chan KW, Wong WL, Poon WS, Metreweli C.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44488

Study title: Tiagabine therapy for complex partial seizures: A dose-frequency study RC Sachdeo, et al., RC Sachdeo, Archives of Neurology 1997, 54(5): 595-601Tiagabine therapy for complex partial seizures: A dose-frequency study RC Sachdeo, et al., RC Sachdeo, Archives of Neurology 1997, 54(5): 595-601

Active substance: TIAGABINE

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Document reference: 38436

Study title: Tiagabine. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential in the management of epilepsy ; JCNoble S Adkins & JC Adkins, JC Adkins, Drugs 1998, 55(3): 437-460Tiagabine. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential in the management of epilepsy ; JCNoble S Adkins & JC Adkins, JC Adkins, Drugs 1998, 55(3): 437-460

Active substance: TIAGABINE

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Document reference: 38435

Active substance: TIAGABINE

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Document reference: 38487

Study title: Clinical and Neurobiological findings in children suffering from tic disease following treatment with tiapride - Eggers C. et al. - 1988 (Eur Arch Psychiatry Neurol Sci.;237(4):223-9)

Active substance: TIAPRIDE

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Document reference: 44743

Study title: Anticancer Res. 2000 Sep-Oct;20(5C):3967-70. Assessment of chemosensitivity in patients with malignant bone and soft tissue tumors using thallium-201 scintigraphy and doxorubicin binding assay. Murata H, Kusuzaki K, Takeshita H, Hirata M, Hashiguchi S, Anticancer Res. 2000 Sep-Oct;20(5C):3967-70. Assessment of chemosensitivity in patients with malignant bone and soft tissue tumors using thallium-201 scintigraphy and doxorubicin binding assay. Murata H, Kusuzaki K, Takeshita H, Hirata M, Hashiguchi S,

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44517

Study title: Med Pediatr Oncol. 1998 May;30(5):297-300. Misleading leads. Thallium-201 uptake in rebound thymic hyperplasia. Roebuck DJ, Nicholls WD, Bernard EJ, Kellie SJ, Howman-Giles R. Med Pediatr Oncol. 1998 May;30(5):297-300. Misleading leads. Thallium-201 uptake in rebound thymic hyperplasia. Roebuck DJ, Nicholls WD, Bernard EJ, Kellie SJ, Howman-Giles R.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44663

Study title: Neurol Med Chir (Tokyo). 1997 Aug;37(8):594-9. Thallium-201 single photon emission computed tomography imaging of meningioma cells in hyperostosis. Mori K, Cho K, Suda K, Ishimaru S, Maeda M. Neurol Med Chir (Tokyo). 1997 Aug;37(8):594-9. Thallium-201 single photon emission computed tomography imaging of meningioma cells in hyperostosis. Mori K, Cho K, Suda K, Ishimaru S, Maeda M.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44665

Study title: Neuromuscul Disord. 2001 Jul;11(5):464-9. Depressed myocardial fatty acid metabolism in patients with muscular dystrophy. Momose M, Iguchi N, Imamura K, Usui H, Ueda T, Miyamoto K, Inaba S. Neuromuscul Disord. 2001 Jul;11(5):464-9. Depressed myocardial fatty acid metabolism in patients with muscular dystrophy. Momose M, Iguchi N, Imamura K, Usui H, Ueda T, Miyamoto K, Inaba S.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44666

Study title: Neurosurg Rev. 2005 Apr;28(2):96-103. Epub 2004 Dec 3. 201Tl-SPECT and 1H-MRS study of benign lateral ventricle tumors: differential diagnosis of subependymoma. Kawaguchi T, Kumabe T, Shimizu H, Watanabe M, Tominaga T Neurosurg Rev. 2005 Apr;28(2):96-103. Epub 2004 Dec 3. 201Tl-SPECT and 1H-MRS study of benign lateral ventricle tumors: differential diagnosis of subependymoma. Kawaguchi T, Kumabe T, Shimizu H, Watanabe M, Tominaga T

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44667

Study title: Neurosurgery. 1999 Jul;45(1):183-7; discussion 187. Thallium-201 single-photon emission computed tomographic and proton magnetic resonance spectroscopic characteristics of intracranial ganglioglioma: three technical case reports. Kumabe T, Shimizu H, SoNeurosurgery. 1999 Jul;45(1):183-7; discussion 187. Thallium-201 single-photon emission computed tomographic and proton magnetic resonance spectroscopic characteristics of intracranial ganglioglioma: three technical case reports. Kumabe T, Shimizu H, So

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44668

Study title: Nippon Igaku Hoshasen Gakkai Zasshi. 1989 Dec 25;49(12):1567-72. [Clinical evaluation of Tl-201 ECG-gated myocardial SPECT--comparison with ECG-gated blood pool SPECT] [Article in Japanese] Mochizuki T. Nippon Igaku Hoshasen Gakkai Zasshi. 1989 Dec 25;49(12):1567-72. [Clinical evaluation of Tl-201 ECG-gated myocardial SPECT--comparison with ECG-gated blood pool SPECT] [Article in Japanese] Mochizuki T.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44669

Study title: COMPARE EFFICACY OF PROPHYLACTIC PREOPERATIVE DOSES OF FASIGYN 500 AND METROGYL AS ADJUNCTS TO ANTIMICROBIAL REGIMENS OF AMPICILLIN AND/OR GENTAMICIN IN ELECTIVE INTRAABDOMINAL OR PELVIC SURGERY.

Active substance: TINIDAZOLE

Study summary document link (including results): TND-II-88-003 EMEA Pediatrics Web Synopsis.pdf

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Document reference: 44775

Study title: Levocabastine nasal spray in the treatment of perennial rhinitis: a double-blind comparison with placebo following by an open comparison with beclomethasone (6.5-70 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62486_Interventional_Levocabastine.xls

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Document reference: 31083

Study title: Levocabastine nasal spray in the treatment of rhinitis in asthmatic children: a double-blind comparison with placebo (6-15 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62485_Interventional_Levocabastine.xls

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Document reference: 31077

Study title: Levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a single-blind comparison with beclomethasone and placebo (12-50 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62488_Interventional_Levocabastine.xls

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Document reference: 31080

Study title: Metabolic aspects of myocardial disease and a role for L-carnitine in the tratment of childhood cardiomyopathy. Helton E, Darragh R, Francis P, Fricker FJ, Jue K, Koch G, Mair D, Pierpont ME, Prochazka JV, Linn LS, Winter SC. Pediatrics. 2000 Jun; 105(6):1260-70. Metabolic aspects of myocardial disease and a role for L-carnitine in the tratment of childhood cardiomyopathy. Helton E, Darragh R, Francis P, Fricker FJ, Jue K, Koch G, Mair D, Pierpont ME, Prochazka JV, Linn LS, Winter SC. Pediatrics. 2000 Jun; 105(6):1260-70.

Active substance: LEVOCABASTINE

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Document reference: 31140

Study title: Onset of action, effectiveness and tolerance of levocabastine and nedocromil in topical therapy of seasonal allergic rhinoconjunctivitis. Arzneirnittel-Forschung 48(II) (9), p.925-930, 1998Onset of action, effectiveness and tolerance of levocabastine and nedocromil in topical therapy of seasonal allergic rhinoconjunctivitis. Arzneirnittel-Forschung 48(II) (9), p.925-930, 1998

Active substance: LEVOCABASTINE

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Document reference: 31128

Study title: Oral treatment of perennial allergic rhinitis with R 50 547. A 2-week double-blind placebo-controlled study (16-75 yrs)

Active substance: LEVOCABASTINE

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Document reference: 31072

Study title: AJNR Am J Neuroradiol. 1996 May;17(5):925-32. Preoperative grading of glioma malignancy with thallium-201 single-photon emission CT: comparison with conventional CT. KÃ¤llÃ©n K, Heiling M, Andersson AM, Brun A, HoltÃ¥s S, Ryding E. AJNR Am J Neuroradiol. 1996 May;17(5):925-32. Preoperative grading of glioma malignancy with thallium-201 single-photon emission CT: comparison with conventional CT. KÃ¤llÃ©n K, Heiling M, Andersson AM, Brun A, HoltÃ¥s S, Ryding E.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44490

Study title: AJNR Am J Neuroradiol. 1998 May;19(5):801-6. Comment in: AJNR Am J Neuroradiol. 1998 May;19(5):807-9. AJNR Am J Neuroradiol. 1998 May;19(5):810. AJNR Am J Neuroradiol. 1998 May;19(5):811. Cerebral gangliogliomas: preoperative grading using FDGAJNR Am J Neuroradiol. 1998 May;19(5):801-6. Comment in: AJNR Am J Neuroradiol. 1998 May;19(5):807-9. AJNR Am J Neuroradiol. 1998 May;19(5):810. AJNR Am J Neuroradiol. 1998 May;19(5):811. Cerebral gangliogliomas: preoperative grading using FDG

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44491

Study title: AJNR Am J Neuroradiol. 2000 May;21(5):901-9. Posttherapeutic intraaxial brain tumor: the value of perfusion-sensitive contrast-enhanced MR imaging for differentiating tumor recurrence from nonneoplastic contrast-enhancing tissue. Sugahara T, Korogi Y, TAJNR Am J Neuroradiol. 2000 May;21(5):901-9. Posttherapeutic intraaxial brain tumor: the value of perfusion-sensitive contrast-enhanced MR imaging for differentiating tumor recurrence from nonneoplastic contrast-enhancing tissue. Sugahara T, Korogi Y, T

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44492

Study title: Phase 3, randomized, double-blind, placebo-controlled, parallel study with an open-label extension designed to evaluate the safety and efficacy of topiramate in subjects 6 to 15 years of age who had headache symptoms that met the proposed IHS Classification of Pediatric Migraine with or without aura.

Active substance: TOPIRAMATE

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Document reference: 44935

Study title: Anticancer Res. 2003 Jul-Aug;23(4):3513-6. Differentiating recurrent or residual nasopharyngeal carcinomas from post-radiotherapy changes with 18-fluoro-2-deoxyglucose positron emission tomography and thallium-201 single photon emission computed tomograpAnticancer Res. 2003 Jul-Aug;23(4):3513-6. Differentiating recurrent or residual nasopharyngeal carcinomas from post-radiotherapy changes with 18-fluoro-2-deoxyglucose positron emission tomography and thallium-201 single photon emission computed tomograp

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44518

Study title: Arch Fr Pediatr. 1993 Oct;50(8):653-6. [Left ventricular involvement in mucoviscidosis after 2 years of age] [Article in French] Ambrosi P, Chazalettes JP, Viard L, Raynaud M, Faugere G, Noirclerc M, Bernard PJ. Arch Fr Pediatr. 1993 Oct;50(8):653-6. [Left ventricular involvement in mucoviscidosis after 2 years of age] [Article in French] Ambrosi P, Chazalettes JP, Viard L, Raynaud M, Faugere G, Noirclerc M, Bernard PJ.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44519

Study title: Arch Intern Med. 1992 Apr;152(4):769-72. Utility of various radionuclide techniques for distinguishing ischemic from nonischemic dilated cardiomyopathy. Glamann DB, Lange RA, Corbett JR, Hillis LD. Arch Intern Med. 1992 Apr;152(4):769-72. Utility of various radionuclide techniques for distinguishing ischemic from nonischemic dilated cardiomyopathy. Glamann DB, Lange RA, Corbett JR, Hillis LD.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44520

Study title: Arch Mal Coeur Vaiss. 1997 May;90(5):631-7. [Alteration of myocardial viability and systemic ventricular dysfunction after Senning procedure] [Article in French] LabbÃ© L, Douard H, Barat JL, Broustet JP, Bordenave L, Ducassou D, Valli N, Jimenez M, BaArch Mal Coeur Vaiss. 1997 May;90(5):631-7. [Alteration of myocardial viability and systemic ventricular dysfunction after Senning procedure] [Article in French] LabbÃ© L, Douard H, Barat JL, Broustet JP, Bordenave L, Ducassou D, Valli N, Jimenez M, Ba

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44522

Study title: Arch Mal Coeur Vaiss. 2003 May;96(5):507-10. [Abnormalities of myocardial perfusion in sickle cell disease in childhood: a study of myocardial scintigraphy] [Article in French] Acar P, Maunoury C, de Montalembert M, Dulac Y. Arch Mal Coeur Vaiss. 2003 May;96(5):507-10. [Abnormalities of myocardial perfusion in sickle cell disease in childhood: a study of myocardial scintigraphy] [Article in French] Acar P, Maunoury C, de Montalembert M, Dulac Y.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44523

Study title: EVALUATE EFFICACY AND TOLERATION OF FASIGYN 500 MG IN SYMPTOMATIC INTESTINAL AMEBIASIS.

Active substance: TINIDAZOLE

Study summary document link (including results): TND-II-88-001 EMEA Pediatrics Web Synopsis.pdf

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Document reference: 44773

Study title: Clin Nucl Med. 1994 Nov;19(11):975-8. Resting Tl-201 scintigraphy in the evaluation of coronary artery disease in children with Hurler syndrome. du Cret RP, Weinberg EJ, Jackson CA, Braunlin EA, Boudreau RJ, Kuni CC, Carpenter BM, Hunter DW, Krivit W, BClin Nucl Med. 1994 Nov;19(11):975-8. Resting Tl-201 scintigraphy in the evaluation of coronary artery disease in children with Hurler syndrome. du Cret RP, Weinberg EJ, Jackson CA, Braunlin EA, Boudreau RJ, Kuni CC, Carpenter BM, Hunter DW, Krivit W, B

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44552

Study title: Results of the treatment of the seasonal pollinosis allergic rhinitis with topical preparations Livostin, Bicromat and Vibrocil. Allergy 52(37) (suppl.), p.200-201, 1997Results of the treatment of the seasonal pollinosis allergic rhinitis with topical preparations Livostin, Bicromat and Vibrocil. Allergy 52(37) (suppl.), p.200-201, 1997

Active substance: LEVOCABASTINE

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Document reference: 31127

Study title: Double-blind comparison of levocabastine eye drops with placebo in patients with seasonal allergic conjunctivitis: a Belgian multicentre study (5-67 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62497_Interventional_Levocabastine.xls

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Document reference: 31103

Study title: Double-blind comparison of levocabastine eye drops with sodium cromoglycate and placebo in the topical treatment of seasonal allergic conjunctivitis (9-55 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62496_Interventional_Levocabastine.xls

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Document reference: 31100

Study title: Double-blind comparison of levocabastine eye drops with sodium cromoglycate in the topical treatment of season allergic conjunctivitis (9-54 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD59785_Interventional_Levocabastine.xls

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Document reference: 31098

Study title: Double-blind comparison of levocabastine nasal spray with sodium cromoglycate nasal spray in the treatment of seasonal allergic rhinitis (11-50 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62483_Interventional_Levocabastine.xls

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Document reference: 31090

Study title: Double-blind placebo-controlled evaluation of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a Belgian multicentre study (5-64 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62489_Interventional_Levocabastine.xls

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Document reference: 31085

Study title: Double-blind placebo-controlled evaluation of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a Dutch multicentre study (9-52 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62500_Interventional_Levocabastine.xls

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Document reference: 31086

Study title: J Clin Neurosci. 2002 Nov;9(6):653-8. Comparison of thallium-201 uptake and retention indices for evaluation of brain lesions with SPECT. Katano H, Karasawa K, Sugiyama N, Yamashita N, Ohkura A, Watanabe K, Kamiya K. J Clin Neurosci. 2002 Nov;9(6):653-8. Comparison of thallium-201 uptake and retention indices for evaluation of brain lesions with SPECT. Katano H, Karasawa K, Sugiyama N, Yamashita N, Ohkura A, Watanabe K, Kamiya K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44602

Study title: J Clin Neurosci. 2005 Jan;12(1):27-31. Thallium-201 versus Tc99m-glucoheptonate SPECT for evaluation of recurrent brain tumours: a within-subject comparison with pathological correlation. Barai S, Rajkamal , Bandopadhayaya GP, Pant GS, Haloi AK, MalhotJ Clin Neurosci. 2005 Jan;12(1):27-31. Thallium-201 versus Tc99m-glucoheptonate SPECT for evaluation of recurrent brain tumours: a within-subject comparison with pathological correlation. Barai S, Rajkamal , Bandopadhayaya GP, Pant GS, Haloi AK, Malhot

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44603

Study title: J Clin Oncol. 1999 Feb;17(2):554-60. Value of combined approach with thallium-201 single-photon emission computed tomography and Epstein-Barr virus DNA polymerase chain reaction in CSF for the diagnosis of AIDS-related primary CNS lymphoma. Antinori A, J Clin Oncol. 1999 Feb;17(2):554-60. Value of combined approach with thallium-201 single-photon emission computed tomography and Epstein-Barr virus DNA polymerase chain reaction in CSF for the diagnosis of AIDS-related primary CNS lymphoma. Antinori A,

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44604

Study title: J Neurol Neurosurg Psychiatry. 1997 Nov;63(5):569-74. Evaluation of malignancy in ring enhancing brain lesions on CT by thallium-201 SPECT. KÃ¤llÃ©n K, Heiling M, Andersson AM, Brun A, HoltÃ¥s S, Ryding E, RosÃ©n I. J Neurol Neurosurg Psychiatry. 1997 Nov;63(5):569-74. Evaluation of malignancy in ring enhancing brain lesions on CT by thallium-201 SPECT. KÃ¤llÃ©n K, Heiling M, Andersson AM, Brun A, HoltÃ¥s S, Ryding E, RosÃ©n I.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44605

Study title: Relief of posttonsillectomy pain with low-dose tramadol given at induction of anaesthesia in children - Özköse and Coll. - 2000 (Int. J. Pediatr. Otorhinolaryngol., 2000, 53: 207-214)Relief of posttonsillectomy pain with low-dose tramadol given at induction of anaesthesia in children - Özköse and Coll. - 2000 (Int. J. Pediatr. Otorhinolaryngol., 2000, 53: 207-214)

Active substance: TRAMADOL

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Document reference: 45035

Study title: Jpn Heart J. 1993 Jan;34(1):51-61. Evaluation of myocardial damage in Duchenne's muscular dystrophy with thallium-201 myocardial SPECT. Tamura T, Shibuya N, Hashiba K, Oku Y, Mori H, Yano K. Jpn Heart J. 1993 Jan;34(1):51-61. Evaluation of myocardial damage in Duchenne's muscular dystrophy with thallium-201 myocardial SPECT. Tamura T, Shibuya N, Hashiba K, Oku Y, Mori H, Yano K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44638

Study title: Clin Nucl Med. 1995 Jul;20(7):601-4. Detection of a 2.1 cm hepatocellular carcinoma in an 11-year-old boy by Tl-201 chloride. Case presentation and correlative imaging findings. Kempf JS, Abdel-Dayem H. Clin Nucl Med. 1995 Jul;20(7):601-4. Detection of a 2.1 cm hepatocellular carcinoma in an 11-year-old boy by Tl-201 chloride. Case presentation and correlative imaging findings. Kempf JS, Abdel-Dayem H.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44553

Study title: Clin Nucl Med. 1997 Dec;22(12):835-7. Tl-201 positive, Ga-67 negative hepatoblastoma: a case report of a 12-year-old boy. Bernard EJ, Nicholls W, Howman-Giles R, Kan A, Stevens M Clin Nucl Med. 1997 Dec;22(12):835-7. Tl-201 positive, Ga-67 negative hepatoblastoma: a case report of a 12-year-old boy. Bernard EJ, Nicholls W, Howman-Giles R, Kan A, Stevens M

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44554

Study title: Clin Nucl Med. 1997 Nov;22(11):752-5. Thallium-201 SPECT in differentiating bone infarction from metastatic lesions in osteosarcoma. Hori A, Sumiya H, Taki J, Tonami N, Tsuchiya H, Tomita K. Clin Nucl Med. 1997 Nov;22(11):752-5. Thallium-201 SPECT in differentiating bone infarction from metastatic lesions in osteosarcoma. Hori A, Sumiya H, Taki J, Tonami N, Tsuchiya H, Tomita K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44555

Study title: Clin Nucl Med. 2000 Jan;25(1):56. Bilateral increased Tl-201 uptake of lacrimal glands caused by crying of a child during injection. Capa G, DeÄŸirmenci B, Durak H. Clin Nucl Med. 2000 Jan;25(1):56. Bilateral increased Tl-201 uptake of lacrimal glands caused by crying of a child during injection. Capa G, DeÄŸirmenci B, Durak H.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44557

Study title: Clin Nucl Med. 2000 Jan;25(1):77-8. Detection of Coxsackie B2 virus myocarditis in a neonate using Tl-201 and I-123 BMIPP myocardial imaging. Sawada T, Kohno Y, Ikegami H, Tsujii H, Ikuta H, Okabe H, Sugihara H. Clin Nucl Med. 2000 Jan;25(1):77-8. Detection of Coxsackie B2 virus myocarditis in a neonate using Tl-201 and I-123 BMIPP myocardial imaging. Sawada T, Kohno Y, Ikegami H, Tsujii H, Ikuta H, Okabe H, Sugihara H.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44558

Study title: Clin Nucl Med. 2003 Jul;28(7):591-3. Bizarre parosteal osteochondromatous proliferation detected by Tl-201 scintigraphy. Mackie GC. Clin Nucl Med. 2003 Jul;28(7):591-3. Bizarre parosteal osteochondromatous proliferation detected by Tl-201 scintigraphy. Mackie GC.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44560

Active substance: Traumeel - Ampullen

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Document reference: 40283

Study title: Double-blind, placebo-controlled, dose-response study of levocabastine nasal spray in the treatment of seasonal allergic rhinitis (11-65 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62490_Interventional_Levocabastine.xls

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Document reference: 31082

Study title: Efficacy and safety of carebastine compared to levocabastine, both nasal sprays, in the management of seasonal allergic rhinitis. Annual Meeting of the European Academy of Allergology and Clinical Immunology, Lisbon, Portugal, July 1-5,2000Efficacy and safety of carebastine compared to levocabastine, both nasal sprays, in the management of seasonal allergic rhinitis. Annual Meeting of the European Academy of Allergology and Clinical Immunology, Lisbon, Portugal, July 1-5,2000

Active substance: LEVOCABASTINE

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Document reference: 31117

Active substance: LEVOCABASTINE

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Document reference: 31133

Study title: Efficacy of topical levocabastine in the treatment of allergic rhinitis. Korean Journal of Rhinology 3(1), p.58-65, 1996Efficacy of topical levocabastine in the treatment of allergic rhinitis. Korean Journal of Rhinology 3(1), p.58-65, 1996

Active substance: LEVOCABASTINE

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Document reference: 31121

Active substance: LEVOCABASTINE

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Document reference: 31122

Study title: Eosinophil cationic protein (ECP) and tryptase in the nasal lavage fluid (NLF) of children with grass pollen rhinitis: levocabastine effect. Allergy and Asthma Proceedings 19(2), p.75-80, 1998Eosinophil cationic protein (ECP) and tryptase in the nasal lavage fluid (NLF) of children with grass pollen rhinitis: levocabastine effect. Allergy and Asthma Proceedings 19(2), p.75-80, 1998

Active substance: LEVOCABASTINE

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Document reference: 31120

Study title: J Nucl Med. 1981 Oct;22(10):849-55. Clinical evaluation of thallium-201 emission myocardial tomography using a rotating gamma camera: comparison with seven-pinhole tomography. Tamaki N, Mukai T, Ishii Y, Yonekura Y, Kambara H, Kawai C, Torizuka K. J Nucl Med. 1981 Oct;22(10):849-55. Clinical evaluation of thallium-201 emission myocardial tomography using a rotating gamma camera: comparison with seven-pinhole tomography. Tamaki N, Mukai T, Ishii Y, Yonekura Y, Kambara H, Kawai C, Torizuka K.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44607

Study title: J Nucl Med. 1990 May;31(5):567-72. Thallium-201 scintigraphy in bone sarcoma: comparison with gallium-67 and technetium-MDP in the evaluation of chemotherapeutic response. Ramanna L, Waxman A, Binney G, Waxman S, Mirra J, Rosen G. J Nucl Med. 1990 May;31(5):567-72. Thallium-201 scintigraphy in bone sarcoma: comparison with gallium-67 and technetium-MDP in the evaluation of chemotherapeutic response. Ramanna L, Waxman A, Binney G, Waxman S, Mirra J, Rosen G.

Active substance: THALLIUM 201T1 CHLORIDE

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Document reference: 44609

Study title: Hoefnagel et al. 131I-MIBG as a first-line treatment in high-risk neuroblastoma patients, Nuclear medicine communications (1994), 15(9), 712-7

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48319

Study title: Michel G et al. Use of recombinant human granulocyte colony-stimulating factor to increase chemotherapy dose-intensity: a randomized trial in very high-risk childhood acute lymphoblastic leukemia. J Clin Oncol. 2000 Apr;18(7):1517-24Michel G et al. Use of recombinant human granulocyte colony-stimulating factor to increase chemotherapy dose-intensity: a randomized trial in very high-risk childhood acute lymphoblastic leukemia. J Clin Oncol. 2000 Apr;18(7):1517-24

Active substance: MITOXANTRONE

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Document reference: 32211

Study title: Milano GM et al High histologic and overall response to dose intensification of ifosfamide, carboplatin, and etoposide with cyclophosphamide, doxorubicin, and vincristine in patients with high-risk Ewing sarcoma family tumors: the Bambino Gesù Children's Hospital experience Cancer. 2006 Apr 15;106(8):1838-45. Erratum in: Cancer. 2006 Sep 15;107(6):1421Milano GM et al High histologic and overall response to dose intensification of ifosfamide, carboplatin, and etoposide with cyclophosphamide, doxorubicin, and vincristine in patients with high-risk Ewing sarcoma family tumors: the Bambino Gesù Children's Hospital experience Cancer. 2006 Apr 15;106(8):1838-45. Erratum in: Cancer. 2006 Sep 15;107(6):1421

Active substance: MITOXANTRONE

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Document reference: 32093

Study title: Milpied N et al. Initial treatment of aggressive lymphoma with high-dose chemotherapy and autologous stem-cell support. N Engl J Med. 2004 Mar 25;350(13):1287-95Milpied N et al. Initial treatment of aggressive lymphoma with high-dose chemotherapy and autologous stem-cell support. N Engl J Med. 2004 Mar 25;350(13):1287-95

Active substance: MITOXANTRONE

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Document reference: 32248

Study title: Gschnait F. [Oral photochemotherapy (author's transl)], Wien Klin Wochenschr Suppl. 1977;75:1-30.Gschnait F. [Oral photochemotherapy (author's transl)], Wien Klin Wochenschr Suppl. 1977;75:1-30.

Active substance: METHOZSALEN

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Document reference: 31715

Study title: Langner A. Comparison of the effectiveness of 5-Methoxypsoralen and 8-Methoxypsoralen in photochemotherapy (PUVA) Przegl Dermatol 1991; 21-25.Langner A. Comparison of the effectiveness of 5-Methoxypsoralen and 8-Methoxypsoralen in photochemotherapy (PUVA) Przegl Dermatol 1991; 21-25.

Active substance: METHOZSALEN

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Document reference: 31716

Study title: Metz D. [Photochemotherapy of psoriasis using 8-MOP and UVA. Results of interval treatment. Clinical experiences from 6 dermatology hospitals], Dermatol Monatsschr. 1980 Jun;166(6):415-7.Metz D. [Photochemotherapy of psoriasis using 8-MOP and UVA. Results of interval treatment. Clinical experiences from 6 dermatology hospitals], Dermatol Monatsschr. 1980 Jun;166(6):415-7.

Active substance: METHOZSALEN

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Document reference: 31714

Study title: Oesterwitz H. Photochemical donor pretreatment in clinical kidney transplantation--preliminary report, Urol Res. 1987;15(4):211-3.Oesterwitz H. Photochemical donor pretreatment in clinical kidney transplantation--preliminary report, Urol Res. 1987;15(4):211-3.

Active substance: METHOZSALEN

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Document reference: 31723

Study title: Ruszczak Z. [Immunological findings in photochemotherapy of psoriasis][Article in German], Dermatol Monatsschr. 1982 Sep;168(9):598-607.Ruszczak Z. [Immunological findings in photochemotherapy of psoriasis][Article in German], Dermatol Monatsschr. 1982 Sep;168(9):598-607.

Active substance: METHOZSALEN

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Document reference: 31718

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2003

Active substance: METAMIZOLE

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Document reference: 31702

Study title: Disposition kinetics of metronidazole in children - AmonI; et al. - 1983 - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommendation for use in children also included - 12/1985Disposition kinetics of metronidazole in children - AmonI; et al. - 1983 - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommendation for use in children also included - 12/1985

Active substance: METRONIDAZOLE

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Document reference: 31967

Study title: Metronidazole FLAGYL injection 0.5% v/v. Adverse reactions.

Active substance: METRONIDAZOLE

Study summary document link (including results): Metronidazole STUDY Safety Review.xls

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Document reference: 48000

Study title: 107.208 - A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis.

Active substance: MELOXICAM

Study summary document link (including results): Meloxicam_U03-1727_synopsis.pdf

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Document reference: 31592

Study title: A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis.

Active substance: MELOXICAM

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Document reference: 31594

Active substance: MELOXICAM

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Document reference: 31595

Active substance: MELOXICAM

Study summary document link (including results): Meloxicam_U03-1429_synopsis.pdf

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Document reference: 31596

Active substance: MELOXICAM

Study summary document link (including results): Meloxicam_U00-1093_synopsis.pdf

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Document reference: 31593

Study title: The effect of methylperon (Eunerpan) on aggressive and auto-aggressive behaviour in mentally retarded patients--a double blind study (author's transl)a

Active substance: MELPERONE

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Document reference: 31602

Study title: Nathan PC et al Adjuvant chemotherapy for the treatment of advanced pediatric nonrhabdomyosarcomasoft tissue sarcoma: the National Cancer Institute experience Pediatr Blood Cancer. 2005 May;44(5):449-54Nathan PC et al Adjuvant chemotherapy for the treatment of advanced pediatric nonrhabdomyosarcomasoft tissue sarcoma: the National Cancer Institute experience Pediatr Blood Cancer. 2005 May;44(5):449-54

Active substance: MITOXANTRONE

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Document reference: 32167

Study title: Navid F et al Concomitant administration of vincristine, doxorubicin, cyclophosphamide,ifosfamide, and etoposide for high-risk sarcomas: the St. Jude Children's Research Hospital experience Cancer. 2006 Apr 15;106(8):1846-56Navid F et al Concomitant administration of vincristine, doxorubicin, cyclophosphamide,ifosfamide, and etoposide for high-risk sarcomas: the St. Jude Children's Research Hospital experience Cancer. 2006 Apr 15;106(8):1846-56

Active substance: MITOXANTRONE

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Document reference: 32158

Study title: No study title available; Nineteen infants, between the age from 25 days and 2 years, having acute watery diarrhoea.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD79083_Noninterventional_Loperamide hydrochloride.xls

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Document reference: 31434

Study title: A double blind placebo-controlled study of lithium in hospitalized aggressive children and adolescents with conduct disorder. - Malone R, Delaney M, Luebbert J, et al (2000) - (Arch Gen Psychiatry 57:649-54)A double blind placebo-controlled study of lithium in hospitalized aggressive children and adolescents with conduct disorder. - Malone R, Delaney M, Luebbert J, et al (2000) - (Arch Gen Psychiatry 57:649-54)

Active substance: LITHIUM

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Document reference: 31302

Study title: A prospective 4-5 year follow up of juvenile onset bipolar disorder. - Jairam R, Srinath S, Girimaji, SC, Seshadri SP (2004) - (Bipolar Disorder 6:386-394)A prospective 4-5 year follow up of juvenile onset bipolar disorder. - Jairam R, Srinath S, Girimaji, SC, Seshadri SP (2004) - (Bipolar Disorder 6:386-394)

Active substance: LITHIUM

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Document reference: 31303

Study title: A systematic chart review of the naturalistic course and treatment of early-onset bipolar disorder in a child and adolescent psychiatry center. - Rajeev J, Srinath S, Girimaji S, et al. (2004) - (Compr. Psychiatry 45:148-54)A systematic chart review of the naturalistic course and treatment of early-onset bipolar disorder in a child and adolescent psychiatry center. - Rajeev J, Srinath S, Girimaji S, et al. (2004) - (Compr. Psychiatry 45:148-54)

Active substance: LITHIUM

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Document reference: 31304

Study title: Elevated thyrotropin in bipolar youths prescribed both lithium and divalproex sodium. - Gracious BL, Findling RL, Seman C et al (2004) - (J AM Acad Child Adolesc Psychiatry 43:215-20)Elevated thyrotropin in bipolar youths prescribed both lithium and divalproex sodium. - Gracious BL, Findling RL, Seman C et al (2004) - (J AM Acad Child Adolesc Psychiatry 43:215-20)

Active substance: LITHIUM

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Document reference: 31307

Study title: Pharmacokinetics and tissue distribution of metronidazole in the newborn infant - Jager.Roman, E. et al. - 1982 - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommandation for use in children also included - 12/1985Pharmacokinetics and tissue distribution of metronidazole in the newborn infant - Jager.Roman, E. et al. - 1982 - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommandation for use in children also included - 12/1985

Active substance: METRONIDAZOLE

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Document reference: 31968

Study title: Single day prophylaxis with metronidazole in infants during abdominal surgery: a pharmacokinetic surgery - Rubenson A., Rosetzsky A. - No date - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommandation for use in children also included - 12/1985Single day prophylaxis with metronidazole in infants during abdominal surgery: a pharmacokinetic surgery - Rubenson A., Rosetzsky A. - No date - Publication in Human pharmacological and clinical documentation in support for a change of dosage for prophylaxis and treatment of anaerobic infections. Dose recommandation for use in children also included - 12/1985

Active substance: METRONIDAZOLE

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Document reference: 31972

Study title: 1-a-hydroxyvitamin D in Nutritional Rickets Glasgow J.R.T., and Reid M. One-Alpha-hydroxyvitamin D in Nutritional Rickets The Lancet (1977) iii, 3021-a-hydroxyvitamin D in Nutritional Rickets Glasgow J.R.T., and Reid M. One-Alpha-hydroxyvitamin D in Nutritional Rickets The Lancet (1977) iii, 302

Active substance: ALFACALCIDOL

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Document reference: 46331

Study title:

Active substance: ACICLOVIR

Study summary document link (including results): Study BKCT-86-003 Aciclovir.xls

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Document reference: 47637

Study title: Open-label study; Children aged between 5 and 14 years with acute diarrhea due to viral infection or food allergy

Active substance: LOPERAMIDE

Study summary document link (including results): LMD5513_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31409

Study title: Open-label, placebo-control study.; Male children between the age of 6 and 36 months with a history of diarrhoea who were at least 5% dehydrated clinically.

Active substance: LOPERAMIDE

Study summary document link (including results): LMD67655_Interventional_Loperamide Hydrochloride.xls

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Document reference: 31435

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

Active substance: LORATADINE

Study summary document link (including results): Claritine_Clarityn Syrup_Loratadine_P00677.pdf

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Document reference: 31464

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

Active substance: LORATADINE

Study summary document link (including results): Claritine_Clarityn Syrup_Loratadine_P00687.pdf

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Document reference: 31465

Study title: LORATADINE SYRUP FOR CHILDREN 2 - 5 YEARS OLD

Active substance: LORATADINE

Study summary document link (including results): Claritine_Clarityn Syrup_Loratadine_C98566.pdf

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Document reference: 31461

Study title: SCH 29851: SINGLE DOSE BIOAVAILABILITY OF LORATADINE IN HEALTHY PEDIATRIC VOLUNTEERS

Active substance: LORATADINE

Study summary document link (including results): Claritine_Clarityn Syrup_Loratadine_C97033.pdf

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Document reference: 31460

Study title: SCH 29851: Single-Dose Bioavailability of Loratadine Syrup in Pediatric Volunteers 6 Months to 2 Years of Age

Active substance: LORATADINE

Study summary document link (including results): Claritine_Clarityn Syrup_Loratadine_P00241.pdf

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Document reference: 31462

Study title: Determination of lormetazepam and glucuronide in plasma and milk in mothers and in plasma of babies, women 2 - 3 days after delivery p.o. for 10 days

Active substance: LORMETAZEPAM

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Document reference: 31469

Study title: Intraoperative tolerance of lormetazepam I.V. (intravenous) in infants, children and adolescents

Active substance: LORMETAZEPAM

Study summary document link (including results): Bayer Pharma_Lormetazepam_80011_study_synopsis.pdf

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Document reference: 31468

Study title: Trial of prostaglandin-synthetase inhibitors in primary dysmenorrhoea.; Anderson AB et al. , Lancet. 1978 Feb 18;1(8060):345-8.Trial of prostaglandin-synthetase inhibitors in primary dysmenorrhoea.; Anderson AB et al. , Lancet. 1978 Feb 18;1(8060):345-8.

Active substance: MEFENAMIC ACID

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Document reference: 31580

Study title:

Active substance: MELOXICAM

Study summary document link (including results): Meloxicam_U00-1833_synopsis.pdf

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Document reference: 31598

Study title: Lithium treatment in children and adolescents: a select review and integration of reserch findings. - Duffy A (2006) - (In: Bauer M, Grof P, Müller-Oerlinghausen B Lithium in neuropsychiatry. The comprehensive guide. Informa healthcare, London, pp. 193-205)Lithium treatment in children and adolescents: a select review and integration of reserch findings. - Duffy A (2006) - (In: Bauer M, Grof P, Müller-Oerlinghausen B Lithium in neuropsychiatry. The comprehensive guide. Informa healthcare, London, pp. 193-205)

Active substance: LITHIUM

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Document reference: 31308

Study title: A comparative field trial of five measles vaccines produced in human diploid cell, MRC-5

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41234

Study title: A comparative field trial of five measles vaccines produced in human diploid cell, MRC-5

Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE

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Document reference: 41370

Study title: Cleary-S-F, Link-M-P, Donaldson-S-S. Department of Radiation Oncology, Stanford University School of Medicine, Stanford University Hospital, CA 94305. Hodgkin's disease in the very young. International journal of radiation oncology biology physics, {Int-J- Radiat-Oncol-Biol-Phys}, 1 Jan 1994, vol. 28, no. 1, p. 77-83, ISSN: 0360-3016.Cleary-S-F, Link-M-P, Donaldson-S-S. Department of Radiation Oncology, Stanford University School of Medicine, Stanford University Hospital, CA 94305. Hodgkin's disease in the very young. International journal of radiation oncology biology physics, {Int-J- Radiat-Oncol-Biol-Phys}, 1 Jan 1994, vol. 28, no. 1, p. 77-83, ISSN: 0360-3016.

Active substance: PREDNISOLONE

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Document reference: 34684

Study title: Ruszczak Z. [Photochemotherapy and activity of lysosomal enzymes in the serum of psoriasis patients][Article in German], Dermatol Monatsschr. 1984;170(9):573-7.Ruszczak Z. [Photochemotherapy and activity of lysosomal enzymes in the serum of psoriasis patients][Article in German], Dermatol Monatsschr. 1984;170(9):573-7.

Active substance: METHOZSALEN

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Document reference: 31717

Study title: Siddiqui AH. Comparison of serum levels and clinical results of PUVA therapy with three different dosage forms of 8-methoxypsoralen, Arch Dermatol Res. 1984;276(5):343-5.Siddiqui AH. Comparison of serum levels and clinical results of PUVA therapy with three different dosage forms of 8-methoxypsoralen, Arch Dermatol Res. 1984;276(5):343-5.

Active substance: METHOZSALEN

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Document reference: 31719

Study title: Tanew A. Photochemotherapy for severe psoriasis without or in combination with acitretin: a randomized, double-blind comparison study, J Am Acad Dermatol. 1991 Oct;25(4):682-4.Tanew A. Photochemotherapy for severe psoriasis without or in combination with acitretin: a randomized, double-blind comparison study, J Am Acad Dermatol. 1991 Oct;25(4):682-4.

Active substance: METHOZSALEN

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Document reference: 31720

Study title: J.C. Escher et al. Treatment of inflammatory bowel disease in childhood: Best available evidence. Inflammatory bowel disease 2003;9:34-58. J.C. Escher et al. Treatment of inflammatory bowel disease in childhood: Best available evidence. Inflammatory bowel disease 2003;9:34-58.

Active substance: MESALAZINE

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Document reference: 31640

Study title: L. Barden et. al. Mesalazine in childhood in inflammatory bowel disease. Aliment Pharmacol Ther 1989;3:597-603.L. Barden et. al. Mesalazine in childhood in inflammatory bowel disease. Aliment Pharmacol Ther 1989;3:597-603.

Active substance: MESALAZINE

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Document reference: 31636

Study title: L.D. D`Agata et al. Mesalazine in pediatric inflammatory bowel disease: a 10 year experience. Gastroenterology 1995;108(4):A805. L.D. D`Agata et al. Mesalazine in pediatric inflammatory bowel disease: a 10 year experience. Gastroenterology 1995;108(4):A805.

Active substance: MESALAZINE

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Document reference: 31637

Study title: Observational study of the efficacy and safety of Salofalk 500mg/1000mg Granu-Stix for the acute and maintenance of remission treatment of ulcerative colitis patients

Active substance: MESALAZINE

Study summary document link (including results): EUdraCT_reduced_datafields_paediatric data_Mesalazine_Salofalk granules_Dr Falk Pharma GmbH.xls

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Document reference: 31627

Study title: Lormetazepam intravenous as premedication in paediatric surgery

Active substance: LORMETAZEPAM

Study summary document link (including results): Bayer Pharma_Lormetazepam_79137_study_synopsis.pdf

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Document reference: 46902

Study title: Leung et al. Specificity of radioiodinated MIBG for neural crest tumors in childhoodJ Nucl Med. 1997 Sep; 38(9):1352-7

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): Leung A 1997.pdf

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Document reference: 48322

Study title: ND: 29874 AU: Azeka-E. IN: Dr. E. Azeka, Hospital das Clinicas, Medicine School, Universidade de Sao Paulo (FMUSP), Sao Paulo, SP. TI: The impact of L-carnitine on nutritional status in juvenile idiopathic dilated cardiomyopathy.; SO: Jornal de Pediatria {J-PEDIATR}, 2005, Vol/Iss/Pg. 81/5 (355-356), ISSN: 0021-7557ND: 29874 AU: Azeka-E. IN: Dr. E. Azeka, Hospital das Clinicas, Medicine School, Universidade de Sao Paulo (FMUSP), Sao Paulo, SP. TI: The impact of L-carnitine on nutritional status in juvenile idiopathic dilated cardiomyopathy.; SO: Jornal de Pediatria {J-PEDIATR}, 2005, Vol/Iss/Pg. 81/5 (355-356), ISSN: 0021-7557

Active substance: LEVOCARNITINE

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Document reference: 31143

Study title: The role of L-carnitine in nutritional status and echocardiographic parameters in idiopathic dilated cardiomyopathy in children. Azevedo VM, Albanesi Filho FM, Santos MA, Castier MB, Cunha MO. J Pediatr (Rio J). 2005 Sep-Oct; 81(5): 368-72The role of L-carnitine in nutritional status and echocardiographic parameters in idiopathic dilated cardiomyopathy in children. Azevedo VM, Albanesi Filho FM, Santos MA, Castier MB, Cunha MO. J Pediatr (Rio J). 2005 Sep-Oct; 81(5): 368-72

Active substance: LEVOCARNITINE

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Document reference: 31142

Study title: A non-controlled, pilot, multi-centric, open study of the efficacy and safety of levocetirizine dihydrochloride 5 mg/mL oral drops given 0.125 mg/kg b.i.d. during 90 days in the treatment of recurrent cough associated with other allergic symptoms, e.g. wheezing, in children aged 1-2 years.

Active substance: LEVOCETIRIZINE

Study summary document link (including results): A00315 - Levocetirizine - RRCE03C1301.pdf

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Document reference: 47308

Study title: Wolff K. Oral photochemotherapy - results, follow-up, and pathology , From the Dep. of Dermatology, University Innsbruck and the Division for Experimental Dermatology, Dep. of Dermatology I, University of Vienna. 1975.Wolff K. Oral photochemotherapy - results, follow-up, and pathology , From the Dep. of Dermatology, University Innsbruck and the Division for Experimental Dermatology, Dep. of Dermatology I, University of Vienna. 1975.

Active substance: METHOZSALEN

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Document reference: 31722

Active substance: METHOZSALEN

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Document reference: 31724

Study title: A double-blind parallel group study comparing EMLA cream 5% with placebo in capillary blood sampling of neonates

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 15_AG-EML-002 (87EM10) CSR Synopsis.pdf

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Document reference: 47243

Study title: Analgesia for the surgical removal of molluscum contagiosum in children: a double-blind, placebo-controlled, time-repsonse study of EMLA(R) (lidocaine/prilocaine) cream. Astra Report 802-10 AC 082-1, February 05, 1990.

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 06_86EM25 CSR Synopsis.pdf

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Document reference: 47251

Study title: R.J. Grand et al. Inflammatory bowel disease in the pediatric patient. Gastroenerol Clinics of North America, Vol 24 No 24. September 1995;24:613-632 10. R.J. Grand et al. Inflammatory bowel disease in the pediatric patient. Gastroenerol Clinics of North America, Vol 24 No 24. September 1995;24:613-632 10.

Active substance: MESALAZINE

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Document reference: 31643

Study title: Pharmacokinetic evaluation and ex vivo serum protein binding. levocetirizine dihydrochloride (ucb 28556). a non-controlled, pilot, multi-centric, open study of the efficacy and safety of levocetirizine dihydrochloride 5 mg/ml oral drops given 0.125 mg/kg b.i.d. during 90 days in the treatment of recurrent cough associated with other allergic symptoms, e.g. wheezing, in children aged 1-2 years.

Active substance: LEVOCETIRIZINE

Study summary document link (including results): ARVD04B1001 - Levocetirizine.pdf

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Document reference: 31151

Study title: The early prevention of asthma in atopic children (EPAAC(TM)) study. a multi-country, double blind, placebo-controlled, randomized, parallel group trial: evaluation of the efficacy and safety of levocetirizine (5 mg/ml oral drops - 0.125 mg/kg b.w. b.i.d.) administered for 18 months in preventing the onset of asthma in 12 to 24 months old children who suffer from atopic dermatitis and are sensitized to grass pollen and / or house dust mite allergens.

Active substance: LEVOCETIRIZINE

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Document reference: 31154

Study title: Takeo Shimo et al, Central Research Laboratory, Hokuriku Seiyaku Co., Ltd. Oral Arthrotoxicity Study of NY-198 in adult rats. Internal report.Vernal keratoconjunctivitis in Thailand. Kosrirukvongs P, Vichyanond P, Wongsawad W. Asian Pac J Allergy Immunol. 2003 Mar;21(1):25-30.

Active substance: LOMEFLOXACIN

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Document reference: 31405

Study title: The combined experience of the safety of lome-floxacin 0.3% and lomefloxacin 0.5% and the efficacy of lomefloxacin 0.3% compared with ofloxacin 0.3% in the treatment of acute bacterial conjunctivitis and other infections of the eye in children under 15 years old reported upon in three previous studies of lome-floxacin in JapanThe combined experience of the safety of lome-floxacin 0.3% and lomefloxacin 0.5% and the efficacy of lomefloxacin 0.3% compared with ofloxacin 0.3% in the treatment of acute bacterial conjunctivitis and other infections of the eye in children under 15 years old reported upon in three previous studies of lome-floxacin in Japan

Active substance: LOMEFLOXACIN

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Document reference: 31360

Study title: Astra Report No 802 10 AC 093-1 A Clinical Study On A Single Unit Dose Package of Emla (Emla Patch) and Emla 5% Cream Used to Reduse Pain From Venupuncture in Children.

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 24_89 EM 04 CSR Synopsis.pdf

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Document reference: 47236

Study title: Astra Report No. 802-10 AC 094 Clinical Study On Two Single Unit Dose Packages (Emla Patch) and Emla 5 % Cream Used to Reduce Pain at I.V Cannulation in Children

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 29_88EM01 CSR Synopsis.pdf

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Document reference: 47231

Study title: Biometrical analysis of a controlled double-blind crossover study on 48 patients. EMLA vs Placebo WG85EM01 (Astra Study 802-10 AC 068-1)

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 25_85-EM01 (WG85EM01) CSR Synopsis.pdf

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Document reference: 47235

Study title: Determination of a minimum application time for efficacy of a 5% lidocaine-prilocaine cream, EMLA (Eutectic Mixture of Local Anaesthetics), used for relief of venipuncture pain in children. Astra Report 802-10 AC 015-2, March 31, 1983.

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 07_81PO34 CSR Synopsis.pdf

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Document reference: 47250

Study title: Clinical Experience with a combination Endoxan/Mesna in pediatric. Contributions to Oncology. New Experience with the Oxazaphosphoriens with special reference to the Uroprotector Uromitexan . (de Kraker, J., Voute, P.A. and Stassen, M. - eds. Burkert, H. and Nagel, G.A.; S. Karger, 1981, 99-101)Clinical Experience with a combination Endoxan/Mesna in pediatric. Contributions to Oncology. New Experience with the Oxazaphosphoriens with special reference to the Uroprotector Uromitexan . (de Kraker, J., Voute, P.A. and Stassen, M. - eds. Burkert, H. and Nagel, G.A.; S. Karger, 1981, 99-101)

Active substance: MESNA

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Document reference: 31645

Study title: The effects of milrinone on platelets in patients undergoing cardiac surgery - Kikura M et al. - 1995 (Anest Analg 1995, 81, 44 -48)The effects of milrinone on platelets in patients undergoing cardiac surgery - Kikura M et al. - 1995 (Anest Analg 1995, 81, 44 -48)

Active substance: MILRINONE

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Document reference: 32036

Study title: Altomare M.,Bugnoni L.,Riva M. La Biochetasi nella terapia dell’emesi gravidica Eur.Rev.Med.Pharm.Sci.,6,573-576,1984Altomare M.,Bugnoni L.,Riva M. La Biochetasi nella terapia dell’emesi gravidica Eur.Rev.Med.Pharm.Sci.,6,573-576,1984

Active substance: MINERALS AND VITAMINS

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Document reference: 32040

Study title: Barzani G.,Liotta M.,Merli B.,Olivieri M.,Tamburini G. Sul trattamento delle sindromi acetonemiche infantili Clin.Ter.,76(5),437,1976Barzani G.,Liotta M.,Merli B.,Olivieri M.,Tamburini G. Sul trattamento delle sindromi acetonemiche infantili Clin.Ter.,76(5),437,1976

Active substance: MINERALS AND VITAMINS

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Document reference: 32044

Study title: Bieber G.,Casario S. Risultati preliminari di un trattamento farmacologico di un gruppo di insufficienti mentali in eta scolare Ming.Med.,60,2151,1969 Bieber G.,Casario S. Risultati preliminari di un trattamento farmacologico di un gruppo di insufficienti mentali in eta scolare Ming.Med.,60,2151,1969

Active substance: MINERALS AND VITAMINS

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Document reference: 32049

Study title: Chabrol H, Netter JC, Carriere JP. Arch Fr Pediatr 1982;39:650.Chabrol H, Netter JC, Carriere JP. Arch Fr Pediatr 1982;39:650.

Active substance: MIANSERIN

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Document reference: 31984

Study title: Chand S, Crome P, Dawling S. Pharmacopsychiatrie 14, 15-17 1981Chand S, Crome P, Dawling S. Pharmacopsychiatrie 14, 15-17 1981

Active substance: MIANSERIN

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Document reference: 31993

Study title: Dugas M, Mouren MC, Halfon O, Moron P. Acta Psychiatr Scand Suppl. 1985;320:48-53 Dugas M, Mouren MC, Halfon O, Moron P. Acta Psychiatr Scand Suppl. 1985;320:48-53

Active substance: MIANSERIN

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Document reference: 31987

Study title: Use of Positron Emission Tomography for Presurgical Localization of Eloquent Brain Areas in Children with Seizures.Pediatr Neurosurg 1997;26:144-156. Jolznily D. Dtlncane, S. David h foss a, Daniel J. Baiidy, Kiln rManwaringa, Allen Af. Kaplan, Eric AL Rei~nalt, Kewei Cheizd, Michael A. La~son, David L. CVodrichc.

Active substance: Steripet

Study summary document link (including results): duncan-1997.pdf

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Document reference: 48727

Study title: Mouren MC, Denis HP, Dugas M. Neuropsychiatr Enfance Adolesc. 1983;31(10):485-90Mouren MC, Denis HP, Dugas M. Neuropsychiatr Enfance Adolesc. 1983;31(10):485-90

Active substance: MIANSERIN

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Document reference: 31986

Study title: Vitamin B6, Magnesium and combined B6-Mg : therapeutic effects in childhood autism - J. Martineau et al. - 1985 (Biol. Psychiatry vol 20) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Vitamin B6, Magnesium and combined B6-Mg : therapeutic effects in childhood autism - J. Martineau et al. - 1985 (Biol. Psychiatry vol 20) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31502

Study title: Efficacy of vitamin B6 and magnesium in the treatment of autism : a methodology review an summary of outcomes - S.I Pfeiffer et al. - 1995 (Journal of Autism and Developmental Disorders vol 25) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Convulsions hypomagnésemique chez le nouveau-né - Stern L, Harpur ER - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31506

Study title: The effect of single dose mebendazole on the egg reduction rates (ERR) and cure rates (CR) in patients with Ascaris-, Trichuris- and hookworm infestations. 1985

Active substance: MEBENDAZOLE

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Document reference: 31549

Study title: Therapeutical effectiveness and safety of 2% mebendazole syrup In various helminthiases. 1975

Active substance: MEBENDAZOLE

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Document reference: 31547

Study title: Connell AM. Physiological and clinical assessment of the effect of the musculotropic agent mebeverine on the human colon.; Br Med J. 1965 Oct 9;2(5466):848-51.

Active substance: MEBEVERINE

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Document reference: 31556

Study title: Downey, L.J. A multicentre, double-blind, placebo-controlled study of the efficacy and acceptability of mebeverine liquid in the treatment of the irritable bowel syndrome of childhood. (Non-organic recurrent abdominal pain).; Duphar Report 1985 No. H. 103.905/M

Active substance: MEBEVERINE

Study summary document link (including results): Mebeverinr-H.103.905M.pdf

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Document reference: 31559

Study title: Falcone R.,Giannotti G.,Calenduccia A.,Mannino O. Impiego della Biochetasi fiale e bustine in pediatria Aggiorn.Pediat.,35(1),147-150,1984Falcone R.,Giannotti G.,Calenduccia A.,Mannino O. Impiego della Biochetasi fiale e bustine in pediatria Aggiorn.Pediat.,35(1),147-150,1984

Active substance: MINERALS AND VITAMINS

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Document reference: 32043

Study title: Mastrangelo et al. Critical observations on neuroblastoma treatment with 131-Imetaiodobenzylguanidine at diagnosisMedical and pediatric oncology (1993), 21(6), 411-5

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48324

Study title: Modak et al. Transient sialoadenitis: a complication of 131I-metaiodobenzylguanidine therapyPediatric blood & cancer (2008), 50(6), 1271-3

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48325

Study title: Phase II study of high-dose [131I] metaiodobenzylguanidine therapy for patients with metastatic pheochromocytoma and paragangliomaJ Clin Oncol. 2009 Sep 1; 27(25):4162-8. Epub 2009 Jul 27

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48317

Study title: Schwabe et al. 131-Metaiodobenzylguanedine therapy of neuroblastoma in childhood.One year of therapeutic experience European journal of pediatrics (1987), 146(3), 246-50

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48327

Study title: Therapeutic use of 131I-metaiodobenzylguanidine (MIBG) in neuroblastoma: a phase II study in nine patientsMedical and pediatric oncology (1987), 15(4), 205-11

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48318

Study title: Grillage MG et al. A randomised, double-blind study of mebeverine versus dicyclomine in the treatment of functional abdominal pain in young adults.; Br J Clin Pract. 1990 May;44(5):176-9.

Active substance: MEBEVERINE

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Document reference: 31554

Study title: Martin, Dr. A.J. A multi-centre double-blind placebo controlled study of the efficacy and acceptability of the Mebeverine liquid in the treatment of the irritable bowel syndrome of childhood (non-organic recurrent abdominal pain); Duphar Report 1982 No. H.103.905

Active substance: MEBEVERINE

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Document reference: 31558

Study title: BASSALY M., BOROLOSSY A.W., MOUSA A.H. Oral therapy of urinary schistosomiasis with Lucanthone HCl. The effect of Meclizine HCl on the incidence of its side effects. J.EGYPT.MED.ASSOC. 1961. 44:704-11.

Active substance: MECLIZINE HYDROCHLORIDE

Study summary document link (including results): Bassaly.xls

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Document reference: 47882

Study title: FAGAN J.E., KAPLAN B.J., RAYMOND J.E., EDGINGTON E.S. & AL. The failure of antimotion sickness medication to improve reading in developmental dyslexia: results of a randomized trial. J.DEV.BEHAV.PEDIATR. DEC-1988. 9(6):359-366.

Active substance: MECLIZINE HYDROCHLORIDE

Study summary document link (including results): Fagan.xls

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Document reference: 47883

Study title: LEVINSON H.N. Dramatic favorable responses of children with learning disabilities or dyslexia and attention deficit disorder to antimotion sickness medications : four case reports. PERCEPT.MOT.SKILLS 1991. 73/3 PT 1,723-738

Active substance: MECLIZINE HYDROCHLORIDE

Study summary document link (including results): Levinson.xls

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Document reference: 47884

Study title:

Active substance: MECLOZINE

Study summary document link (including results): RAE90C1918P.pdf

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Document reference: 31566

Study title: "Comparison of an intravenous pulse of methylprednisolone versus oral corticosteroid in severe acute rheumatic carditis: a randomized clinical trial - Camara EJ - March 2002 (Cardiol Young 12(2):119-24) - Publication in CES0735-EN-E01 - Leonetti L - 29/09/2007 -"

Active substance: METHYLPREDNISOLONE

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Document reference: 31921

Study title: Controlled, double-blind group comparison of a twice daily (maximum 3 weeks) use of methylprednisolone aceponate 0.1 % cream and prednicarbate 0.25 % cream (Dermatop) in children with atopic dermatitis

Active substance: METHYLPREDNISOLONE

Study summary document link (including results): Bayer Intendis_Methylprednisolone Aceponate_87105_study_synopsis.pdf

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Document reference: 47736

Study title: Double-blind, randomized, reference-controlled, multicenter, parallelgroup study to compare the efficacy and safety of Advantan ointment once daily with Protopic 0.03% ointment twice daily over maximum 3 weeks in 250 children and adolescents with atopic dermatitis

Active substance: METHYLPREDNISOLONE

Study summary document link (including results): Bayer Intendis_Methylprednisolone Aceponate_308962_study_synopsis.pdf

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Document reference: 47734

Study title: Slow-release 5-ASA therapy in children with small intestinal Crohn's disease; Griffits A et al J. of Pediatric Gastroent. and Nutrition, 1993,17:186-192 Slow-release 5-ASA therapy in children with small intestinal Crohn's disease; Griffits A et al J. of Pediatric Gastroent. and Nutrition, 1993,17:186-192

Active substance: MESALAZINE

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Document reference: 31632

Study title: Symptoms of sulphasalazine or 5-aminosalicylic acid intolerance in children with ulcerative colitis; Iwaneczak B et al, Pediatria Polska, 1999, 74(8): 777-781Symptoms of sulphasalazine or 5-aminosalicylic acid intolerance in children with ulcerative colitis; Iwaneczak B et al, Pediatria Polska, 1999, 74(8): 777-781

Active substance: MESALAZINE

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Document reference: 31631

Study title: Treatment of IBD with oral 5-ASA (Pentasa) in the pediatric age group; Scagnelli GP et al, Gastroenterology (100, No 5, Pt.2, A248, 1991) Treatment of IBD with oral 5-ASA (Pentasa) in the pediatric age group; Scagnelli GP et al, Gastroenterology (100, No 5, Pt.2, A248, 1991)

Active substance: MESALAZINE

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Document reference: 31633

Study title: V. Tolia et al.. Oral 5-Aminosalicylic acid in children with colonic chronic inflammatory bowel disease: Clinical and pharmacokinetic experience. Journal of Pediatric Gastroenterology and Nutrition 8: 333-338, 1989 V. Tolia et al.. Oral 5-Aminosalicylic acid in children with colonic chronic inflammatory bowel disease: Clinical and pharmacokinetic experience. Journal of Pediatric Gastroenterology and Nutrition 8: 333-338, 1989

Active substance: MESALAZINE

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Document reference: 31634

Study title: A phase II, open, case-controlled clinical study to assess the immunogenicity, reactogenicity and safety of a 2nd dose of GlaxoSmithKline Biologicals’ measles-mumps-rubella-varicella (MeMuRu-OKA) vaccine given in healthy children of 5 to 6 years of age

Active substance: Live attenuated measles, mumps, rubella, varicella vaccine

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Document reference: 47877

Study title: Godovanetz Yu.D., et al: Effectiveness of antihomotoxic therapy in the correction of neurological and metabolical impairments in newborns suffered from perinatal hypoxic stress. Biological Therapy (Ukraine), 2004, 2: 16-23 and 3-4: 36-45 [IIT-publication

Active substance: Lymphomyosot - Tropfen

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Document reference: 40063

Study title: Van Hasselt et al. Pretreatment with [131I] metaiodobenzylguanidine and surgical resection of advanced neuroblastoma, European journal of pediatric surgery official journal of Austrian Association of Pediatric Surgery = Zeitschrift fur Kinderchirurgie (1996), 6(3), 155-8

Active substance: META-IODOBENZYLGUANIDINE

Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc

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Document reference: 48328

Study title: Antipyretic efficacy and tolerability of oral ibuprfen, oral dipyrone and intramuscular dipyrone in children:a randomized controlled trial - Prado J. et al. - 2006 (Sao Paulo Med, 124(3):135-140) - Publication in CES EXPRC-CES0691-EN-E01 -

Active substance: METAMIZOLE

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Document reference: 31711

Study title: The prolongation of the EPAAC(TM) trial (early prevention of asthma in atopic children), a multi-country, double-blind, placebo controlled, follow-up trial with 3 parallel groups (lctz-lctz, lctz-plc and plc-plc): evaluating the long term efficacy and safety of levocetirizine (5 mg/ml oral drops - 0.125 mg/kg b.w. b.i.d.) administered for an additional 18-month period in preventing the onset of asthma in children coming from the epaactm trial (A00309).

Active substance: LEVOCETIRIZINE

Study summary document link (including results): ARVD02J2302 - Levocetirizine.pdf

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Document reference: 31150

Study title: The prolongation of the EPAAC™ trial (Early Prevention of Asthma in Atopic Children), a multi-country, double-blind, placebo controlled, follow-up trial with 3 parallel groups (LCTZ-LCTZ, LCTZ-PLC and PLC-PLC) : Evaluating the long term efficacy and safety of levocetirizine (5 mg/mL oral drops - 0.125 mg/kg b.w. b.i.d.) administered for an additional 18-month period in preventing the onset of asthma in children coming from the EPAAC™ trial (A00309)

Active substance: LEVOCETIRIZINE

Study summary document link (including results): A00384 - Levocetirizine - RPCE04B0203.pdf

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Document reference: 47307

Study title: Humanitarian Use of Imipenem/Cilastatin Sodium in Neonates.Corboz RJ. Klinische Aspekte depressiver Zustände. Helv. Paediat. Acta 1983; 38: 425-437

Active substance: LEVODROPROPIZINE

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Document reference: 31162

Study title: Paradis B. Analgesic and Anaesthetic Properties of Levomepromazine (Nozinan) (R.P. 7044). Canad Anaesth Soc J 1962; 9/2: 153-160Paradis B. Analgesic and Anaesthetic Properties of Levomepromazine (Nozinan) (R.P. 7044). Canad Anaesth Soc J 1962; 9/2: 153-160

Active substance: LEVODROPROPIZINE

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Document reference: 31163

Study title: Rosthoj S et al. (1996). Randomized trial comparing intravenous immunoglobulin with methylprednisolone pulse therapy in acute idiopathic thrombocytopenic purpura . Danish I .T .P. Study Group. Acta Paediatr 85(8):910-5.Rosthoj S et al. (1996). Randomized trial comparing intravenous immunoglobulin with methylprednisolone pulse therapy in acute idiopathic thrombocytopenic purpura . Danish I .T .P. Study Group. Acta Paediatr 85(8):910-5.

Active substance: METHYLPREDNISOLONE

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Document reference: 31925

Study title: Rubin BK, Marcushamer S, Priel I, App EM . (1990) . Emergency management of the child with asthma [published erratum appears in Pediatr Pulmonol 1990 ;8(3):219-20].Pediatr Pulmonol 8(1) :45-57. Rubin BK, Marcushamer S, Priel I, App EM . (1990) . Emergency management of the child with asthma [published erratum appears in Pediatr Pulmonol 1990 ;8(3):219-20].Pediatr Pulmonol 8(1) :45-57.

Active substance: METHYLPREDNISOLONE

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Document reference: 31926

Study title: EMLA cream 5% for removal of mollusca. A clinical study of plasma concentrations of lidocaine and prilocaine and analgesic effect in children.

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 19_86EM13 CSR Synopsis.pdf

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Document reference: 47239

Study title: Etude in vivo de l’activite mucolytique du mesna (mucofluid spray nasal a 2,5 %) + analyse statistique.

Active substance: MESNA

Study summary document link (including results): CE69L071 - Mesna.pdf

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Document reference: 31656

Study title: Results of a vaccination campaign in Brazil (1974 - 1975) using the meningococcal polysaccharide A + C vaccine.

Active substance: Meningococcal polysaccharide vaccine (strains A+C)

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Document reference: 41272

Study title: Evaluation of analgesic effect and tolerability of EMLA Cream 5% in the laser treatment of port wine stains. Multicentre, randomised, double-blind versus placebo.

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 28_EM 9301 CSR Synopsis.pdf

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Document reference: 47232

Study title: Evaluation of Emla 5% Cream for Alleviation of Pain in Connection with Tetanus Vaccination in School Children. 83P027

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 26_83-P027 CSR Synopsis.pdf

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Document reference: 47234

Study title: Evaluation of the Safety of EMLA Cream 5% on Intact Skin of Full-term Neonates

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 16_95EM24 CSR Synopsis.pdf

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Document reference: 47242

Study title: Plasma concentrations of prilocaine and lidocaine and methaemoglobin formation in infants after dermal application of a 5% lidocaine-prilocaine cream (EMLA).

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 17_84-EM02 CSR Synopsis.pdf

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Document reference: 47241

Study title: Topical analgesia with EMLA cream for curettage of molluscum contagiosum in children. 85-EM24

Active substance: LIDOCAINE AND PRILOCAINE

Study summary document link (including results): 30_85EM24 CSR Synopsis.pdf

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Document reference: 47230

Study title: A Retrospective Analysis of the Effect of Kaletra (lopinavir/ritonavir) Compared with Viracept (nelfinavir) and Norvir (ritonavir) in HIV-Infected Pediatric Patients - Switzerland

Active substance: lopinavir / ritonavir

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Document reference: 41523

Study title: ABT-378/r (ABT-378/ritonavir) Brun et al. ABT-378/r (ABT-378/ritonavir) Early Access Program

Active substance: lopinavir / ritonavir

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Document reference: 41520

Study title: An international study on the treatment of NRTI-experienced HIV-infected children

Active substance: lopinavir / ritonavir

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Document reference: 41526

Study title: De Luca M, Miccinesi G, Chiappini E, Zappa M, Galli L, De Martino M. Different kinetics of immunologic recovery using nelfinavir or lopinavir/ritonavir-based regimens in children with perinatal HIV-1 infection. Int J Immunopathol Pharmacol. 2005 Oct-Dec;18(4):729-35.De Luca M, Miccinesi G, Chiappini E, Zappa M, Galli L, De Martino M. Different kinetics of immunologic recovery using nelfinavir or lopinavir/ritonavir-based regimens in children with perinatal HIV-1 infection. Int J Immunopathol Pharmacol. 2005 Oct-Dec;18(4):729-35.

Active substance: lopinavir / ritonavir

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Document reference: 41532

Study title: Reflex increase in blood pressure during the intracoronary administration of adenosine in Man - Cox D et al. - 1989 ( J. Clin. Invest, 84, 592-596)Reflex increase in blood pressure during the intracoronary administration of adenosine in Man - Cox D et al. - 1989 ( J. Clin. Invest, 84, 592-596)

Active substance: ADENOSINE

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Document reference: 46303

Study title: Ifosfamide (IFO) is an active drug in Wilms´tumor (WT). A phase II Study of the French Society of Pediatric Oncology. (Demeoq, F. et al. - Proc. Ann. Meet. Am. Soc. Clin. Oncol. 5 (1986): Abstr. 8000)Ifosfamide (IFO) is an active drug in Wilms´tumor (WT). A phase II Study of the French Society of Pediatric Oncology. (Demeoq, F. et al. - Proc. Ann. Meet. Am. Soc. Clin. Oncol. 5 (1986): Abstr. 8000)

Active substance: MESNA

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Document reference: 31646

Study title: Safety and efficacy comparison of emedastine 0.05% ophthalmic solution compared to levocabastine 0.05% ophthalmic suspension in pediatric subjects with allergic conjunctivitis. Acta Ophthalmica Scandinavica 78, p.42-47,2000Safety and efficacy comparison of emedastine 0.05% ophthalmic solution compared to levocabastine 0.05% ophthalmic suspension in pediatric subjects with allergic conjunctivitis. Acta Ophthalmica Scandinavica 78, p.42-47,2000

Active substance: LEVOCABASTINE

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Document reference: 31135

Study title: Single-blind comparison of levocabastine eye drops with sodium cromoglycate eye drops in the treatment of season allergic conjunctivitis (15-59 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62436_Interventional_Levocabastine.xls

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Document reference: 31097

Study title: The efficacy and safety of levocabastine eye drops in grass and birch pollinosis (17-52 yrs)

Active substance: LEVOCABASTINE

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Document reference: 31113

Study title: The role of L-carnitine in pediatric cardiomyopathy. Winter S, Jue K, Prochazka J, Frances P, Hamilton W, Linn L, Helton E. J Child Neurol. 1995 Nov; 10 Suppl 2: S45-51.The role of L-carnitine in pediatric cardiomyopathy. Winter S, Jue K, Prochazka J, Frances P, Hamilton W, Linn L, Helton E. J Child Neurol. 1995 Nov; 10 Suppl 2: S45-51.

Active substance: LEVOCABASTINE

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Document reference: 31139

Active substance: MEPHENYTOIN

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Document reference: 31605

Study title: Susceptibility to antifungal agents of Candida species isolated from paediatric and adult patients with haematological diseases; U. Nawrot, J. Nowicka, K. Juszczak and B. Gusin; 2005 Mycoses, 48, 385–390Susceptibility to antifungal agents of Candida species isolated from paediatric and adult patients with haematological diseases; U. Nawrot, J. Nowicka, K. Juszczak and B. Gusin; 2005 Mycoses, 48, 385–390

Active substance: MICONAZOLE

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

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Document reference: 47618

Study title: An exploratory unblinded trail of Levovist (SH U 508A) used in B-mode sonography in comparison with radiologically monitored voiding cystourethrography in diagnosis of vesicoureterorenal reflux in children (with subsequent blinded reading of the results)

Active substance: MICROPARTICLES OF GALACTOSE

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Document reference: 31999

Study title: Open, uncontrolled dose finding study with SH U 454 as an echocardiographic contrast agent for clarification of congenital malformations involving the right heart in patients from 0 - 18 years

Active substance: MICROPARTICLES OF GALACTOSE

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Document reference: 32000

Study title: de Gast-Bakker, D.A., et al., Age is of influence on midazolam requirements in a paediatric intensive care unit. Acta Paediatr, 2007. 96(3): p. 414-7. 2.de Gast-Bakker, D.A., et al., Age is of influence on midazolam requirements in a paediatric intensive care unit. Acta Paediatr, 2007. 96(3): p. 414-7. 2.

Active substance: MIDAZOLAM

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Document reference: 32001

Study title: Kain, Z.N., et al., Effects of age and emotionality on the effectiveness of midazolam administered preoperatively to children. Anesthesiology, 2007. 107(4): p. 545-52Kain, Z.N., et al., Effects of age and emotionality on the effectiveness of midazolam administered preoperatively to children. Anesthesiology, 2007. 107(4): p. 545-52

Active substance: MIDAZOLAM

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Document reference: 32004

Study title: Lucas da Silva, P.S., et al., Procedural sedation for insertion of central venous catheters in children: comparison of midazolam/fentanyl with midazolam/ketamine. Paediatr Anaesth, 2007. 17(4): p. 358-63. 6. Lucas da Silva, P.S., et al., Procedural sedation for insertion of central venous catheters in children: comparison of midazolam/fentanyl with midazolam/ketamine. Paediatr Anaesth, 2007. 17(4): p. 358-63. 6.

Active substance: MIDAZOLAM

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Document reference: 32005

Study title: Furosemide and mannitol suppressionof epileptic activity in the human brain (please refer to this study by its PMID: 15728766) Furosemide and mannitol suppressionof epileptic activity in the human brain (please refer to this study by its PMID: 15728766)

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31522

Study title: Drug Metabolism Report No. 35: Tabulation of Plasma Concentration Data for a Four-Week Oral Toxicity Study of Abbott-157378 in Combination with Ritonavir (Abbott-84538) in Immature (Juvenile) RatsDrug Metabolism Report No. 35: Tabulation of Plasma Concentration Data for a Four-Week Oral Toxicity Study of Abbott-157378 in Combination with Ritonavir (Abbott-84538) in Immature (Juvenile) Rats

Active substance: lopinavir / ritonavir

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Document reference: 41524

Study title: HIV-NAT 017: Lopinavir with saquinavir in HIV-infected children: PK and 2-year treatment follow-up

Active substance: lopinavir / ritonavir

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Document reference: 41525

Study title: Jullien V, Urien S, Hirt D, Delaugerre C, Rey E, Teglas JP, Vaz P, Rouzioux C, Chaix ML, Macassa E, Firtion G, Pons G, Blanche S, Tréluyer JM. Population analysis of weight-, age-, and sex-related differences in the pharmacokinetics of lopinavir in children from birth to 18 years.Antimicrob Agents Chemother. 2006; Nov;50(11):3548-55. Epub 2006 Aug 28.

Active substance: lopinavir / ritonavir

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Document reference: 21187

Study title: Phase I trial of the effectiveness and safety of loperamide oxide in the treatment of diarrhoea resulting from different pathophysiological mechanisms (12-75 yrs)

Active substance: LOPERAMIDE AND SIMETICONE

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Document reference: 31448

Study title: Kline MW, Rugina S, Ilie M, Matusa RF, Schweitzer AM, Calles NR, Schwarzwald HL. Long-term follow-up of 414 HIV-infected Romanian children and adolescents receiving lopinavir/ritonavir-containing highly active antiretroviral therapy. Pediatrics. 2007 May;119(5):e1116-20. Epub 2007 Apr 9.Kline MW, Rugina S, Ilie M, Matusa RF, Schweitzer AM, Calles NR, Schwarzwald HL. Long-term follow-up of 414 HIV-infected Romanian children and adolescents receiving lopinavir/ritonavir-containing highly active antiretroviral therapy. Pediatrics. 2007 May;119(5):e1116-20. Epub 2007 Apr 9.

Active substance: lopinavir / ritonavir

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Document reference: 41529

Study title: Larrú B, Resino S, Bellón JM, de José MI, Fortuny C, Navarro ML, Gurbindo MD, Ramos JT, Soler P, Léon JA, Asensi M, Mellado MJ, Muñoz-Fernández MA. Long-term response to highly active antiretroviral therapy with lopinavir/ritonavir in pre-treated vertically HIV-infected children.Larrú B, Resino S, Bellón JM, de José MI, Fortuny C, Navarro ML, Gurbindo MD, Ramos JT, Soler P, Léon JA, Asensi M, Mellado MJ, Muñoz-Fernández MA. Long-term response to highly active antiretroviral therapy with lopinavir/ritonavir in pre-treated vertically HIV-infected children.

Active substance: lopinavir / ritonavir

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Document reference: 41528

Study title: An evaluation of antiemetic agents in the control of vomiting in children.

Active substance: MECLOZINE

Study summary document link (including results): DE76M282P.pdf

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Document reference: 31563

Study title: A comparison of tiaprofenic acid, mefenamic acid and placebo in the treatment of dysmenorrhoea in general practice; Tilyard MW et al. , Aust N Z J Obstet Gynaecol. 1992 May;32(2):165-8.

Active substance: MEDROXYPROGESTERONE ACETATE

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Document reference: 31569

Study title: Aspirin-induced asthma in children; Botey J et al., Allergol Immunopathol (Madr). 1988 May-Jun;16(3):145-9.

Active substance: MEDROXYPROGESTERONE ACETATE

Study summary document link (including results): MPAASC-0012-277 EMA Pediatrics Web Synopsis.pdf

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Document reference: 31568

Study title: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non Hormonal Contraceptive Users

Active substance: MEDROXYPROGESTERONE ACETATE

Study summary document link (including results): A6791022 PhRMA Web Synopsis.pdf

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Document reference: 48025

Study title: Therapeutic value of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a double-blind comparison with sodium cromoglycate and placebo (9-52 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62487_Interventional_Levocabastine.xls

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Document reference: 31079

Study title: Mamula, P., et al., Safety of intravenous midazolam and fentanyl for pediatric GI endoscopy: prospective study of 1578 endoscopies. Gastrointest Endosc, 2007. 65(2): p. 203-10. 7. Mamula, P., et al., Safety of intravenous midazolam and fentanyl for pediatric GI endoscopy: prospective study of 1578 endoscopies. Gastrointest Endosc, 2007. 65(2): p. 203-10. 7.

Active substance: MIDAZOLAM

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Document reference: 32006

Study title: Assessment of the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ live attenuated Measles (Schwarz strain) - Mumps (RIT 4385 strain) - Rubella (RA 27/3 strain) - Varicella (Oka-strain) vaccine. An open clinical study in healthy 12 to 24 month old children.

Active substance: Live attenuated measles, mumps, rubella, varicella vaccine

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Document reference: 47879

Active substance: Live attenuated measles, mumps, rubella, varicella vaccine

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Document reference: 47880

Study title: Assessment of the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ live attenuated varicella vaccine (Oka-strain) when administered at the same time as routine MMR (measles, mumps, rubella) vaccine but at different injection sites. An open clinical study in healthy 15- to 18-month-old children.

Active substance: Live attenuated varicella vaccine (OKA strain)

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Document reference: 47336

Study title: A double-blind, randomised, controlled multi-centre safety study of a refrigerator-stable formulation of VARIVAX® in healthy 12 to 15 month-old children.

Active substance: Live attenuated varicella virus [Oka/ Merck strain]

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Document reference: 47287

Study title: Rapport d'expertise clinique sur MAGNE B6 Comprimés dragéifiés (50mg de Mg). - Pr. GASTAUTRapport d'expertise clinique sur MAGNE B6 Comprimés dragéifiés (50mg de Mg). - Pr. GASTAUT- 12/1967

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

Study summary document link (including results): Magnesium lactate, pyridoxine chlorhydrate STUDY 444.6.002.xls

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Document reference: 31514

Study title: Rapport d'expertise clinique sur MAGNE B6 Comprimés dragéifiés (50mg de Mg)Rapport d'expertise clinique sur MAGNE B6 Comprimés dragéifiés (50mg de Mg). - Pr. NAYRAC- 11/1967

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

Study summary document link (including results): Magnesium lactate, pyridoxine chlorhydrate STUDY 444.6.001.xls

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Document reference: 31515

Study title: "Antipyretic efficacy and tolerability of oral ibuprfen, oral dipyrone and intramuscular dipyrone in children:a randomized controlled trial - Prado J. et al. - 2006 (Sao Paulo Med, 124(3):135-140) - Publication in CES EXPRC-CES0691-EN-E01 -"

Active substance: METAMIZOLE

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Document reference: 31712

Study title: Antipyretic therapy - Rajeshwari K. - 1997 (Indian Pediatr., 34; 5, 407-413) - Publication in a clinical overview - No author - 24/05/2006 -

Active substance: METAMIZOLE

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Document reference: 31691

Study title: Metamizole (dipyrone) suppositories versus paracetamol suppositories in the treatment of fever in children. Final clinical and statistical report No.X107/4037 respectively X107/4/M/T/401/FI-Thailand, Hoechst AG, Frankfurt. Simasathien S. et al.;1995 - Publication in Part IC3 Clinical Documentation - HAUKE - 28/02/2000 -

Active substance: METAMIZOLE

Study summary document link (including results): Metamizol STUDY X107-4037 THAILAND.xls

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Document reference: 31708

Study title: A comparison of tiaprofenic acid, mefenamic acid and placebo in the treatment of dysmenorrhoea in general practice; Tilyard MW et al. , Aust N Z J Obstet Gynaecol. 1992 May;32(2):165-8.A comparison of tiaprofenic acid, mefenamic acid and placebo in the treatment of dysmenorrhoea in general practice; Tilyard MW et al. , Aust N Z J Obstet Gynaecol. 1992 May;32(2):165-8.

Active substance: MEFENAMIC ACID

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Document reference: 31575

Study title: Analgesic and antipyretic effect of mefenaminic acid in children and adolescents; Fehlhaber C et al., Med Welt. 1967 Jul 15;28:1655-8. Analgesic and antipyretic effect of mefenaminic acid in children and adolescents; Fehlhaber C et al., Med Welt. 1967 Jul 15;28:1655-8.

Active substance: MEFENAMIC ACID

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Document reference: 41621

Study title: Aspirin-induced asthma in children; Botey J et al., Allergol Immunopathol (Madr). 1988 May-Jun;16(3):145-9. Aspirin-induced asthma in children; Botey J et al., Allergol Immunopathol (Madr). 1988 May-Jun;16(3):145-9.

Active substance: MEFENAMIC ACID

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Document reference: 31578

Study title: Choice of antipyretic in children; Khubchandani RP et al., J Assoc Physicians India. 1995 Sep;43(9):614-6Choice of antipyretic in children; Khubchandani RP et al., J Assoc Physicians India. 1995 Sep;43(9):614-6

Active substance: MEFENAMIC ACID

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Document reference: 31572

Study title: Storr J et al. (1987) . Effect of a single oral dose of prednisolone in acute childhood asthma. Lancet 1(8538) :879-82.Storr J et al. (1987) . Effect of a single oral dose of prednisolone in acute childhood asthma. Lancet 1(8538) :879-82.

Active substance: METHYLPREDNISOLONE

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Document reference: 31928

Study title: "Tuncer AM et al . (1995) . The effect of high-dose methylprednisolone on CD34-positive bone marrow cells in children with acute myeloblastic leukemia . Turk J Pediatr 37(4) :345-9." "Tuncer AM et al . (1995) . The effect of high-dose methylprednisolone on CD34-positive bone marrow cells in children with acute myeloblastic leukemia . Turk J Pediatr 37(4) :345-9."

Active substance: METHYLPREDNISOLONE

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Document reference: 31930

Study title: Pyridoxine in atopic dermatitis - D.C Mabin et al. - 1995 (British Journal of Dermatology vol 133) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Pyridoxine in atopic dermatitis - D.C Mabin et al. - 1995 (British Journal of Dermatology vol 133) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31490

Study title: Efficacy of vitamin B6 and magnesium in the treatment of autism : a methodology review an summary of outcomes - S.I Pfeiffer et al. - 1995 (Journal of Autism and Developmental Disorders vol 25) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Efficacy of vitamin B6 and magnesium in the treatment of autism : a methodology review an summary of outcomes - S.I Pfeiffer et al. - 1995 (Journal of Autism and Developmental Disorders vol 25) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -

Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6)

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Document reference: 31484

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/1994

Active substance: METAMIZOLE

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Document reference: 31694

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/1995

Active substance: METAMIZOLE

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Document reference: 31695

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/1996

Active substance: METAMIZOLE

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Document reference: 31696

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/1998

Active substance: METAMIZOLE

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Document reference: 31697

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/1999

Active substance: METAMIZOLE

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Document reference: 31698

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2000

Active substance: METAMIZOLE

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Document reference: 31699

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2001

Active substance: METAMIZOLE

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Document reference: 31700

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2002

Active substance: METAMIZOLE

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Document reference: 31701

Study title: A four-weeks evaluation of HOE777 fatty ointment 0,25%in young patients with severe atopic dermatitis of long duration - G. Rajka - 1987 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - A four-weeks evaluation of HOE777 fatty ointment 0,25%in young patients with severe atopic dermatitis of long duration - G. Rajka - 1987 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -

Active substance: LEVONORGESTREL

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Document reference: 31168

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

Active substance: LEVOPROMAZINE

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Document reference: 31167

Study title: Congenital Hyperthyroidism: optimal management in light of 15 years experience of screening, Arch Dis Child 72, 185-189, 1995 Congenital Hyperthyroidism: optimal management in light of 15 years experience of screening, Arch Dis Child 72, 185-189, 1995

Active substance: LEVOTHYROXINE

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Document reference: 31171

Study title: Weinberger M . (1988) . Corticosteroids for exacerbations of asthma : current status of the controversy . Pediatrics 81(5) :726-9.Weinberger M . (1988) . Corticosteroids for exacerbations of asthma : current status of the controversy . Pediatrics 81(5) :726-9.

Active substance: METHYLPREDNISOLONE

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Document reference: 31931

Study title: Wolfson DH et al . (1994) . A controlled trial of methylprednisolone in the early emergency department treatment of acute asthma in children . Pediatr Emerg Care 10(6) :335-8.Wolfson DH et al . (1994) . A controlled trial of methylprednisolone in the early emergency department treatment of acute asthma in children . Pediatr Emerg Care 10(6) :335-8.

Active substance: METHYLPREDNISOLONE

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Document reference: 31932

Study title: Patten, B. M. and Zeller, R. S. Clinical trials of vasoactive and antiserotonin drugs in Duchenne muscular dystrophy Ann.Clin.Res 1983;15:164-166.Patten, B. M. and Zeller, R. S. Clinical trials of vasoactive and antiserotonin drugs in Duchenne muscular dystrophy Ann.Clin.Res 1983;15:164-166.

Active substance: METHYLSERGIDE

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Document reference: 31958

Study title: Treatment for congenital hypothyroidism: Thyroxine alone or thyroxine plus triiodothyronine?Cassio A., 2003 Pediatrics 2003, 111, 5: 1055-60

Active substance: LIOTHYRONINE

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

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Document reference: 31281

Study title: 48 Hour Human Patch Test for Skin Irritation of a range of Oilatum Plus Lotion Formulations.A comparative study: the efficacy of liquid paraffin and lactulose in management of chronic functional constipation. Urganci N, Akyildiz B, Polat TB. Pediatr Int. 2005 Feb;47(1):15-9.

Active substance: LIQUID PARAFFIN

Study summary document link (including results): Article 45_Ref_C0472_Final For Submission_27 Oct 2011.xlsx

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Document reference: 31284

Study title: Phase II trial of ifosfamode with mesna in patients with pediatric malignant solid tumors (Pratt, C.B. Et al.-Proc.Ann. Meet.Am.Soc.Clin.Oncol.4 1985: Abstr. C-912)Phase II trial of ifosfamode with mesna in patients with pediatric malignant solid tumors (Pratt, C.B. Et al.-Proc.Ann. Meet.Am.Soc.Clin.Oncol.4 1985: Abstr. C-912)

Active substance: MESNA

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Document reference: 31648

Study title: Clinical investigations.

Active substance: PENTOXYVERINE

Study summary document link (including results): ARCE92G0609 - Pentoxyverine.pdf

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Document reference: 45859

Active substance: LIDOCAINE

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Document reference: 31227

Study title: Bowie MD, et al. Loperamide for treatment of acute diarrhoea in infants and young children. A double-blind placebo controlled trial. S Afr Med J 1995; 85: 885–7Bowie MD, et al. Loperamide for treatment of acute diarrhoea in infants and young children. A double-blind placebo controlled trial. S Afr Med J 1995; 85: 885–7

Active substance: LOPERAMIDE

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Document reference: 31425

Study title: E-BRO-AWB 1 (Nov. 2005 - Mar. 2006): not-randomized, open post-marketing surveillance study

Active substance: liquid thyme extract (extracting ratio: 1 : 2 - 2.5, extracting agents: ammonia solution 10% [m/m] : glycerol 85% [m/m]: ethanol 90 % [V/V] : water (1:20:70:109)) liquid Ivy leaf extract (extracting ratio: 1:1, extracting agent: ethanol 70 % [V/V])

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Document reference: 40048

Study title: A Double Blind Randomized Dose Response Study of Lisinopril in Children with Hypertension. (Protocol 115) and An Open Two Period Crossover Study to Determine the Relative Bioavailability of Lisinopril Suspension

Active substance: LISINOPRIL

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Document reference: 31291

Study title: Lopinavir/ritonavir once-daily in HIV-1 infected children: A pharmacokinetic and dose finding study. Published as Verweel G, Burger DM, Sheehan NL, Bergshoeff AS, Warris A, van der Knaap LC,Driessen G, de Groot R, Hartwig NG. Plasma concentrations of the HIV-protease inhibitor lopinavir are suboptimal in children aged 2 years and below. Antivir Ther. 2007;12(4):453-8. Lopinavir/ritonavir once-daily in HIV-1 infected children: A pharmacokinetic and dose finding study. Published as Verweel G, Burger DM, Sheehan NL, Bergshoeff AS, Warris A, van der Knaap LC,Driessen G, de Groot R, Hartwig NG. Plasma concentrations of the HIV-protease inhibitor lopinavir are suboptimal in children aged 2 years and below. Antivir Ther. 2007;12(4):453-8.

Active substance: lopinavir / ritonavir

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Document reference: 41521

Study title: Efficacy and tolerability of Ambroxol Lozenges 20mg in relieving the pain of sore throat in adolescent patients with acute viral pharyngitis Â– A randomised, double-blind, placebo-controlled parallel group...

Active substance: AMBROXOL

Study summary document link (including results): Ambroxol Hydrochloride_U06-1404_Synopsis.pdf

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Document reference: 46554

Study title: Tolerance of levocabastine eye drops; an open study in volunteers and patients (13-65 yrs)

Active substance: LEVOCABASTINE

Study summary document link (including results): LMD62435_Interventional_Levocabastine.xls

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Document reference: 31096

Study title: L-carnitine in children with idiopathic dilated cardiomyopathy. Kothari SS, Sharma M. Indian Heart J. 1998 Jan-Feb; 50(1):59-61. L-carnitine in children with idiopathic dilated cardiomyopathy. Kothari SS, Sharma M. Indian Heart J. 1998 Jan-Feb; 50(1):59-61.

Active substance: LEVOCARNITINE

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Document reference: 31141

Study title: ND: 20138 AU: Winter-S, Jue-K, Prochazka-J, Francis-P, Hamilton-W, Linn-L, Helton- E. IN: Genetics/Metabolism, Valley Children's Hospital, 3151 North Millbrook, Fresno, CA 93703, United States. TI: The role of L-carnitine in pediatric cardiomyopathy.; SO: J-CHILD-NEUROL, 1995, VOL/ISS/PG. 10/SUPPL. 2 (2S45-2S51)ND: 20138 AU: Winter-S, Jue-K, Prochazka-J, Francis-P, Hamilton-W, Linn-L, Helton- E. IN: Genetics/Metabolism, Valley Children's Hospital, 3151 North Millbrook, Fresno, CA 93703, United States. TI: The role of L-carnitine in pediatric cardiomyopathy.; SO: J-CHILD-NEUROL, 1995, VOL/ISS/PG. 10/SUPPL. 2 (2S45-2S51)

Active substance: LEVOCARNITINE

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Document reference: 31146

Study title: ND: 27179 AU: BOUISSOU F, FABRE C, REMESY M, MESTERY D,YUNG M, CABAL G, PIQUEMAL J, MARMIN G, BOESEN G, FOURES M F, BARTHE PH. IN: NEPHROLOGIE PEDIATRIQUE, HOPITAL DES ENFANTS, TOULOUSE, FRANCE. TI: CARNITINE SUPPLEMENTATION IN HEMODIALYSED CHILDREN: EFFECTS ON HEMATOLOGICAL FINDINGS, LIPID PROFILE AND MUSCLES. UROPEAN SOCIETY FOR PAEDIATRIC NEPHROLOGY; SO: 33RD ANNUAL MEETING OF THE EUROPEAN SOCIETY FOR PAEDIATRIC NEPHROLOGY, PRAGUE, CZECH REPUBLIC, SEPTEMBER 2-5, 1999 SPONSORED BY: EUROPEAN SOCIETY FORPAEDIATRIC NEPHROLOGY. PEDIATRIC-NEPHROLOGY, SEPT., 1999, VOL. 13, NO. 7, C82;REUNION ANNUELLE NOVEMBER 1998, LUXEMBOURGND: 27179 AU: BOUISSOU F, FABRE C, REMESY M, MESTERY D,YUNG M, CABAL G, PIQUEMAL J, MARMIN G, BOESEN G, FOURES M F, BARTHE PH. IN: NEPHROLOGIE PEDIATRIQUE, HOPITAL DES ...

Active substance: LEVOCARNITINE

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Document reference: 31145

Study title: Shany, E., O. Benzaqen, and N. Watemberg, Comparison of continuous drip of midazolam or lidocaine in the treatment of intractable neonatal seizures. J Child Neurol, 2007. 22(3): p. 255-9Shany, E., O. Benzaqen, and N. Watemberg, Comparison of continuous drip of midazolam or lidocaine in the treatment of intractable neonatal seizures. J Child Neurol, 2007. 22(3): p. 255-9

Active substance: MIDAZOLAM

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Document reference: 32008

Study title: A survey of the side effects of midecamycin acetate (Miocamycin) dry syrup after marketing - T. Mayama, K. Maruyama, T. Nakazawa and M. Iida - International journal of clinical Pharmacology, therapy and toxicology, vol.28 nr6 - 1990 (245-250)

Active substance: MIDECAMYCIN

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Document reference: 32012

Study title: Comparison of Miocamycin versus Amoxicillin in lower respiratory tract infections in children. Clinical response and effect on natural killer activity - C. Agostini et al. - Journal Internat. Medical Research 1988, 16; 305-311

Active substance: MIDECAMYCIN

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Document reference: 32016

Study title: Studio comparativo tra miocamicina ed eritromicina nell'erradicazione di streptococco B-emolitico di Gruppo a ed influenza di miocamicina sulla fagocitosi dei polimorfonucleati verso streptococco autologo - M. Borzani, F. Varotto, L.Garlaschi, et al. - Riv. Inf. Ped. 1989, 1, 29-35

Active substance: MIDECAMYCIN

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Document reference: 32014

Study title: Studio preliminare sulla Farmacocinetica della miocamicina nell'età pediatrica - L. Tarani, A. Teggi, L. Bruni, et al Riv. Inf. Ped. 1989, 4, 251-255

Active substance: MIDECAMYCIN

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Document reference: 32013

Study title: Upper respiratory tract infections in children: Antibiotic treatment - Marchisio P., Principi, N. - Drugs Exptl. Clin. Res. XIII(9) 585-588 (1987)

Active substance: MIDECAMYCIN

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Document reference: 32017

Study title: Clinical trial for efficacy and safety of miglitol ( Bay m 1099) in insulin - dependent diabetic children - Petzinna D. and al. - 16/06/1994 Miglitol Initial Registration Dossier - 1995 - Part IV Vol 294

Active substance: MIGLITOL

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Document reference: 32018

Study title: Clinical trial to assess the efficacy and tolerability of Bay m 1099 (Miglitol) in insulin-dependent diabetic children - H Schulz and al. - 27/11/1990 Migliotl Initial Registration Dossier - 1995 - Part IV Vol 292

Active substance: MIGLITOL

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Document reference: 32019

Study title: Chavarria AP, et al. Control of pediatric diarrhea. Adv Ther 1984 1: 115–119Chavarria AP, et al. Control of pediatric diarrhea. Adv Ther 1984 1: 115–119

Active substance: LOPERAMIDE

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Document reference: 31444

Study title: Ramos JT, De José MI, Dueñas J, Fortuny C, González-Montero R, Mellado MJ, Mur A, Navarro M, Otero C, Pocheville I, Muñoz-Fernández MA, Cabrero E; Spanish Collaborative Group on HIV Infection in Children. Safety and antiviral response at 12 months of lopinavir/ritonavir therapy in human immunodeficiency virus-1-infected children experienced with three classes of antiretrovirals. Pediatr Infect Dis J. 2005 Oct;24(10):867-73Ramos JT, De José MI, Dueñas J, Fortuny C, González-Montero R, Mellado MJ, Mur A, Navarro M, Otero C, Pocheville I, Muñoz-Fernández MA, Cabrero E; Spanish Collaborative Group on HIV Infection in Children. Safety and antiviral response at 12 months of lopinavir/ritonavir therapy in human immunodeficiency virus-1-infected children experienced with three classes of anti...

Active substance: lopinavir / ritonavir

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Document reference: 41531

Study title: Resino S, Bellón JM, Muñoz-Fernández MA; Spanish Group of HIV Infection. Antiretroviral activity and safety of lopinavir/ritonavir in protease inhibitor-experienced HIV-infected children with severe-moderate immunodeficiency. J Antimicrob Chemother. 2006Resino S, Bellón JM, Muñoz-Fernández MA; Spanish Group of HIV Infection. Antiretroviral activity and safety of lopinavir/ritonavir in protease inhibitor-experienced HIV-infected children with severe-moderate immunodeficiency. J Antimicrob Chemother. 2006

Active substance: lopinavir / ritonavir

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Document reference: 41530

Study title: van der Lee M, Verweel G, de Groot R, Burger D. Pharmacokinetics of a once-daily regimen of lopinavir/ritonavir in HIV-1-infected children. Antivir Ther. 2006;11(4):439-45 See Neth 378-00-66van der Lee M, Verweel G, de Groot R, Burger D. Pharmacokinetics of a once-daily regimen of lopinavir/ritonavir in HIV-1-infected children. Antivir Ther. 2006;11(4):439-45 See Neth 378-00-66

Active substance: lopinavir / ritonavir

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Document reference: 41522

Study title: Virological and immunological response in HIV infected children with lopinavir/r qd vs. lopinavir/r bid. Published as:Lopinavir/ritonavir exposure in treatment-naive HIV-infected children following twice or once daily administration. J Antimicrob Chemother. 2006 Jun;57(6):1168-71. Epub 2006 Apr 10. Virological and immunological response in HIV infected children with lopinavir/r qd vs. lopinavir/r bid. Published as:Lopinavir/ritonavir exposure in treatment-naive HIV-infected children following twice or once daily administration. J Antimicrob Chemother. 2006 Jun;57(6):1168-71. Epub 2006 Apr 10.

Active substance: lopinavir / ritonavir

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Document reference: 41527

Study title: Lorabid in acute otitis media: 10-day vs 5-day therapy

Active substance: LORACARBEF

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Document reference: 31453

Study title: Lorabid in acute otitis media: 10-day vs 5-day therapy

Active substance: LORACARBEF

Study summary document link (including results): Loracarbef - B9U-MC-AZAZ aCSR redacted.PDF

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Document reference: 31454

Study title: Comparison of fennel and mefenamic acid for the treatment of primary dysmenorrhea; Namavar Jahromi B et al. , Int J Gynaecol Obstet. 2003 Feb;80(2):153-7.Comparison of fennel and mefenamic acid for the treatment of primary dysmenorrhea; Namavar Jahromi B et al. , Int J Gynaecol Obstet. 2003 Feb;80(2):153-7.

Active substance: MEFENAMIC ACID

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Document reference: 41620

Study title: ND: 27405 AU: Van-Oudheusden-L-J, Scholte-H-R. IN: Westfries Gasthuis, Dept Pediat, POB 600, NL-1620 AR Hoorn, Netherlands. Erasmus Univ, Rotterdam, Netherlands. TI: Efficacy of carnitine in the treatment of children with attention- deficithyperactivity disorder; SO: PROSTAGLANDINS-LEUKOTRIENES-AND-ESSENTIAL-FATTY-ACIDS, 2002, V67, N1, JUL,pp 33-38 ND: 27405 AU: Van-Oudheusden-L-J, Scholte-H-R. IN: Westfries Gasthuis, Dept Pediat, POB 600, NL-1620 AR Hoorn, Netherlands. Erasmus Univ, Rotterdam, Netherlands. TI: Efficacy of carnitine in the treatment of children with attention- deficithyperactivity disorder; SO: PROSTAGLANDINS-LEUKOTRIENES-AND-ESSENTIAL-FATTY-ACIDS, 2002, V67, N1, JUL,pp 33-38

Active substance: LEVOCARNITINE

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Document reference: 31144

Study title: Montero J, Pastor JC et al. Double blind clinical trial between lomefloxacin 0.3% (DR 1303) eye drops and gentamicin 0.3% in patients with acute bacterial conjunctivitis. December 15, 1994.

Active substance: LOMEFLOXACIN

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Document reference: 31395

Study title: Patterson A, Agius-Fernandez A. Use of topically applied lomefloxacin 0.3% (DR 1303) in comparison to chloramphenicol 0.5% in the treatment of acute bacterial conjunctivitis. July 7, 1993.

Active substance: LOMEFLOXACIN

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Document reference: 31397

Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6)

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Document reference: 31521

Study title: Troubles during dentition. Study concerning treatment with a homeopatic complex preparation

Active substance: Magnesium phosphoricum C6, Chamomilla recutita D6, Calcium carbonicum C8, Passiflora D6

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Document reference: 40066

Study title: "ARDOUIN P. Intérêt du NECYRANE dans la pratique O.R.L courante. Revue de Méd. De Tours ; 1973 – T.7 – N°8."

Active substance: Magnesium Ritiometan

Study summary document link (including results): Necyrane-option1.xls

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Document reference: 47881

Study title: "Furosemide and mannitol suppression of epileptic activity in the human brain"http://www.ncbi.nlm.nih.gov/pubmed?term=15728766 "Furosemide and mannitol suppression of epileptic activity in the human brain"http://www.ncbi.nlm.nih.gov/pubmed?term=15728766

Active substance: MANNITOL

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Document reference: 31524

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2004

Active substance: METAMIZOLE

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Document reference: 31703

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2005

Active substance: METAMIZOLE

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Document reference: 31704

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2006

Active substance: METAMIZOLE

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Document reference: 31705

Study title: Study in : Dypyrone in Acute pain - Clinical Expert Report - C. MOLKENTELLER - 26/05/2007

Active substance: METAMIZOLE

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Document reference: 31706

Study title: Three-year experience with Novalgin inj. In the treatment of acute pain in child age: analgetic effect, safety of treatment and incidence of indesirable effects. Kralinsky K. et al.; Cs Pediat 1998; 53:689-692 - Publication in Part IC3 Clinical Documentation - HAUKE - 28/02/2000 -

Active substance: METAMIZOLE

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Document reference: 31707

Study title: Tolfenamic acid and mefenamic acid in the treatment of primary dysmenorrhoea.; Delgado J et al., Pharmacol Toxicol. 1994;75 Suppl 2:89-91. Tolfenamic acid and mefenamic acid in the treatment of primary dysmenorrhoea.; Delgado J et al., Pharmacol Toxicol. 1994;75 Suppl 2:89-91.

Active substance: MEFENAMIC ACID

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Document reference: 31573

Study title: Treatment of primary dysmenorrhea with mefenamic acid.Kintis GA et al, Int J Gynaecol Obstet. 1980;18(3):172-5. Treatment of primary dysmenorrhea with mefenamic acid.Kintis GA et al, Int J Gynaecol Obstet. 1980;18(3):172-5.

Active substance: MEFENAMIC ACID

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Document reference: 31579

Study title: Zusammenfassung der einzelberichte von 13 klinischen prufern uber paspertin-suppositorien fur kinder(8 mg metoclopramid pro zapfchen) - Hennies - 05/10/1971

Active substance: METOCLOPRAMIDE

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Document reference: 31959

Study title: Estudio del vogalen gotas en los reflujos gastroesofagios del lactante confrontacion clinica-radiologica-endoscopia e histologica - Ghisolfi J., Olives J.P., Rives J.J. - 09/1979

Active substance: METOPIMAZINE

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Document reference: 31960

Study title: Observational use study of the tolerability of Octenisept in premature infants in the neonatal intensive care unit of Innsbruck University Hospital. University clinic for paediatric and juvenile medicine. 2000.

Active substance: OCTENIDINE

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Document reference: 32739

Study title: HAB-053

Active substance: inactivated hepatitis a virus and hepatitis b surface antigen (rdna)

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Document reference: 41482

Study title: Erfahrungen mit dem Präparat Bebulin bei Therapie von Patienten mit Hämophilie B (Lechner K 1974) (BEBULIN Experiences with Bebulin in the Therapy of Hemophilia B patients

Active substance: FACTOR VIII INHIBITOR BYPASSING ACT

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Document reference: 26992

Study title: Sposto R et al. Comparison of long-term outcome of children and adolescents with disseminated non-lymphoblastic non-Hodgkin lymphoma treated with COMP or daunomycin-COMP: A report from the Children's Cancer Group. Med Pediatr Oncol. 2001 Nov;37(5):432-41.Sposto R et al. Comparison of long-term outcome of children and adolescents with disseminated non-lymphoblastic non-Hodgkin lymphoma treated with COMP or daunomycin-COMP: A report from the Children's Cancer Group. Med Pediatr Oncol. 2001 Nov;37(5):432-41.

Active substance: MITOXANTRONE

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Document reference: 32208

Study title: Starling KA et al Mitoxantrone in refractory acute leukemia in children: a phase I study Invest New Drugs. 1985;3(2):191-5 Starling KA et al Mitoxantrone in refractory acute leukemia in children: a phase I study Invest New Drugs. 1985;3(2):191-5

Active substance: MITOXANTRONE

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Document reference: 32080

Study title: Steinherz PG et al. Development of a new intensive therapy for acute lymphoblastic leukemia in children at increased risk of early relapse. The Memorial Sloan-Kettering-New York-II protocol. Cancer. 1993 Nov 15;72(10):3120-30.Steinherz PG et al. Development of a new intensive therapy for acute lymphoblastic leukemia in children at increased risk of early relapse. The Memorial Sloan-Kettering-New York-II protocol. Cancer. 1993 Nov 15;72(10):3120-30.

Active substance: MITOXANTRONE

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Document reference: 32218

Study title: Steuber CP et al Toxicity evaluation of dihydroxyanthracenedione (DHAD) in combination with cytosine arabinoside (Ara-C) Invest New Drugs. 1987 Dec;5(4):379-82 Steuber CP et al Toxicity evaluation of dihydroxyanthracenedione (DHAD) in combination with cytosine arabinoside (Ara-C) Invest New Drugs. 1987 Dec;5(4):379-82

Active substance: MITOXANTRONE

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Document reference: 32088

Study title: Stevens MC et al Treatment of nonmetastatic rhabdomyosarcoma in childhood and adolescence: third study of the International Society of Paediatric Oncology--SIOP Malignant Mesenchymal Tumor 89 J Clin Oncol. 2005 Apr 20;23(12):2618-28. Epub 2005 Feb 22Stevens MC et al Treatment of nonmetastatic rhabdomyosarcoma in childhood and adolescence: third study of the International Society of Paediatric Oncology--SIOP Malignant Mesenchymal Tumor 89 J Clin Oncol. 2005 Apr 20;23(12):2618-28. Epub 2005 Feb 22

Active substance: MITOXANTRONE

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Document reference: 32148

Study title: Statement on the safety of medicinal products used by children. Contribution to the safety of medicinal products used by children younger than 12 years in Germany by data on compulsory rebate on OTC medicinal products and surveillance of adverse drug effects. Here: Recessan.Statement on the safety of medicinal products used by children. Contribution to the safety of medicinal products used by children younger than 12 years in Germany by data on compulsory rebate on OTC medicinal products and surveillance of adverse drug effects. Here: Recessan.

Active substance: POLIDOCANOL

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Document reference: 46072

Study title: Ten years experience with paravariceal injection sclerotherapy of esophageal varices in children; Paquet,K.J.;J. Pediatr. Surg.(1985) vol.20, n°2, p.109-112Ten years experience with paravariceal injection sclerotherapy of esophageal varices in children; Paquet,K.J.;J. Pediatr. Surg.(1985) vol.20, n°2, p.109-112

Active substance: POLIDOCANOL

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Document reference: 46069

Study title: Upper gastro-intestinal tract bleeding in cirrhotic children candidates for liver transplantation. Sokal,E.M.;Eur. J.Pediatr.(1992) vol.151p.326-328Upper gastro-intestinal tract bleeding in cirrhotic children candidates for liver transplantation. Sokal,E.M.;Eur. J.Pediatr.(1992) vol.151p.326-328

Active substance: POLIDOCANOL

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Document reference: 46071

Study title: Renal function and cardiac angiography; NIBOSHI A; Indian J. Pediatr.; 2006 vol.73 n.1 p.49 53Renal function and cardiac angiography; NIBOSHI A; Indian J. Pediatr.; 2006 vol.73 n.1 p.49 53

Active substance: IOVERSOL

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Document reference: 30426

Study title: A double-blind, single dose evaluation of the comparative analgesic efficacy of acetaminophen 1000 mg, ibuprofen 400 mg, ibuprofen 200 mg, and placebo in the treatment of pain following oral surgery. Stat Rpt 58. Protocol 3-278, Unpublished Report 172.

Active substance: IBUPROFEN AND PARACETAMOL

Study summary document link (including results): ibuprofen_paracetamol 3-278.pdf

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Document reference: 47389

Study title: Kubba, H., MacAndie, C., Botma, M., Robison, J., O'Donnell, M., Robertson, G., and Geddes, N. Department of Otolaryngology Head and Neck Surgery, Royal Hospital for Sick Children, Yorkhill, Glasgow, UK. A prospective, single-blind, randomized controlled trial of antiseptic cream for recurrent epistaxis in childhood Clin.Otolaryngol.Allied Sci. 2001;26:465-468.

Active substance: CHLORHEXIDINE_AND_NEOMYCIN

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Document reference: 23934

Study title: Open label pharmacokinetic evaluation of single oral doses of dolasetron mesilate for the prevention of acute (24-hour) nausea and vomiting in paediatric cancer patients receiving moderately to highly emetogenic chemotherapy - Lariviere - 28 April 1995

Active substance: DOLASETRON

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Document reference: 26302

Study title: Extension of Study LUI-01-00 in Austria: LUIVAC treatment under daily life conditions in patients with recurrent respiratory tract infections including obstructive pulmonary diseases

Active substance: Bacterial lysate

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Document reference: 41833

Study title: Heron-B, Gautier-A, Dulac-O, Ponsot-G. Service de Neurologie Pediatrique, Hopital Saint-Vincent-de-Paul, Paris. Biotinidase deficiency. Progressive encephalopathy curable with biotin. Archives francaises de pediatrie, {Arch-Fr-Pediatr}, Dec 1993, vol. 50, no. 10, p. 875-8, ISSN: 0003-9764.Heron-B, Gautier-A, Dulac-O, Ponsot-G. Service de Neurologie Pediatrique, Hopital Saint-Vincent-de-Paul, Paris. Biotinidase deficiency. Progressive encephalopathy curable with biotin. Archives francaises de pediatrie, {Arch-Fr-Pediatr}, Dec 1993, vol. 50, no. 10, p. 875-8, ISSN: 0003-9764.

Active substance: BIOTIN

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Document reference: 22625

Study title: Cohen-M-E, Duffner-P-K. Street; Buffalo, NY 14222., United States. Long-term consequences of CNS treatment for childhood cancer, Part I: Pathologic consequences and potential for oncogenesis. Pediatric Neurology {PEDIATR-NEUROL}, 1991, Vol/Iss/Pg. 7/3 (157-63), ISSN: 0887-8994.Cohen-M-E, Duffner-P-K. Street; Buffalo, NY 14222., United States. Long-term consequences of CNS treatment for childhood cancer, Part I: Pathologic consequences and potential for oncogenesis. Pediatric Neurology {PEDIATR-NEUROL}, 1991, Vol/Iss/Pg. 7/3 (157-63), ISSN: 0887-8994.

Active substance: PREDNISOLONE

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Document reference: 34685

Study title: "Short term linear growth in asmathic children during treatment with prednisolone - Wolthers OD., Pedersen S. - 21/071990 (BMJ;301(6744):145-148) - Publication in Response Document Nasacort Triamcinolone Acetonide Aquaeous nasal spray -" "Short term linear growth in asmathic children during treatment with prednisolone - Wolthers OD., Pedersen S. - 21/071990 (BMJ;301(6744):145-148) - Publication in Response Document Nasacort Triamcinolone Acetonide Aquaeous nasal spray -"

Active substance: PREDNISOLONE

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Document reference: 45113

Study title: Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans. Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6.Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans. Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6.

Active substance: PREDNISOLONE AND SULFACETAMIDE

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Document reference: 46113

Study title: Theralene pectoral, clinical expertise - Giraud - 06/01/65

Active substance: ALIMEMAZINE

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Document reference: 46441

Study title: EFFICACY AND SAFETY OF CIPROFLOXACIN VS TOBRAMYCIN AND CEFTAZIDIME IN THE TREATMENT OF CHILDREN AND JUVENILES SUFFERING FROM ACUTE PULMONARY EXACERBATION OF CYSTIC FIBROSIS (AMENDMENT NO.3/09.MARCH 95)

Active substance: CIPROFLOXACIN

Study summary document link (including results): Bayer Pharma_Ciprofloxacin_1310_study_synopsis.pdf

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Document reference: 24219

Study title: A double blind, cross-over study to examine the effect of an inhaled corticosteroid (BUD) on the response to histamine challenge in a group of 12 mild asthmatics (aged 17 to 54 years) subjects

Active substance: BUDESONIDE

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Document reference: 48406

Study title: A double blind, cross-over, randomized study with 2 periods of 2 weeks with 2weeks washout. To investigate the mechanisms for the clinical effects of budesonide on LAR, by measuring inflammatory cells and markers in bronchoalveolar lavage (BAL) fluid. Mean age (range): 24.5 years (17 - 30 years)

Active substance: BUDESONIDE

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Document reference: 48404

Study title: A double-blind crossover study to assess the efficacy of nebulized BUD (0.5 mg BID) against placebo in the management of asthma in 23 infants aged 3 to 17 months.

Active substance: BUDESONIDE

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Document reference: 48427

Study title: A double-blind study to investigate whether prolonged corticosteroid therapy potentiates the effects of beta-2 agonist on pulmonary function in 14 asthmatic children (8-15 years).

Active substance: BUDESONIDE

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Document reference: 48407

Study title: A double-blind, placebo-controlled study to compare different treatments for acute wheezy bronchitis in 123 children aged 1.5-18 months.

Active substance: BUDESONIDE

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Document reference: 48430

Study title: A double-blind, randomized, cross-over studytTo determine whether the inhaled glucocorticoid BUD has any adverse effect on short-term linear growth in 15 children (6-13 years) with mild asthma.

Active substance: BUDESONIDE

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Document reference: 48419

Study title: A prospective, double-blind, parallel study to investigate the effect on the baseline adrenal function of increasing doses of topical steroids in 41 children (aged 7-15 years) with mild bronchial asthma.

Active substance: BUDESONIDE

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Document reference: 48408

Study title: A randomised cross-over study of two consecutive week treatment periods to compare the ease of handling and application by the parents and the acceptability by the child of two spacer devices, NebuChamber® and Babyhaler®, in the treatment of young children aged 6 – 59 months with symptoms of asthma.

Active substance: BUDESONIDE

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Document reference: 48424

Study title: Ehrich JHH. Long versus standard prednisone therapy for initial treatment of idiopathic nephritic dyndrome in children Eur J Pediatr 1993; 152: 357-361Ehrich JHH. Long versus standard prednisone therapy for initial treatment of idiopathic nephritic dyndrome in children Eur J Pediatr 1993; 152: 357-361

Active substance: PREDNISONE

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Document reference: 34689

Study title: Hoyer PF. Initial Treatment of Idiopathic Nephrotic Syndrome in Children: Prednisone versus Prednisone Plus Cyclosprorine A: A Prospective, Randomized Trial J Am Soc Nephrol 2006; 17: 1151-1157Hoyer PF. Initial Treatment of Idiopathic Nephrotic Syndrome in Children: Prednisone versus Prednisone Plus Cyclosprorine A: A Prospective, Randomized Trial J Am Soc Nephrol 2006; 17: 1151-1157

Active substance: PREDNISONE

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Document reference: 34688

Study title: Foresti F. Sul trattamento medico delle insufficienze mentali infantili. (Rilievo su 60 casi trattati con un prodotto di associazione di farmaci ad azione psiconeurotrofica) Il Lavoro Neuropsichiatrico,56(1), gennaio-febbraio, 1975Foresti F. Sul trattamento medico delle insufficienze mentali infantili. (Rilievo su 60 casi trattati con un prodotto di associazione di farmaci ad azione psiconeurotrofica) Il Lavoro Neuropsichiatrico,56(1), gennaio-febbraio, 1975

Active substance: MINERALS AND VITAMINS

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Document reference: 32046

Study title: Pisana F.,De Pasquale C.,Foresti F. Attività psicotrofica di una associazione farmacologica nel ritardo mentale Neuropsichiatria Infantile ,n.164-165, (nuova serie), 225,1975Pisana F.,De Pasquale C.,Foresti F. Attività psicotrofica di una associazione farmacologica nel ritardo mentale Neuropsichiatria Infantile ,n.164-165, (nuova serie), 225,1975

Active substance: MINERALS AND VITAMINS

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Document reference: 32047

Study title: CGS 5649 B, a new compound, reverses age-related cognitive dysfunctions in rats.

Active substance: PIRACETAM

Study summary document link (including results): PDEE92G0101 - Piracetam.pdf

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Document reference: 46037

Active substance: MITOXANTRONE

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Document reference: 32072

Study title: Bernstein ML et al Intensive therapy with growth factor support for patients with Ewing tumormetastatic at diagnosis: Pediatric Oncology Group/Children's Cancer Group Phase II Study 9457--a report from the Children's Oncology Group J Clin Oncol. 2006 Jan 1;24(1):152-9Bernstein ML et al Intensive therapy with growth factor support for patients with Ewing tumormetastatic at diagnosis: Pediatric Oncology Group/Children's Cancer Group Phase II Study 9457--a report from the Children's Oncology Group J Clin Oncol. 2006 Jan 1;24(1):152-9

Active substance: MITOXANTRONE

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Document reference: 32108

Study title: Massimino M et al, Hyperfractionated radiotherapy and chemotherapy for childhood ependymoma: final results of the first prospective AIEOP (Associazione Italiana di, Ematologia-Oncologia Pediatrica) study, Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1336-45

Active substance: ETOPOSIDE

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Document reference: 26826

Study title: An open, prospective study to assess the long-term safety, as well as efficacy, of BUD in 52 asthmatic children aged 4-13 years (mean 9.6) whose asthma was not adequately controlled by their current therapy.

Active substance: BUDESONIDE

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Document reference: 48413

Study title: An open, prospective study to evalute the efficacy and safety of a 1-year administration of inhaled BUD via a spacer device in 16 children (3.5-7 years) with severe asthma lasting from 1 to 4 years (mean 3 years).

Active substance: BUDESONIDE

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Document reference: 48412

Study title: Tolerability of cetirizine in children. results of a prospective clinical observation study in 305 children suffering from allergic disorders of the upper respiratory tract and allergic pruritus.

Active substance: CETIRIZINE

Study summary document link (including results): SRCE92E2202 - Cetirizine.pdf

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Document reference: 23783

Study title: Comparision of equal dose of budesonide inhaled from a Nebuhaler (aerosol) and from a Turbuhaler (powder) in a 4-weeks cross-over study in asthmatic children 10 - 15 years old

Active substance: BUDESONIDE

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Document reference: 48435

Study title: Spata N. Esperienza clinica con preparato ad azione antiacetonemica Agg.Pediat.,35(2),275-278,1984Spata N. Esperienza clinica con preparato ad azione antiacetonemica Agg.Pediat.,35(2),275-278,1984

Active substance: MINERALS AND VITAMINS

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Document reference: 32041

Study title: Campese VM. Minoxidil: a review of its pharmacological properties and therapeutic use. Drugs 1981; 22(4):257-278Campese VM. Minoxidil: a review of its pharmacological properties and therapeutic use. Drugs 1981; 22(4):257-278

Active substance: MINOXIDIL

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Document reference: 32055

Study title: Double-blind, randomized, placebo-controlled trial of the efficacy and safety of 5% minoxidil foam in the treatment of androgenetic alopecia in males

Active substance: MINOXIDIL

Study summary document link (including results): minoxidil A6221001.pdf

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Document reference: 32064

Study title: Halling SE et al., Minoxidil therapy in children and young adult patients with renal disease and refractory hypertension: value when multidrug regimens have failed to achieve blood pressure control. Journal of Human Hypertension 2010;24:552-554Halling SE et al., Minoxidil therapy in children and young adult patients with renal disease and refractory hypertension: value when multidrug regimens have failed to achieve blood pressure control. Journal of Human Hypertension 2010;24:552-554

Active substance: MINOXIDIL

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Document reference: 32056

Study title: Packer RJ et al Phase III study of craniospinal radiation therapy followed by adjuvant chemotherapy for newly diagnosed average-risk medulloblastoma. J Clin Oncol. 2006 Sep 1;24(25):4202-8Packer RJ et al Phase III study of craniospinal radiation therapy followed by adjuvant chemotherapy for newly diagnosed average-risk medulloblastoma. J Clin Oncol. 2006 Sep 1;24(25):4202-8

Active substance: MITOXANTRONE

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Document reference: 32232

Study title: Pappo AS et al A phase II trial of ifosfamide in previously untreated children and adolescents with unresectable rhabdomyosarcoma Cancer. 1993 Mar 15;71(6):2119-25Pappo AS et al A phase II trial of ifosfamide in previously untreated children and adolescents with unresectable rhabdomyosarcoma Cancer. 1993 Mar 15;71(6):2119-25

Active substance: MITOXANTRONE

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Document reference: 32157

Study title: Pappo AS et al Phase II trial of neoadjuvant vincristine, ifosfamide, and doxorubicin with granulocyte colony-stimulating factor support in children and adolescents with advanced-stage nonrhabdomyosarcomatous soft tissue sarcomas: a Pediatric Oncology Group Study J Clin Oncol. 2005 Jun 20;23(18):4031-8. Epub 2005 Mar 14Pappo AS et al Phase II trial of neoadjuvant vincristine, ifosfamide, and doxorubicin with granulocyte colony-stimulating factor support in children and adolescents with advanced-stage nonrhabdomyosarcomatous soft tissue sarcomas: a Pediatric Oncology Group Study J Clin Oncol. 2005 Jun 20;23(18):4031-8. Epub 2005 Mar 14

Active substance: MITOXANTRONE

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Document reference: 32168

Study title: Bernstein ML et al. Intensive therapy with growth factor support for patients with Ewing tumor metastatic at diagnosis: Pediatric Oncology Group/Children's Cancer Group Phase II Study 9457--a report from the Children's Oncology Group. J Clin Oncol. 2006 Jan 1;24(1):152-9.Bernstein ML et al. Intensive therapy with growth factor support for patients with Ewing tumor metastatic at diagnosis: Pediatric Oncology Group/Children's Cancer Group Phase II Study 9457--a report from the Children's Oncology Group. J Clin Oncol. 2006 Jan 1;24(1):152-9.

Active substance: MITOXANTRONE

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Document reference: 32176

Study title: Berrak SG et al High-dose ifosfamide in relapsed pediatric osteosarcoma: therapeutic effects and renal toxicity Pediatr Blood Cancer. 2005 Mar;44(3):215-9Berrak SG et al High-dose ifosfamide in relapsed pediatric osteosarcoma: therapeutic effects and renal toxicity Pediatr Blood Cancer. 2005 Mar;44(3):215-9

Active substance: MITOXANTRONE

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Document reference: 32132

Study title: Berthold F et al. Myeloablative megatherapy with autologous stem-cell rescue versus oral maintenance chemotherapy as consolidation treatment in patients with high-risk neuroblastoma: a randomised controlled trial. Lancet Oncol. 2005 Sep;6(9):649-58.Berthold F et al. Myeloablative megatherapy with autologous stem-cell rescue versus oral maintenance chemotherapy as consolidation treatment in patients with high-risk neuroblastoma: a randomised controlled trial. Lancet Oncol. 2005 Sep;6(9):649-58.

Active substance: MITOXANTRONE

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Document reference: 32234

Study title: Stewart RJ et al Treatment of children with nonmetastatic paratesticular rhabdomyosarcoma: results of the Malignant Mesenchymal Tumors studies (MMT 84 and MMT 89) of the International Society of Pediatric Oncology J Clin Oncol. 2003 Mar 1;21(5):793-8Stewart RJ et al Treatment of children with nonmetastatic paratesticular rhabdomyosarcoma: results of the Malignant Mesenchymal Tumors studies (MMT 84 and MMT 89) of the International Society of Pediatric Oncology J Clin Oncol. 2003 Mar 1;21(5):793-8

Active substance: MITOXANTRONE

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Document reference: 32149

Study title: Strauss SJ et al Single center experience of a new intensive induction therapy for ewing's family of tumors: feasibility, toxicity, and stem cell mobilization properties J Clin Oncol. 2003 Aug 1;21(15):2974-81Strauss SJ et al Single center experience of a new intensive induction therapy for ewing's family of tumors: feasibility, toxicity, and stem cell mobilization properties J Clin Oncol. 2003 Aug 1;21(15):2974-81

Active substance: MITOXANTRONE

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Document reference: 32110

Study title: Sullivan MP et al. High-dose cyclophosphamide-high-dose methotrexate with coordinated intrathecal therapy for advanced nonlymphoblastic lymphoma of childhood: results of a Pediatric Oncology Group study. Am J Pediatr Hematol Oncol. 1991 Fall;13(3):288-95. Sullivan MP et al. High-dose cyclophosphamide-high-dose methotrexate with coordinated intrathecal therapy for advanced nonlymphoblastic lymphoma of childhood: results of a Pediatric Oncology Group study. Am J Pediatr Hematol Oncol. 1991 Fall;13(3):288-95.

Active substance: MITOXANTRONE

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Document reference: 32251

Study title: Immunogenicity and safety study of two doses of Fluvirin (0.25 mL and 0.5 mL) with Vaxigrip (0.25 mL), in Healthy naive pediatric subjects aged 6 to 35 months.

Active substance: INFLUENZA VACCINE

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Document reference: 48403

Study title: AN 16018227 Medline 20070101. TI The treatment of pediatric migraine. SO Pediatric annals, {Pediatr-Ann}, Jun 2005, vol. 34, no. 6, p. 448-60, 52 refs, ISSN: 0090-4481.AN 16018227 Medline 20070101. TI The treatment of pediatric migraine. SO Pediatric annals, {Pediatr-Ann}, Jun 2005, vol. 34, no. 6, p. 448-60, 52 refs, ISSN: 0090-4481.

Active substance: CYPROHEPTADINE

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Document reference: 25238

Study title: Pharmacokinetics and Pharmacodynamics in Elderly Adults, Young Adults, and Children, Simons, K.J., J.Clin. Pharmacol. 1990; 30: 665-671Pharmacokinetics and Pharmacodynamics in Elderly Adults, Young Adults, and Children, Simons, K.J., J.Clin. Pharmacol. 1990; 30: 665-671

Active substance: DEXAMETHASONE AND DIPHENHYDRAMINE

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Document reference: 25720

Study title: Patte C et al. Granulocyte colony-stimulating factor in induction treatment of children withnon-Hodgkin's lymphoma: a randomized study of the French Society of PediatricOncology. J Clin Oncol. 2002 Jan 15;20(2):441-8.Patte C et al. Granulocyte colony-stimulating factor in induction treatment of children withnon-Hodgkin's lymphoma: a randomized study of the French Society of PediatricOncology. J Clin Oncol. 2002 Jan 15;20(2):441-8.

Active substance: MITOXANTRONE

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Document reference: 32207

Study title: Paulussen M et al Localized Ewing tumor of bone: final results of the cooperative Ewing's Sarcoma Study CESS 86 J Clin Oncol. 2001 Mar 15;19(6):1818-29Paulussen M et al Localized Ewing tumor of bone: final results of the cooperative Ewing's Sarcoma Study CESS 86 J Clin Oncol. 2001 Mar 15;19(6):1818-29

Active substance: MITOXANTRONE

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Document reference: 32096

Study title: Pfreundschuh M et al. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomisedcontrolled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006 May;7(5):379-91Pfreundschuh M et al. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomisedcontrolled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006 May;7(5):379-91

Active substance: MITOXANTRONE

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Document reference: 32247

Study title: Mecillinam in cerebrospinal fluid in children; Garborg O. 1981, Clinical Pharmacokinetics, 6:475-479 Mecillinam in cerebrospinal fluid in children; Garborg O. 1981, Clinical Pharmacokinetics, 6:475-479

Active substance: PIVMECILLINAM

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Document reference: 34534

Study title: Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans. Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6. Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans. Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6.

Active substance: POLYMYXIN B AND TRIMETHOPRIM

Study summary document link (including results): Clinical evaluation of trimethoprim-containing.pdf

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Document reference: 25749

Study title: Results of a survey of children with acute bacterial conjunctivitis treated with trimethoprim-polymyxin B ophthalmic solution.Wagner RS. Clin Ther. 1995 Sep-Oct;17(5):875-81. J Antimicrob Chemother. 1989 Feb;23(2):261-6.Results of a survey of children with acute bacterial conjunctivitis treated with trimethoprim-polymyxin B ophthalmic solution.Wagner RS. Clin Ther. 1995 Sep-Oct;17(5):875-81. J Antimicrob Chemother. 1989 Feb;23(2):261-6.

Active substance: POLYMYXIN B AND TRIMETHOPRIM

Study summary document link (including results): Results of a survey of children with acute bacterial conjunc.pdf

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Document reference: 34586

Study title: Trimethoprim-polymyxin B ophthalmic solution in treatment of surface ocular bacterial infections.Nozik RA, Smolin G, Knowlton G, Austin R. Ann Ophthalmol. 1985 Dec;17(12):746-8.Trimethoprim-polymyxin B ophthalmic solution in treatment of surface ocular bacterial infections.Nozik RA, Smolin G, Knowlton G, Austin R. Ann Ophthalmol. 1985 Dec;17(12):746-8.

Active substance: POLYMYXIN B AND TRIMETHOPRIM

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Document reference: 34585

Study title: Adler – Effective Treatment of Constipation and Encopresis with MOVICOL (Macrogol 3350 with electrolytes) in Children and Adolescents.

Active substance: POLIDOCANOL COMBINATIONS

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Document reference: 34581

Study title: Effect of piracetam on endocrine activities, linear growth, puberty and cognitive functions in 60 children with learning disabilities. a double-blind study of 24 and 52 weeks. Part I - endocrinological aspects. Part II - psychological aspects.

Active substance: PIRACETAM

Study summary document link (including results): CE88K241 - Piracetam.pdf

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Document reference: 45901

Study title: A phase II, controlled, single-center study to assess safety and immunogenicity of a primary vaccination course with one dose of Haemophilus influenzae type b (Hib) conjugate vaccine containing Aluminum Phosphate (Hib/AlPO4 vaccine), given alone or concomitantly with Measles, Mumps and Rubella Vaccine (MMR, Morupar®, licensed by Chiron, now Novartis Vaccines and Diagnostics), in healthy children 12-15 months of age.

Active substance: Influenza Vaccine (Split Virion, Inactivated)

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Document reference: 48391

Study title: General toxicity of formoterol fumarate (D2522) given orally to young rats for three months.

Active substance: FORMOTEROL

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Document reference: 47844

Study title: Prasad Uta. Malays J Surg June 1975;1(1): Juvenile layrngeal papillomaPrasad Uta. Malays J Surg June 1975;1(1): Juvenile layrngeal papilloma

Active substance: INOSINE

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Document reference: 30158

Study title: Mecillinam in enteric fever; Mandal BK et al, BMJ, 1979, 1:586-587 Mecillinam in enteric fever; Mandal BK et al, BMJ, 1979, 1:586-587

Active substance: PIVMECILLINAM

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Document reference: 34531

Study title: Mecillinam in the treatment of neonates; de Louvois J et al, 1981, J. Pernat. Med. 9: 87-95 Mecillinam in the treatment of neonates; de Louvois J et al, 1981, J. Pernat. Med. 9: 87-95

Active substance: PIVMECILLINAM

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Document reference: 34532

Study title: Pivmecillinam cotrimoxazole and oral mecillinam in gastro enteritis due to vibrio spp; Uylangco C. et al, 1984, JAC, 13: 171-175 Pivmecillinam cotrimoxazole and oral mecillinam in gastro enteritis due to vibrio spp; Uylangco C. et al, 1984, JAC, 13: 171-175

Active substance: PIVMECILLINAM

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Document reference: 34538

Study title: Randomised trial of pivampicillin plus pivmecillinam vs pivampicillin in children and young adults with chronic obstructive pulmonary disease and infection with Haemophilus influenzae; Johansen HK et al 1999 Curr Med Res Opin, 15: 300-309 Randomised trial of pivampicillin plus pivmecillinam vs pivampicillin in children and young adults with chronic obstructive pulmonary disease and infection with Haemophilus influenzae; Johansen HK et al 1999 Curr Med Res Opin, 15: 300-309

Active substance: PIVMECILLINAM

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Document reference: 34539

Study title: Slow replenishment of carnitine deficiency after cessation of longterm treatment with pivaloyl-containing antibiotics; Diep, Pharmacy World Sci Vol. 15(5), 1993. 225-229 Slow replenishment of carnitine deficiency after cessation of longterm treatment with pivaloyl-containing antibiotics; Diep, Pharmacy World Sci Vol. 15(5), 1993. 225-229

Active substance: PIVMECILLINAM

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Document reference: 34529

Study title: Double blind, placebo controlled study of the efficacy of polytar in treatment of seborrhoeic dermatitis and eczema of the scalp.

Active substance: Pix pini, Pix juniperi, Solutio picis lithantracis, Extractum oleatum picis lithantracis

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Document reference: 40132

Study title: Bibliography - Resistant pneumococci in paediatrics : therapeutic indications - E. Bingen and A. Bourrillon - January 4th, 1995 - La Presse Médicale (24:N°2)Bibliography - Resistant pneumococci in paediatrics : therapeutic indications - E. Bingen and A. Bourrillon - January 4th, 1995 - La Presse Médicale (24:N°2)

Active substance: PRISTINAMYCIN

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Document reference: 46115

Study title: Buchanan GR et al. Alternating drug pairs with or without periodic reinduction in children with acute lymphoblastic leukemia in second bone marrow remission: a Pediatric Oncology Group Study. Cancer. 2000 Mar 1;88(5):1166-74.Buchanan GR et al. Alternating drug pairs with or without periodic reinduction in children with acute lymphoblastic leukemia in second bone marrow remission: a Pediatric Oncology Group Study. Cancer. 2000 Mar 1;88(5):1166-74.

Active substance: MITOXANTRONE

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Document reference: 32212

Study title: Buchanan GR et al. Improved treatment results in boys with overt testicular relapse during or shortly after initial therapy for acute lymphoblastic leukemia. A Pediatric Oncology group study. Cancer. 1991 Jul 1;68(1):48-55.Buchanan GR et al. Improved treatment results in boys with overt testicular relapse during or shortly after initial therapy for acute lymphoblastic leukemia. A Pediatric Oncology group study. Cancer. 1991 Jul 1;68(1):48-55.

Active substance: MITOXANTRONE

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Document reference: 32226

Study title: Endovascular treatment of acute and subacute hemorrhage in the head and neck. ; Remonda-L. Archives of Otolaryngology - Head and Neck Surgery, 2000, Vol/Iss/Pg. 126/10 (1255-1262)Endovascular treatment of acute and subacute hemorrhage in the head and neck. ; Remonda-L. Archives of Otolaryngology - Head and Neck Surgery, 2000, Vol/Iss/Pg. 126/10 (1255-1262)

Active substance: IODINE

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Document reference: 30249

Study title: Phase IV, double- blind, double-dummy, multicenter clinical study randomized in two parallel groups comparing the efficacy and safety of pristinamycin (PYOSTACINE) at an oral dose of 1 gram twice a day for ten days versus oxacillin (BRISTOPEN) at an oral dose of 1 gram twice a day for 10 days in the treatment of superficial bacterial skin infections in 250 outpatients. Study report PY 403 - Phase IV, double blind, double-dummy, multicenter clinical study, randomised, in two parallel groups, comparing the efficacy and safety of pristinamycin (Pyostacine®) at the posology of 1 gramm orally twice a day for 10 days, versus oxacilline (Bristopen®) at the posology of 1 gramm orally twice a day for 10 days, in the treatment of superficial cutaneous bacterial infections in 250 out-patient. -...

Active substance: PRISTINAMYCIN

Study summary document link (including results): Pristinamycin STUDY SPECIA PY 403.xls

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Document reference: 46118

Study title: Doireau-V, Grill-J, Zerah-M, Lellouch-Tubiana-A, Couanet-D, Chastagner-P, Marchal-J-C, Grignon-Y, Chouffai-Z, Kalifa-C. Department of Paediatrics, Gustave Roussy Institute, Villejuif, France. Chemotherapy for unresectable and recurrent intramedullary glial tumours in children. Brain Tumours Subcommittee of the French Society of Paediatric Oncology (SFOP). British journal of cancer, {Br-J-Cancer}, Nov 1999, vol. 81, no. 5, p. 835-40, ISSN: 0007-0920.Doireau-V, Grill-J, Zerah-M, Lellouch-Tubiana-A, Couanet-D, Chastagner-P, Marchal-J-C, Grignon-Y, Chouffai-Z, Kalifa-C. Department of Paediatrics, Gustave Roussy Institute, Villejuif, France. Chemotherapy for unresectable and recurrent intramedullary glial tumours in children. Brain Tumours Subcommi...

Active substance: PROCARBAZINE

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Document reference: 34697

Study title: Miller K. Pharmacological management of hypertension in paediatric patients. A comprehensive review of the efficacy, safety and dosage guidelines of the available agents. Drugs 1994; 48: 868-87, Update on the 1987 Task Force Report on High Blood Pressure in Children and Adolescents: A Working Group Report from the National High Blood Pressure Education Program. Pediatrics 1996;98;649-658Miller K. Pharmacological management of hypertension in paediatric patients. A comprehensive review of the efficacy, safety and dosage guidelines of the available agents. Drugs 1994; 48: 868-87, Update on the 1987 Task Force Report on High Blood Pressure in Children and Adolescents: A Working Group Report from the National High Blood Pressure Education Program. Pediatrics 1996;98;649-658

Active substance: MINOXIDIL

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Document reference: 32051

Study title: Puri H C et al. Severe hypertension in children with renal disease: treatment with minoxidil. American Journal of Kidney Diseases.1983;3:71-5Puri H C et al. Severe hypertension in children with renal disease: treatment with minoxidil. American Journal of Kidney Diseases.1983;3:71-5

Active substance: MINOXIDIL

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Document reference: 32059

Study title: Clinical observations with regard to the effects of UCB 6215 on some brain functions in schoollchildren.

Active substance: PIRACETAM

Study summary document link (including results): DE73C201 - Piracetam.pdf

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Document reference: 46017

Study title: Comparison of cimetidine and diphenhydramine in the treatment of acute urticaria, Moscati R.M., Ann. Emerg. Med. 1990; 19: 12-15

Active substance: Dextromethorphan + Diphenhydramine + L-Menthol

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Document reference: 25867

Study title: Strife C F et al, Pediatrics. Minoxidil for control of acute blood pressure elevation in chronically hypertensive children. 1986;78: 861-5Strife C F et al, Pediatrics. Minoxidil for control of acute blood pressure elevation in chronically hypertensive children. 1986;78: 861-5

Active substance: MINOXIDIL

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Document reference: 32061

Study title: Suresh et al. Emergency management of pediatric hypertension. Clinical Pediatrics. 2005; 44/9:739-745Suresh et al. Emergency management of pediatric hypertension. Clinical Pediatrics. 2005; 44/9:739-745

Active substance: MINOXIDIL

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Document reference: 32057

Study title: Hamann K.-F. and Bonkowsky V., Minzöl - Wirkung auf die Nasenschleimhaut von Gesunden, DAZ 15/1987 pp.:855-858

Active substance: Mint oil, partly dementolised (HERB)

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Document reference: 40072

Study title: Philip T et al High-dose methotrexate and HELP [Holoxan (ifosfamide), eldesine (vindesine), platinum]--doxorubicin in non-metastatic osteosarcoma of the extremity: a French multicentre pilot study. Fédération Nationale des Centres de Lutte contre le Cancer and Société Française d'Oncologie Pédiatrique Ann Oncol. 1999 Sep;10(9):1065-71Philip T et al High-dose methotrexate and HELP [Holoxan (ifosfamide), eldesine (vindesine), platinum]--doxorubicin in non-metastatic osteosarcoma of the extremity: a French multicentre pilot study. Fédération Nationale des Centres de Lutte contre le Cancer and Société Française d'Oncologie Pédiatrique Ann Oncol. 1999 Sep;10(9):1065-71

Active substance: MITOXANTRONE

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Document reference: 32136

Study title: Worden FP et al Randomized phase II evaluation of 6 g/m2 of ifosfamide plus doxorubicin and granulocyte colony-stimulating factor (G-CSF) compared with 12 g/m2 of ifosfamide plus doxorubicin and G-CSF in the treatment of poor-prognosis soft tissue sarcoma J Clin Oncol. 2005 Jan 1;23(1):105-12. Erratum in: J Clin Oncol. 2006 Sep1;24(25):4223Worden FP et al Randomized phase II evaluation of 6 g/m2 of ifosfamide plus doxorubicin and granulocyte colony-stimulating factor (G-CSF) compared with 12 g/m2 of ifosfamide plus doxorubicin and G-CSF in the treatment of poor-prognosis soft tissue sarcoma J Clin Oncol. 2005 Jan 1;23(1):105-12. Erratum in: J Clin Oncol. 2006 Sep1;24(25):4223

Active substance: MITOXANTRONE

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Document reference: 32171

Study title: Yalcin B et al High-dose ifosfamide with hematopoietic growth factor support in advanced bone and soft tissue sarcomas Exp Oncol. 2004 Dec;26(4):320-5Yalcin B et al High-dose ifosfamide with hematopoietic growth factor support in advanced bone and soft tissue sarcomas Exp Oncol. 2004 Dec;26(4):320-5

Active substance: MITOXANTRONE

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Document reference: 32170

Study title: Yang CP et al. Treatment of childhood acute lymphoblastic leukemia with protocol TCL-842 inTaiwan: the Taiwan Children's Cancer Study Group. J Formos Med Assoc. 1993 May;92(5):431-9.Yang CP et al. Treatment of childhood acute lymphoblastic leukemia with protocol TCL-842 inTaiwan: the Taiwan Children's Cancer Study Group. J Formos Med Assoc. 1993 May;92(5):431-9.

Active substance: MITOXANTRONE

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Document reference: 32222

Study title: Results of plasma samples analysis for mivacurium from a study of the efficacy and safety of mivacurium in paediatric patients (P45-19). TBZZ/89/0014/00 referenced in THRS/89/0031 as available on request (in D921698) .

Active substance: MIVACURIUM

Study summary document link (including results): Study TBZZ-89-0014-00-Mivacurium Chloride.xls

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Document reference: 32256

Study title: Code 9115 2015 USA 90 - Tremblements instabilité emotionnelle. Malformation vasculaire intra-cranienne hemorragie cerebrale. Diplopie.Code 9115 2015 USA 90 - Tremblements instabilité emotionnelle. Malformation vasculaire intra-cranienne hemorragie cerebrale. Diplopie.

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46074

Study title: Duran J.P., Ensel J., Verneuil M.F., Essai clinique du Tranxene en premedication, en anestheie infantile, Ouest Med., 1976, 29, (3), 235-237Duran J.P., Ensel J., Verneuil M.F., Essai clinique du Tranxene en premedication, en anestheie infantile, Ouest Med., 1976, 29, (3), 235-237

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46075

Study title: Double-blind comparison of cefixime and cefaclor in the treatment of acute otitis media in children; Scand J Infect Dis 1991; 23:459-465Double-blind comparison of cefixime and cefaclor in the treatment of acute otitis media in children; Scand J Infect Dis 1991; 23:459-465

Active substance: CEFACLOR

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Document reference: 23381

Study title: Kantar M et al Treatment results of osteosarcoma of the extremity in children and adolescents at Ege University Hospital Pediatr Hematol Oncol. 2002 Oct-Nov;19(7):475-82Kantar M et al Treatment results of osteosarcoma of the extremity in children and adolescents at Ege University Hospital Pediatr Hematol Oncol. 2002 Oct-Nov;19(7):475-82

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 24947

Study title: Report/protocol/study N°: NGB 8855

Active substance: CLEMASTINE

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Document reference: 24315

Study title: Pritchard J et al. High dose melphalan in the treatment of advanced neuroblastoma: results of arandomised trial (ENSG-1) by the European Neuroblastoma Study Group. Pediatr Blood Cancer. 2005 Apr;44(4):348-57.Pritchard J et al. High dose melphalan in the treatment of advanced neuroblastoma: results of arandomised trial (ENSG-1) by the European Neuroblastoma Study Group. Pediatr Blood Cancer. 2005 Apr;44(4):348-57.

Active substance: MITOXANTRONE

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Document reference: 32236

Study title: To study the effects of Fongitar (Polytar AF) in Pityriasis and squamous conditions of the scalp.

Active substance: Pix pini, Pix juniperi, Solutio picis lithantracis, Extractum oleatum picis lithantracis

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Document reference: 40133

Study title: PASSAGE OF BC 105 INTO RAT MILK.; N/A - Klybeck archive

Active substance: PIZOTIFEN

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Document reference: 34543

Study title: Five-year follow-up on the PAT study: specific immunotherapy and long-term prevention of asthma in children

Active substance: Plantago Ovata Tinnevelly Senna Pods

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Document reference: 40138

Study title: Nolan T et al., Randomized trial of laxatives in treatment of childhood encopresis.The Lancet 338, 1991, 8766: 523-527

Active substance: Plantago Ovata Tinnevelly Senna Pods/ (HERB) Ispaghula seed Ispaghula husk/ Ispaghula husk/Ispaghula seeds/Senna pods (HERB)

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Document reference: 40036

Study title: Roth OA., Therapeutic observations on constipation; Med. Welt 1969;20:536-7

Active substance: Plantago Ovata Tinnevelly Senna Pods/ (HERB) Ispaghula seed Ispaghula husk/ Ispaghula husk/Ispaghula seeds/Senna pods (HERB)

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Document reference: 40038

Study title: Sölter et al., Summary of clinical results with Prodiem Plain, a bowel-regulating agent; Today´s Therapeutic Trends (1983);1(1):45-59

Active substance: Plantago Ovata Tinnevelly Senna Pods/ (HERB) Ispaghula seed Ispaghula husk/ Ispaghula husk/Ispaghula seeds/Senna pods (HERB)

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Document reference: 40039

Study title: Zawodsky L., Problems of a double-blind trial, as exemplified by a laxative; Der Praktische Arzt 1976;30:1182-92

Active substance: Plantago Ovata Tinnevelly Senna Pods/ (HERB) Ispaghula seed Ispaghula husk/ Ispaghula husk/Ispaghula seeds/Senna pods (HERB)

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Document reference: 40037

Study title: Effets chez le nouveau-né des benzodiazépines administrée à la mère - Bavoux F., Olivier C., Pons G. - Journées Parisiennes de PediatrieEffets chez le nouveau-né des benzodiazépines administrée à la mère - Bavoux F., Olivier C., Pons G. - Journées Parisiennes de Pediatrie

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46076

Study title: Étude de l'activit+é d'un anxiolytique administré par voie intraveineuse au cours de l'accouchement et de ses effets sur la fréquence cardiaque foetale - Schick A.R., Dellenbach P., Muller P. - Rev. Fr. Gynécol. Obstétr., 1977, 72, (2), 155-160Étude de l'activit+é d'un anxiolytique administré par voie intraveineuse au cours de l'accouchement et de ses effets sur la fréquence cardiaque foetale - Schick A.R., Dellenbach P., Muller P. - Rev. Fr. Gynécol. Obstétr., 1977, 72, (2), 155-160

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46077

Study title: Experimentation du clorazepate dipotassique en psychiatrie infantile - Lacnay Cl.m Houzel D. - Rev. Neuropsychiatr. Infant., 1972, 20, (Mai), 491-495.Experimentation du clorazepate dipotassique en psychiatrie infantile - Lacnay Cl.m Houzel D. - Rev. Neuropsychiatr. Infant., 1972, 20, (Mai), 491-495.

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46078

Study title: Expérimentation du Clorazepate dipotassique en psychiatrie infantile - Launay Cl., Houzel D. - Ver. Neuropsychiatr. Infant., 1972, 20, (Mai), 491-495Expérimentation du Clorazepate dipotassique en psychiatrie infantile - Launay Cl., Houzel D. - Ver. Neuropsychiatr. Infant., 1972, 20, (Mai), 491-495

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46079

Study title: Indications du Tranxene en cure ambulatoire en pédo-psychiatrie. Étude de 31 observations. - Sallou Cl. - Ver. Neuropsychiatr. Infant., 1973, 21, 701-705Indications du Tranxene en cure ambulatoire en pédo-psychiatrie. Étude de 31 observations. - Sallou Cl. - Ver. Neuropsychiatr. Infant., 1973, 21, 701-705

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46080

Study title: Pharmacokinatics of the placental transfer and distribution of Clorazepate and its metabolite nordiazepam in the feto-placental unit and in the neonate - Rey E., Giraux P., d'Athis Ph., Turquais J.M., Chavinie J., Olive G. - Europ. J. Clin. Pharmacol., 1979, 15, 181-185Pharmacokinatics of the placental transfer and distribution of Clorazepate and its metabolite nordiazepam in the feto-placental unit and in the neonate - Rey E., Giraux P., d'Athis Ph., Turquais J.M., Chavinie J., Olive G. - Europ. J. Clin. Pharmacol., 1979, 15, 181-185

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46081

Study title: Utilisation du Chlorazepate dipotassium en debut de travail - Amandruz M., Extermann Ph., Beguin F. - Med.-Hyg., 1983, 41, (1520) 2061-2065Utilisation du Chlorazepate dipotassium en debut de travail - Amandruz M., Extermann Ph., Beguin F. - Med.-Hyg., 1983, 41, (1520) 2061-2065

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46082

Study title: Doz F et al Etoposide and carboplatin in extraocular retinoblastoma: a study by the Société Française d'Oncologie Pédiatrique J Clin Oncol 1995 Apr;13(4):902-9Doz F et al Etoposide and carboplatin in extraocular retinoblastoma: a study by the Société Française d'Oncologie Pédiatrique J Clin Oncol 1995 Apr;13(4):902-9

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 24851

Study title: Clinical trial of the pneumococcal 23-valent vaccine in children with sickle cell disease or splenectomy (> 6 months-15 years old)

Active substance: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENCES)

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Document reference: 41324

Study title: Safety and immunogenicity of the 23-valent pneumococcal vaccine after storage at 4°C for one year. (age 10-52 years old)

Active substance: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENCES)

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Document reference: 41325

Study title: A Pilot Study of the Safety, Tolerability and Immunogenicity of Monovalent Pneumococcal Type 6B Conjugate Vaccine in Adults, Children and Infants

Active substance: Pneumococcal polysaccharides (serotypes 1,2,3,4,5,6B,7F,8,9N,9V,10A,11A,12F,14,15B,17F,18C, 19F,20,22F,23F,33F)

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Document reference: 47769

Study title: A Phase III Randomized, Controlled Study to Compare the Safety and Immunogenicity of Two Different Formulations of a 9-Valent Pneumococcal, Meningococcal Group C Saccharide Conjugate Combination Vaccine Concurrently Administered at Two Different Sites With DTaP-IPV- HepB/Hib in Healthy Infants at 3, 4 and 5 Months of Age

Active substance: Pneumococcal saccharide conjugated vaccine, absorbed

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Document reference: 41589

Study title: EXPRES (EXacerbation PRevention with Elidel Survey)

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CNL01 Art45 listing 2011.xls

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Document reference: 34115

Study title: Naturalistic, open-label, multicenter study of long-term management in patients >=3 months of age with mild to moderate atopic dermatitis using Elidel (pimecrolimus) cream 1%.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CTR01 Art45 listing 2011.xls

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Document reference: 34122

Study title: Naturalistic, open-label, multicenter study of long-term management in patients >=3 months of age with mild to moderate atopic dermatitis using Elidel (pimecrolimus) cream 1%.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CTR01 Art45 listing 2011.xls

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Document reference: 47711

Study title: Naturalistic, open-label, multicenter study of short-term management in early school-aged 6-10 years old) children with mild or moderate atopic dermatitis using Elidel (pimecrolimus) cream 1%.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CPL01 Art45 listing 2011.xls

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Document reference: 34101

Study title: Oncogenicity study by dermal administration to CD-1 mice for 52 weeks

Active substance: PIMECROLIMUS

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Document reference: 34128

Study title: Bhatia S et al. Therapy-related myelodysplasia and acute myeloid leukemia after Ewing sarcoma and primitive neuroectodermal tumor of bone: A report from the Children's Oncology Group. Blood. 2007 Jan 1;109(1):46-51. Epub 2006 Sep 19. Bhatia S et al. Therapy-related myelodysplasia and acute myeloid leukemia after Ewing sarcoma and primitive neuroectodermal tumor of bone: A report from the Children's Oncology Group. Blood. 2007 Jan 1;109(1):46-51. Epub 2006 Sep 19.

Active substance: MITOXANTRONE

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Document reference: 32174

Study title: Bisogno G et al Desmoplastic small round cell tumour in children and adolescents Med Pediatr Oncol. 2000 May;34(5):338-42Bisogno G et al Desmoplastic small round cell tumour in children and adolescents Med Pediatr Oncol. 2000 May;34(5):338-42

Active substance: MITOXANTRONE

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Document reference: 32090

Study title: Bisogno G et al Intensive chemotherapy for children and young adults with metastatic primitive neuroectodermal tumors of the soft tissue Bone Marrow Transplant. 2002 Sep;30(5):297-302Bisogno G et al Intensive chemotherapy for children and young adults with metastatic primitive neuroectodermal tumors of the soft tissue Bone Marrow Transplant. 2002 Sep;30(5):297-302

Active substance: MITOXANTRONE

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Document reference: 32172

Study title: Bisogno G et al The IVADo regimen--a pilot study with ifosfamide, vincristine, actinomycin D, and doxorubicin in children with metastatic soft tissue sarcoma: a pilot study of behalf of the European pediatric Soft tissue sarcoma Study Group Cancer. 2005 Apr 15;103(8):1719-24Bisogno G et al The IVADo regimen--a pilot study with ifosfamide, vincristine, actinomycin D, and doxorubicin in children with metastatic soft tissue sarcoma: a pilot study of behalf of the European pediatric Soft tissue sarcoma Study Group Cancer. 2005 Apr 15;103(8):1719-24

Active substance: MITOXANTRONE

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Document reference: 32169

Study title: Bacci G et al Long-term outcome for patients with nonmetastatic osteosarcoma of the extremity treated at the istituto ortopedico rizzoli according to the istituto ortopedicorizzoli/osteosarcoma-2 protocol: an updated report J Clin Oncol. 2000 Dec 15;18(24):4016-27Bacci G et al Long-term outcome for patients with nonmetastatic osteosarcoma of the extremity treated at the istituto ortopedico rizzoli according to the istituto ortopedicorizzoli/osteosarcoma-2 protocol: an updated report J Clin Oncol. 2000 Dec 15;18(24):4016-27

Active substance: CYCLOPHOSPHAMIDE

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Document reference: 24740

Study title: A Stratified, Randomized, Double-Blind, Parallel-Group Trial Assessing the Efficacy and Safety of Fluticasone Propionate via the Multi-Dose Powder Inhaler 50mcg BID, 100mcg QD, and Placebo in Subjects Aged 4 to 11 Years With Chronic Asthma.

Active substance: FLUTICASONE

Study summary document link (including results): Fluticasone-Propionate-FLTA2007-ICHE3.pdf

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Document reference: 28376

Study title: Retrospective Review of Routine Prophylaxis and Inhibitor Treatment with Fanhdi (Bonn)

Active substance: HUMAN COAGULATION FACTOR VIII

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Document reference: 29147

Study title: PMS: Pimecrolimus Cream 1% in childhood atopic dermatitis

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CHU02 Art45 listing 2011.xls

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Document reference: 34112

Study title: StabiEL Stabilisierung des Hautzustandes mit Elidel® (Pimecrolimus) – Post Marketing Surveillance Study.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CDE18 Art45 listing 2011.xls

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Document reference: 34097

Study title: Study title: A Multicentre, single arm prospective, open label study to assess the safety of Elidelâ (SDZ ASM 981 - pimecrolimus) cream 1% in patients with atopic dermatitis (Rainbow study)

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CAE01 Art45 listing 2011.xls

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Document reference: 34111

Study title: Two prospective studies each conducted during 7 months in different locations: * with tacrolimus ointment 0.1%, a randomized, double-blind, placebo-controlled * with pimecrolimus cream 1%, a nonrandomized control study.

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981CBE02 Art45 listing 2011.xls

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Document reference: 48118

Study title: Mirtazapine in the treatment of adolescents with major depression, an open−label, multicenter pilot study; Haapasalo-Pesu KM, Vuola T, Lahelma L, Marttunen M.J Child Adolesc Psychopharmacol. 2004 Summer;14(2):175-84.Mirtazapine in the treatment of adolescents with major depression, an open−label, multicenter pilot study; Haapasalo-Pesu KM, Vuola T, Lahelma L, Marttunen M.J Child Adolesc Psychopharmacol. 2004 Summer;14(2):175-84.

Active substance: MIRTAZAPINE

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Document reference: 32067

Study title: Post-marketing study 2004- 2005 with NHD Mites/Pollen Cluster-dose escalation

Active substance: MITES

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Document reference: 47785

Study title: Anderson JR et al. Long-term follow-up of patients treated with COMP or LSA2L2 therapy for childhood non-Hodgkin's lymphoma: a report of CCG-551 from the Childrens Cancer Group. J Clin Oncol. 1993 Jun;11(6):1024-32Anderson JR et al. Long-term follow-up of patients treated with COMP or LSA2L2 therapy for childhood non-Hodgkin's lymphoma: a report of CCG-551 from the Childrens Cancer Group. J Clin Oncol. 1993 Jun;11(6):1024-32

Active substance: MITOXANTRONE

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Document reference: 32221

Study title: Chou AJ et al Treatment of osteosarcoma at first recurrence after contemporary therapy: the Memorial Sloan-Kettering Cancer Center experience Cancer. 2005 Nov 15;104(10):2214-21Chou AJ et al Treatment of osteosarcoma at first recurrence after contemporary therapy: the Memorial Sloan-Kettering Cancer Center experience Cancer. 2005 Nov 15;104(10):2214-21

Active substance: MITOXANTRONE

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Document reference: 32121

Study title: Coze C et al. NB87 induction protocol for stage 4 neuroblastoma in children over 1 year of age: a report from the French Society of Pediatric Oncology. Clin Oncol. 1997 Dec;15(12):3433-40Coze C et al. NB87 induction protocol for stage 4 neuroblastoma in children over 1 year of age: a report from the French Society of Pediatric Oncology. Clin Oncol. 1997 Dec;15(12):3433-40

Active substance: MITOXANTRONE

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Document reference: 32241

Study title: Joynt, RL et al.: Dantrolene sodium suspension in treatment of spastic cerebral palsy; Dev.Med. Child. Neurol. 22, 755-767 (1980)Joynt, RL et al.: Dantrolene sodium suspension in treatment of spastic cerebral palsy; Dev.Med. Child. Neurol. 22, 755-767 (1980)

Active substance: DANTROLENE

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Document reference: 25531

Study title: Final medical report Acceptance study with Mucosolvan 15 mg and 30 mg in children.

Active substance: AMBROXOL

Study summary document link (including results): Ambroxol Hydrochloride_U87-0438_Synopsis.pdf

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Document reference: 46537

Study title: ZANNINO L, et al. CONTROLLED CLINICAL STUDY ON A NEW MUCOLYTIC AGENT - AMBROXOL HYDROCHLORIDE - IN HYPERSECRETORY BRONCHIALDISEASE IN CHILDREN. “La Clinica Pediatrica” Vol. 64 - Number 4 - 1982

Active substance: AMBROXOL

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Document reference: 48437

Study title: Guarnieri J.,Ciliberto R. Osservazioni cliniche sull’impiego di una nuova associazione antibiotica Aggior.Pediat.,23(1-2-3)1-10,1972Guarnieri J.,Ciliberto R. Osservazioni cliniche sull’impiego di una nuova associazione antibiotica Aggior.Pediat.,23(1-2-3)1-10,1972

Active substance: AMPICILLIN AND CLOXACILLIN

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Document reference: 46653

Study title: Arndt C et al. Age is a risk factor for chemotherapy-induced hepatopathy with vincristine,dactinomycin, and cyclophosphamide. J Clin Oncol. 2004 May 15;22(10):1894-901.Arndt C et al. Age is a risk factor for chemotherapy-induced hepatopathy with vincristine,dactinomycin, and cyclophosphamide. J Clin Oncol. 2004 May 15;22(10):1894-901.

Active substance: MITOXANTRONE

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Document reference: 32178

Study title: Rosito P et al Italian Cooperative Study for the treatment of children and young adults with localized Ewing sarcoma of bone: a preliminary report of 6 years of experience Cancer. 1999 Aug 1;86(3):421-8. Erratum in: Cancer. 2005 Aug 1;104(3):667. dosage error in textRosito P et al Italian Cooperative Study for the treatment of children and young adults with localized Ewing sarcoma of bone: a preliminary report of 6 years of experience Cancer. 1999 Aug 1;86(3):421-8. Erratum in: Cancer. 2005 Aug 1;104(3):667. dosage error in text

Active substance: MITOXANTRONE

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Document reference: 32099

Study title: Rousseau P et al Primary chemotherapy in rhabdomyosarcomas and other malignant mesenchymal tumors of the orbit: results of the International Society of Pediatric Oncology MMT 84 Study J Clin Oncol. 1994 Mar;12(3):516-21Rousseau P et al Primary chemotherapy in rhabdomyosarcomas and other malignant mesenchymal tumors of the orbit: results of the International Society of Pediatric Oncology MMT 84 Study J Clin Oncol. 1994 Mar;12(3):516-21

Active substance: MITOXANTRONE

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Document reference: 32151

Study title: Sackmann-Muriel F et al. Hodgkin disease in children: results of a prospective randomized trial in a single institution in Argentina. Med Pediatr Oncol. 1997 Dec;29(6):544-52.Sackmann-Muriel F et al. Hodgkin disease in children: results of a prospective randomized trial in a single institution in Argentina. Med Pediatr Oncol. 1997 Dec;29(6):544-52.

Active substance: MITOXANTRONE

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Document reference: 32246

Study title: Bunin N et al. Randomized trial of busulfan vs total body irradiation containing conditioning regimens for children with acute lymphoblastic leukemia: a Pediatric Blood and Marrow Transplant Consortium study. Bone Marrow Transplant. 2003 Sep;32(6):543-8Bunin N et al. Randomized trial of busulfan vs total body irradiation containing conditioning regimens for children with acute lymphoblastic leukemia: a Pediatric Blood and Marrow Transplant Consortium study. Bone Marrow Transplant. 2003 Sep;32(6):543-8

Active substance: MITOXANTRONE

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Document reference: 32200

Study title: Burgert EO et al. Multimodal therapy for the management of nonpelvic, localized Ewing's sarcoma of bone: intergroup study IESS-II. J Clin Oncol. 1990 Sep;8(9):1514-24.Burgert EO et al. Multimodal therapy for the management of nonpelvic, localized Ewing's sarcoma of bone: intergroup study IESS-II. J Clin Oncol. 1990 Sep;8(9):1514-24.

Active substance: MITOXANTRONE

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Document reference: 32191

Study title: Castleberry RP et al. Radiotherapy improves the outlook for patients older than 1 year with Pediatric Oncology Group stage C neuroblastoma.J Clin Oncol. 1991 May;9(5):789-95Castleberry RP et al. Radiotherapy improves the outlook for patients older than 1 year with Pediatric Oncology Group stage C neuroblastoma.J Clin Oncol. 1991 May;9(5):789-95

Active substance: MITOXANTRONE

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Document reference: 32244

Study title: Weston CL et al Establishing long-term survival and cure in young patients with Ewing's sarcoma Br J Cancer. 2004 Jul 19;91(2):225-32Weston CL et al Establishing long-term survival and cure in young patients with Ewing's sarcoma Br J Cancer. 2004 Jul 19;91(2):225-32

Active substance: MITOXANTRONE

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Document reference: 32094

Study title: Wexler LH et al Ifosfamide and etoposide plus vincristine, doxorubicin, and cyclophosphamide for newly diagnosed Ewing's sarcoma family of tumors Cancer. 1996 Aug 15;78(4):901-11. Erratum in: Cancer 1997 Feb 15;79(4):867Wexler LH et al Ifosfamide and etoposide plus vincristine, doxorubicin, and cyclophosphamide for newly diagnosed Ewing's sarcoma family of tumors Cancer. 1996 Aug 15;78(4):901-11. Erratum in: Cancer 1997 Feb 15;79(4):867

Active substance: MITOXANTRONE

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Document reference: 32114

Study title: "Risks of intravenous amiodarone in neonates. Gandy J et al. - 1998 (Canad. J. Cardiol., 14 (6):855-858) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" "Risks of intravenous amiodarone in neonates. Gandy J et al. - 1998 (Canad. J. Cardiol., 14 (6):855-858) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -"

Active substance: AMIODARONE

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Document reference: 45158

Study title: Betaxolol SL75.212-10 Acute oral toxicity in "young" rats - AM. Orloff, D. Branceni Betaxolol Core Dossier - April 1999 - Part III Pharmaco-toxicological documentation Volume 2

Active substance: BETAXOLOL

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Document reference: 41927

Study title: Study 1: An open label study to investigate whether BUD tehrapy given for four weeks could possibly potentiate the effect of terbutaline inhaled 15 minutes before exercise challenge in 14 children with exercise-induced asthma; Study 2: A double-blind, placebo controlled, cross-over study to investigate the effect of inhaled BUD on exercise-induced asthma in children in 14 asthmatic children (different from those in Study 1)

Active substance: BUDESONIDE

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Document reference: 48409

Study title: 1α-hydroxycholecalciferol treatment of long-term haemodialysis patients1α-hydroxycholecalciferol treatment of long-term haemodialysis patients

Active substance: ALFACALCIDOL

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Document reference: 46332

Study title: Sandler E et al Efficacy of ifosfamide and doxorubicin given as a phase II "window" in children with newly diagnosed metastatic rhabdomyosarcoma: a report from the IntergroupRhabdomyosarcoma Study Group Med Pediatr Oncol. 2001 Nov;37(5):442-8Sandler E et al Efficacy of ifosfamide and doxorubicin given as a phase II "window" in children with newly diagnosed metastatic rhabdomyosarcoma: a report from the IntergroupRhabdomyosarcoma Study Group Med Pediatr Oncol. 2001 Nov;37(5):442-8

Active substance: MITOXANTRONE

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Document reference: 32145

Study title: A Randomized, Double Blind, Study of the Safety and Immunogenicity of Nine Valent (1, 4, 5, 6B, 9V, 14, 18C, 19F, 23F) Pneumococcal Conjugate Vaccine in Healthy Infants at 2, 4, and 6 Months of Age. Amendment # 1: Safety and Immunogenicity of a Booster Dose of Nine Valent (1, 4, 5, 6B, 9V, 14, 18C, 19F, 23F) Pneumococcal Conjugate Vaccine Administered Concurrently with MMR in Toddlers 12-15 Months of Age.

Active substance: Pneumococcal saccharide conjugated vaccine, absorbed

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Document reference: 41592

Study title: An Open-Label Pilot Study to Evaluate the Safety Of Pneumococcal 7-Valent Conjugate Vaccine [Diphtheria Crm197 Protein] (Prevenar) in Healthy Adults and Children at 3 to 5 Years Old.

Active substance: Pneumococcal saccharide conjugated vaccine, absorbed

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Document reference: 41595

Study title: Boulad F et al High-dose induction chemoradiotherapy followed by autologous bone marrow transplantation as consolidation therapy in rhabdomyosarcoma, extraosseous Ewing's sarcoma, and undifferentiated sarcoma J Clin Oncol. 1998 May;16(5):1697-706Boulad F et al High-dose induction chemoradiotherapy followed by autologous bone marrow transplantation as consolidation therapy in rhabdomyosarcoma, extraosseous Ewing's sarcoma, and undifferentiated sarcoma J Clin Oncol. 1998 May;16(5):1697-706

Active substance: MITOXANTRONE

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Document reference: 32113

Study title: Brecher ML et al. Fractionated cylophosphamide and back to back high dose methotrexate and cytosinearabinoside improves outcome in patients with stage III high grade small non-cleaved cell lymphomas (SNCCL): a randomized trial of the Pediatric Oncology Group. Med Pediatr Oncol. 1997 Dec;29(6):526-33.Brecher ML et al. Fractionated cylophosphamide and back to back high dose methotrexate and cytosinearabinoside improves outcome in patients with stage III high grade small non-cleaved cell lymphomas (SNCCL): a randomized trial of the Pediatric Oncology Group. Med Pediatr Oncol. 1997 Dec;29(6):526-33.

Active substance: MITOXANTRONE

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Document reference: 32249

Study title: Breitfeld PP et al Ifosfamide and etoposide are superior to vincristine and melphalan for pediatric metastatic rhabdomyosarcoma when administered with irradiation and combination chemotherapy: a report from the Intergroup Rhabdomyosarcoma Study Group J Pediatr Hematol Oncol. 2001 May;23(4):225-33Breitfeld PP et al Ifosfamide and etoposide are superior to vincristine and melphalan for pediatric metastatic rhabdomyosarcoma when administered with irradiation and combination chemotherapy: a report from the Intergroup Rhabdomyosarcoma Study Group J Pediatr Hematol Oncol. 2001 May;23(4):225-33

Active substance: MITOXANTRONE

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Document reference: 32144

Study title: Uderzo C et al. High-dose vincristine, fractionated total-body irradiation and cyclophosphamide as conditioning regimen in allogeneic and autologous bone marrow transplantation for childhood acute lymphoblastic leukaemia in second remission: a 7-year Italian multicentre study. Br J Haematol. 1995 Apr;89(4):790-7.Uderzo C et al. High-dose vincristine, fractionated total-body irradiation and cyclophosphamide as conditioning regimen in allogeneic and autologous bone marrow transplantation for childhood acute lymphoblastic leukaemia in second remission: a 7-year Italian multicentre study. Br J Haematol. 1995 Apr;89(4):790-7.

Active substance: MITOXANTRONE

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Document reference: 32217

Study title: Ungerleider RS et al Phase I trial of mitoxantrone in children Cancer Treat Rep. 1985 Apr;69(4):403-7Ungerleider RS et al Phase I trial of mitoxantrone in children Cancer Treat Rep. 1985 Apr;69(4):403-7

Active substance: MITOXANTRONE

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Document reference: 32079

Active substance: MITOXANTRONE

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Document reference: 32087

Study title: Van Winkle P et al Ifosfamide, carboplatin, and etoposide (ICE) reinduction chemotherapy in a large cohort of children and adolescents with recurrent/refractory sarcoma: the Children's Cancer Group (CCG) experience Pediatr Blood Cancer. 2005 Apr;44(4):338-47Van Winkle P et al Ifosfamide, carboplatin, and etoposide (ICE) reinduction chemotherapy in a large cohort of children and adolescents with recurrent/refractory sarcoma: the Children's Cancer Group (CCG) experience Pediatr Blood Cancer. 2005 Apr;44(4):338-47

Active substance: MITOXANTRONE

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Document reference: 32159

Study title: Randomized Controlled Comparison of PREVEsNAR booster Dose Administration at 15 or 18 Months of Age.

Active substance: Pneumococcal saccharide conjugated vaccine, absorbed

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Document reference: 41598

Study title: An open, comparative study of the efficacy of 0.5% podophyllotoxin lotion (self-application) and 25% podophyllin solution (hospital based application) in the treatment of Condylomata acuminata in males and females.

Active substance: PODOPHYLLOTOXIN

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Document reference: 34545

Study title: A double-blind randomized, uninational, multicenter, two parallel groups, active controlled study to compare the effects of the treatment with Transipeg 2,95 g or Forlax Junior 4 g in children with constipation

Active substance: POLIDOCANOL

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Document reference: 46073

Study title: A long term post sclerotherapy follow up of EHPVO children with upper gastrointestinal haemorrhage. Patrawala, V.;Bombay Hosp.J. (2001) vol.43 p.1-4A long term post sclerotherapy follow up of EHPVO children with upper gastrointestinal haemorrhage. Patrawala, V.;Bombay Hosp.J. (2001) vol.43 p.1-4

Active substance: POLIDOCANOL

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Document reference: 46070

Study title: Current therapeutic strategy in bleeding esophageal varices in babies and children and long-term results of endoscopic paravariceal sclerotherapy over twenty years. Paquet,K.J.;Eur. J. Pediatr.Surg.(1994) vol.4 p.165-172 Current therapeutic strategy in bleeding esophageal varices in babies and children and long-term results of endoscopic paravariceal sclerotherapy over twenty years. Paquet,K.J.;Eur. J. Pediatr.Surg.(1994) vol.4 p.165-172

Active substance: POLIDOCANOL

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Document reference: 46068

Study title: Gallet JP, Dicetel capsules, report of the clinical expert evaluation (in children), report no 20, May 7, 1975.

Active substance: PINAVERIUM

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Document reference: 34139

Study title: A Single- and Multiple-Dose Pharmacokinetic and Safety Study of 15 mg, 30 mg, and 45 mg ACTOS® (Pioglitazone HCl) Administered Orally to Adolescents With Type 2 (Non-Insulin-Dependent) Diabetes Mellitus

Active substance: pioglitazone

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Document reference: 47468

Study title: "Etude clinique chez l'enfant d'un nouveau neuroleptique, la pipotiazine (Piportil) - De Villard et Maillet - 1974 (J. Med. Lyon, 55, 949-952) - Publication mentioned in the summary report -" Doc. 102843"Etude clinique chez l'enfant d'un nouveau neuroleptique, la pipotiazine (Piportil) - De Villard et Maillet - 1974 (J. Med. Lyon, 55, 949-952) - Publication mentioned in the summary report -" Doc. 102843

Active substance: PIPOTIAZINE

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Document reference: 34140

Study title: "Interet de l'utilisation de la pipotiazine chez les sujets ages de 8 a 24 ans. Bilan de 18 mois d'experimentation - Campanie et al. - 1974 (Psychol. Med., 6, 8, 1603-1611) - Publication mentioned in the summary report -" Doc. 102843 "Interet de l'utilisation de la pipotiazine chez les sujets ages de 8 a 24 ans. Bilan de 18 mois d'experimentation - Campanie et al. - 1974 (Psychol. Med., 6, 8, 1603-1611) - Publication mentioned in the summary report -" Doc. 102843

Active substance: PIPOTIAZINE

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Document reference: 34141

Study title: Crist W et al. The Third Intergroup Rhabdomyosarcoma Study. J Clin Oncol. 1995 Mar;13(3):610-30Crist W et al. The Third Intergroup Rhabdomyosarcoma Study. J Clin Oncol. 1995 Mar;13(3):610-30

Active substance: MITOXANTRONE

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Document reference: 32187

Study title: Crist WM et a lIntergroup rhabdomyosarcoma study-IV: results for patients with nonmetastaticDiseaseJ Clin Oncol. 2001 Jun 15;19(12):3091-102Crist WM et a lIntergroup rhabdomyosarcoma study-IV: results for patients with nonmetastaticDiseaseJ Clin Oncol. 2001 Jun 15;19(12):3091-102

Active substance: MITOXANTRONE

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Document reference: 32143

Study title: D'Angio GJ et al. Treatment of Wilms' tumor. Results of the Third National Wilms' Tumor Study. Cancer. 1989 Jul 15;64(2):349-60D'Angio GJ et al. Treatment of Wilms' tumor. Results of the Third National Wilms' Tumor Study. Cancer. 1989 Jul 15;64(2):349-60

Active substance: MITOXANTRONE

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Document reference: 32255

Active substance: MITOXANTRONE

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Document reference: 32183

Study title: Dunst J et al. Radiation therapy in Ewing's sarcoma: an update of the CESS 86 trial. Int J Radiat Oncol Biol Phys. 1995 Jul 15;32(4):919-30.Dunst J et al. Radiation therapy in Ewing's sarcoma: an update of the CESS 86 trial. Int J Radiat Oncol Biol Phys. 1995 Jul 15;32(4):919-30.

Active substance: MITOXANTRONE

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Document reference: 32186

Study title: Dusenbery KE et al. Autologous bone marrow transplantation in acute myeloid leukemia: the University of Minnesota experience. Int J Radiat Oncol Biol Phys. 1996 Sep 1;36(2):335-43.Dusenbery KE et al. Autologous bone marrow transplantation in acute myeloid leukemia: the University of Minnesota experience. Int J Radiat Oncol Biol Phys. 1996 Sep 1;36(2):335-43.

Active substance: MITOXANTRONE

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Document reference: 32194

Study title: A double-blind, placebo controlled, randomized, cross over study of the efficacy and safety of mizolastine 10mg in patients suffreing from primary acquired cold uticaria (URICOLD study). Dubertret L. Murrietta Aguguttes M. Ben-Soussen P. Magnier G. Pelenc M.-N. Pellegri-Guegnault B., Tudor D. 13/02/1997.

Active substance: MIZOLASTINE

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

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Document reference: 32259

Study title: A multicenter study of pharmacokinetics of oral fexofenadine hydrochloride administered as granulation powder in applesauce in children from 6 months to 2 years of age (MO164559/1123)

Active substance: FEXOFENADINE

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Document reference: 27266

Study title: Comparison of oral transmucosal fentanyl citrate and intramuscular meperidine, promethazine, and chlorpromazine for conscious sedation of children undergoing laceration repair; Annals of Emergency Medicine 1996, 28(4): 385-90

Active substance: FENTANYL

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Document reference: 27140

Study title: Hiddemann W et al. Antifungal treatment by amphotericin B and 5-fluorocytosine delays the recovery of normal hematopoietic cells after intensive cytostatic therapy for acute myeloid leukemia. Cancer. 1991 Jul 1;68(1):9-14

Active substance: FLUCOCYTOSIN

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Document reference: 27303

Study title: Nesbit ME et al. Chemotherapy for induction of remission of childhood acute myeloid leukemia followed by marrow transplantation or multiagent chemotherapy: a report from the Childrens Cancer Group. J Clin Oncol. 1994 Jan;12(1):127-35Nesbit ME et al. Chemotherapy for induction of remission of childhood acute myeloid leukemia followed by marrow transplantation or multiagent chemotherapy: a report from the Childrens Cancer Group. J Clin Oncol. 1994 Jan;12(1):127-35

Active substance: MITOXANTRONE

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Document reference: 32197

Study title: Neudorf S et al. Allogeneic bone marrow transplantation for children with acute myelocytic leukemia in first remission demonstrates a role for graft versus leukemia in the maintenance of disease-free survival. Blood. 2004 May 15;103(10):3655-61. Epub 2004 Jan 29Neudorf S et al. Allogeneic bone marrow transplantation for children with acute myelocytic leukemia in first remission demonstrates a role for graft versus leukemia in the maintenance of disease-free survival. Blood. 2004 May 15;103(10):3655-61. Epub 2004 Jan 29

Active substance: MITOXANTRONE

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Document reference: 32193

Active substance: MITOXANTRONE

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Document reference: 32092

Study title: A trial of UCB 6215 (piracetam) in infantile neuro-psychiatry.

Active substance: PIRACETAM

Study summary document link (including results): DE73L152 - Piracetam.pdf

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Document reference: 45965

Study title: Arndt CA et al Comparison of results of a pilot study of alternating vincristine/doxorubicin/cyclophosphamide and etoposide/ifosfamide with IRS-IV in intermediate risk rhabdomyosarcoma: a report from the Children's Oncology Group Pediatr Blood Cancer. 2008 Jan;50(1):33-6Arndt CA et al Comparison of results of a pilot study of alternating vincristine/doxorubicin/cyclophosphamide and etoposide/ifosfamide with IRS-IV in intermediate risk rhabdomyosarcoma: a report from the Children's Oncology Group Pediatr Blood Cancer. 2008 Jan;50(1):33-6

Active substance: MITOXANTRONE

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Document reference: 32153

Study title: Bacci G et al Long-term outcome for patients with nonmetastatic osteosarcoma of the extremity treated at the istituto ortopedico rizzoli according to the istituto ortopedico rizzoli/osteosarcoma-2 protocol: an updated report J Clin Oncol. 2000 Dec 15;18(24):4016-27Bacci G et al Long-term outcome for patients with nonmetastatic osteosarcoma of the extremity treated at the istituto ortopedico rizzoli according to the istituto ortopedico rizzoli/osteosarcoma-2 protocol: an updated report J Clin Oncol. 2000 Dec 15;18(24):4016-27

Active substance: MITOXANTRONE

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Document reference: 32126

Study title: Bacci G et al Neoadjuvant chemotherapy for Ewing's sarcoma of bone: no benefit observed afteradding ifosfamide and etoposide to vincristine, actinomycin, cyclophosphamide,and doxorubicin in the maintenance phase--results of two sequential studies Cancer. 1998 Mar 15;82(6):1174-83Bacci G et al Neoadjuvant chemotherapy for Ewing's sarcoma of bone: no benefit observed afteradding ifosfamide and etoposide to vincristine, actinomycin, cyclophosphamide,and doxorubicin in the maintenance phase--results of two sequential studies Cancer. 1998 Mar 15;82(6):1174-83

Active substance: MITOXANTRONE

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Document reference: 32102

Study title: Taylor RE et al. Outcome for patients with metastatic (M2-3) medulloblastoma treated withSIOP/UKCCSG PNET-3 chemotherapy Eur J Cancer. 2005 Mar;41(5):727-34. Epub 2005 Jan 18Taylor RE et al. Outcome for patients with metastatic (M2-3) medulloblastoma treated withSIOP/UKCCSG PNET-3 chemotherapy Eur J Cancer. 2005 Mar;41(5):727-34. Epub 2005 Jan 18

Active substance: MITOXANTRONE

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Document reference: 32235

Study title: Taylor RE et al. Results of a randomized study of preradiation chemotherapy versus radiotherapy alone for nonmetastatic medulloblastoma: The International Society of Paediatric Oncology/United Kingdom Children's Cancer Study Group PNET-3 Study. J Clin Oncol. 2003 Apr 15;21(8):1581-91Taylor RE et al. Results of a randomized study of preradiation chemotherapy versus radiotherapy alone for nonmetastatic medulloblastoma: The International Society of Paediatric Oncology/United Kingdom Children's Cancer Study Group PNET-3 Study. J Clin Oncol. 2003 Apr 15;21(8):1581-91

Active substance: MITOXANTRONE

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Document reference: 32237

Study title: Tubergen DG et al. Comparison of treatment regimens for pediatric lymphoblastic non-Hodgkin's lymphoma: a Childrens Cancer Group study. J Clin Oncol. 1995 Jun;13(6):1368-76Tubergen DG et al. Comparison of treatment regimens for pediatric lymphoblastic non-Hodgkin's lymphoma: a Childrens Cancer Group study. J Clin Oncol. 1995 Jun;13(6):1368-76

Active substance: MITOXANTRONE

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Document reference: 32215

Study title: Uchida A et al Neoadjuvant chemotherapy for pediatric osteosarcoma patients Cancer. 1997 Jan 15;79(2):411-5Uchida A et al Neoadjuvant chemotherapy for pediatric osteosarcoma patients Cancer. 1997 Jan 15;79(2):411-5

Active substance: MITOXANTRONE

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Document reference: 32129

Study title: Eczematous disorders and corticoid-sensitive dermatoses - Treatment with prednicarbate 0,25% solution- S. Nolting et al. - 1994 (Z Allg Med vol 70) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - Eczematous disorders and corticoid-sensitive dermatoses - Treatment with prednicarbate 0,25% solution- S. Nolting et al. - 1994 (Z Allg Med vol 70) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -

Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD

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Document reference: 34565

Study title: Multicentre study (HOE777 5D-402DT) Evaluation of efficacity and tolerance of prednicarbate 0,25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses - No author -1991 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - Multicentre study (HOE777 5D-402DT) Evaluation of efficacity and tolerance of prednicarbate 0,25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses - No author -1991 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -

Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD

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Document reference: 34573

Study title: Antibiotics in Acute Osteomyelitis in Children;Blockey N J, McAllister T A J Bone Jt Surg Ser B 1972; 54(2): 299-309

Active substance: FUSIDIC ACID

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Document reference: 28707

Study title:

Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT)

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Document reference: 41160

Study title: AN OPEN-LABEL EXTENSION STUDY OF GABAPENTIN IN CHILDREN WITH EPILEPSY WHO HAVE PARTICIPATED IN THE DOUBLE-BLIND STUDY 945-186

Active substance: GABAPENTIN

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Document reference: 28763

Study title: Mylonas I, Friese K. Fetal cytomegalovirus infection: From research to clinical application. Geburtshilfe und Frauenheilkunde. 2005; 65(5):465-473.Mylonas I, Friese K. Fetal cytomegalovirus infection: From research to clinical application. Geburtshilfe und Frauenheilkunde. 2005; 65(5):465-473.

Active substance: FOSCARNET

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Document reference: 39593

Study title: Eur J Nucl Med Mol Imaging. 2005 Jun;32(6):674-81. Epub 2005 Mar 4. The value of [18F]FDG-PET in the diagnosis of large-vessel vasculitis and the assessment of activity and extent of disease. Walter MA, Melzer RA, Schindler C, MÃ¼ller-Brand J, Tyndall A, Nitzsche EU.

Active substance: FLUDEOXYGLUCOSE

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Document reference: 28108

Study title: A multicenter comparative trial of cefprozil (500 mg QD) versus cefaclor (250 mg TID) in the treatment of mild to moderate skin and skin structure infections in pediatric patients (final report on study AI414-075).

Active substance: CEFPROZIL

Study summary document link (including results): Protocol ai414-075 All centers Cefprozil.pdf

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Document reference: 23570

Study title: Olivieri A et al. Upfront high-dose sequential therapy (HDS) versus VACOP-B with or without HDS in aggressive non-Hodgkin's lymphoma: long-term results by the NHLCSG. Ann Oncol. 2005 Dec;16(12):1941-8. Epub 2005 Sep 12Olivieri A et al. Upfront high-dose sequential therapy (HDS) versus VACOP-B with or without HDS in aggressive non-Hodgkin's lymphoma: long-term results by the NHLCSG. Ann Oncol. 2005 Dec;16(12):1941-8. Epub 2005 Sep 12

Active substance: MITOXANTRONE

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Document reference: 32201

Study title: Orbach D et al Soft tissue sarcoma or malignant mesenchymal tumors in the first year of life: experience of the International Society of Pediatric Oncology (SIOP) Malignant Mesenchymal Tumor Committee J Clin Oncol. 2005 Jul 1;23(19):4363-71Orbach D et al Soft tissue sarcoma or malignant mesenchymal tumors in the first year of life: experience of the International Society of Pediatric Oncology (SIOP) Malignant Mesenchymal Tumor Committee J Clin Oncol. 2005 Jul 1;23(19):4363-71

Active substance: MITOXANTRONE

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Document reference: 32166

Study title: Bacci G et al Neoadjuvant chemotherapy for osteosarcoma of the extremities with metastases atpresentation: recent experience at the Rizzoli Institute in 57 patients treated with cisplatin, doxorubicin, and a high dose of methotrexate and ifosfamide Ann Oncol. 2003 Jul;14(7):1126-34Bacci G et al Neoadjuvant chemotherapy for osteosarcoma of the extremities with metastases atpresentation: recent experience at the Rizzoli Institute in 57 patients treated with cisplatin, doxorubicin, and a high dose of methotrexate and ifosfamide Ann Oncol. 2003 Jul;14(7):1126-34

Active substance: MITOXANTRONE

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Document reference: 32123

Study title: Bacci G et al Neoadjuvant chemotherapy for radioinduced osteosarcoma of the extremity: The Rizzoli experience in 20 cases Int J Radiat Oncol Biol Phys. 2007 Feb 1;67(2):505-11. Epub 2006 Nov 21Bacci G et al Neoadjuvant chemotherapy for radioinduced osteosarcoma of the extremity: The Rizzoli experience in 20 cases Int J Radiat Oncol Biol Phys. 2007 Feb 1;67(2):505-11. Epub 2006 Nov 21

Active substance: MITOXANTRONE

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Document reference: 32119

Study title: Bacci G et al Neoadjuvant treatment of Ewing's sarcoma: results obtained in 122 patientstreated with a 6-drug chemotherapeutic protocol (vincristine, adriamycin,cyclophosphamide, dactinomycin, ifosfamide and etoposide) Minerva Pediatr. 1995 Nov;47(11):457-69. ItalianBacci G et al Neoadjuvant treatment of Ewing's sarcoma: results obtained in 122 patientstreated with a 6-drug chemotherapeutic protocol (vincristine, adriamycin,cyclophosphamide, dactinomycin, ifosfamide and etoposide) Minerva Pediatr. 1995 Nov;47(11):457-69. Italian

Active substance: MITOXANTRONE

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Document reference: 32103

Study title: Shamberger RC et al. Ewing sarcoma of the rib: results of an intergroup study with analysis of outcome by timing of resection. J Thorac Cardiovasc Surg. 2000 Jun;119(6):1154-61Shamberger RC et al. Ewing sarcoma of the rib: results of an intergroup study with analysis of outcome by timing of resection. J Thorac Cardiovasc Surg. 2000 Jun;119(6):1154-61

Active substance: MITOXANTRONE

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Document reference: 32180

Study title: Simon T et al. Topotecan, cyclophosphamide, and etoposide (TCE) in the treatment of high-risk neuroblastoma. Results of a phase-II trial. J Cancer Res Clin Oncol. 2007 Sep;133(9):653-61. Epub 2007 May 4.Simon T et al. Topotecan, cyclophosphamide, and etoposide (TCE) in the treatment of high-risk neuroblastoma. Results of a phase-II trial. J Cancer Res Clin Oncol. 2007 Sep;133(9):653-61. Epub 2007 May 4.

Active substance: MITOXANTRONE

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Document reference: 32230

Study title: Sokolov T et al Treatment of Ewing's sarcoma with 2 different protocols Ann Med Interne (Paris). 2001 Dec;152(8):497-501. FrenchSokolov T et al Treatment of Ewing's sarcoma with 2 different protocols Ann Med Interne (Paris). 2001 Dec;152(8):497-501. French

Active substance: MITOXANTRONE

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Document reference: 32095

Study title: Verdonck LF et al.Intensified 12-week CHOP (I-CHOP) plus G-CSF compared with standard 24-week CHOP (CHOP-21) for patients with intermediate-risk aggressive non-Hodgkin lymphoma: a phase 3 trial of the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON). Blood. 2007 Apr 1;109(7):2759-66.Verdonck LF et al.Intensified 12-week CHOP (I-CHOP) plus G-CSF compared with standard 24-week CHOP (CHOP-21) for patients with intermediate-risk aggressive non-Hodgkin lymphoma: a phase 3 trial of the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON). Blood. 2007 Apr 1;109(7):2759-66.

Active substance: MITOXANTRONE

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Document reference: 32203

Study title: Wang WQ et alClinical study on mitoxantrone contained regimen for treatment of newly diagnosed childhood acute lymphoblastic leukemiaZhong Nan Da Xue Xue Bao Yi Xue Ban. 2004 Oct;29(5):602-3 Chinese (No abstract available) .Wang WQ et alClinical study on mitoxantrone contained regimen for treatment of newly diagnosed childhood acute lymphoblastic leukemiaZhong Nan Da Xue Xue Bao Yi Xue Ban. 2004 Oct;29(5):602-3 Chinese (No abstract available) .

Active substance: MITOXANTRONE

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Document reference: 32073

Study title: Candy D et al Study title: A single centre study to assess the safety and efficacy of Movicol in the treatment of faecal impaction in children followed by a double-blind randomised phase to compare the safety and efficacy of Movicol and lactulose for maintenance therapy. J of Paediatric Gastro Enterol & Nutrition 2006;43: 65-70

Active substance: POLIDOCANOL COMBINATIONS

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Document reference: 34579

Study title: Guest JF, Candy D, Clegg JP et al – Clinical and economic impact of using macrogol 3350 plus electrolytes in an outpatient setting compared to enemas and suppositories and manual evacuation to treat paediatric faecal impaction based on actual clinical proactive in England and Wales. Curr Med Res Opin. 2007 Sep;23(9):2213-25

Active substance: POLIDOCANOL COMBINATIONS

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Document reference: 34580

Study title: JF Mougenot non blind controlled study on 32 patients aged from 3 to 13.5 years old in Feb 1995.

Active substance: POLIDOCANOL COMBINATIONS

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Document reference: 47214

Study title: lodixanol in paediatric gastrointestinal imaging: safety and efficacy comparison with iohexolWright NB 2002. The British Journal of Radiology, 75 (2002), 127- 135

Active substance: IODIXANOL

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

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Document reference: 48194

Study title: Pertl C, Odell E, Hofmann-Wellenhof R, Lorenzoni M, Eskici A: A differential therapy concept fort he treatment of recurrent stomatitis aphthosa. Stomatologie, Austria 94/4; 175-179, 1997 Pertl C, Odell E, Hofmann-Wellenhof R, Lorenzoni M, Eskici A: A differential therapy concept fort he treatment of recurrent stomatitis aphthosa. Stomatologie, Austria 94/4; 175-179, 1997

Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD

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Document reference: 35093

Study title: CROSSOVER COMPARATIVE PHARMACOKINETIC STUDY OF TWO 3MG PRAZOSIN SUSTAINED RELEASE DELIVERY SYSTEMS: SIXTEEN HOUR VS TWENTY HOUR 85% RELEASE TIMES

Active substance: PRAZOCIN

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Document reference: 46105

Study title: LONG TERM FOLLOW-UP EXPERIENCE IN A MINIZIDE TABLET (0.5MG PRAZOSIN/0.25MG POLYTHIAZIDE) MULTICENTER TRIAL

Active substance: PRAZOCIN /POLYTHIAZIDE

Study summary document link (including results): MZ-76-03 EMA Pediatrics Web Synopsis.pdf

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Document reference: 46107

Study title: Minizide (Brand of Prazosin/Polythiazide) Tablets (0.5 mg/0.25 mg) Clinical Experience in a Non-Comparative, Multicenter Trial

Active substance: PRAZOCIN /POLYTHIAZIDE

Study summary document link (including results): MZ-76-01 and MZ-76-02 EMA Pediatric Web Synopsis.pdf

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Document reference: 46108

Study title: Shawdon A, Kiss ZS, Fuller P. The bipartite tarsal navicular bone: radiographic and computed tomography findings. Australas Radiol. 1995 May;39(2):192-4. Shawdon A, Kiss ZS, Fuller P. The bipartite tarsal navicular bone: radiographic and computed tomography findings. Australas Radiol. 1995 May;39(2):192-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43601

Study title: Myoglobinuria with acute renal failure and hot kidneys seen on bone imaging. Sheth KJ, Sty JR, Johnson F, Tisdale P. Clin Nucl Med. 1984 Sep;9(9):498-501.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43985

Study title: Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44206

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44253

Study title: Transient ischaemia of the proximal femoral epiphysis in the child. Interpretation of bone scintimetry for diagnosis in hip pain. Wingstrand H, Bauer GC, Brismar J, Carlin NO, Pettersson H, Sundén G. Acta Orthop Scand. 1985 Jun;56(3):197-203.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43942

Study title: Transient synovitis of the hip in the child. Wingstrand H. Acta Orthop Scand Suppl. 1986;219:1-61. No abstract available. PMID: 3518331 [PubMed - indexed for MEDLINE]

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43923

Study title: [SAPHO syndrome: case report of an 18-year-old man and review of the literature] German. Wolf G, Aigner RM, Schwarz T, Lorbach MP. Wien Klin Wochenschr. 2002 May 15;114(8-9):341-4. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43439

Study title: Wolff MH, Sty JR. Painful ankle. Os trigonum vs fracture. Clin Nucl Med. 1985 Mar;10(3):197. No abstract available. Wolff MH, Sty JR. Painful ankle. Os trigonum vs fracture. Clin Nucl Med. 1985 Mar;10(3):197. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43954

Study title: Use of Stereotactic PET Images in Dosimetry Planning of Radiosurgery for Brain Tumors: Clinical Experience and Proposed ClassificationTHE JOURNAL OF NUCLEAR MEDICINE, Vol. 45, No. 7, July 2004. Marc Levivier, MD, PhD1; Nicolas Massager, MD1; David Wikler, MS2; Jose´ Lorenzoni, MD1; Salvador Ruiz, MD1; Daniel Devriendt, MD3; Philippe David, MD4; Franc¸oise Desmedt, MS3; Ste´phane Simon, MS3; Paul Van Houtte, MD3; Jacques Brotchi, MD1; and Serge Goldman, MD2

Active substance: Steripet

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

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Document reference: 48737

Study title: TO STUDY THE EFFICACY AND TOLERATION OF PIROXICAM GEL 0.5% IN THE TREATMENT OF SELECTED MUSCULOSKELETAL DISORDERS.

Active substance: PIROXICAM

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Document reference: 34410

Study title: TO STUDY THE EFFICACY AND TOLERATION OF PIROXICAM GEL 0.5% IN THE TREATMENT OF SELECTED MUSCULOSKELETAL DISORDERS.

Active substance: PIROXICAM

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Document reference: 34434

Study title: Vrasse, R., Schuhmann, C., and Regenstreif, P. [Action of the anthraquinone derivatives of the rhubarb in 47 cases of gingivostomatitis] Action des derives anthraquinoniques de la rhubarbe dans 47 cas de gingivostomatites. Rev.Fr.Odontostomatol. 1967. 14: (7) 1215-1220 47 subjects, 11f, 36 m, 16-84 yVrasse, R., Schuhmann, C., and Regenstreif, P. [Action of the anthraquinone derivatives of the rhubarb in 47 cases of gingivostomatitis] Action des derives anthraquinoniques de la rhubarbe dans 47 cas de gingivostomatites. Rev.Fr.Odontostomatol. 1967. 14: (7) 1215-1220 47 subjects, 11f, 36 m, 16-84 y

Active substance: RHUBARB AND SALICYLIC ACID

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Document reference: 35295

Study title: Clinical and diagnostic features of osteomyelitis occurring in the first three months of life. Wong M, Isaacs D, Howman-Giles R, Uren R. Pediatr Infect Dis J. 1995 Dec;14(12):1047-53.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43574

Study title: Serum osteocalcin and other indices of bone formation: an 8-decade population study in healthy men and women. Worsfold M, Sharp CA, Davie MW. Clin Chim Acta. 1988 Dec 15;178(2):225-35.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43800

Study title: Maurer AH, Holder LE, Espinola DA, Rupani HD, Wilgis EF. Three-phase radionuclide scintigraphy of the hand. Radiology. 1983 Mar;146(3):761-75. Maurer AH, Holder LE, Espinola DA, Rupani HD, Wilgis EF. Three-phase radionuclide scintigraphy of the hand. Radiology. 1983 Mar;146(3):761-75.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44047

Study title: McCarthy KE, Heyman S. Diphosphonate intestinal activity seen on two bone images in neuroblastoma. Clin Nucl Med. 1986 Jul;11(7):501-2. McCarthy KE, Heyman S. Diphosphonate intestinal activity seen on two bone images in neuroblastoma. Clin Nucl Med. 1986 Jul;11(7):501-2.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43901

Study title: Pineoblastoma imaged during bone scintigraphy. McCormack S, Raftery R, Palmgren D, Leonard JC. Clin Nucl Med. 1995 Nov;20(11):1023-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43580

Study title: McCullough RW, Gandsman EJ, Litchman H, Schatz SL, Deutsch SD. Computerized blood-flow analysis in osteochondritis dissecans. Clin Nucl Med. 1986 Jul;11(7):511-3. McCullough RW, Gandsman EJ, Litchman H, Schatz SL, Deutsch SD. Computerized blood-flow analysis in osteochondritis dissecans. Clin Nucl Med. 1986 Jul;11(7):511-3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43900

Study title: Sandler MS, Heyman S, Watts H. Localization of 99mTc methylene diphosphonate within synovial fluid in osteosarcoma. AJR Am J Roentgenol. 1984 Aug;143(2):349-50. No abstract available. Sandler MS, Heyman S, Watts H. Localization of 99mTc methylene diphosphonate within synovial fluid in osteosarcoma. AJR Am J Roentgenol. 1984 Aug;143(2):349-50. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43990

Study title: Sartoris DJ, Resnick DL. Tarsal coalition. Arthritis Rheum. 1985 Mar;28(3):331-8. No abstract available. Sartoris DJ, Resnick DL. Tarsal coalition. Arthritis Rheum. 1985 Mar;28(3):331-8. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43955

Study title: Criteria and quantification of fibrous dysplasia on MDP scanning. Sathekge MM, Clauss RP. Nuklearmedizin. 1995 Dec;34(6):229-31.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43576

Study title: Secondary ossification center of transverse process: a bone-scan normal variant. Shore RM, Cain GP, Lloyd TV. Eur J Nucl Med. 1985;10(1-2):88-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43971

Study title: Shulkin BL, Shapiro B, Hutchinson RJ. Iodine-131-metaiodobenzylguanidine and bone scintigraphy for the detection of neuroblastoma. J Nucl Med. 1992 Oct;33(10):1735-40. Shulkin BL, Shapiro B, Hutchinson RJ. Iodine-131-metaiodobenzylguanidine and bone scintigraphy for the detection of neuroblastoma. J Nucl Med. 1992 Oct;33(10):1735-40.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43686

Study title: Treatment of pain in pediatric patients; Journal of Pharmacy Practice 2003, 16(4): 261-275

Active substance: FENTANYL

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Document reference: 27189

Study title: Clival osteoblastoma in a child. Case illustration. McDonald PJ, Matouk CC, Papsin B, Rutka JT. J Neurosurg. 2003 May;98(5):1133. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43422

Study title: McKendry RJ, Hamdy H. Acne, arthritis and sacroiliitis. Can Med Assoc J. 1983 Jan 15;128(2):156-8. No abstract available. McKendry RJ, Hamdy H. Acne, arthritis and sacroiliitis. Can Med Assoc J. 1983 Jan 15;128(2):156-8. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44053

Study title: Sakai T, Sugano N, Nishii T, Miki H, Ohzono K, Yoshikawa H. Bone scintigraphy screening for osteonecrosis of the shoulder in patients with non-traumatic osteonecrosis of the femoral head. Skeletal Radiol. 2002 Nov;31(11):650-5. Epub 2002 Aug 21. Sakai T, Sugano N, Nishii T, Miki H, Ohzono K, Yoshikawa H. Bone scintigraphy screening for osteonecrosis of the shoulder in patients with non-traumatic osteonecrosis of the femoral head. Skeletal Radiol. 2002 Nov;31(11):650-5. Epub 2002 Aug 21.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43432

Study title: Madanat-F-F. Department of Pediatrics, Jordan University Medical School and Hospital, Amman. MOPP therapy in children with Hodgkin's disease. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Winter 1989, vol. 11, no. 4, p. 407-10, ISSN: 0192-8562.Madanat-F-F. Department of Pediatrics, Jordan University Medical School and Hospital, Amman. MOPP therapy in children with Hodgkin's disease. The American journal of pediatric hematology/oncology, {Am-J-Pediatr-Hematol-Oncol}, Winter 1989, vol. 11, no. 4, p. 407-10, ISSN: 0192-8562.

Active substance: PROCARBAZINE

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Document reference: 34778

Study title: Abdominal masses in children: multiorgan imaging with 99mTc methylene diphosphonate. Siddiqui AR, Cohen M, Moran DP. AJR Am J Roentgenol. 1982 Jul;139(1):35-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44079

Study title: [Clinical evaluation of multiple exostoses (17 cases) on bone scintigraphy] Japanese. Yamada T, Nakamura M, Sugita R, Satou A, Sakamoto K. Nippon Igaku Hoshasen Gakkai Zasshi. 1991 Mar 25;51(3):282-8. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43744

Study title: Tc-99m MDP uptake by an advanced colon cancer lesion in a juvenile patient. Yamada T, Shuke N, Takahashi K, Katada R, Mineta M, Nagasawa K, Hanaoka H, Aburano T, Miyamoto K, Suzuki Y. Clin Nucl Med. 2000 Apr;25(4):295-6. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43487

Study title: Yamagishi Y, Komata K, Yamamoto H, Takahashi M, Hikita F, Sato M, Watanabe H. [Usefulness of 99mTc-MDP scintigraphy for normal roentgen variants of bone] Kaku Igaku. 1993 May;30(5):549-56. Japanese. Yamagishi Y, Komata K, Yamamoto H, Takahashi M, Hikita F, Sato M, Watanabe H. [Usefulness of 99mTc-MDP scintigraphy for normal roentgen variants of bone] Kaku Igaku. 1993 May;30(5):549-56. Japanese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43667

Study title: Yamagishi Y. [Bone scintigraphy] Nippon Ika Daigaku Zasshi. 1992 Feb;59(1):70-4. Japanese. No abstract available. Yamagishi Y. [Bone scintigraphy] Nippon Ika Daigaku Zasshi. 1992 Feb;59(1):70-4. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43709

Study title: Yamagishi Y. [Role of the scintigram in the diagnosis of bones and calcifications] Rinsho Hoshasen. 1986 Apr;31(4):499-504. Japanese. No abstract available. Yamagishi Y. [Role of the scintigram in the diagnosis of bones and calcifications] Rinsho Hoshasen. 1986 Apr;31(4):499-504. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43913

Study title: Yang CC, Wu CC, Chen MF. [Bone metastases of malignancies. A radionuclide study] Gaoxiong Yi Xue Ke Xue Za Zhi. 1986 Jul;2(7):435-45. Chinese. No abstract available. Yang CC, Wu CC, Chen MF. [Bone metastases of malignancies. A radionuclide study] Gaoxiong Yi Xue Ke Xue Za Zhi. 1986 Jul;2(7):435-45. Chinese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43903

Study title: A double-blind, placebo-controlled, multicentred study of mizolastine (SL85.0324) (10mg/d) efficacy in patients suffering from perennial allergic rhinoconjunctivitis (RIPERAN study). - Scadding G. Bachert C. Dunmore C. Favennec C. Mathieu G. Steinerstauch P. Weber F.- 06/09/1994

Active substance: MIZOLASTINE

Study summary document link (including results): Mizolastine STUDY 94-00611-EN-00.xls

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Document reference: 32260

Study title: An open-labelled, multicentred study of mizolastine (SL85.0324-00) (10mg and 15mg/d) to assess the long-term safety and long-term efficacy in patients suffering from perennial allergic rhinoconjunctivitis (RIPEREX Study). - Scadding G. Tasman A.J. Dunmore C. Favennec E. Mathieu G. Steinerstauch P. Weber F.- 10/06/1998

Active substance: MIZOLASTINE

Study summary document link (including results): Mizolastine STUDY 94-00939-EN-01.xls

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Document reference: 32261

Study title: Assessment of the therapeutic efficacy and safety of mizolastine in the treatment of chronic idiopathic urticaria. Open-label study of increasing doses (5-10-20mg per day in 2 divided doses) (URTIOC study). -Sayag J. Tudor D. Demontrond V. Narbonne G. Ben-soussen P.- 05/05/1993

Active substance: MIZOLASTINE

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Document reference: 32262

Study title: Comparative safety and efficacy of 3 doses of mizolastine versus placebo in the treatment of seasonnal allergic rhinitis (RHINASE study). - Dry J. Theron M. DEMONTROND V. ATTALI P.- 14/05/1992 STUDY 85.0324.FR.05

Active substance: MIZOLASTINE

Study summary document link (including results): Mizolastine STUDY 85.0324.FR.05.xls

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Document reference: 32263

Study title: Comparative study to determine the efficacy and safety of mizolastine (15mg/d as a single dose) versus dexchlorpheniramine (12mg/d as two devided doses) in the treatment of chronic rhinitis in adults (POLRIC study). - Haguenauer J.P. Tudor D. Mathieu G. Demontrond V. Guerault E. Soubrane C.- 09/07/1993

Active substance: MIZOLASTINE

Study summary document link (including results): Mizolastine STUDY M.44.04.93.03.xls

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Document reference: 32266

Study title: Comparison of the efficacy, safety and onset of action of mizolastine, cetirizine and placebo in the management of seasonal allergic rhinoconjonctivitis. Sabbah A et al (MIZOCET group). (Ann Allerg Asthm Immunol 1999 ; 83: 319-325) Publication 12 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005 Comparison of the efficacy, safety and onset of action of mizolastine, cetirizine and placebo in the management of seasonal allergic rhinoconjonctivitis. Sabbah A et al (MIZOCET group). (Ann Allerg Asthm Immunol 1999 ; 83: 319-325) Publication 12 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005

Active substance: MIZOLASTINE

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Document reference: 32272

Study title: CStudy to compare the efficacy and safety of 3 doses of mizolastine (SL85.0324) versus placebo in the treatment of perennial allergic rhinitis.

Active substance: MIZOLASTINE

Study summary document link (including results): Mizolastine STUDY M.44.02.93.002.xls

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Document reference: 47994

Study title: Utilisation du Tranxene 5 mg gélules en pédo-psychiatrie - Sauvage D., Psychol. Méd., 1975, 7, 1637-1643Utilisation du Tranxene 5 mg gélules en pédo-psychiatrie - Sauvage D., Psychol. Méd., 1975, 7, 1637-1643

Active substance: POTASSIUM CLORAZEPATE

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Document reference: 46083

Study title: Yang JS. [Evaluation of 113mIn-DTPMP and 99mTc-MDP for bone scanning] Zhonghua Fang She Xue Za Zhi. 1984 Feb;18(1):58-62. Chinese. No abstract available. Yang JS. [Evaluation of 113mIn-DTPMP and 99mTc-MDP for bone scanning] Zhonghua Fang She Xue Za Zhi. 1984 Feb;18(1):58-62. Chinese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44006

Study title: Evaluation of activity of epiphyseal plates in growing males and females. Yang KT, Yang AD. Calcif Tissue Int. 2006 Jun;78(6):348-56. Epub 2006 Jun 21.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43374

Study title: Yeh SD, Rosen G, Caparros B, Benua RS. Semiquantitative gallium scintigraphy in patients with osteogenic sarcoma. Clin Nucl Med. 1984 Apr;9(4):175-83. Yeh SD, Rosen G, Caparros B, Benua RS. Semiquantitative gallium scintigraphy in patients with osteogenic sarcoma. Clin Nucl Med. 1984 Apr;9(4):175-83.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44003

Study title: Nonfunctioning adrenocortical tumor showing concentration of Tc-99m MDP in a child. Yen TC, Yeh SH. Clin Nucl Med. 1996 Jul;21(7):579-80. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43564

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

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43618

Study title: McKillop JH, Etcubanas E, Goris ML. The indications for and limitations of bone scintigraphy in osteogenic sarcoma: a review of 55 patients. Cancer. 1981 Sep 1;48(5):1133-8. McKillop JH, Etcubanas E, Goris ML. The indications for and limitations of bone scintigraphy in osteogenic sarcoma: a review of 55 patients. Cancer. 1981 Sep 1;48(5):1133-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44112

Study title: Role of radionuclide imaging in the diagnosis of chondrosarcoma. McLean RG, Choy D, Höschl R, Nayanar V, Murray IP. Med Pediatr Oncol. 1985;13(1):32-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43972

Study title: Meindok H, Rapoport A, Oreopoulos DG, Rabinovich S, Meema HE, Meema S. Quantitative radionuclide scanning in metabolic bone disease. Nucl Med Commun. 1985 Mar;6(3):141-8. Meindok H, Rapoport A, Oreopoulos DG, Rabinovich S, Meema HE, Meema S. Quantitative radionuclide scanning in metabolic bone disease. Nucl Med Commun. 1985 Mar;6(3):141-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43953

Study title: Minizide (Brand of Prazosin/Polythiazide) Tablets (0.5 mg/0.25 mg) Clinical Experience in a Non-Comparative, Multicenter Trial

Active substance: PRAZOCIN /POLYTHIAZIDE

Study summary document link (including results): MZ-76-01 and MZ-76-02 EMA Pediatric Web Synopsis.pdf

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Document reference: 46109

Study title: A double- blind study comparing HOE777 fatty ointment with Ibaril fatty ointment in patients with moderate to severe psoriasis - B. Gjertsen et al . - 1985 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" A double- blind study comparing HOE777 fatty ointment with Ibaril fatty ointment in patients with moderate to severe psoriasis - B. Gjertsen et al . - 1985 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -"

Active substance: PREDNICARBATE

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Document reference: 34664

Study title: "A double-blind parallel group study comparing HOE777 0,25% emolient cream, HOE777 0,1% emollient cream and vehicle in psoriatic patients - T. Fredriksson - 1983 (Hoeschst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -" "A double-blind parallel group study comparing HOE777 0,25% emolient cream, HOE777 0,1% emollient cream and vehicle in psoriatic patients - T. Fredriksson - 1983 (Hoeschst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -"

Active substance: PREDNICARBATE

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Document reference: 34666

Study title: Report on the clinical use of Nootropil (UCB 6215) in psychic disorders occurring in severely burnt patients.

Active substance: PIRACETAM

Study summary document link (including results): CE72E041 - Piracetam.pdf

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Document reference: 45911

Study title: "Management of scalp psoriasis. Guidelines for corticosteroid use in combination treatment - CJM. Van der Vleuten et al. - 2001 (Drugs vol 61) - Publication in Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005 -" "Management of scalp psoriasis. Guidelines for corticosteroid use in combination treatment - CJM. Van der Vleuten et al. - 2001 (Drugs vol 61) - Publication in Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005 -"

Active substance: PREDNICARBATE

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Document reference: 34674

Study title: "Multicentre study (HOE777 5D-402DT) Evaluation of efficacity and tolerance of prednicarbate 0,25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses - No author -1991 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" "Multicentre study (HOE777 5D-402DT) Evaluation of efficacity and tolerance of prednicarbate 0,25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses - No author -1991 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -"

Active substance: PREDNICARBATE

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Document reference: 34675

Study title: "Patch testing with HOE777 ointment, 0,1% and 0,25% and non-medicated ointment, with and without preservatives -H. Tronnier - 1984 (unpublished report) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-" "Patch testing with HOE777 ointment, 0,1% and 0,25% and non-medicated ointment, with and without preservatives -H. Tronnier - 1984 (unpublished report) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-"

Active substance: PREDNICARBATE

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Document reference: 34677

Study title: "Prednicarbate embollient cream 0,1% in pedriatric patients with atopic dermatitis - T. Moshang - 2001 (Cutis vol 68) - Publication in Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005 -" "Prednicarbate embollient cream 0,1% in pedriatric patients with atopic dermatitis - T. Moshang - 2001 (Cutis vol 68) - Publication in Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005 -"

Active substance: PREDNICARBATE

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Document reference: 34678

Study title: A DOUBLE BLIND PLACEBO CONTROLLED STUDY OF THE EFFICACY AND TOLERATION OF PIROXICAM 0.5% TOPICAL GEL IN COMBINATION WITH IONTOPHORESIS IN THE TREATMENT OF TENDINITIS OF THE SHOULDER OR ELBOW.

Active substance: PIROXICAM

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Document reference: 34436

Study title: Economopoulos T et al. Treatment of intermediate- and high-grade non-Hodgkin's lymphoma using CEOP versus CNOP. Eur J Haematol. 2002 Mar;68(3):135-43.Economopoulos T et al. Treatment of intermediate- and high-grade non-Hodgkin's lymphoma using CEOP versus CNOP. Eur J Haematol. 2002 Mar;68(3):135-43.

Active substance: MITOXANTRONE

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Document reference: 32204

Study title: The clinical investigation of piracetam (UCB 6215, Nootropil) in treatment of mentally delayed children with hyperactivity.

Active substance: PIRACETAM

Study summary document link (including results): DRU85G241P - Piracetam.pdf

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Document reference: 45920

Study title: Jennings MT et al. Preradiation chemotherapy in primary high-risk brainstem tumors: phase II study CCG-9941 of the Children's Cancer Group.J Clin Oncol. 2002 Aug 15;20(16):3431-7Jennings MT et al. Preradiation chemotherapy in primary high-risk brainstem tumors: phase II study CCG-9941 of the Children's Cancer Group.J Clin Oncol. 2002 Aug 15;20(16):3431-7

Active substance: MITOXANTRONE

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Document reference: 32238

Active substance: MITOXANTRONE

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Document reference: 32106

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

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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

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Document reference: 34366

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF 0.5% TOPICAL FELDENE (PRX) GEL IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS

Active substance: PIROXICAM

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Document reference: 34469

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF 0.5% TOPICAL PIROXICAM GEL IN THE TREATMENT OF SPORTS INJURIES

Active substance: PIROXICAM

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Document reference: 34455

Study title: AN OPEN NON-COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF 0.5% TOPICAL PIROXICAM GEL IN THE TREATMENT OF SPORTS INJURIES DUE TO SOCCER OR BASKETBALL.

Active substance: PIROXICAM

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Document reference: 34437

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

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Document reference: 34494

Study title: Elomaa I et al Five-year results in Ewing's sarcoma. The Scandinavian Sarcoma Group experience with the SSG IX protocol Eur J Cancer. 2000 May;36(7):875-80Elomaa I et al Five-year results in Ewing's sarcoma. The Scandinavian Sarcoma Group experience with the SSG IX protocol Eur J Cancer. 2000 May;36(7):875-80

Active substance: MITOXANTRONE

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Document reference: 32098

Study title: Entz-Werle N et al Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogenic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group reportLeukemia. 2005 Dec;19(12):2072-81.Entz-Werle N et al Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogenic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group reportLeukemia. 2005 Dec;19(12):2072-81.

Active substance: MITOXANTRONE

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Document reference: 32074

Active substance: MITOXANTRONE

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Document reference: 32084

Study title: Eselgrim M et al Dose intensity of chemotherapy for osteosarcoma and outcome in the Cooperative Osteosarcoma Study Group (COSS) trials Pediatr Blood Cancer. 2006 Jul;47(1):42-50Eselgrim M et al Dose intensity of chemotherapy for osteosarcoma and outcome in the Cooperative Osteosarcoma Study Group (COSS) trials Pediatr Blood Cancer. 2006 Jul;47(1):42-50

Active substance: MITOXANTRONE

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Document reference: 32122

Study title: Ferrari S et al Neoadjuvant chemotherapy with high-dose Ifosfamide, high-dose methotrexate,cisplatin, and doxorubicin for patients with localized osteosarcoma of theextremity: a joint study by the Italian and Scandinavian Sarcoma Groups J Clin Oncol. 2005 Dec 1;23(34):8845-52. Epub 2005 Oct 24Ferrari S et al Neoadjuvant chemotherapy with high-dose Ifosfamide, high-dose methotrexate,cisplatin, and doxorubicin for patients with localized osteosarcoma of theextremity: a joint study by the Italian and Scandinavian Sarcoma Groups J Clin Oncol. 2005 Dec 1;23(34):8845-52. Epub 2005 Oct 24

Active substance: MITOXANTRONE

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Document reference: 32120

Study title: Efficacy and safety of mizolastine in seasonal allergic rhinitis. Leynadier F et al (RHINASE study group). (Ann All Asthm Immunol 1996; 76: 163-168) Publication 10 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005 Efficacy and safety of mizolastine in seasonal allergic rhinitis. Leynadier F et al (RHINASE study group). (Ann All Asthm Immunol 1996; 76: 163-168) Publication 10 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005

Active substance: MIZOLASTINE

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Document reference: 32273

Study title: Five-month open-design extension of the controlled study of mizolastine in treatment of perennial allergic rhinitis in adults (POLRIXT study). - Haguenauer J.P. Tudor D. Mathieu G. Guerault E. Senn N. Soubrane C.- 25/04/1994

Active substance: MIZOLASTINE

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Document reference: 32268

Active substance: MITOXANTRONE

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Document reference: 32125

Study title: Kolb EA et al Long-term event-free survival after intensive chemotherapy for Ewing's family of tumors in children and young adults J Clin Oncol. 2003 Sep 15;21(18):3423-30Kolb EA et al Long-term event-free survival after intensive chemotherapy for Ewing's family of tumors in children and young adults J Clin Oncol. 2003 Sep 15;21(18):3423-30

Active substance: MITOXANTRONE

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Document reference: 32109

Study title: Kushner BH et al Desmoplastic small round-cell tumor: prolonged progression-free survival with aggressive multimodality therapy J Clin Oncol. 1996 May;14(5):1526-31Kushner BH et al Desmoplastic small round-cell tumor: prolonged progression-free survival with aggressive multimodality therapy J Clin Oncol. 1996 May;14(5):1526-31

Active substance: MITOXANTRONE

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Document reference: 32089

Study title: OPEN, NON-COMPARATIVE STUDY OF EFFICACY AND TOLERATION OF PRX GEL 0.5% IN FENCERS.

Active substance: PIROXICAM

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Document reference: 34368

Study title: OPEN, NONCOMPARATIVE STUDY ON THE EFFICACY AND SAFETY OF PIROXICAM TOPICAL GEL 0.5% IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS

Active substance: PIROXICAM

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Document reference: 34446

Study title: Kaps HP, Georgi P, Becker W. [111-In leukocyte scintigraphy in inflammatory diseases of the support and motor systems--initial results] Z Orthop Ihre Grenzgeb. 1985 Sep-Oct;123(5):880-8. German. Kaps HP, Georgi P, Becker W. [111-In leukocyte scintigraphy in inflammatory diseases of the support and motor systems--initial results] Z Orthop Ihre Grenzgeb. 1985 Sep-Oct;123(5):880-8. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43932

Study title: Karanauskas S, Starshak RJ, Sty JR. Heterotopic Tc-99m MDP uptake secondary to phlebitis. Clin Nucl Med. 1991 May;16(5):329-31. Karanauskas S, Starshak RJ, Sty JR. Heterotopic Tc-99m MDP uptake secondary to phlebitis. Clin Nucl Med. 1991 May;16(5):329-31.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43737

Study title: Limb-sparing procedures: postoperative planar bone scan appearance. Kaste SC, Rao BN, Meyer WM, Lynch M. Pediatr Radiol. 1996 Oct;26(10):750-3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43561

Study title: Bone scans in the diagnosis of bone crisis in patients who have Gaucher disease. Katz K, Mechlis-Frish S, Cohen IJ, Horev G, Zaizov R, Lubin E. J Bone Joint Surg Am. 1991 Apr;73(4):513-7. Erratum in: J Bone Joint Surg Am 1991 Jun;73(5):791.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43741

Study title: MR imaging findings in recurrent primary osseous Ewing sarcoma. Kauffman WM, Fletcher BD, Hanna SL, Meyer WH. Magn Reson Imaging. 1994;12(8):1147-53.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43640

Study title: Simons KS, Pickkers P, Bleeker-Rovers CP, Oyen WJ, van der Hoeven JG.. Epub 2009 Oct 22. F-18-fluorodeoxyglucose positron emission tomography combined with CT in critically ill patients with suspected infection. [simons-2010]Intensive Care Med. 2010 Mar;36(3):504-11. Simons KS 2010

Active substance: Steripet

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

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Document reference: 48699

Study title: Mizolastine is effective and well-tolerated in the long-term treatment of perennial allergic rhinoconjonctivitis. Scadding GK et al. (RIPEREX study group). (J Int Med Res 1999; 27: 273-285) Publication 14 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005 Mizolastine is effective and well-tolerated in the long-term treatment of perennial allergic rhinoconjonctivitis. Scadding GK et al. (RIPEREX study group). (J Int Med Res 1999; 27: 273-285) Publication 14 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005

Active substance: MIZOLASTINE

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Document reference: 32274

Study title: Mizolastine therapy also has an effect on nasal blockade in perennial allergic rhinoconjonctivitis. Bachert C et al. (RIPERAN study group) (Allergy 1998; 53: 969-975) Publication 13 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005 Mizolastine therapy also has an effect on nasal blockade in perennial allergic rhinoconjonctivitis. Bachert C et al. (RIPERAN study group) (Allergy 1998; 53: 969-975) Publication 13 in CES DOSFILIRF-CES0386-EN-E01 - N. BLAY - 30/06/2005

Active substance: MIZOLASTINE

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Document reference: 32275

Study title: A 6-Week, Double-Blind, Placebo-Controlled, Parallel-Group Randomized-Withdrawel Study to Evaluate the Continued Efficacy of Modafinil at Dosages Up to 425 mg/day in Patients with Attention-Defizit/Hyperactivity Disorder who are Resonders to Modafinil Treatment, Followed by a 12-month Open-Label Extension Period.

Active substance: MODAFINIL

Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls

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Document reference: 45280

Study title: A double-blind parallel group study comparing HOE777 0.25% fatty ointment with vehicle in patients with mild to moderate atopic or eczematous contact dermatitis.

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Fredriksson.xls

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Document reference: 34667

Study title: A double-blind three centre parallel group study comparing HOE777 0,25%emollient cream with Ultralan emollent cream in patients with mild to very severe atopic or eczematous contact dermatitis and in psoriasis patients - J. Deschilder et al. - 1982 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Deschilder.xls

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Document reference: 34656

Study title: "A double-blind two centre parallel group study comparing HOE277 0,25% aqueous cream and vehicle patients with mild to very severe contact or atopic dermatitis - A. Lassus et al. - 1984 (Hoechst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -" "A double-blind two centre parallel group study comparing HOE277 0,25% aqueous cream and vehicle patients with mild to very severe contact or atopic dermatitis - A. Lassus et al. - 1984 (Hoechst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -"

Active substance: PREDNICARBATE

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Document reference: 34668

Study title: A double-blind two centre parallel group study comparing HOE777 0.25% aqueous cream, with betamethasone valerate 0.1% aqueous cream in patients with slight to very severe atopic or excematous contact dermatitis

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Pestzoldt.xls

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Document reference: 48014

Study title: Quantitative scintigraphy of sacroiliac joints: effects of age, gender, and laterality. Vyas K, Eklem M, Seto H, Bobba VR, Brown P, Haines J, Krishnamurthy GT. AJR Am J Roentgenol. 1981 Mar;136(3):589-92.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44130

Study title: [Diagnostic evaluation of skeletal scintigraphy in comparison to roentgen studies in histiocytosis X in childhood. Case report] German. Wagenknecht C, Lips H, Nitz I, Hilgenfeld E. Kinderarztl Prax. 1990 Jul;58(7):355-62. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43760

Study title: Wallace AL, Strachan RK, Blane A, Best JJ, Hughes SP. Quantitative early phase scintigraphy in the prediction of healing of tibial fractures. Skeletal Radiol. 1992;21(4):241-5. Wallace AL, Strachan RK, Blane A, Best JJ, Hughes SP. Quantitative early phase scintigraphy in the prediction of healing of tibial fractures. Skeletal Radiol. 1992;21(4):241-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43714

Study title: Positive bone scan in cat-scratch disease. Walterspiel JN, Nimityongskul P. Pediatr Infect Dis J. 1987 Oct;6(10):944-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43843

Study title: Wang K, Allen L, Fung E, Chan CC, Chan JC, Griffith JF. Bone scintigraphy in common tumors with osteolytic components. Clin Nucl Med. 2005 Oct;30(10):655-71. Review. Wang K, Allen L, Fung E, Chan CC, Chan JC, Griffith JF. Bone scintigraphy in common tumors with osteolytic components. Clin Nucl Med. 2005 Oct;30(10):655-71. Review.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43385

Study title: Stauss J, Franzius C, Pfluger T, Juergens KU, Biassoni L, Begent J, et al..Guidelines for 18F-FDG PET and PET-CT imaging in paediatric oncology. [stauss-2008]Eur J Nucl Med Mol Imaging 2008; 35:1581–1588. Stauss J 2008

Active substance: Steripet

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

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Document reference: 48701

Study title: Stumpe KD, Urbinelli M, Steinert HC, Glanzmann C, Buck A, von Schulthess GK. Whole-body positron emission tomography using fluorodeoxyglucose for staging of lymphoma: effectiveness and comparison with computed tomography. [stumpe-1998]Eur J Nucl Med. 1998 Jul;25(7):721-8. Stumpe KD 1998

Active substance: Steripet

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

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Document reference: 48702

Study title: Tan LT, Ong KL.. Semiquantitative measurements of normal organs with variable metabolic activity on FDG PET imaging. [tan-2004]Ann Acad Med Singapore. 2004 Mar;33(2):183-5. Tan LT 2004

Active substance: Steripet

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

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Document reference: 48703

Study title: " Kurian-B-T, Ray-W-A, Arbogast-P-G, Fuchs-D-C, Dudley-J-A, Cooper-W-O. Dr. W.O. Cooper, Department of Pediatrics, Vanderbilt University Medical Center, AA-0216 MCN, Nashville, TN 37232, United States e-mail: william.cooper@vanderbilt.edu. Effect of regulatory warnings on antidepressant prescribing for children and adolescents. Archives of Pediatrics and Adolescent Medicine {ARCH-PEDIATR-ADOLESC- MED}, 2007, Vol/Iss/Pg. 161/7 (690-696), eISSN: 1538-3628, ISSN: 1072-4710. " " Kurian-B-T, Ray-W-A, Arbogast-P-G, Fuchs-D-C, Dudley-J-A, Cooper-W-O. Dr. W.O. Cooper, Department of Pediatrics, Vanderbilt University Medical Center, AA-0216 MCN, Nashville, TN 37232, United States e-mail: william.cooper@vanderbilt.edu. Effect of regulatory warnings on antidepr...

Active substance: PRAZEPAM

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Document reference: 34641

Study title: "Le-Heuzey-M-F, Jacqz-Aigrain-E. M.F. Le Heuzey, Serv. Psychopathol. l'Enfant/l'Adol., Hopital Robert Debre, 48, boulevard Serurier, 75019 Paris, France e-mail: marie-france.leheuzey@rdb.ap-hop-paris.fr. Drugs and sleep disorders in children. Archives de Pediatrie {ARCH-PEDIATR}, 2002, Vol/Iss/Pg. 9/SUPPL. 2 (187s-189s), ISSN: 0929-693X." " "Le-Heuzey-M-F, Jacqz-Aigrain-E. M.F. Le Heuzey, Serv. Psychopathol. l'Enfant/l'Adol., Hopital Robert Debre, 48, boulevard Serurier, 75019 Paris, France e-mail: marie-france.leheuzey@rdb.ap-hop-paris.fr. Drugs and sleep disorders in children. Archives de Pediatrie {ARCH-PEDIATR}, 2002, Vol/Iss/Pg. 9/SUPPL. 2 (187s-189s), ISSN: 0929-693X." "

Active substance: PRAZEPAM

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Document reference: 34643

Study title: "Mancini-J, Thirion-X, Masut-A, Saillard-C, Pradel-V, Romain-F, Pastor-M-J-J, Coudert-C, Micallef-J. X. Thirion, Service d'Information Medicale, Hopital Sainte Marguerite, 270 Bd de Sainte Marguerite, Marseille, France e-mail: xavier.thirion@mail.ap.hm.fr. Anxiolytics, hypnotics, and antidepressants dispensed to adolescents in a French region in 2002. Pharmacoepidemiology and Drug Safety {PHARMACOEPIDEMIOL-DRUG-SAF}, 2006, Vol/Iss/Pg. 15/7 (494-503), eISSN: 1099-1557, ISSN: 1053-8569. " "Mancini-J, Thirion-X, Masut-A, Saillard-C, Pradel-V, Romain-F, Pastor-M-J-J, Coudert-C, Micallef-J. X. Thirion, Service d'Information Medicale, Hopital Sainte Marguerite, 270 Bd de Sainte Marguerite, Marseille, France e-mail: xavier.thirion@mail.ap.hm....

Active substance: PRAZEPAM

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Document reference: 34638

Study title: Piracetam (UCB 6215) in the reeducation of children with speech disorders.

Active substance: PIRACETAM

Study summary document link (including results): CE71K081 - Piracetam.pdf

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Document reference: 45912

Study title: A double-blind two centre parallel group study comparing HOE777 0.25% fatty ointment with topisolon 0.25% fatty ointment in patients with mild to severe atopic or eczematous contact dermatitis

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Plewig.xls

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Document reference: 48015

Study title: A four-weeks evaluation of HOE777 fatty ointment 0,25%in young patients with severe atopic dermatitis of long duration - G. Rajka - 1987 (unpublished report) Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Rajka.xls

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Document reference: 34657

Study title: An open study with HOE 777 0.25% emollient cream in children aged from 1 to 12 years with contact dermatitis, atopic dermatitis, seborrhoeic eczema or psoriasis

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Herz.xls

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Document reference: 34669

Study title: An open study with HOE 777 0.25% emollient cream in children up to 1 year with seborrhoeic eczema

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Herz 1year.xls

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Document reference: 34676

Study title: "Berlin dermatologists study. Clinical efficacy and tolerance of prednicarbate cream ointment and fatty ointment - C.E Orfanos - 1985 (Hoechst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -" "Berlin dermatologists study. Clinical efficacy and tolerance of prednicarbate cream ointment and fatty ointment - C.E Orfanos - 1985 (Hoechst AG report) - Study in Expert report -Clinical Documentation - No author-14/12/1987 -"

Active substance: PREDNICARBATE

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Document reference: 34670

Study title: The value of the use of piracetam (UCB 6215) in adjustment disturbances of children

Active substance: PIRACETAM

Study summary document link (including results): CE72B281 - Piracetam.pdf

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Document reference: 45937

Study title: Evaluation of temporal and facial osteomyelitis by simultaneous In-WBC/Tc-99m-MDP bone SPECT scintigraphy and computed tomography scan. Weber PC, Seabold JE, Graham SM, Hoffmann HH, Simonson TM, Thompson BH. Otolaryngol Head Neck Surg. 1995 Jul;113(1):36-41.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43594

Study title: [Extraosseous tumor uptake of 99m technetium methylendiphosphonate in children with neuroblastoma (author's transl)] Italian Mancini AF, Turba E, Vallicelli R, Vitelli A, Fini A, Rosito P. Pediatr Med Chir. 1981 Nov-Dec;3(6):535-9. Italian. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44189

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

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43919

Study title: Mandell GA, Harcke HT, Sharkey C, Cooley L. Postprandial blush in multiphase bone scanning. J Nucl Med. 1987 Oct;28(10):1550-3. Mandell GA, Harcke HT, Sharkey C, Cooley L. Postprandial blush in multiphase bone scanning. J Nucl Med. 1987 Oct;28(10):1550-3.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43845

Study title: Mandell GA, Harcke HT. Scintigraphic manifestations of infraction of the second metatarsal (Freiberg's disease). J Nucl Med. 1987 Feb;28(2):249-51. Mandell GA, Harcke HT. Scintigraphic manifestations of infraction of the second metatarsal (Freiberg's disease). J Nucl Med. 1987 Feb;28(2):249-51.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43875

Study title: Accumulation of MDP in primary childhood hepatic malignancies and their metastases. Mandell GA, Heyman S. Clin Nucl Med. 1983 Dec;8(12):594-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44019

Study title: The Value of 18F-FDG PET in the Detection of Stage M0 Carcinoma of the NasopharynxJ Nucl Med 2005; 46:405–410 .Tzu-Chen Yen, MD, PhD1; Joseph Tung-Chieh Chang, MD, MHA2; Shu-Hang Ng, MD3; Yu-Chen Chang, MD1; Sheng-Chieh Chan, MD1; Kun-Ju Lin, MD1; Wuu-Jyh Lin, PhD4; Ying-Kai Fu, PhD4; and Chen-Yu Lin2

Active substance: Steripet

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

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Document reference: 48748

Study title: Flamant F et al Treatment of non-metastatic rhabdomyosarcomas in childhood and adolescence.Results of the second study of the International Society of Paediatric Oncology: MMT84 Eur J Cancer. 1998 Jun;34(7):1050-62Flamant F et al Treatment of non-metastatic rhabdomyosarcomas in childhood and adolescence.Results of the second study of the International Society of Paediatric Oncology: MMT84 Eur J Cancer. 1998 Jun;34(7):1050-62

Active substance: MITOXANTRONE

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Document reference: 32150

Study title: Laver JH et al. Results of a randomized phase III trial in children and adolescents with advanced stage diffuse large cell non-Hodgkin's lymphoma: a Pediatric Oncology Group study. Leuk Lymphoma. 2002 Jan;43(1):105-9Laver JH et al. Results of a randomized phase III trial in children and adolescents with advanced stage diffuse large cell non-Hodgkin's lymphoma: a Pediatric Oncology Group study. Leuk Lymphoma. 2002 Jan;43(1):105-9

Active substance: MITOXANTRONE

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Document reference: 32205

Study title: Le Deley MC et al SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients Eur J Cancer. 2007 Mar;43(4):752-61. Epub 2007 Jan 30Le Deley MC et al SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients Eur J Cancer. 2007 Mar;43(4):752-61. Epub 2007 Jan 30

Active substance: MITOXANTRONE

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Document reference: 32117

Study title: Link MP et al Treatment of children and young adults with early-stage non-Hodgkin's lymphoma. N Engl J Med. 1997 Oct 30;337(18):1259-66Link MP et al Treatment of children and young adults with early-stage non-Hodgkin's lymphoma. N Engl J Med. 1997 Oct 30;337(18):1259-66

Active substance: MITOXANTRONE

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Document reference: 32213

Study title: Extraosseous uptake of technetium-99m MDP in secondary deposits of neuroblastoma.Mandell GA, Heyman S. Clin Nucl Med. 1986 May;11(5):337-40.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43912

Study title: Mandell GA, Heyman S. Mid-line circular photopenic defects of the sternum. Br J Radiol. 1983 Oct;56(670):761-3. No abstract available. Mandell GA, Heyman S. Mid-line circular photopenic defects of the sternum. Br J Radiol. 1983 Oct;56(670):761-3. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44026

Study title: Ritter G. [Perthes' disease in scintigraphy - early diagnosis, course and therapeutic consequences] Z Orthop Ihre Grenzgeb. 1982 Nov-Dec;120(6):850-9. German. Ritter G. [Perthes' disease in scintigraphy - early diagnosis, course and therapeutic consequences] Z Orthop Ihre Grenzgeb. 1982 Nov-Dec;120(6):850-9. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44067

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

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43754

Study title: Rohlin M. Diagnostic value of bone scintigraphy in osteomyelitis of the mandible. Oral Surg Oral Med Oral Pathol. 1993 May;75(5):650-7. Rohlin M. Diagnostic value of bone scintigraphy in osteomyelitis of the mandible. Oral Surg Oral Med Oral Pathol. 1993 May;75(5):650-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43666

Study title: Gerhartz HH et al. Randomized, double-blind, placebo-controlled, phase III study of recombinant human granulocyte-macrophage colony-stimulating factor as adjunct to induction treatment of high-grade malignant non-Hodgkin's lymphomas. Blood. 1993 Oct 15;82(8):2329-39.Gerhartz HH et al. Randomized, double-blind, placebo-controlled, phase III study of recombinant human granulocyte-macrophage colony-stimulating factor as adjunct to induction treatment of high-grade malignant non-Hodgkin's lymphomas. Blood. 1993 Oct 15;82(8):2329-39.

Active substance: MITOXANTRONE

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Document reference: 32220

Study title: Geyer JR et al Multiagent chemotherapy and deferred radiotherapy in infants with malignant brain tumors: a report from the Children's Cancer Group. J Clin Oncol. 2005 Oct 20;23(30):7621-31Geyer JR et al Multiagent chemotherapy and deferred radiotherapy in infants with malignant brain tumors: a report from the Children's Cancer Group. J Clin Oncol. 2005 Oct 20;23(30):7621-31

Active substance: MITOXANTRONE

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Document reference: 32233

Study title: Goorin AM et al Phase II/III trial of etoposide and high-dose ifosfamide in newly diagnosed metastatic osteosarcoma: a pediatric oncology group trial J Clin Oncol. 2002 Jan 15;20(2):426-33Goorin AM et al Phase II/III trial of etoposide and high-dose ifosfamide in newly diagnosed metastatic osteosarcoma: a pediatric oncology group trial J Clin Oncol. 2002 Jan 15;20(2):426-33

Active substance: MITOXANTRONE

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Document reference: 32133

Study title: Green DM et al. Treatment of children with stage IV favorable histology Wilms tumor: a report from the National Wilms Tumor Study Group. Med Pediatr Oncol. 1996 Mar;26(3):147-52.Green DM et al. Treatment of children with stage IV favorable histology Wilms tumor: a report from the National Wilms Tumor Study Group. Med Pediatr Oncol. 1996 Mar;26(3):147-52.

Active substance: MITOXANTRONE

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Document reference: 32252

Study title: A 9-Week, Randomized, Double-Blind, Placebo-Controlled, fixed-dosage (340 or 425 mg/day), Parallel-Group Study to Evaluate the Efficacy and Safety of Modafinil (Film-Coated Tablet) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder, Including a 2-Week (Blined) Withdrawel Period.

Active substance: MODAFINIL

Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls

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Document reference: 45282

Study title: Longhi A et al Fertility in male patients treated with neoadjuvant chemotherapy forOsteosarcoma J Pediatr Hematol Oncol. 2003 Apr;25(4):292-6Longhi A et al Fertility in male patients treated with neoadjuvant chemotherapy forOsteosarcoma J Pediatr Hematol Oncol. 2003 Apr;25(4):292-6

Active substance: MITOXANTRONE

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Document reference: 32141

Study title: MacDonald TJ et al. Phase II study of high-dose chemotherapy before radiation in children with newly diagnosed high-grade astrocytoma: final analysis of Children's Cancer Group Study 9933. Cancer. 2005 Dec 15;104(12):2862-71.MacDonald TJ et al. Phase II study of high-dose chemotherapy before radiation in children with newly diagnosed high-grade astrocytoma: final analysis of Children's Cancer Group Study 9933. Cancer. 2005 Dec 15;104(12):2862-71.

Active substance: MITOXANTRONE

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Document reference: 32231

Study title: Magrath I et al A phase II study of ifosfamide in the treatment of recurrent sarcomas in young people Cancer Chemother Pharmacol. 1986;18 Suppl 2:S25-8Magrath I et al A phase II study of ifosfamide in the treatment of recurrent sarcomas in young people Cancer Chemother Pharmacol. 1986;18 Suppl 2:S25-8

Active substance: MITOXANTRONE

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Document reference: 32164

Study title: Magrath I et al. Adults and children with small non-cleaved-cell lymphoma have a similar excellent outcome when treated with the same chemotherapy regimen. J Clin Oncol. 1996 Mar;14(3):925-34.Magrath I et al. Adults and children with small non-cleaved-cell lymphoma have a similar excellent outcome when treated with the same chemotherapy regimen. J Clin Oncol. 1996 Mar;14(3):925-34.

Active substance: MITOXANTRONE

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Document reference: 32250

Study title: THE EFFICACY AND SAFETY OF 0.5% TOPICAL PIROXICAM GEL IN THE TREATMENT OF ACUTE MUSCULOSKELETAL DISORDERS

Active substance: PIROXICAM

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Document reference: 34475

Study title: TO ASSESS THE EFFECT OF PIROXICAM 0.5% GEL ON THE PAIN AND STIFFNESS IN OSTEOARTHRITIC JOINT AS COMPARED TO PLACEBO.

Active substance: PIROXICAM

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Document reference: 34438

Study title: Acute epiphyseal osteomyelitis in children. Rosenbaum DM, Blumhagen JD. Radiology. 1985 Jul;156(1):89-92.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43939

Study title: Sato Y, Nakayama C, Nakata H, Suzuki K. [Bone scintigraphy of non-ossifying fibroma] Rinsho Hoshasen. 1988 Feb;33(2):265-9. Japanese. No abstract available. PMID: 3385950 [PubMed - indexed for MEDLINE] Sato Y, Nakayama C, Nakata H, Suzuki K. [Bone scintigraphy of non-ossifying fibroma] Rinsho Hoshasen. 1988 Feb;33(2):265-9. Japanese. No abstract available. PMID: 3385950 [PubMed - indexed for MEDLINE]

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43827

Study title: Schauwecker DS, Park HM, Mock BH, Burt RW, Kernick CB, Ruoff AC 3rd, Sinn HJ, Wellman HN. Evaluation of complicating osteomyelitis with Tc-99m MDP, In-111 granulocytes, and Ga-67 citrate. J Nucl Med. 1984 Aug;25(8):849-53. Schauwecker DS, Park HM, Mock BH, Burt RW, Kernick CB, Ruoff AC 3rd, Sinn HJ, Wellman HN. Evaluation of complicating osteomyelitis with Tc-99m MDP, In-111 granulocytes, and Ga-67 citrate. J Nucl Med. 1984 Aug;25(8):849-53.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43989

Study title: Schettini F, Mele M, De Mattia D, Falcone G, D'Addabbo A. Bone metabolism in thalassemia major. J Pediatr. 1987 Jul;111(1):158. No abstract available. Schettini F, Mele M, De Mattia D, Falcone G, D'Addabbo A. Bone metabolism in thalassemia major. J Pediatr. 1987 Jul;111(1):158. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43857

Study title: Radionuclide techniques In: Resnick D and Kransdorf MJ eds. Bone and joint imaging. 3rd Ed. Philidelphia. PA.Schneider R. Chapter 7: Radionuclide techniques In: Resnick D and Kransdorf MJ eds. Bone and joint imaging. 3rd Ed. Philidelphia. PA. Elsevier Saunders; 2005:86-117

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 47923

Study title: A 9-Week, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dosage (up to 425 mg/day), Parallel-Group Study to Evaluate the Efficacy and Safety of Modafinil (Film-Coated Tablet) in Children with Attention-Deficit/Hyperactivity Disorder.

Active substance: MODAFINIL

Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls

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Document reference: 45281

Active substance: MODAFINIL

Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls

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Document reference: 45283

Study title: "Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005" "Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005"

Active substance: PREDNICARBATE

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Document reference: 34671

Study title: Schurawitzki H, Wickenhauser J, Fezoulidis I, Sadil V, Fialka V. [Sudeck syndrome--a combined clinico-roentgenologic-nuclear medicine study] Unfallchirurgie. 1988 Oct;14(5):238-46. German. Schurawitzki H, Wickenhauser J, Fezoulidis I, Sadil V, Fialka V. [Sudeck syndrome--a combined clinico-roentgenologic-nuclear medicine study] Unfallchirurgie. 1988 Oct;14(5):238-46. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43809

Study title: Bone scan patterns in acute osteomyelitis. Scoles PV, Hilty MD, Sfakianakis GN. Clin Orthop Relat Res. 1980 Nov-Dec;(153):210-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44136

Study title: A 16-week, randomized, multi-center, parallel- group, pimecrolimus-blinded, controlled study (4 week treatment period followed by a 12 week observational period) to evaluate the safety of concomitant use of ASM981 (pimecrolimus) cream 1% (BID) plus topical corticosteroids (BID) for the treatment of severe atopic dermatitis in patients 2 to 17 years of age

Active substance: PIMECROLIMUS

Study summary document link (including results): ASM981C2439 Art45 listing 2011.xls

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Document reference: 34090

Study title: Lindenschmidt Th, Aleksic D. Der paralytische Ileus in der Chirurgie. Internistische Praxis 1970;10(3):447-58. Lindenschmidt Th, Aleksic D. Der paralytische Ileus in der Chirurgie. Internistische Praxis 1970;10(3):447-58.

Active substance: PYRIDOSTIGMINE

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Document reference: 35226

Study title: Webster DL, Hurwitz GA, DeVeber LL, Troster M, Driedger AA. Increased activity on immediate phase of bone imaging does not always indicate increased blood volume. Clin Nucl Med. 1986 Nov;11(11):749-50. Webster DL, Hurwitz GA, DeVeber LL, Troster M, Driedger AA. Increased activity on immediate phase of bone imaging does not always indicate increased blood volume. Clin Nucl Med. 1986 Nov;11(11):749-50.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43889

Study title: Extraosseous bone-tracer uptake. Plasma cell granuloma. Wells RG, Sty JR. Clin Nucl Med. 1986 Jul;11(7):527.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43899

Study title: Whallett A, Evans N, Bradley S, Jobanputra P. Isotope bone scans: an assessment of their diagnostic use in polyarticular pain of uncertain origin. Ann Rheum Dis. 2003 Aug;62(8):784-5. No abstract available. Whallett A, Evans N, Bradley S, Jobanputra P. Isotope bone scans: an assessment of their diagnostic use in polyarticular pain of uncertain origin. Ann Rheum Dis. 2003 Aug;62(8):784-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43416

Study title: Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans.Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6.Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans.Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6.

Active substance: POLYMYXIN B AND TRIMETHOPRIM

Study summary document link (including results): Clinical evaluation of trimethoprim-containing.pdf

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Document reference: 34584

Study title: Pulce-C, Mollon-P, Pham-E, Frantz-P, Descotes-J. Service de Pharmaco-Toxicovigilance, Hospital E. Herriot, Lyon, France. Acute poisonings with ethyle loflazepate, flunitrazepam, prazepam and triazolam in children. Veterinary and human toxicology, {Vet-Hum-Toxicol}, Apr 1992, vol. 34, no. 2, p. 141-3, ISSN: 0145-6296.Pulce-C, Mollon-P, Pham-E, Frantz-P, Descotes-J. Service de Pharmaco-Toxicovigilance, Hospital E. Herriot, Lyon, France. Acute poisonings with ethyle loflazepate, flunitrazepam, prazepam and triazolam in children. Veterinary and human toxicology, {Vet-Hum-Toxicol}, Apr 1992, vol. 34, no. 2, p. 141-3, ISSN: 0145-6296.

Active substance: PRAZEPAM

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Document reference: 34637

Study title: "Rochet-T, Revol-O, Maillet-J, De-Villard-R. Service de Psychopathologie de, l'Enfant et de l'Adolescent, Hopital Neurologique, 59, Bd Pinel,69003 Lyon, France. Psychoactive drugs in child and adolescent psychiatry. Annales de Pediatrie {ANN-PEDIATR}, 1993, Vol/Iss/Pg. 40/9 (555-563), ISSN: 0066-2097. " "Rochet-T, Revol-O, Maillet-J, De-Villard-R. Service de Psychopathologie de, l'Enfant et de l'Adolescent, Hopital Neurologique, 59, Bd Pinel,69003 Lyon, France. Psychoactive drugs in child and adolescent psychiatry. Annales de Pediatrie {ANN-PEDIATR}, 1993, Vol/Iss/Pg. 40/9 (555-563), ISSN: 0066-2097. "

Active substance: PRAZEPAM

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Document reference: 34639

Study title: "Shader-R-I, Pary-R-J, Harmatz-J-S, Allison-S, Locniskar-A, Greenblatt-D-J. Tufts Univ, New England Med Ctr, Dept Psychiat, Boston, Ma, 02111. Tufts Univ, New England Med Ctr, Div Clin Pharmacol, Boston, Ma, 02111. Plasma-Concentrations And Clinical Effects After Single Oral Doses Of Prazepam, Clorazepate, And Diazepam. Journal-Of-Clinical-Psychiatry, 1984, V45, N10, P411-413." "Shader-R-I, Pary-R-J, Harmatz-J-S, Allison-S, Locniskar-A, Greenblatt-D-J. Tufts Univ, New England Med Ctr, Dept Psychiat, Boston, Ma, 02111. Tufts Univ, New England Med Ctr, Div Clin Pharmacol, Boston, Ma, 02111. Plasma-Concentrations And Clinical Effects After Single Oral Doses Of Prazepam, Clorazepate, And Diazepam. Journal-Of-Clinical-Psychiatry, 1984, V45, N10, ...

Active substance: PRAZEPAM

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Document reference: 34642

Study title: " Stojanovski-S-D, Rasu-R-S, Balkrishnan-R, Nahata-M-C. Prof. M.C. Nahata, Ohio State University College of Pharmacy, 500 W. 12th Avenue, Columbus, OH 43210, United States e-mail: nahata.1@osu.edu. Trends in medication prescribing for pediatric sleep difficulties in US outpatient settings. Sleep {SLEEP}, 01 AUG 2007, Vol/Iss/Pg. 30/8 (1013-1017), ISSN: 0161-8105. " " Stojanovski-S-D, Rasu-R-S, Balkrishnan-R, Nahata-M-C. Prof. M.C. Nahata, Ohio State University College of Pharmacy, 500 W. 12th Avenue, Columbus, OH 43210, United States e-mail: nahata.1@osu.edu. Trends in medication prescribing for pediatric sleep difficulties in US outpatient settings. Sleep {SLEEP}, 01 AUG 2007, Vol/Iss/Pg. 30/8 (1013-1017), ISSN: 0161-8105. "

Active substance: PRAZEPAM

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Document reference: 34640

Study title: Doehring-Schwertfeger E. Ultrasonographical Investigation of Periportal Fibrosis in Children with Schistosoma Mansoni Infection: Reversibility of Morbidity Twenty-Three Months after Treatment with Praziquantel. Am J Trop Med Hyg 1992; 46 (4): 409-415. Doehring-Schwertfeger E. Ultrasonographical Investigation of Periportal Fibrosis in Children with Schistosoma Mansoni Infection: Reversibility of Morbidity Twenty-Three Months after Treatment with Praziquantel. Am J Trop Med Hyg 1992; 46 (4): 409-415.

Active substance: PRAZIQUANTEL

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Document reference: 34647

Study title: Metwally A. Impact of drug dosage and brand on bioavailability and efficacy of Praziquantel. Pharmacol Res 1995; 31 (1): 53-59.Metwally A. Impact of drug dosage and brand on bioavailability and efficacy of Praziquantel. Pharmacol Res 1995; 31 (1): 53-59.

Active substance: PRAZIQUANTEL

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Document reference: 34645

Study title: "Determination of the efficacity and safety of prednicarbate 0,25% solution for dematoses sensitive to topical corticosteroids - K. Drebinger - 1989 (unpublished report) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-" "Determination of the efficacity and safety of prednicarbate 0,25% solution for dematoses sensitive to topical corticosteroids - K. Drebinger - 1989 (unpublished report) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-"

Active substance: PREDNICARBATE

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Document reference: 34672

Study title: Determination of the efficacy and safety of prednicarbate 0.25% solution for dermatoses sensitive to topical corticosteroids

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Drebinger topical 313DT.xls

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Document reference: 34659

Study title: " Eczematous disorders and corticoid-sensitive dermatoses - Treatment with prednicarbate 0,25% solution- S. Nolting et al. - 1994 (Z Allg Med vol 70) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" " Eczematous disorders and corticoid-sensitive dermatoses - Treatment with prednicarbate 0,25% solution- S. Nolting et al. - 1994 (Z Allg Med vol 70) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -"

Active substance: PREDNICARBATE

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Document reference: 34660

Study title: Evaluation of efficacy and tolerance of prednicarbate 0.25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses.

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Drebinger 405DT.xls

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Document reference: 48010

Study title: Evaluation of efficacy and tolerance of prednicarbate 0.25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses.

Active substance: PREDNICARBATE

Study summary document link (including results): Prednicarbate STUDY Drebinger 402DT.xls

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Document reference: 48011

Study title: Final report on the clinical trial of the substance LS 519 Cl 2.

Active substance: PIRENZEPINE

Study summary document link (including results): Pirenzepine dihydrochloride_U75-0353_synopsis.pdf

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Document reference: 34298

Study title: Study of the drug LS 519.

Active substance: PIRENZEPINE

Study summary document link (including results): Pirenzepine dihydrochloride_U73-0300_synopsis.pdf

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Document reference: 34297

Study title: Study on changes in appetite and body weight after administration of LS 519.

Active substance: PIRENZEPINE

Study summary document link (including results): Pirenzepine dihydrochloride_U73-0298_synopsis.pdf

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Document reference: 34296

Study title: Klinisches gutachten - 3.4 Wirksamkeit nephrotischen syndrome (page 26) - Studie 65: kinder mit lipoid nephrose - Dr. Drebinger - 03/10/1980

Active substance: PIRETANIDE

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Document reference: 34299

Study title: Therapeutisch Erprobung - 2.6.4: Indikation nephrotisches syndrom (pages 1307 to 1380) - Studie 65 : Clinical assessment of HOE118 in children with nephrotic syndrom - Grünberg J - No date

Active substance: PIRETANIDE

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Document reference: 34300

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43504

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44159

Study title: Mandell GA, Keret D, Harcke HT, Bowen JR. Chondrolysis: detection by bone scintigraphy. J Pediatr Orthop. 1992 Jan;12(1):80-5. Mandell GA, Keret D, Harcke HT, Bowen JR. Chondrolysis: detection by bone scintigraphy. J Pediatr Orthop. 1992 Jan;12(1):80-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43712

Study title: Mandell GA, Morales RW, Harcke HT, Bowen JR. Bone scintigraphy in patients with atypical lumbar Scheuermann disease. J Pediatr Orthop. 1993 Sep-Oct;13(5):622-7. Mandell GA, Morales RW, Harcke HT, Bowen JR. Bone scintigraphy in patients with atypical lumbar Scheuermann disease. J Pediatr Orthop. 1993 Sep-Oct;13(5):622-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43653

Study title: Manfrini M, Rimondi E, Bruno A, Capanna R, Albisinni U, Picci P, Bacci G, Gaiani L, Tarozzi C. Total body bone scan in the evaluation of tumor response to preoperative chemotherapy in the treatment of osteosarcoma. Chir Organi Mov. 1990 Oct-Dec;75(4):325-30. English, Italian. Manfrini M, Rimondi E, Bruno A, Capanna R, Albisinni U, Picci P, Bacci G, Gaiani L, Tarozzi C. Total body bone scan in the evaluation of tumor response to preoperative chemotherapy in the treatment of osteosarcoma. Chir Organi Mov. 1990 Oct-Dec;75(4):325-30. English, Italian.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44175

Study title: Marchandise X, Dhellemmes P, Pellerin P, Dujardin MH. [Evaluation of scintigraphy of the skull. Apropos of 84 cases of craniostenosis] Ann Radiol (Paris). 1983 Sep-Oct;26(6):505-9. French. No abstract available. Marchandise X, Dhellemmes P, Pellerin P, Dujardin MH. [Evaluation of scintigraphy of the skull. Apropos of 84 cases of craniostenosis] Ann Radiol (Paris). 1983 Sep-Oct;26(6):505-9. French. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44029

Study title: Mariconda M, Cozzolino A, Attingenti P, Cozzolino F, Milano C. Osteoarticular tuberculosis in a developed country. J Infect. 2007 Apr;54(4):375-80. Epub 2006 Jul 24. Mariconda M, Cozzolino A, Attingenti P, Cozzolino F, Milano C. Osteoarticular tuberculosis in a developed country. J Infect. 2007 Apr;54(4):375-80. Epub 2006 Jul 24.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43373

Study title: Marks PH, Goldenberg JA, Vezina WC, Chamberlain MJ, Vellet AD, Fowler PJ. Subchondral bone infractions in acute ligamentous knee injuries demonstrated on bone scintigraphy and magnetic resonance imaging. J Nucl Med. 1992 Apr;33(4):516-20. Marks PH, Goldenberg JA, Vezina WC, Chamberlain MJ, Vellet AD, Fowler PJ. Subchondral bone infractions in acute ligamentous knee injuries demonstrated on bone scintigraphy and magnetic resonance imaging. J Nucl Med. 1992 Apr;33(4):516-20.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43701

Study title: Comparison of the visual analogue scale (VAS) and Smiley Analog Scale (SAS) for evaluation of pain in children. Pain World Congress 1984, Seattle. Raven, New York, p.25 Comparison of the visual analogue scale (VAS) and Smiley Analog Scale (SAS) for evaluation of pain in children. Pain World Congress 1984, Seattle. Raven, New York, p.25

Active substance: PIRITRAMIDE

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

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Document reference: 34302

Study title: Maurer HM et al. The Intergroup Rhabdomyosarcoma Study-II. Cancer. 1993 Mar 1;71(5):1904-22Maurer HM et al. The Intergroup Rhabdomyosarcoma Study-II. Cancer. 1993 Mar 1;71(5):1904-22

Active substance: MITOXANTRONE

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Document reference: 32188

Study title: Martin-Simmerman P, Cohen MD, Siddiqui A, Mirkin D, Provisor A. Calcification and uptake of Tc-99m diphosphonates in neuroblastomas: concise communication. J Nucl Med. 1984 Jun;25(6):656-60. Martin-Simmerman P, Cohen MD, Siddiqui A, Mirkin D, Provisor A. Calcification and uptake of Tc-99m diphosphonates in neuroblastomas: concise communication. J Nucl Med. 1984 Jun;25(6):656-60.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43997

Study title: Marymont JV. Comparative imaging. Massive osteolysis (Gorham's syndrome, disappearing bone disease). Clin Nucl Med. 1987 Feb;12(2):153-4. No abstract available. Marymont JV. Comparative imaging. Massive osteolysis (Gorham's syndrome, disappearing bone disease). Clin Nucl Med. 1987 Feb;12(2):153-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43873

Study title: Rossleigh MA, Smith J, Yeh SD. Scintigraphic features of primary sacral tumors. J Nucl Med. 1986 May;27(5):627-30. Rossleigh MA, Smith J, Yeh SD. Scintigraphic features of primary sacral tumors. J Nucl Med. 1986 May;27(5):627-30.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43909

Study title: The irritable hip. Scintigraphy in 192 children. Royle SG, Galasko CS. Acta Orthop Scand. 1992 Feb;63(1):25-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43706

Study title: Three-phase radionuclide bone imaging in sports medicine. Rupani HD, Holder LE, Espinola DA, Engin SI. Radiology. 1985 Jul;156(1):187-96.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43940

Study title: Rypens F, Gevenois PA, Struyven J. Multifocal Ewing's sarcoma. J Belge Radiol. 1994 Oct;77(5):222. No abstract available. Rypens F, Gevenois PA, Struyven J. Multifocal Ewing's sarcoma. J Belge Radiol. 1994 Oct;77(5):222. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43612

Study title: Gururangan S et al Primary extracranial rhabdoid tumors. Clinicopathologic features and response to ifosfamide Cancer. 1993 Apr 15;71(8):2653-9Gururangan S et al Primary extracranial rhabdoid tumors. Clinicopathologic features and response to ifosfamide Cancer. 1993 Apr 15;71(8):2653-9

Active substance: MITOXANTRONE

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Document reference: 32142

Study title: Gururangan S et al Treatment of children with peripheral primitive neuroectodermal tumor or extraosseous Ewing's tumor with Ewing's-directed therapy J Pediatr Hematol Oncol. 1998 Jan-Feb;20(1):55-61Gururangan S et al Treatment of children with peripheral primitive neuroectodermal tumor or extraosseous Ewing's tumor with Ewing's-directed therapy J Pediatr Hematol Oncol. 1998 Jan-Feb;20(1):55-61

Active substance: MITOXANTRONE

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Document reference: 32104

Study title: Hachimi-Idrissi S et al Reversible cardiopathy after accidental overdose of mitoxantrone Pediatr Hematol Oncol. 1993 Jan-Mar;10(1):35-40Hachimi-Idrissi S et al Reversible cardiopathy after accidental overdose of mitoxantrone Pediatr Hematol Oncol. 1993 Jan-Mar;10(1):35-40

Active substance: MITOXANTRONE

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Document reference: 32081

Study title: Harris MB et al Treatment of osteosarcoma with ifosfamide: comparison of response in pediatric patients with recurrent disease versus patients previously untreated: a Pediatric Oncology Group study Med Pediatr Oncol. 1995 Feb;24(2):87-92Harris MB et al Treatment of osteosarcoma with ifosfamide: comparison of response in pediatric patients with recurrent disease versus patients previously untreated: a Pediatric Oncology Group study Med Pediatr Oncol. 1995 Feb;24(2):87-92

Active substance: MITOXANTRONE

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Document reference: 32130

Study title: Huber R et al Isolated hyperthermic perfusion with mitoxantrone of melphalan in malignant melanoma of the limb IAmJ Surg. 1995 Oct;170(4):345-52 Huber R et al Isolated hyperthermic perfusion with mitoxantrone of melphalan in malignant melanoma of the limb IAmJ Surg. 1995 Oct;170(4):345-52

Active substance: MITOXANTRONE

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Document reference: 32075

Study title: Intragumtornchai T et al. CHOP versus CHOP plus ESHAP and high-dose therapy with autologous peripheral blood progenitor cell transplantation for high-intermediate-risk and high-risk aggressive non-Hodgkin's lymphoma. Clin Lymphoma. 2000 Dec;1(3):219-25Intragumtornchai T et al. CHOP versus CHOP plus ESHAP and high-dose therapy with autologous peripheral blood progenitor cell transplantation for high-intermediate-risk and high-risk aggressive non-Hodgkin's lymphoma. Clin Lymphoma. 2000 Dec;1(3):219-25

Active substance: MITOXANTRONE

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Document reference: 32209

Study title: McTiernan A et al A phase I/II study of doxorubicin, ifosfamide, etoposide and interval methotrexate in patients with poor prognosis osteosarcoma Pediatr Blood Cancer. 2006 Mar;46(3):345-50McTiernan A et al A phase I/II study of doxorubicin, ifosfamide, etoposide and interval methotrexate in patients with poor prognosis osteosarcoma Pediatr Blood Cancer. 2006 Mar;46(3):345-50

Active substance: MITOXANTRONE

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Document reference: 32131

Study title: McWilliams NB et al.Cyclophosphamide/doxorubicin vs. cisplatin/teniposide in the treatment of children older than 12 months of age with disseminated neuroblastoma: a Pediatric Oncology Group Randomized Phase II study. Med Pediatr Oncol. 1995 Mar;24(3):176-80McWilliams NB et al.Cyclophosphamide/doxorubicin vs. cisplatin/teniposide in the treatment of children older than 12 months of age with disseminated neuroblastoma: a Pediatric Oncology Group Randomized Phase II study. Med Pediatr Oncol. 1995 Mar;24(3):176-80

Active substance: MITOXANTRONE

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Document reference: 32242

Study title: Meyers PA et al Osteosarcoma: a randomized, prospective trial of the addition of ifosfamide and/or muramyl tripeptide to cisplatin, doxorubicin, and high-dose methotrexate J Clin Oncol. 2005 Mar 20;23(9):2004-11Meyers PA et al Osteosarcoma: a randomized, prospective trial of the addition of ifosfamide and/or muramyl tripeptide to cisplatin, doxorubicin, and high-dose methotrexate J Clin Oncol. 2005 Mar 20;23(9):2004-11

Active substance: MITOXANTRONE

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Document reference: 32118

Study title: Meyers PA et al. Intensification of preoperative chemotherapy for osteogenic sarcoma: results of the Memorial Sloan-Kettering (T12) protocol. J Clin Oncol. 1998 Jul;16(7):2452-8.Meyers PA et al. Intensification of preoperative chemotherapy for osteogenic sarcoma: results of the Memorial Sloan-Kettering (T12) protocol. J Clin Oncol. 1998 Jul;16(7):2452-8.

Active substance: MITOXANTRONE

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Document reference: 32184

Study title: Sahin M, Bernay I, Basoglu T, Canturk F. Comparison of Tc-99m MDP, Tc-99m HSA and Tc-99m HIG uptake in rheumatoid arthritis and its variants. Ann Nucl Med. 1999 Dec;13(6):389-95. Sahin M, Bernay I, Basoglu T, Canturk F. Comparison of Tc-99m MDP, Tc-99m HSA and Tc-99m HIG uptake in rheumatoid arthritis and its variants. Ann Nucl Med. 1999 Dec;13(6):389-95.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43497

Study title: Saito S, Inoue A, Ono K. Intramedullary haemorrhage as a possible cause of avascular necrosis of the femoral head. The histology of 16 femoral heads at the silent stage. J Bone Joint Surg Br. 1987 May;69(3):346-51. Saito S, Inoue A, Ono K. Intramedullary haemorrhage as a possible cause of avascular necrosis of the femoral head. The histology of 16 femoral heads at the silent stage. J Bone Joint Surg Br. 1987 May;69(3):346-51.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43864

Study title: Cranial osteomyelitis: diagnosis and follow-up with In-111 white blood cell and Tc-99m methylene diphosphonate bone SPECT, CT, and MR imaging. Seabold JE, Simonson TM, Weber PC, Thompson BH, Harris KG, Rezai K, Madsen MT, Hoffman HT. Radiology. 1995 Sep;196(3):779-88.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44260

Study title: Segall GM, Gurevich N. Uterine blush in multiphase imaging. J Nucl Med. 1986 Sep;27(9):1500-1. No abstract available. Segall GM, Gurevich N. Uterine blush in multiphase imaging. J Nucl Med. 1986 Sep;27(9):1500-1. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43896

Study title: Shanley DJ, Buckner AB, Alexander HG. Unusual pelvic activity found on bone scan. Clin Nucl Med. 1991 Jun;16(6):453-4. No abstract available. Shanley DJ, Buckner AB, Alexander HG. Unusual pelvic activity found on bone scan. Clin Nucl Med. 1991 Jun;16(6):453-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43735

Study title: Turner CD, Chi S, Marcus KJ, MacDonald T, Packer RJ, Poussaint TY, et al.. Epub 2006 Sep 22. Phase II study of thalidomide and radiation in children with newly diagnosed brain stem gliomas and glioblastoma multiforme. [turner-2007]J Neurooncol. 2007 Mar;82(1):95-101. Turner CD 2007

Active substance: Steripet

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

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Document reference: 48705

Study title: Uchida Y, Minoshima S, Kawata T, Motoori K, Nakano K, Kazama T, et al.. Diagnostic value of FDG PET and salivary gland scintigraphy for parotid tumors. [uchida-2005]Clin Nucl Med. 2005 Mar;30(3):170-6. Uchida Y 2005

Active substance: Steripet

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

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Document reference: 48706

Study title: LARGE SCALE MULTICENTRIC EVALUATION OF EFFICACY AND TOLERABILITY OF PRX GEL 0.5% IN THE TREATMENT OF AMEAS

Active substance: PIROXICAM

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Document reference: 34351

Study title: Topiramate, carbamazepine and valproate monotherapy: double-blind comparison in children with newly diagnosed epilepsy. JM Wheless, J Child Neurol 2004;19:135-141 in CES EXPCRC-CES0296-EN-E01 Topiramate, carbamazepine and valproate monotherapy: double-blind comparison in children with newly diagnosed epilepsy. JM Wheless, J Child Neurol 2004;19:135-141 in CES EXPCRC-CES0296-EN-E01

Active substance: URINARY CONCREMENT SOLVENTS

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Document reference: 39154

Study title: A multicentre, randomised, double-blind, parallel, placebo controlled study of two dosing regimens of valaciclovir compared to placebo for the prevention/blockage of the progression of the cold sore lesion beyond the papular stage.

Active substance: VALACICLOVIR

Study summary document link (including results): Valaciclovir-HS230028-ICHE3.pdf

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Document reference: 45427

Study title: A multicentre, randomised, double-blind, parallel, placebo-controlled study of two dosing regimens of valaciclovir compared to placebo for the reduction in length of cold sore episodes.

Active substance: VALACICLOVIR

Study summary document link (including results): Valaciclovir-HS230027-ICHE3.pdf

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Document reference: 45426

Study title: A randomised, double-blind, multicentre study to evaluate the efficacy of valaciclovir in episodic treatment of recurrent facial herpes simplex virus (HSV) infection.

Active substance: VALACICLOVIR

Study summary document link (including results): Study HS240011 Valaciclovir.xls

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Document reference: 45428

Study title: A study to investigate the steady state pharmacokinetics of oral Valaciclovir (Valtrex) in immunocompromised children

Active substance: VALACICLOVIR

Study summary document link (including results): Valaciclovir-HS2B4005-ICHE3.pdf

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Document reference: 45429

Study title: An open-label, multiple-dose, multicenter, pharmacokinetic safety and tolerability study of valaciclovir oral suspension in infants and children with HSV infection

Active substance: VALACICLOVIR

Study summary document link (including results): Valaciclovir-HS210915-ICHE3.pdf

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Document reference: 45424

Study title: A multicenter, open-label, single-dose study to evaluate the pharmacokinetics (i.e. 24 hour pharmacokinetic sampling period) of valsartan given as an oral suspension in pediatric patients 1 year to 16 years of age with hypertension.DOI: 10.1177/0091270008329547 Journal publication: Journal Clinical Pharmacology 2009;49:235-241

Active substance: VALSARTAN

Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2305_2.xls

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Document reference: 47269

Study title: Burmester M, Mok Q. Randomised controlled trial comparing cisatracurium and vecuronium infusions in a paediatric intensive care unit. Intensive Care Med 2005;31:686-92.Burmester M, Mok Q. Randomised controlled trial comparing cisatracurium and vecuronium infusions in a paediatric intensive care unit. Intensive Care Med 2005;31:686-92.

Active substance: VECURONIUM

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Document reference: 45533

Study title: A comparison of intravenous salbutamol, aminophylline and the combination in the treatment of acute severe asthma in children. Report No. GPM/85/008

Active substance: SALBUTAMOL

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Document reference: 35567

Study title: Hennon DK, Stookey GK, Beiswanger BB. Fluoride-vitamin supplements: effects on dental caries and fluorosis when used in areas with suboptimal fluoride in the water supply. JADA 1977; 95: 965-971Hennon DK, Stookey GK, Beiswanger BB. Fluoride-vitamin supplements: effects on dental caries and fluorosis when used in areas with suboptimal fluoride in the water supply. JADA 1977; 95: 965-971

Active substance: SODIUM FLUORIDE

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Document reference: 42263

Active substance: SODIUM FLUORIDE

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Document reference: 42295

Active substance: SODIUM FLUORIDE

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Document reference: 42327

Study title: A multicentre, randomised, double-blind, parallel group study comparing the efficacy and safety of inhaled salmeterol xinafoate 50mcg bd with that of salbutamol 200mcg to use “as required” from Diskhalers for twelve months in children with asthma.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SLGB3019-ICHE3.pdf

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Document reference: 42050

Study title: A Multicentre, Randomised, Double-Blind, Parallel-Group Study Comparing Pressurised Inhaler and Dry Powder Formulations of Salmeterol Xinafoate 50μg bd in Children With Reversible Airways Obstruction

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SLPT03-ICHE3.pdf

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Document reference: 47697

Study title: A multicentre, randomised. double-blind, crossover study to investigate the efficacy and safety of inhaled salmeterol xinafoate (50mcg twice daily from the diskhaler) compared with placebo (from the diskhaler) with salbutamol (200mcg to use 'as required' from the diskhaler) in children with asthma. Report No. GRP/95/011

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SMS30013-ICHE3.pdf

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Document reference: 42048

Study title: A phase III, multi-centre, double-blind, placebo controlled, parallel group study assessing the efficacy and safety of inhaled salmeterol xinafoate (Serevent™) 50 micrograms BD via the Diskhaler™ when added to the existing treatment of moderate to severe asthmatic children.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SALMP-AH93-J119-ICHE3.pdf

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Document reference: 42041

Study title: Comparative study of corticotrophin vs vigabatrin therapy in infantile spasm - Ahmed R. - 2007 (Pak J Med Sci 2007; 23: 1 141-144) Publication in CES 0759 dated 16 Nov 2007 signed A. Giudicelli

Active substance: VIGABATRIN

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Document reference: 39387

Study title: Drug therapy for West's syndrome - Chiron C - 2002 (Adv Exp Med Biol. 2002;497:51-6) Publication in CES dated 14 Nov 2005 signed A. Giudicelli

Active substance: VIGABATRIN

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Document reference: 39388

Study title: Infantile spasms and West Syndrome Efficacy of short-term ACTH and vigabatrin treatment - Pintaudi M, Baglietto G, Pessagno A, Gaggero R - 2005 (Boll. Lega Ital. Epilepsia 2005; 169-170) Publication in CES 0741 dated 16 Nov 2006 signed A Giudicelli

Active substance: VIGABATRIN

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Document reference: 39390

Study title: MDL71754 (vigabatrin): 2-week oral range-finding toxicity study in juvenile rats

Active substance: VIGABATRIN

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Document reference: 39391

Study title: MDL71754 (vigabatrin): 4-week oral ocular toxicity study in Sprague Dawley juvenile rats (from postnatal day 4)

Active substance: VIGABATRIN

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Document reference: 39392

Study title: A phase I evaluation of oral and intravenous vinorelbine tartrate in Paediatric Cancer Patients

Active substance: VINORELBINE

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Document reference: 39399

Study title: An Open-Label, Multiple-Dose, Multicenter, Pharmacokinetic Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children with VZV Infection

Active substance: VALACICLOVIR

Study summary document link (including results): Valaciclovir-HS210916-ICHE3.pdf

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Document reference: 45425

Study title: An open-label, single-dose, multicenter, pharmacokinetic, safety and tolerability study of valaciclovir oral suspension in infants and children.

Active substance: VALACICLOVIR

Study summary document link (including results): Valaciclovir-HS210914-ICHE3.pdf

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Document reference: 45423

Study title: Hruby K et al Pharmacotherapy of Amanita phalloides Poisoning with Silibinin, (Chemotherapy of Amanita phalloides poisoning with intravenous silibinin.)Wiener klin.Wochenschrift (and Human Toxicology); 1983; 7 (and 2 (2): 183-95 )

Active substance: Silibinine dihydrogen succinate, disodium

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Document reference: 40191

Study title: Hruby K et al Pharmacotherapy of Amanita phalloides Poisoning with Silibinin, (Chemotherapy of Amanita phalloides poisoning with intravenous silibinin.). Wiener klin.Wochenschrift (and Human Toxicology); 1983; 7 (and 2 (2): 183-95 )

Active substance: Silibinine dihydrogen succinate, disodium

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Document reference: 39870

Study title: Strenge-Hesse Postmarkting surveillance study (evaluation of 154 Legalon-SIL-case reports,18 children) 1983-1992 Internal Report; Internal Report, Strenge-Hesse, March 1996

Active substance: Silibinine dihydrogen succinate, disodium

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Document reference: 40194

Study title: Von Kleist-Retzow J-C et al Klinik und Therapie der Knollenblätterpilzvergiftung im Kindesalter. Clinical findings and treatment of Amanita phalloides poisoning in childhood); Monatsschrift fur Kinderheilkunde; 143/11 (1118-1127); 1995

Active substance: Silibinine dihydrogen succinate, disodium

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Document reference: 39871

Study title: Von Kleist-Retzow J-C et al Klinik und Therapie der Knollenblätterpilzvergiftung im Kindesalter. Clinical findings and treatment of Amanita phalloides poisoning in childhood)Monatsschrift fur Kinderheilkunde; 143/11 (1118-1127); 1995

Active substance: Silibinine dihydrogen succinate, disodium

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Document reference: 40192

Study title: Nutzen der medikamentösen Lebertherapie in der hausärztlichen Praxis; Die Medizinische Welt 1995; 46(4): 222-227

Active substance: Silimarin (HERB)

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Document reference: 39876

Study title: Nutzen der medikamentösen Lebertherapie in der hausärztlichen Praxis; Die Medizinische Welt 1995; 46(4): 222-227

Active substance: Silimarin (HERB)

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Document reference: 40197

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SALMP-AH91-D89-ICHE3.pdf

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Document reference: 47699

Study title: A phase IV, multi-centre, double-blind, randomised, parallel group study in general practice to compare the efficacy and tolerability of inhaled salmeterol xinafoate 50 micrograms bd with placebo, both administered via the Diskhaler, in the treatment of episodic asthma induced by upper respiratory tract infection (URTI) in children.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SALMP-AH91-D89-ICHE3.pdf

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Document reference: 42040

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SALMP-AH93-J119-ICHE3.pdf

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Document reference: 47698

Study title: An Open-Label, Uncontrolled Pharmacokinetic and Clinical Evaluation Study of Valaciclovir Hydrochloride in Children with Chickenpox.

Active substance: VALACICLOVIR

Study summary document link (including results): Valaciclovir-HS2101951-ICHE3.pdf

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Document reference: 45422

Study title: Pharmacokinetics and Safety of valaciclovir in children with Epstein-Barr virus illness; Drugs R&D, 2002: 3(6), SimonPharmacokinetics and Safety of valaciclovir in children with Epstein-Barr virus illness; Drugs R&D, 2002: 3(6), Simon

Active substance: VALACICLOVIR

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Document reference: 45421

Study title: Pharmacokinetics of acyclovir in immunocompromised children with leukopenia and mucositis after chemotherapy: Can intravenous acyclovir be substituted by oral valacyclovir?Med Pediatr Oncol 2002:38:240-246, EksborgPharmacokinetics of acyclovir in immunocompromised children with leukopenia and mucositis after chemotherapy: Can intravenous acyclovir be substituted by oral valacyclovir?Med Pediatr Oncol 2002:38:240-246, Eksborg

Active substance: VALACICLOVIR

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Document reference: 45430

Study title: Post-marketing surveillance trial evaluating efficacy and tolerability of a valerian root extract in 55 children.

Active substance: Valerian root extract 6.15:1 (HERB)

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Document reference: 40297

Study title: Francis AJ, Dempster RJ. Effect of valerian, Valeriana edulis, on sleep difficulties in children with intellectual deficits: randomised trial. Phytomedicine. 2002 May;9(4):273-9.

Active substance: Valeriana dry extract

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Document reference: 40299

Study title: Müller SF, Klement S. A combination of valerian and lemon balm is effective in the treatment of restlessness and dyssomnia in children. Phytomedicine. 2006 Jun;13(6):383-7. Epub 2006 Feb 17.

Active substance: Valeriana dry extract

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Document reference: 40298

Study title: An open-label, multiple-dose, multicenter, pharmacokinetic safety and tolerability study of valaciclovir oral suspension in infants and children with HSV infection

Active substance: VALGACICLOVIR

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Document reference: 45433

Study title: An Open-Label, Multiple-Dose, Multicenter, Pharmacokinetic Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children with VZV Infection

Active substance: VALGACICLOVIR

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Document reference: 45434

Study title: An open-label, single-dose, multicenter, pharmacokinetic, safety and tolerability study of valaciclovir oral suspension in infants and children.

Active substance: VALGACICLOVIR

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Document reference: 45432

Study title: An Open-Label, Uncontrolled Pharmacokinetic and Clinical Evaluation Study of Valaciclovir Hydrochloride in Children with Chickenpox.

Active substance: VALGACICLOVIR

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Document reference: 45431

Study title: A clinical study of 57 children with fetal anticonvulsant syndromes. - Moore et al. - J Med Genet 2000;37:489-497.

Active substance: VALPROIC ACID

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Document reference: 45435

Study title: A comparative review of the adverse effects of anticonvulsants in children with epilepsy. - Wallace SJ. - Drug safety 1996; 15(6): 378-393.

Active substance: VALPROIC ACID

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Document reference: 45436

Study title: A cohort study of childhood hypertrophic cardiomyopathy: improved survival following high−dose beta−adrenoceptor antagonist treatment.Ostman−Smith I, Wettrell G, Riesenfeld T. Journal of the American College of Cardiology, 15 Nov 1999, vol. 34, no. 6, p.1813−22, A cohort study of childhood hypertrophic cardiomyopathy: improved survival following high−dose beta−adrenoceptor antagonist treatment.Ostman−Smith I, Wettrell G, Riesenfeld T. Journal of the American College of Cardiology, 15 Nov 1999, vol. 34, no. 6, p.1813−22,

Active substance: VERAPAMIL

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Document reference: 45540

Study title: Antagonisty kal'tsiia v lechenii nefrogennoi gipertenzii. (Calcium antagonists in the treatment of nephrogenic hypertension).Antonchenko IV, Tareeva IE, Kutyrina IM, Galstian GM, Rogov VA. Klinicheskaia meditsina, Aug 1990, vol. 68, no. 8, p. 52−6,Antagonisty kal'tsiia v lechenii nefrogennoi gipertenzii. (Calcium antagonists in the treatment of nephrogenic hypertension).Antonchenko IV, Tareeva IE, Kutyrina IM, Galstian GM, Rogov VA. Klinicheskaia meditsina, Aug 1990, vol. 68, no. 8, p. 52−6,

Active substance: VERAPAMIL

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Document reference: 45555

Study title: Assessment of blindness in the Danish Verapamil Infarction Trial II (DAVIT II). Danish Study Group on Verapamil in Myocardial Infarction.Jespersen CM. European journal of clinical pharmacology, 1990, vol. 39, no. 1, p. 75−6, Assessment of blindness in the Danish Verapamil Infarction Trial II (DAVIT II). Danish Study Group on Verapamil in Myocardial Infarction.Jespersen CM. European journal of clinical pharmacology, 1990, vol. 39, no. 1, p. 75−6,

Active substance: VERAPAMIL

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Document reference: 45556

Study title: Beta−adrenoblokatory i antagonisti kal'tsiia pri gipertroficheskoi kardiomiopatii. (Beta−adrenergic blockers and calcium antagonists in hypertrophic cardiomyopathy).Korovina EP. Klinicheskaia meditsina, 1998, vol. 76, no. 12, p. 30−5, Beta−adrenoblokatory i antagonisti kal'tsiia pri gipertroficheskoi kardiomiopatii. (Beta−adrenergic blockers and calcium antagonists in hypertrophic cardiomyopathy).Korovina EP. Klinicheskaia meditsina, 1998, vol. 76, no. 12, p. 30−5,

Active substance: VERAPAMIL

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Document reference: 45542

Study title: Calcium channel blockers and cardiac mortality in the treatment of hypertension: a report from the Department of Health Hypertension Care Computing Project (DHCCP).Bulpitt CJ, Palmer AJ, Beevers DG, Coles EC, Ledingham JG, Petrie JC, Webster J. Journal of human hypertension, Apr 1997, vol. 11, no. 4, p. 205−11, Calcium channel blockers and cardiac mortality in the treatment of hypertension: a report from the Department of Health Hypertension Care Computing Project (DHCCP).Bulpitt CJ, Palmer AJ, Beevers DG, Coles EC, Ledingham JG, Petrie JC, Webster J. Journal of human hypertension, Apr 1997, vol. 11, no. 4, p. 205−11,

Active substance: VERAPAMIL

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Document reference: 45543

Study title: Calcium channel blockers in cirrhotic patients with portal hypertension.Li D, Lu H, Li X, Quan Q, Li X, Lu W. Chinese medical journal, Nov 1995, vol. 108, no. 11, p. 803−8, Calcium channel blockers in cirrhotic patients with portal hypertension.Li D, Lu H, Li X, Quan Q, Li X, Lu W. Chinese medical journal, Nov 1995, vol. 108, no. 11, p. 803−8,

Active substance: VERAPAMIL

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Document reference: 45547

Study title: Albrecht M./Strenge-Hesse et al. The treatment of Toxic Liver Damage with Legalon. Z Klin Med; 1992, 47(2): 87-92 Albrecht M./Strenge-Hesse et al. The treatment of Toxic Liver Damage with Legalon. Z Klin Med; 1992, 47(2): 87-92

Active substance: SILYMARIN

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Document reference: 42171

Study title: Grüngreiff K./Strenge-Hesse et al. Nutzen der medikamentösen Lebertherpaie in der hausärztlichen Praxis. The value of drug therapy for liver disease in general practice. Die Medizinische Welt 1995; 46(4): 222-227.Grüngreiff K./Strenge-Hesse et al. Nutzen der medikamentösen Lebertherpaie in der hausärztlichen Praxis. The value of drug therapy for liver disease in general practice. Die Medizinische Welt 1995; 46(4): 222-227.

Active substance: SILYMARIN

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Document reference: 42173

Study title: Jdl J et al. Therapeutische M+oglichkeiten mit Legalon in der Pädiatrie. Therapeutic uses of Legalon in paediatrics. Medica 1983; 4 (11): 3-6. Jdl J et al. Therapeutische M+oglichkeiten mit Legalon in der Pädiatrie. Therapeutic uses of Legalon in paediatrics. Medica 1983; 4 (11): 3-6.

Active substance: SILYMARIN

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Document reference: 42172

Study title: Albert J et al. Simethicone for small bowel preparation for capsule endoscopy: a systematic, single-blinded, controlled study. Gastrointest Endosc. 2004 Apr;59(4):487-91 Albert J et al. Simethicone for small bowel preparation for capsule endoscopy: a systematic, single-blinded, controlled study. Gastrointest Endosc. 2004 Apr;59(4):487-91

Active substance: SIMETICONE

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Document reference: 42205

Study title: Fanning EA, Cellier KM, Leadbeater MM, Somerville CM. South Australian kindergarten children: fluoride tablet supplements and dental caries. Aust Dent J 1975: 20: 7-9Fanning EA, Cellier KM, Leadbeater MM, Somerville CM. South Australian kindergarten children: fluoride tablet supplements and dental caries. Aust Dent J 1975: 20: 7-9

Active substance: SODIUM FLUORIDE

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Document reference: 42276

Active substance: SODIUM FLUORIDE

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Document reference: 42308

Study title: Ota FS, Abramo TJ, Maxson RT. Ominous findings in toddlers with increasing abdominal girth: Two unusual cases and a review of the clinical evaluation. Ann Emerg Med. May 1, 2005, 517-23Ota FS, Abramo TJ, Maxson RT. Ominous findings in toddlers with increasing abdominal girth: Two unusual cases and a review of the clinical evaluation. Ann Emerg Med. May 1, 2005, 517-23

Active substance: SIMETICONE

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Document reference: 42182

Study title: Savino F et al. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics. 2007 Jan;119(1):e124-30 Savino F et al. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics. 2007 Jan;119(1):e124-30

Active substance: SIMETICONE

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Document reference: 42201

Study title: Sethi KS, Sethi JK. Simethicone in the management of infant colic. Practitioner. 1988 May 9;232(1448):508Sethi KS, Sethi JK. Simethicone in the management of infant colic. Practitioner. 1988 May 9;232(1448):508

Active substance: SIMETICONE

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Document reference: 42214

Study title: Final report of the study a double-blind, randomised, controlled, multi-centre safety study of a refrigerator-stable formulation of VARIVAX in healthy 12 to 15 month-old children, X04-VAR-402. :

Active substance: virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella

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Document reference: 45265

Study title: Effect of long-acting garlic tablets "allicor" on the incidence of acute respiratory viral infections in children. Andrianova IV, Sobenin IA, Sereda EV, Borodina LI, Studenikin MI. Ter Arkh. 2003;75(3):53-6.Effect of long-acting garlic tablets "allicor" on the incidence of acute respiratory viral infections in children. Andrianova IV, Sobenin IA, Sereda EV, Borodina LI, Studenikin MI. Ter Arkh. 2003;75(3):53-6.

Active substance: VITAMINS

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Document reference: 45569

Study title: Garlic extract therapy in children with hypercholesterolemia. McCrindle BW, Helden E, Conner WT. Arch Pediatr Adolesc Med. 1998 Nov;152(11):1089-94. Garlic extract therapy in children with hypercholesterolemia. McCrindle BW, Helden E, Conner WT. Arch Pediatr Adolesc Med. 1998 Nov;152(11):1089-94.

Active substance: VITAMINS

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Document reference: 45570

Study title: Immunological and clinical study on therapeutic efficacy of inosine pranobex, Gołebiowska-Wawrzyniak M, Markiewicz K, Kozar A, Derentowicz P, Czerwińska-Kartowicz I, Jastrzebska-Janas K, Wacławek J, Wawrzyniak ZM, Siwińska-Gołebiowska H. Pol Merkur Lekarski. 2005 Sep;19(111):379-82.Immunological and clinical study on therapeutic efficacy of inosine pranobex, Gołebiowska-Wawrzyniak M, Markiewicz K, Kozar A, Derentowicz P, Czerwińska-Kartowicz I, Jastrzebska-Janas K, Wacławek J, Wawrzyniak ZM, Siwińska-Gołebiowska H. Pol Merkur Lekarski. 2005 Sep;19(111):379-82.

Active substance: VITAMINS

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Document reference: 45568

Study title: A multicentre comparative trial of sodium valproate and carbamazepine in paediatric epilepsy. CM Verity Developmental medicine and child neurology,37,97-108, 1995 in CES EXPCRC-CES0002-ENE01

Active substance: VALPROIC ACID

Study summary document link (including results): Valproic Acid STUDY 022-6-133-V1.xls

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Document reference: 45437

Active substance: VALPROIC ACID

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Document reference: 45440

Active substance: VALPROIC ACID

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Document reference: 45441

Study title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Clinical Trial Assessing the Safety and Efficacy of Albuterol Powder 200mcg QID via the DISKUS versus Albuterol Aerosol 200mcg (180mcg Ex-Actuator) versus Placebo in Pediatric Subjects Aged 4-11 Years with Asthma. Report No. RM1997/00754/00

Active substance: SALBUTAMOL

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Document reference: 35569

Study title: Sferra TJ, Heitlinger LA. Gastrointestinal gas formation and infantile colic. Pediatr Clin North Am. May 7, 1996, 489-510Sferra TJ, Heitlinger LA. Gastrointestinal gas formation and infantile colic. Pediatr Clin North Am. May 7, 1996, 489-510

Active substance: SIMETICONE

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Document reference: 42192

Study title: Sherbaniuk RW et al. Comparative study of cimetidine and Mylanta II in the 6-week treatment of gastric ulcer. J Clin Gastroenterol. 1985 Jun;7(3):211-5Sherbaniuk RW et al. Comparative study of cimetidine and Mylanta II in the 6-week treatment of gastric ulcer. J Clin Gastroenterol. 1985 Jun;7(3):211-5

Active substance: SIMETICONE

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Document reference: 42216

Study title: Simón A et al. The use of gastric ultrasonography in the evaluation of a new antiflatulent preparation in human volunteers. Methods Find Exp Clin Pharmacol. 1985 Jul;7(7):393-8Simón A et al. The use of gastric ultrasonography in the evaluation of a new antiflatulent preparation in human volunteers. Methods Find Exp Clin Pharmacol. 1985 Jul;7(7):393-8

Active substance: SIMETICONE

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Document reference: 42215

Study title: Sofo L et al. SELG-simeticone vs standard preparation in patients undergoing an endoscopic examination of large bowel. G Ital Endosc Dig. May 29, 1995, 37-42Sofo L et al. SELG-simeticone vs standard preparation in patients undergoing an endoscopic examination of large bowel. G Ital Endosc Dig. May 29, 1995, 37-42

Active substance: SIMETICONE

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Document reference: 42193

Study title: Spiro DM et al. Association between antibiotic use and primary idiopathic intussusception. Arch Pediatr Adolesc Med. January 1, 2003, 54-9Spiro DM et al. Association between antibiotic use and primary idiopathic intussusception. Arch Pediatr Adolesc Med. January 1, 2003, 54-9

Active substance: SIMETICONE

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Document reference: 42187

Study title: Adab et al. Additional educational needs in children born to mothers with epilepsy. J Neurol Neurosurg Psychiatry 2001;70:15-21.

Active substance: VALPROIC ACID

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Document reference: 45443

Study title: Additional educational needs in children born to mothers with epilepsy. -Adab et al. - J Neurol Neurosurg Psychiatry 2001;70:15-21.

Active substance: VALPROIC ACID

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Document reference: 45444

Study title: Barnes SE et al. Sodium valproate in the treatment of intractable childhood epilepsy. Develop Med Child Neurol 1975;17:175-81.

Active substance: VALPROIC ACID

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Document reference: 45450

Study title: Baumann RJ. Prevention and management of febrile convulsions. Paedriatr Drugs 2001; 3: 585-592.

Active substance: VALPROIC ACID

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Document reference: 45452

Study title: Camfield PR et al. Febrile seizures. In: epileptic syndromes in infancy, childhood and adolescence. J Roger et al editors. John Libbey and Co Ltd publishers. 3rd edition. 2002; chapter 11: 145-152.

Active substance: VALPROIC ACID

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Document reference: 45455

Study title: 5 days subchronic oral toxicity study in the young dog - Fournier R. and al. - 19/09/90

Active substance: ROXYTHROMYCIN

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Document reference: 35469

Study title: A multicentre, open, centrally randomised, parallel group study of the evaluation of the efficacy and tolerance of roxithromycin 5 - 8mg/Kg/day bid versus ceflacor 20mg/Kg/day bid in a 5 to 10 days treatment of lower respiratory tract infections in children - Kotze A. - 06/98

Active substance: ROXYTHROMYCIN

Study summary document link (including results): RU28965D3003.pdf

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Document reference: 45230

Study title: A single blind study of the efficacy and tolerance of roxithromycin (25mg bid) and erythromycin ethylsuccinate (1OOmg bid) in children with chlamydia! conjunctivitis

Active substance: ROXYTHROMYCIN

Study summary document link (including results): Roxithromycin STUDY S8796508a.xls

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Document reference: 48008

Study title: Koppers B. [Dysplasia epiphysialis multiplex--scintigraphic, roentgenologic and clinical correlation] Rofo. 1982 Sep;137(3):291-305. German. Koppers B. [Dysplasia epiphysialis multiplex--scintigraphic, roentgenologic and clinical correlation] Rofo. 1982 Sep;137(3):291-305. German.

Active substance: SALICYLIC ACID

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Document reference: 44076

Study title: Margolis FJ, Rheames HR, Freshman E et al. Fluoride: ten year prospective study of deciduous teeth and permanent dentition. Am J Dis Child 1975; 129: 794-800.Margolis FJ, Rheames HR, Freshman E et al. Fluoride: ten year prospective study of deciduous teeth and permanent dentition. Am J Dis Child 1975; 129: 794-800.

Active substance: SODIUM FLUORIDE

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Document reference: 42248

Active substance: SODIUM FLUORIDE

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Document reference: 42280

Active substance: SODIUM FLUORIDE

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Document reference: 42312

Study title: Marthaler TM, König KG. Der Einfluß von Fluoridtablettengaben in der Schule auf den Kariesbefall 6- bis 15-Jähriger Kinder. Schweiz Monatsschr Zahnmed 1967; 77: 539-554Marthaler TM, König KG. Der Einfluß von Fluoridtablettengaben in der Schule auf den Kariesbefall 6- bis 15-Jähriger Kinder. Schweiz Monatsschr Zahnmed 1967; 77: 539-554

Active substance: SODIUM FLUORIDE

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Document reference: 42264

Study title: A Randomized, Double-Blind, Double-Dummy, Five-Way Crossover Comparative Clinical Trial of Single Doses of Salmeterol 25, 50, and 100 mcg via the Diskus (Multidose Powder Inhaler), Albuterol Rotacaps 200 mcg via Rotahaler, and placebo in Pediatirc Subjects Aged 4-11 Years with Asthma. Report No. RM1996/00351/00;

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42021

Study title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparative Clinical Trial of the Effects of Twelve Week Courses of 50mcg and 25mcg Salmeterol Powder Bid via the Diskus Versus Ventolin Rotacaps 200mcg QID Versus Placebo in Pediatric Subjects Aged 4-11 Years with Mild to Moderate Asthma. Report No. RM1997/00414/00;

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42022

Study title: A randomized, double-blind, double-dummy, single-dose, four-way cross-over comparison of salmeterol 25mcg and 50mcg given by the multi-dose powder inhaler (DISKUSTM), albuterol 180mcg given by the metered-dose inhaler, and placebo for the prevention of exercise-induced bronchospasm in pediatric subjects with asthma.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol Xinafoate-SLGA2014-ICHE3.pdf

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Document reference: 42020

Study title: A Randomized, Double-Blind, Double-Dummy, Single-Dose, Three-Way Crossover Comparison of Salmeterol Xinafoate 50mcg and Placebo Given by the Multi-Dose Powder Inhaler and Diskhaler for the Prevention of Exercise-Induced Bronchospasm in Pediatric Patients with Asthma. Report No. UCR/95/014

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42019

Study title: Suntaree, RE. Effects of multivitamin and folic acid supplementation in malnourished children. J Med Assoc Thailand, 2003:86;S537-42.Suntaree, RE. Effects of multivitamin and folic acid supplementation in malnourished children. J Med Assoc Thailand, 2003:86;S537-42.

Active substance: VITAMINS

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Document reference: 45574

Study title: Wessely P. Klinischer Erfahrungsbericht. 1985. AKH Wien, Neurologische Univ-Klinik Wessely P. Klinischer Erfahrungsbericht. 1985. AKH Wien, Neurologische Univ-Klinik

Active substance: VITAMINS

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Document reference: 45567

Study title: An Historical Control Study of the Efficacy of Standard Therapy in Acute Aspergillosis to Allow Comparison with the Efficacy of Voriconazole in Protocol 150-304

Active substance: VORICONAZOLE

Study summary document link (including results): A1501003 EMA Pediatrics Web Synopsis.pdf

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Document reference: 48054

Study title: Camfield PR et al. Treatment of febrile seizures. In: epilepsy: a comprehensive textbook. J Engel and TA Pedley editors. Lippincott-Raven publishers. Philadelphia (USA) 1997; chapter 118: 1305-1309

Active substance: VALPROIC ACID

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Document reference: 45456

Study title: Carbamazepine versus valproate montherapy for epilepsy: a meta-analysis - AG Marson - 2002 (Epilepsia 2002;43:505-513) - Publication in CES EXPCRC-CES0640-EN-E01 -

Active substance: VALPROIC ACID

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Document reference: 45457

Study title: Wound healing in posttraumatic and postoperative oedematous tissue: results of treatment with serrapeptase (G.H. Willital et al., Acta therap. 15: pp. 395-409 (1989)) Wound healing in posttraumatic and postoperative oedematous tissue: results of treatment with serrapeptase (G.H. Willital et al., Acta therap. 15: pp. 395-409 (1989))

Active substance: SERRAPEPTASE

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Document reference: 42123

Study title: Van Esso D.; Fajo G.; Losada I., Vilallonga M, Casanovas JM; Clanxet J.; Aliaga A. Clinical Therapeutics 1995; 17:264-269 Sertaconazole in the treatment of paediatric patients with cutaneous dermatophyte infections PMID: 7614526 http://www.ncbi.nlm.nih.gov/pubmed?term=7614526 Van Esso D.; Fajo G.; Losada I., Vilallonga M, Casanovas JM; Clanxet J.; Aliaga A. Clinical Therapeutics 1995; 17:264-269 Sertaconazole in the treatment of paediatric patients with cutaneous dermatophyte infections PMID: 7614526 http://www.ncbi.nlm.nih.gov/pubmed?term=7614526

Active substance: SERTACONAZOLE

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Document reference: 45241

Study title: A multicenter 10-week randomized double-blind, placebo-controlled flexible dose outpatient study of sertraline in children and adolescents with major depressive disorder. (Strength: 25, 50mg; Pharmaceutical form: tablet)

Active substance: SERTRALINE

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Document reference: 42143

Study title: A multicenter 24-week open-label extension study of sertraline in children and adolescent putpatients previously diagnosed with major depressive disorder. (Strenght: 50mg; Pharmaceutical form: tablet)

Active substance: SERTRALINE

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Document reference: 42144

Study title: A single-blind comparative study of sertraline in the treatment of depressed patients. (Strength: 25, 50mg; Pharmaceutical form: tablet)

Active substance: SERTRALINE

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Document reference: 42149

Study title: A single centre, double blind, parallel group, placebo controlled study, to evaluate the effect of inhaled Salmeterol xinafoate (50mcg bd from a Diskhaler) on variations in bronchoconstriction induced by methacholine, in paediatric patients with mild to moderate asthma. Report No. VCL/ME/1998/004

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SLMP03-ICHE3.pdf

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Document reference: 42058

Study title: A single centre, open crossover study to compare the duration of protection against exercise-induced bronchoconstriction following single and chronic dosing with salmeterol 50mcg (as xinafoate) twice daily and sodium cromoglycate 20mg four times daily in children with reversible airways' constriction. Report No. GRP/94/046

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42055

Study title: A single centre, randomised, open crossover study to compare the duration of protection against exercise-induced bronchoconstriction following single dosing with salmeterol xinafoate 50mcg delivered via the multi-dose powder inhaler and sodium cromoglycate 20mg delivered via the spinhaler in children aged 6-11 years with reversible airways disease. Report No. GRP/95/025

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Study SMDT08-Salmetrol Xinafoate (Serevent Diskus).xls

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Document reference: 42033

Study title: Clinical evaluation report - Loiseau - 25.11.1980

Active substance: VALPROIC ACID

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Document reference: 45462

Study title: Clinical pharmacokinetics of valproic acid - Zaccara G. Messori A. and al. - 1988 (Clin Pharmacokinet, 15 : 367-89) - Publication in expert report on the clinical documentation - Giudicelli A. - 05/2002 -

Active substance: VALPROIC ACID

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Document reference: 45463

Study title: Comparative clinical and pharmacokinetic study of a new slow release versus conventional preparations of valproic acid in children with intractable epilepsy - Braisn and Development, 1992, 14 (5), p.304-308 - Imaizumi T., Izumi T., Fukuyama Y.

Active substance: VALPROIC ACID

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Document reference: 45467

Study title: Continuous sodium valproate or pheobarbitone in the prevention of simple febrile-Comparison by a double blind trial - E. Ngwane. - 1980 (Arch Dis Childhood 1980;55:171-174)

Active substance: VALPROIC ACID

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Document reference: 45468

Study title: Dean JCS et al. Long term health and neurodevelopment in children exposed to antiepileptic drugs before birth. J Med Genet 2002;39:251-9.

Active substance: VALPROIC ACID

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Document reference: 45469

Study title: Divalproex sodium treatment in late adolescent and young adult acute mania - Papatheodorou G. Kutcher SP. - 1993 (Psychopharmacol Bull 1993, 29 : 213-19) - Publication in expert report on the clinical documentation - Giudicelli A. -05/2002 -

Active substance: VALPROIC ACID

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Document reference: 45472

Study title: Do seizures in children cause intellectual deterioration ? - Ellenberg JH et al. - N Engl J. Med 1986; 314:1085-88.

Active substance: VALPROIC ACID

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Document reference: 45473

Study title: A twelve week double blind multicentre comparaison of sertraline and placebo in patients with obsessive-compulsive disorder. (Strength: 50mg; Pharmaceutical form: capsules)

Active substance: SERTRALINE

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Document reference: 42142

Study title: Driscoll WS, Heifetz SB, Korts DC. Effect of chewable fluoride tablets on dental caries in schoolchildren: results after six years of use. J Am Dent Assoc. 1978 Nov;97(5):820-4.Driscoll WS, Heifetz SB, Korts DC. Effect of chewable fluoride tablets on dental caries in schoolchildren: results after six years of use. J Am Dent Assoc. 1978 Nov;97(5):820-4.

Active substance: SODIUM FLUORIDE

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Document reference: 42255

Active substance: SODIUM FLUORIDE

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Document reference: 42287

Active substance: SODIUM FLUORIDE

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Document reference: 42319

Study title: Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7.Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7.

Active substance: SODIUM FLUORIDE

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Document reference: 42256

Active substance: SODIUM FLUORIDE

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Document reference: 42288

Active substance: SODIUM FLUORIDE

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Document reference: 42320

Study title: Brouwers JR et al. A controlled trial of senna preparations and other laxatives used for bowel cleansing prior to radiological examination. Pharmacology. 1980;20 Suppl 1:58-64Brouwers JR et al. A controlled trial of senna preparations and other laxatives used for bowel cleansing prior to radiological examination. Pharmacology. 1980;20 Suppl 1:58-64

Active substance: SIMETICONE

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Document reference: 42221

Study title: Chitkara DK et al. Aerophagia in children: Characterization of a functional gastrointestinal disorder. Neurogastroenterol Motil. August 1, 2005, 518-22Chitkara DK et al. Aerophagia in children: Characterization of a functional gastrointestinal disorder. Neurogastroenterol Motil. August 1, 2005, 518-22

Active substance: SIMETICONE

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Document reference: 42179

Study title: Coco TJ, King WD, Slattery AP. Descriptive epidemiology of infant ingestion calls to a regional poison control center. South Med J. August 1, 2005, 779-83)Coco TJ, King WD, Slattery AP. Descriptive epidemiology of infant ingestion calls to a regional poison control center. South Med J. August 1, 2005, 779-83)

Active substance: SIMETICONE

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Document reference: 42178

Study title: Connor F. Gastrointestinal complications of fundoplication. Curr Gastroenterol Rep. June 1, 2005, 219-26Connor F. Gastrointestinal complications of fundoplication. Curr Gastroenterol Rep. June 1, 2005, 219-26

Active substance: SIMETICONE

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Document reference: 42180

Study title: Traitement par Hormone biosynthétique MAXOMAT d'enfants en cours de puberté présentant un retard de croissance sévère à début intra-utérin (retard d'au moins -2,5 DS)

Active substance: Somatropin

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Document reference: 41825

Study title: Tsou VM et al. Multicenter, randomized, double-blind study comparing 20 and 40 mg of pantoprazole for symptom relief in adolescents (12 to 16 years of age) with gastroesophageal reflux disease (GERD). Clin Pediatr (Phila). 2006 Oct;45(8):741-9Tsou VM et al. Multicenter, randomized, double-blind study comparing 20 and 40 mg of pantoprazole for symptom relief in adolescents (12 to 16 years of age) with gastroesophageal reflux disease (GERD). Clin Pediatr (Phila). 2006 Oct;45(8):741-9

Active substance: SIMETICONE

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Document reference: 42203

Study title: Wiberg JM, Nordsteen J, Nilsson N. The short-term effect of spinal manipulation in the treatment of infantile colic: a randomized controlled clinical trial with a blinded observer. J Manipulative Physiol Ther. 1999 Oct;22(8):517-22Wiberg JM, Nordsteen J, Nilsson N. The short-term effect of spinal manipulation in the treatment of infantile colic: a randomized controlled clinical trial with a blinded observer. J Manipulative Physiol Ther. 1999 Oct;22(8):517-22

Active substance: SIMETICONE

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Document reference: 42208

Study title: B. Romański - ,,Comparative clinical trial of the prep. Xylogel 0.05% and 0.1% in the form of nasal gel and Xylometazolin 0.05% and 0.1% in the form of nasal drops manufactured by WPW Polfa in patients with rhinitis of nose mucous membrane"

Active substance: XYLOMETAZOLINE

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Document reference: 45637

Study title: De Sa, JV. (1960) Clinical evaluation of a new topical vaso-constrictor in rhinology. Indian Pract. 12, 725-728

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - de Sa_1960.xls

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Document reference: 45639

Study title: Driscoll WS, Nowjack-Raymer R, Selwitz RH, Li SH, Heifetz SB. A comparison of the caries-preventive effects of fluoride mouthrinsing, fluoride tablets, and both procedures combined: final results after eight years. J Public Health Dent. 1992 Winter;52(2):111-6.Driscoll WS, Nowjack-Raymer R, Selwitz RH, Li SH, Heifetz SB. A comparison of the caries-preventive effects of fluoride mouthrinsing, fluoride tablets, and both procedures combined: final results after eight years. J Public Health Dent. 1992 Winter;52(2):111-6.

Active substance: SODIUM FLUORIDE

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Document reference: 42257

Active substance: SODIUM FLUORIDE

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Document reference: 42289

Study title: An international, multi - center, randomised, open - label, parallel group, observer - blind study of the efficacy and tolerance of roxithromycin 5 - 8mg/Kg/day, administered bid and amoxicillin / clavulanic acid 40/10mg/Kg/day administered tid in the treatmetn of lower respiratory tract infections in children - Rostand A. - 11/86

Active substance: ROXYTHROMYCIN

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Document reference: 35472

Study title: An open, multicenter study of oral Roxithromycin sachet formulation - 2.5mg/kg to 5.Omg/kg bid - in the treatment of pediatrics patients with respiratory and cutaneous infections.

Active substance: ROXYTHROMYCIN

Study summary document link (including results): Roxithromycin STUDY FF8596548.xls

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Document reference: 48004

Study title: Effect of RU 28965 administered orally for 10 days on bone tissue in infant dogs

Active substance: ROXYTHROMYCIN

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Document reference: 35477

Study title: Effects of RU 28 965 (RXM) on toothformation in infant beagle dogs - Sasaki T. - 29/10/94

Active substance: ROXYTHROMYCIN

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Document reference: 35479

Study title: Effects of RU 28 965 administered orally for 10 days on bone tissue in infant dogs - Tateta C. and al. - 22/12/94

Active substance: ROXYTHROMYCIN

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Document reference: 35480

Study title: Efficacy and tolerance study of roxithromycin in the treatment of respiratory and cutaneous infections in children - Astruc J. and al. - 27/03/87 - Publication in RU 28 965-Reference rapport 2.19-50mg paediatric sachet-synthesis of pharmacokinetics and clinical studies in children - Blanc F. - 07/88 -Efficacy and tolerance study of roxithromycin in the treatment of respiratory and cutaneous infections in children - Astruc J. and al. - 27/03/87 - Publication in RU 28 965-Reference rapport 2.19-50mg paediatric sachet-synthesis of pharmacokinetics and clinical studies in children - Blanc F. - 07/88 -

Active substance: ROXYTHROMYCIN

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Document reference: 35481

Study title: An international, multi - center, randomised, open - label, parallel group, observer - blind study of the efficacy and tolerance of roxithromycin 5 - 8mg/Kg/day, administered bid and amoxicillin / clavulanic acid 40/10mg/Kg/day administered tid in the treatment of lower respiratory tract infections in children - Rostand A. - 11/86

Active substance: ROXYTHROMYCIN

Study summary document link (including results): FF9296530.pdf

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Document reference: 35458

Study title: Efficacy and tolerance study of roxithromycin in the treatment of respiratory tract infections in children - Blanc F. and al. - 1987 - Publication in RU 28 965-Reference rapport 2.19-50mg paediatric sachet-synthesis of pharmacokinetics and clinical studies in children - Blanc F. - 07/88 -Efficacy and tolerance study of roxithromycin in the treatment of respiratory tract infections in children - Blanc F. and al. - 1987 - Publication in RU 28 965-Reference rapport 2.19-50mg paediatric sachet-synthesis of pharmacokinetics and clinical studies in children - Blanc F. - 07/88 -

Active substance: ROXYTHROMYCIN

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Document reference: 35482

Study title: A 2-week, randomized, double-blind, parallel-group study in pediatric subjects with asthma aged 4 to11 years to examine the pharmacokinetics of fluticasone propionate (FP) and salmeterol (SALM) from the FP/SALM combination product administered twice daily via the Diskus (FP 100mcg/SALM 50mcg) and the FP Diskus (FP 100mcg). Report No. RM2004/00114/00

Active substance: SALMETEROL

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Document reference: 35602

Study title: A Multicentre, Randomised, Double-blind, Double-dummy, Parallel Group Comparison of Three Treatments: 1) Seretide (50/100 mcg Strength)bd via Diskus/Accuhaler Inhaler, 2) Fluticasone Propionate 200 mcg bd via Diskus Inhaler, 3) Fluticasone Propionate 100mcg bd via Diskus/Accuhaler Inhaler in Children Aged 4-11 Years with Asthma. Report No. BP1999/00102/00

Active substance: SALMETEROL

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Document reference: 35594

Study title: A pilot single centre, randomised, double-blind crossover study to demonstrate the superiority of Salmeterol/fluticasone propionate combination product 50/100mcg bd versus fluticasone propionate 100mcg bd when treated for two weeks with respect to activity levels in children aged 7 15 years. Report No. GM2003/00237/00;

Active substance: SALMETEROL

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Document reference: 35591

Study title: A Randomized, Double-Blind, 12-Week Trial Evaluating the Safety of the Fluticasone Propionate/Sameterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Sympotmatic Pediatric Subjects (4-11 Years) With Asthma. Report No. RM2002/00268/00;

Active substance: SALMETEROL

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Document reference: 35596

Study title: A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID versus Fluticasone Propionate DISKUS 100/50mcg BID in Pediatric and Adolescent Subjects with Activity-Induced Bronchospasm. Report No. RM2005/00343/00

Active substance: SALMETEROL

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Document reference: 35592

Study title: A Stratified, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial Evaluating the Safety and Efficacy of the Fluticasone Propionate/Salmeterol Diskus Combination Product 100/50mcg Once Daily Versus Fluticasone Propionate Diskus 100mcg Once Daily and Placebo in Symptomatic Pediatric Subjects (4-11 Years) With Asthma. Report No. RM2001/00010/07

Active substance: SALMETEROL

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Document reference: 35595

Study title: Yang JC et al. The role of gastric acid and Helicobacter pylori in the natural course of duodenal ulcer. J Microbiol Immunol Infect. 1999 Sep;32(3):155-62Yang JC et al. The role of gastric acid and Helicobacter pylori in the natural course of duodenal ulcer. J Microbiol Immunol Infect. 1999 Sep;32(3):155-62

Active substance: SIMETICONE

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Document reference: 42207

Study title: De Oliveira Netto N.V. & Diegues A. (1976): Estudo aberto n¿o comparativo do PR-S/109*, no tratamento das broncopatias obstrutivas por secreç¿es. Folha Med. 72(4): 393-7. De Oliveira Netto N.V. & Diegues A. (1976): Estudo aberto n¿o comparativo do PR-S/109*, no tratamento das broncopatias obstrutivas por secreç¿es. Folha Med. 72(4): 393-7.

Active substance: SOBREROL

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Document reference: 42231

Study title: Di Tommaso G. and Mader R. Traitment des hypersecretions bronchiques dans les bronchopneumopathies aigues et chroniques. Di Tommaso G. and Mader R. Traitment des hypersecretions bronchiques dans les bronchopneumopathies aigues et chroniques.

Active substance: SOBREROL

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Document reference: 42226

Study title: Etude contrôlée d¿un nouveau composé à action mucolytique. Acta Therapeutica 7: 243-60. Romano C., Gargani G.F., Cotellessa M. and Rossi C. (1977): Valutazione comparativa del sobrerolo nel trattamento delle broncopneumopatie croniche dell¿età pediatrica. Terzo Congresso Europeo sulle malattie del torace: 52-61. Trombetti E. & Mancino V. (1971) Etude contrôlée d¿un nouveau composé à action mucolytique. Acta Therapeutica 7: 243-60. Romano C., Gargani G.F., Cotellessa M. and Rossi C. (1977): Valutazione comparativa del sobrerolo nel trattamento delle broncopneumopatie croniche dell¿età pediatrica. Terzo Congresso Europeo sulle malattie del torace: 52-61. Trombetti E. & Mancino V. (1971)

Active substance: SOBREROL

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Document reference: 42227

Active substance: SODIUM FLUORIDE

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Document reference: 42296

Active substance: SODIUM FLUORIDE

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Document reference: 42328

Study title: Petersson LG, Koch G, Rasmusson CG, Stanke H. Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study. Swed Dent J. 1985;9(3):97-104.Petersson LG, Koch G, Rasmusson CG, Stanke H. Effect on caries of different fluoride prophylactic programs in preschool children. A two year clinical study. Swed Dent J. 1985;9(3):97-104.

Active substance: SODIUM FLUORIDE

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Document reference: 42265

Study title: Effects of valproate in 100 children with special reference to weight. - Egger J et al. - Br Med J 1981;283:577-81.

Active substance: VALPROIC ACID

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Document reference: 45476

Study title: Ellenberg JH et al. Do seizures in children cause intellectual deterioration ? N Engl J. Med 1986; 314:1085-88.

Active substance: VALPROIC ACID

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Document reference: 45477

Study title: Ethosuximide, sodium valproate or lamotrigine for absence seizures in children and adolescents. EB Posner. Cochrane database Syst Rev. 2005;(4):CD003032 in CES EXPCRC-CES733-EN-E01.

Active substance: VALPROIC ACID

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Document reference: 45479

Study title: Febrile seizures. In: epileptic syndromes in infancy, childhood and adolescence. - Camfield PR et al. - J Roger et al editors. John Libbey and Co Ltd publishers. 3rd edition. 2002; chapter 11: 145-152.

Active substance: VALPROIC ACID

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Document reference: 45481

Study title: Haigh D et al. The treatment of childhood epilepsy with sodium valproate. Develop Med Child Neurol 1975;17:743-8

Active substance: VALPROIC ACID

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Document reference: 45485

Study title: Intravenous valproate : experience in neurosurgery - Proceedings of the fourth International Symposium of Sodium Valproate and Epilepsy - Price D.J and Chadwick D. - 1989 ( International Congress and Symposium Series n° 152 ) ( London : Royal Society of Medecines Services, 1989 - 197-203 ) Publication 5 in Ergenyl Via Expert report on the clinical documentation - Hufnagel A. - 14/11/2006

Active substance: VALPROIC ACID

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Document reference: 45490

Study title: Fradis, M.D. et al. (1987) Treatment of perennial allergic rhinitis by sodium cromoglycate plus 0.025% xylometazoline (a double blind study). J. Laryngol Otology, 101, 666-672.

Active substance: XYLOMETAZOLINE

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Document reference: 45642

Study title: Evaluation of the efficacy and tolerance of roxithromycin 5-8 mg/kg/day taken B.I.D. and clarithromycin 11-21 mg/kg/day taken B.I.D. in a 5 to 10 days treatment of lower respiratory tract infections in children.

Active substance: ROXYTHROMYCIN

Study summary document link (including results): FF9496564.pdf

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Document reference: 45229

Study title: Roxithromycin 50 mg paediatric tablet - Multicenter clinical trial.

Active substance: ROXYTHROMYCIN

Study summary document link (including results): Roxithromycin STUDY FFR 87 965 19.xls

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Document reference: 48006

Study title: Study in children and young adults of the diffusion of roxithromycin (RU 28965) into tonsillar tissue following administration of 2 or 3 doses.

Active substance: ROXYTHROMYCIN

Study summary document link (including results): Roxithromycin STUDY Begue &Cotin.xls

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Document reference: 48009

Study title: Study of the diffusion of Roxithromycin (RU 28 965) in the middle ear secretions of children after repeated oral administration

Active substance: ROXYTHROMYCIN

Study summary document link (including results): Roxithromycin STUDY FFR869652.xls

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Document reference: 48005

Study title: An observational study to assess the health related quality of life impact of treating poorly controlled asthmatic children with SeretideÔ 50/100mcg

Active substance: SALMETEROL

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Document reference: 35600

Study title: Summary of the efficacy and safety and safety of salmeterol 50mcg and fluticasone propionate 100mcg administered in Diskus Dry Powder Inhaler twice daily in steroid experienced children with reversible airways obstruction

Active substance: SALMETEROL

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Document reference: 35601

Study title: A comparison of salmeterol via diskhalerTM with salmeterol via multi dose powder inhaler in children with exercise-induced asthma. Report No. GRP/95/016

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42026

Study title: A comparison of salmeterol via diskhalerTM with salmeterol via multi dose powder inhaler in children with exercise-induced asthma. Report No. GRP/95/018

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42034

Active substance: SODIUM FLUORIDE

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Document reference: 42297

Active substance: SODIUM FLUORIDE

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Document reference: 42329

Study title: Plasschaert AJM, König KG: Die Wirkung von Zahngesundheitsinformation und von Fluoridtabletten auf den Karieszuwachs bei Schulkindern. I Experimentelle Ergebnisse nach 2 Jahren Versuchsdauer. Schweiz Mschr zahnkeilk 1973; 83: 421-445Plasschaert AJM, König KG: Die Wirkung von Zahngesundheitsinformation und von Fluoridtabletten auf den Karieszuwachs bei Schulkindern. I Experimentelle Ergebnisse nach 2 Jahren Versuchsdauer. Schweiz Mschr zahnkeilk 1973; 83: 421-445

Active substance: SODIUM FLUORIDE

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Document reference: 42266

Active substance: SODIUM FLUORIDE

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Document reference: 42298

Study title: A Single-Centre Study to Determine the Pharmacodynamics and Duration of Action of Single Doses of Salmeterol Xinafoate 50mcg and 100ug as the Dry Powder Formulation Over a 12 Hour Period and to Further Assess the Tolerability of Salmeterol Xinafoate 50mcg BD in Children with Moderate to Severe Asthma. Report No. GRP/95/020

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42052

Study title: A single-centre, cross-over study to compare the duration of protection against exercise-induced bronchoconstriction following single dose Salmeterol 50mcg and Sodium cromoglycate 40mcg in children with reversible airways.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SMS40124-ICHE3.pdf

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Document reference: 42068

Study title: Hagen, W.J. and Trelles, M.G. (1960) A new local decongestant of unusually low toxicity. The eye, ear, nose & throat monthly, 35, 1,56.

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Hagen_1960.xls

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Document reference: 45635

Study title: Hochban, W et al. Nasal decongestion with imidazoline derivatives: acoustic rhinometry measurements. Eur J Clin Pharmacol 1999; 55(1):7-12

Active substance: XYLOMETAZOLINE

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Document reference: 45634

Study title: Jacques, A.A. and Fuchs, V.H. (1959) A new topical nasal decongestant. J. Louisiana State Med. Soc. 111(10), 384-386.

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Jacques_1959.xls

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Document reference: 45644

Study title: Jensen, J.H. et al. (1990) Topical application of decongestant in dysfunction of the Eustachian tube: a randomised, double-blind, placebo-controlled trial. Clin. Otolaryngol, 15, 197-201

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Jensen_1990.xls

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Document reference: 45645

Study title: Michel O et al. The value of Ems Mineral Salts in the treatment of rhinosinusitis in children: Prospective study on the efficacy of mineral salts versus xylometazoline in the topical nasal treatment of children. Int J Pediatr Otorhinolaryngol 2005; 69(10):1359-1365

Active substance: XYLOMETAZOLINE

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Document reference: 45632

Study title: Otten F.W:A. and Grote J.J. (1988) Treatment of chronic maxillary sinusitis in children. Int. J. Pediat. Otorhinolaryngology, 15, 269-278

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Otten_1988.xls

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Document reference: 45651

Study title: Petruson B. et al. (1985) Study in acute infectious rhinitis in children. Larkartidningen 82, 26-27.

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Petruson_1985.xls

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Document reference: 45652

Study title: Sertraline in the treatment of obsessive disorder (O.C.D) in childrn and adolescents. (Strength: 25, 50mg; Pharmaceutical form: capsules)

Active substance: SERTRALINE

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Document reference: 42145

Study title: Sertraline treatment of adolescent depressive and dysthymic disorders and an open trial. (Strength: 50mg)

Active substance: SERTRALINE

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Document reference: 42147

Study title: Sertraline treatment of adolescent outpatients with major depression.

Active substance: SERTRALINE

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Document reference: 42133

Study title: Sertraline treatment of adolescent outpatients with major depression. (Strength: 50mg; Pharmaceutical form: tablet)

Active substance: SERTRALINE

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Document reference: 42146

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

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Document reference: 42199

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

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Document reference: 42213

Study title: Gaburro D, Burlina A. Management of acute infectious diarrhea in childhood. Riv Ital Pediatr. December 1, 1985, 122-7Gaburro D, Burlina A. Management of acute infectious diarrhea in childhood. Riv Ital Pediatr. December 1, 1985, 122-7

Active substance: SIMETICONE

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Document reference: 42198

Study title: A single-centre, randomised, double-blind, placebo controlled, parallel group study to evaluate the efficacy of salmeterol (50mcg BD via the diskhaler) in children aged 6-16 years who have asthma that is difficult to control. Report No. GRP/95/024;

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Study SLPX01- SMS30029-Salmeterol Xinafoate-Serevent Rotadisks.xls

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Document reference: 42062

Study title: A two centre study to assess the ease of handling and efficacy of salmeterol 50mcg twice daily delivered via a multidose powder inhaler compared with terbutaline sulphate 500mcg three times daily delivered via a turbohalerTM in children aged 6-11 years with reversible airways disease. Report No. GRP/95/017

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Study SMDT07-SLGB4005-Salmetrol Xinafoate (Serevent Diskus).xls

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Document reference: 42032

Study title: A two-centre, double-blind, placebo controlled three way cross-over study to determine the duration of action of salmeterol 25mcg and 50mcg administered via Diskhaler against exercise induced bronchoconstriction in children with asthma. Further to compare the effect of salmeterol 50mcg x 2 and salbutamol 200mcg x 2 administered via adiskhaler for 6 weeks, on bronchial hyperreactivity in two parallel groups.

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42057

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

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Document reference: 45492

Study title: Long term health and neurodevelopment in children exposed to antiepileptic drugs before birth. - Dean JCS et al. - J Med Genet 2002;39:251-9.

Active substance: VALPROIC ACID

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Document reference: 45493

Study title: 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

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Document reference: 45497

Study title: Monotherapie par le valproate de sodium dans les epilepsies de l'enfant - Dulac O. and al. - 1982 (arch. Fr. Pediatr., 1982, 39, (6), 347-352)

Active substance: VALPROIC ACID

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Document reference: 45499

Study title: Monotherapy with sodium valproate in childhood epilepsy - Jeavons P.M. and al. - 1980 (Symp. Reckitt-labaz: Birmingham, 8-9th, nov. 1979 - Int. Congr. & Simp. Series, 1980, 1, (30), 53-58)

Active substance: VALPROIC ACID

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Document reference: 45501

Study title: Overview: Syndromes of Infancy and Early childhood - Epilepsy: A coprehensive Textbook - 1997, p, 2263 - 65

Active substance: VALPROIC ACID

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Document reference: 45504

Active substance: SODIUM FLUORIDE

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Document reference: 42321

Study title: Hanauer SB et al. Randomized, double-blind, placebo-controlled clinical trial of loperamide plus simethicone versus loperamide alone and simethicone alone in the treatment of acute diarrhea with gas-related abdominal discomfort. Curr Med Res Opin. 2007 May;23(5):1033-43Hanauer SB et al. Randomized, double-blind, placebo-controlled clinical trial of loperamide plus simethicone versus loperamide alone and simethicone alone in the treatment of acute diarrhea with gas-related abdominal discomfort. Curr Med Res Opin. 2007 May;23(5):1033-43

Active substance: SIMETICONE

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Document reference: 42200

Study title: Hodgkinson R et al. Comparison of cimetidine (Tagamet) with antacid for safety and effectiveness in reducing gastric acidity before elective cesarean section. Anesthesiology. 1983 Aug;59(2):86-90Hodgkinson R et al. Comparison of cimetidine (Tagamet) with antacid for safety and effectiveness in reducing gastric acidity before elective cesarean section. Anesthesiology. 1983 Aug;59(2):86-90

Active substance: SIMETICONE

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Document reference: 42219

Study title: Füchte W. Ergebnisse einer Kariesprophylaxe mit Fluor-Kalktabletten. ZM 3/1971, 1-5Füchte W. Ergebnisse einer Kariesprophylaxe mit Fluor-Kalktabletten. ZM 3/1971, 1-5

Active substance: SODIUM FLUORIDE

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Document reference: 42258

Study title: Füchte W. Ergebnisse einer Kariesprophylaxe mit Fluor-Kalktabletten. ZM 3/1971, 1-5Füchte W. Ergebnisse einer Kariesprophylaxe mit Fluor-Kalktabletten. ZM 3/1971, 1-5

Active substance: SODIUM FLUORIDE

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Document reference: 42290

Study title: Füchte W. Ergebnisse einer Kariesprophylaxe mit Fluor-Kalktabletten. ZM 3/1971, 1-5Füchte W. Ergebnisse einer Kariesprophylaxe mit Fluor-Kalktabletten. ZM 3/1971, 1-5

Active substance: SODIUM FLUORIDE

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Document reference: 42322

Study title: Prospective, multicenter, observational study to document therapeutic data relating to the treatment of spasms by children aged up to 11 years old with Spascupreel S (suppositories) [AWB-135]

Active substance: Spascupreel - Zäpfchen/ Spascupreel S

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Document reference: 40212

Study title: Orlandi O., Verzellino A., Bruna S. and Perino A. (1973): Osservazioni cliniche su di un nuovo broncodisostruente di sintesi: il sobrerolo. Gazzetta Medica Italiana 132: 18-23.Orlandi O., Verzellino A., Bruna S. and Perino A. (1973): Osservazioni cliniche su di un nuovo broncodisostruente di sintesi: il sobrerolo. Gazzetta Medica Italiana 132: 18-23.

Active substance: SOBREROL

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Document reference: 42230

Study title: Pellegrini U. Double-blind evaluation of the bronchial cleansing effect of cyclidrol in paediatrics. Report non pubblicato. Milvio C.,Pellegrini U. Double-blind evaluation of the bronchial cleansing effect of cyclidrol in paediatrics. Report non pubblicato. Milvio C.,

Active substance: SOBREROL

Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication - Mucodox (Sobrerol).pdf

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Document reference: 42225

Study title: Seidita F., Deiana M. and Careddu P. (1984): Acute bronchial diseases in paediatrics: therapeutic approach with sobrerol granules. Giornale Italiano Malattie del Torace 38(3): 191-4. Seidita F., Deiana M. and Careddu P. (1984): Acute bronchial diseases in paediatrics: therapeutic approach with sobrerol granules. Giornale Italiano Malattie del Torace 38(3): 191-4.

Active substance: SOBREROL

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Document reference: 42229

Study title: Pubication in well established dossier of hydroxychloroquine: Advanced drug therapy for Juvenile rheumatoid arthritis - Rosenberg AM -1989

Active substance: SODIUM AUROTHIOMALATE

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Document reference: 42232

Study title: Publ. authors & ref: Jamal, T.S. (1995) Avoidance of postoperative blockage of ventilation tubes. Laryngoscope, 105, 833-834

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Jamal_1995.xls

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Document reference: 45653

Study title: Report/protocol/study N°: Testing of Otrivin nasal gel in acute rhinitis Investigator: Dr Maier Report date: 22.05.1975

Active substance: XYLOMETAZOLINE

Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - N OTR A3_Kost_1975.xls

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Document reference: 45654

Study title: Coursaget P, Fritzell B, Blondeau C, Saliou P and Diop-Mar I. Simultaneous injection of plasma-derived or recombinant hepatitis B vaccines with yellow fever and killed polio vaccines. Vaccine 1995; 13: 109-111

Active substance: Yellow Fever Vaccine (Live)

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Document reference: 41386

Study title: Lhuillier M, Mazzariol MJ, Zadi S, Le Cam N, Bentejac MC, Adamowicz L, Marie NL and Fritzell B. Study of combined vaccination against yellow fever and measles in infants from six to nine months. J Biol Stand 1989; 17: 9-15.

Active substance: Yellow Fever Vaccine (Live)

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Document reference: 41387

Study title: Mouchon D, Pignon D, Vicens R, Tu-Ha-Tnanh, Tekaia F, Teulières L and Garrigue G. Etude de la vaccination combinée rougeole-fièvre jaune chez l’enfant africain âgé de 6 à 10 mois. [Study of the combined vaccination against measles and yellow fever in African infants aged 6-10 months]. Bull Soc Path Ex 1990; 83: 537-551

Active substance: Yellow Fever Vaccine (Live)

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Document reference: 41388

Study title: 9188IL0138: A Multicenter, Randomized, Double-blind,Placebo-controlled Parallel-group, 15-week Trial of Zafirlukast (ACCOLATE) Versus Low-dose Inhaled Corticosteroids After a 7-day Course of Oral Corticosteroids in Subjects With Asthma

Active substance: ZAFIRLUKAST

Study summary document link (including results): 9188IL0138 CSR Synopsis.pdf

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Document reference: 45604

Study title: A Dose-ranging, Safety, and Efficacy Trial with Zafirlukast (ACCOLATE)in the Treatment of Pediatric Subjects with Mild-to-moderate Asthma; Up toa 52-week Open Label Safety Extension

Active substance: ZAFIRLUKAST

Study summary document link (including results): 9188IL0139 CSR Summary.pdf

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Document reference: 45606

Study title: Effect of fortnightly rinsing with a 0.2% NaF solution and a fluoride varnish with 5% NaF in dental caries prevention: comparative study in students of the northern region of Sao Paulo city, Brazil, 1992-1993

Active substance: SODIUM FLUORIDE

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Document reference: 42402

Active substance: SODIUM FLUORIDE

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Document reference: 42515

Study title: The use of macrolides in the treatment of Paediatric infections - Kafetzis - 14th International Congress of Chemotherapy - 1985, Kyoto The use of macrolides in the treatment of Paediatric infections - Kafetzis - 14th International Congress of Chemotherapy - 1985, Kyoto

Active substance: ROXYTHROMYCIN

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Document reference: 35459

Study title: Results of retrospective Analysis about application of NHO Pollen for hypersensitivity. Age of patients: 6 to79 Years, 104 Patients

Active substance: Rye grass;Velvet grass;Timothy Grass;Dermatophagoides farinae;Dermatophagoides farinae;Dermatophagoides pteronyssinus;Dermatophagoides pteronyssinus;Fescue;Grama;Hazel;Alder;Birch-tree;Rye;Rye;Barley extract;Wheat;Gramineous;Gramineous;

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Document reference: 40155

Study title: 14. Mycoserological study of the treatment of paediatric cystic fibrosis patients with Saccharomyces boulardii (Saccharomyces cerevisiae Hansen CBS 5926).; Mycoses 1995 ; 38 : 119-123.

Active substance: Saccharomyces boulardii

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Document reference: 40168

Study title: 15. Die Therapie der Diarrhöe bei kleinkindern mit Perenterol. Kinder- und Jungendmedizin 2/2001 : 48 – 49

Active substance: Saccharomyces boulardii

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Document reference: 40169

Study title: 16. The probiotic effect of Saccharomyces boulardii in a pediatric age group; Journal of Tropical Pediatrics, 2004 ; 50 (4) :234-236

Active substance: Saccharomyces boulardii

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Document reference: 40170

Study title: 17. Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea in children: a randomized double-blind placebo-controlled trial; Aliment Pharmacol Ther. 2005 ; 21 (5) : 583-590

Active substance: Saccharomyces boulardii

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Document reference: 40171

Study title: 18. Effects of Saccharomyces boulardii in children with acute diarrhoea.; Acta Paediatrica 2005, 94 (1) : 44-47

Active substance: Saccharomyces boulardii

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Document reference: 40172

Study title: Haugejorgen O, Birkeland JM. Analysis of the ups and downs of caries experience among Norwegian children aged five years between 1997 and 2003. Acta Odonttol Scand 2005; 63 (2): 115-122.Haugejorgen O, Birkeland JM. Analysis of the ups and downs of caries experience among Norwegian children aged five years between 1997 and 2003. Acta Odonttol Scand 2005; 63 (2): 115-122.

Active substance: SODIUM FLUORIDE

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Document reference: 42260

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42292

Active substance: SODIUM FLUORIDE

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Document reference: 42324

Study title: Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315.Haugejorgen O, Birkeland JM. Evidence of reversal of the caries decline among Norwegian children. Int J Paediatr Dent 2002; 12 (5): 306-315.

Active substance: SODIUM FLUORIDE

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Document reference: 42261

Study title: A double-blind randomised, placebo controlled, crossover study to evaluate the duration of protection from exercise induced bronchospasm of inhaled salmeterol xinafoate 50μg (from a Diskhaler) after a single dose and after treatment with 50μg twice daily, for 28 days in children and adolescents with asthma.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SLGB4003-ICHE3.pdf

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Document reference: 42046

Study title: A double-blind, double-dummy, placebo-controlled, crossover study to compare the effects of salmeterol 50mcg inhaled from a Diskus inhaler at low and high flow rates in children with exercise induced bronchoconstriction. Report No. GRP/95/041

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42024

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42031

Study title: A double-blind, three-way crossover study assessing the efficacy and safety of inhaled salmeterol xinafoate 50mcg bd and 100mcg bd compared with salbutamol 200mcg qds for the treatment of severe chronic asthma in children 5-16 years old. Report No. GRP/95/019

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42049

Study title: Congenital nonspherocytic haemolytic jaundice due to pyruvate kinase deficiency: splenic destruction of chromium-51 –labeled erythrocytes.Haematologica. 1973;58(11):803-9.

Active substance: SODIUM CHROMATE

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

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Document reference: 48290

Study title: Erythrocyte Sodium-Lithium Countertransport and Proliferative Diabetic Retinopathy.Invest Ophthalmol Vis Sci. 2000 May;41(6):1482-5.

Active substance: SODIUM CHROMATE

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

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Document reference: 48285

Study title: Erythrocyte survival in the newborn infant, as measured by chromium 51 and its relation to the postnatal serum bilirubin level.J Pediatr. 1961 Aug;59:194-9.

Active substance: SODIUM CHROMATE

Study summary document link (including results): Vest MF 1961.pdf

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Document reference: 48289

Study title: Impiego di una nuova molecola di sintesi, il sobrerolo, nelle affezioni dell¿albero respiratorio in pediatria. Il Lattante 42: 309-13. Impiego di una nuova molecola di sintesi, il sobrerolo, nelle affezioni dell¿albero respiratorio in pediatria. Il Lattante 42: 309-13.

Active substance: SOBREROL

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Document reference: 42228

Study title: Kinetics, distribution, and sites of destruction of indium-111 oxine labeled red cells in haemolytic anemia.J Clin Pathol 1985;38:128-32.

Active substance: SODIUM CHROMATE

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

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Document reference: 48287

Study title: Quantitative estimation of hemorrhage in chronic subdural hematoma using the 51Cr erythrocyte labeling method.J Neurosurg. 1987 Jun;66(6):862-4.

Active substance: SODIUM CHROMATE

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

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Document reference: 48286

Study title: Sequestration studies with chromium-51 labeled red cells as criteria for splenectomy.Isr J Med Sci. 1967 Nov-Dec;3(6):832-7.

Active substance: SODIUM CHROMATE

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

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Document reference: 48288

Study title: Björklund SI. Miniture enema in children’s practice. The Swedish Medical Journal 1961:58:2763-2766, Björklund SI. Miniture enema in children’s practice. The Swedish Medical Journal 1961:58:2763-2766,

Active substance: SODIUM CITRATE SODIUM LAURYL SULFOACETATE

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Document reference: 42236

Active substance: SODIUM FLUORIDE

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Document reference: 42330

Study title: Poulsen S, Gadegaard E, Mortensen B. Cariostatic effect of daily use of a fluoride-containing lozenge compared to forthnightly rinses with 0,2% sodium fluoride. Caries Res 1981; 15: 236-242.Poulsen S, Gadegaard E, Mortensen B. Cariostatic effect of daily use of a fluoride-containing lozenge compared to forthnightly rinses with 0,2% sodium fluoride. Caries Res 1981; 15: 236-242.

Active substance: SODIUM FLUORIDE

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Document reference: 42267

Study title: Prevention and management of febrile convulsions. - Baumann RJ. - Paedriatr Drugs 2001; 3: 585-592.

Active substance: VALPROIC ACID

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Document reference: 45509

Study title: Prospective study of development of infants born to mothers with epilepsy. - James FH et al. - J Neurol Neurosurg Psychiatry 2002;72:135.

Active substance: VALPROIC ACID

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Document reference: 45511

Study title: Status Epilepticus in children. Experience with intravenous valproate. Update of treatment guidelines - Campistol and al. - 1999 ( Rev. Neurol.1999 - 29 : 359-65 ) Publication 1 in Ergenyl Via Expert report on the clinical documentation - Hufnagel A. - 14/11/2006

Active substance: VALPROIC ACID

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Document reference: 45513

Study title: The longer term outcome of children born to mothers with epilepsy. - Adab et al. - J Neurol Neurosurg Psychiatry 2004;75:1575-83.

Active substance: VALPROIC ACID

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Document reference: 45517

Study title: The treatment of childhood epilepsy with sodium valproate. - Haigh D et al. - Develop Med Child Neurol 1975;17:743-8

Active substance: VALPROIC ACID

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Document reference: 45519

Study title: Treatment of febrile seizures. In: epilepsy: a comprehensive textbook. - Camfield PR et al. - J Engel and TA Pedley editors. Lippincott-Raven publishers. Philadelphia (USA) 1997; chapter 118: 1305-1309

Active substance: VALPROIC ACID

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Document reference: 45522

Study title: Treatment of generalized epilepsies of childhood and adolescence with sodium valproate. - Jeavons PM et al. - Develop Med Child Neurol 1977;19:9-25.

Active substance: VALPROIC ACID

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Document reference: 45523

Study title: A multicenter, double-blind comparison of ACCOLATE (ICI 204,219) with cromolyn sodium (INTAL, Fisons) and placebo in mild to moderate asthmatic patients - 9188/0057

Active substance: ZAFIRLUKAST

Study summary document link (including results): 9188IL0057 Summary.pdf

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Document reference: 45583

Study title: 20. Role of a probiotic (Saccharomyces boulardii) in management and prevention of diarrhoea.; World J Gastroenterol. 2006 ; 12(28) : 4557-60.

Active substance: Saccharomyces boulardii

Study summary document link (including results):

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Document reference: 40174

Study title: 21. Saccharomyces boulardii in acute childhood diarrhoea : a randomized, placebo-controlled study.; Acta Paediatrica, 2007;96(4) : 538-4122. J Int Med Res. 2007 Mar-Apr;35(2):201-

Active substance: Saccharomyces boulardii

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Document reference: 40175

Study title: 22. Effect of Saccharomyces boulardii in children with acute gastroenteritis and its relationship to the immune response.; BMJ. 2007 Aug 18;335:340.

Active substance: Saccharomyces boulardii

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Document reference: 40176

Study title: Efectos de Saccharomyces boulardii en ninos con diarrea cronica, en especial causada por giardiasis.Revista Mexicana de Puericultura et Pediatria 1995 ; 2 (12) : 5 pages

Active substance: Saccharomyces boulardii

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Document reference: 40165

Study title: Estudio contra placebo del Saccharomyces boulardii en el tratamiento de la diarrea aguda infantil.; Archivos Venezolanos de Puericultura y Pediatria 1992 ; 55 (1) : 27-36.

Active substance: Saccharomyces boulardii

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Document reference: 40167

Study title: Evaluacion clinica de la administracion de Saccharomyces boulardii "vitales" en el tratamiento de la diarrea aguda en ninos. Informe preliminar.; La Semana Medica 1985 ; 167 (9) : 254-262.

Active substance: Saccharomyces boulardii

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Document reference: 40182

Study title: Evaluacion terapeutica de Saccharomyces boulardii en ninos con diarrea aguda.; Tribuna Medica 1989; 56 (2) : 111-115.

Active substance: Saccharomyces boulardii

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Document reference: 40181

Study title: A Multi-centre, Randomised, Double-Blind, 3-Limbed, Parallel-Group Study Comparing the Efficacy and Tolerability of Dry Powder Formulations of Salmeterol Xinafoate 25μg and 50μg Twice Daily With Salbutamol 200μg Twice Daily Given in Children With Reversible Airways Obstruction

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SLPT02-ICHE3.pdf

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Document reference: 42071

Study title: A multicentre, open study to assess the ease of handling and efficacy of salmeterol xinafoate 50mcg twice daily delivered via a multi-dose powder inhaler in both adult and paediatric patients with reversible airways disease. Report No. GRP/94/034

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42023

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42030

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42299

Active substance: SODIUM FLUORIDE

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Document reference: 42331

Study title: Clinical assessment of inhaled salmeterol xinafoate Diskus [SN408D] in subjects with paediatric bronchial asthma - Assessment of efficacy and safety of the regimen at 50mcg twice daily in an open-label study

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results):

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Document reference: 42069

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results):

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Document reference: 42072

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42074

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

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Document reference: 41780

Study title: A 12-Month Study to Assess the Safety and Efficacy of Meridia® (sibutramine hydrochloride monohydrate) 10 and 15 mg in Obese Adolescents

Active substance: SIBUTRAMINE

Study summary document link (including results): Sibutramine-SB238.pdf

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Document reference: 47621

Study title: 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

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Document reference: 42211

Study title: Korman MG et al. Influence of smoking on healing rate of duodenal ulcer in response to cimetidine or high-dose antacid. Gastroenterology. 1981 Jun;80(6):1451-3Korman MG et al. Influence of smoking on healing rate of duodenal ulcer in response to cimetidine or high-dose antacid. Gastroenterology. 1981 Jun;80(6):1451-3

Active substance: SIMETICONE

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Document reference: 42220

Study title: Lesperance MM. A pediatric otolaryngologist learns to diagnose acute otitis media. Arch Otolaryngol Head Neck Surg. August 1, 2007, 745-6Lesperance MM. A pediatric otolaryngologist learns to diagnose acute otitis media. Arch Otolaryngol Head Neck Surg. August 1, 2007, 745-6

Active substance: SIMETICONE

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Document reference: 42175

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

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Document reference: 42185

Study title: Lifschitz CH, Irving CS, Smith EO. Effect of a simethicone-containing tablet on colonic gas elimination in breath. Dig Dis Sci. 1985 May;30(5):426-30Lifschitz CH, Irving CS, Smith EO. Effect of a simethicone-containing tablet on colonic gas elimination in breath. Dig Dis Sci. 1985 May;30(5):426-30

Active substance: SIMETICONE

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Document reference: 42217

Study title: Clinical assessment of inhaled salmeterol xinafoate Diskus [SN408D] in subjects with pediatric bronchial asthma - Assessment of efficacy and safety of the regimen at 50mcg twice daily in an open-label study-

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-102095-ICHE3.pdf

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Document reference: 42018

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

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Document reference: 45537

Study title: Use of injectable valproic acid in status epilepticus - Giroud M. and al. - 1993 ( Drug Invest 1993 ; 5 : 154-9 ) Publication 2 in Ergenyl Via Expert report on the clinical documentation - Hufnagel A. - 14/11/2006

Active substance: VALPROIC ACID

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Document reference: 45525

Study title: Wallace SJ. A comparative review of the adverse effects of anticonvulsants in children with epilepsy. Drug safety 1996; 15(6): 378-393.

Active substance: VALPROIC ACID

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Document reference: 45528

Study title: A 4-week, double-blind, randomized, multi-center study followed by 12 months open-label treatment to evaluate the dose-response and safety of valsartan in pediatric hypertensive patients 1-5 years of ageDOI: 10.1161/HYPERTENSIONAHA.108.111054 Journal reference: Hypertension - Journal of the American Heart Association 2008;52:1-7.

Active substance: VALSARTAN

Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2307_2-.xls

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Document reference: 47270

Active substance: VALSARTAN

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Document reference: 48169

Study title: A Double-Blind, Randomized, Multicenter Study followed by 12 Months Open-label Treatment to Evaluate the Dose-response and Safety of Valsartan in Pediatric Hypertensive PatientsDOI: 1111/j.1751-7176.2011.00432.x Journal Clinical Hypertension: 2011;13:357-365

Active substance: VALSARTAN

Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2302_2.xls

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Document reference: 47268

Study title: Dluholucky S et al Amanita phalloides intoxication - Fully treatable event. 25-Year's experience in children.

Active substance: Silibinine dihydrogen succinate, disodium

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Document reference: 39872

Study title: Dluholucky S et al Amanita phalloides intoxication - Fully treatable event. 25-Year's experience in children.Cesko-Slovenska Pediatrie; VOL: 61 (6); p. 350-356 /2006/

Active substance: Silibinine dihydrogen succinate, disodium

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Document reference: 40193

Study title: Lucassen PL et al. Effectiveness of treatments for infantile colic: systematic review. BMJ. 1998 May 23;316(7144):1563-9Lucassen PL et al. Effectiveness of treatments for infantile colic: systematic review. BMJ. 1998 May 23;316(7144):1563-9

Active substance: SIMETICONE

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Document reference: 42209

Study title: Nykamp D. Nonprescription medications in the pediatric population. Am Pharm. May 3, 1995, 10-27Nykamp D. Nonprescription medications in the pediatric population. Am Pharm. May 3, 1995, 10-27

Active substance: SIMETICONE

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Document reference: 42194

Study title: Orenstein SR et al. Nizatidine for the treatment of pediatric gastroesophageal reflux symptoms: An open-label, multiple-dose, randomized, multicenter clinical trial in 210 children. Clin Ther. April 1, 2005, 472-83Orenstein SR et al. Nizatidine for the treatment of pediatric gastroesophageal reflux symptoms: An open-label, multiple-dose, randomized, multicenter clinical trial in 210 children. Clin Ther. April 1, 2005, 472-83

Active substance: SIMETICONE

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Document reference: 42181

Active substance: SODIUM FLUORIDE

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Document reference: 42293

Active substance: SODIUM FLUORIDE

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Document reference: 42325

Study title: Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125.Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125.

Active substance: SODIUM FLUORIDE

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Document reference: 42262

Active substance: SODIUM FLUORIDE

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Document reference: 42294

Active substance: SODIUM FLUORIDE

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Document reference: 42326

Study title: Zur antiarrhythmischen Wirksamkeit von Disopyramid bei ventrikulärer Extrasystolie und Vorhofflimmern. (Antiarrhythmic effect of disopyramide in ventricular extrasystole and auricular fibrillation).Breithardt G, Haerten K, Seipel L. Zeitschrift für Kardiologie, Aug 1976, vol. 65, no. 8, p. 713−23,Zur antiarrhythmischen Wirksamkeit von Disopyramid bei ventrikulärer Extrasystolie und Vorhofflimmern. (Antiarrhythmic effect of disopyramide in ventricular extrasystole and auricular fibrillation).Breithardt G, Haerten K, Seipel L. Zeitschrift für Kardiologie, Aug 1976, vol. 65, no. 8, p. 713−23,

Active substance: VERAPAMIL

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Document reference: 45565

Study title: Endo et al. The use of GC-120 to children with metabolic acidosis; Shinyaku to Rhinsho 1986;35(8): 8(1804) - 12(1808)

Active substance: URINARY CONCREMENT SOLVENTS

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Document reference: 39157

Active substance: SODIUM FLUORIDE

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Document reference: 42244

Study title: Saccharomyces boulardii for Clostridium difficile-associated enteropathies in infants. Journal of Pediatric Gastroenterology and Nutrition 1993 ; 16 : 419-425.

Active substance: Saccharomyces boulardii

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Document reference: 40180

Study title: Saccharomyces boulardii in the management of toddler diarrhea : a double-blind-placebo controlled study.Journal of Pediatric Gastroenterology and Nutrition 1995 ; 20 (4) : 463.

Active substance: Saccharomyces boulardii

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Document reference: 40164

Study title: Traitement des diarrhées aiguës infantiles : Essai contrôlé de Saccharomyces boulardii. Annales de Pédiatrie 1985 ; 32 (6) : 561-563.

Active substance: Saccharomyces boulardii

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Document reference: 40178

Study title: Treatment of acne with a yeast preparation;Fortschr Med. 1989 Sep 10; 107(26):563-6. German.

Active substance: Saccharomyces boulardii

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Document reference: 40184

Study title: Factor analysis as a means of determining response to chemotherapy in patients with osteogenic sarcoma. Edeline V, Frouin F, Bazin JP, Di Paola M, Kalifa C, Contesso G, Parmentier C, Lumbroso J, Di Paola R. Eur J Nucl Med. 1993 Dec;20(12):1175-85.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43642

Study title: Egashira K, Ohno M, Uchino A, Hayashi K, Nakayama C, Nakata H. [Bone scintigraphy of decompression sickness] Nippon Igaku Hoshasen Gakkai Zasshi. 1988 Jun 25;48(6):749-58. Japanese. No abstract available. Egashira K, Ohno M, Uchino A, Hayashi K, Nakayama C, Nakata H. [Bone scintigraphy of decompression sickness] Nippon Igaku Hoshasen Gakkai Zasshi. 1988 Jun 25;48(6):749-58. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43814

Study title: Ehara S, Nishida J, Shiraishi H, Tamakawa Y. Pasteurized intercalary autogenous bone graft: radiographic and scintigraphic features. Skeletal Radiol. 2000 Jun;29(6):335-9. Ehara S, Nishida J, Shiraishi H, Tamakawa Y. Pasteurized intercalary autogenous bone graft: radiographic and scintigraphic features. Skeletal Radiol. 2000 Jun;29(6):335-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43479

Study title: Sports-related groin pain: evaluation with MR imaging. Ekberg O, Sjöberg S, Westlin N. Eur Radiol. 1996;6(1):52-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43571

Study title: Wong VC, Sun JG, Yeung DW. Pilot study of positron emission tomography (PET) brain glucose metabolism to assess the efficacy of tongue and body acupuncture in cerebral palsy. [wong-2006-a]J Child Neurol. 2006 Jun;21(6):456-62. Wong VC 2006

Active substance: Steripet

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

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Document reference: 48712

Study title: The long-term safety and efficacy of Risperdal® in conduct disorder in mild, moderate and borderline mentally retarded children aged 5 to 14 years.

Active substance: RISPERIDONE

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Document reference: 35423

Study title: The safety and efficacy of open-label risperidone in conduct disorder in mild, moderate and borderline mentally retarded children aged 5 to 12 years.

Active substance: RISPERIDONE

Study summary document link (including results): RIS-USA-97_Interventional_Risperidone.xls

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Document reference: 35431

Study title: Fishwick NG, Krarup KC, Belton IP, Finlay DB. An audit of paediatric technetium-99m methylene diphosphonate bone scans. Br J Radiol. 1994 Jun;67(798):552-5. Fishwick NG, Krarup KC, Belton IP, Finlay DB. An audit of paediatric technetium-99m methylene diphosphonate bone scans. Br J Radiol. 1994 Jun;67(798):552-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43624

Study title: Myocardial localization of technetium-99m MDP in an infant. Fleming JC, Pysher TJ, Leonard JC. Clin Nucl Med. 1986 May;11(5):369-70. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43910

Study title: Thallium- 201 uptake in eosinophilic granuloma of the frontal bone: Comparison with Technitium- 99m-MDP imaqinq.Flores LG II, Hoshi H. Nagamachi S, Ohnishi T, Watanabe K, Fukiyama J, et al. J Nucl Med 1995; 36:107-10.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 47918

Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.

Active substance: TAMOXIFEN

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Document reference: 43181

Active substance: TAMOXIFEN

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Document reference: 43191

Active substance: TAMOXIFEN

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Document reference: 43201

Active substance: TAMOXIFEN

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Document reference: 43215

Study title: Cassidy JT; Drugs 1999 Nov; 58 (5): 831-850 Medical Management of Children with Juvenile Rheumatoid ArthritisCassidy JT; Drugs 1999 Nov; 58 (5): 831-850 Medical Management of Children with Juvenile Rheumatoid Arthritis

Active substance: SULFASALAZINE

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Document reference: 42881

Study title: Walter MA, Melzer RA, Schindler C, Müller-Brand J, Tyndall A, Nitzsche EU.. Epub 2005 Mar 4. The value of [18F]FDG-PET in the diagnosis of large-vessel vasculitis and the assessment of activity and extent of disease. [walter-2005]Eur J Nucl Med Mol Imaging. 2005 Jun;32(6):674-81. Walter MA 2005

Active substance: Steripet

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

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Document reference: 48709

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

Active substance: SODIUM CITRATE SODIUM LAURYL SULFOACETATE

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Document reference: 42234

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

Active substance: SODIUM CITRATE SODIUM LAURYL SULFOACETATE

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Document reference: 42235

Study title: National Poisons Information Service Center, United Kingdom. Poison Information Monograph: Camphor, 1996

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40230

Study title: Plant-induced seizures: reappearance of an old problem, Burkhard, P.R., J.Neurol. 199; 246 (8): 667-670

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40242

Study title: Reports of Postmarketing Experience, Post Authorisation safety study, Tavipec capsules, Panosch, B., 2007

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40231

Study title: Compared Biodisponibility in human - Rovamycin Syrup 0,375 MUI - J. Gaillot - August 26, 1976Compared Biodisponibility in human - Rovamycin Syrup 0,375 MUI - J. Gaillot - August 26, 1976

Active substance: SPIRAMYCIN

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Document reference: 42577

Study title: Expert Clinical Assessment - Rovamycine 1.5 M.I.U. - Freeze-dried preparation and solution for slow intravenous injection - F. Vachon - March 1985Expert Clinical Assessment - Rovamycine 1.5 M.I.U. - Freeze-dried preparation and solution for slow intravenous injection - F. Vachon - March 1985

Active substance: SPIRAMYCIN

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Document reference: 42579

Study title: Fetal Toxoplasmosis: Outcome of Pregnancy and Infant Follow-Up After In Utero Treatment.Hohlfeld P; Daffos F; Thulliez P; Aufrant C; Couvreur J; MacAleese J J.Pediatr. 115, No. 5, Pt. 1, 765-69, 1989

Active substance: SPIRAMYCIN

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Document reference: 42587

Study title: Etude de la biodisponibilité relative de la suspension à 10 pour cent par rapport au comprimé dose à 500 mg (formulation de référence) chez le sujet jeune en bonne santé - MM. A. Le Liboux, G. Montay, A. Frydman et J. Gaillot - No date

Active substance: SECNIDAZOLE

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Document reference: 42120

Study title: RP 14539 - Comparative acute oral toxicity of secnidazole in juvenil rats aged 4 weeks and in rats aged 8 weeks - André S., Curaudeau A., Caillaud J.M., Boddaert A. Mazuret A. & Cordier A. - 1989 (Rapport ST/CRV/Tox. N° 254)

Active substance: SECNIDAZOLE

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Document reference: 42117

Study title: Study of the relative bioavailability of the 10 % suspension in relation to the tablet each containing 500 mg (reference formulation) in the young healthy subject - A. Le Liboux, G. Montay, A. Frydman and J. Gaillot - 1987 (registration dossier)

Active substance: SECNIDAZOLE

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Document reference: 42119

Study title: Prospective multicentric observational study/long term use

Active substance: Sedacur forte; 1 coated tablet contains: 75 mg valerian root dry extract (5-6:1) (extractive agent: ethanol 70% (v/v)), 23 mg hop strobile dry extract (4-8:1) (extractive agent: methanol 40% (v/v)), 45 mg balm leaves dry extract (4-6:1) (extractive agent: purified water) Sedacur forte Beruhigungsdragees; 1 coated tablet contains: 75 mg valerian root dry extract (5-6:1) (extractive agent: et...

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Document reference: 39756

Study title: Prospective observational study

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Document reference: 39757

Active substance: TAMOXIFEN

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Document reference: 43225

Active substance: TAMOXIFEN

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Document reference: 43235

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.

Active substance: TAMOXIFEN

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Document reference: 43219

Active substance: TAMOXIFEN

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Document reference: 43229

Active substance: TAMOXIFEN

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Document reference: 43239

Study title: Allmark C, Green HP, Linney et al. A community study of fluoride tablets for schoolchildren in Portsmouth. Results after six years. Br Dent J 1982; 153: 426-430.Allmark C, Green HP, Linney et al. A community study of fluoride tablets for schoolchildren in Portsmouth. Results after six years. Br Dent J 1982; 153: 426-430.

Active substance: SODIUM FLUORIDE

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Document reference: 42249

Active substance: SODIUM FLUORIDE

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Document reference: 42281

Active substance: SODIUM FLUORIDE

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Document reference: 42313

Study title: Strübig W, Gülzow HJ. Die Abhängigkeit des Fluoridgehaltes im Zahnschmelz von regelmäßiger oder unkontrollierter Fluoridaufnahme. Dtsch zahnärztl Z 1979; 34: 172-175Strübig W, Gülzow HJ. Die Abhängigkeit des Fluoridgehaltes im Zahnschmelz von regelmäßiger oder unkontrollierter Fluoridaufnahme. Dtsch zahnärztl Z 1979; 34: 172-175

Active substance: SODIUM FLUORIDE

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Document reference: 42270

Study title: A double blind clinical study of Serrapeptidase enteric coated granule capsule in the treatment of asthmatic bronchitis in children [E. Oka, Y. Kojima, et al., Medical Consultation & New Remedies, Vol 5, 1 (1968)]A double blind clinical study of Serrapeptidase enteric coated granule capsule in the treatment of asthmatic bronchitis in children [E. Oka, Y. Kojima, et al., Medical Consultation & New Remedies, Vol 5, 1 (1968)]

Active substance: SERRAPEPTASE

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Document reference: 42124

Study title: De Liefde B, Herbison GP. Prevalence of developmental defects of enamel and denatl caries in New Zealand children receiving differing fluoride supplementation. Community Dent Oral Epidemiol 1985; 13: 164-167De Liefde B, Herbison GP. Prevalence of developmental defects of enamel and denatl caries in New Zealand children receiving differing fluoride supplementation. Community Dent Oral Epidemiol 1985; 13: 164-167

Active substance: SODIUM FLUORIDE

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Document reference: 42243

Active substance: SODIUM FLUORIDE

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Document reference: 42275

Active substance: SODIUM FLUORIDE

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Document reference: 42307

Study title: DePaola PF, Lax M. the caries-inhibiting effect of acidulated phosphate-fluoride chewable tablets: a two-year double-blind study. J Dent Assoc 1968; 76: 554-557.DePaola PF, Lax M. the caries-inhibiting effect of acidulated phosphate-fluoride chewable tablets: a two-year double-blind study. J Dent Assoc 1968; 76: 554-557.

Active substance: SODIUM FLUORIDE

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Document reference: 42253

Active substance: SODIUM FLUORIDE

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Document reference: 42285

Active substance: SODIUM FLUORIDE

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Document reference: 42317

Active substance: TAMOXIFEN

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Document reference: 43249

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515.

Active substance: TAMOXIFEN

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Document reference: 43313

Study title: Ben Ami T, Treves ST, Tumeh S, Cox-Bryan J, McCarthy C. Stress fractures after surgery for osteosarcoma: scintigraphic assessment. Radiology. 1987 Apr;163(1):157-62. Ben Ami T, Treves ST, Tumeh S, Cox-Bryan J, McCarthy C. Stress fractures after surgery for osteosarcoma: scintigraphic assessment. Radiology. 1987 Apr;163(1):157-62.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43869

Study title: Bennett RJ, Grennan DM, Johns CW, Taylor L, Brown JD. A comparative evaluation of thermography and scintigraphy in the assessment of sacroiliitis. Int J Nucl Med Biol. 1984;11(1):42-5. No abstract available. Bennett RJ, Grennan DM, Johns CW, Taylor L, Brown JD. A comparative evaluation of thermography and scintigraphy in the assessment of sacroiliitis. Int J Nucl Med Biol. 1984;11(1):42-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44014

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

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44128

Study title: Berding G, Schliephake H, Neumann G, Schmelzeisen R, Neukam FW, Meyer GJ, Gratz KF, Hundeshagen H. [Bone SPECT of the jaws after fracture, onlay osteoplasty of insertion of implants] Nuklearmedizin. 1996 Oct;35(5):156-63. German. Berding G, Schliephake H, Neumann G, Schmelzeisen R, Neukam FW, Meyer GJ, Gratz KF, Hundeshagen H. [Bone SPECT of the jaws after fracture, onlay osteoplasty of insertion of implants] Nuklearmedizin. 1996 Oct;35(5):156-63. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43559

Study title: Bereiter H, Hedström SA, Lidgren L. [Skeletal scintigraphy as early diagnostic aid in acute haematogenous osteomyelitis in the iliosacral joint (author's transl)] Z Orthop Ihre Grenzgeb. 1981 Aug;119(4):364-5. German. Bereiter H, Hedström SA, Lidgren L. [Skeletal scintigraphy as early diagnostic aid in acute haematogenous osteomyelitis in the iliosacral joint (author's transl)] Z Orthop Ihre Grenzgeb. 1981 Aug;119(4):364-5. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44114

Study title: A study to test the efficacy of E45 Cream on nappy rash

Active substance: SOFT PARAFFIN

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Document reference: 42563

Study title: Camphor, Sweetman, S.C., Martindale, The complete drug reference, 33 edition, Pharmaceutical Press, 1589-1590.

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40227

Study title: Camphora (Campher), Monographie BGA/BfArM (Komission E), 1984, Heftnummer 228

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40228

Study title: Clinical effects and management of eucalyptus oil ingestion in infants and young children, Tibballs, J., Med. J. Aust. 1995; 163: 177-180

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40232

Study title: Clinical Toxicology of Commercial Products. 5th ed. Baltimore: Williams and Wilkins, 1984, p.III-85, Gosselin, R.E.

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40238

Study title: Myrtol standardized in the treatment of acute and chronic respiratory infections in children. A multicenter post-marketing surveillance study. Sengespeik HC et al., Arzneimittelforschung, 1998: 990-4.

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40234

Active substance: SODIUM FLUORIDE

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Document reference: 42302

Active substance: SODIUM FLUORIDE

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Document reference: 42334

Study title: Kaladze N.N., Titova E.V.: Antihomotoxic preparations in the combined treatment of secondary osteopenia in children suffering from chronic pyelonephritis. Therapy (Ukraine), 2007, 3: 15-19 [IIT-publication]

Active substance: Solidago compositum-Heel - Ampullen

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Document reference: 40198

Study title: PK in adolescent subjects with rizatriptan 5 mg

Active substance: RIZATRIPTAN

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Document reference: 47417

Study title: Uncontrolled, pharmacokinetic, efficacy and safety study of ropivacaine 3 mg/kg (5 mg/mL solution). Single peripheral nerve block (ilioinguinal block). 1-12 years.

Active substance: ROPIVACAINE

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Document reference: 35454

Study title: The safety and efficacy of risperidone versus placebo in conduct disorder in mild, moderate and borderline mentally retarded children aged 5 to 12 years.

Active substance: RISPERIDONE

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Document reference: 35426

Study title: Uncontrolled, pharmacokinetic, efficacy and safety study using a dose rate of 0.2 mg/kg/h in 0 to 180-day-old infants and 0.4 mg/kg/h infants over 181 days old. The epidural infusion was preceeded by a bolus injection of 1-2 mg/kg (0.5-1 mL/kg of 2 mg/mL solution). Continuous epidural infusion. 0-12 months.

Active substance: ROPIVACAINE

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Document reference: 35457

Study title: A 30-Week, Forced-titration and Randomised, Crossover, Multicentre, Multinational Trial to Evaluate the Efficacy and Safety of rosuvastatin and Atorvastatin in Subjects with Homozygous Familial Hypercholesterolaemia (4522IL/0054): Full Report of the First 18 Weeks (forced-titration) and Last 12 Weeks of Treatment (crossover period) for Efficacy and for Safety

Active substance: ROSUVASTATIN CALCIUM

Study summary document link (including results): Study 4522IL0054_CSR Synopsis.pdf

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Document reference: 47886

Study title: Pharmacokinetics of Rosuvastatin in Children and Adolescents with Heterozygous Familial Hypercholesterolemia (4522IL/0086)

Active substance: ROSUVASTATIN CALCIUM

Study summary document link (including results): Study 4522IL0086_CSR Synopsis.pdf

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Document reference: 47885

Study title: 10 day oral toxicity study in the young dog - Thien - Aubert and al. - 31/12/95

Active substance: ROXYTHROMYCIN

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Document reference: 35461

Study title: 28 day oral toxicity study and recovery study of RU 28 965 in infant beagle dogs - Moriya A. And al. - 31/07/90

Active substance: ROXYTHROMYCIN

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Document reference: 35463

Study title: Bhattacharya A, Prasad V, Thomas EJ, Singh B, Mittal BR. Tc-99m MDP scintigraphy in a case of idiopathic calcinosis cutis. Clin Nucl Med. 2005 Jun;30(6):431-2. No abstract available. Bhattacharya A, Prasad V, Thomas EJ, Singh B, Mittal BR. Tc-99m MDP scintigraphy in a case of idiopathic calcinosis cutis. Clin Nucl Med. 2005 Jun;30(6):431-2. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43387

Study title: Bibbo C, Patel DV, Mackessy RP, Lin SS, Barricella RL. Pyomyositis of the leg with early neurologic compromise. Pediatr Emerg Care. 2000 Oct;16(5):352-4. Bibbo C, Patel DV, Mackessy RP, Lin SS, Barricella RL. Pyomyositis of the leg with early neurologic compromise. Pediatr Emerg Care. 2000 Oct;16(5):352-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43473

Study title: Chronic recurrent multifocal osteomyelitis involving both jaws: report of a case including magnetic resonance correlation. Flygare L, Norderyd J, Kubista J, Ohlsson J, Vallo-Christiansen J, Magnusson B. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Feb;83(2):300-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43553

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

Active substance: TECHNETIUM (99m)

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

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Document reference: 48232

Study title: Optimization of aerosol deposition by pressure support in children with cystic fibrosis: an experimental and clinical study. Fauroux B, Itti E, Pigeot J, Isabey D, Meignan M, Ferry G, Lofaso F, Willemot JM, Clément A, Harf A. Am J Respir Crit Care Med. 2000 Dec;162(6):2265-71.

Active substance: TECHNETIUM (99m)

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

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Document reference: 48230

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

Active substance: TECHNETIUM (99m)

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

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Document reference: 48229

Study title: Pseudo pulmonary embolism in complex congenital heart disease. Cook GJ, Fogelman I. J Nucl Med. 1996 Aug;37(8):1359-61.

Active substance: TECHNETIUM (99m)

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

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Document reference: 48251

Study title: Bone mineral density and bone scintigraphy in children and adolescents with osteomalacia. El-Desouki M, Al-Jurayyan N. Eur J Nucl Med. 1997 Feb;24(2):202-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43554

Study title: Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Metzger DL, Kerrigan JR. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Metzger DL, Kerrigan JR. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.

Active substance: TAMOXIFEN

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Document reference: 43303

Study title: Estrogenic activity of tamoxifen on normal mammary parenchyma in the luteal phase of the menstrual cycle. Facina G, Rodrigues De LG, Simoes MJ, Novo NF, Gebrim LH. International Journal of Gynecology and Obstetrics 1997;56(1):19-24 1997;(1):19-24.Estrogenic activity of tamoxifen on normal mammary parenchyma in the luteal phase of the menstrual cycle. Facina G, Rodrigues De LG, Simoes MJ, Novo NF, Gebrim LH. International Journal of Gynecology and Obstetrics 1997;56(1):19-24 1997;(1):19-24.

Active substance: TAMOXIFEN

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Document reference: 43295

Study title: Facina G, Rodrigues De LG, Simoes MJ, Novo NF, Gebrim LH. Estrogenic activity of tamoxifen on normal mammary parenchyma in the luteal phase of the menstrual cycle. International Journal of Gynecology and Obstetrics 1997; 56(1):19-24.Facina G, Rodrigues De LG, Simoes MJ, Novo NF, Gebrim LH. Estrogenic activity of tamoxifen on normal mammary parenchyma in the luteal phase of the menstrual cycle. International Journal of Gynecology and Obstetrics 1997; 56(1):19-24.

Active substance: TAMOXIFEN

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Document reference: 43153

Study title: Faulkner LB, Hajdu SI, Kher U, La QM, Exelby PR, Heller G et al. Pediatric desmoid tumor: Retrospective analysis of 63 cases. Journal of Clinical Oncology 13(11)()(pp 2813-2818), 1995 Date of Publication: Nov 1995 1995;(11):2813-2818.Faulkner LB, Hajdu SI, Kher U, La QM, Exelby PR, Heller G et al. Pediatric desmoid tumor: Retrospective analysis of 63 cases. Journal of Clinical Oncology 13(11)()(pp 2813-2818), 1995 Date of Publication: Nov 1995 1995;(11):2813-2818.

Active substance: TAMOXIFEN

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Document reference: 43119

Study title: Diffuse hepatic uptake of technetium-99m methylene diphosphonate in a patient receiving high dose methotrexate. Flynn BM, Treves ST. J Nucl Med. 1987 Apr;28(4):532-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43868

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42063

Study title: Fordyce MJ, Solomon L. Early detection of avascular necrosis of the femoral head by MRI. J Bone Joint Surg Br. 1993 May;75(3):365-7. Fordyce MJ, Solomon L. Early detection of avascular necrosis of the femoral head by MRI. J Bone Joint Surg Br. 1993 May;75(3):365-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43665

Active substance: TAMOXIFEN

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Document reference: 43245

Active substance: TAMOXIFEN

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Document reference: 43318

Active substance: TAMOXIFEN

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Document reference: 43336

Active substance: TAMOXIFEN

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Document reference: 43346

Study title: Cuarón A, Acero A, Cárdenas M. [Bayesian analysis of myocardial scintigraphy using 99mTc-Sn(II)-methylenediphosphonate and using 99mTc-Sn(II)-pyrophosphate] Arch Inst Cardiol Mex. 1982 Sep-Oct;52(5):365-72. Spanish. Cuarón A, Acero A, Cárdenas M. [Bayesian analysis of myocardial scintigraphy using 99mTc-Sn(II)-methylenediphosphonate and using 99mTc-Sn(II)-pyrophosphate] Arch Inst Cardiol Mex. 1982 Sep-Oct;52(5):365-72. Spanish.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44074

Study title: Chronic recurrent multifocal osteomyelitis. Cyrlak D, Pais MJ Skeletal Radiol. 1986;15(1):32-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43918

Study title: De Boeck H, Casteleyn PP, Bossuyt A, Jacobs A. Intraoperative radioactive localization of small bone tumours. Int Orthop. 1992;16(2):172-5. De Boeck H, Casteleyn PP, Bossuyt A, Jacobs A. Intraoperative radioactive localization of small bone tumours. Int Orthop. 1992;16(2):172-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43716

Study title: De Geeter F, Van Steelandt H, Degomme P. Greatly increased humeral uptake as a sign of leukemia. Clin Nucl Med. 1995 Nov;20(11):1022-3. No abstract available. De Geeter F, Van Steelandt H, Degomme P. Greatly increased humeral uptake as a sign of leukemia. Clin Nucl Med. 1995 Nov;20(11):1022-3. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43581

Study title: Declerck P, Schiepers C, Mortelmans L, De Roo M. Stage II reflex sympathetic dystrophy syndrome with unexpected bone changes due to the use of walking crutches. Clin Nucl Med. 1993 Jul;18(7):604-5. No abstract available. Declerck P, Schiepers C, Mortelmans L, De Roo M. Stage II reflex sympathetic dystrophy syndrome with unexpected bone changes due to the use of walking crutches. Clin Nucl Med. 1993 Jul;18(7):604-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43660

Study title: Degrossi OJ, Oliveri P, García del Río H, Labriola R, Artagaveytía D, Degrossi EB. Technetium-99m APD compared with technetium-99m MDP as a bone scanning agent. J Nucl Med. 1985 Oct;26(10):1135-9. Degrossi OJ, Oliveri P, García del Río H, Labriola R, Artagaveytía D, Degrossi EB. Technetium-99m APD compared with technetium-99m MDP as a bone scanning agent. J Nucl Med. 1985 Oct;26(10):1135-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43931

Study title: Transient ureteral dilatation associated with infantile infectious sacroiliitis. Dejter SW, Eggli DF, Gibbons MD. J Urol. 1989 May;141(5):1154-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43785

Study title: Rovamycine infant 0.375MIU, children 0.750MIU,older children 1.5 MIU - Spiramycin granules in sachets - part IV A.2.1

Active substance: SPIRAMYCIN

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Document reference: 42591

Study title: Rovamycine nourrissons 0.375 MUI-rovamycine enfants 0.750MUI rovamycine grands enfants 1.5MUI:grnules de spiramycine en sachets (partie IV A.2. etude n°1 du dossier d'AMM) - Mai 1992

Active substance: SPIRAMYCIN

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Document reference: 42592

Study title: Rovamycine sirop - Sirop dosé à 2,5 p.100 (p/v) soit 125 mg ou 0,375 M.U.I. de spiramycine par cuillerée à café - J. Gaillot - 15 mars 1976

Active substance: SPIRAMYCIN

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Document reference: 42593

Study title: Spiramycin and erythromycin in the treatment of acute tonsillopharyngitis : a comparative study. - I. Soekrawinata et al. - 1984 - Curr Med Res Opin (9 (5):296-300) Spiramycin and erythromycin in the treatment of acute tonsillopharyngitis : a comparative study. - I. Soekrawinata et al. - 1984 - Curr Med Res Opin (9 (5):296-300)

Active substance: SPIRAMYCIN

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Document reference: 42581

Study title: Traitement presomptif de première intention des infections cutanées par la spiramycine - H. Meilo - 1993 - Médecine d'Afrique Noire (40(3): 213-215)Traitement presomptif de première intention des infections cutanées par la spiramycine - H. Meilo - 1993 - Médecine d'Afrique Noire (40(3): 213-215)

Active substance: SPIRAMYCIN

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Document reference: 42584

Study title: Treatment of toxoplasmosis during pregnancy: multicenter study of impact on fetal transmission and children's sequelae at age 1 year - Foulon W, Villena I, Stray-Pedersen B., Decoster A, Lappalainen M, Pinon JM, Jenum PA, Hedman K, Naessens A. - Am J Obstet Gynecol 1999 Feb; 180(2Pt1): 410-5 Treatment of toxoplasmosis during pregnancy: multicenter study of impact on fetal transmission and children's sequelae at age 1 year - Foulon W, Villena I, Stray-Pedersen B., Decoster A, Lappalainen M, Pinon JM, Jenum PA, Hedman K, Naessens A. - Am J Obstet Gynecol 1999 Feb; 180(2Pt1): 410-5

Active substance: SPIRAMYCIN

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Document reference: 42594

Active substance: SPIRAMYCIN

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Document reference: 42599

Study title: The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.

Active substance: TAMOXIFEN

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Document reference: 43301

Study title: Tolis G, Karalis K, Kyriakos GM. Gynecomastia. Current Therapy in Endocrinology & Metabolism 1994; 5:370-371.Tolis G, Karalis K, Kyriakos GM. Gynecomastia. Current Therapy in Endocrinology & Metabolism 1994; 5:370-371.

Active substance: TAMOXIFEN

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Document reference: 43121

Study title: Treatment of desmoid tumor. Moral DA, Piulachs CJ, Targarona Soler EM, Combalia AA, Ramon SR, Trias FM. Medicina Clinica 1994;102(7):250-253 1994;(7):250-253.Treatment of desmoid tumor. Moral DA, Piulachs CJ, Targarona Soler EM, Combalia AA, Ramon SR, Trias FM. Medicina Clinica 1994;102(7):250-253 1994;(7):250-253.

Active substance: TAMOXIFEN

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Document reference: 43304

Study title: Urban T, Lazor R, Lacronique J, Murris M, Labrune S, Valeyre D et al. Pulmonary lymphangioleiomyomatosis: A study of 69 patients. Medicine 78(5)()(pp 321-337), 1999 Date of Publication: Sep 1999 1999;(5):321-337.Urban T, Lazor R, Lacronique J, Murris M, Labrune S, Valeyre D et al. Pulmonary lymphangioleiomyomatosis: A study of 69 patients. Medicine 78(5)()(pp 321-337), 1999 Date of Publication: Sep 1999 1999;(5):321-337.

Active substance: TAMOXIFEN

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Document reference: 43113

Study title: Lawrence SE, Arnold FK, Vethamuthu J, Lawson ML. Beneficial effects of raloxifene and tamoxifen in the treatment of pubertal gynecomastia. Journal of Pediatrics 145(1)()(pp 71-76), 2004 Date of Publication: Jul 2004 2004;(1):71-76.Lawrence SE, Arnold FK, Vethamuthu J, Lawson ML. Beneficial effects of raloxifene and tamoxifen in the treatment of pubertal gynecomastia. Journal of Pediatrics 145(1)()(pp 71-76), 2004 Date of Publication: Jul 2004 2004;(1):71-76.

Active substance: TAMOXIFEN

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Document reference: 43095

Active substance: TAMOXIFEN

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Document reference: 43321

Active substance: TAMOXIFEN

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Document reference: 43339

Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137.

Active substance: TAMOXIFEN

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Document reference: 43118

Active substance: TAMOXIFEN

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Document reference: 43131

Active substance: TAMOXIFEN

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Document reference: 43189

Active substance: TAMOXIFEN

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Document reference: 43199

Active substance: TAMOXIFEN

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Document reference: 43209

Active substance: TAMOXIFEN

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Document reference: 43214

Study title: Bibby BG, Wilkins E, Witol E. A preliminary study of the effects of fluoride lozenges and pills on dental caries. Oral Surg Oral Med Oral Pathol 1955; 8 : 213-216.Bibby BG, Wilkins E, Witol E. A preliminary study of the effects of fluoride lozenges and pills on dental caries. Oral Surg Oral Med Oral Pathol 1955; 8 : 213-216.

Active substance: SODIUM FLUORIDE

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Document reference: 42250

Active substance: SODIUM FLUORIDE

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Document reference: 42282

Active substance: SODIUM FLUORIDE

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Document reference: 42314

Study title: Busse H, Geiger L. Fluoridierungsmaßnahmen und Kariesprävalenz bei Schülern in der ehemaligen DDR. Oralprophylaxe 1990; 12: 145-153Busse H, Geiger L. Fluoridierungsmaßnahmen und Kariesprävalenz bei Schülern in der ehemaligen DDR. Oralprophylaxe 1990; 12: 145-153

Active substance: SODIUM FLUORIDE

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Document reference: 42251

Active substance: SODIUM FLUORIDE

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Document reference: 42283

Active substance: SODIUM FLUORIDE

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Document reference: 42315

Study title: Viviani RS, Gebrim LH, Baracat EC, De Lima GR. Evaluation of the ultrasonographic volume of breast fibroadenomas in women treated with tamoxifen. Minerva Ginecologica 2002; 54(6):531-535.Viviani RS, Gebrim LH, Baracat EC, De Lima GR. Evaluation of the ultrasonographic volume of breast fibroadenomas in women treated with tamoxifen. Minerva Ginecologica 2002; 54(6):531-535.

Active substance: TAMOXIFEN

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Document reference: 43103

Study title: Alexander JE, Seibert JJ, Aronson J, Williamson SL, Glasier CM, Rodgers AB, Corbitt SL. A protocol of plain radiographs, hip ultrasound, and triple phase bone scans in the evaluation of the painful pediatric hip. Clin Pediatr (Phila). 1988 Apr;27(4):175-81. Alexander JE, Seibert JJ, Aronson J, Williamson SL, Glasier CM, Rodgers AB, Corbitt SL. A protocol of plain radiographs, hip ultrasound, and triple phase bone scans in the evaluation of the painful pediatric hip. Clin Pediatr (Phila). 1988 Apr;27(4):175-81.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44271

Study title: Amico S, Lucas P, Liehn JC, Valeyre J. Unusual site of extraosseous uptake of Tc 99m-HMDP due to subcutaneous heparin injections. Report of two cases. Eur J Nucl Med. 1989;15(10):670-2. Amico S, Lucas P, Liehn JC, Valeyre J. Unusual site of extraosseous uptake of Tc 99m-HMDP due to subcutaneous heparin injections. Report of two cases. Eur J Nucl Med. 1989;15(10):670-2.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43796

Active substance: TAMOXIFEN

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Document reference: 43349

Study title: Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251.Walter AW, Gajjar A, Reardon DA, Thompson SJ, Langston JW, Jones-Wallace D et al. Tamoxifen and Carboplatin for Children With Low-Grade Gliomas: A Pilot Study at St Jude Children's Research Hospital. Journal of Pediatric Hematology/Oncology 2000;22(3):247-251 2000;(3):247-251.

Active substance: TAMOXIFEN

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Document reference: 43107

Active substance: TAMOXIFEN

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Document reference: 43128

Study title: Bittini A, Dominguez PL, Martinez Pueyo ML, López Longo FJ, Monteagudo I, Carreño L. Comparison of bone and gallium-67 imaging in heroin users' arthritis. J Nucl Med. 1985 Dec;26(12):1377-81. Bittini A, Dominguez PL, Martinez Pueyo ML, López Longo FJ, Monteagudo I, Carreño L. Comparison of bone and gallium-67 imaging in heroin users' arthritis. J Nucl Med. 1985 Dec;26(12):1377-81.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43926

Study title: Blackmore CC, Perkins A. Lytic bone lesion in a 12-year-old. Acad Radiol. 1995 Jun;2(6):541-3. No abstract available. Blackmore CC, Perkins A. Lytic bone lesion in a 12-year-old. Acad Radiol. 1995 Jun;2(6):541-3. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43598

Active substance: TAMOXIFEN

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Document reference: 43198

Active substance: TAMOXIFEN

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Document reference: 43208

Active substance: TAMOXIFEN

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Document reference: 43218

Active substance: TAMOXIFEN

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Document reference: 43228

Active substance: TAMOXIFEN

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Document reference: 43238

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

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43578

Study title: Arat ZM, Gökalp H, Atasever T, Türkkahraman H. 99mTechnetium-labeled methylene diphosphonate uptake in maxillary bone during and after rapid maxillary expansion. Angle Orthod. 2003 Oct;73(5):545-9. Arat ZM, Gökalp H, Atasever T, Türkkahraman H. 99mTechnetium-labeled methylene diphosphonate uptake in maxillary bone during and after rapid maxillary expansion. Angle Orthod. 2003 Oct;73(5):545-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43411

Study title: Bone scintigraphy in preschool children with lower extremity pain of unknown origin. Englaro EE, Gelfand MJ, Paltiel HJ. J Nucl Med. 1992 Mar;33(3):351-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43702

Study title: Esdaile J, Rosenthall L. Radionuclide joint imaging. Compr Ther. 1983 Sep;9(9):54-63. Esdaile J, Rosenthall L. Radionuclide joint imaging. Compr Ther. 1983 Sep;9(9):54-63.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44028

Study title: Esterhai J, Alavi A, Mandell GA, Brown J. Sequential technetium-99m/gallium-67 scintigraphic evaluation of subclinical osteomyelitis complicating fracture nonunion. J Orthop Res. 1985;3(2):219-25. Esterhai J, Alavi A, Mandell GA, Brown J. Sequential technetium-99m/gallium-67 scintigraphic evaluation of subclinical osteomyelitis complicating fracture nonunion. J Orthop Res. 1985;3(2):219-25.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43965

Study title: Blom J, Pauwels EK, Piso LN, Taminiau AH. Misleading 67Ga uptake and serial bone scintigraphy in osteoid osteoma. Diagn Imaging. 1983;52(5):276-9. Blom J, Pauwels EK, Piso LN, Taminiau AH. Misleading 67Ga uptake and serial bone scintigraphy in osteoid osteoma. Diagn Imaging. 1983;52(5):276-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44057

Study title: Boas SR, Charron M, Ledesma-Medina J, Noyes BE, Kurland G. Hypertrophic osteoarthropathy in a child with follicular bronchiolitis. Clin Nucl Med. 1995 Jan;20(1):49-51. Boas SR, Charron M, Ledesma-Medina J, Noyes BE, Kurland G. Hypertrophic osteoarthropathy in a child with follicular bronchiolitis. Clin Nucl Med. 1995 Jan;20(1):49-51.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43604

Study title: Bockisch A, König R, Wahl G, Hotze A, Biersack HJ. [Scintigraphic panoramic imaging of the jaws] Dtsch Z Mund Kiefer Gesichtschir. 1991 May-Jun;15(3):215-20. German. Bockisch A, König R, Wahl G, Hotze A, Biersack HJ. [Scintigraphic panoramic imaging of the jaws] Dtsch Z Mund Kiefer Gesichtschir. 1991 May-Jun;15(3):215-20. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43739

Study title: Francis IR, Glazer GM, Shapiro B, Sisson JC, Gross BH. Complementary roles of CT and 131I-MIBG scintigraphy in diagnosing pheochromocytoma. AJR Am J Roentgenol. 1983 Oct;141(4):719-25. Francis IR, Glazer GM, Shapiro B, Sisson JC, Gross BH. Complementary roles of CT and 131I-MIBG scintigraphy in diagnosing pheochromocytoma. AJR Am J Roentgenol. 1983 Oct;141(4):719-25.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44027

Study title: Frater C, Van Gaal W, Kannangara S, Van der Wall H. Scintigraphy of injuries to the distal tibiofibular syndesmosis. Clin Nucl Med. 2002 Sep;27(9):625-7. Frater C, Van Gaal W, Kannangara S, Van der Wall H. Scintigraphy of injuries to the distal tibiofibular syndesmosis. Clin Nucl Med. 2002 Sep;27(9):625-7.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43441

Study title: The bullhead sign: scintigraphic pattern of sternocostoclavicular hyperostosis and pustulotic arthroosteitis. Freyschmidt J, Sternberg A. Eur Radiol. 1998;8(5):807-12.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43532

Study title: Pulmonary arteriovenous malformations: effect of embolization on right-to-left shunt, hypoxemia, and exercise tolerance in 66 patients. Gupta P, Mordin C, Curtis J, Hughes JM, Shovlin CL, Jackson JE. AJR Am J Roentgenol. 2002 Aug;179(2):347-55.

Active substance: TECHNETIUM (99m)

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

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Document reference: 48226

Study title: Pulmonary perfusion after endovascular stenting of pulmonary artery stenosis. Oyen WJ, van Oort AM, Tanke RB, van Mill GJ, Aengevaeren WR, Corstens FH. J Nucl Med. 1995 Nov;36(11):2006-8.

Active substance: TECHNETIUM (99m)

Study summary document link (including results): Oyen WJ 1995.pdf

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Document reference: 48259

Study title: Reduced effect of inhaled beta 2-adrenergic agonists on lung mucociliary clearance in patients with cystic fibrosis. Mortensen J, Hansen A, Falk M, Nielsen IK, Groth S Chest. 1993 Mar;103(3):805-11.

Active substance: TECHNETIUM (99m)

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

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Document reference: 48273

Study title: Reversal of intrapulmonary shunting in cirrhosis after liver transplantation demonstrated by perfusion lung scan. Levin DP, Pison CF, Brandt M, Weber A, Paradis K, Laberge JM, Blanchard H. J Nucl Med. 1991 May;32(5):862-4.

Active substance: TECHNETIUM (99m)

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Document reference: 48281

Study title: Govrin-Yehudain J, Kogan L, Cohen HI, Falik-Zaccai TC. Familial juvenile hypertrophy of the breast. Journal of Adolescent Health 2004; 35(2):151-155.Govrin-Yehudain J, Kogan L, Cohen HI, Falik-Zaccai TC. Familial juvenile hypertrophy of the breast. Journal of Adolescent Health 2004; 35(2):151-155.

Active substance: TAMOXIFEN

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Document reference: 43092

Study title: Gynecomastia. Tolis G, Karalis K, Kyriakos GM. Current Therapy in Endocrinology & Metabolism 1994; 5:370-371.Gynecomastia. Tolis G, Karalis K, Kyriakos GM. Current Therapy in Endocrinology & Metabolism 1994; 5:370-371.

Active substance: TAMOXIFEN

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Document reference: 43305

Study title: Haddad NARA, E-mail: nhaddad@iupui.edu], Eugster E. An update on the treatment of precocious puberty in McCune-Albright syndrome and testotoxicosis. Journal of Pediatric Endocrinology & Metabolism~ 20(6):653-661, JUN 2007 2007;(6):-661, JUN.Haddad NARA, E-mail: nhaddad@iupui.edu], Eugster E. An update on the treatment of precocious puberty in McCune-Albright syndrome and testotoxicosis. Journal of Pediatric Endocrinology & Metabolism~ 20(6):653-661, JUN 2007 2007;(6):-661, JUN.

Active substance: TAMOXIFEN

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Document reference: 43086

Study title: Frier M, Wastie ML. To report or not? Nucl Med Commun. 1997 Jun;18(6):589. No abstract available. Frier M, Wastie ML. To report or not? Nucl Med Commun. 1997 Jun;18(6):589. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43549

Study title: Which diphosphonate for routine bone scintigraphy (MDP, HDP or DPD)?Frühling J, Verbist A, Balikdjian D. Nucl Med Commun. 1986 Jun;7(6):415-25.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43906

Study title: Maddalozzo J, Tenta LT, Hutchinson LR, Crawford SE, Morse DS. Juvenile fibromatosis: Hormonal receptors. International Journal of Pediatric Otorhinolaryngology 1993; 25(1-3):191-199.Maddalozzo J, Tenta LT, Hutchinson LR, Crawford SE, Morse DS. Juvenile fibromatosis: Hormonal receptors. International Journal of Pediatric Otorhinolaryngology 1993; 25(1-3):191-199.

Active substance: TAMOXIFEN

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Document reference: 43160

Study title: Mastronardi l, Puzzilli F, Ruggeri A. Tamoxifen as a potential treatment of glioma. (Review, 65 refs). Anti-cancer Drugs 1998;9(7):581-586 1998;(7):581-586.Mastronardi l, Puzzilli F, Ruggeri A. Tamoxifen as a potential treatment of glioma. (Review, 65 refs). Anti-cancer Drugs 1998;9(7):581-586 1998;(7):581-586.

Active substance: TAMOXIFEN

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Document reference: 43114

Study title: McAuliffe PF, Cance WG. Preemptive surgery. Surgery (St Louis) 2006 ; 140(1):1-5.McAuliffe PF, Cance WG. Preemptive surgery. Surgery (St Louis) 2006 ; 140(1):1-5.

Active substance: TAMOXIFEN

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Document reference: 43135

Study title: [Left distal femoral diaphysis-metaphyseal injury in a 13-year-old patient] Spanish. Delgado García M, Mitjavila Casanovas M, Balsa Bretón MA, Castillejos Rodríguez L, Alonso García P, Cañamaque García L, Penín González J, Pey Illera C. Rev Esp Med Nucl. 2000 Sep;19(5):356-60. Spanish.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44251

Study title: Delpassand ES, Dhekne RD, Barron BJ, Moore WH. Evaluation of soft tissue injury by Tc-99m bone agent scintigraphy. Clin Nucl Med. 1991 May;16(5):309-14. Delpassand ES, Dhekne RD, Barron BJ, Moore WH. Evaluation of soft tissue injury by Tc-99m bone agent scintigraphy. Clin Nucl Med. 1991 May;16(5):309-14.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43740

Study title: Imaging of non-central nervous system primitive neuroectodermal tumours: diagnostic features and correlation with outcome. Dick EA, McHugh K, Kimber C, Michalski A. Clin Radiol. 2001 Mar;56(3):206-15.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43457

Study title: Djupesland G, Nakken KF, Müller C, Skjørten F, Tøhrt R, Eldevik P. Bone scintigraphy in the diagnosis of fracture and infection of the temporal bone. Acta Otolaryngol. 1983 May-Jun;95(5-6):670-5. Djupesland G, Nakken KF, Müller C, Skjørten F, Tøhrt R, Eldevik P. Bone scintigraphy in the diagnosis of fracture and infection of the temporal bone. Acta Otolaryngol. 1983 May-Jun;95(5-6):670-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44036

Study title: Dodig D, Domljan Z, Popović S, Simonović I. Effect of imaging time on the values of the sacroiliac index. Eur J Nucl Med. 1988;14(9-10):504-6. Dodig D, Domljan Z, Popović S, Simonović I. Effect of imaging time on the values of the sacroiliac index. Eur J Nucl Med. 1988;14(9-10):504-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43834

Study title: Dolen EG, Berdon WE, Ruzal-Shapiro C. "Cold bone scans" as a sign of hemorrhagic infarcts of the spine in Gaucher's disease. Pediatr Radiol. 1997 Jun;27(6):514-6. Dolen EG, Berdon WE, Ruzal-Shapiro C. "Cold bone scans" as a sign of hemorrhagic infarcts of the spine in Gaucher's disease. Pediatr Radiol. 1997 Jun;27(6):514-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43550

Study title: Wickmann L, Lüders H, Dörffel W.. [18- FDG-PET-findings in children and adolescents with Hodgkin's disease: retrospective evaluation of the correlation to other imaging procedures in initial staging and to the predictive value of follow up examinations] [Translated] [wickmann-2003-en]Klin Padiatr. 2003 May-Jun;215(3):146-50. Wickmann L 2003

Active substance: Steripet

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

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Document reference: 48711

Study title: Treatment of toxoplasmosis in the pregnant mother and newborn child - Stray-Pedersen B. Dept of Gynecology and Obstetrics, Aker Hospital, University of Oslo,0514 Oslo Norway Scandinavian Journal of Infectious Diseases, Supplement ( SCAND. J. INFECT. DIS. SUPPL. ) (Norway) 1992, 23/84 (23-31)Treatment of toxoplasmosis in the pregnant mother and newborn child - Stray-Pedersen B. Dept of Gynecology and Obstetrics, Aker Hospital, University of Oslo,0514 Oslo Norway Scandinavian Journal of Infectious Diseases, Supplement ( SCAND. J. INFECT. DIS. SUPPL. ) (Norway) 1992, 23/84 (23-31)

Active substance: SPIRAMYCIN

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Document reference: 42595

Active substance: SPIRAMYCIN

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Document reference: 42598

Study title: A Multicenter, Double–Blind, Vehicle Controlled Study of Topical 5% Spironolactone Cream in the Treatment of Nodulocystic Acne

Active substance: SPIRONOLACTONE

Study summary document link (including results): S84-89-02-016 EMEA Paediatric Web Synopsis.pdf

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Document reference: 42601

Study title: Multizentrische, nicht-randomisierte offene Anwendungs-beobachtung mit Texx 300

Active substance: (St. John´s wort) dry extract (4,1-7,1:1)

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Document reference: 39752

Study title: ACTG 338 Week 48 Analysis Report, A Phase II Rolling Arm Protocol (PRAM) of Novel Antiretroviral Therapy in Stable Experienced HIV- Infected Children

Active substance: stavudine

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Document reference: 41614

Study title: Blake GM et al. Strontium-89 therapy: strontium kinetics and dosimetry in two patients treated for metastasizing osteosarcoma. Blake GM 1987 Br J Radiol. 1987 Mar; 60(711):253-9

Active substance: STRONTIUM 89

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

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Document reference: 48216

Study title: Vizner B, Vilibic T, Brkic K, Vrkljan M, Smircic L, Sekso M. Gynecomastia - clinical and therapeutic aspects. [Serbian]. Acta Clinica Croatica 33(3-4)()(pp 205-212), 1994 Date of Publication: 1994 1994;(3-4):205-212.Vizner B, Vilibic T, Brkic K, Vrkljan M, Smircic L, Sekso M. Gynecomastia - clinical and therapeutic aspects. [Serbian]. Acta Clinica Croatica 33(3-4)()(pp 205-212), 1994 Date of Publication: 1994 1994;(3-4):205-212.

Active substance: TAMOXIFEN

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Document reference: 43122

Active substance: TAMOXIFEN

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Document reference: 43105

Active substance: TAMOXIFEN

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Document reference: 43126

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515.

Active substance: TAMOXIFEN

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Document reference: 43145

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515.

Active substance: TAMOXIFEN

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Document reference: 43165

Study title: Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994;79(2):513-518 1994;(2):513-518.

Active substance: TAMOXIFEN

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Document reference: 43120

Active substance: TAMOXIFEN

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Document reference: 43132

Study title: Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994; 79(2):51Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994; 79(2):51

Active substance: TAMOXIFEN

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Document reference: 43156

Study title: Ludemann JP, Hughes CA, Bouzoukis J, Maddalozzo J, Goldman S. Aggressive Fibromatosis of the Neck in Two Brothers: Diagnostic and Therapeutic Implications. Journal of Otolaryngology 1999;28(5):288-292 1999;(5):288-292.Ludemann JP, Hughes CA, Bouzoukis J, Maddalozzo J, Goldman S. Aggressive Fibromatosis of the Neck in Two Brothers: Diagnostic and Therapeutic Implications. Journal of Otolaryngology 1999;28(5):288-292 1999;(5):288-292.

Active substance: TAMOXIFEN

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Document reference: 43109

Active substance: TAMOXIFEN

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Document reference: 43224

Active substance: TAMOXIFEN

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Document reference: 43234

Active substance: TAMOXIFEN

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Document reference: 43244

Active substance: TAMOXIFEN

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Document reference: 43326

Study title: Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137Delepine N, Delepine G, Cornille H, Ishak S, Markowska B, Desbois JC. The desmoid fibroma in children and adults. Clinical and therapeutical aspects in 1995. [French]. Cahiers d'Oncologie 4(4)()(pp 131-137), 1995 Date of Publication: 1995 1995;(4):131-137

Active substance: TAMOXIFEN

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Document reference: 43333

Active substance: TAMOXIFEN

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Document reference: 43344

Active substance: TAMOXIFEN

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Document reference: 43354

Study title: Christen F, Hotz P. [Long-term effect of fluoride prophylaxis: a follow-up study of 151 subjects 13 to 15 years after tablet fluoridation] SSO Schweiz Monatsschr Zahnheilkd. 1981 Nov;91(11):932-9. German.Christen F, Hotz P. [Long-term effect of fluoride prophylaxis: a follow-up study of 151 subjects 13 to 15 years after tablet fluoridation] SSO Schweiz Monatsschr Zahnheilkd. 1981 Nov;91(11):932-9. German.

Active substance: SODIUM FLUORIDE

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Document reference: 42252

Active substance: SODIUM FLUORIDE

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Document reference: 42284

Study title: Aso K, Amano M, Sekiya S, Komatani A. [Scintigraphic investigation of the clavicular bone area in patients with psoriasis] Nippon Hifuka Gakkai Zasshi. 1984 Nov;94(13):1515-20. Japanese. No abstract Aso K, Amano M, Sekiya S, Komatani A. [Scintigraphic investigation of the clavicular bone area in patients with psoriasis] Nippon Hifuka Gakkai Zasshi. 1984 Nov;94(13):1515-20. Japanese. No abstract

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43977

Study title: Ayabe K, Higashi K, Oguchi M, Taniguchi M, Motomura Y, Tonami H, Okimura T, Yamamoto I, Niimura J, Koh E. Photopenic area visualized on bone scintigraphy in a patient with eosinophilic granuloma. Clin Nucl Med. 1999 Mar;24(3):184-5. No abstract available. Ayabe K, Higashi K, Oguchi M, Taniguchi M, Motomura Y, Tonami H, Okimura T, Yamamoto I, Niimura J, Koh E. Photopenic area visualized on bone scintigraphy in a patient with eosinophilic granuloma. Clin Nucl Med. 1999 Mar;24(3):184-5. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44255

Study title: Ayres R, Curry NS, Gordon L, Bradford BF. Renal metastases from osteogenic sarcoma. Urol Radiol. 1985;7(1):39-41. Ayres R, Curry NS, Gordon L, Bradford BF. Renal metastases from osteogenic sarcoma. Urol Radiol. 1985;7(1):39-41.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43969

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

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44257

Active substance: TAMOXIFEN

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Document reference: 43186

Active substance: TAMOXIFEN

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Document reference: 43196

Active substance: TAMOXIFEN

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Document reference: 43206

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

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 48469

Study title: Bonnin F, Buvat I, Benali H, Di Paola R. A comparative study of scatter correction methods for scintigraphic images. Eur J Nucl Med. 1994 May;21(5):388-93. Bonnin F, Buvat I, Benali H, Di Paola R. A comparative study of scatter correction methods for scintigraphic images. Eur J Nucl Med. 1994 May;21(5):388-93.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43626

Active substance: TAMOXIFEN

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Document reference: 43248

Study title: Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin 2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999; 17(3):968-975.Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL et al. Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin 2 and Interferon Alfa-2b. Journal of Clinical Oncology 1999; 17(3):968-975.

Active substance: TAMOXIFEN

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Document reference: 43316

Active substance: TAMOXIFEN

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Document reference: 43325

Active substance: TAMOXIFEN

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Document reference: 43343

Study title: An Open Label, Randomized, Multi-center, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Risedronate Administered as a Single Oral Dose of 2.5 mg or 5 mg in Children ≤ 30 kg and 5 mg or 10 mg in Children> 30 kg with Osteogenesis Imperfecta

Active substance: RISEDRONIC ACID

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

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Document reference: 35390

Study title: Assessing the safety and efficacy of Actonel in children ages 4-14 with mild Osteogenesis Imperfecta -F.Glorieux (abstract available) Assessing the safety and efficacy of Actonel in children ages 4-14 with mild Osteogenesis Imperfecta -F.Glorieux (abstract available)

Active substance: RISEDRONIC ACID

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Document reference: 35388

Study title: 6 weeks 1st episode psychosis (minimum age 15 years)

Active substance: RISPERIDONE

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Document reference: 35393

Study title: "Alpha-Project" Long time Neuroleptic Therapy with Risperidone, age of the patients 14-85. To acquire - modalities of administration of RISPERDAL, mode and frequency of adverse reactions, mode and extent of therapeutic action of RISPERDAL under the routine of daily practice.

Active substance: RISPERIDONE

Study summary document link (including results): AlphaProject_Non-interventional_Risperidone.xls

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Document reference: 35410

Study title: Children and adolescents (5-17 yrs) with Conduct or other DBD

Active substance: RISPERIDONE

Study summary document link (including results): RIS-INT-79_Interventional_Risperidone.xls

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Document reference: 35427

Study title: Children and adolescents (5-17 yrs) with Conduct or other DBD

Active substance: RISPERIDONE

Study summary document link (including results): RIS-INT-84_Interventional_Risperidone.xls

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Document reference: 35433

Study title: Children and adolescents (5-17 yrs) with conduct or other OBD.

Active substance: RISPERIDONE

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Document reference: 35414

Study title: Determination of the pharmacokinetics and safety of risperidone at steady state in children and adolescents 5 to less than 18 years of age.

Active substance: RISPERIDONE

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Document reference: 35434

Study title: Multicenter, multinational retrospective analysis on the safety of Risperdal in adolescent subjects with schizophrenia (13-17 yrs)

Active substance: RISPERIDONE

Study summary document link (including results): RIS-SCH-4083_Non-interventional_Risperidone.xls

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Document reference: 35391

Study title: Non interventional study for optimisation of ambulant therapy-switch to Risperdal (SWITCH), age of patients 16-100

Active substance: RISPERIDONE

Study summary document link (including results): JC-AWB-RIS-0004_Non-interventional_Risperidone.xls

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Document reference: 35412

Study title: Fehring TK, Green NE. Negative radionuclide scan in osteoid osteoma. A case report. Clin Orthop Relat Res. 1984 May;(185):245-9. Fehring TK, Green NE. Negative radionuclide scan in osteoid osteoma. A case report. Clin Orthop Relat Res. 1984 May;(185):245-9.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43999

Study title: Feine U, Ahlemann LM. [Periosteal desmoid of the metaphysis; differential diagnosis from malignant bone tumours by bone scintigrams (author's transl)] Rofo. 1981 Aug;135(2):193-6. German. No abstract available. Feine U, Ahlemann LM. [Periosteal desmoid of the metaphysis; differential diagnosis from malignant bone tumours by bone scintigrams (author's transl)] Rofo. 1981 Aug;135(2):193-6. German. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44117

Study title: Bos SD, Piers DA, Mensink HJ. Routine bone scan and serum alkaline phosphatase for staging in patients with renal cell carcinoma is not cost-effective. Eur J Cancer. 1995 Dec;31A(13-14):2422-3. No abstract available. Bos SD, Piers DA, Mensink HJ. Routine bone scan and serum alkaline phosphatase for staging in patients with renal cell carcinoma is not cost-effective. Eur J Cancer. 1995 Dec;31A(13-14):2422-3. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43575

Study title: Bouvier JF, Chassard JL, Brunat-Mentigny M, Bobin JY, Domenach M, Roojee N, Riffat G, Mayer M, Lahneche BE. Radionuclide bone imaging in diaphyseal aclasis with malignant change. Cancer. 1986 Jun 15;57(12):2280-4. Bouvier JF, Chassard JL, Brunat-Mentigny M, Bobin JY, Domenach M, Roojee N, Riffat G, Mayer M, Lahneche BE. Radionuclide bone imaging in diaphyseal aclasis with malignant change. Cancer. 1986 Jun 15;57(12):2280-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43905

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

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43831

Study title: Bower GD, Sprague P, Geijsel H, Holt K, Lovegrove FT. Isotope bone scans in the assessment of children with hip pain or limp. Pediatr Radiol. 1985;15(5):319-23. Bower GD, Sprague P, Geijsel H, Holt K, Lovegrove FT. Isotope bone scans in the assessment of children with hip pain or limp. Pediatr Radiol. 1985;15(5):319-23.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43961

Study title: Fuller C, Leonard JC. Extraosseous localization of technetium-99m MDP in benign cystic teratoma. Clin Nucl Med. 1986 Aug;11(8):574-6. Fuller C, Leonard JC. Extraosseous localization of technetium-99m MDP in benign cystic teratoma. Clin Nucl Med. 1986 Aug;11(8):574-6.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43898

Study title: The contribution of perfusion scintigraphy in the evaluation of children suffering from recurrent localized pneumonia. Hardoff R, Rivlin J, Front A. Eur J Nucl Med. 1990;17(3-4):152-5.

Active substance: TECHNETIUM (99m)

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

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Document reference: 48284

Study title: The value of bronchodilator administration in asthmatic patients before lung imaging. Roach PJ, Treves ST. Clin Nucl Med. 1995 Jun;20(6):491-3.

Active substance: TECHNETIUM (99m)

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

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Document reference: 48260

Study title: Usefulness of selective contrast echocardiography and selective scintigraphy for the evaluation of pulmonary arteriovenous fistula in a patient with systemic arterial supply to a normal lung. Masutani S, Senzaki H, Taketazu M, Kobayashi J, Kobayashi T, Asano H, Kyo S, Yokote Y. J Pediatr Surg. 2005 Mar;40(3):E51-4

Active substance: TECHNETIUM (99m)

Study summary document link (including results): Masutani S 2005.pdf

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Document reference: 48223

Study title: 107: Kumar R, Sood A, Marwah A, Sharma R, Padhy AK, Moorthy D. Metaphyseal chondrodysplasia: interesting findings on bone scintigraphy. Clin Nucl Med. 2000 Dec;25(12):1047-9. No abstract available. 107: Kumar R, Sood A, Marwah A, Sharma R, Padhy AK, Moorthy D. Metaphyseal chondrodysplasia: interesting findings on bone scintigraphy. Clin Nucl Med. 2000 Dec;25(12):1047-9. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43468

Study title: Kreher NC, Eugster EA, Shankar RR. The use of tamoxifen to improve height potential in short pubertal boys. Pediatrics 2005; 116(6):1513-1515.Kreher NC, Eugster EA, Shankar RR. The use of tamoxifen to improve height potential in short pubertal boys. Pediatrics 2005; 116(6):1513-1515.

Active substance: TAMOXIFEN

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Document reference: 43090

Active substance: TAMOXIFEN

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Document reference: 43094

Active substance: TAMOXIFEN

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Document reference: 43123

Study title: Furuta A, Tanohata K, Itake T, Hashizume T, Kobayashi Y, Nakazima H. [Clinical evaluation of stress fractures using bone scintigraphy] Kaku Igaku. 1984 May;21(5):435-43. Japanese. No abstract available. Furuta A, Tanohata K, Itake T, Hashizume T, Kobayashi Y, Nakazima H. [Clinical evaluation of stress fractures using bone scintigraphy] Kaku Igaku. 1984 May;21(5):435-43. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44000

Study title: [Acute hematogenic osteomyelitis after impetiginized scabies] Gaida G, Töllner U, Krüpe H, Haas JP. Klin Padiatr. 1985 Nov-Dec;197(6):489-91. German.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43927

Study title: Neuroblastoma: imaging evaluation by sequential Tc-99m MDP, I-131 MIBG, and Ga-67 citrate studies. Garty I, Friedman A, Sandler MP, Kedar A. Clin Nucl Med. 1989 Jul;14(7):515-22.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43783

Study title: Bone scintigraphy in two siblings with pulmonary alveolar microlithiasis. Garty I, Giladi N, Flatau E. Br J Radiol. 1985 Aug;58(692):763-6. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43935

Study title: Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994; 79(2):51Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994; 79(2):51

Active substance: TAMOXIFEN

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Document reference: 43169

Study title: Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994; 79(2):51Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994; 79(2):51

Active substance: TAMOXIFEN

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Document reference: 43174

Study title: Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994; 79(2):51Metzger DL, Kerrigan JR. Estrogen Receptor Blockade with Tamoxifen Diminishes Growth Hormone Secretion in Boys: Evidence for a Stimulatory Role of Endogenous Estrogens during Male Adolescence. Journal of Clinical Endocrinology and Metabolism 1994; 79(2):51

Active substance: TAMOXIFEN

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Document reference: 43180

Study title: Dong QR, Wang JX, Dong TH. [Early diagnosis by scintigraphy of segmental collapse of the femur head following femur neck fracture] J Radiol. 1994 Aug-Sep;75(8-9):423-5. French. Dong QR, Wang JX, Dong TH. [Early diagnosis by scintigraphy of segmental collapse of the femur head following femur neck fracture] J Radiol. 1994 Aug-Sep;75(8-9):423-5. French.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43620

Study title: Dong QR, Wang JX, Dong TH. [Prediction of segmental collapse of femoral head after femoral neck fracture by scintimetry] Zhonghua Wai Ke Za Zhi. 1994 Sep;32(9):520-2. Chinese. Dong QR, Wang JX, Dong TH. [Prediction of segmental collapse of femoral head after femoral neck fracture by scintimetry] Zhonghua Wai Ke Za Zhi. 1994 Sep;32(9):520-2. Chinese.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43617

Study title: Stress fractures in athletes. Dowey KE, Moore GW. Ulster Med J. 1984;53(2):121-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44009

Study title: Osteoid osteoma of the femoral head. Dunlap H, Martin DJ. Pediatr Radiol. 1985;15(4):262-3. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43964

Study title: Durak H, Aras T, Sungur C, Erbengi G, Bekdik CF. Tl-201 uptake in brown tumors of hyperparathyroidism. Clin Nucl Med. 1991 Dec;16(12):931-5. Durak H, Aras T, Sungur C, Erbengi G, Bekdik CF. Tl-201 uptake in brown tumors of hyperparathyroidism. Clin Nucl Med. 1991 Dec;16(12):931-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43719

Study title: Ebata K. [Diagnostic imaging of skeletal disorders, with special reference to systemic diagnosis of malignant bone tumors] Nippon Ika Daigaku Zasshi. 1982 Oct;49(5):601-8. Japanese. No abstract available. Ebata K. [Diagnostic imaging of skeletal disorders, with special reference to systemic diagnosis of malignant bone tumors] Nippon Ika Daigaku Zasshi. 1982 Oct;49(5):601-8. Japanese. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44070

Study title: Serevent VS Placebo : Paediatric asthma, exercise-induced. A multicentre, double-blind. parallel group study to assesss the efficacy of serevent 50mcg.bd vs placebo.bd (via the accuhaler) on the prevention of exercise induced asthma in children. A real-life situation. Report No. SLGB4021R

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42027

Study title: The effect of salmeterol (50mcg bd) and sustained release theophylline (uniphyllin 200mg bd) on night-time symptoms and sleep quality in children aged 5-16 years with nocturnal asthma. Report No. GRP/95/036

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Study SLPT06- SMS30014-Salmeterol Xinafoate-Serevent Rotadisks.xls

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Document reference: 42047

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42067

Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 2004; 26(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 2004; 26(8):518-522.

Active substance: TAMOXIFEN

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Document reference: 43139

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515.

Active substance: TAMOXIFEN

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Document reference: 43170

Study title: von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breats: A randomized, controlled, open phase IIb study. Journal of Clinical Oncology 2001; 19(15)3506-1515.

Active substance: TAMOXIFEN

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Document reference: 43176

Active substance: TAMOXIFEN

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Document reference: 43184

Active substance: TAMOXIFEN

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Document reference: 43194

Active substance: TAMOXIFEN

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Document reference: 43190

Active substance: TAMOXIFEN

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Document reference: 43200

Active substance: TAMOXIFEN

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Document reference: 43210

Active substance: TAMOXIFEN

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Document reference: 43216

Study title: Open-label study of the Efficacy and Safety of salmeterol 50mcg bid in Asthmatic children(4-15y)

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42038

Study title: Derman O, Kanbur NO, Tokur TE. The effect of tamoxifen on sex hormone binding globulin in adolescents with pubertal gynecomastia. Journal of Pediatric Endocrinology & Metabolism JPEM 2004;17(8):1115-1119 2004;(8):1115-1119.Derman O, Kanbur NO, Tokur TE. The effect of tamoxifen on sex hormone binding globulin in adolescents with pubertal gynecomastia. Journal of Pediatric Endocrinology & Metabolism JPEM 2004;17(8):1115-1119 2004;(8):1115-1119.

Active substance: TAMOXIFEN

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Document reference: 43091

Study title: Derman O, Oksoz KN, Kutluk T. Tamoxifen treatment for pubertal gynecomastia. International Journal of Adolescent Medicine and Health 15(4)()(pp 359-363), 2003 Date of Publication: Oct 2003 2003;(4):359-363.Derman O, Oksoz KN, Kutluk T. Tamoxifen treatment for pubertal gynecomastia. International Journal of Adolescent Medicine and Health 15(4)()(pp 359-363), 2003 Date of Publication: Oct 2003 2003;(4):359-363.

Active substance: TAMOXIFEN

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Document reference: 43099

Study title: Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study. von Minckwitz GRa, Costa SD, Raab G, Blohmer JU, Eidtmann H, Hilfrich J et al. Journal of Clinical Oncology~ 19(15):3506-3515, August 1, 2001 2001;(15):-3515, August.

Active substance: TAMOXIFEN

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Document reference: 43282

Study title: Effects of tamoxifen on lipid profile and coagulation parameters in male patients with pubertal gynecomastia. Novoa FJ, Boronat M, Carrillo A, Tapia M, Diaz CJ, Chirino R. Hormone Research 2002;57(5-6):187-91 2002;(5-6):187-191.Effects of tamoxifen on lipid profile and coagulation parameters in male patients with pubertal gynecomastia. Novoa FJ, Boronat M, Carrillo A, Tapia M, Diaz CJ, Chirino R. Hormone Research 2002;57(5-6):187-91 2002;(5-6):187-191.

Active substance: TAMOXIFEN

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Document reference: 43276

Study title: Endometrial carcinoma associated with breast carcinoma: low incidence with tamoxifen use. Cuenca RE, Giachino J, Arredondo MA, Hempling R, Edge SB. Cancer 1996; 77(10):2058-2063.Endometrial carcinoma associated with breast carcinoma: low incidence with tamoxifen use. Cuenca RE, Giachino J, Arredondo MA, Hempling R, Edge SB. Cancer 1996; 77(10):2058-2063.

Active substance: TAMOXIFEN

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Document reference: 43300

Active substance: SODIUM FLUORIDE

Study summary document link (including results):

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Document reference: 42316

Active substance: TAMOXIFEN

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Document reference: 43204

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

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 44249

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

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43397

Study title: Barai S, Bandopadhayaya GP, Malhotra A, Agarwal S, Kumar R, Dhanapathi H. Does I-131-MIBG underestimate skeletal disease burden in neuroblastoma? J Postgrad Med. 2004 Oct-Dec;50(4):257-60; discussion 260-1. Barai S, Bandopadhayaya GP, Malhotra A, Agarwal S, Kumar R, Dhanapathi H. Does I-131-MIBG underestimate skeletal disease burden in neuroblastoma? J Postgrad Med. 2004 Oct-Dec;50(4):257-60; discussion 260-1.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43392

Study title: Batte WG Jr, Yeh SD, Larson SM. Diffuse lung uptake of Tc-99m MDP associated with pneumocystis carinii pneumonia in a patient with neuroblastoma. Clin Nucl Med. 1991 May;16(5):321-4. No abstract available. Batte WG Jr, Yeh SD, Larson SM. Diffuse lung uptake of Tc-99m MDP associated with pneumocystis carinii pneumonia in a patient with neuroblastoma. Clin Nucl Med. 1991 May;16(5):321-4. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43738

Study title: Open-label study of the Efficacy and Safety of salmeterol 50mcg bid in Asthmatic children(4-15y)

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-102095-ICHE3.pdf

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Document reference: 42066

Study title: Open-label study of the Efficacy and Safety of salmeterol 50mcg bid in Asthmatic children(4-15y)

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42070

Study title: Open-label study of the Efficacy and Safety of salmeterol 50mcg bid in Asthmatic children(4-15y)

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42073

Study title: Open-label study of the Efficacy and Safety of salmeterol 50mcg bid in Asthmatic children(4-15y)

Active substance: SALMETEROL (XINAFOATE)

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Document reference: 42075

Study title: Salmeterol dry powder 50mcg bd versus usual treatment in children with moderate asthma.

Active substance: SALMETEROL (XINAFOATE)

Study summary document link (including results): Salmeterol-Xinafoate-SMS40069-ICHE3.pdf

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Document reference: 42029

Study title: American Association of Poison Control Centers. Camphor Poisoning: an evidence-based practice guideline for out-of-hospital management, Manoguerra, A.S., Clin.Toxicol. (Phila) 2006; 44 (4): 357-370

Active substance: Spike oil

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Document reference: 40219

Study title: Are one or two dangerous? Camphor exposure in toddlers, Love, JN, J.Emerg.Med. 2004; 27 (1): 49-54

Active substance: Spike oil

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Document reference: 40218

Study title: Camphor hepatotoxicity, Uc, A., South Med.J. 2000; 93 (6): 596-598

Active substance: Spike oil

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Document reference: 40226

Study title: Camphor ingestion for abortion (case report), Rabl, W., Forensic Sci Int. 1997; 89 (1-2): 137-140

Active substance: Spike oil

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Document reference: 40221

Study title: Camphor ingestion in a 10-year-old male, Ragucci, K.R., South Med.J. 2007; 100 (2): 204-207

Active substance: Spike oil

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Document reference: 40222

Study title: Camphor ingestion, Gibson, D.E., Am. J. Emerg. Med. 1989; 7 (1): 41-43

Active substance: Spike oil

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Document reference: 40216

Study title: Camphor toxicity, Emery, D.P., J.Paediatr.Child Health 1999; 35 81): 105-106

Active substance: Spike oil

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Document reference: 40214

Study title: Clinical effects and management of eucalyptus oil ingestion in infants and young children. Tibballs J, Med J Aust., 1995, 163:177-80.

Active substance: Spike oil

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Document reference: 40224

Study title: Clinical Toxicology of Commercial Products. 5th ed. Baltimore: Williams and Wilkins, 1984, p.III-85, Gosselin, R.E.

Active substance: Spike oil

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Document reference: 40217

Active substance: TAMOXIFEN

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Document reference: 43353

Study title: Sultan C. Gynecomasties pubertaires. Revue de Pediatrie 1990; 26(4):155-167.Sultan C. Gynecomasties pubertaires. Revue de Pediatrie 1990; 26(4):155-167.

Active substance: TAMOXIFEN

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Document reference: 43164

Study title: Tamoxifen as a potential treatment of glioma. (Review, 65 refs). Tolis G, Karalis K, Kyriakos GM. Current Therapy in Endocrinology & Metabolism 1994; 5:370-371Tamoxifen as a potential treatment of glioma. (Review, 65 refs). Tolis G, Karalis K, Kyriakos GM. Current Therapy in Endocrinology & Metabolism 1994; 5:370-371

Active substance: TAMOXIFEN

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Document reference: 43292

Study title: Tamoxifen treatment for pubertal gynecomastia. Derman O, Oksoz KN, Kutluk T. International Journal of Adolescent Medicine and Health 15(4)()(pp 359-363), 2003 Date of Publication: Oct 2003 2003;(4):359-363.Tamoxifen treatment for pubertal gynecomastia. Derman O, Oksoz KN, Kutluk T. International Journal of Adolescent Medicine and Health 15(4)()(pp 359-363), 2003 Date of Publication: Oct 2003 2003;(4):359-363.

Active substance: TAMOXIFEN

Study summary document link (including results):

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Document reference: 43271

Study title: Tanaka CI, Gebrim LH, De Lima GR, Simoes MD. Study of the action of tamoxifen on the mammary gland epithelium of premenopausal patients by lysosome quantification. Sao Paulo Medical Journal = Revista Paulista de Medicina 1997; 115(2):1390-1394.Tanaka CI, Gebrim LH, De Lima GR, Simoes MD. Study of the action of tamoxifen on the mammary gland epithelium of premenopausal patients by lysosome quantification. Sao Paulo Medical Journal = Revista Paulista de Medicina 1997; 115(2):1390-1394.

Active substance: TAMOXIFEN

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Document reference: 43116

Study title: "Organon Risperdal - Non interventional study 2002, age of the patients 15-92. To document efficacy and tolerance of RISPERDAL in psychotic and psychosis-associated symptoms

Active substance: RISPERIDONE

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Document reference: 35411

Study title: "Organon Risperdal -AWB 2002" /(Organon Risperdal - Non Interventional study 2002) age of the patients 15-92

Active substance: RISPERIDONE

Study summary document link (including results): AWB2002_Non-interventional_Risperidone.xls

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Document reference: 35400

Study title: Baydas B, Yavuz I, Uslu H, Dagsuyu IM, Ceylan I. Nonsurgical rapid maxillary expansion effects on craniofacial structures in young adult females. A bone scintigraphy study. Angle Orthod. 2006 Sep;76(5):759-67. Baydas B, Yavuz I, Uslu H, Dagsuyu IM, Ceylan I. Nonsurgical rapid maxillary expansion effects on craniofacial structures in young adult females. A bone scintigraphy study. Angle Orthod. 2006 Sep;76(5):759-67.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43370

Study title: Beatrous TE, Choyke PL, Frank JA. Diagnostic evaluation of cancer patients with pelvic pain: comparison of scintigraphy, CT, and MR imaging. AJR Am J Roentgenol. 1990 Jul;155(1):85-8. Beatrous TE, Choyke PL, Frank JA. Diagnostic evaluation of cancer patients with pelvic pain: comparison of scintigraphy, CT, and MR imaging. AJR Am J Roentgenol. 1990 Jul;155(1):85-8.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43761

Study title: Fig LM, Shapiro B, Shulkin BL. Uptake of Tc-99m MDP in soft tissue calcific deposits due to the tumor lysis syndrome. Clin Nucl Med. 1988 Oct;13(10):765-7. No abstract available. Fig LM, Shapiro B, Shulkin BL. Uptake of Tc-99m MDP in soft tissue calcific deposits due to the tumor lysis syndrome. Clin Nucl Med. 1988 Oct;13(10):765-7. No abstract available.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43807

Study title: Fig LM, Shulkin BL. Scintigraphic detection of sinusitis. Eur J Nucl Med. 1988;14(11):552-4. Fig LM, Shulkin BL. Scintigraphic detection of sinusitis. Eur J Nucl Med. 1988;14(11):552-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43835

Study title: Fink-Bennett DM, Shapiro EE. The Angle of Louis. A potential pitfall ("Louie's Hot Spot") in bone scan interpretation. Clin Nucl Med. 1984 Jun;9(6):352-4. Fink-Bennett DM, Shapiro EE. The Angle of Louis. A potential pitfall ("Louie's Hot Spot") in bone scan interpretation. Clin Nucl Med. 1984 Jun;9(6):352-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43996

Study title: Fischer-Brandies E, Seifert C. Bone scintigraphy: an aid in deciding on the extent of bone resection in malignant oral tumors. J Oral Maxillofac Surg. 1995 Jul;53(7):768-70. Fischer-Brandies E, Seifert C. Bone scintigraphy: an aid in deciding on the extent of bone resection in malignant oral tumors. J Oral Maxillofac Surg. 1995 Jul;53(7):768-70.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43595

Study title: Fisher MC, Gainey MA, Capitanio MA. Atypical radionuclide scan appearance in cellulitis due to group A streptococcus. Clin Nucl Med. 1988 May;13(5):359-62. Fisher MC, Gainey MA, Capitanio MA. Atypical radionuclide scan appearance in cellulitis due to group A streptococcus. Clin Nucl Med. 1988 May;13(5):359-62.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43817

Active substance: Spike oil

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Document reference: 40225

Study title: National Poisons Information Service Center, United Kingdom. Poison Information Monograph: Camphor, 1996

Active substance: Spike oil

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Document reference: 40220

Study title: Plant-induced seizures: reappearance of an old problem, Burkhard, P.R., J.Neurol. 199; 246 (8): 667-670

Active substance: Spike oil

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Document reference: 40213

Study title: Adverse effects of herbal drugs in dermatology, Ernst, E., Br.J.Dermatol. 2000; 143 (5): 923-929

Active substance: Spike oil

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Document reference: 40215

Study title: Reports of Postmarketing experience, Post Authorisation safety study. Panosch B, Montavit, 2007-05-23.

Active substance: Spike oil

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Document reference: 40223

Study title: Adverse effects of herbal drugs in dermatology, Ernst, E., Br.J.Dermatol. 2000; 143 (5): 923-929 Camphor ingestion, Gibson, D.E., Am. J. Emerg. Med. 1989; 7 (1): 41-43

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40239

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40229

Study title: Antiobstruktive Wirksamkeit von Cineol bei Atemwegserkrankungen, Grimm, H., Therapiewoche 1987; 37: 4306-4311

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40241

Study title: Are one or two dangerous? Camphor exposure in toddlers, Love, JN, J.Emerg.Med. 2004; 27 (1): 49-54

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40237

Study title: Camphor hepatotoxicity, Uc, A., South Med.J. 2000; 93 (6): 596-598

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40233

Study title: Camphor ingestion for abortion (case report), Rabl, W., Forensic Sci Int. 1997; 89 (1-2): 137-140

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40236

Study title: Camphor ingestion in a 10-year-old male, Ragucci, K.R., South Med.J. 2007; 100 (2): 204-207

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40235

Study title: Camphor toxicity, Emery, D.P., J.Paediatr.Child Health 1999; 35 81): 105-106

Active substance: Spike oil, Eucalyptus oil, Turpentine oil, Camphor

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Document reference: 40240

Study title: Devaux j, Bernard JL, Mouly-Bandini a, Raybaud CI. Use of a peptisant gel in a pediatric ward. Méditerranée Médicale 1975:3:65-68 No.67 (English translation), Nolan T, Debelle G, Oberklaid F, Coffey C. Devaux j, Bernard JL, Mouly-Bandini a, Raybaud CI. Use of a peptisant gel in a pediatric ward. Méditerranée Médicale 1975:3:65-68 No.67 (English translation), Nolan T, Debelle G, Oberklaid F, Coffey C.

Active substance: SODIUM CITRATE SODIUM LAURYL SULFOACETATE

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Document reference: 42237

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

Active substance: SODIUM CITRATE SODIUM LAURYL SULFOACETATE

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Document reference: 42239

Study title: Randomised trial of laxatives in treatment of childhood encopresis. Lancet 1991:338:523-527, Grosse K-P, Keller KM, Behrens R, Becker M. Chronische Obstipation im Kindesalter. Monatsschr Kinderheilk 1990:138:231-233 Randomised trial of laxatives in treatment of childhood encopresis. Lancet 1991:338:523-527, Grosse K-P, Keller KM, Behrens R, Becker M. Chronische Obstipation im Kindesalter. Monatsschr Kinderheilk 1990:138:231-233

Active substance: SODIUM CITRATE SODIUM LAURYL SULFOACETATE

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Document reference: 42238

Study title: Abe K, Sasaki M, Kuwabara Y, Koga H, Baba S, Kaneko K, Hayashi K, Shioyama Y, Tajiri T, Suita S, Honda H. Extraosseous accumulation of (99m)Tc-HMDP to radiation nephropathy, mimicking recurrent neuroblastoma. Ann Nucl Med. 2005 Feb;19(1):35-40. Abe K, Sasaki M, Kuwabara Y, Koga H, Baba S, Kaneko K, Hayashi K, Shioyama Y, Tajiri T, Suita S, Honda H. Extraosseous accumulation of (99m)Tc-HMDP to radiation nephropathy, mimicking recurrent neuroblastoma. Ann Nucl Med. 2005 Feb;19(1):35-40.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43389

Study title: Adams BK. Scintigraphy in benign bone tumours. A report of 4 cases. S Afr Med J. 1989 Aug 5;76(3):112-4. Adams BK. Scintigraphy in benign bone tumours. A report of 4 cases. S Afr Med J. 1989 Aug 5;76(3):112-4.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43781

Study title: Adatepe MH, Powell OM, Isaacs GH, Nichols K, Cefola R. Hematogenous pyogenic vertebral osteomyelitis: diagnostic value of radionuclide bone imaging. J Nucl Med. 1986 Nov;27(11):1680-5. Adatepe MH, Powell OM, Isaacs GH, Nichols K, Cefola R. Hematogenous pyogenic vertebral osteomyelitis: diagnostic value of radionuclide bone imaging. J Nucl Med. 1986 Nov;27(11):1680-5.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43890

Study title: Aglietti P, Zaccherotti G, De Biase P, Taddei I. A comparison between medial meniscus repair, partial meniscectomy, and normal meniscus in anterior cruciate ligament reconstructed knees. Clin Orthop Relat Res. 1994 Oct;(307):165-73. Aglietti P, Zaccherotti G, De Biase P, Taddei I. A comparison between medial meniscus repair, partial meniscectomy, and normal meniscus in anterior cruciate ligament reconstructed knees. Clin Orthop Relat Res. 1994 Oct;(307):165-73.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43613

Study title: al Hindawi AY, Qutaishat SA. Survey of 1725 bone scans in patients with malignant disease with particular emphasis on carcinoma of the breast. Nuklearmedizin. 1992 Dec;31(6):239-41. al Hindawi AY, Qutaishat SA. Survey of 1725 bone scans in patients with malignant disease with particular emphasis on carcinoma of the breast. Nuklearmedizin. 1992 Dec;31(6):239-41.

Active substance: TECHNETIUM (99mTc) MEDRONIC ACID

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Document reference: 43680

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