- Trials with a EudraCT protocol (12)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (15)

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: Fábián K, Velkey L, Fodor E. [Preventive value of vitamin D in various doses based on a prospective study of healthy infants. [Article in Hungarian] Orv Hetil. 1990 Mar 4;131(9):447-50. |
Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
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Document reference: 24635 |
Study title: AN 07994334 Medline 20070101. TI (Acute urine retention: a rare mode of revelation of cervico-dorsal syringomyelia caused by cyproheptadine). TT Retention aigue d'urines: un mode de revelation rare d'une syringomyelie cervicodorsale a l'occasion de la prise de cyproheptadine. SO Archives de pediatrie : organe officiel de la Societe francaise de pediatrie, {Arch-Pediatr}, Mar 1994, vol. 1, no. 3, p. 260-3, ISSN: 0929-693X. AU Houang-M, Leroy-B, Forin-V, Sinnassamy-P, Bensman-A. IN Service de nephrologie pediatrique, hopital Trousseau, Paris, France. YR 1994.AN 07994334 Medline 20070101. TI (Acute urine retention: a rare mode of revelation of cervico-dorsal syringomyelia caused by cyproheptadine). TT Retention aigue d'urines: un mode de r... |
Active substance: CYPROHEPTADINE |
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Document reference: 25227 |
Study title: Comparison of dextranomer and streptokinase-streptodornase in the treatment of venous leg ulcers and other infected wounds.Hulkko A, Holopainen YV, Orava S, Kangas J, Kuusisto P, Hyvärinen E, Ervasti E, Silvennoinen E. Ann Chir Gynaecol. 1981;70(2):65-70. |
Active substance: streptokinase and streptodornase |
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Document reference: 48946 |
Study title: [Conservative treatment of anal cryptitis and fissure as well as anal thrombosis with a streptokinase-streptodornase gel]. [Article in German] Frank W, Wilhelm E, Bouillon M. ZFA (Stuttgart). 1982 Apr 30;58(12):713-6. |
Active substance: streptokinase and streptodornase |
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Document reference: 48945 |
Study title: [Postoperative care with varidase following phimosis surgery. A comparative study of various application forms]. [Article in German] Tuchen W, Inglis R. ZFA (Stuttgart). 1980 Dec 10;56(34):2419-22. |
Active substance: streptokinase and streptodornase |
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Document reference: 48950 |
Study title: The effectiveness of Varidase was evaluated in the local treatment of skin lesions, particularly wounds with fibrinous or necrotic crusts.Luger et al. 1981 |
Active substance: streptokinase and streptodornase |
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Document reference: 48949 |
Study title: Varidase topical (Streptokinase-Streptodornase) has been clinically evaluated in patients for its efficacy, tolerance, and side effects.Chang et al. 1980 |
Active substance: streptokinase and streptodornase |
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Document reference: 48948 |
Study title: Buccally administered streptokinase: a double blind study.Macalister AD. Aust Dent J. 1966 Jun;11(3):165-7. |
Active substance: streptokinase and streptodornase |
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Document reference: 48957 |
Study title: An open study to evaluate the efficacy, safety and tolerance of the topical application of Varidase to treat patients with various kinds of open wounds with problems of inflammation, excessive accumulation of clotted blood or exudates, and tissue with necrosis.Wang et al. |
Active substance: streptokinase and streptodornase |
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Document reference: 48947 |
Study title: Ink J. Buenos Aires, Argentina: Teodoro Alvarez Hospital and Del Carmen Hospital. 1972. (Summary expert clinical report to Newport Pharmaceuticals International, Inc.) Isoprinosine® syrup against different acute viral diseasesInk J. Buenos Aires, Argentina: Teodoro Alvarez Hospital and Del Carmen Hospital. 1972. (Summary expert clinical report to Newport Pharmaceuticals International, Inc.) Isoprinosine® syrup against different acute viral diseases |
Active substance: INOSINE |
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Document reference: 30127 |
Study title: Gaillard WD, Bhatia S, Bookheimer SY, Fazilat S, Sato S, Theodore WH.. FDG-PET and volumetric MRI in the evaluation of patients with partial epilepsy. [gaillard-1995]Neurology. 1995 Jan;45(1):123-6. Gaillard WD 1995 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48653 |
Study title: 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: Schwabe-D, Gussetis-E, Jacobi-G, Gerein-V, Kornhuber-B. Klinik. J.W. Goethe Univ., Zentrum der Kinderheilkunde, Theodor- Stern-Kai 7,6000 Frankfurt 70, Germany. High-dose methotrexate combined with '8 in 1' in the treatment of class III/IV brain tumors in children. Klinische Padiatrie {KLIN-PADIATR}, 1992, Vol/Iss/Pg. 204/2 (72-77), ISSN: 0300-8630.Schwabe-D, Gussetis-E, Jacobi-G, Gerein-V, Kornhuber-B. Klinik. J.W. Goethe Univ., Zentrum der Kinderheilkunde, Theodor- Stern-Kai 7,6000 Frankfurt 70, Germany. High-dose methotrexate combined with '8 in 1' in the treatment of class III/IV brain tumors in children. Klinische Padiatrie {KLIN-PADIATR}, 1992, Vol/Iss/Pg. 204/2 (72-77), ISSN: 0300-8630. |
Active substance: PROCARBAZINE |
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Document reference: 34839 |
Study title: Schallen E, De Odorico I, Shapiro B. Scintigraphy of proximal femoral focal deficiency. Clin Nucl Med. 1997 Oct;22(10):730-2. No abstract available. Schallen E, De Odorico I, Shapiro B. Scintigraphy of proximal femoral focal deficiency. Clin Nucl Med. 1997 Oct;22(10):730-2. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43542 |
Study title: 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 |