- Trials with a EudraCT protocol (78)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (35)

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: Samoilenko I.G.,Yulish E.I., Gadetskaya S.G., Buchtiarov E.V.: New approach to treat pediatric patients suffering from bronchial asthma associated with intracellular infection. Biological Therapy (Ukraine), 2006, 4: 10-13 [IIT-publication] |
Active substance: Echinacea compositum-Heel - Ampullen |
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Document reference: 39861 |
Study title: Comparison of emedastine 0.05% or nedocromil sodium 2% eye drops and placebo in controlling local reactions in subjects with allergic conjunctivitis. Orfeo V, Vardaro A, Lena P, Mensitieri I, Tracey M, De Marco R Eur J Ophthalmol. 2002 Jul-Aug;12(4):262-6. Comparison of emedastine 0.05% or nedocromil sodium 2% eye drops and placebo in controlling local reactions in subjects with allergic conjunctivitis. Orfeo V, Vardaro A, Lena P, Mensitieri I, Tracey M, De Marco R Eur J Ophthalmol. 2002 Jul-Aug;12(4):262-6. |
Active substance: emedastine |
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Document reference: 41505 |
Study title: Eur J Contracep Repro Health Care 2007;12(3):240-7 |
Active substance: ETHINYLESTRADIOL_AND_ETONOGESTREL |
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Document reference: 26637 |
Study title: Observational trial regarding contraceptive efficacy, cycle control and tolerance of Miranova® (levonorgestrel 100 µg + ethinyl estradiol 20 µg) in 13,085 women over 6 treatment cycles |
Active substance: ETHINYLESTRADIOL_AND_LEVONORGESTREL |
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Document reference: 26640 |
Study title: Arribas Mir L. et al. Indicación de un método anticonceptivo a una adolescente: implante subcutáneo de gestágeno. (Indication of a contraceptive method to a teenager: subcutaneous implant of gestagen). Atención Primaria 2004;34:499-503 |
Active substance: ETONOGESTREL |
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Document reference: 26667 |
Study title: Arzneimittelkommission der deutchen Ärzteschaft. Aus der UAW-Datenbank: Misslungene Explantation des implantierbaren Kontrazeptivums Implanon® (From the AE database: Failed removals of the implantable contraceptive Implanon®). Deutsches Ärzteblatt 2006;25:A1771 |
Active substance: ETONOGESTREL |
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Document reference: 26669 |
Study title: Ahrendt HJ, Karck U, Pichl T, Mueller T, Ernst, U. The effects of an oestrogen-free, desogestrel-containing oral contraceptive in women with cyclical symptoms: Results from two studies on oestrogen-related symptoms and dysmenorrhoea. Eu J Contraception R |
Active substance: DESOGESTREL AND ETHINYLESTRADIOL |
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Document reference: 25674 |
Study title: Arul GS, Dolan G, Rance CH, Singh SJ, Sommers J. Coeliac axis thrombosis associated with the combined oral contraceptive pill: a rare cause of an acute abdominal . Pediatr. Surg. Int. 1998;13/4:285-7.Arul GS, Dolan G, Rance CH, Singh SJ, Sommers J. Coeliac axis thrombosis associated with the combined oral contraceptive pill: a rare cause of an acute abdominal . Pediatr. Surg. Int. 1998;13/4:285-7. |
Active substance: DESOGESTREL AND ETHINYLESTRADIOL |
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Document reference: 25671 |
Study title: Pelletier J, Cabanot C, Levrier O, Thuillier JN, Cherif AA. Angiodysplasia of Moya-Moya type disclosed by choreic unvoluntary abnormal movements during oral contraception. Rev Neurol (Paris) 1997;153:393-7.Pelletier J, Cabanot C, Levrier O, Thuillier JN, Cherif AA. Angiodysplasia of Moya-Moya type disclosed by choreic unvoluntary abnormal movements during oral contraception. Rev Neurol (Paris) 1997;153:393-7. |
Active substance: DESOGESTREL AND ETHINYLESTRADIOL |
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Document reference: 25675 |
Study title: Ahrendt HJ, Karck U, Pichl T, Mueller T, Ernst, U. The effects of an oestrogen-free, desogestrel-containing oral contraceptive in women with cyclical symptoms: Results from two studies on oestrogen-related symptoms and dysmenorrhoea. Eu J Contraception R |
Active substance: DESOGESTREL |
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Document reference: 25669 |
Study title: Samoilenko I.G.,Yulish E.I., Gadetskaya S.G., Buchtiarov E.V.: New approach to treat pediatric patients suffering from bronchial asthma associated with intracellular infection. Biological Therapy (Ukraine), 2006, 4: 10-13 [IIT-publication] |
Active substance: Mucosa compositum |
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Document reference: 40075 |
Study title: Eur J Nucl Med Mol Imaging. 2004 Aug;31(8):1105-13. Epub 2004 Mar 9. Non-malignant FDG uptake in infradiaphragmatic adipose tissue: a new site of physiological tracer biodistribution characterised by PET/CT. Bar-Shalom R, Gaitini D, Keidar Z, Israel O. |
Active substance: FLUDEOXYGLUCOSE |
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Document reference: 28132 |
Study title: Oral contraceptive use and focal nodular hyperplasia of the liver;Mathieu D; Gastroenterology; 2000 vol.118 p.560-564Oral contraceptive use and focal nodular hyperplasia of the liver;Mathieu D; Gastroenterology; 2000 vol.118 p.560-564 |
Active substance: GADOTERIC ACID |
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Document reference: 28855 |
Study title: Therapeutic interventions to prevent intracerebral hemorrhage in preterm infants. |
Active substance: INDOMETHACIN |
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Document reference: 30043 |
Study title: Bar-Shalom R, Gaitini D, Keidar Z, Israel O.. Non-malignant FDG uptake in infradiaphragmatic adipose tissue: a new site of physiological tracer biodistribution characterised by PET/CT. [bar-shalam-2004Eur J Nucl Med Mol Imaging. 2004 Aug;31(8):1105-13. Epub 2004 Mar 9. Bar-Shalom R 2004 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48628 |
Study title: Clin Nucl Med. 1999 Jun;24(6):435-9. Tc-99m DTPA used as reference imaging to evaluate the distribution of other tumor-seeking tracers in tumors associated with neurofibromatosis. Suga K, Hirabayashi A, Kishimoto K, Kume N, Matsumoto T, Matsunaga N. Clin Nucl Med. 1999 Jun;24(6):435-9. Tc-99m DTPA used as reference imaging to evaluate the distribution of other tumor-seeking tracers in tumors associated with neurofibromatosis. Suga K, Hirabayashi A, Kishimoto K, Kume N, Matsumoto T, Matsunaga N. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44556 |
Study title: Iodine supplementation: A comparison of oral and intramuscular methods in the improvement of thyroid function and prophylaxis of goitre. ; Malone-F-J. Trace Elements and Electrocytes, 1996, Vol /Iss/Pg. 13/3 (133-135)Iodine supplementation: A comparison of oral and intramuscular methods in the improvement of thyroid function and prophylaxis of goitre. ; Malone-F-J. Trace Elements and Electrocytes, 1996, Vol /Iss/Pg. 13/3 (133-135) |
Active substance: IODINE |
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Document reference: 30271 |
Study title: Jacobs F, Thierens H, Piepsz A, Bacher K, van de Wiele C, Ham H et al. Optimised tracer-dependent dosage cards to obtain weight-independent effective doses. [jacobs 2005Eur J Nucl Med Mol Imaging 2005; 32 : 581 - 588. Jacobs F 2005 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48662 |
Study title: DECREASED TRACER UPTAKE IN BONE TISSUE IN PAEDIATRIC REFLEX SYMPATHETIC DYSTROPHYX. Le Loet, J. Lefort, A. Daragon, B. Derumeaux, P. Deshayes Rheumatology Department, La Prévotière, Hôpital de Bois Guillaume, BP 100, F 76230 Bois Guillaume |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48845 |
Study title: Pickuth D, McCready VR. Focal areas of increased renal tracer uptake on bone scans can mimic metastases in the lower ribs. Br J Radiol. 1996 May;69(821):407-9. Pickuth D, McCready VR. Focal areas of increased renal tracer uptake on bone scans can mimic metastases in the lower ribs. Br J Radiol. 1996 May;69(821):407-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43568 |