- Trials with a EudraCT protocol (412)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (38)

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: Amantadine in Pediatric Patients with Traumatic Brain Injury: A Retrospective, Case-Controlled StudyAmantadine in Pediatric Patients with Traumatic Brain Injury: A Retrospective, Case-Controlled Study |
Active substance: AMANTADINE |
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Document reference: 46491 |
Study title: Amantadine treatment following traumatic brain injury in childrenAmantadine treatment following traumatic brain injury in children |
Active substance: AMANTADINE |
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Document reference: 46493 |
Study title: Dopamine agonist therapy in low-response children following traumatic brain injury.Dopamine agonist therapy in low-response children following traumatic brain injury. |
Active substance: AMANTADINE |
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Document reference: 46501 |
Study title: Neurobehavioral effects of amantadine after pediatrics traumatic brain injury Neurobehavioral effects of amantadine after pediatrics traumatic brain injury |
Active substance: AMANTADINE |
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Document reference: 46510 |
Study title: 3.) Oral Enzyme Therapy in the Treat- ment and Prophy- laxis of Posttraumatic and Postperative Swelling |
Active substance: Bromelain (HERB) Trypsin Rutosid • 3 H2O |
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Document reference: 39810 |
Study title: Enzyme Therapy as Antidematous and anti-inflammatory Therapy of traumatic Injuries in children |
Active substance: Bromelain (HERB) Trypsin Rutosid • 3 H2O |
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Document reference: 39809 |
Study title: Percutaneous puncture and pre-operative cyanoacrylate obliteration of a traumatic false aneurysm of an angular artery branch. |
Active substance: Ethyl esters of iodized fatty acids of poppy seed oil |
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Document reference: 39913 |
Study title: Emergency endovascular embolization of traumatic intrarenal arterial pseudoaneurysms with N-Butyl cyanoacrylate. |
Active substance: Ethyl esters of iodized fatty acids of poppy seed oil |
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Document reference: 39914 |
Study title: Controlled study of Voltaren Emulgel 1% in post traumatic conditions of the locomotive apparatusControlled study of Voltaren Emulgel 1% in post traumatic conditions of the locomotive apparatus |
Active substance: DICLOFENAC |
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Document reference: 26016 |
Study title: Van Husen H. Effect of DR 1200/1 in “posttraumatic” disease. February 12, 1985. (2 paediatric patients, both age 13 years) Van Husen H. Effect of DR 1200/1 in “posttraumatic” disease. February 12, 1985. (2 paediatric patients, both age 13 years) |
Active substance: DICLOFENAC |
Study summary document link (including results): Voltaren Ophtha Paediatric Studies_Van Husen 12-Feb-1985_EMA spreadsheet.xls |
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Document reference: 26053 |
Study title: Cander B, et all.The effectiveness of analgesics in traumatic injuries of the extremities. Adv Ther. 2005 Sep-Oct;22(5):462-6.Cander B, et all.The effectiveness of analgesics in traumatic injuries of the extremities. Adv Ther. 2005 Sep-Oct;22(5):462-6. |
Active substance: DICLOFENAC |
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Document reference: 25979 |
Study title: Cander B, et all.The effectiveness of analgesics in traumatic injuries of the extremities. Adv Ther. 2005 Sep-Oct;22(5):462-6.Cander B, et all.The effectiveness of analgesics in traumatic injuries of the extremities. Adv Ther. 2005 Sep-Oct;22(5):462-6. |
Active substance: DICLOFENAC |
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Document reference: 25990 |
Study title: Tolerability of nimesulide and ketoprofen in paediatric patients with traumatic or surgical fracture - Facchini R., Selva G., Peretti G. - 1993 ( Drugs 1993, 46, Suppl. 1, p. 238) |
Active substance: KETOPROFEN |
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Document reference: 30874 |
Study title: Bylander B, Hansson LI, Kärrholm J, Naversten Y. Scintimetric evaluation of posttraumatic and postoperative growth disturbance using 99Tcm MDP. Acta Radiol Diagn (Stockh). 1983;24(1):85-96. Bylander B, Hansson LI, Kärrholm J, Naversten Y. Scintimetric evaluation of posttraumatic and postoperative growth disturbance using 99Tcm MDP. Acta Radiol Diagn (Stockh). 1983;24(1):85-96. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44058 |
Study title: Acta Neurochir Suppl. 2005;95:165-8. Glucose metabolism in traumatic brain injury: a combined microdialysis and [18F]-2-fluoro-2-deoxy-D-glucose-positron emission tomography (FDG-PET) study. O'Connell MT, Seal A, Nortje J, Al-Rawi PG, Coles JP, Fryer TD, Menon DK, Pickard JD, Hutchinson PJ. |
Active substance: FLUDEOXYGLUCOSE |
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Document reference: 28090 |
Study title: Emergency endovascular embolization of traumatic intrarenal arterial pseudoaneurysms with N-Butyl cyanoacrylate. 02/12/2010Emergency endovascular embolization of traumatic intrarenal arterial pseudoaneurysms with N-Butyl cyanoacrylate. 02/12/2010 |
Active substance: IODINE |
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Document reference: 30243 |
Study title: Percutaneous puncture and pre-operative cyanoacrylate obliteration of a traumatic false aneurysm of an angular artery branch. ;Huang-F. British Journal of Radiology, 2003, Vol/Iss/Pg. 76/910 (746-749)Percutaneous puncture and pre-operative cyanoacrylate obliteration of a traumatic false aneurysm of an angular artery branch. ;Huang-F. British Journal of Radiology, 2003, Vol/Iss/Pg. 76/910 (746-749) |
Active substance: IODINE |
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Document reference: 30300 |
Study title: Scintimetric evaluation of posttraumatic and postoperative growth disturbance using 99Tcm MDP.Bylander B, Hansson LI, Kärrholm J, Naversten Y. Acta Radiol Diagn 1983;24(1):85-96. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48587 |
Study title: O'Connell MT, Seal A, Nortje J, Al-Rawi PG, Coles JP, Fryer TD, et al.. Glucose metabolism in traumatic brain injury: a combined microdialysis and [18F]-2-fluoro-2-deoxy-D-glucose-positron emission tomography (FDG-PET) study. [oconnell-2005]Acta Neurochir Suppl. 2005;95:165-8. O'Connell MT 2005 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48686 |
Study title: [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 |