| Document Date: 2010-10-27 13:07:27
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Company AEs / Aventis / Micropakine LP / NO3AG01 Pharmaceutical / ITT / CBC / Sanofi / Sanofi-Aventis / / Continent Europe / / Country France / United States / United Kingdom / / Event Product Recall / FDA Phase / Product Issues / Natural Disaster / / Facility Epillim Chronosphere MR INN / / IndustryTerm pharmaceutical formulation / acute otitis media / valproate containing products / medicinal products / treatment of bipolar disease / treatment of manic episode in bipolar disorder / acid/valproate containing medicinal products / pharmaceutical forms / medicinal product / / MedicalCondition unstable seizure / severe prolonged epileptic seizure / absence seizures / severe myoclonic epilepsy / Seizures / infections disorders / acute otitis media / bipolar disease / nausea / psychiatric disorders SOC / CMD / tremor / partial epilepsy / acute Rhinitis Viral rhinitis N / concomitant diseases / renal dysfunction / infections / mild lymphocytosis / Disease / behavioural disorders / neurological disease / Febrile infection Viral infection Otitis media / seizure / Constipation Gastroenteritis Gastroenteritis / epilepsy / cough / varicella / bipolar disorder / / Organization European Committee for Medicinal Products for Human Use / European Union / / Person Valproic Acid / / Position investigator / physician / EXECUTIVE / Vp/F / / Product topiramate / carbamazepine / Valproate sodium / patients Selected N=81 Included N=81 Study / Consent / clonazepam / ethosuximide / diazepam / phenytoin / lamotrigine / gabapentin / Valproic Acid / SR / Valproic / MAH / valproate / / ProgrammingLanguage EC / / Technology pharmacokinetics / 1 Protocol / /
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Public Assessment Report for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No1901/2006, as amended Depakine Chronosphere, Depakine Chrono microgranules, Depakine