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Pharmaceuticals - Community Register
List of nationally authorised medicinal products for human use
|Indication:||Levetiracetam is a pyrrolidone derivative that is chemically unrelated to other existing antiepileptic drugs (AEDs). The International Birth Date (IBD) is 30 Nov 1999 (29 Sep 2000 in the EU).|
Authorised indications of levetiracetam are the following:
- monotherapy in the treatment of partial onset seizures (POS) with or without secondary
generalisation in patients from 16 years who are newly diagnosed with epilepsy.
- adjunctive therapy in the treatment of:
• Partial onset seizures (POS) in adults, children and infants from 1 month of age with epilepsy (from 4 years of aged for parenteral formulations).
• Myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (JME)
• Primary generalised tonic-clonic seizures (PGTCS) in adults and children from 12 years of age with idiopathic generalised epilepsy (IGE).
|Marketing Authorisation Holder:||Not applicable|
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|15/11/2016||PSUSA - Modification||EMEA/H/C/PSUSA/1846/201511||(2016)7456 of 14/11/2016|