Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use


Product name: levetiracetam
Active substance: Levetiracetam
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

European Commission proceduresGoto top of the page

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