The marketing authorisation for for Exalief has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.
Exalief : EPAR - Summary for the public (PDF/233.46 KB)
First published: 19/05/2009
Last updated: 16/08/2012
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
BIAL - Portela Ca, S.A.
|Date of issue of marketing authorisation valid throughout the European Union||
21/04/2012 Exalief - EMEA/H/C/000987 - IB/0025
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Exalief is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.