Exalief

Lapsed

This medicine's authorisation has lapsed

eslicarbazepine acetate

Overview

On 21 April 2009, the European Commission issued a marketing authorisation valid throughout the European Union (EU) for the medicinal product Exalief (eslicarbazepine acetate), indicated for adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation. The Marketing Authorisation Holder (MAH) responsible for Exalief was BIAL - Portela & Ca, S.A.. 

Exalief has not been marketed anywhere in the EU for three consecutive years from the granting of the marketing authorisation. The Agency notified by letter dated 24 July 2012 the European Commission that in accordance with Article 14(4) of Regulation (EC) N° 726/2004 (“Sunset Clause”), the marketing authorisation of Exalief has ceased to be valid. 

Exalief was a duplicate application to Zebinix, which is marketed in several EU countries. The MAH will maintain the Marketing Authorisations for Zebinix. 

The European Public Assessment Report for Exalief is updated to reflect that the marketing authorisation is no longer valid.

Exalief : EPAR - Summary for the public

Product information

Exalief : EPAR - Product Information

Exalief : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Exalief
• Active substance:
  eslicarbazepine acetate
• International non-proprietary name (INN) or common name:
  eslicarbazepine acetate
• Therapeutic area (MeSH):
  Epilepsy
• Anatomical therapeutic chemical (ATC) code:
  N03AF04

Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

Exalief is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.

Authorisation details

• EMA product number:
  EMEA/H/C/000987
• Marketing authorisation holder:
  BIAL - Portela Ca, S.A.

  A Avenida da Siderurgia Nacional; PT-4745-457 S. Mamede do Coronado; Portugal

• Marketing authorisation issued:
  21/04/2009
• Lapse of marketing authorisation:
  24/07/2012
• Revision:
  5

Assessment history

Changes since initial authorisation of medicine

Exalief : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Exalief : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Exalief

Reference Number: EMEA/CHMP/98344/2009