Exalief

RSS

eslicarbazepine acetate

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

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.

This EPAR was last updated on 16/08/2012

Authorisation details

Product details
Name
Exalief
Agency product number
EMEA/H/C/000987
Active substance
eslicarbazepine acetate
International non-proprietary name (INN) or common name
eslicarbazepine acetate
Therapeutic area (MeSH)
Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AF04
Publication details
Marketing-authorisation holder
BIAL - Portela Ca, S.A.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
21/04/2009
Contact address
A Avenida da Siderurgia Nacional
PT-4745-457 S. Mamede do Coronado
Portugal

Product information

21/04/2012 Exalief - EMEA/H/C/000987 - IB/0025

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

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

Assessment history

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