Zebinix

RSS

eslicarbazepine acetate

Authorised
This medicine is authorised for use in the European Union.

Overview

Zebinix is an epilepsy medicine used to treat adults with partial-onset seizures (epileptic fits) with or without secondary generalisation. This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness or a sudden sense of fear. Secondary generalisation occurs when the overactivity later reaches the whole brain. Zebinix can be taken on its own, in newly diagnosed epilepsy, or can be added to existing antiepileptic medicines.

Zebinix can also be used in adolescents and children above 6 years of age, in combination with existing therapies, to treat partial-onset seizures with or without secondary generalisation.

Zebinix contains the active substance eslicarbazepine acetate.

This EPAR was last updated on 08/11/2018

Authorisation details

Product details
Name
Zebinix
Agency product number
EMEA/H/C/000988
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
24
Date of issue of marketing authorisation valid throughout the European Union
21/04/2009
Contact address
BIAL - Portela & Ca, S.A.
A Avenida da Siderurgia Nacional
PT-4745-457 S. Mamede do Coronado
Portugal

Product information

28/06/2018 Zebinix - EMEA/H/C/000988 - P46/025

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.

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Pharmacotherapeutic group

Anti epileptics

Therapeutic indication

Zebinix is indicated as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.

Assessment history

Changes since initial authorisation of medicine

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