Zebinix
eslicarbazepine acetate
Table of contents
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.
Authorisation details
Product details | |
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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 | |
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Marketing-authorisation holder |
BIAL - Portela & Ca, S.A.
|
Revision |
31
|
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
04/03/2022 Zebinix - EMEA/H/C/000988 - PSUSA/00001267/202104
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Pharmacotherapeutic group
Antiepileptics
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.