Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: BIAL-Portela & Ca SA, À Av. da Siderurgia Nacional, 4745-457, S. Mamede do Coronado, Portugal, tel: +351 22 986 61 00, fax: +351 22 986 61 99, e-mail: info@bial.com
Zebinix 200 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. White oblong tablets, engraved ‘ESL 200’ on one side and scored on the other side, with a length of 11 mm. The tablet can be divided into equal doses. |
Each tablet contains 200 mg of eslicarbazepine acetate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Eslicarbazepine |
Eslicarbazepine and its metabolites stabilise the inactivated state of voltage-gated sodium channels, precluding their return to the activated state and thereby preventing repetitive neuronal firing. Therefore eslicarbazepine is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation. |
| List of Excipients |
|---|
|
Povidone K29/32 |
PVC/Aluminium blisters placed into cardboard boxes containing 20 or 60 tablets.
HDPE bottles with polypropylene child resistant closure, inside a cardboard box, containing 60 tablets.
Not all pack sizes may be marketed.
BIAL-Portela & Ca SA, À Av. da Siderurgia Nacional, 4745-457, S. Mamede do Coronado, Portugal, tel: +351 22 986 61 00, fax: +351 22 986 61 99, e-mail: info@bial.com
EU/1/09/514/021-023
Date of first authorisation: 21.04.2009
Date of latest renewal: 22.01.2014
| Drug | Countries | |
|---|---|---|
| ZEBINIX | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, Turkey, United Kingdom |
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