Zebinix (eslicarbazepine acetate)
- Region
- 🇪🇺 EU
- Active substance
- eslicarbazepine acetate
- Company
- BIAL - Portela & Ca, S.A.
- Status
- Authorised
- Therapeutic area
- Epilepsy
- CHMP opinion
- Thu 19 Feb 2009
- EU approval
- Tue 21 Apr 2009
- Application
- EMEA/H/C/000988
- ATC
- N03AF04
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Exalief Lapsed · BIAL - Portela Ca, S.A.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.