The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail


BIAL-Portela & Ca, S.A.EU/1/09/514/024

Main Information

Trade NameZebinix
Active SubstancesEslicarbazepine acetate
Dosage FormOral suspension
Licence HolderBIAL-Portela & Ca, S.A.
Licence NumberEU/1/09/514/024

Group Information

ATC CodeN03AF Carboxamide derivatives
N03AF04 eslicarbazepine


License statusAuthorised
Licence Issued08/12/2016
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back