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

Sabril 500mg Film Coated Tablets

500 milligram(s) Film-coated tablet

PCO Manufacturing Ltd.PPA0465/203/001

Main Information

Trade NameSabril 500mg Film Coated Tablets
Active SubstancesVigabatrin
Strength500 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderPCO Manufacturing Ltd.
Licence NumberPPA0465/203/001

Group Information

ATC CodeN03AG Fatty acid derivatives
N03AG04 vigabatrin


Licence Issued01/02/2008
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceThis authorisation permits the holder to parallel-disbribute only the product marketed in Ireland under the product authorisation PA0540/023/001.
Marketing StatusUnknown


Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
« Back