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 info@hpra.ie


Ontilyv



BIAL-Portela & Ca, S.A.EU/1/21/1578/005-010

Main Information

Trade NameOntilyv
Active SubstancesOpicapone
Dosage FormCapsule, hard
Licence HolderBIAL-Portela & Ca, S.A.
Licence NumberEU/1/21/1578/005-010

Group Information

ATC CodeN04BX04 opicapone

Status

License statusAuthorised
Licence Issued21/02/2022
Legal status*** AWAITING VALUE ***
Supply Status
Advertising Status*** AWAITING VALUE ***
Conditions of Licence
Marketing StatusUnknown

Documents

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