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


Aripiprazole Zentiva



Zentiva k.s.EU/1/15/1009/001-005

Main Information

Trade NameAripiprazole Zentiva
Active SubstancesAripiprazole
Dosage FormTablet
Licence HolderZentiva k.s.
Licence NumberEU/1/15/1009/001-005

Group Information

ATC CodeN05AX Other antipsychotics
N05AX12 aripiprazole

Status

License statusAuthorised
Licence Issued25/06/2015
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown

Documents

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

Generics Information

Interchangeable ListAripiprazole 5mg Tablets
Interchangeable List CodeIC0092-001-002
Interchangeable List DocumentPDF of Interchangeable List
« Back