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


Zytiga



Janssen-Cilag International NVEU/1/11/714/001

Main Information

Trade NameZytiga
Active SubstancesAbiraterone acetate
Dosage FormTablet
Licence HolderJanssen-Cilag International NV
Licence NumberEU/1/11/714/001

Group Information

ATC CodeL02BX Other hormone antagonists and related agents
L02BX03 abiraterone

Status

License statusAuthorised
Licence Issued05/09/2011
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 ListAbiraterone 250 mg Tablets
Interchangeable List CodeIC0123-130-002
Interchangeable List DocumentPDF of Interchangeable List
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