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


Abiraterone Krka



KRKA, d.d., Novo mestoEU/1/21/1553/001-003

Main Information

Trade NameAbiraterone Krka
Active SubstancesAbiraterone acetate
Dosage FormFilm-coated tablet
Licence HolderKRKA, d.d., Novo mesto
Licence NumberEU/1/21/1553/001-003

Group Information

ATC CodeL02BX03 abiraterone

Status

License statusAuthorised
Licence Issued24/06/2021
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 List CodeIC0123-117-003
Interchangeable List DocumentPDF of Interchangeable List
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