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 Mylan



Mylan IRE Healthcare LimitedEU/1/21/1571/009-012

Main Information

Trade NameAbiraterone Mylan
Active SubstancesAbiraterone acetate
Dosage FormFilm-coated tablet
Licence HolderMylan IRE Healthcare Limited
Licence NumberEU/1/21/1571/009-012

Group Information

ATC CodeL02BX03 abiraterone

Status

Authorised/WithdrawnAuthorised
Licence Issued20/08/2021
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
« Back