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500 milligram(s) Film-coated tablet

Janssen-Cilag International NVEU/1/11/714/002-003

Main Information

Trade NameZytiga
Active SubstancesAbiraterone acetate
Strength500 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderJanssen-Cilag International NV
Licence NumberEU/1/11/714/002-003

Group Information

ATC CodeL02BX Other hormone antagonists and related agents
L02BX03 abiraterone


Licence Issued09/11/2016
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 StatusMarketed


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