Basic Information
Zytiga
Regulatory Information
EMEA/H/C/002321
September 5, 2011
July 21, 2011
28
October 18, 2024
Company Information
Belgium
Turnhoutseweg 30 BE-2340 Beerse
Janssen-Cilag International NV
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Zytiga is indicated with prednisone or prednisolone for: - the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated - the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Zytiga. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zytiga. For practical information about using Zytiga, patients should read the package leaflet or contact their doctor or pharmacist.