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.
Zytiga : EPAR - Summary for the public (PDF/82.84 KB)
First published: 23/09/2011
Last updated: 12/01/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Janssen-Cilag International N.V.
|Date of issue of marketing authorisation valid throughout the European Union||
12/06/2018 Zytiga - EMEA/H/C/002321 - N/0050
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.