Zytiga

RSS

abiraterone

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 23/07/2018

Authorisation details

Product details
Name
Zytiga
Agency product number
EMEA/H/C/002321
Active substance
abiraterone acetate
International non-proprietary name (INN) or common name
abiraterone
Therapeutic area (MeSH)
Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code
L02BX03
Publication details
Marketing-authorisation holder
Janssen-Cilag International N.V.
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
05/09/2011
Contact address
Turnhoutseweg 30
BE-2340 Beerse
Belgium

Product information

12/06/2018 Zytiga - EMEA/H/C/002321 - N/0050

Contents

  • 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.

Pharmacotherapeutic group

ENDOCRINE THERAPY

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.

Assessment history

Changes since initial authorisation of medicine

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