Zytiga
abiraterone
Table of contents
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.
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Zytiga : EPAR - Summary for the public (PDF/82.84 KB)
First published: 23/09/2011
Last updated: 12/01/2018 -
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Zytiga : EPAR - Risk Management Plan (PDF/1.31 MB)
First published: 06/12/2022
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
|
Accelerated assessment |
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment. |
Publication details | |
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Marketing-authorisation holder |
Janssen-Cilag International N.V.
|
Revision |
26
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Date of issue of marketing authorisation valid throughout the European Union |
05/09/2011
|
Contact address |
Turnhoutseweg 30 |
Product information
28/06/2022 Zytiga - EMEA/H/C/002321 - IB/0067/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.