Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zytiga   
Auth. number : EU/1/11/714
INN : abiraterone
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L02 - Endocrine therapy
Pharmacological subgroup: L02B - Hormone antagonists and related agents
Chemical subgroup: L02BX - Other hormone antagonists and related agents
Chemical substance: L02BX03 - Abiraterone
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
07/09/2011 Centralised - Authorisation EMEA/H/C/2321 (2011)6379 of 05/09/2011
01/06/2012 Centralised - Variation EMEA/H/C/2321/II/2 (2012)3613 of 25/05/2012
04/09/2012 Centralised - Variation EMEA/H/C/2321/II/3 (2012)6137 of 30/08/2012
20/12/2012 Centralised - Variation EMEA/H/C/2321/II/4/G (2012)9866 of 18/12/2012
25/07/2013 Centralised - Variation EMEA/H/C/2321/II/10
Updated with Decision(2014)325 of 16/01/2014
29/07/2013 PSUSA - Modification EMEA/H/C/2321/PSU/3 (2013)4947 of 25/07/2013
19/09/2013 Centralised - Variation EMEA/H/C/2321/II/12
Updated with Decision(2014)325 of 16/01/2014
21/11/2013 Centralised - Variation EMEA/H/C/2321/II/14/G
Updated with Decision(2014)325 of 16/01/2014
21/01/2014 PSUSA - Modification EMEA/H/C/2321/PSUV/17 (2014)325 of 16/01/2014
22/05/2014 Centralised - Variation EMEA/H/C/2321/II/18/G
Updated with Decision(2014)5262 of 18/07/2014
23/07/2014 PSUSA - Modification EMEA/H/C/2321/PSUV/19 (2014)5262 of 18/07/2014
24/07/2014 Centralised - Variation EMEA/H/C/2321/II/22
20/11/2014 Centralised - Variation EMEA/H/C/2321/II/25
04/03/2015 Centralised - Variation EMEA/H/C/2321/IG/526/G