Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Xtandi   
Auth. number : EU/1/13/846
INN : enzalutamide
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L02 - Endocrine therapy
Pharmacological subgroup: L02B - Hormone antagonists and related agents
Chemical subgroup: L02BB - Anti-androgens
Chemical substance: L02BB04 - Enzalutamide
(See WHO ATC Index)
Indication: Xtandi is indicated for:
• the treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)
• the treatment of adult men with metastatic castration resistant prostate cancer whose disease has progressed on or after docetaxel therapy.
Marketing Authorisation Holder: Astellas Pharma Europe B.V.
Sylviusweg 62, NL-2333 BE Leiden, Nederland

  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
25/06/2013 Centralised - Authorisation EMEA/H/C/2639 (2013)4019 of 21/06/2013
17/09/2014 Centralised - Variation EMEA/H/C/2639/IB/10
Updated with Decision(2014)9277 of 28/11/2014
25/09/2014 Centralised - Variation EMEA/H/C/2639/II/6/G
Updated with Decision(2014)9277 of 28/11/2014
25/09/2014 Centralised - Variation EMEA/H/C/2639/II/7/G
Updated with Decision(2014)9277 of 28/11/2014
02/12/2014 Centralised - 2-Monthly update EMEA/H/C/2639/II/8 (2014)9277 of 28/11/2014
09/12/2014 Centralised - Variation EMEA/H/C/2639/IB/12
16/01/2015 Centralised - Variation EMEA/H/C/2639/IB/14