Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Xtandi   
Auth. number : EU/1/13/846
Active substance : 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
• 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
Updated with Decision(2015)3677 of 27/05/2015
16/01/2015 Centralised - Variation EMEA/H/C/2639/IB/14
Updated with Decision(2015)3677 of 27/05/2015
26/03/2015 Centralised - Variation EMEA/H/C/2639/II/16
Updated with Decision(2015)3677 of 27/05/2015
23/04/2015 Centralised - Variation EMEA/H/C/2639/II/18
Updated with Decision(2015)4366 of 22/06/2015
29/05/2015 PSUSA - Modification EMEA/H/C/2639/PSUSA/10095/201408 (2015)3677 of 27/05/2015
24/06/2015 Centralised - 2-Monthly update EMEA/H/C/2639/II/15 (2015)4366 of 22/06/2015
01/09/2015 Rectificative Decision (2015)6119 of 28/08/2015
17/09/2015 Centralised - Variation EMEA/H/C/2639/II/20
Updated with Decision(2015)8605 of 27/11/2015
01/12/2015 PSUSA - Modification EMEA/H/C/2639/PSUSA/10095/201502 (2015)8605 of 27/11/2015
17/12/2015 Centralised - Variation EMEA/H/C/2639/II/26
01/04/2016 Centralised - Variation EMEA/H/C/2639/II/28