Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Xofigo   
Auth. number : EU/1/13/873
Active substance : Radium Ra 223 dichloride
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V10 - Therapeutic radiopharmaceuticals
Pharmacological subgroup: V10X - Other therapeutic radiopharmaceuticals
Chemical subgroup: V10XX - Various therapeutic radiopharmaceuticals
Chemical substance: V10XX03 - radium (223Ra) dichloride
(See WHO ATC Index)
Indication: Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
Marketing Authorisation Holder: Bayer AG
D-51368 Leverkusen, Deutschland
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
14/11/2013 Centralised - Authorisation EMEA/H/C/2653 (2013)8087 of 13/11/2013
11/04/2014 Centralised - Notification EMEA/H/C/2653/N/3
Updated with Decision(2015)6268 of 08/09/2015
19/09/2014 Centralised - Variation EMEA/H/C/2653/IAIN/6
Updated with Decision(2015)6268 of 08/09/2015
17/10/2014 Corrigendum (2014)7661 of 15/10/2014
20/01/2015 Centralised - Variation EMEA/H/C/2653/II/7
Updated with Decision(2015)6268 of 08/09/2015
10/09/2015 Centralised - 2-Monthly update EMEA/H/C/2653/II/11 (2015)6268 of 08/09/2015
30/05/2016 Centralised - Variation EMEA/H/C/2653/IA/18
Updated with Decision(2017)2280 of 03/04/2017
21/06/2016 Centralised - Notification EMEA/H/C/2653/N/19
Updated with Decision(2017)2280 of 03/04/2017
05/04/2017 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2653/T/24 (2017)2280 of 03/04/2017
22/06/2017 Centralised - Variation EMEA/H/C/2653/II/25
Updated with Decision(2017)5755 of 14/08/2017
17/08/2017 PSUSA - Modification EMEA/H/C/2653/PSUSA/10132/201611 (2017)5755 of 14/08/2017
21/03/2018 Referral EMEA/H/C/2653/A-20 (2018)1767 of 19/03/2018
21/03/2018 Corrigendum (2018)1767 of 19/03/2018