Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Xofigo   
Auth. number : EU/1/13/873
INN : 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 Pharma AG
D-13342 Berlin, 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 - Variation EMEA/H/C/2653/N/3