radium Ra223 dichloride
Table of contents
Xofigo is a radiopharmaceutical (a medicine containing a radioactive substance) that is used to treat adults with cancer of the prostate (a gland of the male reproductive system).
Xofigo is used when castration (to stop the production of male hormones) by surgery or with medicines does not work, and when the cancer has spread to the bones (bone metastases) and is causing symptoms such as pain, but has not spread to other internal organs. It should be used only for patients who have had at least two previous treatments for prostate cancer or who cannot receive other treatments.
Xofigo is used on its own or in combination with a medicine known as an ‘LHRH analogue’.
Xofigo contains the active substance radium-223 dichloride.
Xofigo : EPAR - Medicine overview (PDF/77.16 KB)
First published: 28/11/2013
Last updated: 11/10/2018
Xofigo : EPAR - Risk-management-plan summary (PDF/339.82 KB) (new)
First published: 16/05/2023
|Agency product number||
radium (223Ra) dichloride
|International non-proprietary name (INN) or common name||
radium Ra223 dichloride
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
|Date of issue of marketing authorisation valid throughout the European Union||
04/05/2023 Xofigo - EMEA/H/C/002653 - IB/0051
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 201320/09/2013