Xofigo Bayer AG · Authorised · authorised 13 Nov 2013 · ATC V10XX03
Therapeutic indication (EMA)
Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
Active substance
Radium dichloride
- EMA 1
- Safety 2
EMA European Union — centrally authorised medicines
Safety signals and safety-related labeling changes
- EMA PRAC 30 Nov 2017 PRAC signal: Fractures and fatal cases in chemotherapy-naïve patients
Action for MAH: update of the product information: No - EMA PRAC 6 Nov 2014 PRAC signal: Cerebral haemorrhage
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.