Xofigo (radium Ra223 dichloride)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- radium Ra223 dichloride
- Company
- Bayer AG
- Status
- Authorised
- Therapeutic area
- Prostatic Neoplasms
- EU approval
- Wed 13 Nov 2013
- Designations
- Additional monitoring
- Application
- EMEA/H/C/002653
- ATC
- V10XX03
- Official record
- www.ema.europa.eu
Indication
Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.