Orgovyx (relugolix)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- relugolix
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Prostatic Neoplasms
- CHMP opinion
- Thu 24 Feb 2022
- EU approval
- Fri 29 Apr 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005353
- ATC
- L02BX
- Official record
- www.ema.europa.eu
Indication
Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Ryeqo Authorised · Gedeon Richter Plc.
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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.