Sorafenib Accord (sorafenib)
Generic
- Region
- 🇪🇺 EU
- Active substance
- sorafenib
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Carcinoma, Hepatocellular; Carcinoma, Renal Cell
- CHMP opinion
- Thu 15 Sep 2022
- EU approval
- Wed 09 Nov 2022
- Designations
- Generic
- Application
- EMEA/H/C/005921
- ATC
- L01EX02
- Official record
- www.ema.europa.eu
Indication
Hepatocellular carcinomaSorafenib Accord is indicated for the treatment of hepatocellular carcinoma (see section 5.1). Renal cell carcinomaSorafenib Accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Nexavar Authorised · Bayer AG
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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.