Sunitinib Accord (sunitinib)
- Region
- 🇪🇺 EU
- Active substance
- sunitinib
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Neuroendocrine Tumors
- CHMP opinion
- Thu 10 Dec 2020
- EU approval
- Thu 11 Feb 2021
- Designations
- Generic
- Application
- EMEA/H/C/005419
- ATC
- L01EX01
- Official record
- www.ema.europa.eu
Indication
Gastrointestinal stromal tumour (GIST) Sunitinib Accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance. Metastatic renal cell carcinoma (MRCC) Sunitinib Accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sunitinib Accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Sutent Authorised · Pfizer Limited
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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.