Sunitinib Accord is a medicine used to treat adults with the following cancers:
- gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel where there is uncontrolled growth of cells in the supporting tissues of these organs. Sunitinib Accord is used in patients with GISTs that cannot be removed with surgery or have spread to other parts of the body. It is used after treatment with imatinib (another cancer medicine) has failed;
- metastatic renal cell carcinoma, a type of kidney cancer, that has spread to other parts of the body;
- pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas) that have spread or cannot be removed with surgery. Sunitinib Accord is used if the disease is getting worse and the tumour cells are well-differentiated (similar to normal cells in the pancreas).
Sunitinib Accord contains the active substance sunitinib and is a ‘generic medicine’. This means that Sunitinib Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Sutent.
Sunitinib Accord : EPAR - Medicine overview (PDF/158.42 KB)
First published: 06/04/2021
Sunitinib Accord : EPAR - Risk-management-plan summary (PDF/206.68 KB)
First published: 06/04/2021
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This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
Accord Healthcare S.L.U.
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World Trade Center
14/12/2021 Sunitinib Accord - EMEA/H/C/005419 - IA/0001
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.