This is a summary of the European public assessment report (EPAR) for Sutent. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sutent.
Sutent : EPAR - Summary for the public (PDF/83.21 KB)
First published: 12/08/2009
Last updated: 03/10/2014
Sutent : EPAR - Risk-management-plan summary (PDF/110.95 KB)
First published: 11/11/2019
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04/08/2021 Sutent - EMEA/H/C/000687 - IA/0082
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)
Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesilate treatment due to resistance or intolerance.
Metastatic renal cell carcinoma (MRCC)
Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.
Pancreatic neuroendocrine tumours (pNET)
Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults.
Experience with Sutent as first-line treatment is limited (see section 5.1).
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 201823/02/2018