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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31/10/2019 Sutent - EMEA/H/C/000687 - IAIN/0077
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
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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