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
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22/02/2018 Sutent - EMEA/H/C/000687 - II/0068
- 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
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Gastrointestinal stromal tumour (GIST)
Sutent is indicated for the treatment of unresectable and / or metastatic malignant GIST after failure of imatinib-mesilate treatment due to resistance or intolerance.
Metastatic renal-cell carcinoma (MRCC)
Sutent is indicated for the treatment of advanced / MRCC in adults.
Pancreatic neuroendocrine tumours (pNET)
Sutent is indicated for the treatment of unresectable or metastatic, well differentiated pNET with disease progression in adults.
Experience with Sutent as first-line treatment is limited.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 201823/02/2018