Sutent

RSS

sunitinib

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 14/03/2019

Authorisation details

Product details
Name
Sutent
Agency product number
EMEA/H/C/000687
Active substance
sunitinib
International non-proprietary name (INN) or common name
sunitinib
Therapeutic area (MeSH)
  • Gastrointestinal Stromal Tumors
  • Carcinoma, Renal Cell
  • Neuroendocrine Tumors
Anatomical therapeutic chemical (ATC) code
L01XE04
Publication details
Marketing-authorisation holder
Pfizer Limited
Revision
36
Date of issue of marketing authorisation valid throughout the European Union
19/07/2006
Contact address
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

14/02/2019 Sutent - EMEA/H/C/000687 - PSUSA/00002833/201804

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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).

Assessment history

Changes since initial authorisation of medicine

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