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 24/07/2018

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
33
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

22/02/2018 Sutent - EMEA/H/C/000687 - II/0068

Contents

  • 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.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTINEOPLASTIC AGENTS

Therapeutic indication

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.

Assessment history

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