This is a summary of the European public assessment report (EPAR) for Stivarga. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Stivarga.
For practical information about using Stivarga, patients should read the package leaflet or contact their doctor or pharmacist.
Stivarga : EPAR - Summary for the public (PDF/78.37 KB)
First published: 12/09/2013
Last updated: 01/09/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Bayer Pharma AG
|Date of issue of marketing authorisation valid throughout the European Union||
16/08/2018 Stivarga - EMEA/H/C/002573 - IB/0027
- 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.
Protein kinase inhibitors
Stivarga is indicated as monotherapy for the treatment of adult patients with:
- metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies - these include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy;
- unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib;
- hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.