Stivarga
regorafenib
Table of contents
Overview
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.
This EPAR was last updated on 15/10/2019
Authorisation details
Product details | |
---|---|
Name |
Stivarga
|
Agency product number |
EMEA/H/C/002573
|
Active substance |
regorafenib
|
International non-proprietary name (INN) or common name |
regorafenib
|
Therapeutic area (MeSH) |
Colorectal Neoplasms
|
Anatomical therapeutic chemical (ATC) code |
L01XE21
|
Publication details | |
---|---|
Marketing-authorisation holder |
Bayer Pharma AG
|
Revision |
15
|
Date of issue of marketing authorisation valid throughout the European Union |
26/08/2013
|
Contact address |
Product information
27/09/2019 Stivarga - EMEA/H/C/002573 - IAIN/0029
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
Pharmacotherapeutic group
-
Antineoplastic agents
-
Protein kinase inhibitors
Therapeutic indication
Therapeutic indication
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.