Stivarga

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regorafenib

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

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 08/10/2018

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
14
Date of issue of marketing authorisation valid throughout the European Union
25/08/2013
Contact address
13342 Berlin
Germany

Product information

16/08/2018 Stivarga - EMEA/H/C/002573 - IB/0027

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

  • Protein kinase inhibitors

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.

Assessment history

Changes since initial authorisation of medicine

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