Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Stivarga   
Auth. number : EU/1/13/858
Active substance : regorafenib
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE21 - Regorafenib
(See WHO ATC Index)
Indication: Stivarga is indicated 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 (see section 5.1).
- unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.
Marketing Authorisation Holder: Bayer Pharma AG
D-13342 Berlin, Deutschland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
29/08/2013 Centralised - Authorisation EMEA/H/C/2573 (2013)5622 of 26/08/2013
24/02/2014 Corrigendum (2014)1250 of 20/02/2014
02/06/2014 Centralised - Variation EMEA/H/C/2573/IB/3/G
Updated with Decision(2014)5493 of 28/07/2014
30/07/2014 Centralised - Variation EMEA/H/C/2573/II/1 (2014)5493 of 28/07/2014
18/12/2014 PSUSA - Modification EMEA/H/C/2573/PSUV/4 (2014)10072 of 16/12/2014
23/04/2015 Centralised - Variation EMEA/H/C/2573/IB/10
Updated with Decision(2015)9625 of 16/12/2015
21/05/2015 Centralised - Variation EMEA/H/C/2573/II/8
Updated with Decision(2015)9625 of 16/12/2015
22/10/2015 Centralised - Variation EMEA/H/C/2573/II/14/G
Updated with Decision(2015)9625 of 16/12/2015
19/11/2015 Centralised - Variation EMEA/H/C/2573/II/13
Updated with Decision(2016) 6715 of 14/10/2016
18/12/2015 PSUSA - Modification EMEA/H/C/PSUSA/10133/201503 (2015)9625 of 16/12/2015
17/03/2016 Centralised - Variation EMEA/H/C/2573/II/16
Updated with Decision(2016) 6715 of 14/10/2016
28/04/2016 Centralised - Variation EMEA/H/C/2573/II/15/G
Updated with Decision(2016) 6715 of 14/10/2016
18/10/2016 Centralised - Yearly update (2016) 6715 of 14/10/2016
15/12/2016 Centralised - Variation EMEA/H/C/2573/II/19
Updated with Decision(2017)575 of 27/01/2017
31/01/2017 Centralised - 2-Monthly update EMEA/H/C/2573/II/18 (2017)575 of 27/01/2017
14/06/2017 PSUSA - Modification EMEA/H/C/PSUSA/00010133/201609 (2017)4167 of 12/06/2017