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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/13/858|
|ATC:||Anatomical main group: L - Antineoplastic and immunomodulating agents|
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
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
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.
|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||Centralised - Modification||EMEA/H/C/2573/PSUV/4||(2014)10072 of 16/12/2014|