Pharmaceuticals - Union Register


Union Register of medicinal products for human use


Product information

Invented name: Braftovi   
Auth. number : EU/1/18/1314
Active substance : encorafenib
ATC: Pending
Indication: Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation
Marketing Authorisation Holder: Pierre Fabre Médicament
45, place Abel Gance, 92100 Boulogne-Billancourt, France

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 Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
24/09/2018 Centralised - Authorisation EMEA/H/C/4580/ (2018)6216 of 20/09/2018
7/11/2018 Centralised - Variation EMEA/H/C/4580/IB/1/G