Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Mektovi   
Auth. number : EU/1/18/1315
Active substance : binimetinib
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: L01XE41 - antineoplastic agent, protein kinase inhibitor
(See WHO ATC Index)
Indication: Binimetinib in combination with encorafenib 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 Community 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/4579 (2018)6217 of 20/09/2018
30/10/2018 Centralised - Variation EMEA/H/C/4579/IB/1