EMA — authorised 20 September 2018
- Marketing authorisation holder: Pierre Fabre Medicament
- Local brand name: Mektovi
- Status: approved
🇪🇺 Mektovi in European Union
EMA authorised Mektovi on 20 September 2018
Marketing authorisations
EMA — authorised 20 September 2018
- Application: EMEA/H/C/004579
- Marketing authorisation holder: Pierre Fabre Medicament
- Local brand name: Mektovi
- Indication: MelanomaBinimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.Non-small cell lung cancer (NSCLC)Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.
- Status: approved
Mektovi in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in European Union
Frequently asked questions
Is Mektovi approved in European Union?
Yes. EMA authorised it on 20 September 2018; EMA authorised it on 20 September 2018.
Who is the marketing authorisation holder for Mektovi in European Union?
Pierre Fabre Medicament holds the EU marketing authorisation.