Mektovi (binimetinib)
- Region
- 🇪🇺 EU
- Active substance
- binimetinib
- Company
- Pierre Fabre Medicament
- Status
- Authorised
- Therapeutic area
- Melanoma
- EU approval
- Thu 20 Sep 2018
- Application
- EMEA/H/C/004579
- ATC
- L01EE03
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Balimek Application withdrawn · Pierre Fabre Médicament
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.