Cotellic (cobimetinib)
- Region
- 🇪🇺 EU
- Active substance
- cobimetinib
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Melanoma
- CHMP opinion
- Thu 24 Sep 2015
- EU approval
- Fri 20 Nov 2015
- Application
- EMEA/H/C/003960
- ATC
- L01XE38
- Official record
- www.ema.europa.eu
Indication
Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Regulatory milestones
No milestones recorded in the last year.
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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.