Zelboraf (vemurafenib)
- Region
- 🇪🇺 EU
- Active substance
- vemurafenib
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Melanoma
- CHMP opinion
- Thu 15 Dec 2011
- EU approval
- Fri 17 Feb 2012
- Application
- EMEA/H/C/002409
- ATC
- L01EC01
- Official record
- www.ema.europa.eu
Indication
Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.
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.