Fotivda (tivozanib hydrochloride monohydrate)
- Region
- 🇪🇺 EU
- Active substance
- tivozanib hydrochloride monohydrate
- Company
- Recordati Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Carcinoma, Renal Cell
- CHMP opinion
- Thu 22 Jun 2017
- EU approval
- Thu 24 Aug 2017
- Application
- EMEA/H/C/004131
- ATC
- L01EK03
- Official record
- www.ema.europa.eu
Indication
Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC. Treatment of advanced renal cell carcinoma.
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.