Javlor (vinflunine)
- Region
- 🇪🇺 EU
- Active substance
- vinflunine
- Company
- Pierre Fabre Medicament
- Status
- Authorised
- Therapeutic area
- Carcinoma, Transitional Cell; Urologic Neoplasms
- EU approval
- Mon 21 Sep 2009
- Application
- EMEA/H/C/000983
- ATC
- L01CA05
- Official record
- www.ema.europa.eu
Indication
Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional-cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen. Efficacy and safety of vinflunine have not been studied in patients with performance status ? 2.
Regulatory milestones
No milestones recorded in the last year.
Follow Javlor
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.