🇪🇺 Vinflunine plus Capecitabine in European Union

EMA authorised Vinflunine plus Capecitabine on 21 September 2009

Marketing authorisation

EMA — authorised 21 September 2009

  • Application: EMEA/H/C/000983
  • Marketing authorisation holder: Pierre Fabre Medicament
  • Local brand name: Javlor
  • 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.
  • Status: approved

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Other Oncology approved in European Union

Frequently asked questions

Is Vinflunine plus Capecitabine approved in European Union?

Yes. EMA authorised it on 21 September 2009.

Who is the marketing authorisation holder for Vinflunine plus Capecitabine in European Union?

Pierre Fabre Medicament holds the EU marketing authorisation.