Basic Information
Javlor
Regulatory Information
EMEA/H/C/000983
Authorised
September 21, 2009
11
April 18, 2024
Company Information
France
Les Cauquillous 81500 - Lavaur
PIERRE FABRE MEDICAMENT
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Javlor. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Javlor.