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.
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.
Therapeutic Area (MeSH)
ATC Code
L01CA05
ATC Item
vinflunine
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| vinflunine | N/A | Vinflunine |
EMA Name
Javlor
Medicine Name
Javlor
Aliases
N/ANo risk management plan link.
