Javlor

RSS

vinflunine

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 23/11/2022

Authorisation details

Product details
Name
Javlor
Agency product number
EMEA/H/C/000983
Active substance
vinflunine
International non-proprietary name (INN) or common name
vinflunine
Therapeutic area (MeSH)
  • Carcinoma, Transitional Cell
  • Urologic Neoplasms
Anatomical therapeutic chemical (ATC) code
L01CA05
Publication details
Marketing-authorisation holder
Pierre Fabre Medicament
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
21/09/2009
Contact address

Pierre Fabre Medicament
Les Cauquillous
81500 - Lavaur
France

Product information

07/11/2022 Javlor - EMEA/H/C/000983 - IB/0024

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

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.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating
Average
1 rating
2 ratings