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 06/03/2018

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 Médicament
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
21/09/2009
Contact address
45, place Abel Gance
F-92100 Boulogne
France

Product information

19/02/2018 Javlor - EMEA/H/C/000983 - N/0019

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

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