Javlor
vinflunine
Table of contents
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.
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Javlor : EPAR - Summary for the public (PDF/57.21 KB)
First published: 08/10/2009
Last updated: 29/08/2013 -
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Javlor : EPAR - Risk management plan summary (PDF/76.26 KB)
First published: 23/11/2022
Authorisation details
Product details | |
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Name |
Javlor
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Agency product number |
EMEA/H/C/000983
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Active substance |
vinflunine
|
International non-proprietary name (INN) or common name |
vinflunine
|
Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
L01CA05
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Publication details | |
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Marketing-authorisation holder |
Pierre Fabre Medicament
|
Revision |
10
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Date of issue of marketing authorisation valid throughout the European Union |
21/09/2009
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Contact address |
Pierre Fabre Medicament |
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.