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.
Javlor : EPAR - Summary for the public (PDF/57.21 KB)
First published: 08/10/2009
Last updated: 29/08/2013
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Pierre Fabre Médicament
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19/02/2018 Javlor - EMEA/H/C/000983 - N/0019
- 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
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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.