This is a summary of the European public assessment report (EPAR) for Voriconazole Accord. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Voriconazole Accord.
For practical information about using Voriconazole Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Voriconazole Accord : EPAR - Summary for the public (PDF/74.98 KB)
First published: 07/06/2013
Last updated: 15/03/2016
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This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
Accord Healthcare S.L.U.
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20/02/2019 Voriconazole Accord - EMEA/H/C/002669 - T/0021
- 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.
Voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged two years and above as follows:
- treatment of invasive aspergillosis;
- treatment of candidaemia in non-neutropenic patients;
- treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei);
- Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.
Voriconazole Accord should be administered primarily to patients with progressive, possibly life-threatening infections.