This is a summary of the European public assessment report (EPAR) for Vfend. 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 Vfend.
Vfend : EPAR - Summary for the public (PDF/87.85 KB)
First published: 07/11/2006
Last updated: 14/08/2014
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|International non-proprietary name (INN) or common name||
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Pfizer Europe MA EEIG
|Date of issue of marketing authorisation valid throughout the European Union||
Boulevard de la Plaine 17
26/03/2021 Vfend - EMEA/H/C/000387 - WS/1939
- 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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Antimycotics for systemic use
Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:
- treatment of invasive aspergillosis;
- treatment of in candidaemianon-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.
Vfend should be administered primarily to patients with progressive, possibly life-threatening infections.
Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.