Vfend
voriconazole
Table of contents
Overview
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.
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Vfend : EPAR - Summary for the public (PDF/87.85 KB)
First published: 07/11/2006
Last updated: 14/08/2014 -
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Vfend : EPAR - Risk Management Plan (PDF/2.94 MB)
First published: 13/02/2023
Authorisation details
Product details | |
---|---|
Name |
Vfend
|
Agency product number |
EMEA/H/C/000387
|
Active substance |
voriconazole
|
International non-proprietary name (INN) or common name |
voriconazole
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
J02AC03
|
Publication details | |
---|---|
Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
52
|
Date of issue of marketing authorisation valid throughout the European Union |
19/03/2002
|
Contact address |
Boulevard de la Plaine 17 |
Product information
04/05/2022 Vfend - EMEA/H/C/000387 - IB/0146/G
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
Antimycotics for systemic use
Therapeutic indication
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.