Vfend

RSS

voriconazole

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 13/05/2019

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)
  • Candidiasis
  • Mycoses
  • Aspergillosis
Anatomical therapeutic chemical (ATC) code
J02AC03
Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
45
Date of issue of marketing authorisation valid throughout the European Union
19/03/2002
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

09/04/2019 Vfend - EMEA/H/C/000387 - N/0133

Contents

  • 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.

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.

Assessment history

Changes since initial authorisation of medicine

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