Voriconazole Accord

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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 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.

This EPAR was last updated on 24/05/2019

Authorisation details

Product details
Name
Voriconazole Accord
Agency product number
EMEA/H/C/002669
Active substance
voriconazole
International non-proprietary name (INN) or common name
voriconazole
Therapeutic area (MeSH)
  • Aspergillosis
  • Candidiasis
  • Mycoses
Anatomical therapeutic chemical (ATC) code
J02AC03
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
16/05/2013
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

20/02/2019 Voriconazole Accord - EMEA/H/C/002669 - T/0021

Contents

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Pharmacotherapeutic group

voriconazole

Therapeutic indication

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.

Assessment history

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