Voriconazole Hikma (previously Voriconazole Hospira)

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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 Hikma. 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 Hikma.
For practical information about using Voriconazole Hikma, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 07/05/2019

Authorisation details

Product details
Name
Voriconazole Hikma (previously Voriconazole Hospira)
Agency product number
EMEA/H/C/003737
Active substance
voriconazole
International non-proprietary name (INN) or common name
voriconazole
Therapeutic area (MeSH)
  • Bacterial Infections and Mycoses
  • Aspergillosis
  • Candidiasis
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
Hikma Farmaceutica (Portugal) S.A.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
27/05/2015
Contact address
Estrada do Rio da Mo, 8, 8A-B – Fervenca
2705-906 Terrugem SNT
Portugal

Product information

03/04/2019 Voriconazole Hikma (previously Voriconazole Hospira) - EMEA/H/C/003737 - IAIN/0008

Contents

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 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 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

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