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.
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.
Therapeutic Area (MeSH)
ATC Code
J02AC03
ATC Item
N/A
Pharmacotherapeutic Group
Antimycotics for systemic use
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| voriconazole | N/A | voriconazole |
EMA Name
Voriconazole Hikma (previously Voriconazole Hospira)
Medicine Name
Voriconazole Hikma (previously Voriconazole Hospira)
Aliases
N/ANo risk management plan link.
