Voriconazole Accord
Authorised
This medicine is authorised for use in the European Union
voriconazole
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
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.
Voriconazole Accord is an antifungal medicine that contains the active substance voriconazole. It is used for the treatment of adults and children over the age of two years with:
- invasive aspergillosis (a type of fungal infection due to Aspergillus);
- candidaemia (another type of fungal infection due to Candida) in non?neutropenic patients (patients with a normal white blood cell count);
- serious invasive Candida infections when the fungus is resistant to fluconazole (another antifungal medicine);
- serious fungal infections caused by Scedosporium or Fusarium (two different types of fungus).
When used for treating fungal infections, Voriconazole Accord is intended mainly for patients with worsening, possibly life-threatening, fungal infections.
Voriconazole Accord is also used to prevent fungal infections in patients who have had haematopoietic (blood) stem-cell transplantation (a transplant of a type of stem cells that can develop into blood cells) and are at high risk of infection.
Voriconazole Accord is a ‘generic medicine’. This means that Voriconazole Accord is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Vfend.
Voriconazole Accord is available as tablets (50 mg or 200 mg). It is given twice a day. The dose of Voriconazole Accord depends on the weight of the patient. Patients need to receive an initial higher dose (loading dose) on the first day of treatment. The aim of the loading dose is to attain effective blood levels quickly. The loading dose is then followed by a maintenance dose that can be adjusted according to the patient’s response. The dose may be increased or decreased according to how the patient responds.
The tablets are to be taken at least one hour before or after a meal. For full information, see the package leaflet. The medicine can only be obtained with a prescription.
The active substance in Voriconazole Accord, voriconazole, is an antifungal medicine that belongs to the ‘triazole’ group. It works by preventing the formation of ergosterol, which is an important part of fungal cell membranes. Without ergosterol, the fungus is killed or prevented from spreading. The list of fungi against which Voriconazole Accord is active can be found in the summary of product characteristics (also part of the EPAR).
Because Voriconazole Accord is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Vfend. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Because Voriconazole Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Voriconazole Accord has been shown to have comparable quality and to be bioequivalent to Vfend. Therefore, the CHMP’s view was that, as for Vfend, the benefit outweighs the identified risks. The Committee recommended that Voriconazole Accord be approved for use in the EU.
A risk management plan has been developed to ensure that Voriconazole Accord is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Voriconazole Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
The European Commission granted a marketing authorisation valid throughout the European Union for Voriconazole Accord on 16 May 2013.
For more information about treatment with Voriconazole Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:
IB/0040
08/08/2024
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).
Product details
- Name of medicine
- Voriconazole Accord
- Active substance
- voriconazole
- International non-proprietary name (INN) or common name
- voriconazole
- Therapeutic area (MeSH)
- Aspergillosis
- Candidiasis
- Mycoses
- Anatomical therapeutic chemical (ATC) code
- J02AC03
Pharmacotherapeutic group
- Antimycotics for systemic use
- Triazole derivatives
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.
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