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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/177319/2016

EMEA/H/C/003737

EPAR summary for the public

Voriconazole Hospira

voriconazole

This is a summary of the European public assessment report (EPAR) for Voriconazole Hospira. 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 Hospira.

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

What is Voriconazole Hospira and what is it used for?

Voriconazole Hospira is an antifungal medicine used for the treatment of adults and children over the age of two years who have the following infections caused by a fungus:

•    invasive aspergillosis (a type of fungal infection due to Aspergillus);

•    candidaemia (a type of fungal infection due to Candida) in patients with a normal white blood cell count;

•    other 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 Hospira is intended mainly for patients with infections that are worsening and possibly life-threatening.

Voriconazole Hospira 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 Hospira contains the active substance voriconazole. It is a 'generic medicine'. This means that Voriconazole Hospira is similar to a 'reference medicine' already authorised in the European Union

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(EU) called Vfend. For more information on generic medicines, see the question-and-answer document here.

How is Voriconazole Hospira used?

Voriconazole Hospira is available as a powder to be made up into a solution for infusion (drip) into a vein. It is given twice a day. The dose of Voriconazole Hospira depends on the weight of the patient.

Patients need to receive an initial higher dose (loading dose) on the first day. 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.

Both the loading and the maintenance doses are given by infusion, but once patients improve prescribers should consider switching patients to a voriconazole medicine that can be given by mouth.

The medicine can only be obtained with a prescription.

How does Voriconazole Hospira work?

The active substance in Voriconazole Hospira, voriconazole, belongs to the 'triazole' class of antifungal medicines. It works by disrupting 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 Hospira is active can be found in the summary of product characteristics (also part of the EPAR).

How has Voriconazole Hospira been studied?

The company provided data from the published literature on voriconazole. No additional studies were needed as Voriconazole Hospira is a generic medicine that is given by infusion and contains the same active substance as the reference medicine Vfend.

What are the benefits and risks of Voriconazole Hospira?

Because Voriconazole Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Voriconazole Hospira approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Voriconazole Hospira has been shown to be comparable to Vfend. Therefore, the CHMP's view was that, as for Vfend, the benefit outweighs the identified risk. The Committee recommended that Voriconazole Hospira be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Voriconazole Hospira?

A risk management plan has been developed to ensure that Voriconazole Hospira 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 Hospira, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Voriconazole Hospira

The European Commission granted a marketing authorisation valid throughout the European Union for Voriconazole Hospira on 27 May 2015.

The full EPAR and risk management plan summary for Voriconazole Hospira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Voriconazole Hospira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency's website.

This summary was last updated in 02-2016.

Voriconazole Hospira

EMA/177319/2016

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