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.

Voriconazole Hikma 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 Hikma is intended mainly for patients with infections that are worsening and possibly life-threatening.

Voriconazole Hikma 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 Hikma contains the active substance voriconazole. It is a ‘generic medicine’. This means that Voriconazole Hikma is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Vfend. For more information on generic medicines, see the question-and-answer document here.

Voriconazole Hikma 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 Hikma 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.

The active substance in Voriconazole Hikma, 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 cannot spread or dies. The list of fungi against which Voriconazole Hikma is active can be found in the summary of product characteristics (also part of the EPAR).

As for every medicine, the company provided studies on the quality of voriconazole. There was no need for ‘bioequivalence’ studies to investigate whether voriconazole is absorbed similarly to the reference medicine, Vfend, to produce the same level of the active substance in the blood. This is because voriconazole is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.

Because Voriconazole Hikma is a generic 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 Hikma 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 Hikma be approved for use in the EU.

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

Further information can be found in the summary of the Voriconazole Hospira : EPAR - Risk-management-plan summary.

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

For more information about treatment with Voriconazole Hikma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

български (BG) (126.13 KB - PDF)

View

español (ES) (98.6 KB - PDF)

View

čeština (CS) (123.57 KB - PDF)

View

dansk (DA) (98.07 KB - PDF)

View

Deutsch (DE) (99.75 KB - PDF)

View

eesti keel (ET) (97.05 KB - PDF)

View

ελληνικά (EL) (128.56 KB - PDF)

View

français (FR) (99.33 KB - PDF)

View

hrvatski (HR) (117.24 KB - PDF)

View

italiano (IT) (97.8 KB - PDF)

View

latviešu valoda (LV) (119.49 KB - PDF)

View

lietuvių kalba (LT) (121.08 KB - PDF)

View

magyar (HU) (116.07 KB - PDF)

View

Malti (MT) (124.09 KB - PDF)

View

Nederlands (NL) (98.54 KB - PDF)

View

polski (PL) (122.84 KB - PDF)

View

português (PT) (98.75 KB - PDF)

View

română (RO) (119.36 KB - PDF)

View

slovenčina (SK) (121.84 KB - PDF)

View

slovenščina (SL) (115.89 KB - PDF)

View

Suomi (FI) (97.55 KB - PDF)

View

svenska (SV) (98.04 KB - PDF)

View

Product information

български (BG) (1009.09 KB - PDF)

View

español (ES) (795.97 KB - PDF)

View

čeština (CS) (895.35 KB - PDF)

View

dansk (DA) (800.14 KB - PDF)

View

Deutsch (DE) (817.99 KB - PDF)

View

eesti keel (ET) (767.71 KB - PDF)

View

ελληνικά (EL) (998.87 KB - PDF)

View

français (FR) (726.11 KB - PDF)

View

hrvatski (HR) (976.96 KB - PDF)

View

íslenska (IS) (758.14 KB - PDF)

View

italiano (IT) (785.33 KB - PDF)

View

latviešu valoda (LV) (906.92 KB - PDF)

View

lietuvių kalba (LT) (1012.33 KB - PDF)

View

magyar (HU) (840.35 KB - PDF)

View

Malti (MT) (948.1 KB - PDF)

View

Nederlands (NL) (867.82 KB - PDF)

View

norsk (NO) (786.67 KB - PDF)

View

polski (PL) (894 KB - PDF)

View

português (PT) (800.86 KB - PDF)

View

română (RO) (896.54 KB - PDF)

View

slovenčina (SK) (926.58 KB - PDF)

View

slovenščina (SL) (846.81 KB - PDF)

View

Suomi (FI) (715.84 KB - PDF)

View

svenska (SV) (802.26 KB - PDF)

View

Latest procedure affecting product information: IA/0021/G

10/11/2023

icon globe

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).

български (BG) (29.72 KB - PDF)

View

español (ES) (26.83 KB - PDF)

View

čeština (CS) (27.67 KB - PDF)

View

dansk (DA) (27.99 KB - PDF)

View

Deutsch (DE) (28.71 KB - PDF)

View

eesti keel (ET) (26.45 KB - PDF)

View

ελληνικά (EL) (29.47 KB - PDF)

View

français (FR) (27.02 KB - PDF)

View

hrvatski (HR) (27.28 KB - PDF)

View

íslenska (IS) (28.01 KB - PDF)

View

italiano (IT) (26.25 KB - PDF)

View

latviešu valoda (LV) (28 KB - PDF)

View

lietuvių kalba (LT) (27.52 KB - PDF)

View

magyar (HU) (27.49 KB - PDF)

View

Malti (MT) (28.21 KB - PDF)

View

Nederlands (NL) (26.9 KB - PDF)

View

norsk (NO) (28.34 KB - PDF)

View

polski (PL) (28.69 KB - PDF)

View

português (PT) (28.33 KB - PDF)

View

română (RO) (27.72 KB - PDF)

View

slovenčina (SK) (28.14 KB - PDF)

View

slovenščina (SL) (26.87 KB - PDF)

View

Suomi (FI) (26.32 KB - PDF)

View

svenska (SV) (24.59 KB - PDF)

View

Product details

Name of medicine
Voriconazole Hikma (previously Voriconazole Hospira)
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

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.

Authorisation details

EMA product number
EMEA/H/C/003737

Generic

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.

Marketing authorisation holder
Hikma Farmaceutica (Portugal) S.A.

Estrada do Rio da Mo, 8, 8A-B – Fervenca
2705-906 Terrugem SNT
Portugal

Opinion adopted
26/03/2015
Marketing authorisation issued
27/05/2015
Revision
13

Assessment history

News on Voriconazole Hikma (previously Voriconazole Hospira)

This page was last updated on

Share this page