Voriconazole Hikma (previously Voriconazole Hospira)

voriconazole

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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.

What is Voriconazole Hikma and what is it used for?

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.

How is Voriconazole Hikma used?

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.

How does Voriconazole Hikma work?

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).

How has Voriconazole Hikma been studied?

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.

What are the benefits and risks of Voriconazole Hikma?

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

Why is Voriconazole Hikma approved?

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.

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

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 risk management plan

Other information about Voriconazole Hikma

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.

Name Language First published Last updated
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public BG = bălgarski 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public ES = español 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public CS = čeština 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public DA = dansk 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public DE = Deutsch 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public ET = eesti keel 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public EL = elliniká 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public FR = français 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public IT = italiano 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public LV = latviešu valoda 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public LT = lietuvių kalba 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public HU = magyar 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public MT = Malti 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public NL = Nederlands 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public PL = polski 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public PT = português 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public RO = română 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public SK = slovenčina 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public SL = slovenščina 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public FI = suomi 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public SV = svenska 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public HR = Hrvatski 2015-06-25 2017-03-01
Name Language First published Last updated
Voriconazole Hospira : EPAR - Risk-management-plan summary (English only) 2015-06-25  

This EPAR was last updated on 01/03/2017 .

Authorisation details

Product details

Product details for Voriconazole Hikma (previously Voriconazole Hospira)
NameVoriconazole Hikma (previously Voriconazole Hospira)
Agency product numberEMEA/H/C/003737
Active substance

voriconazole

International non-proprietary name (INN) or common name

voriconazole

Therapeutic area AspergillosisBacterial Infections and MycosesCandidiasis
Anatomical therapeutic chemical (ATC) code J02AC03
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Voriconazole Hikma (previously Voriconazole Hospira)
Marketing-authorisation holder

Hikma Farmaceutica (Portugal) S.A.

Revision3
Date of issue of marketing authorisation valid throughout the European Union27/05/2015

Contact address:

Hikma Farmaceutica (Portugal) S.A.
Estrada do Rio da Mo, 8, 8A-B – Fervenca
2705-906 Terrugem SNT
Portugal

Product information

Product information

15/12/2016  Voriconazole Hikma (previously Voriconazole Hospira) -EMEA/H/C/003737 -IAIN/0006

Name Language First published Last updated
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Product Information EN = English 2015-06-25 2017-03-01

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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.


Name Language First published Last updated
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - All Authorised presentations EN = English 2015-06-25 2017-03-01

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Voriconazole Hospira : EPAR - Public assessment report EN = English 2015-06-25  
CHMP summary of positive opinion for Voriconazole Hospira EN = English 2015-03-27  

Authorised

This medicine is approved for use in the European Union

More information on Voriconazole Hospira