Tacforius

tacrolimus

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

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

What is Tacforius and what is it used for?

Tacforius is used for the long-term treatment of adult patients who have had a kidney or liver transplant, to prevent rejection (when the immune system attacks the transplanted organ). Tacforius can also be used to treat organ rejection in adult patients when other immunosuppressive medicines (medicines that reduce the activity of the immune system) are not effective.

Tacforius contains the active substance tacrolimus and is a ‘generic medicine’. This means that Tacforius contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Advagraf.

How is Tacforius used?

Tacforius is available as prolonged-release capsules containing tacrolimus. The prolonged-release capsules allow tacrolimus to be released slowly from the capsule over several hours so that it needs to be taken only once a day.

Doses of Tacforius are calculated on the basis of the patient’s weight and the type of transplant the patient has had. Starting doses are between 0.1 and 0.3 mg per kg bodyweight daily. The doses are then adjusted according to the patient’s response and the medicine’s blood levels. Tacforius should be taken once daily with water, on an empty stomach. For further information, see the package leaflet.

Tacforius can only be obtained with a prescription. Only doctors experienced in immunosuppressive medicines and in the management of transplant patients should prescribe it and make changes to immunosuppressive treatment.

How does Tacforius work?

Tacrolimus, the active substance in Tacforius, is an immunosuppressive medicine. Tacrolimus reduces the activity of cells in the immune system, called T-cells, that are primarily involved in attacking the transplanted organ (organ rejection).

How has Tacforius been studied?

Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Advagraf, and do not need to be repeated for Tacforius.

As for every medicine, the company provided studies on the quality of Tacforius. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Tacforius?

Because Tacforius 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.

Why is Tacforius approved?

The European Medicines Agency concluded that, in accordance with EU requirements, Tacforius has been shown to have comparable quality and to be bioequivalent to Advagraf. Therefore, the Agency’s view was that, as for Advagraf, the benefit outweighs the identified risk. The Agency recommended that Tacforius be approved for use in the EU.

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

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tacforius have been included in the summary of product characteristics and the package leaflet.

Other information about Tacforius

The European Commission granted a marketing authorisation valid throughout the European Union for Tacforius on 8 December 2017.

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

Name Language First published Last updated
Tacforius : EPAR - Summary for the public BG = bălgarski 2018-01-26  
Tacforius : EPAR - Summary for the public ES = español 2018-01-26  
Tacforius : EPAR - Summary for the public CS = čeština 2018-01-26  
Tacforius : EPAR - Summary for the public DA = dansk 2018-01-26  
Tacforius : EPAR - Summary for the public DE = Deutsch 2018-01-26  
Tacforius : EPAR - Summary for the public ET = eesti keel 2018-01-26  
Tacforius : EPAR - Summary for the public EL = elliniká 2018-01-26  
Tacforius : EPAR - Summary for the public EN = English 2018-01-26  
Tacforius : EPAR - Summary for the public FR = français 2018-01-26  
Tacforius : EPAR - Summary for the public IT = italiano 2018-01-26  
Tacforius : EPAR - Summary for the public LV = latviešu valoda 2018-01-26  
Tacforius : EPAR - Summary for the public LT = lietuvių kalba 2018-01-26  
Tacforius : EPAR - Summary for the public HU = magyar 2018-01-26  
Tacforius : EPAR - Summary for the public MT = Malti 2018-01-26  
Tacforius : EPAR - Summary for the public NL = Nederlands 2018-01-26  
Tacforius : EPAR - Summary for the public PL = polski 2018-01-26  
Tacforius : EPAR - Summary for the public PT = português 2018-01-26  
Tacforius : EPAR - Summary for the public RO = română 2018-01-26  
Tacforius : EPAR - Summary for the public SK = slovenčina 2018-01-26  
Tacforius : EPAR - Summary for the public SL = slovenščina 2018-01-26  
Tacforius : EPAR - Summary for the public FI = suomi 2018-01-26  
Tacforius : EPAR - Summary for the public SV = svenska 2018-01-26  
Tacforius : EPAR - Summary for the public HR = Hrvatski 2018-01-26  

This EPAR was last updated on 26/01/2018 .

Authorisation details

Product details

Product details for Tacforius
NameTacforius
Agency product numberEMEA/H/C/004435
Active substance

tacrolimus monohydrate

International non-proprietary name (INN) or common name

tacrolimus

Therapeutic area Kidney TransplantationLiver Transplantation
Anatomical therapeutic chemical (ATC) code L04AD02
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 Tacforius
Marketing-authorisation holder

Teva B.V.

Revision0
Date of issue of marketing authorisation valid throughout the European Union08/12/2017

Contact address:

Swensweg 5 
2031 GA Haarlem
Netherlands

Product information

Product information

08/12/2017  Tacforius -EMEA/H/C/004435 --

Name Language First published Last updated
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  
Tacforius : EPAR - Product Information HR = Hrvatski 2018-01-26  

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
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  
Tacforius : EPAR - All Authorised presentations HR = Hrvatski 2018-01-26  

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.

Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Tacforius : EPAR - Public assessment report HR = Hrvatski 2018-01-26  
CHMP summary of positive opinion for Tacforius HR = Hrvatski 2017-10-13  

Authorised

This medicine is approved for use in the European Union

More information on Tacforius