Tacforius

RSS

tacrolimus

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 26/01/2018

Authorisation details

Product details
Name
Tacforius
Agency product number
EMEA/H/C/004435
Active substance
tacrolimus monohydrate
International non-proprietary name (INN) or common name
tacrolimus
Therapeutic area (MeSH)
  • Liver Transplantation
  • Kidney Transplantation
Anatomical therapeutic chemical (ATC) code
L04AD02
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 medicines.

Publication details
Marketing-authorisation holder
Teva B.V.
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
08/12/2017
Contact address
Swensweg 5
2031 GA Haarlem
Netherlands

Product information

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

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.

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

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