Table of contents
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.
Tacforius : EPAR - Summary for the public (PDF/91.94 KB)
First published: 26/01/2018
Last updated: 26/01/2018
Tacforius : EPAR - Risk management plan summary (PDF/174.86 KB)
First published: 19/08/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
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.
|Date of issue of marketing authorisation valid throughout the European Union||
2031 GA Haarlem
10/01/2023 Tacforius - EMEA/H/C/004435 - IB/0013/G
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.