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
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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.
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16/04/2020 Tacforius - EMEA/H/C/004435 - IB/0004/G
- 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.
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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.