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EMA Product

Tacforius

Product approved by European Medicines Agency (EU)

Basic Information

Tacforius

Regulatory Information

EMEA/H/C/004435

Authorised

December 8, 2017

October 12, 2017

10

December 11, 2024

Company Information

Netherlands

Swensweg 5 2031 GA Haarlem

Teva Pharma B.V.

Drug Classification

Generic Medicine

Active Substances Detail

tacrolimus monohydrate

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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.

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