Envarsus

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 Envarsus. 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 Envarsus.

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

This EPAR was last updated on 16/08/2019

Authorisation details

Product details
Name
Envarsus
Agency product number
EMEA/H/C/002655
Active substance
tacrolimus
International non-proprietary name (INN) or common name
tacrolimus
Therapeutic area (MeSH)
Graft Rejection
Anatomical therapeutic chemical (ATC) code
L04AD02
Publication details
Marketing-authorisation holder
Chiesi Farmaceutici S.p.A.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
18/07/2014
Contact address
Via Palermo 26/A
43122 Parma
Italy

Product information

06/06/2019 Envarsus - EMEA/H/C/002655 - R/0014

Contents

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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