Modigraf

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tacrolimus

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

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 15/11/2022

Authorisation details

Product details
Name
Modigraf
Agency product number
EMEA/H/C/000954
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
Astellas Pharma Europe B.V.
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
15/05/2009
Contact address
Elisabethhof 19
NL-2353 EW Leiderdorp
The Netherlands

Product information

06/10/2022 Modigraf - EMEA/H/C/000954 - WS2241/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:

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.

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients.

Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.

Assessment history

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