mycophenolate mofetil

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Myclausen. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Myclausen.

This EPAR was last updated on 04/08/2022

Authorisation details

Product details
Agency product number
Active substance
mycophenolate mofetil
International non-proprietary name (INN) or common name
mycophenolate mofetil
Therapeutic area (MeSH)
Graft Rejection
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.

Publication details
Marketing-authorisation holder
Passauer Pharma GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Eiderstedter Weg 3
14129 Berlin

Product information

01/08/2022 Myclausen - EMEA/H/C/001218 - IB/0054/G

Other EU languages available icon 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.

Pharmacotherapeutic group


Therapeutic indication

Myclausen is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

Assessment history

How useful was this page?

Add your rating