Myclausen

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mycophenolate mofetil

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

Overview

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 04/04/2018

Authorisation details

Product details
Name
Myclausen
Agency product number
EMEA/H/C/001218
Active substance
mycophenolate mofetil
International non-proprietary name (INN) or common name
mycophenolate mofetil
Therapeutic area (MeSH)
Graft Rejection
Anatomical therapeutic chemical (ATC) code
L04AA06
Generic

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
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
06/10/2010
Contact address
Eiderstedter Weg 3
14129 Berlin
Germany

Product information

05/03/2018 Myclausen - EMEA/H/C/001218 - PSUSA/00010550/201705

Contents

  • 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.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Immunosuppressants

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

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