Myfenax
mycophenolate mofetil
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Myfenax. 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 Myfenax.
Authorisation details
Product details | |
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Name |
Myfenax
|
Agency product number |
EMEA/H/C/000884
|
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 | |
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Marketing-authorisation holder |
Teva B.V.
|
Revision |
23
|
Date of issue of marketing authorisation valid throughout the European Union |
21/02/2008
|
Contact address |
Swensweg 5 |
Product information
01/02/2021 Myfenax - EMEA/H/C/000884 - IA/0043
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
Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.