Myfenax

mycophenolate mofetil

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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.

What is Myfenax?

Myfenax is a medicine containing the active substance mycophenolate mofetil. It is available as capsules (250 mg) and tablets (500 mg).

Myfenax is a ‘generic medicine’. This means that Myfenax is similar to a ‘reference medicine’ already authorised in the European Union (EU) called CellCept.

What is Myfenax used for?

Myfenax is used to prevent the body from rejecting a transplanted kidney, heart or liver. It is used with ciclosporin and corticosteroids (other medicines used to prevent organ rejection).

The medicine can only be obtained with a prescription.

How is Myfenax used?

Myfenax treatment should be initiated and maintained by a qualified transplant specialist.

The way that Myfenax should be given and the dose depend on the type of organ transplant and the patient’s age and size.

For kidney transplants, the recommended dose in adults is 1.0 g twice a day starting within 72 hours after the transplant. In children aged between two and 18 years, the dose of Myfenax is calculated depending on height and weight.

For heart transplants, the recommended adult dose is 1.5 g twice a day, starting within five days following the transplant.

For liver transplants in adults, mycophenolate mofetil should be given as an infusion (drip into a vein) for the first four days after the transplant, before the patient is switched to 1.5 g Myfenax twice a day as soon as it can be tolerated.

The dose may need to be adjusted in patients with liver or kidney disease. For more information, see the summary of product characteristics (also part of the EPAR).

How does Myfenax work?

The active substance in Myfenax, mycophenolate mofetil, is an immunosuppressive medicine. In the body, it is converted into mycophenolic acid, which blocks an enzyme called ‘inosine monophosphate dehydrogenase’. This enzyme is important for the formation of DNA in cells, particularly in the lymphocytes (a type of white blood cell which is involved in the rejection of organ transplants). By preventing the production of new DNA, Myfenax reduces the rate at which the lymphocytes multiply. This makes them less effective at recognising and attacking the transplanted organ, lowering the risk of the organ being rejected.

How has Myfenax been studied?

Because Myfenax is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, CellCept. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Myfenax?

Because Myfenax is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why has Myfenax been approved?

The CHMP concluded that, in accordance with EU requirements, Myfenax has been shown to have comparable quality and to be bioequivalent to CellCept. Therefore, the CHMP’s view was that, as for CellCept, the benefit outweighs the identified risk. The Committee recommended that Myfenax be given marketing authorisation.

Other information about Myfenax

The European Commission granted a marketing authorisation valid throughout the EU for Myfenax on 21 February 2008.

For more information about treatment with Myfenax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Myfenax : EPAR - Summary for the public BG = bălgarski 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public ES = español 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public CS = čeština 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public DA = dansk 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public DE = Deutsch 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public ET = eesti keel 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public EL = elliniká 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public EN = English 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public FR = français 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public IT = italiano 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public LV = latviešu valoda 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public LT = lietuvių kalba 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public HU = magyar 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public MT = Malti 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public NL = Nederlands 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public PL = polski 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public PT = português 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public RO = română 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public SK = slovenčina 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public SL = slovenščina 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public FI = suomi 2008-03-11 2012-12-11
Myfenax : EPAR - Summary for the public SV = svenska 2008-03-11 2012-12-11

This EPAR was last updated on 18/05/2018 .

Authorisation details

Product details

Product details for Myfenax
NameMyfenax
Agency product numberEMEA/H/C/000884
Active substance

mycophenolate mofetil

International non-proprietary name (INN) or common name

mycophenolate mofetil

Therapeutic area Graft Rejection
Anatomical therapeutic chemical (ATC) code L04AA06
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Myfenax
Marketing-authorisation holder

Teva B.V.

Revision19
Date of issue of marketing authorisation valid throughout the European Union21/02/2008

Contact address:

Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Product information

Product information

19/03/2018  Myfenax -EMEA/H/C/000884 -N/0030

Name Language First published Last updated
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18
Myfenax : EPAR - Product Information SV = svenska 2009-10-15 2018-07-18

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.


Name Language First published Last updated
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27
Myfenax : EPAR - All Authorised presentations SV = svenska 2008-03-11 2016-05-27

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.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Myfenax : EPAR - Public assessment report SV = svenska 2008-04-08  
Committee for medicinal products for human use, summary of positive opinion for Myfenax SV = svenska 2008-01-14  

Authorised

This medicine is approved for use in the European Union

More information on Myfenax