Myfenax

Authorised

This medicine is authorised for use in the European Union

mycophenolate mofetil

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.

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.

Myfenax : EPAR - Summary for the public

Product information

Myfenax : EPAR - Product Information

Latest procedure affecting product information: PSUSA/00010550/202305

25/03/2024

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).

Myfenax : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Myfenax
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000884
• 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.

• Marketing authorisation holder:
  Teva B.V.

  Swensweg 5; 2031GA Haarlem; The Netherlands

• Opinion adopted:
  13/12/2007
• Marketing authorisation issued:
  21/02/2008
• Revision:
  28

Assessment history

Changes since initial authorisation of medicine

Myfenax : EPAR - Procedural steps taken and scientific information after authorisation

Myfenax H/C/PSUSA/00010550/202305 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/148370/2024

Myfenax-H-C-PSUSA-00010550-202105 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/45415/2022

Myfenax-PSUSA-00010550-201705 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/187794/2018

Initial marketing authorisation documents

Myfenax : EPAR - Public assessment report

CHMP summary of positive opinion for Myfenax

Reference Number: EMEA/CHMP/562878/2007, corr.