o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/665088/2012

EMEA/H/C/000884

EPAR summary for the public

Myfenax

mycophenolate mofetil

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. For more information on generic medicines, see the question-and-answer document here.

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.

7 Westferry Circus • Canary Wharf • London E14 4HB • United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu

© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

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.

The full EPAR for Myfenax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Myfenax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the EMEA's website.

This summary was last updated in 11-2012.

Myfenax

EMA/665088/2012