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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/664784/2012

EMEA/H/C/000882

EPAR summary for the public

Mycophenolate mofetil Teva

mycophenolate mofetil

This is a summary of the European public assessment report (EPAR) for Mycophenolate mofetil Teva. 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 Mycophenolate mofetil Teva.

What is Mycophenolate mofetil Teva?

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

Mycophenolate mofetil Teva is a 'generic medicine'. This means that Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva used for?

Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva used?

Mycophenolate mofetil Teva treatment should be initiated and maintained by a qualified transplant specialist.

The way that Mycophenolate mofetil Teva should be given and the dose depend on the type of organ transplant and the patient's age and size.

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© 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 Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva work?

The active substance in Mycophenolate mofetil Teva, 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, Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva been studied?

Because Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva?

Because Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva been approved?

The CHMP concluded that, in accordance with EU requirements, Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva be given marketing authorisation.

Other information about Mycophenolate mofetil Teva

The European Commission granted a marketing authorisation valid throughout the European Union for Mycophenolate mofetil Teva on 21 February 2008.

The full EPAR for Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva, 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.

Mycophenolate mofetil Teva

EMA/664784/2012

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