Author: Teva Pharma B.V.


Long information

What is it?

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.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it 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 it 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.
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. Mycophenolate mofetil Teva is not recommended for use in children after heart or liver transplants because of a lack of information on its effects in this group.
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 it 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 it been studied?

Because Mycophenolate mofetil Teva is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine (they produce the same levels of the active substance in the body).

What benefits has it shown during the studies?

Because Mycophenolate mofetil Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

What is the risk associated?

Because Mycophenolate mofetil Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has it been approved?

The Committee for Medicinal Products for Human Use (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.

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