What is Mycophenolate Mofetil Teva?
Mycophenolate mofetil Teva is a medicine that contains the active substance mycophenolate mofetil. It is available as capsules (250 mg) and tablets (500 mg).
Mycophenolate mofetil Teva is a "generic medicine", which means that it is similar to a "reference drug", already authorized in the European Union (EU), called CellCept. For more information on generic medicines, see the questions and answers by clicking here.
What is Mycophenolate Mofetil Teva used for?
Mycophenolate mofetil Teva is used to prevent the rejection of a renal, cardiac or hepatic transplant by the body. It is used with cyclosporine and corticosteroids (other medicines used to prevent organ rejection).
The medicine can only be obtained with a prescription.
How is Mycophenolate Mofetil Teva used?
Treatment with mycophenolate mofetil Teva should be started and continued by appropriately qualified transplant specialists.
The way in which Mycophenolate Mofetil Teva should be administered and the dose depend on the type of organ transplanted, as well as the age and build of the patient.
For kidney transplants, the recommended dose in adults is 1.0 g twice a day within the first 72 hours after transplantation. In children and adolescents aged 2 to 18 years, the dose of mycophenolate mofetil Teva is calculated according to height and weight.
For heart transplants, the recommended dose in adults is 1.5 g twice a day, starting within the first five days after the transplant.
For liver transplants in adults, mycophenolate mofetil should be administered intravenously (drip into a vein) for the first four days after transplantation, then switched to 1.5 g of mycophenolate mofetil Teva twice a day when it can be tolerated. The use of mycophenolate mofetil Teva is not recommended in children and adolescents after a cardiac or hepatic transplant, due to the lack of information on its effects on this group of patients.
In patients with kidney or liver disease it may be necessary to adjust the dose. For more information, see the summary of product characteristics, also included with 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 transformed into mycophenolic acid which inhibits an enzyme called "inosine-monophosphate-dehydrogenase". This enzyme is important for the formation of DNA in cells, particularly in lymphocytes (a type of white blood cell that contributes to the rejection of transplanted organs). By inhibiting the production of new DNA, Mycophenolate Mofetil Teva reduces the speed of multiplication of lymphocytes, therefore the effectiveness of the latter in recognizing and attacking the transplanted organ, with consequent lower risk of rejection of the same.
What studies have been performed on Mycophenolate Mofetil Teva?
Since mycophenolate mofetil Teva is a generic medicine, studies have limited itself to demonstrating that the drug is bioequivalent to the reference drug (they produce the same amounts of active ingredient in the body).
What are the benefits and risks of mycophenolate mofetil Teva?
Since mycophenolate mofetil Teva is a generic medicine and is bioequivalent to the reference drug, the benefits and risks are assumed to be the same as the latter.
Why has Mycophenolate Mofetil Teva been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, based on the requirements in the EU, mycophenolate mofetil Teva has been shown to have comparable quality and to be bioequivalent to CellCept. The CHMP is therefore of the opinion that, as in the case of CellCept, the benefits outweigh the identified risks. The Committee recommended the granting of a marketing authorization for Mycophenolate Mofetil Teva.
More information about Mycophenolate Mofetil Teva:
On 21 February 2008, the European Commission granted a marketing authorization valid for the whole of the European Union for Mycophenolate Mofetil Teva to Teva Pharma BV.
For the full EPAR version of Mycophenolate Mofetil Teva click here.
The full EPAR of the reference drug can also be consulted on the EMEA website.
Last update of this summary: 01-2008.
