Mycophenolate mofetil Teva

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 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.

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.

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.

For more information about treatment with Mycophenolate mofetil Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Mycophenolate mofetil Teva : EPAR - Summary for the public

Product information

Mycophenolate mofetil Teva : EPAR - Product Information

Mycophenolate mofetil Teva : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Mycophenolate mofetil Teva
• 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

Mycophenolate mofetil Teva 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/000882
• 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 Pharma B.V.

  Computerweg 10; NL-3542 DR Utrecht; The Netherlands

• Opinion adopted:
  13/12/2007
• Marketing authorisation issued:
  21/02/2008
• Revision:
  26

Assessment history

Changes since initial authorisation of medicine

Mycophenolate mofetil Teva : EPAR - Procedural steps taken and scientific information after authorisation

Mycophenolate mofetil Teva-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

Mycophenolate mofetil Teva-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

Mycophenolate mofetil Teva-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

Mycophenolate mofetil Teva : EPAR - Public assessment report

Committee for medicinal products for human use, summary of positive opinion for Mycophenolate

Reference Number: EMEA/CHMP/563031/2007, corr