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.

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.

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.

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).

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.

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.

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.

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.

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

български (BG) (92.89 KB - PDF)
español (ES) (57.06 KB - PDF)
čeština (CS) (83.22 KB - PDF)
dansk (DA) (54.93 KB - PDF)
Deutsch (DE) (56.93 KB - PDF)
eesti keel (ET) (55.56 KB - PDF)
ελληνικά (EL) (94.74 KB - PDF)
français (FR) (118.7 KB - PDF)
italiano (IT) (118.6 KB - PDF)
latviešu valoda (LV) (82.11 KB - PDF)
lietuvių kalba (LT) (141.31 KB - PDF)
magyar (HU) (79.47 KB - PDF)
Malti (MT) (82.67 KB - PDF)
Nederlands (NL) (56.29 KB - PDF)
polski (PL) (143.67 KB - PDF)
português (PT) (118.01 KB - PDF)
română (RO) (140.47 KB - PDF)
slovenčina (SK) (79.55 KB - PDF)
slovenščina (SL) (137.87 KB - PDF)
Suomi (FI) (115.49 KB - PDF)
svenska (SV) (115.72 KB - PDF)

Product information

Mycophenolate mofetil Teva : EPAR - Product Information

български (BG) (596.42 KB - PDF)
español (ES) (687.91 KB - PDF)
čeština (CS) (711.96 KB - PDF)
dansk (DA) (472.9 KB - PDF)
Deutsch (DE) (737.58 KB - PDF)
eesti keel (ET) (813.93 KB - PDF)
ελληνικά (EL) (789.6 KB - PDF)
français (FR) (581.25 KB - PDF)
hrvatski (HR) (532.09 KB - PDF)
íslenska (IS) (418.35 KB - PDF)
italiano (IT) (448.63 KB - PDF)
latviešu valoda (LV) (564.19 KB - PDF)
lietuvių kalba (LT) (553.92 KB - PDF)
magyar (HU) (560.03 KB - PDF)
Malti (MT) (670.94 KB - PDF)
Nederlands (NL) (641.88 KB - PDF)
norsk (NO) (431.67 KB - PDF)
polski (PL) (653.65 KB - PDF)
português (PT) (438.63 KB - PDF)
română (RO) (583.43 KB - PDF)
slovenčina (SK) (579.91 KB - PDF)
slovenščina (SL) (650.19 KB - PDF)
Suomi (FI) (444.76 KB - PDF)
svenska (SV) (649.96 KB - PDF)

Latest procedure affecting product information: IB/0046/G

24/06/2022

Globe icon

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Mycophenolate mofetil Teva : EPAR - All Authorised presentations

български (BG) (48.99 KB - PDF)
español (ES) (11.38 KB - PDF)
čeština (CS) (24.95 KB - PDF)
dansk (DA) (10.69 KB - PDF)
Deutsch (DE) (9.74 KB - PDF)
eesti keel (ET) (11.28 KB - PDF)
ελληνικά (EL) (48.34 KB - PDF)
français (FR) (13.6 KB - PDF)
hrvatski (HR) (51.8 KB - PDF)
íslenska (IS) (13.43 KB - PDF)
italiano (IT) (10.43 KB - PDF)
latviešu valoda (LV) (41.08 KB - PDF)
lietuvių kalba (LT) (43.71 KB - PDF)
magyar (HU) (56.69 KB - PDF)
Malti (MT) (42.95 KB - PDF)
Nederlands (NL) (9.5 KB - PDF)
norsk (NO) (10.3 KB - PDF)
polski (PL) (41.57 KB - PDF)
português (PT) (11.76 KB - PDF)
română (RO) (45.01 KB - PDF)
slovenčina (SK) (28.01 KB - PDF)
slovenščina (SL) (27.18 KB - PDF)
Suomi (FI) (10.69 KB - PDF)
svenska (SV) (11.06 KB - PDF)

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
25

Assessment history

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

Mycophenolate mofetil Teva-H-C-PSUSA-00010550-202105 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Mycophenolate mofetil Teva-PSUSA-00010550-201705 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Mycophenolate mofetil Teva : EPAR - Public assessment report

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

This page was last updated on

How useful do you find this page?