Mycophenolate mofetil Teva

mycophenolate mofetil

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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.

Name Language First published Last updated
Mycophenolate mofetil Teva : EPAR - Summary for the public BG = bălgarski 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public ES = español 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public CS = čeština 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public DA = dansk 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public DE = Deutsch 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public ET = eesti keel 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public EL = elliniká 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public EN = English 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public FR = français 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public IT = italiano 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public LV = latviešu valoda 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public LT = lietuvių kalba 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public HU = magyar 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public MT = Malti 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public NL = Nederlands 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public PL = polski 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public PT = português 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public RO = română 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public SK = slovenčina 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public SL = slovenščina 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public FI = suomi 2008-03-10 2012-12-11
Mycophenolate mofetil Teva : EPAR - Summary for the public SV = svenska 2008-03-10 2012-12-11

This EPAR was last updated on 09/04/2018 .

Authorisation details

Product details

Product details for Mycophenolate mofetil Teva
NameMycophenolate mofetil Teva
Agency product numberEMEA/H/C/000882
Active substance

mycophenolate mofetil

International non-proprietary name (INN) or common name

mycophenolate mofetil

Therapeutic area Graft Rejection
Anatomical therapeutic chemical (ATC) code L04AA06
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Mycophenolate mofetil Teva
Marketing-authorisation holder

Teva Pharma B.V.

Revision19
Date of issue of marketing authorisation valid throughout the European Union21/02/2008

Contact address:

Teva Pharma B.V.
Computerweg 10
NL-3542 DR Utrecht
The Netherlands

Product information

Product information

19/03/2018  Mycophenolate mofetil Teva -EMEA/H/C/000882 -N/0030

Name Language First published Last updated
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09
Mycophenolate mofetil Teva : EPAR - Product Information SV = svenska 2009-10-15 2018-04-09

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20
Mycophenolate mofetil Teva : EPAR - All Authorised presentations SV = svenska 2008-03-10 2016-05-20

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.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Authorised

This medicine is approved for use in the European Union

More information on Mycophenolate mofetil Teva