Myclausen

mycophenolate mofetil

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This is a summary of the European public assessment report (EPAR) for Myclausen. 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 Myclausen.

What is Myclausen?

Myclausen is a medicine that contains the active substance mycophenolate mofetil. It is available as white, round tablets (500 mg) and capsules (250 mg).

Myclausen is a ‘generic medicine’. This means that Myclausen is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Cellcept.

What is Myclausen used for?

Myclausen 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 Myclausen used?

Myclausen treatment should be initiated and maintained by a qualified transplant specialist.

The way that Myclausen should be given and the dose depend on the type of organ transplant.

For kidney transplants, the recommended dose in adults is 1 g twice a day by mouth starting within 72 hours after the transplant. In children aged between two and 18 years, the dose of Myclausen 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 Myclausen 1.5 g twice a day as soon as it can be tolerated. Myclausen 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 Myclausen work?

The active substance in Myclausen, 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, Myclausen 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 Myclausen been studied?

Because Myclausen 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 benefit and risk of Myclausen?

Because Myclausen 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 Myclausen been approved?

The CHMP concluded that, in accordance with EU requirements, Myclausen 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 Myclausen be given marketing authorisation.

Other information about Myclausen

The European Commission granted a marketing authorisation valid throughout the EU for Myclausen on 7 October 2010.

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

Name Language First published Last updated
Myclausen : EPAR - Summary for the public BG = bălgarski 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public ES = español 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public CS = čeština 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public DA = dansk 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public DE = Deutsch 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public ET = eesti keel 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public EL = elliniká 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public EN = English 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public FR = français 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public IT = italiano 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public LV = latviešu valoda 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public LT = lietuvių kalba 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public HU = magyar 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public MT = Malti 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public NL = Nederlands 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public PL = polski 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public PT = português 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public RO = română 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public SK = slovenčina 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public SL = slovenščina 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public FI = suomi 2010-10-14 2011-11-25
Myclausen : EPAR - Summary for the public SV = svenska 2010-10-14 2011-11-25

This EPAR was last updated on 25/10/2016 .

Authorisation details

Product details

Product details for Myclausen
NameMyclausen
Agency product numberEMEA/H/C/001218
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 Myclausen
Marketing-authorisation holder

Passauer Pharma GmbH

Revision11
Date of issue of marketing authorisation valid throughout the European Union07/10/2010

Contact address:

Passauer Pharma GmbH
Eiderstedter Weg 3
14129 Berlin
Germany

Product information

Product information

13/10/2016  Myclausen -EMEA/H/C/001218 -N/0038

Name Language First published Last updated
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25
Myclausen : EPAR - Product Information SV = svenska 2010-10-14 2016-10-25

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
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29
Myclausen : EPAR - All Authorised presentations SV = svenska 2010-10-14 2016-02-29

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Myclausen 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

Name Language First published Last updated
Myclausen : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2011-03-07 2016-10-25

Initial marketing-authorisation documents

Name Language First published Last updated
Myclausen : EPAR - Public assessment report SV = svenska 2010-10-14  
CHMP positive summary of opinion for Myclausen SV = svenska 2010-07-23  

Authorised

This medicine is approved for use in the European Union

More information on Myclausen