Myclausen
Authorised
This medicine is authorised for use in the European Union
mycophenolate mofetil
MedicineHumanAuthorised
Overview
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.
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.
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.
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).
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.
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.
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.
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.
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.
Product information
Latest procedure affecting product information: PSUSA/00010550/202305
27/03/2024
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).
Product details
- Name of medicine
- Myclausen
- 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
ImmunosuppressantsTherapeutic 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.
News on Myclausen
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