Basic Information
Simulect
Regulatory Information
EMEA/H/C/000207
October 9, 1998
June 23, 1998
29
December 18, 2024
Company Information
Ireland
Vista Building Elm Park Merrion Road Dublin 4
NOVARTIS EUROPHARM LIMITED
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Simulect is indicated for the prophylaxis of acute organ rejection in de-novo allogeneic renal transplantation in adult and paediatric patients (1-17 years). It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.
Overview Summary
This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine. If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).