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).
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.
Therapeutic Area (MeSH)
ATC Code
L04AC02
ATC Item
basiliximab
Pharmacotherapeutic Group
Immunosuppressants
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| basiliximab | N/A | Basiliximab |
EMA Name
Simulect
Medicine Name
Simulect
Aliases
N/ANo risk management plan link.
