Simulect (basiliximab)
- Region
- 🇪🇺 EU
- Active substance
- basiliximab
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Graft Rejection; Kidney Transplantation
- CHMP opinion
- Tue 23 Jun 1998
- EU approval
- Fri 09 Oct 1998
- Application
- EMEA/H/C/000207
- ATC
- L04AC02
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.