United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - basiliximab (unii: 9927mt646m) (basiliximab - unii:9927mt646m) - basiliximab 10 mg in 2.5 ml - simulect® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, usp (modified), and corticosteroids. the efficacy of simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated. simulect® (basiliximab) is contraindicated in patients with known hypersensitivity to basiliximab or any other component of the formulation. see composition of simulect under description. simulect® (basiliximab) should be administered under qualified medical supervision. patients should be informed of the potential benefits of therapy and the risks associated with administration of immunosuppressive therapy. while neither the incidence of lymphoproliferative disorders nor opportunistic infections was higher in simulect-treated patients than in placebo-treated patients, patients on immunosuppressive therapy are at increased risk for dev

Israel - English - Ministry of Health

novartis israel ltd - basiliximab - powder and solvent for solution for injection/infusion - basiliximab 20 mg/vial - basiliximab - basiliximab - prophylaxis of acute organ rejection in de novo renal transplantation in combination with cyclosporin and corticosteroid based immunosuppression

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - basiliximab, quantity: 20 mg - injection, powder for - excipient ingredients: sucrose; mannitol; glycine; monobasic potassium phosphate; sodium chloride; dibasic sodium phosphate - simulect is indicated for the prophylaxis of acute organ rejection in renal transplantation.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - basiliximab -

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - basiliximab - graft rejection; kidney transplantation - immunosuppressants - 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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - basiliximab - powder and solvent for solution for injection - 20mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - basiliximab - powder and solvent for solution for injection - 10mg

Canada - English - Health Canada

novartis pharmaceuticals canada inc - basiliximab - powder for solution - 20mg - basiliximab 20mg - immunosuppressive agents

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - basiliximab 10mg (murine/human; formulated with a 7.5% total overage);   - powder for injection - 10 mg - active: basiliximab 10mg (murine/human; formulated with a 7.5% total overage)   excipient: dibasic sodium phosphate glycine mannitol monobasic potassium phosphate sodium chloride sucrose water for injection - simulect is indicated for the prophylaxis of acute organ rejection in de novo renal transplantation in adult and paediatric patients. it is to be used concomitantly with cyclosporin for microemulsion- and corticosteroid-based immunosuppression or in a triple maintenance immunosuppressive regimen containing cyclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - basiliximab 20mg (murine/human; formulated with a 7.5% total overage) - powder for injection - 20 mg - active: basiliximab 20mg (murine/human; formulated with a 7.5% total overage) excipient: dibasic sodium phosphate glycine mannitol monobasic potassium phosphate sodium chloride sucrose water for injection - simulect is indicated for the prophylaxis of acute organ rejection in de novo renal transplantation in adult and paediatric patients. it is to be used concomitantly with cyclosporin for microemulsion- and corticosteroid-based immunosuppression or in a triple maintenance immunosuppressive regimen containing cyclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.