Is Basiliximab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Basiliximab, including SIMULECT 20 MG I.V VIAL (20 mg, Powder and solvent for solution for injection, SAR 4922.75).

Is Basiliximab approved by the US FDA?

Drugs@FDA lists 1 application product line for Basiliximab, including SIMULECT (Prescription).

Is Basiliximab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Basiliximab: Simulect.

Are there safety signals or safety updates for Basiliximab?

EMA PRAC: 3 entries; MHRA: 1 entry (latest 2014-12-11).

Active substance

Basiliximab

SFDA 1
US FDA 1
EMA 1
Health Canada 1
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
SIMULECT 20 MG I.V VIAL	20 mg	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 4922.75	NCE · Prescription	NOVARTIS PHARMA AG	Valid

Indications — CHI Daman Drug Formulary

GRAFT VERSUS HOST DISEASE - ACUTE; RENAL TRANSPLANT

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
SIMULECT	10MG; 20MG	vial · single-use	NOVARTIS	Prescription	12 May 1998

EMA European Union — centrally authorised medicines

Simulect Novartis Europharm Limited · Authorised · authorised 9 Oct 1998 · ATC L04AC02

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SIMULECT	02242815	20 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	NOVARTIS PHARMACEUTICALS CANADA INC

Safety signals and safety-related labeling changes

MHRA 11 Dec 2014 Basiliximab: indicated for renal transplantation only; efficacy and safety not shown in heart transplantation
Basiliximab (Simulect) is indicated for preventing acute organ rejection only for allogeneic renal transplantation in patients receiving organ transplantation for the first time.
EMA PRAC 6 Feb 2014 PRAC signal: Cardiovascular instability resulting in fatal outcome following off-label use in heart transplantation
Action for MAH: update of the product information: Yes
EMA PRAC 16 May 2013 PRAC signal: Cardiovascular instability resulting in fatal outcome following off-label use in heart transplantation
Action for MAH: update of the product information: No
EMA PRAC 7 Feb 2013 PRAC signal: Cardiovascular instability resulting in fatal outcome following off-label use in heart transplantation
Action for MAH: update of the product information: No

All safety entries for basiliximab →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.