SIMULECT

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug SIMULECT contains one active pharmaceutical ingredient (API):

1 Basiliximab UNII 9927MT646M - BASILIXIMAB

Basiliximab is a murine/human chimeric monoclonal antibody (IgG1κ) that is directed against the interleukin-2 receptor α-chain (CD25 antigen), which is expressed on the surface of T-lymphocytes in response to antigenic challenge. Basiliximab specifically binds with high affinity (KD-value 0.1 nM) to the CD25 antigen on activated T-lymphocytes expressing the high affinity interleukin-2 receptor (IL-2R) and thereby prevents binding of interleukin-2, a critical signal for T-cell proliferation in the cellular immune response involved in allograft rejection. Read about Basiliximab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
Simulect 10mg and 20mg powder and solvent for solution for injection or infusion	Medicines & Healthcare Products Regulatory Agency (GB)	MPI, EU: SmPC
SIMULECT Powder and solvent for solution for injection/infusion / Powder for solution for injection or infusion	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
L04AC02	Basiliximab	L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AC Interleukin inhibitors
Discover more medicines within L04AC02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 526513901154419, 526518070093607
Country: CA	Health Products and Food Branch	Identifier(s): 02242815
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 22.508-1-03-06
Country: EE	Ravimiamet	Identifier(s): 1040117, 1210059
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 98084001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 013783, 522706
Country: FR	Base de données publique des médicaments	Identifier(s): 68944294, 69890052
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 47735, 50079
Country: HK	Department of Health Drug Office	Identifier(s): 44725
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7006
Country: IT	Agenzia del Farmaco	Identifier(s): 034232013
Country: JP	医薬品医療機器総合機構	Identifier(s): 6399418D1032, 6399418D2020
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1006242, 1030800, 1074720
Country: NL	Z-Index G-Standaard	Identifier(s): 14233746, 14884755
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 51330, 69876
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 8188
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100125626, 100316148
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64598001
Country: SG	Health Sciences Authority	Identifier(s): 10441P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 1243051H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699504790405
Country: US	FDA, National Drug Code	Identifier(s): 0078-0331, 0078-0393
Country: ZA	Health Products Regulatory Authority	Identifier(s): 32/30.4/0752