BESPONSA

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

Active ingredients

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

1 Inotuzumab ozogamicin UNII P93RUU11P7 - INOTUZUMAB OZOGAMICIN

Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of a recombinant humanised IgG4 kappa CD22-directed monoclonal antibody that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide. The small molecule, N-acetyl-gamma-calicheamicin, is a cytotoxic product. N-acetyl-gamma-calicheamicin is covalently attached to the antibody via an acid-cleavable linker. Activation of N-acetyl-gamma-calicheamicin dimethylhydrazide induces double-stranded DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death. Read about Inotuzumab ozogamicin

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
BESPONSA Powder for concentrate for solution for 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
L01FB01	Inotuzumab ozogamicin	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FB CD22 (Clusters of Differentiation 22) inhibitors
Discover more medicines within L01FB01

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 11668D, 11673J, 11680R, 11696N
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 522719060082602
Country: CA	Health Products and Food Branch	Identifier(s): 02473909
Country: EE	Ravimiamet	Identifier(s): 1749753
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1171200001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 437493
Country: FR	Base de données publique des médicaments	Identifier(s): 61847017
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 346463
Country: HK	Department of Health Drug Office	Identifier(s): 65947
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8286
Country: JP	医薬品医療機器総合機構	Identifier(s): 4239401D1026
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1083264
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 20366
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100392095
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64817001
Country: SG	Health Sciences Authority	Identifier(s): 15747P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8681308279194
Country: US	FDA, National Drug Code	Identifier(s): 0008-0100