BESPONSA

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

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 more about Inotuzumab ozogamicin

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
BESPONSA Powder for concentrate for solution for infusion	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

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

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