KESIMPTA

This brand name is authorized in United States. It is also authorized in Brazil, Croatia, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, UK.

Active ingredients

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

1	Ofatumumab UNII M95KG522R0 - OFATUMUMAB
	Ofatumumab is a human monoclonal antibody (IgG1) that binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule. The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from the pre-B to mature B lymphocyte stage and on B-cell tumours. The binding of ofatumumab to the membrane-proximal epitope of the CD20 molecule induces recruitment and activation of the complement pathway at the cell surface, leading to complement dependent cytotoxicity and resultant lysis of tumour cells.
	Read more about Ofatumumab

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
KESIMPTA Solution for injection	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
L01FA02	Ofatumumab	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FA CD20 (Clusters of Differentiation 20) inhibitors
Discover more medicines within L01FA02
L04AG12		L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AG Monoclonal antibodies
Discover more medicines within L04AG12

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	526521080099402
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	236-MBE-0822
EE	Ravimiamet	1845491, 1845503, 1845514, 1845525
FI	Lääkealan turvallisuus- ja kehittämiskeskus	031172
FR	Base de données publique des médicaments	60596291, 60690011
GB	Medicines & Healthcare Products Regulatory Agency	396082
HK	Department of Health Drug Office	67210
IE	Health Products Regulatory Authority	89128
IL	מִשְׂרַד הַבְּרִיאוּת	8900
IT	Agenzia del Farmaco	049429018, 049429020, 049429032, 049429044
JP	医薬品医療機器総合機構	1190405G1024
LT	Valstybinė vaistų kontrolės tarnyba	1092335, 1092336, 1092337, 1092338
PL	Rejestru Produktów Leczniczych	100450780
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W67565001, W67565002
US	FDA, National Drug Code	0078-1007