KESIMPTA

This brand name is authorized in Brazil, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United Kingdom, United States

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 about Ofatumumab

Medication package inserts

Below package inserts are available for further reading:

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