BRUKINSA

This brand name is authorized in Austria, Cyprus, Ecuador, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom, United States

Active ingredients

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

1 Zanubrutinib UNII AG9MHG098Z - ZANUBRUTINIB

Zanubrutinib is an inhibitor of Bruton’s tyrosine kinase (BTK). Zanubrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK activity. BTK is a signalling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. Read about Zanubrutinib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
BRUKINSA Capsule	FDA, National Drug Code (US)	MPI, US: SPL/PLR

Medicine classification

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

ATC code	Group title	Classification
L01EL03		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EL Bruton's tyrosine kinase (BTK) inhibitors
Discover more medicines within L01EL03

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 6861-MEE-1221
Country: EE	Ravimiamet	Identifier(s): 1867798
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1211576001
Country: FR	Base de données publique des médicaments	Identifier(s): 65919841
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8764
Country: IT	Agenzia del Farmaco	Identifier(s): 049782016
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1093771
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100461024
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W69200001
Country: US	FDA, National Drug Code	Identifier(s): 72579-011