CALQUENCE

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

Active ingredients

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

1 Acalabrutinib UNII I42748ELQW - ACALABRUTINIB

Acalabrutinib is a small-molecule inhibitor of BTK (Bruton’s tyrosine kinase). Acalabrutinib and its active metabolite, ACP-5862, form a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. In nonclinical studies, acalabrutinib inhibited BTK-mediated activation of downstream signaling proteins CD86 and CD69 and inhibited malignant B-cell proliferation and tumor growth in mouse xenograft models. Read about Acalabrutinib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
CALQUENCE Capsule	FDA, National Drug Code (US)	MPI, US: SPL/PLR
CALQUENCE Hard capsule	European Medicines Agency (EU)	MPI, EU: SmPC
CALQUENCE Film-coated tablet	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
L01EL02		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EL Bruton's tyrosine kinase (BTK) inhibitors
Discover more medicines within L01EL02

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): 12117R
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 502319040034002
Country: CA	Health Products and Food Branch	Identifier(s): 02491788
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 6428-MEE-0721
Country: EE	Ravimiamet	Identifier(s): 1831935, 1831946
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1201479002
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 479280
Country: FR	Base de données publique des médicaments	Identifier(s): 62599329
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 391553
Country: HK	Department of Health Drug Office	Identifier(s): 66870
Country: IE	Health Products Regulatory Authority	Identifier(s): 89107
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8293
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291070M1024
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1091311, 1091312
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 206644
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 21368
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100444521
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W67375001, W67375002
Country: SG	Health Sciences Authority	Identifier(s): 15753P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699786150010, 8699786150027
Country: US	FDA, National Drug Code	Identifier(s): 0310-0512
Country: ZA	Health Products Regulatory Authority	Identifier(s): 55/26/0390