CALQUENCE

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

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 more about Acalabrutinib

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
CALQUENCE Hard capsule	MPI, EU: SmPC	European Medicines Agency (EU)
CALQUENCE Film-coated tablet	MPI, EU: SmPC	European Medicines Agency (EU)
CALQUENCE Capsule	MPI, US: SPL/PLR	FDA, National Drug Code (US)

Medicine classification

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

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