CALQUENCE Hard capsule Ref.[51592] Active ingredients: Acalabrutinib

Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden

Product name and form

Calquence 100 mg hard capsules.

Pharmaceutical Form
Hard capsule (capsule). Yellow body, blue cap, size 1 (20 mm) hard capsule, marked with “ACA 100 mg” in black ink.

Qualitative and quantitative composition

Each hard capsule contains 100 mg of acalabrutinib.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
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.

List of Excipients
Capsule content: Microcrystalline cellulose Colloidal anhydrous silica Partially pregelatinised maize starch Magnesium stearate (E470b) Sodium starch glycollate Capsule shell: Gelatin Titanium dioxide (E171) Yellow iron oxide (E172) Indigo carmine (E132) Printing ink: Shellac Black iron oxide (E172) Propylene glycol (E1520) Ammonium hydroxide

Pack sizes and marketing

Aluminium/Aluminium blisters with sun/moon symbols containing 6 or 8 hard capsules. Cartons of 56 or 60 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Marketing authorization dates and numbers

EU/1/20/1479/001
EU/1/20/1479/002

Date of first authorisation: 05 November 2020

Drugs

Drug	Countries
CALQUENCE	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

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