Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Calquence 100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Orange, 7.5 × 13 mm, oval, biconvex tablet, debossed with ‘ACA 100’ on one side and plain on the reverse. |
Each film-coated tablet contains 100 mg of acalabrutinib (as acalabrutinib maleate).
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 |
|---|
|
Tablet core: Mannitol (E421) Tablet coating: Hypromellose (E464) |
Aluminium/Aluminium blister packs with sun/moon symbols containing 8 or 10 film-coated tablets. Cartons of 56 or 60 tablets.
Not all pack sizes may be marketed.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
EU/1/20/1479/003
EU/1/20/1479/004
Date of first authorisation: 05 November 2020
| 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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