EMA
approval
· 2025-09-19
EMA Authorised: Calquence (acalabrutinib;acalabrutinib maleate) — AstraZeneca AB
Summary
EMA authorised Calquence (acalabrutinib) for use in chronic lymphocytic leukemia and small lymphocytic lymphoma; the product is manufactured by AstraZeneca AB.
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Diseases / indications
Drugs mentioned
Snippet
Status: Authorised. Therapeutic area: Leukemia, Lymphocytic, Chronic, B-Cell. MAH: AstraZeneca AB. Decision date: 28/08/2025