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EMA approval · 2025-09-19

EMA Authorised: Calquence (acalabrutinib;acalabrutinib maleate) — AstraZeneca AB

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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

  • CALQUENCE (ACALABRUTINIB)

Snippet

Status: Authorised. Therapeutic area: Leukemia, Lymphocytic, Chronic, B-Cell. MAH: AstraZeneca AB. Decision date: 28/08/2025