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🇪🇺EU · EMAAuthorisedATC: L01EA02

Dasatinib Accord Healthcare(Dasatinib monohydrate)

Precursor Cell Lymphoblastic Leukemia-Lymphoma;Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Marketing Authorisation Holder: Accord Healthcare S.L.U.

EMA Authorisation: 26/07/2024

INN: dasatinib

Indication

Dasatinib Accord Healthcare is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib. Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.  Dasatinib Accord Healthcare is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ ALL in combination with chemotherapy.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.