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ARTGAustralian Register of Therapeutic Goods (ARTG) information for HIBRUKA orelabrutinib 50 mg tablet bottle.
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Prescription medicine decision summaryHibruka (orelabrutinib) has provisional approval in Australia for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
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Mar-2025Prescription medicine evaluationActive ingredient: Orelabrutinib.
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Designation or determinationOrphan drug
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Designation or determinationProvisional determination