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Australian Public Assessment Report (AusPAR)Fetroja (cefiderocol) has been approved for the treatment of infections due to proven or strongly suspected carbapenem-resistant aerobic Gram-negative organisms in adults with limited treatment options, including complicated urinary tract infections, pyelonephritis, hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
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Australian Public Assessment Report (AusPAR)Hibruka has provisional approval in Australia for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The decision to approve this indication has been made on the basis of overall response rate (ORR). Continued approval of this indication depends on verification and description of benefit in confirmatory trials.
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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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Prescription medicine registrationActive ingredients: orelabrutinib.
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Designation or determinationProvisional determination
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Designation or determinationOrphan drug