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12 result(s) found, displaying 1 to 10
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Australian public assessment report (AusPar)Enrylaze (crisantaspase) has been approved as a component of a multi-agent chemotherapeutic regimen, for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adults and paediatric patients (1 month and older) who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for ENRYLAZE recombinant crisantaspase 10 mg/0.5 mL solution for injection/infusion vial.
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Prescription medicine registrationActive ingredients: crisantaspase.
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Designation or determinationOrphan drug
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for VYXEOS daunorubicin (as hydrochloride) 44 mg and cytarabine 100 mg powder for injection vial.
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Australian public assessment report (AusPar)New AusPAR for Vyxeos (daunorubicin and cytarabine) for the treatment of acute myeloid leukaemia.
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Designation or determinationOrphan drug
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Prescription medicine decision summaryTGA decision: VYXEOS (daunorubicin and cytarabine) is approved to treat therapy-related acute myeloid leukaemia and AML-MRC.
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Prescription medicine registrationActive ingredients: daunorubicin hydrochloride, cytarabine.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for EPIDYOLEX cannabidiol 100 mg/mL oral liquid solution bottle.