The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Jazz Pharmaceuticals ANZ Pty Ltd
Regulatory activities for this sponsor.
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4 result(s) found, displaying 1 to 4
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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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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.