Jazz Pharmaceuticals ANZ Pty Ltd
Regulatory activities for this sponsor.
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Sponsor content
11 result(s) found, displaying 1 to 10
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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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Oct-2023Prescription medicine evaluationActive ingredient: 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.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for DEFITELIO defibrotide 200 mg/2.5 mL concentrated solution for infusion vial.