Sponsor content
28 result(s) found, displaying 1 to 10
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for ZIRDAWNY donidalorsen (as sodium) 80 mg/0.8 mL solution for injection pre-filled pen.
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Prescription medicine decision summaryZirdawny has been approved for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
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Jul-2025Prescription medicine evaluationActive ingredient: donidalorsen.
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Designation or determinationOrphan drug
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Cancellation by sponsorRequested by Otsuka Australia Pharmaceutical Pty Ltd
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Cancellation by sponsorRequested by Otsuka Australia Pharmaceutical Pty Ltd
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Australian public assessment report (AusPar)Australian Public Assessment Report for Decitabine and cedazuridine
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Prescription medicine registrationActive ingredients: cedazuridine; decitabine.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for JINARC tolvaptan 30 mg tablet blister pack.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for JINARC tolvaptan 30 mg + 90 mg tablet blister composite pack.