The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Astellas Pharma Australia Pty Ltd
Regulatory activities for this sponsor.
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44 result(s) found, displaying 21 to 30
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Prescription medicine registrationActive ingredients: gilteritinib fumarate.
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Prescription medicine registrationActive ingredients: enzalutamide.
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Designation or determinationPriority review
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Designation or determinationOrphan drug
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for ADVAGRAF XL tacrolimus 0.5 mg prolonged-release capsule blister pack.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for ADVAGRAF XL tacrolimus 1 mg prolonged-release capsule blister pack.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for ADVAGRAF XL tacrolimus 5 mg prolonged-release capsule blister pack.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for XTANDI enzalutamide 40 mg soft capsule blister pack.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for BETMIGA mirabegron 50 mg film-coated prolonged-release tablet blister pack.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for BETMIGA mirabegron 25 mg film-coated prolonged-release tablet blister pack.