The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Vertex Pharmaceuticals Australia Pty Ltd
Regulatory activities for this sponsor.
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8 result(s) found, displaying 1 to 8
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for ORKAMBI 100/125 lumacaftor/ivacaftor 100mg/125mg granules sachet.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for ORKAMBI 150/188 lumacaftor/ivacaftor 150mg/188mg granules sachet.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for SYMDEKO 100/150 tezacaftor 100 mg/ivacaftor 150 mg film-coated tablet and ivacaftor 150 mg film-coated tablet composite pack.
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Designation or determinationOrphan drug
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Australian Public Assessment Report (AusPAR)Australian Public Assessment Report for Tezacaftor/Ivacaftor and Ivacaftor
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Prescription medicine registrationActive ingredients: lumacaftor/ivacaftor.
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Prescription medicine registrationActive ingredients: ivacaftor.
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Prescription medicine registrationActive ingredients: ivacaftor; tezacaftor.