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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43 result(s) found, displaying 1 to 10
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for KALYDECO ivacaftor 13.4 mg granules sachet.
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Prescription medicine registrationActive ingredients: ivacaftor.
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Sep-2024Prescription medicine evaluationActive ingredient: deutivacaftor, tezacaftor, vanzacaftor.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for TRIKAFTA 80/40/60 GRANULES elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg granules and ivacaftor 59.5 mg granules sachet composite pack.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for TRIKAFTA 100/50/75 GRANULES elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg granules and ivacaftor 75 mg granules sachet composite pack.
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Designation or determinationOrphan drug
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Apr-2024Prescription medicine evaluationActive ingredient: elexacaftor, ivacaftor, tezacaftor.
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Prescription medicine registrationActive ingredients: elexacaftor, ivacaftor, tezacaftor.
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Designation or determinationOrphan drug
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for ORKAMBI 75/94 lumacaftor/ivacaftor 75mg/94mg granules sachet.