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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6 result(s) found, displaying 1 to 6
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for KALYDECO ivacaftor 25 mg granules sachet.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for SYMDEKO 50/75 tezacaftor 50 mg/ivacaftor 75 mg film-coated tablet and ivacaftor 75 mg film-coated tablet composite pack.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for TRIKAFTA 100/50/75 elexacaftor 100mg/tezacaftor 50mg/ivacaftor 75mg film-coated tablet and ivacaftor 150mg film-coated tablet blister composite pack.
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Designation or determinationOrphan drug
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Designation or determinationOrphan drug
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Prescription medicine registrationActive ingredients: elexacaftor; ivacaftor; tezacaftor.