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 11 to 20
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Designation or determinationOrphan drug
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for TRIKAFTA 50/25/37.5 elexacaftor 50mg/tezacaftor 25mg/ivacaftor 37.5mg film-coated tablet and ivacaftor 75mg film-coated tablet blister composite pack.
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Prescription medicine registrationActive ingredients: Ivacaftor.
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Designation or determinationOrphan drug
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for KALYDECO ivacaftor 25 mg granules sachet.
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Prescription medicine registrationActive ingredients: elexacaftor, ivacaftor, tezacaftor.
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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