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42 result(s) found, displaying 1 to 10
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Sep-2024Prescription medicine evaluationActive ingredient: deutivacaftor, tezacaftor, vanzacaftor.
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Designation or determinationOrphan drug
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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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Apr-2024Prescription medicine evaluationActive ingredient: ivacaftor.
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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.
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Designation or determinationOrphan Drug