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94 result(s) found, displaying 1 to 10
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for HEPCLUDEX bulevirtide (as acetate) 2 mg powder for injection vial.
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Sep-2024Prescription medicine evaluationActive ingredient: bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate.
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Prescription medicine decision summaryHepcludex (bulevirtide acetate) was approved to treat chronic hepatitis delta virus infection in adults with compensated liver disease.
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Prescription medicine registrationActive ingredients: bulevirtide acetate.
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Cancellation by sponsorRequested by Gilead Sciences Pty Ltd
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Australian Public Assessment Report (AusPAR)Sunlenca (Lenacapavir) has been approved to treat adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for SUNLENCA lenacapavir (as sodium) 300 mg film coated tablet blister pack.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for SUNLENCA lenacapavir (as sodium) 463.5 mg/1.5 mL solution for injection vial.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for Cellular Therapies - T Cells - Axicabtagene ciloleucel, cryopreserved - T - Yescarta - Gilead Sciences Pty Ltd - Injection, intravenous infusion - Bag.
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Prescription medicine registrationActive ingredients: sacituzumab govitecan.