Sponsor content
98 result(s) found, displaying 31 to 40
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Australian public assessment report (AusPar)Tibsovo (Ivosidenib) has been approved for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) R132 mutation after at least one prior line of systemic therapy.
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Prescription medicine decision summaryTibsovo (ivosidenib) is approved to treat acute myeloid leukaemia that carries an IDH1 R132 mutation.
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Prescription medicine registrationActive ingredients: ivosidenib.
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Cancellation by sponsorRequested by Servier Laboratories (Aust) Pty Ltd
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Designation or determinationOrphan drug
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Designation or determinationPriority review
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Prescription medicine decision summaryTGA decision: Tibsovo (ivosidenib) is approved to treat cancer.
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Prescription medicine registrationActive ingredients: ivosidenib.
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Cancellation by sponsorRequested by Servier Laboratories (Aust) Pty Ltd
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Cancellation by sponsorRequested by Servier Laboratories (Aust) Pty Ltd