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16 result(s) found, displaying 1 to 10
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for RISVAN risperidone 75 mg modified release powder for injection pre-filled syringe plus diluent pre-filled syringe with needles.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for RISVAN risperidone 100 mg modified release powder for injection pre-filled syringe plus diluent pre-filled syringe with needles.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for PERINDOPRIL ARGININE SANDOZ perindopril arginine 10 mg tablet bottle.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for PERINDOPRIL ARGININE SANDOZ perindopril arginine 5 mg tablet bottle.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for PERINDOPRIL ARGININE SANDOZ perindopril arginine 2.5 mg tablet bottle.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for TIBSOVO ivosidenib 250 mg film-coated tablet bottle.
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Designation or determinationPriority Review
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Designation or determinationOrphan drug
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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.