Australian prescription medicine decision summaries
These decision summaries provide an overview of our evaluation process leading to the registration of a new prescription medicine.
For more information please visit the Australian prescription medicine decision summaries information page.
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225 result(s) found, displaying 151 to 175
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Prescription medicine decision summaryAustralian prescription medicine decision summary
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Prescription medicine decision summaryAustralian prescription medicine decision summary
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Prescription medicine decision summaryTGA decision: Ovaleap (follitropin alfa) is approved to treat anovulatory infertility in woman who are unresponsive to clomiphene citrate.
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Prescription medicine decision summaryTGA decision: Spravato (esketamine hydrochloride) is approved for the treatment of treatment resistant depression.
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Prescription medicine decision summaryTGA decision: Ruxience (rituximab) is approved to treat non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, GPA and MPA.
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Prescription medicine decision summaryTGA decision: Zolgensma (onasemnogene abeparvovec) is approved to treat patients less than 9 months old with symptomatic/pre-symptomatic SMA.
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Prescription medicine decision summaryAustralian prescription medicine decision summary
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Prescription medicine decision summaryTGA decision: Trientine Waymade (trientine dihydrochloride) is approved to treat Wilson's disease patients intolerant to penicillamine.
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Prescription medicine decision summaryTGA decision: TERROSA (teriparatide) is approved to treat osteoporosis in postmenopausal women and primary osteoporosis in men.
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Prescription medicine decision summaryTGA decision: ENSPRYNG (satralizumab) is approved to treat adults with neuromyelitis optica spectrum disorders who have an AQP4-IgG.
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Prescription medicine decision summaryTGA decision: Reagila (cariprazine hydrochloride) is approved to treat schizophrenia in adult patients.
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Prescription medicine decision summaryTGA decision: Scenesse (afamelanotide) is approved to prevent phototoxicity in adult patients with erythropoietic protoporphyria.