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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 176 to 200
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Prescription medicine decision summaryTGA decision: Inqovi 35/100 (decitabine and cedazuridine) is approved to treat adult patients with myelodysplastic syndromes and CMML.
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Prescription medicine decision summaryTGA decision: MenQuadfi Quadrivalent meningococcal vaccine is approved for the prevention of invasive meningococcal disease.
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Prescription medicine decision summaryTGA decision: Truvelog (insulin aspart) is approved to treat diabetes mellitus
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Prescription medicine decision summaryTGA decision: Rymti, Etera (etanercept) is approved to treat rheumatoid arthritis and certain other inflammatory conditions.
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Prescription medicine decision summaryTGA decision: Ongentys (opicapone) is approved as adjunctive therapy in adult patients with Parkinson's disease.
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Prescription medicine decision summaryTGA decision: Epidyolex (cannabidiol) is approved as adjunctive therapy for seizures associated with Dravet and Lennox-Gastaut syndrome
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Prescription medicine decision summaryTGA decision: Vitrakvi - larotrectinib sulfate is provisionally approved to treat patient with NTRK gene fusion metastatic solid tumours
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Prescription medicine decision summaryTGA decision: Flucelvax Quad (quadrivalent influenza vaccine, surface antigen, inactivated) is approved for influenza vaccination
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Prescription medicine decision summaryTGA decision: Tukysa (tucatinib), in combination with trastuzumab and capecitabine, is approved to treat HER2-positive breast cancer.
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Prescription medicine decision summaryTGA decision: Luxturna (voretigene neparvovec) is approved to treat inherited retinal dystrophy caused by RPE65 mutations
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Prescription medicine decision summaryTGA decision: Fluzone High-Dose Quadrivalent (influenza virus haemagglutinin) is approved for influenza immunisation.
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Prescription medicine decision summaryDefitelio (defibrotide) is approved to treat severe hepatic veno-occlusive disease
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Prescription medicine decision summaryLibtayo (cemiplimab) is provisionally approved to treat cutaneous squamous cell carcinoma in adults
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Prescription medicine decision summaryAustralian prescription medicine decision summary
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Prescription medicine decision summaryTGA decision: Veklury (remdesivir) is provisionally approved to treat Coronavirus Disease 2019 (COVID-19) in adults and adolescents
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