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Australian prescription medicine decision summaries
Search our decision summaries for the registration of new prescription medicines.
For more information, visit the About Australian prescription medicine decision summaries information page.
We have redesigned our prescription medicine decision summaries (AusPMDSs) to make it easier to understand how prescription medicines are registered in Australia.
The redesigned AusPMDSs will offer clear, accessible information about recent medicine registration decisions.
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226 result(s) found, displaying 176 to 200
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Prescription medicine decision summaryTGA decision: Scenesse (afamelanotide) is approved to prevent phototoxicity in adult patients with erythropoietic protoporphyria.
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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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