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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 101 to 125
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Prescription medicine decision summaryTGA Decision: Saphnelo (anifrolumab) is approved to treat adult patients with active systemic lupus erythematosus (SLE).
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Prescription medicine decision summaryTGA Decision: Yuflyma (adalimumab) is approved to treat multiple auto-immune conditions.
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Prescription medicine decision summaryTGA Decision: Bimzelx (bimekizumab) is approved to treat moderate to severe plaque psoriasis in adult patients.
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Prescription medicine decision summaryTGA Decision: Vaxelis (DTPa5-HB-IPV-Hib) is approved as a vaccine for diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib.
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Prescription medicine decision summaryTGA Decision: Vumerity (diroximel fumarate) is approved to treat relapsing multiple sclerosis.
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Prescription medicine decision summaryTGA decision: Ponvory (ponesimod) is approved to treat relapsing forms of multiple sclerosis.
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Prescription medicine decision summaryTGA decision: Xpovio (selinexor) is approved to treat multiple myeloma.
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Prescription medicine decision summaryTGA decision: Evusheld (tixagevimab/cilgavimab) is approved for the treatment of pre-exposure prophylaxis of COVID-19.
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Prescription medicine decision summaryTGA decision: Sogroya (somapacitan) is approved to treat adults with growth hormone deficiency (AGHD).
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Prescription medicine decision summaryTGA decision: Jemperli (dostarlimab) is approved to treat patients with recurrent or advanced mismatch repair deficient endometrial cancer.
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Prescription medicine decision summaryTGA decision: Rybelsus (semaglutide) is approved to treat type 2 diabetes mellitus
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Prescription medicine decision summaryTGA decision: Empaveli (pegcetacoplan) is approved to treat adult patients with paroxysmal nocturnal haemoglobinuria (PNH).
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Prescription medicine decision summaryTGA decision: Tepmetko (tepotinib) is approved to treat locally advanced or metastatic non-small cell lung cancer (NSCLC).
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Prescription medicine decision summaryAustralian prescription medicine decision summary
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Prescription medicine decision summaryTGA decision: Lagevrio (molnupiravir) is approved for the treatment of adults with COVID-19.
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Prescription medicine decision summaryANSTO Lutetium (177Lu) chloride (lutetium (177 Lu) chloride) is approved to treat non resectable or metastatic neuroendocrine tumours.
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Prescription medicine decision summaryTGA decision: Paxlovid (nirmatrelvir/ritonavir) is approved for the treatment of adults with COVID-19.
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Prescription medicine decision summaryTGA decision: Koselugo (selumetinib) is approved to treat paediatric patients aged 2 years and above, with neurofibromatosis type 1 (NF1)
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Prescription medicine decision summaryTGA decision: Ngenla (somatrogon) is approved to treat paediatric growth disturbance
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Prescription medicine decision summaryTGA decision: Nextstellis (estetrol monohydrate and drospirenone) is approved for use by women of reproductive potential to prevent pregnancy.
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Prescription medicine decision summaryTGA decision: Nexviazyme (avalglucosidase alfa) is approved to treat Pompe disease (acid α-glucosidase deficiency)
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Prescription medicine decision summaryTGA decision: Verquvo (vericiguat) is approved to treat symptomatic chronic heart failure