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What's new
93 result(s) found, displaying 1 to 25
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Corporate reportsFind out about the seasonal influenza vaccines available for the 2026 southern hemisphere season.
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DatasetSearch companion diagnostics (CDx) we have approved for supply in Australia.
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Prescription medicine decision summaryElahere (mirvetuximab soravtansine) has been approved to treat adults with folate receptor-alpha (FRα) positive cancer of the ovary, fallopian tubes, or peritoneum who have stopped responding to platinum based chemotherapy and who have had one to 3 chemotherapy treatments before.
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Australian public assessment report (AusPar)Lynkuet is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
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Australian public assessment report (AusPar)Lytgobi (futibatinib) has been approved for the treatment of locally advanced or metastatic intrahepatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
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PageFind contact details for the state and territory recall coordinators as well as the Australian recall coordinator.
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PagePharmaceutical company Novo Nordisk will gradually discontinue some of its earlier generation insulin products between late 2024 and late 2026. We recognise the vital role of insulin for people with diabetes in Australia and will work to minimise the impact of these discontinuations by providing early advice that includes alternative options.
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PageNew Active Substance (NAS) work sharing initiative through ACCESS consortium.
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PageCheck your product is a medical device that needs to be included in the Australian Register of Therapeutic Goods (ARTG).
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News articlesInformation on the recently announced concept papers proposing to update the Good Manufacturing Practice (GMP) guide for Annex 6 and Annex 15.
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FormsThis form is to be completed by the ingredient owner to authorise sponsors to use a protected ingredient that is the subject of an exclusivity period to list a medicine in the Register
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PageThe aim is to improve clarity, efficiency and internationally harmonise our regulatory framework, wherever possible.
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GuidanceGuidance to help sponsors understand the potential overlap between certain foods, medicines, devices and cosmetics.
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PageBe careful about buying medicines or medical devices online they can be unsafe or counterfeit.
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Safety alertsWe are issuing an updated safety advisory after testing confirmed counterfeit imported weight loss products.
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Australian public assessment report (AusPar)Hepcludex (bulevirtide) is approved for treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease.
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PageSerious Scarcity Substitution Instruments (SSSIs) allow community pharmacists to substitute specific medicines without prior approval from the prescriber so long as the permitted circumstances within the SSSI are met.
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Regulatory decision noticesListed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2026, which commenced on 1 March 2026.
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PageInformation about the shortage and the Serious Scarcity Substitution Instrument
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PageFour pathways medical professionals can use to give patients unapproved medicinal cannabis.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/239/95 Rev. 1, Corr.1*
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PageLearn how Australia’s UDI framework aligns globally and fits within the Essential Principles.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/239/95 final
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DatasetSearch approvals to import and supply medicines not in the Australian Register of Therapeutic Goods (ARTG) to address medicine shortages.
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Medicine shortage alertsWe have extended the SSSI in response to the ongoing shortage