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This page lists items that we have published for the first time or updated in the last 7, 30 or 60 days. Use the filters to narrow results by audience, product type, content type or topic.
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What's new
95 result(s) found, displaying 26 to 50
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Australian public assessment report (AusPar)Ixifi (infliximab) is approved for treatment of several conditions including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease, refractory fistulising Crohn’s disease, and ulcerative colitis.
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Australian public assessment report (AusPar)Vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are anti acetylcholine receptor (AChR) antibody positive.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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PagePharmaceutical companies Novo Nordisk and Eli Lilly are gradually discontinuing some of their earlier generation insulin products. Our webpage lists affected products and includes alternative options.
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PageInformation about the shortages of HRT products for patients and healthcare professionals
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Prescription medicine decision summaryJaypirca (pirtobrutinib) is approved for the treatment of adults with chronic lymphocytic leukemia/small lymphocytic lymphoma who have been previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.
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PageFind out more about post market reviews of medical devices, including safety and performance updates and emerging issues.
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PageFind out more about the medical device post-market review process.
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PageFind out more about the post-market review we are undertaking on plastic syringes.
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PageFind information on consultation in relation to Therapeutic Goods Advertising.
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TopicInformation on the statutory advisory committees, working groups and industry consultation groups that support our work.
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Australian public assessment report (AusPar)Imdelltra (tarlatamab) has been provisionally approved for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
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Australian public assessment report (AusPar)Elfabrio (pegunigalsidase alfa) has been approved for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease.
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PageUnderstand what software is and isn’t excluded from our regulation.
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GuidanceGuidance on when consumer software products that encourage behavioural change to improve general health or wellness may be excluded from our regulations.
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GuidanceGuidance on when software that makes calculations may be excluded from our regulatory requirements.
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GuidanceGuidance on when software used for clinical workflow management may be excluded from our regulatory requirements.
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GuidanceGuidance on when software that enables communications to support the delivery of health services may be excluded from our regulatory requirements.
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GuidanceGuidance on when consumer software products like apps or websites intended to support users' mental health are excluded from our regulatory requirements.
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GuidanceSoftware or a combination of software and hardware that is an electronic health record (EHR) may be excluded from our regulatory requirements.
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GuidanceGuidance on when consumer software products that promote general health or wellness may be excluded from our regulatory requirements.
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GuidanceGuidance on when software used for the administration or management of health processes or facilities may be excluded from our regulatory requirements.
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GuidanceGuidance on when software products for consumers to self-manage an existing disease or health condition may be excluded from our regulatory requirements.
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GuidanceGuidance on when software products with the sole purpose of storing or transmitting patient images may be excluded from our regulatory requirements.