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What's new
79 result(s) found, displaying 1 to 25
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PageThe shortages of most methylphenidate modified-release products have resolved.
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PageRead about court actions. It is our practice to publish details of regulatory compliance decisions and actions on our website.
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Media releasesThe Federal Court of Australia has ordered Key Promotional Products Pty Ltd to pay $1,750,000 for the unlawful import and supply of over 240,000 COVID-19 detection rapid antigen test kits. An individual was also ordered to pay $250,000.
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PageWe’re transforming the way you interact with us by building a modern, intuitive digital platform that aims to make interactions with us easy, seamless and efficient.
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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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Prescription medicine decision summaryZynlonta is provisionally approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Zynlonta contains the active ingredient loncastuximab tesirine.
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PageInformation about influenza reference reagents for testing influenza vaccines and how to order them.
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Australian public assessment report (AusPar)Alyftrek is indicated for the treatment of those who meet the diagnostic criteria for CF in people aged 6 years and older who have at least one mutation in the CFTR gene that is responsive based on clinical or in vitro evidence.
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DatasetView prescription medicines eligible for orphan drug status, registration via priority review or provisional approval.
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PageInformation for applicants on requesting and preparing for pre-submission meetings for medicines and biologicals.
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PageNew shortage expected during May 2026.
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PageBacteriophages are viruses that kill bacteria. In Australia, bacteriophage therapy when used in humans are regulated as a medicine.
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PageThe EU MDR transition web publication service provides notifications to providers and consumers going through low-risk changes, as part of the transition.
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Medicine shortage alertsSerious Scarcity Substitution Instrument (SSSI) allows continuous access to Catapres (clonidine) 150 mcg tablets during an anticipated new shortage.
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PageSearch for infringement notices whereby a financial penalty may be issued in response to certain breaches of the Therapeutic Goods Act 1989 (the Act).
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GuidanceGuidance on when a manufacturing licence is required for bacteriophage therapy products and how a time-limited Goods Manufacturing Practice exemption will apply. Understand your regulatory obligations when producing bacteriophage products in Australia.
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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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Media releasesWe have issued 4 infringement notices totalling $79,200 to Switch Nutrition Pty Ltd (Switch Nutrition) for the alleged unlawful advertising of therapeutic goods.
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PageThe Freedom of Information disclosure log gives access to information we've released in response to an FOI request.
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FormsInformation on when a manufacturer's statutory declaration should be provided.
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PageThis page contains a list of therapeutic vaping goods, for use in smoking cessation or the management of nicotine dependence, that can be legally supplied in Australia. Healthcare practitioners can use this list when prescribing and supplying unapproved therapeutic vaping goods as they have been notified as complying with applicable standards.
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PageMedicines and other therapeutic goods must comply with applicable standards to be supplied in Australia.
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Regulatory decision noticesThe delegate believes, on reasonable grounds, that it is in the interests of public health or safety to give Veganic SKN Limited directions under section 42YT of the Therapeutic Goods Act 1989.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.