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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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- Advertising (18)
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What's new
191 result(s) found, displaying 176 to 191
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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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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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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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PageBacteriophages are viruses that kill bacteria. In Australia, bacteriophage therapy when used in humans are regulated as a medicine.
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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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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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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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ConsultationWe are reviewing our rules for personalised medical devices to make sure they keep pace with new technology and continue to be used safely.
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FormsInformation on when a manufacturer's statutory declaration should be provided.
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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.
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User guideAuthorised Prescribers must submit a report every 6 months for each AP authorisation they hold.
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Media releasesWe have issued an enforceable direction to Veganic SKN Limited on the basis that a delegate of the Secretary believes that Veganic SKN is not complying with the Therapeutic Goods Act 1989.