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What's new
190 result(s) found, displaying 26 to 50
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Media releasesWe have issued 5 infringement notices totalling $19,800 to a health practitioner and an individual for the alleged unlawful importation of unapproved cosmetic injectables.
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Prescription medicine decision summaryHibruka (orelabrutinib) has provisional approval in Australia for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
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User guideA step-by-step guide to completing the form
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Australian public assessment report (AusPar)Zynlonta (loncastuximab tesirine) has been provisionally approved as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
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Australian public assessment report (AusPar)Niktimvo (axatilimab) has been approved for the treatment of chronic graft-versus host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and paediatric patients 6 years and older.
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Australian public assessment report (AusPar)Orserdu monotherapy is indicated for the treatment of postmenopausal women and men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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PageKey information and updates about the shortage of Creon (pancreatic extract) capsules.
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PageLearn about the AusUDID and how to use it to meet UDI requirements.
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PageRead the latest enhancements and fixes to the Australian UDI Database.
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ChecklistsThese checklists summarise key obligations for psychiatrists applying to prescribe and access MDMA and psilocybine under the Authorised Prescriber scheme.
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Medicine shortage alertsSupply constraints will continue until 31 January 2027.
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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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PageClinical resources and guidance on accessing MDMA and psilocybine under the Authorised Prescriber scheme.
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PageThe following instruments are made under section 47B of the Therapeutic Goods Regulations 1990.
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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 noticesSix monthly report – supply of unapproved therapeutic goods by a sponsor.
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PageUnderstand and apply the Unique Device Identification (UDI) requirements to your medical devices.
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PageUnderstand the AusUDID Pre-Production environment and how you can use it to ensure compliance with the UDI requirements.
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User guideLearn how to complete an application for consent to import, supply or export medical devices that do not meet UDI-related Essential Principles.
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GuidanceThis guidance supports psychiatrists in understanding their regulatory requirements when prescribing MDMA and psilocybine from 1 July 2023.
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PageRead about our new compliance principles and our priority focus areas for 2026 and 2027.
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Media releasesWe have expanded our priority focus areas to include unapproved peptide products, following increased detection of unlawful importation, supply and advertising, posing potential risks to consumer safety.
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Meeting statementsThe Advisory Committee on Medical Devices (ACMD) convened its 89th meeting on 19 February 2026.
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Meeting statementsThe Advisory Committee on Medical Devices (ACMD) held its 90th meeting on 16 April 2026.