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What's new
122 result(s) found, displaying 51 to 75
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Safety alertsThe Therapeutic Goods Administration (TGA) is advising consumers that several sexual enhancement products have been found to contain undeclared ingredients and may pose a serious risk to your health.
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PageFind out about fees and charges that apply from July 2026.
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Advertising permissionThis instrument is made under section 42DK of the Therapeutic Goods Act 1989.
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Compositional guidelinesCompositional guideline for Akkermansia muciniphila strain ATCC BAA-835 permitted for use in listed medicines.
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Prescription medicine decision summaryTabrecta has been approved for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation. Tabrecta contains the active ingredient capmatinib.
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PageInformation and updates about the shortages of cyclophosphamide and ifosfamide injections.
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Meeting statementsAdvisory Committee on Complementary Medicines meeting statement for 26 March 2026
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GuidanceUnderstand the regulatory requirements for supplying UDI compliant medical devices in Australia
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GuidanceTimeframes for supplying UDI compliant medical devices in Australia
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PageLearn about Required Advisory Statements for Medicine Labels (RASML).
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Australian public assessment report (AusPar)Rhapsido (remibrutinib) has been approved for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment.
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Advertising permissionThis instrument is made under section 42DK of the Therapeutic Goods Act 1989.
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Advertising permissionThis instrument is made under section 42DK of the Therapeutic Goods Act 1989.
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PageThe TGA is introducing a streamlined Consent to Supply process for Unique Device Identification related Essential Principles.
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Prescription medicine decision summaryZirdawny has been approved for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
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Meeting statementsAdvisory Committee on Medicines meeting statement
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PageThe Australian UDI sponsor link template allows sponsors to add sponsor information to UDI records in the Australian Unique Device Identification Database (AusUDID).
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GuidanceThis guidance explains the prohibitions that apply to advertising for prescription medicines.
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Advertising permissionApproval under section 42DF for use of restricted representations by Molnlycke Health Care Pty Ltd
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PageLearn how to add sponsor information to UDI records using the Australian UDI sponsor link template.
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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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User guideHow to install the ADR reporting template in the Best Practice software.
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User guideHow to use the ADR reporting template in the Best Practice software
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ChecklistsThese checklist summarises key obligations for psychiatrists applying to prescribe and access MDMA and psilocybine under the Authorised Prescriber scheme.