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What's new
191 result(s) found, displaying 76 to 100
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Market actionsMindray Medical Australia Pty Ltd is conducting a product correction for the BeneHeart D1 Automated External Defibrillator. The operator’s manual is being updated for the procedure of switching patient types.
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BlogMedicinal cannabis prescribing in Australia has increased significantly in recent years. However, many patients are unaware that most medicinal cannabis products are unapproved goods. As a prescriber, you play a critical role in ensuring patients are informed, protected and supported when these products are being considered for their clinical situation.
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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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Scheduling decisions (final)This web publication constitutes a notice for the purposes of regulation 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations).
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PageAn initiative to help sponsors of medicines meet their pharmacovigilance obligations.
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Corporate reportsThis report summarises the outcomes of the Pharmacovigilance Inspection Program in the 2-year period. The deficiencies identified are presented along with case studies of critical deficiencies from this reporting period, to support medicine sponsors in the continual improvement of their pharmacovigilance systems.
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BlogUnderstanding the difference between an approved and unapproved therapeutic good can help you make informed decisions and have meaningful conversations with your healthcare practitioner, especially when considering treatments like medicinal cannabis.
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PageLearn about GCP inspections of clinical trial sites of investigational biologicals, medicines and medical devices.
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PageThe Poisons Standard consists of decisions regarding the classification of medicines and poisons into Schedules for inclusion in the relevant legislation of the States and Territories.
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Scheduling decisions (interim)Interim decision on proposed amendment to the Poisons Standard closing date has been extended to 31 July 2026.
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DatasetSearch our database of sponsor-requested cancellations from the ARTG.
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Prescription medicine decision summaryRhapsido has been approved for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. Rhapsido contains the active ingredient remibrutinib.
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Australian public assessment report (AusPar)Tezspire has been approved as an add-on maintenance treatment in patients aged 12 years and older with severe asthma who are inadequately controlled despite optimal therapy including medium or high dose inhaled corticosteroids plus another non-steroidal medicinal product.
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Medicine shortage alertsProgressive discontinuation of all products will start with the 600 mg strength from 30 November 2026.
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Australian public assessment report (AusPar)mNEXSPIKE XBB.1.5 COVID-19 Vaccine is indicated for: Active immunisation to prevent coronavirus disease 2019 (COVID-19)
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PageSet up your account and understand the different system roles.
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Australian public assessment report (AusPar)Adzynma is a recombinant ADAMTS13 enzyme replacement therapy that has been approved for the treatment of ADAMTS13 deficiency in patients with congenital thrombotic thrombocytopenic purpura (cTTP).
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Market actionsAA-Med Pty Ltd is recalling two lots of Dexcom G7 sensors. These lots were identified for disposal and destruction in the USA due to incomplete sterilisation and deployment failure during testing.
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PageFind important annual charge deadlines for therapeutic goods, including key dates, payment requirements, and reminders to help you stay compliant with TGA obligations.
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Corporate reportsThis report provides information about the TGA’s regulatory performance for the 2024-25 financial year.
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News articlesWe have published the outcomes from the targeted consultation, roundtable and stakeholder discussions reviewing certain Authorised Prescriber (AP) scheme requirements for accessing MDMA and psilocybine.
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Meeting statementsCommunique from the 12th meeting of the Women's Health Products Working Group, 31 March 2026.
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PageInformation and updates about the shortages of cyclophosphamide and ifosfamide injections.
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User guideThe Special Access Scheme (SAS) & Authorised Prescriber (AP) Online System (SAS & AP online system) is the preferred method of submission for AP applications.
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PageApproved COVID-19 home use self-tests for supply in Australia