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What's new
76 result(s) found, displaying 1 to 25
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ConsultationHave your say about the content and level of detection for ethylene oxide, propylene oxide and epichlorohydrin in end use products.
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ConsultationWe would like your feedback on our proposal to improve information sharing about the safety, quality and performance of medical devices.
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ConsultationWe are seeking feedback on proposed changes to support automated decision making (ADM) for applications to change listed medicines.
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ConsultationWe are seeking feedback on whether 11 international scientific guidelines should be adopted.
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ConsultationWe are seeking feedback on proposed changes to the Required Advisory Statements for Medicine Labels (RASML).
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ConsultationWe are seeking feedback on proposed changes to improve the Therapeutic Goods Advertising Code.
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ConsultationWe are seeking feedback on the regulation of radiopharmaceuticals in Australia. These medicines contain small amounts of radioactive material, used to support the diagnosis and treatment of serious conditions, including cancer and cardiovascular disease.
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Media releasesTGA has issued 10 infringement notices totalling $71,280 to Gezond Pty Ltd and 3 registered pharmacists.
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Australian Public Assessment Report (AusPAR)Enflonsia (clesrovimab) is approved for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. Enflonsia should be used in accordance with official recommendations.
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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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Advertising permissionApproval under section 42DF for use of restricted representations by Aspen Pharmacare Australia Pty Ltd
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DatasetSearch our database of sponsor-requested cancellations from the ARTG.
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Media releasesThe TGA, working with the NSW Police Force and other state and Commonwealth enforcement agencies, supported coordinated enforcement operations targeting a company allegedly involved in the importation, storage and distribution of vaping goods, nicotine pouches, illicit tobacco and other unlawful products.
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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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Australian Public Assessment Report (AusPAR)Zirdawny is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
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PageLearn about patient information materials for healthcare and consumers.
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Safety alertsTGA is warning consumers against using Melanotan II tanning products.
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Media releasesTGA with the assistance of the NSW Police has seized more than $120,000 of illicit peptide and anabolic steroid products from 2 residential premises in New South Wales allegedly linked to a social media influencer.
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PageA list of established AI limits for some nitrosamine impurities. These apply for all routes of administration.
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News articlesThe TGA is updating information for acceptable intake of nitrosamine impurities in medicines.
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PageFind out more about the post-market review we are undertaking on plastic syringes.
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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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Medicine shortage alertsDapsone 50 mg tablets can be supplied and halved during the shortage.
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PageRevisions includes updates to nitrosamine and other nitroso-structure acceptable intake (AI) limit information published by the TGA.
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PageInformation and updates about the shortages of cyclophosphamide and ifosfamide injections.