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901 result(s) found, displaying 126 to 150
- Safety updatesFluorouracil and capecitabine - DPD deficiencyMedicines Safety Update - Information for health professionals
- Media releasesIndependent review of paracetamol overdoseThe TGA has published an independent expert report examining the incidence of serious injury and death from intentional paracetamol overdose.
- Safety updatesProduct Information safety updates - August 2022Medicines safety update - Information for health professionals
- COVID-19 vaccine safety reportsCOVID-19 vaccine safety report - 08-09-2022Information about the TGA's safety monitoring of COVID-19 vaccines.
- Media releasesFirst combination COVID-19 and influenza self-tests approved for AustraliaThe TGA has approved the first two nasal combination self-tests (for use at home) that detect both COVID-19 and influenza viral infections in humans.
- Media releasesInternational work-sharing - First medicines approved by all five Access Consortium regulatorsTGA approves asciminib and faricimab through the Access New Active Substance Work-Sharing Initiative
- Media releasesCyclotek Queensland fined $93,240 for allegedly breaching conditions of its manufacturing licenceThe TGA has issued 7 infringement notices totalling $93,240 to Cyclotek Queensland Pty Ltd
- Media releasesWorld Environmental Technologies fined $13,320 for alleged unlawful importation of ivermectinWA-based company World Environmental Technologies Pty Ltd fined $13,320 for alleged unlawful importation of ivermectin, a prescription-only medicine.
- Media releasesTGA provisionally approves Moderna bivalent COVID-19 vaccine for use as a booster dose in adultsTGA provisionally approves Moderna bivalent COVID-19 vaccine for use as a booster dose in adults
- COVID-19 vaccine safety reportsCOVID-19 vaccine safety report - 25-08-2022Information about the TGA's safety monitoring of COVID-19 vaccines.
- NoticesUpdate to the Manufacturing Principles for medicines, APIs & sunscreensUpdate to the manufacturing principles for medicinal products
- Media releasesDoughbot Enterprises and Officer fined $87,312 and company and its Director undertake to comply with advertising rules for nicotine vaping productsVictoria-based Doughbot Enterprises fined $87,312 and undertakes to comply with advertising rules for nicotine vaping products.
- Compliance undertakingsEnforceable undertaking: Doughbot Enterprises Pty Ltd and Stuart SingletonDoughbot Enterprises and its sole director have accepted an enforceable undertaking to not advertise nicotine vaping products or support their advertising.
- Media releasesTGA participates in global operation tackling illicit and counterfeit therapeutic goodsTGA's participation in INTERPOL's Operation Pangea, which tackles the trade of illicit and counterfeit therapeutic goods worldwide, led to intercepting more than $2 million of illegally imported products.
- NewsSME Assist workshops and eventsTGA SME Assist presents "Meeting your Obligations" a free workshop aimed at beginners who are unfamiliar with therapeutic goods regulation.
- Media releasesTGA grants provisional determination for sabizabulin for the treatment of COVID-19TGA grants provisional determination for sabizabulin for the treatment of COVID-19
- NoticesTherapeutic Goods (Poisons Standard) (COVID-19 Treatment - Gilead) (Remdesivir) Labelling Exemption 2022This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
- NoticesTherapeutic Goods (Poisons Standard) (COVID-19 Treatment - GlaxoSmithKline) (Sotrovimab) Labelling Exemption 2022This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
- NoticesTherapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) (Elasomeran) Labelling Exemption 2022This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
- Media releasesWA individual fined $2,664 for alleged unlawful importation (and false declaration) of nicotine vaping productsThe TGA has issued a $2,664 infringement notice to a WA-based individual for allegedly importing liquid nicotine for use in nicotine vaping products.
- COVID-19 vaccine safety reportsCOVID-19 vaccine safety report - 11-08-2022Information about the TGA's safety monitoring of COVID-19 vaccines.
- Media releases2San Pty Ltd fined $66,600 for allegedly failing to provide ongoing evidence to support the performance of its COVID-19 rapid antigen testsThe TGA has issued five infringement notices totalling $66,600 to 2San Pty Ltd for allegedly failing to provide information to the TGA to demonstrate the ongoing minimum level of sensitivity of two COVID-19 rapid antigen tests (RATs).
- Media releasesEnviro Tech Holdings and company officers ordered by the Federal Court to pay $96,000 for unlawful importation of surgical face masksThe Federal Court of Australia has ordered Enviro Tech Holdings Pty Ltd to pay $80,000 for unlawful importation of surgical face masks.
- NoticesDirection about advertisements: 13 Vape Pty LtdThe TGA has issued a direction notice to 13 Vape Pty Ltd and an executive officer to cease promoting the use and supply of nicotine vaping products to Australian consumers.
- NoticesUpdate to listed medicine ingredients in August 2022Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2022.