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949 result(s) found, displaying 176 to 200
- COVID-19 vaccine safety report - 08-09-2022COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
- First combination COVID-19 and influenza self-tests approved for AustraliaMedia releasesThe 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.
- International work-sharing - First medicines approved by all five Access Consortium regulatorsMedia releasesTGA approves asciminib and faricimab through the Access New Active Substance Work-Sharing Initiative
- Cyclotek Queensland fined $93,240 for allegedly breaching conditions of its manufacturing licenceMedia releasesThe TGA has issued 7 infringement notices totalling $93,240 to Cyclotek Queensland Pty Ltd
- World Environmental Technologies fined $13,320 for alleged unlawful importation of ivermectinMedia releasesWA-based company World Environmental Technologies Pty Ltd fined $13,320 for alleged unlawful importation of ivermectin, a prescription-only medicine.
- TGA provisionally approves Moderna bivalent COVID-19 vaccine for use as a booster dose in adultsMedia releasesTGA provisionally approves Moderna bivalent COVID-19 vaccine for use as a booster dose in adults
- COVID-19 vaccine safety report - 25-08-2022COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
- Update to the Manufacturing Principles for medicines, APIs & sunscreensNoticesUpdate to the manufacturing principles for medicinal products
- Doughbot Enterprises and Officer fined $87,312 and company and its Director undertake to comply with advertising rules for nicotine vaping productsMedia releasesVictoria-based Doughbot Enterprises fined $87,312 and undertakes to comply with advertising rules for nicotine vaping products.
- Enforceable undertaking: Doughbot Enterprises Pty Ltd and Stuart SingletonCompliance undertakingsDoughbot Enterprises and its sole director have accepted an enforceable undertaking to not advertise nicotine vaping products or support their advertising.
- TGA participates in global operation tackling illicit and counterfeit therapeutic goodsMedia releasesTGA'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.
- TGA grants provisional determination for sabizabulin for the treatment of COVID-19Media releasesTGA grants provisional determination for sabizabulin for the treatment of COVID-19
- Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Gilead) (Remdesivir) Labelling Exemption 2022NoticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
- Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - GlaxoSmithKline) (Sotrovimab) Labelling Exemption 2022NoticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
- Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) (Elasomeran) Labelling Exemption 2022NoticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
- WA individual fined $2,664 for alleged unlawful importation (and false declaration) of nicotine vaping productsMedia releasesThe 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 report - 11-08-2022COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
- 2San Pty Ltd fined $66,600 for allegedly failing to provide ongoing evidence to support the performance of its COVID-19 rapid antigen testsMedia releasesThe 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).
- Enviro Tech Holdings and company officers ordered by the Federal Court to pay $96,000 for unlawful importation of surgical face masksMedia releasesThe Federal Court of Australia has ordered Enviro Tech Holdings Pty Ltd to pay $80,000 for unlawful importation of surgical face masks.
- Direction about advertisements: 13 Vape Pty LtdNoticesThe 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.
- Update to listed medicine ingredients in August 2022NoticesListed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2022.
- NSW individual fined $2,664 for alleged unlawful advertising of nicotine vaping productsMedia releasesThe TGA has issued an infringement notice to a NSW-based individual for allegedly advertising nicotine vaping products for sale via their website.
- Phenix Health Pty Ltd directed to cease alleged unlawful advertising of nicotine vaping productsMedia releasesThe TGA has issued a direction notice to Phenix Health Pty Ltd (Phenix) to cease promoting the use and supply of nicotine vaping products to Australian consumers.
- TGA commences evaluation of Pfizer's COVID-19 vaccine (COMIRNATY) for children aged 6 months to less than 5 yearsMedia releasesTGA commences evaluation of Pfizer's COVID-19 vaccine (COMIRNATY) for children aged 6 months to less than 5 years
- COVID-19 vaccine safety report - 28-07-2022COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.