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- NewsThe TGA is aware of concerns about decreased effectiveness of monoclonal antibodies against the COVID-19 caused by emerging SAR-COV-2 variants. At this stage, the regulatory status of the products remain unchanged in Australia.
- Media releasesThe TGA is aware of several scams targeting consumers seeking semaglutide (Ozempic). Consumers are strongly advised not to use products unless they have come from a trusted source.
- NoticesListed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2023.
- Media releasesFollowing a safety investigation into pholcodine the TGA are cancelling 55 products (from the ARTG) and recalling them from pharmacy shelves due to an increased risk of anaphylactic reactions.
- Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) (Elasomeran and Davesomeran) Labelling Exemption 2023NoticesThis instrument is made under section 39 of the current Poisons Standard.
- TGA grants provisional approval to Moderna’s COVID-19 bivalent (SPIKEVAX Bivalent Original/Omicron BA.4-5) booster dose vaccineMedia releasesOn 17 February, the TGA granted provisional approval to Moderna’s bivalent COVID-19 vaccine. This is the second bivalent vaccine targeting the Omicron BA.4-5 subvariants that has been provisionally approved by the TGA
- Media releasesThe TGA are updating the Therapeutic Goods (Declared Goods) Order 2019 (Declared Goods Order) on 1 March 2023. This is the first time since 2020 that the Declared Goods Order has been amended to capture an update to WADA’s World Anti-Doping Code International Standard Prohibited List (Prohibited List).
- Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Pfizer) (Tozinameran and Famtozinameran) Labelling Exemption 2023NoticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
- Media releasesFrom 1 July this year, medicines containing the psychedelic substances psilocybin and MDMA can be prescribed by specifically authorised psychiatrists for the treatment of certain mental health conditions.
- Caveman Nutrition Pty Ltd, The Cave Nutrition Store Pty Ltd and their director fined $208,000 for alleged unlawful advertising of sports supplements containing dangerous substancesMedia releasesThe TGA has issued infringement notices to Caveman Nutrition Pty Ltd, The Cave Nutrition Store Pty Ltd and to the director of these companies for the alleged unlawful advertising of sports supplements and therapeutic goods not included in the ARTG.
- Media releasesThe TGA has issued an infringement notice totalling $13,320 to Sydney company JSHealth Vitamins Pty Ltd for supplying a complementary medicine that allegedly did not conform with legal requirements.
- Media releasesThe TGA has confirmed the performance of COVID-19 rapid antigen tests available on the Australian market with COVID-19 variants.
- Mode Medical Pty Ltd and executive officer fined almost $160,000 for alleged unlawful advertising of intravenous infusion productsMedia releasesThe TGA has issued infringement notices to Mode Medical Pty Ltd for the alleged unlawful advertising to Australian consumers on a company website and social media.
- TGA grants provisional approval to Pfizer’s COVID-19 bivalent (COMIRNATY Original/Omicron BA.4-5 COVID-19 vaccine) booster dose vaccineMedia releasesThis is the first vaccine provisionally approved by the TGA that is designed to specifically target the Omicron variants BA.4/BA.5 and follows provisional approval of the Pfizer BA.1 Omicron/original bivalent vaccine.