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907 result(s) found, displaying 126 to 150
- NoticesDirection about advertisements: MDNE Enterprises Pty LtdThe TGA has issued a direction notice to MDNE Enterprises Pty Ltd to cease promoting the use and supply of nicotine vaping products to the Australian public.
- Media releasesMDNE Enterprises and an executive officer fined and directed to cease alleged unlawful advertising of nicotine vaping productsDirection and infringement notices given to MDNE Enterprises Pty Ltd for alleged unlawful advertising of nicotine vaping products
- Media releasesThree medicinal cannabis companies fined almost $1 million for alleged unlawful advertisingFines totalling $972,360 given to three medicinal cannabis companies for alleged unlawful advertising
- COVID-19 vaccine safety reportsCOVID-19 vaccine safety report - 23-09-2022Information about the TGA's safety monitoring of COVID-19 vaccines.
- Media releasesJSHealth Vitamins Pty Ltd fined $26,640 for alleged unlawful advertisingJSHealth Vitamins Pty Ltd fined for alleged unlawful advertising
- Media releasesTGA provisionally approves Pfizer's COVID-19 vaccine, COMIRNATY (tozinameran), for use as a booster dose in individuals 5 years and olderThe TGA has provisionally approved Pfizer's COVID-19 vaccine, COMIRNATY (tozinameran) for use as a booster dose in individuals 5 years to 11 years.
- 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.