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901 result(s) found, displaying 101 to 125
- Media releasesTGA provisionally approves Pfizer bivalent COVID-19 vaccine for use as a booster dose in adultsThe TGA has provisionally approved Pfizer’s bivalent COVID-19 vaccine, tozinameran and riltozinameran (COMIRNATY Original/Omicron BA.1) for use as a booster dose in adults 18 years and over.
- NoticesGMP Clearance: Temporary changes to target processing timesTemporary update to the target timeframes for assessment of Compliance Verification (CV) GMP Clearance applications
- COVID-19 vaccine safety reportsCOVID-19 vaccine safety report - 20-10-2022Information about the TGA's safety monitoring of COVID-19 vaccines.
- Media releasesTGA provisionally approves Moderna’s COVID-19 vaccine for use as a booster dose in individuals 12 years and olderOn 19 October 2022, the TGA provisionally approved Moderna's COVID-19 vaccine, SPIKEVAX (elasomeran), for use as a booster dose in individuals aged 12 years and older.
- Media releasesInspire Cosmetology Pty Ltd fined $26,640 for alleged unlawful import of therapeutic goodsInspire Cosmetology Pty Ltd fined $26,640 for alleged unlawful import of cosmetic injectable products
- Media releasesNSW person fined $2,664 for alleged unlawful import of prescription medicinesNSW medical practitioner fined for allegedly illegally importing prescription medicines
- NewsPharmacovigilance Inspection Program Risk Assessment SurveyThe Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open until 18 December 2022 for medicine sponsors to complete.
- Media releasesQueensland individual fined $5,328 for alleged unlawful advertising of a complementary medicineThe TGA has issued two infringement notices totalling $5,328 to a Queensland-based individual for the alleged unlawful use of a prohibited representation and endorsement in advertising a listed complementary medicine.
- NoticesTherapeutic Goods (Poisons Standard) (COVID-19 Treatment - Gilead) (Remdesivir) Labelling Exemption 2021This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
- NoticesGMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemicUpdate to GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic.
- NoticesTherapeutic Goods (Poisons Standard) (COVID-19 Treatment - GlaxoSmithKline) (Sotrovimab) Labelling Exemption 2021This 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) Labelling Exemption 2021This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
- COVID-19 vaccine safety reportsCOVID-19 vaccine safety report - 06-10-2022Information about the TGA's safety monitoring of COVID-19 vaccines.
- Safety updatesPeripheral neuropathy with supplementary vitamin B6 (pyridoxine)Medicines Safety Update - Information for health professionals
- NewsUser experience survey: DAEN - medicines beta versionTell us your experience using of the beta Database of Adverse Event Notifications (DAEN) - medicines.
- BlogManaging your medicines in an emergencyIn a bushfire or other natural disaster you might need emergency access to an important medicine. Here are some tips on how to plan ahead.
- Media releasesTGA grants provisional determination to Moderna’s COVID-19 bivalent (Original plus Omicron BA.4/BA.5) booster dose vaccineThe TGA has granted a provisional determination to Moderna Australia Pty Ltd’s bivalent COVID-19 vaccine candidate: elasomeran and davesomeran (SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4/BA.5)
- Media releasesTGA provisionally approves Pfizer’s COVID-19 vaccine, COMIRNATY (tozinameran) for use in children aged 6 months to less than 5 yearsThe TGA has provisionally approved a paediatric dose of Pfizer’s COVID-19 vaccine, COMIRNATY (tozinameran), for children aged 6 months to less than 5 years
- Media releasesBest Body Industries Pty Ltd and an executive officer fined almost $130,000 for alleged unlawful advertising of sports supplementsBest Body Industries Pty Ltd fined for alleged unlawful advertising of sports supplements
- 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.