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949 result(s) found, displaying 151 to 175
- TGA provisionally approves Pfizer bivalent COVID-19 vaccine for use as a booster dose in adultsMedia releasesThe 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.
- GMP Clearance: Temporary changes to target processing timesNoticesTemporary update to the target timeframes for assessment of Compliance Verification (CV) GMP Clearance applications
- COVID-19 vaccine safety report - 20-10-2022COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
- TGA provisionally approves Moderna’s COVID-19 vaccine for use as a booster dose in individuals 12 years and olderMedia releasesOn 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.
- Managing your medicines in an emergencyBlogIn a bushfire or other natural disaster you might need emergency access to an important medicine. Here are some tips on how to plan ahead.
- Inspire Cosmetology Pty Ltd fined $26,640 for alleged unlawful import of therapeutic goodsMedia releasesInspire Cosmetology Pty Ltd fined $26,640 for alleged unlawful import of cosmetic injectable products
- NSW person fined $2,664 for alleged unlawful import of prescription medicinesMedia releasesNSW medical practitioner fined for allegedly illegally importing prescription medicines
- Pharmacovigilance Inspection Program Risk Assessment SurveyNewsThe Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open until 18 December 2022 for medicine sponsors to complete.
- Queensland individual fined $5,328 for alleged unlawful advertising of a complementary medicineMedia releasesThe 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.
- GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemicNoticesUpdate to GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic.
- COVID-19 vaccine safety report - 06-10-2022COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
- Peripheral neuropathy with supplementary vitamin B6 (pyridoxine)Safety updatesMedicines Safety Update - Information for health professionals
- User experience survey: DAEN - medicines beta versionNewsTell us your experience using of the beta Database of Adverse Event Notifications (DAEN) - medicines.
- TGA grants provisional determination to Moderna’s COVID-19 bivalent (Original plus Omicron BA.4/BA.5) booster dose vaccineMedia releasesThe 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)
- TGA provisionally approves Pfizer’s COVID-19 vaccine, COMIRNATY (tozinameran) for use in children aged 6 months to less than 5 yearsMedia releasesThe 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
- Best Body Industries Pty Ltd and an executive officer fined almost $130,000 for alleged unlawful advertising of sports supplementsMedia releasesBest Body Industries Pty Ltd fined for alleged unlawful advertising of sports supplements
- Direction about advertisements: MDNE Enterprises Pty LtdNoticesThe 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.
- MDNE Enterprises and an executive officer fined and directed to cease alleged unlawful advertising of nicotine vaping productsMedia releasesDirection and infringement notices given to MDNE Enterprises Pty Ltd for alleged unlawful advertising of nicotine vaping products
- Three medicinal cannabis companies fined almost $1 million for alleged unlawful advertisingMedia releasesFines totalling $972,360 given to three medicinal cannabis companies for alleged unlawful advertising
- COVID-19 vaccine safety report - 23-09-2022COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
- JSHealth Vitamins Pty Ltd fined $26,640 for alleged unlawful advertisingMedia releasesJSHealth Vitamins Pty Ltd fined for alleged unlawful advertising
- TGA provisionally approves Pfizer's COVID-19 vaccine, COMIRNATY (tozinameran), for use as a booster dose in individuals 5 years and olderMedia releasesThe TGA has provisionally approved Pfizer's COVID-19 vaccine, COMIRNATY (tozinameran) for use as a booster dose in individuals 5 years to 11 years.
- Fluorouracil and capecitabine - DPD deficiencySafety updatesMedicines Safety Update - Information for health professionals
- Independent review of paracetamol overdoseMedia releasesThe TGA has published an independent expert report examining the incidence of serious injury and death from intentional paracetamol overdose.
- Product Information safety updates - August 2022Safety updatesMedicines safety update - Information for health professionals