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1309 result(s) found, displaying 651 to 675
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COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
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Media releasesOn 27 April 2022 the TGA granted a provisional determination to Moderna Australia Pty Ltd in relation to its bivalent COVID-19 vaccine, elasomeran/elasomeran 0-omicron (SPIKEVAX Bivalent Zero/Omicron).
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Safety updatesMedicines Safety Update - Information for health professionals
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Safety updatesMedicines Safety Update - Information for health professionals
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News articlesThe TGA has now approved an application from the sponsor for an extension of shelf-life to 18 months when stored at 2°C to 8°C.
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COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
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COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
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Media releasesCheckMe Pty Ltd fined $13,320 for unlawful import of COVID-19 test kits
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Media releasesG1 Resources Pty Ltd fined for alleged unlawful importation and advertising of unapproved rapid antigen tests
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Media releasesCat Media Pty Ltd fined $39,960 for allegedly advertising unregistered Fatblaster weight-loss products
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Media releasesDentist fined $5,328 for alleged unlawful importation of botox
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Media releasesThe TGA has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for use as a booster in individuals aged 12 to 15 years old.
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COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines
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Media releasesThe TGA has issued an infringement notice of $13,320 for alleged breaches of therapeutic goods legislation in relation to pharmacovigilance.
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Media releasesThe TGA has issued an infringement notice of $13,320 for alleged breaches of therapeutic goods legislation in relation to pharmacovigilance.
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Media releasesThe TGA has received an application from GlaxoSmithKline (GSK) Australia Pty Ltd for a higher (1000 mg) dose of its COVID‑19 treatment, sotrovimab (XEVUDY)
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Regulatory decision noticesListed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2022.
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Media releasesTransition to the mandatory statement requirements of the 2021 Advertising Code
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Media releasesShen Neng Herbal Medicines Group Pty Ltd fined $53,280 for alleged breaches of therapeutic goods legislation.
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COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
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COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
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Media releasesThe TGA has issued an infringement notice for $13,320 to Vaxine Pty Ltd of Adelaide for advertising an unapproved COVID-19 vaccine in alleged breach of the Therapeutic Goods Act 1989.
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COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
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Regulatory decision noticesPrevention notice under section 42DKB of the Therapeutic Goods Act 1989.