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1294 result(s) found, displaying 626 to 650
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COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
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News articlesThe Prescribing Medicines in Pregnancy database has now been updated.
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Media releasesFuturePro was convicted and released on recognisance, its directior was convicted and fined $25,000.
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Media releasesIndividual fined $2,664 for unlawful importation of nicotine vaping pods
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Media releasesOn 7 April 2022, the TGA announced receipt of an application from GlaxoSmithKline (GSK) Australia Pty Ltd for a higher (1000 mg) dose of its COVID-19 treatment, XEVUDY (sotrovimab).
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Media releasesThe TGA has granted provisional approval to Gilead Sciences Pty Ltd to extend the use of the COVID-19 treatment, VEKLURY (remdesivir).
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News articlesOn 10 July 2020 the Therapeutic Goods Administration (TGA) granted provisional approval to remdesivir ("Veklury", Gilead Sciences Pty Ltd) as the first treatment option for COVID-19
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News articlesOn 20 August 2021 the TGA granted provisional approval to GlaxoSmithKline Australia Pty Ltd in relation to sotrovimab (XEVUDY).
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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 noticesThe 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 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.