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114 result(s) found, displaying 26 to 50
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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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COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
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Regulatory decision noticesListed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2023.
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Regulatory decision noticesThis instrument is made under section 39 of the current Poisons Standard.
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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 17 February, the TGA granted provisional approval to Moderna’s bivalent COVID-19 vaccine. This is the second bivalent vaccine targeting the Omicron BA.4-5 subvariants that has been provisionally approved by the TGA
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COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
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News articlesNew guidelines and mandatory requirements for listed medicines ingredients have come into effect on 1 February 2023.
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COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
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Media releasesThis is the first vaccine provisionally approved by the TGA that is designed to specifically target the Omicron variants BA.4/BA.5 and follows provisional approval of the Pfizer BA.1 Omicron/original bivalent vaccine.
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Media releasesThe TGA has commenced evaluation of an application from Moderna Australia Pty Ltd to transition its COVID-19 vaccine, SPIKEVAX, to full registration for the immunisation of individuals 6 years and over, and as a booster dose for individuals aged 12 years and older.
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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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COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
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Regulatory decision noticesListed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 5) 2022.
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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 granted a provisional determination to Pfizer's bivalent COVID-19 vaccine candidate: tozinameran & famtozinameran (COMIRNATY BIVALENT OMICRON BA.4/BA.5 COVID-19 VACCINE).
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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 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.
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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 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.
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News articlesThe Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open until 18 December 2022 for medicine sponsors to complete.
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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 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)