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News articlesThe Generic Medicines Work-Sharing Initiative has updated its Operational Procedures document and Expression Of Interest form.
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News articlesA warning to social media influencers and advertisers not to advertise this prescription medicine.
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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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News articlesThe TGA approved Moderna Australia’s application to transition its COVID-19 vaccine, SPIKEVAX (elasomeran), from provisional to full registration.
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Media releasesTGA has released over 95 batches of influenza vaccine, consisting of over 16.8 million doses, for supply in Australia for the 2022 influenza season.
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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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Regulatory decision noticesThis instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Treatment—Merck Sharp and Dohme) (Molnupiravir) Labelling Exemption 2022.
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Regulatory decision noticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.