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334 result(s) found, displaying 126 to 150
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Safety updatesMedicines Safety Update - Information for health professionals
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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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Regulatory decision noticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
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Safety updatesMedicines Safety Update - Information for health professionals
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Regulatory decision noticesThe TGA has issued a direction notice to a Melbourne-based individual to cease advertising of all nicotine vaping products.
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Regulatory decision noticesThis instrument is made under subsection 26BD(3) of the Therapeutic Goods Act 1989.
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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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Therapeutic Goods (Biologicals-Application Form for Priority Applicant Determinations) Approval 2022
Regulatory decision noticesApproval of the Therapeutic Goods (Biologicals—Application Form for Priority Applicant Determinations) -
Safety updatesMedicines Safety Update - Information for health professionals
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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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Regulatory decision noticesArrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under sections 61(3)(a), 61(5AA), and 61(5AB) of the Act
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Regulatory decision noticesThis instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Pfizer) (Tozinameran and Riltozinameran) Labelling Exemption 2022.
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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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Regulatory decision noticesThe 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.
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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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Regulatory decision noticesThis instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) (Elasomeran and Imelasomeran) Labelling Exemption 2022.
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Regulatory decision noticesThe TGA has provisionally approved Moderna's bivalent COVID-19 vaccine, elasomeran/imelasomeran (SPIKEVAX Bivalent Original/Omicron) for use as a booster dose in adults 18 years and over.
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Regulatory decision noticesSection 7 declarations provide greater clarity for consumers, industry and regulators about whether a product is a therapeutic good.
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Regulatory decision noticesThe TGA has granted provisional approval to Biocelect Pty Ltd (on behalf of Novavax Inc) for its COVID-19 vaccine, NUVAXOVID.
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Regulatory decision noticesUpdate to the manufacturing principles for medicinal products
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Regulatory decision noticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.