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217 result(s) found, displaying 201 to 217
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Safety updatesAcellur Dermal Matrix Products used in Breast Reconstruction - clarification on reports of potential higher complication rates.
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Safety updatesMedicines Safety Update - Information for health professionals
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Media releasesThe TGA has granted provisional approval to two oral COVID-19 treatments.
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Media releasesOn 19 January 2022 the TGA granted provisional approval to Biocelect Pty Ltd (on behalf of Novavax Inc) in relation to the COVID-19 vaccine, NVX-CoV2373, for individuals aged 18 years and over.
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Regulatory decision noticesA new Therapeutic Goods Determination for listed medicine ingredients commenced on 18 January 2022.
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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.
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News articlesOn 18 January 2022 the TGA granted provisional approval to Merck Sharp & Dohme (Australia) Pty Ltd for its oral COVID-19 treatment, LAGEVRIO (molnupiravir).
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News articlesOn 18 January 2022 the TGA granted provisional approval to Pfizer Australia Pty Ltd’s oral COVID-19 treatment nirmatrelvir + ritonavir (PAXLOVID).
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Media releasesThe TGA determined that the two dose course of the Gamaleya Institute vaccine (Sputnik V, Russian Federation) would be 'recognised' for the purpose of establishing a traveller's vaccination status.
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Media releasesThe TGA has issued an infringement notice, totalling $26,640, to Ezy Company Pty Ltd for alleged unlawful importation of COVID-19 rapid antigen tests and nicotine vaping products in 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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Safety updatesMedical device safety update regarding pulse oximeters limitations, including the effect of skin pigmentation.
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COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
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Safety updatesMedicines Safety Update - Information for health professionals
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News articlesThe new Therapeutic Goods (Medicines Advisory Statements) Specification 2021 commences 1 January 2022
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Media releasesOn 4 January 2022 the TGA granted a further provisional determination to AstraZeneca Pty Ltd in relation to the COVID-19 treatment tixagevimab and cilgavimab (EVUSHELD).