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1273 result(s) found, displaying 376 to 400
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BlogWant to know what’s in your medicines? The obvious place to start is with the medicine’s label, but there may be more to it.
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COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
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Media releasesInfluenza vaccines can change from year to year as new strains of influenza virus appear. This is one reason vaccination against influenza is given every year.
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Safety updatesA warning about anticoagulant-related nephropathy (ARN) has been added to the Product Information (PI) for all oral anticoagulants.
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News articlesThe TGA has approved applications submitted by Australian Red Cross Lifeblood (Lifeblood) to remove most of the sexual activity ineligibility criteria for plasma donors used for fractionated products only. Lifeblood refers to this approach as ‘the plasma pathway’.
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Media releasesIt is alleged that the individual attempted to import six different types of nicotine vaping products (prescription medicines). The unapproved nicotine vaping products were intercepted by the Australian Border Force and have been seized and will be destroyed under advice from the TGA.
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News articlesTransition period for accepting ISO 13485 ends 26 May 2023.
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Regulatory decision noticesArrangement under subsection 7C(1) of the Therapeutic Goods Act 1989
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Regulatory decision noticesArrangement under subsection 7C(1) 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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News articlesThe Prescribing Medicines in Pregnancy database has now been updated.
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Regulatory decision noticesDelays in processing timeframes of applications to extend GMP Clearances.
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Media releasesThe TGA has issued 5 infringement notices to 3 health practitioners for the alleged unlawful importation of unregistered prescription-only medicines.
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Safety updatesNew warnings for baricitinib, tofacitinib and upadacitinib follow a TGA review of a randomised safety trial called the ORAL Surveillance Study.
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News articlesThe TGA has updated the Australian Regulatory Guidelines for Sunscreens (ARGS) to align with the data requirements for all ingredients proposed to be included in the Therapeutic Goods (Permissible Ingredients) Determination
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News articlesThe TGA will recognise the extended transition for the European Union Medical Device Regulation (EU MDR).
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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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Regulatory decision noticesListed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2023.
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Media releasesThe TGA has published a final decision to reduce the maximum size of packs for various paracetamol products.
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Media releasesFrom 1 June 2023, prescribing of oral ivermectin for ‘off-label’ uses will no longer be limited to specialists such as dermatologists, gastroenterologists and infectious diseases specialists.
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News articlesWe are conducting surveys to collect information about medical devices manufactured at the point-of-care.
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Media releasesThe TGA has approved Moderna Australia’s application to transition its COVID-19 vaccine, SPIKEVAX (elasomeran), from provisional to full registration.
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Media releasesThe TGA has issued nine infringement notices to three companies and two associated individuals for the alleged unlawful importation of nicotine vaping products.
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COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.