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712 result(s) found, displaying 151 to 175
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Media releasesFind out how the prescribing and dispensing requirements for MS-2 Step have changed.
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Media releasesWe have issued 8 infringement notices totalling $105,600 to Nature’s Puff Pty Ltd and a director, for the alleged unlawful advertising of nicotine vaping products.
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Media releasesThis International Coalition of Medicines Regulatory Authorities (ICMRA) statement provides the general public with important information regarding the safety of COVID-19 vaccines, which have now been in use for more than two years.
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Regulatory decision noticesFind out how listed medicine ingredients, and requirements for their use, have been updated in the latest Therapeutic Goods (Permissible Ingredients) Determination.
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Regulatory decision noticesThe 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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Media releasesThe TGA has issued three infringement notices totalling $39,960 to Queensland-based company Pracmed Healthcare Pty Ltd for alleged unlawful advertising of complementary medicines.
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Media releasesThe TGA has issued 38 infringement notices totalling $588,840 to four Sydney-based entities for allegedly importing 22 consignments containing a total of 379,600 nicotine vaping products.
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Media releasesThe TGA has issued 5 infringement notices to Affinity Corp Australia Pty Ltd for the alleged unlawful advertising of medicinal cannabis products.
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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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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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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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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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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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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 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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Media releasesChristopher Ramsey, the Director of AusLabs, Smart Labs and iSARMs, has been sentenced 2 years imprisonment and fined $300,000 for his role in the manufacture, supply and advertising of illegal Selective Androgen Receptor Modulators and nootropic products. Mr Ramsey’s three companies also received significant fines totalling $2,225,000.
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Regulatory decision noticesMore applications for Good Manufacturing Practice (GMP) clearances can now be assessed under the TGA’s MRA pathway.
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Media releasesThe TGA has issued an infringement notice for $13,320 to Sydney company JSHealth Vitamins Pty Ltd for an alleged breach of the Therapeutic Goods Act 1989.
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Media releasesThe TGA has issued 12 infringement notices totalling $159,840 to a manufacturer of listed complementary medicines after a recent inspection of the company’s premises identified unacceptable manufacturing practices.
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Media releasesOn 22 February the TGA, with the assistance of NSW Police, executed 3 search warrants connected to an individual operating in the Newcastle area of New South Wales.
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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.