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- Enforceable undertaking: Strapit Medical and Sports Supplies Pty LtdCompliance undertakingsTGA accepts Enforceable Undertaking by Strapit Medical and Sports Supplies Pty Ltd in relation to breaches of the Therapeutic Goods Act.
- Rapid Antigen Test cancellations not due to the failure to detect the COVID-19 Omicron variantMedia releasesThe TGA is aware of several incorrect recent media reports asserting that some COVID-19 rapid antigen tests have been removed from the market by the TGA for failing to detect the Omicron COVID-19 variant.
- Strapit Medical and Sports Supplies Pty Ltd undertakes to comply with advertising rules for therapeutic goodsMedia releasesTGA accepts Enforceable Undertaking by Strapit Medical and Sports Supplies Pty Ltd in relation to breaches of the Therapeutic Goods Act.
- Court proceedings initiated against Vapor Kings Pty Ltd and its director for alleged unlawful advertising of nicotine vaping productsMedia releasesThe TGA has commenced Federal Court proceedings against Vapor Kings Pty Ltd and its sole director for alleged unlawful advertising of nicotine vaping products.
- Influenza vaccine batch release for 2022 seasonMedia 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.
- TGA approval to change blood donation rules relating to vCJD deferralNewsThe TGA has approved the removal of the geographical deferral of blood and plasma donors from the UK, which was put in place to minimise the risk of variant Creutzfeldt-Jakob disease (vCJD), commonly known as 'mad cow disease'.
- TGA provisionally approves the Biocelect Pty Ltd (Novavax) COVID-19 vaccine, NUVAXOVID, for use in individuals aged 12-17 yearsMedia releasesThe TGA has provisionally approved the Biocelect Pty Ltd (on behalf of Novavax Inc.) COVID-19 vaccine, NUVAXOVID, for use in individuals aged 12 years and older.
- 13 Vape Pty Ltd directed to cease alleged unlawful advertising of nicotine vaping productsMedia releasesThe TGA has issued a direction notice to 13 Vape Pty Ltd and an executive officer to cease promoting the use and supply of nicotine vaping products to Australian consumers.
- Therapeutic Goods (Poisons Standard) (Benzylpenicillin - Seqirus) Exemption 2022NoticesThis labelling exemption is granted under section 1.1(3) of Part 2 of the current Poisons Standard.
- Person fined $31,698 for alleged unlawful advertising of disposable nicotine vaping productsMedia releasesThe TGA has issued 12 infringement notices totalling $31,698 to a NSW based individual for alleged unlawful advertising of disposable nicotine vaping products on several websites.
- TGA provisionally approves Moderna COVID-19 vaccine (SPIKEVAX) for use in children from 6 monthsMedia releasesThe TGA has provisionally approved a paediatric dose of the Moderna COVID-19 vaccine, SPIKEVAX, for use in individuals aged 6 months to less than 6 years (6 months to 5 years).
- COVID-19 vaccine safety report - 14-07-2022COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
- First-generation oral sedating antihistamines - do not use in childrenSafety updatesMedicines Safety Update - Information for health professionals
- Product Information safety updates - July 2022Safety updatesMedicines Safety Update - Information for health professionals
- Surrogate viruses for use in disinfectant efficacy tests to justify claims against MonkeypoxNewsThe TGA is providing guidance on surrogate viruses that may be used to test disinfectants making claims of efficacy against Monkeypox.
- TGA grants provisional determinations to Pfizer for COVID-19 vaccines to target Omicron variantMedia releasesOn 5 July 2022 the TGA granted two provisional determinations to Pfizer Australia Pty Ltd.
- Direction about advertisements: Precision Pharmaceuticals Pty LtdNoticesDirection Notice issued to cease advertisement of prescription and illegal products
- Precision Pharmaceuticals Pty Ltd fined and directed to cease alleged unlawful advertising of nicotine vaping productsMedia releasesPrecision Pharmaceuticals Pty Ltd fined and directed to cease alleged unlawful advertising of nicotine vaping products
- COVID-19 vaccine safety report - 30-06-2022COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
- Provisional determination granted to Pfizer in relation to COVID 19 vaccine, COMIRNATY - for use in individuals 6 months up to 5 yearsMedia releasesOn 28 June 2022 the TGA granted a provisional determination to Pfizer Australia Pty Ltd in relation to its COVID-19 Vaccine, COMIRNATY.
- COVID-19 vaccine weekly safety report - 23-06-2022COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
- Antiepileptic medicines - updated precautions for pregnancy and women of childbearing potentialSafety updatesMedicines Safety Update - Information for health professionals
- Hough Pharma Pty Ltd fined $106,560 for allegedly failing to provide information to demonstrate adequate performance of three COVID-19 rapid antigen tests and for allegedly failing to provide appropriate customer supportMedia releasesThe TGA has issued eight (8) infringement notices totalling $106,560 to Hough Pharma Pty Ltd for allegedly failing to provide information to the TGA to demonstrate the safety and performance of three COVID-19 RATs.
- Single therapeutic goods ordersNoticesThis copy of the Order incorporates amendments made in August 1992 by the Therapeutic Goods (Groups) Order No. 1 of 1992
- Therapeutic Goods (Groups) Order No. 1 of 1992NoticesThis Order may be cited as Therapeutic Goods (Groups) Order No. 1 of 1992.