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What's new
83 result(s) found, displaying 1 to 25
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Market actionsVitality Brands Worldwide Pty Ltd is recalling three batches of Cancer Council Sunscreen Clear Zinc Kids SPF50+ 110g due to the potential for the product to become separated.
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PageInformation about influenza reference reagents for testing influenza vaccines and how to order them.
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FormsAs of 25 June 2024, use this PDF form to order Influenza Reagents.
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DatasetResults and outcomes of the TGA’s listed medicine compliance reviews.
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News articlesWe've updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 19 listed medicines
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BlogHave you experienced an issue with a medicine or medical device?
Every report is important. Reports help us monitor the safety of medicines, vaccines and medical devices. -
Australian public assessment report (AusPar)Sephience (sepiapterin) has been approved for the treatment of hyperphenylalaninaemia in adult and paediatric patients with phenylketonuria.
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ServiceYou can apply to access unapproved therapeutic goods for individual patients through the Special Access Scheme (SAS).
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Meeting statementsAdvisory Committee on Complementary Medicines meeting statement for 31 July 2025
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DatasetView annual charge exemptions (ACE) based on a sponsor declaring $0 turnover.
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PageInformation on issues relating to sunscreens using the same base formulation as Ultra Violette Lean Screen SPF 50+ following the recent CHOICE SPF testing of a range of sunscreens on the Australian market.
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PageThe EU MDR Transition web publication service provides notifications to providers and consumers going through low-risk changes, as part of the transition.
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Safety updatesProduct warnings across the GLP-1 RA class of medicines have been aligned to ensure consistent information regarding the potential risk of suicidal thoughts or behaviours.
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PageFind out more about the medical devices that are being reviewed.
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PagePost-market review of all breast implants with micro transponders included in the Australian Register of Therapeutic Goods (ARTG).
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Safety alertsWe have updated the product warnings for GLP-1 and dual GIP/GLP-1 receptor agonists for two separate safety issues. This relatively new and high-profile class of medicines is used to treat type 2 diabetes mellitus and/or obesity.
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Safety updatesOur investigation into the potential for reduced effectiveness of oral contraception during initiation or dose escalations with Mounjaro (tirzepatide) has found that this association could not be ruled out.
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User guideThis user guide is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD medical device.
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PageThe Australian prescription medicine decision summary (AusPMDS) provides a brief overview of the TGA’s assessment and decision to approve or not approve registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
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PageKey information and updates about the shortage of methylphenidate hydrochloride products.
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PageSummary of legal settings relevant to the prescribing and dispensing of therapeutic nicotine vaping goods to patients under 18 years of age.
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DatasetSearch registrations for new medicines including generic medicines, chemical and biological entities (NCE and NBE), biosimilar medicines, biologicals and combinations. You can also search extensions of indications, which describes new uses of medicines.
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DatasetThese applications for new medicines or new uses for existing medicines are under evaluation by the TGA.
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PageSerious Scarcity Substitution Instruments (SSSIs) allow community pharmacists to substitute specific medicines without prior approval from the prescriber so long as the permitted circumstances within the SSSI are met.