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223 result(s) found, displaying 1 to 25
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NewsUpdated information for nitrosamine impurities in medicines consistent with recent EMA updated information.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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NewsThe dual labelling period for some medicine ingredients is ending on 30 April 2025.
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Compliance undertakingsWe have accepted a court-enforceable undertaking from Your Solution Compounding Pharmacy Pty Ltd, regarding advertising of prescription-only compounded medicines for weight-loss.
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NoticesUpdate on the progress in reducing the backlog of GMP Clearance Compliance Verification (CV) applications.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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NoticesThis instrument is made under subsection 7C(1) of the Therapeutic Goods Act 1989.
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NewsThe updated plan emphasises solidifying our collaborative processes, aligning expectations with industry, and improving our communication strategies.
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NewsFollowing a request from the sponsor to reconsider their decision, the TGA has confirmed the initial decision to not register the medicine on the basis that the safety and efficacy of the medicine were not satisfactorily established.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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NoticesThis instrument is made under subsections 19(5AA), 32CM(1A) and 41HC(1A) of the Therapeutic Goods Act 1989.
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Therapeutic Goods (Special Access Scheme - Application and Notification Forms) Approval (No. 2) 2024
NoticesThis instrument is made under the Therapeutic Goods Regulations 1990, the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Act 1989. -
Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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NoticesMRA GMP clearances that are expiring on 31 December 2024 will be automatically extended.
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NewsFind out about new requirements for labels of injectable electrolyte medicines and updates to guidance for medicine sponsors.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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Media releasesThe TGA has settled judicial review proceedings brought by InstantScripts in respect of infringement notices issued to it by the TGA.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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NewsThe TGA is updating information for nitrosamine impurities in medicines including acceptable intakes (AI).
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NewsTGA has made the decision not to register lecanemab (LEQEMBI) for the treatment of patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease and Mild Alzheimer's dementia (early Alzheimer's disease).
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NewsFollowing our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.
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NewsThe Prescription Medicines in Pregnancy database has been updated to include new and amended entries.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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NoticesFind out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) which commenced on 27 September 2024.