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334 result(s) found, displaying 26 to 50
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Regulatory decision noticesFrom 1 September 2025, the TGA will adopt an updated version of the PIC/S Guide to GMP (PE009-17), with changes focused on Annex 1 for sterile medicines, and a phased compliance approach for manufacturers.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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Regulatory decision noticesThe TGA has issued a direction notice to Dispensed Pty Ltd to cease advertising of medicinal cannabis on all websites, social media accounts or other advertising platforms.
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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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Safety updatesInformation about the indications for the individual products and how to avoid administration errors.
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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) 2025, which commenced on 20 June 2025.
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Safety updatesNew warnings added of risks during anaesthesia or deep sedation.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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Safety updatesRisk of Guillain-Barre syndrome added to Product Information.
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Safety updatesUpdated illustrations clarify how to use measuring syringe for oral solutions.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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Safety updatesUpdates further highlight potential risks of mood-related changes and sexual disorders.
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Regulatory decision noticesUpdate on the progress in reducing the backlog of GMP Clearance Compliance Verification (CV) applications.
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Regulatory decision noticesListed medicines indications and requirements for their use have been updated in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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Regulatory decision noticesThis instrument is made under subsection 7C(1) of the Therapeutic Goods Act 1989.
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Safety updatesMore prominent warnings are being added to the Product Information (PI) and Consumer Medicine Information (CMI) for all oral and injectable (systemic) fluoroquinolones to strengthen existing warnings about serious side effects
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Safety updatesThere may be an increased risk of neurodevelopmental disorders in children born to men who have taken sodium valproate in the 3 months before conception.
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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) 2025, which commenced on 1 March 2025
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Regulatory decision noticesThis instrument is made under Schedule 5A to the Therapeutic Goods Regulations 1990 and Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002.
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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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Safety updatesAdditional safety information is being added to all montelukast products to strengthen and highlight existing warnings about serious neuropsychiatric events.
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Regulatory decision noticesThis consent is given under sections 14 and 14A of the Therapeutic Goods Act 1989.