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What's new
93 result(s) found, displaying 1 to 25
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ConsultationWe are seeking feedback on the regulation of radiopharmaceuticals in Australia. These medicines contain small amounts of radioactive material, used to support the diagnosis and treatment of serious conditions, including cancer and cardiovascular disease.
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ConsultationHave your say about proposals to amend the Poisons Standard. These will be considered at the next meeting of the Advisory Committee on Medicines Scheduling (ACMS), Advisory Committee on Chemicals Scheduling (ACCS), and the joint meeting of the ACMS and ACCS.
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Safety updatesWe have identified reports of FluMist being administered in error to children under 2 years of age.
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PageInformation about current processing times, workload, priorities, and key messages for GMP Clearance applications.
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PageInformation on requesting a pre-submission meeting with the TGA for planned Good Manufacturing Practice (GMP) Licensing, Certification and Clearance applications.
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PageLinks to information on good manufacturing practice (GMP), manufacturing inspections and manufacturer statutory declarations.
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PageFind out more information on the medicinal cannabis vaping devices that are approved in Australia.
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DatasetSearch registrations for new medicines including generic medicines, chemical and biological entities (NCE and NBE), biosimilar medicines, biologicals and combinations. This includes extensions of indications, which describes new uses of medicines.
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DatasetSearch applications for new medicines, or new uses for existing medicines, that are under current evaluation.
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DatasetSearch approvals to import and supply medicines not in the Australian Register of Therapeutic Goods (ARTG) to address medicine shortages.
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Advertising permissionApproval under section 42DF for use of restricted representations by Smith & Nephew Pty Ltd
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Prescription medicine decision summaryCenrifki (tolebrutinib) has been approved for the treatment of Secondary Progressive Multiple Sclerosis (SPMS) in adults.
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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.
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Prescription medicine decision summaryTzield (teplizumab) is approved to delay the onset of Stage 3 type 1 diabetes mellitus (T1D) in adult and paediatric patients aged 8 years and older with Stage 2 type 1 diabetes mellitus.
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Safety alertsWe are advising consumers that ‘Pharmatech’ branded MK-677 capsules (containing ibutamoren) may pose a serious risk to your health and should not be taken.
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PageThe medical devices DAEN is our online database that contains information from suspected adverse events reported to us for medical devices.
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PageThe annual charge exemption (ACE) scheme is a self-declaration scheme.
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GuidanceGuidance about the Annual Charge Exemption (ACE) scheme waiver process.
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PageAll adverse events reported to us are added to this searchable database.
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PageInformation about influenza reference reagents for testing influenza vaccines and how to order them.
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Market actionsSanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare, is recalling the below products due to the potential presence of a glass fragment within the bottle (not within the tablets).
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Market actionsMindray Medical Australia Pty Ltd is conducting a product correction for the BeneHeart D1 Automated External Defibrillator. The operator’s manual is being updated for the procedure of switching patient types.
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BlogMedicinal cannabis prescribing in Australia has increased significantly in recent years. However, many patients are unaware that most medicinal cannabis products are unapproved goods. As a prescriber, you play a critical role in ensuring patients are informed, protected and supported when these products are being considered for their clinical situation.
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PageWe’re transforming the way you interact with us by building a modern, intuitive digital platform that aims to make interactions with us easy, seamless and efficient.