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What's new
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What's new
83 result(s) found, displaying 26 to 50
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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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Medicine shortage alertsPharmacists can substitute whichever brand and strength of nicorandil is available during the shortage.
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PageThe ACCESS Consortium has launched the Generic Medicines Work Initiative, an innovative work sharing model for generic applications
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PageThe Freedom of Information disclosure log gives access to information we've released in response to an FOI request.
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Advertising permissionApproval under section 42DF for use of restricted representations by Haleon Australia Pty Ltd
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Scheduling decisions (final)This web publication constitutes a notice for the purposes of regulation 42ZCZS of the Therapeutic Goods Regulations 1990 (the Regulations).
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Media releasesA decision by the TGA will strengthen safety controls for products containing vitamin B6, and help to reduce the risk of nerve damage associated with the long-term consumption of high doses.
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Australian public assessment report (AusPar)Nexobrid (anacaulase-bcdb) has been approved for eschar removal in adults and paediatric patients with deep partial thickness and/or full thickness thermal burns.
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News articlesSome medical devices could be affected by the end of support for the Microsoft Windows 10 operating system.
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PageKey information about the shortage for patients, carers and health care professionals
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Meeting statementsAdvisory Committee on Vaccines meeting statement 54
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CommitteeInformation on the role and membership of ACV and proposed meeting dates.
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DatasetPrescription medicines eligible for orphan drug status, or for registration via priority review or provisional approval.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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News articlesThis joint statement from the Head of the TGA and Australia’s Chief Medical Officer (CMO), provides you with clear, evidence-informed advice about vaccine safety.
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DatasetSearch approvals to import and supply medicines not in the ARTG to address medicine shortages.
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Safety updatesThe Product Information for denosumab products indicated for the treatment of osteoporosis have been updated to strengthen the existing warning for multiple vertebral fractures following discontinuation or delay of treatment.
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Safety alertsThe safety information for denosumab products used to treat osteoporosis has been updated to strengthen the existing warning for multiple spinal fractures after discontinuation or delay of treatment.
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DatasetSearch our database of cancellations and suspensions from the ARTG.
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GuidanceGuidance on how medical devices must comply with the Essential Principles.
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DatasetDatabase of consents to import, supply or export therapeutic goods that do not comply with standards.
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PageWe are improving the way we monitor, manage impacts and communicate about medicine shortages and discontinuations in Australia.
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Advertising permissionApproval under section 42DF for use of restricted representations by Air Liquide Healthcare Pty Ltd
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Australian public assessment report (AusPar)Enrylaze (crisantaspase) has been approved as a component of a multi-agent chemotherapeutic regimen, for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adults and paediatric patients (1 month and older) who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.