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What's new
95 result(s) found, displaying 51 to 75
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GuidanceGuidance about when certain types of laboratory information management systems (LIMS) and laboratory information systems (LIS) may be excluded from our regulatory requirements.
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GuidanceGuidance on when software that is middleware intended to connect or interface applications may be excluded from our regulatory requirements.
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GuidanceGuidance on when software used as a patient reported outcome measures (PROMs) questionnaire or patient survey may be excluded from our regulation.
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GuidanceGuidance about when certain types of population-based analytics software may be excluded from our regulatory requirements.
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GuidanceGuidance on when software that provides alerts to health professionals in relation to patient care may be excluded from our regulation.
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PageThis page contains a list of therapeutic vaping goods, for use in smoking cessation or the management of nicotine dependence, that can be legally supplied in Australia. Healthcare practitioners can use this list when prescribing and supplying unapproved therapeutic vaping goods as they have been notified as complying with applicable standards.
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DatasetFind products removed from the ARTG after annual charges were not paid.
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PageA list of approved COVID-19 tests included in the ARTG for supply in Australia.
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PageFind out more about the post-market review we have undertaken on metal-backed patella (MBP) implantable devices.
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Market actionsApex Mobility is conducting a product correction on the Rifton TRAM and E-Pacer patient transfer and gait training mobility devices.
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Market actionsThe former liquidator for Trividia Health Australia Pty Ltd (deregistered) is facilitating a product correction for TRUE METRIX® Blood Glucose Monitoring Systems.
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GuidanceGuidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.
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PageInformation about influenza reference reagents for testing influenza vaccines and how to order them.
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PageInformation about current processing times, workload, priorities, and key messages for GMP Clearance applications.
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DatasetView prescription medicines eligible for orphan drug status, registration via priority review or provisional approval.
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PageFind out about the discontinuation of Protaphane InnoLet insulin cartridges and the substitute product available.
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PageInformation about the shortages of IV fluid products
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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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Meeting statementsAdvisory Committee on Medicines meeting statement
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Advertising permissionApproval under section 42DF for use of restricted representations by Coloplast Pty Ltd.
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Advertising permissionApproval under section 42DF for use of restricted representations by Coloplast Pty Ltd
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PageWatch videos and access resources that explain our refreshed portal and case management system.
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Australian public assessment report (AusPar)Lutathera has been approved for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumours in adults.
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DatasetSearch applications for new medicines, or new uses for existing medicines, that are under current evaluation.