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What's new
80 result(s) found, displaying 1 to 25
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PageMedicines and other therapeutic goods must comply with applicable standards to be supplied in Australia.
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Regulatory decision noticesThe delegate believes, on reasonable grounds, that it is in the interests of public health or safety to give Veganic SKN Limited directions under section 42YT of the Therapeutic Goods Act 1989.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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User guideAuthorised Prescribers must submit a report every 6 months for each AP authorisation they hold.
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Media releasesWe have issued an enforceable direction to Veganic SKN Limited on the basis that a delegate of the Secretary believes that Veganic SKN is not complying with the Therapeutic Goods Act 1989.
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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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PageInformation about current processing times, workload, priorities, and key messages for GMP Clearance applications.
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PageInformation for healthcare practitioners to aid their understanding of the rules surrounding importation of therapeutic goods
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Medicine shortage alertsInformation about the cyclophosphamide and ifosfamide injection shortages.
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PageApprovals under section 41HD enable sponsors to import and supply specific medical devices during supply emergencies under special exemptions and conditions.
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PageThe shortages of most methylphenidate modified-release products have resolved.
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Australian public assessment report (AusPar)Dostiva and Dexeva are approved for preventing or managing cancer related bone complications and are biosimilars of Xgeva. Denolia and Deskeltia are approved for treating osteoporosis in men and postmenopausal women, as well as bone loss due to cancer therapies or long term glucocorticoid use and are biosimilars of Prolia.
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PageFind out more about the post-market review we are undertaking on plastic syringes.
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Medicine shortage alertsThe overall supply of methylphenidate modified-release products continues to improve and stabilise.
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Prescription medicine decision summaryYesintek is approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis in adults, and plaque psoriasis in children aged 6 years and older.
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PageThe EU MDR transition web publication service provides notifications to providers and consumers going through low-risk changes, as part of the transition.
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Prescription medicine decision summaryQdenga (live, attenuated - dengue virus serotypes 1, 2, 3, and 4) is a vaccine approved to provide protection against dengue disease for adults, adolescents, and children aged 4 years and over.
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Media releasesThe TGA, assisted by the New South Wales Police Force, has conducted targeted enforcement action across 2 sites in south-west Sydney.
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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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PageInformation on issues relating to sunscreens using the same base formulation as Ultra Violette Lean Screen SPF 50+ following the recent CHOICE SPF testing of a range of sunscreens on the Australian market.
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Media releasesTwo Victorian men and one woman have been charged following a joint investigation into an alleged criminal syndicate importing Performance and Image Enhancing Drugs (PIEDs) into Australia.
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Safety alertsWe are advising consumers that Artri Ajo King tablets may pose a serious risk to your health and should not be taken.
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DatasetSearch our database of sponsor-requested cancellations from the ARTG.
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BlogPatient information materials are required to be supplied with implantable and active implantable medical devices in Australia. Abby’s story highlights the practical importance of the patient information materials.