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- Advertising (3)
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What's new
95 result(s) found, displaying 1 to 25
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Market actionsBoston Scientific is conducting a Product correction and Product alert for ACCOLADE and VISIONIST pacemakers.
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FormsWe are redeveloping the Conformity Assessment application form to enable applicants to provide all the required information at the time of submitting their application.
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FormsComplete this form to authorise or remove an agent (e.g. a regulatory affairs consultant) or people external to your company to undertake regulatory correspondence with us.
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Market actionsAC Newco Pty Ltd (Advanced Cosmeceuticals), on behalf of Medik8, is recalling all unexpired batches of Medik8 Physical Sunscreen SPF50+ 60mL, 60mL Professional, & 15mL due to the product being unlikely to meet its labelled Sun Protection Factor (SPF) rating.
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FormsRequest cancellation of a therapeutic good on the Australian Register of Therapeutic Goods (ARTG).
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FormsThis form is used to nominate a new representative from your organisation to be the administrator
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DatasetRead our results and outcomes of listed medicine compliance reviews.
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News articlesWe’ve updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 32 listed medicines.
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PageUnderstand and apply the Unique Device Identification (UDI) requirements to your medical devices.
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PageKey information about the shortage for patients, carers and health care professionals
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PageKey information and updates about the shortage of methylphenidate hydrochloride products.
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GuidanceGuidance about the requirements for advertising software-based medical devices to consumers or health professionals.
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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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Australian public assessment report (AusPar)Andriga (abiraterone and prednisolone) has been approved for the treatment of prostate cancer.
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PageAsherman Syndrome is a uterine condition linked to intrauterine scarring that can affect fertility and menstruation, with this page outlining risks, symptoms, and the TGA’s regulatory role and guidance.
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PageAll adverse events reported to us are added to this searchable database.
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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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PageMedDRA is an international medical terminology used to code, classify and group medicine adverse event reports in the Database of Adverse Event Notifications, supporting consistent safety monitoring and regulatory reporting.
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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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Australian public assessment report (AusPar)Epyztek (ustekinumab) is approved for treatment of several conditions including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
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Media releasesWe have opened an 8-week public consultation seeking improvements to the regulation of sunscreens in Australia.
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PageSearch for infringement notices whereby a financial penalty may be issued in response to certain breaches of the Therapeutic Goods Act 1989 (the Act).
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Media releasesWe have issued 6 infringement notices totalling $23,760 to 3 health practitioners for the alleged unlawful importation of unapproved therapeutic goods.
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PageLists to help prescribers and pharmacists in prescribing and supplying medicinal cannabis products under the SAS/AP categories.
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DatasetSearch our database of sponsor-requested cancellations from the ARTG.