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147 result(s) found, displaying 1 to 25
- NewsTGA’s new powers will help reduce the impact of medicine shortages on patientsFrom 22 March 2023 changes to the Therapeutic Goods Act 1989 will help alleviate the effects of medicine shortages on patients.
- NewsLapse of provisional registration for Tecentriq (atezolizumab) for the treatment of locally advanced or metastatic triple negative breast cancer (mTNBC)Provisional registration of Tecentriq (atezolizumab) for the treatment in mTNBC will lapse on 22 March 2023.
- NewsUpdate on effectiveness of monoclonal antibodies against COVID variantsThe TGA is aware of concerns about decreased effectiveness of monoclonal antibodies against the COVID-19 caused by emerging SAR-COV-2 variants. At this stage, the regulatory status of the products remain unchanged in Australia.
- NewsDAEN – medicines updateIn response to user feedback, we have been trialling a beta version of the DAEN – medicines since June 2022 alongside the older database.
- NewsLimited Ozempic supplies to commence distribution in AustraliaSupplies of Ozempic (semaglutide) have begun distribution in Australia but will remain quite limited for some time.
- NewsChanges applying to evaluation of new substances for listed medicinesNew guidelines and mandatory requirements for listed medicines ingredients have come into effect on 1 February 2023.
- NewsAntibiotics shortage in AustraliaCurrent antibiotics shortages in Australia include amoxicillin, amoxicillin/clavulanic acid, cefalexin, metronidazole and trimethoprim.
- NewsAccess Generic Medicines work-sharing initiative updateThe Generic Medicines Work-Sharing Initiative has updated its Operational Procedures document and Expression Of Interest form.
- NewsUpdates to the Prescribing Medicines in Pregnancy database, December 2022The Prescribing Medicines in Pregnancy database has now been updated.
- NewsUpdates to the Prescribing Medicines in Pregnancy database, May 2022The Prescribing Medicines in Pregnancy database has now been updated.
- NewsTGA operations over the holiday period 2022-23The TGA will have limited operations from Friday 23 December 2022 until Tuesday 3 January 2023
- NewsA reminder about weight loss productsBefore you take a weight loss supplement or medicine, there are things to consider.
- NewsA warning that advertising Ozempic (semaglutide) is prohibitedA warning to social media influencers and advertisers not to advertise this prescription medicine.
- NewsPost-market review of spinal cord stimulation (SCS) devicesFind out more about the post market review the TGA is undertaking on spinal cord stimulators (SCS).
- NewsStandard for serialisation and data matrix codes commences 1 January 2023Find out about the requirements starting on 1 January 2023 for medicines that are serialised or include a data matrix code.
- NewsBeware the Barbie drug: the dangers of using MelanotanThe TGA urges consumers to steer clear of using products containing 'Melanotan'
- NewsPharmacovigilance Inspection Program Risk Assessment SurveyThe Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open until 18 December 2022 for medicine sponsors to complete.
- NewsUser experience survey: DAEN - medicines beta versionTell us your experience using of the beta Database of Adverse Event Notifications (DAEN) - medicines.
- NewsSurrogate viruses for use in disinfectant efficacy tests to justify claims against MonkeypoxThe TGA is providing guidance on surrogate viruses that may be used to test disinfectants making claims of efficacy against Monkeypox.
- NewsTGA approval to change blood donation rules relating to vCJD deferralThe TGA has approved the removal of the geographical deferral of blood and plasma donors from the UK, which was put in place to minimise the risk of variant Creutzfeldt-Jakob disease (vCJD), commonly known as 'mad cow disease'.
- NewsStandard indications
- NewsScheduling news
- NewsFinal decision on scheduling of cannabis and tetrahydrocannabinols: Frequently asked questionsQuestions and answers on Cannabis and Tetrahydrocannabinols
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