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What's new
72 result(s) found, displaying 51 to 72
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Media releasesA coordinated crackdown on illegal vapes in southeast Queensland has led to a seizure of illegal vaping and tobacco products with a street value exceeding $8.8 million.
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PageHow to submit data in the Electronic Common Technical Document (eCTD) format.
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PageKey information and updates about the shortage of metformin immediate-release tablets.
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PageFind direction and prevention notices and learn how we use them to stop non-compliant advertising.
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Regulatory decision noticesThe TGA has issued a direction notice to Hwangbo SS Pty Ltd and its executive officer in relation to vaping products under section 42DZK of the Therapeutic Goods Act 1989.
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Market actionsPhytologic Holdings Pty Ltd is recalling one batch of Henry Blooms Infant Liquid D3 & K2 with Probiotic due to a dosing syringe error.
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Australian public assessment report (AusPar)Hympavzi is indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older with severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without factor VIII inhibitors or severe haemophilia B (congenital factor IX deficiency, FIX < 1%) without factor IX inhibitors.
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ChecklistsA compliance checklist for advertisers applying to use a restricted representation.
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News articlesWe’re pleased to announce that improvements for industry users will roll out by the end of October.
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PageFind out about the shortage of Pegasys (peginterferon alfa-2a) injection.
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PageWe offer several email subscription options to keep you up to date with news and alerts.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICHER(R1); EMA/CHMP/ICH/436221/2017
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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PageKey information and updates about the shortage of methylphenidate hydrochloride products.
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PageInformation about the shortages of HRT products for patients and healthcare professionals
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DatasetSearch companion diagnostics (CDx) we have approved for supply in Australia.
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Regulatory decision noticesThe TGA has issued a direction notice to Iget Brands Pty Ltd and its executive officer in relation to the advertising of vaping goods under section 42DZK of the Therapeutic Goods Act 1989.
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Regulatory decision noticesThe TGA has issued a direction notice to Iquality Group Pty Ltd and its executive officer in relation to the advertising of vaping goods under section 42DZK of the Therapeutic Goods Act 1989.
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Safety updatesNew warnings on hepatotoxicity risk and monitoring recommendations have been added to the Product Information for Veoza (fezolinetant).
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PagePost-market review of all breast implants with micro transponders included in the Australian Register of Therapeutic Goods (ARTG).
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Australian public assessment report (AusPar)Dexrazoxane-Reach is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumour control.