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910 result(s) found, displaying 26 to 50
- NoticesUpdate to listed medicine ingredients in May 2023Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2023.
- NewsSurveys - Medical devices manufactured at the Point-of-CareWe are conducting surveys to collect information about medical devices manufactured at the point-of-care.
- Media releasesModerna’s COVID-19 vaccine SPIKEVAX receives approval for full registrationThe TGA has approved Moderna Australia’s application to transition its COVID-19 vaccine, SPIKEVAX (elasomeran), from provisional to full registration.
- NewsCOVID-19 vaccine: SPIKEVAX (elasomeran)The TGA approved Moderna Australia’s application to transition its COVID-19 vaccine, SPIKEVAX (elasomeran), from provisional to full registration.
- COVID-19 vaccine safety reportsCOVID-19 vaccine safety report - 20-04-23Information about the TGA's safety monitoring of COVID-19 vaccines.
- Media releasesInfringement notices totalling $66,600 given to three Sydney-based companies and two individuals for alleged unlawful importation of nicotine vaping productsThe TGA has issued nine infringement notices to three companies and two associated individuals for the alleged unlawful importation of nicotine vaping products.
- NewsFirst Mpox (monkeypox) test kit approved for AustraliaThe TGA has approved the first commercially supplied test kit for the detection of Mpox (monkeypox) virus.
- COVID-19 vaccine safety reportsCOVID-19 vaccine safety report – 06-04-23Information about the TGA's safety monitoring of COVID-19 vaccines.
- NewsDual labelled medicines begin transition to sole medicine ingredient names soonFind out about new transition arrangements for dual labelled ingredient names.
- NewsCOVID-19 vaccine provisional determinationsCOVID-19 vaccines that have received a provisional determination from the TGA.
- NoticesTherapeutic Goods (System for Australian Recall Actions) (Arrangement for Computer Programs) Instrument 2023Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989
- BlogUnderstanding the changes to MDMA and psilocybin accessFrom 1 July 2023, authorised psychiatrists can prescribe psychedelic medicines to people with specific mental health conditions under strict controls.
- NewsChanges to medical device essential principles for nanomaterialsEssential principle 7 now mentions nanomaterials explicitly (see EP 7.7)
- Media releasesCompany director sentenced to 2 years imprisonment with personal and company fines of over $2.5 million for selling illegal SARMsChristopher Ramsey, the Director of AusLabs, Smart Labs and iSARMs, has been sentenced 2 years imprisonment and fined $300,000 for his role in the manufacture, supply and advertising of illegal Selective Androgen Receptor Modulators and nootropic products. Mr Ramsey’s three companies also received significant fines totalling $2,225,000.
- Safety updatesProduct Information safety updates - March 2023Medicines Safety Update - Information for health professionals
- 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.
- COVID-19 vaccine safety reportsCOVID-19 vaccine safety report - 23-03-2023Information about the TGA's safety monitoring of COVID-19 vaccines.
- 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.
- NoticesGMP Clearance: Additional countries added to MRA pathwayMore applications for Good Manufacturing Practice (GMP) clearances can now be assessed under the TGA’s MRA pathway.
- Safety updatesCheck for pholcodine use before general anaesthesiaHealth professionals should check if patients undergoing general anaesthesia have used products containing pholcodine in the previous 12 months.
- Media releasesJSHealth Vitamins fined $13,320 for alleged unlawful supply of a complementary medicineThe TGA has issued an infringement notice for $13,320 to Sydney company JSHealth Vitamins Pty Ltd for an alleged breach of the Therapeutic Goods Act 1989.
- Media releasesAustralian manufacturer fined almost $160,000 for allegedly breaching conditions of its medicines manufacturing licenceThe TGA has issued 12 infringement notices totalling $159,840 to a manufacturer of listed complementary medicines after a recent inspection of the company’s premises identified unacceptable manufacturing practices.
- COVID-19 vaccine safety reportsCOVID-19 vaccine safety report - 09-03-2023Information about the TGA's safety monitoring of COVID-19 vaccines.
- Media releasesTGA seizes more than 55,000 potentially dangerous products with the assistance of NSW PoliceOn 22 February the TGA, with the assistance of NSW Police, executed 3 search warrants connected to an individual operating in the Newcastle area of New South Wales.
- Safety updatesProduct Information safety updates – February 2023Medicines Safety Update - Information for health professionals