Temporary Disabled. :) please Go back Media releases & statements | Therapeutic Goods Administration (TGA) www.fgks.org » Address: [go: up one dir, main page] Include Form Remove Scripts Accept Cookies Show Images Show Referer Rotate13 Base64 Strip Meta Strip Title Session Cookies Contact TGA: info@tga.gov.au | 1800 020 653 | More contact info Translate | Subscribe Therapeutic Goods Administration (TGA) Australian Government Department of Health Main menu Home Safety informationReport a problem or side effectReporting adverse events involving medicines, vaccines or medical devices Report an issue with packaging or storage of a medicine AEMS guidance for health professionals AEMS guidance for sponsors Help us promote adverse event reporting: promotional resources kit AlertsCurrent year alerts All alerts RecallsAbout Australian recall actions Recall actions database Uniform recall procedure Prescription opioids Medicine shortages Early warning systemMonitoring communications About the Early Warning System Early Warning System: consumer questions and answers Early Warning System: health professional questions and answers Black Triangle SchemeBlack Triangle Scheme: Information for sponsors Safety information & educationMedicines safety Medical devices safety Database of Adverse Event Notifications (DAEN) COVID-19 COVID-19 vaccinesCOVID-19 vaccine approval process COVID-19 vaccines undergoing evaluation Provisional registrations COVID-19 vaccine safety monitoring and reporting News and updates COVID-19 vaccine advertising and import compliance Information for consumers and health professionals Information for sponsors (industry) International collaboration COVID-19 treatmentsCOVID-19 treatments: Provisional determinations COVID-19 treatments: Provisional registrations COVID-19 treatments: Treatments undergoing evaluation COVID-19 treatments: Advertising compliance COVID-19 treatments: Information for consumers and health professionals COVID-19 treatments: Information for sponsors (industry) COVID-19 testsHow testing works for COVID-19 COVID-19 point-of-care tests COVID-19 rapid antigen self-tests COVID-19 rapid antigen tests - information for manufacturers and sponsors COVID-19 testing in Australia - information for health professionals Advertising COVID-19 rapid antigen point-of-care tests and self-tests (home use tests) Post market review of COVID-19 point-of-care tests ConsumersReport a problem or side effectReporting adverse events involving medicines, vaccines or medical devices Travelling with medicines and medical devicesLeaving Australia Entering Australia Helpful links for travellers Buying medicines and medical devices onlineCounterfeit medicines and devices Can I import it?Personal importation scheme Medicinal cannabis: importation and the traveller's exemption MedicinesHow we regulate medicines Prescription medicines Complementary medicines Over-the-counter (OTC) medicines Vaccines What's on my medicine label? 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Nitrosamine impurities 9 November 2021 TGA investigation – potential contamination of medicines with nitrosamine impurities Nitrosamine impurities in medicines - Information for sponsors and manufacturers 9 November 2021 TGA is working with international regulators and sponsors to investigate and address nitrosamine impurities in medicines. Warning about products claiming to treat or prevent the novel coronavirus 8 November 2021 The TGA has identified certain therapeutic goods being inappropriately promoted for the prevention or treatment of novel coronavirus (2019-nCoV) infections in Australia Melbourne-based individual fined $7,992 for alleged unlawful importation of nicotine vaping products 5 November 2021 The TGA has issued three infringement notices, totalling $7,992, to a Melbourne-based individual for alleged importation breaches involving nicotine vaping products. RV Global Ecommerce Pty Ltd fined $39,960 for alleged unlawful advertising of nicotine vaping products 5 November 2021 The TGA has issued three infringement notices totalling $39,960 to Sydney-based company RV Global Ecommerce Pty Ltd for alleged unlawful advertising of nicotine vaping products. S.W.A.G II Platinum 33K 4 November 2021 S.W.A.G II Platinum 33K products pose a serious risk to your health and should not be taken. Panther Power Platinum 11000 4 November 2021 Panther Power Platinum 11000 capsules pose a serious risk to your health and should not be taken. 777K products 3 November 2021 777K products pose a serious risk to your health and should not be taken. One Night Love tablets 3 November 2021 One Night Love tablets pose a serious risk to your health and should not be taken. TGA warns consumers of counterfeit nicotine vaping products 2 November 2021 The TGA is warning consumers to be aware of counterfeit nicotine vaping products advertised and sold online. TGA recognises two more COVID-19 vaccines not registered in Australia but used widely internationally 1 November 2021 The TGA determined that Covaxin (manufactured by Bharat Biotech, India) and BBIBP-CorV (manufactured by Sinopharm, China) vaccines would be 'recognised' for the purpose of establishing a traveller's vaccination status. October Court proceedings initiated for alleged unlawful importation of face masks 20 October 2021 The TGA has commenced proceedings in the Federal Court against Enviro Tech Holdings Pty Ltd, and its executive officers for the alleged unlawful importation of surgical face masks. Melbourne-based individual fined $18,648 for alleged unlawful advertising of nicotine vaping products 20 October 2021 The TGA has issued seven infringement notices totalling $18,648 to a Melbourne-based individual, for alleged unlawful advertising of nicotine vaping products TGA Provisional Approval of Roche Products Pty Ltd COVID-19 treatment, casirivimab + imdevimab (RONAPREVE) 18 October 2021 The TGA has provisionally approved the use of the Roche Products Pty Ltd combination therapy, casirivimab + imdevimab (RONAPREVE), for the treatment and prevention of COVID-19 in specific target populations. Shortages of tocilizumab (Actemra) medicines 14 October 2021 The TGA published an Actemra (tocilizumab) shortage - consumer information sheet produced by Pain Australia Pentosan polysulfate sodium (Elmiron) 11 October 2021 Safety advisory - Risk of pigmentary maculopathy (changes in the retina of the eye), especially after long-term use Post-market review of ventilators, CPAP and BiPAP devices 11 October 2021 27 August 2021 Ventilator Expert Working Group meeting outcomes available. Discontinuation of DILAUDID hydromorphone hydrochloride 1mg/mL oral liquid 7 October 2021 Updated information regarding alternative overseas products approved for supply to address the discontinuation of DILAUDID liquid. TGA grants provisional determination to Pfizer Australia's COVID-19 treatment PF-07321332 + ritonavir 5 October 2021 On 1 October 2021, the TGA granted provisional determination to Pfizer Australia in relation to a new combination medicine containing PF-07321332 and ritonavir, for the treatment of adult patients with symptomatic, confirmed coronavirus infection. TGA advice on recognition of COVID-19 vaccines not registered in Australia but used internationally 1 October 2021 The TGA has undertaken an assessment on the protection offered by certain COVID-19 vaccines that are administered in certain countries but not currently registered in Australia. Laparoscopic power morcellators - Update 3 1 October 2021 Update Prescriptions now required to import nicotine vaping products 1 October 2021 Australian consumers now require a valid prescription from any of Australia's 100,000 medical practitioners to import nicotine vaping products, purchased from overseas websites. September Court convicts HealthHub247 Pty Ltd and its Director for sports supplements offences 30 September 2021 HealthHub247 Pty Ltd (HealthHub247) and its Director have been convicted of the unlawful manufacture, counterfeit, advertising and supply of sports supplements that contain prohibited substances in the current Poisons Standard. Substitution instrument to address shortage of Imdur Durules and Monodur Durules isosorbide mononitrate 120 mg modified release tablets 28 September 2021 The TGA has made an SSSI for isosorbide mononitrate 120mg modified release tablets to assist patients to access their medicine without delay. TGA grants provisional determination to Roche Products Pty Ltd COVID-19 treatment tocilizumab (ACTEMRA) 28 September 2021 On 27 September 2021 the TGA granted provisional determination to Roche Products Pty Ltd in relation to the COVID-19 treatment tocilizumab (ACTEMRA). Individual fined $18,648 for alleged advertising breaches relating to medicinal cannabis products 28 September 2021 The TGA has issued seven infringement notices totalling $18,648 to the individual responsible for the Invigorate Labs website, for alleged breaches that relate to the advertising of products containing cannabidiol (CBD). Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators 23 September 2021 Consumer and regulatory updates Tianda Pharmaceuticals fined $26,640 for alleged unlawful advertising of Anti-Epidemic Formula 1 in relation to COVID-19 22 September 2021 The TGA has issued two infringement notices totalling $26,640 to Tianda Pharmaceuticals Australia Pty Ltd for alleged unlawful advertising of a listed medicine in relation to COVID-19. TGA's lawyers allege UAP breach of copyright and demand distribution of alleged misleading adverse event reports stop 15 September 2021 Lawyers for the TGA have written to United Australia Party leader, Mr Craig Kelly MP, alleging it has breached copyright and demanding that it stop distributing incomplete extracts of adverse event reports relating to COVID-19 vaccines which the TGA believes could be seriously misleading. CHATTANOOGA Ultrasound Gel Products and Lotions 14 September 2021 Recall due to risk of bacterial contamination New restrictions on prescribing ivermectin for COVID-19 10 September 2021 TGA has placed new restrictions on the prescribing of oral ivermectin Caro white and Carotone products 8 September 2021 Various Caro white and Carotone branded products pose a risk to your health and should not be used. TGA Provisional Approval of Moderna COVID-19 vaccine to include 12-17 years age group 4 September 2021 The TGA has granted provisional approval to Moderna Australia Pty Ltd in relation to the COVID-19 vaccine, Spikevax (elasomeran), for individuals aged 12 years and over. August TGA initiates court proceedings against Medtronic Australasia Pty Ltd 31 August 2021 The Therapeutic Goods Administration (TGA) has initiated proceedings in the Federal Court of Australia (Federal Court) against Medtronic … Joint statement on COVID-19 and COVID-19 vaccines from nation’s regulators 30 August 2021 Joint statement from the TGA, Ahpra, Office of the Health Ombudsman and the Health Care Complaints Commission Advice on the use of tocilizumab (Actemra) intravenous vials post expiry date during the COVID-19 pandemic 30 August 2021 Advice on using tocilizumab (Actemra) vials post expiry date He Absolute King sachets 30 August 2021 He Absolute King sachets pose a serious risk to your health and should not be taken. TGA provisionally approves Pfizer COVID-19 vaccine 27 August 2021 The TGA has granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, making it the first COVID-19 vaccine to receive regulatory approval in Australia. AB SLIM Slim-cellulose capsule 24 August 2021 AB-Slim Slim-cellulose capsules pose a serious risk to your health and should not be taken. Domestic Good Manufacturing Practice (GMP) inspections during the COVID-19 pandemic 24 August 2021 Conducting domestic inspections during the Coronavirus (COVID-19) pandemic TGA grants provisional determination to Celltrion Healthcare Australia Pty Ltd's antiviral COVID-19 treatment regdanvimab 23 August 2021 On 20 August 2021 the TGA granted provisional determination to Celltrion Healthcare Australia Pty Ltd in relation to regdanvimab. TGA grants provisional determination to Roche Products Pty Ltd combination COVID-19 treatment casirivimab + imdevimab (RONAPREVE) 23 August 2021 On 20 August 2021 the TGA granted provisional determination to Roche Products Pty Ltd in relation to the combination therapy casirivimab + imdevimab (RONAPREVE) Risks of importing Ivermectin for treatment of COVID-19 23 August 2021 Ivermectin is a prescription medicine that is not approved in Australia (or in other OECD countries) to prevent or treat COVID-19 disease, and should not be imported for this indication. TGA provisionally approves GlaxoSmithKline's COVID-19 treatment: sotrovimab (XEVUDY) 20 August 2021 On 20 August 2021 the TGA granted provisional approval to GlaxoSmithKline Australia Pty Ltd in relation to sotrovimab (XEVUDY). Azide impurity in 'sartan' blood pressure medicines 20 August 2021 TGA investigation - low levels of contamination with azidomethyl-biphenyl-tetrazole (AZBT) TGA approves name change of COVID-19 Vaccine AstraZeneca to VAXZEVRIA 19 August 2021 The TGA has approved AstraZeneca's submission to change the name of its COVID-19 Vaccine AstraZeneca to VAXZEVRIA. Share your views in the 2021 TGA stakeholder survey 19 August 2021 The TGA is inviting consumers, health professionals, industry and other stakeholders to share their views in our annual stakeholder survey by 27 August 2021. TGA reduces timeframe for publishing adverse event reports 19 August 2021 Changes enhance transparency Regulation of Personal Protective Equipment and COVID-19 18 August 2021 An overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves Advertising nicotine vaping products 18 August 2021 The TGA has today published a revised TGA advertising permission allowing pharmacies and pharmacy marketing to groups to promote, through … TGA batch release of Pfizer vaccine purchased from the Government of Poland 16 August 2021 The TGA has today approved for release doses of the Pfizer/BioNTech vaccine that arrived in Australia late last night from the Republic of Poland. Substitution instrument to address shortage of PROGYNOVA estradiol valerate tablets (multiple strengths) 12 August 2021 The TGA is advising health professionals and consumers of a current shortage for all strengths of PROGYNOVA estradiol valerate tablets. Consumers urged to see their GP ahead of changes to nicotine vaping laws 12 August 2021 Users of nicotine vaping products are encouraged to make an appointment with their GP to discuss their smoking cessation options, ahead of changes from 1 October 2021. TGA grants provisional determination to Merck Sharp & Dohme's antiviral COVID-19 treatment Molnupiravir 10 August 2021 On 9 August 2021 the TGA granted provisional determination to Merck Sharp & Dohme (Australia) Pty Ltd (MSD) in relation to Molnupiravir. TGA provisionally approves Moderna's COVID-19 vaccine 9 August 2021 On 9 August 2021 the TGA granted provisional approval to Moderna Australia Pty Ltd in relation to the COVID-19 vaccine, Spikevax (elasomeran), for individuals aged 18 years and over. Tocilizumab (Actemra) Serious Scarcity Substitution Instrument 6 August 2021 The TGA has published the first Serious Scarcity Substitution Instrument (SSSI) for tocilizumab (Actemra) to assist patients to access medicines during the shortage. Varenicline 5 August 2021 TGA investigation - potential low levels of contamination with N-nitrosovarenicline Black Ant King tablets 2 August 2021 Black Ant King tablets pose a serious risk to your health and should not be taken. Neutrogena Ultra Sheer Body Mist Sunscreen Spray SPF 50+ (aerosol sunscreen) 2 August 2021 Recall - Possible presence of benzene July Canberra dental practice fined $266,400 for alleged unlawful supply of dental implants and bone grafts 30 July 2021 The TGA has issued twenty infringement notices totalling $266,400 to a Canberra-based dental practice. One Night Love tablets 30 July 2021 One Night Love tablets pose a serious risk to your health and should not be taken. Gold Ant tablets 29 July 2021 Gold Ant tablets pose a serious risk to your health and should not be taken. Evolution Supplements Australia and its Director penalised total of $12 million for advertising illegal sports supplements 29 July 2021 The Federal Court of Australia has ordered Evolution Supplements Australia and its Director to pay $12 million Sydney-based individual fined $10,656 for alleged unlawful advertising of medicinal cannabis 28 July 2021 The TGA has issued four infringement notices totalling $10,656 to a Sydney-based individual, for alleged unlawful advertising of Cannabidiol Oil in breach of the Therapeutic Goods Act 1989. Canberra individual fined $2,664 for alleged unlawful advertising of a homoeopathic medicine in relation to COVID-19 23 July 2021 The TGA has issued an infringement notice for $2,664 to an individual from Canberra, for a breach of the Therapeutic Goods Act 1989 in relation to the alleged unlawful advertising of a homoeopathic medicine with COVID-19 claims. Pfizer COVID-19 vaccine (COMIRNATY) - Addition of safety information about myocarditis and pericarditis to Product Information 23 July 2021 PI used by healthcare professionals updated Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness 5 July 2021 Joint ICMRA/WHO Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness. Starpharma Holdings Limited fined $93,240 for alleged unlawful advertising of 'Viraleze' in relation to COVID-19 2 July 2021 The TGA has issued seven infringement notices totalling $93,240 to Melbourne-based global biopharmaceutical company Starpharma Holdings Limited (Starpharma), for alleged illegal advertising of a nasal spray that is not approved for use in Australia. June TGA grants third provisional approval to COVID-19 vaccine: Janssen 25 June 2021 The TGA granted provisional approval to Janssen-Cilag Pty Ltd (known as Johnson & Johnson overseas) for its COVID-19 vaccine Janssen, making it the third COVID-19 vaccine to receive regulatory approval in Australia. TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran 24 June 2021 The TGA, part of the Department of Health, has granted provisional determination to Moderna Australia Pty Ltd in relation to the COVID-19 Vaccine, Elasomeran Promotion of COVID-19 vaccinations: further information for healthcare practitioners and other advertisers 17 June 2021 Interaction between TGA and AHPRA advertising guidelines Novartis-Bio Somatropin Human Growth Hormone (HGH) 16 June 2021 Counterfeit Somatropin Human Growth Hormone (HGH) vials pose a serious risk to your health and should not be taken. Aidacare Pty Ltd fined $26,640 for alleged non-compliance with requests for face masks information 10 June 2021 The TGA has issued two infringement notices totalling $26,640 to Sydney company Aidacare Pty Ltd (Aidacare). Misleading radio messages about COVID-19 vaccine safety 8 June 2021 The TGA is seriously concerned about misleading information that has been broadcast on radio stations providing a distorted picture of the safety of COVID-19 vaccines. New regulatory arrangements support businesses and health professionals to communicate and incentivise COVID-19 vaccination 7 June 2021 The TGA has implemented arrangements to facilitate the communication of information about approved COVID-19 vaccines. V P & Associates Pty Ltd fined $26,640 for alleged unlawful advertising of Liquim in relation to SARS-CoV-2 coronavirus 3 June 2021 The TGA has issued two infringement notices to Perth-based company V P & Associates Pty Ltd (V P & Associates), for alleged unlawful advertising of a medical device in relation to SARS-CoV-2 Human Coronavirus. Queensland man fined $7,992 for alleged unlawful importation of nootropic 'smart drugs' 3 June 2021 The TGA has issued three infringement notices to a Queensland man for the alleged unlawful importation of a medicine containing Armodafinil. Dentist fined $5,328 for alleged unlawful importation of injectables 3 June 2021 The TGA has issued two infringement notices to a dentist from Western Australia for the alleged unlawful importation of cosmetic injectables. Ospolot (sulthiame) tablets 200 mg 3 June 2021 Product Defect Alert - child-resistant caps may not function correctly Zostavax vaccine 2 June 2021 Safety measures to address risk of infection with the vaccine virus May TGA issues warning about unlawful advertising of listed medicines 27 May 2021 The TGA is warning sponsors not to advertise listed medicines that are not included in the ARTG with permitted indications Peter Evans Chef Pty Ltd fined $79,920 for alleged unlawful advertising 25 May 2021 Peter Evans Chef Pty Ltd fined $79,920 for alleged unlawful advertising TGA approves more flexible storage conditions for Pfizer-BioNTech COVID-19 vaccine 24 May 2021 Updated storage conditions for the Pfizer COVID-19 vaccine Hydralyte Strawberry Kiwi Effervescent Electrolyte Tablets 21 May 2021 Recall due to unacceptable risk in pregnancy Arthropharm Pty Ltd fined $13,320 for alleged breaches of therapeutic goods legislation 11 May 2021 The infringement notice relate to the alleged failure to provide information on a contact person responsible for medicine safety. Reminder: supply and advertising controls on medicinal cannabis 3 May 2021 The TGA is reminding businesses involved with medicinal cannabis products of their regulatory obligations under the Therapeutic Goods Act 1989 TGA warns consumers about potential harm from unlawfully supplied medicinal cannabis 3 May 2021 The TGA is warning consumers about the risks of buying medicinal cannabis products online April Tandem t:slim X2 insulin pump 30 April 2021 Update - suspension lifted after review Global Therapeutics fined $119,880 for alleged unlawful advertising of complementary medicines 27 April 2021 Global Therapeutics Pty Ltd has paid penalties of $119,880 in response to nine infringement notices AstraZeneca ChAdOx1-S COVID-19 vaccine 23 April 2021 Three additional Australian cases of TTS likely linked to vaccine AstraZeneca ChAdOx1-S COVID-19 vaccine 16 April 2021 Third Australian case of thrombosis with thrombocytopenia likely linked to vaccine Seasonal flu vaccine (all alerts) 13 April 2021 Information about seasonal flu vaccines 2021 seasonal influenza vaccines 13 April 2021 Information for consumers and health professionals AstraZeneca ChAdOx1-S COVID-19 vaccine 13 April 2021 Second case of thrombosis with thrombocytopenia AstraZeneca ChAdOx1-S COVID-19 vaccine 9 April 2021 Updated safety advisory - rare and unusual blood clotting syndrome (thrombosis with thrombocytopenia) Approval of updated storage conditions for the Pfizer COVID-19 vaccine 8 April 2021 Updated storage conditions for the Pfizer COVID-19 vaccine Wider storage and transportation conditions for the Pfizer COVID-19 vaccine now approved 8 April 2021 TGA has recently approved wider storage and transportation conditions for the Pfizer COVID-19 vaccine in Australia TGA to review advertising of stem cell therapies to the Australian public 7 April 2021 The TGA is investigating the advertising of stem cell therapies to ensure that content in the public domain complies with the Australian rules for advertising therapeutic goods. LIFEPAK CR2 Defibrillator 6 April 2021 Product defect correction - lid magnet may dislodge and cause early battery depletion Statement by Acting Australian Government Chief Medical Officer, Professor Michael Kidd and Head of the Therapeutic Goods Administration Adjunct Professor John Skerritt 2 April 2021 Australia’s vaccine safety and regulatory process is world class and people can be confident that vaccines approved for use are safe and effective. Specific clotting condition reported after COVID-19 vaccination 2 April 2021 Some rare cases of thrombosis associated with thrombocytopenia have been reported overseas following the administration of COVID-19 Vaccine AstraZeneca. March Bulk Buys Pty Ltd fined $13,320 for alleged unlawful importation of surgical face masks 29 March 2021 It is alleged the company breached the Therapeutic Goods Act 1989 in relation to the importation of surgical face masks. Epharmacy Group Pty Ltd fined $26,640 for alleged unlawful advertising on the ePharmacy website 24 March 2021 TGA has issued two infringement notices for alleged unlawful advertising of a complementary medicine cancelled from the Australian Register of Therapeutic Goods. CW IP Pty Ltd fined $53,280 for alleged advertising breaches on the Chemist Warehouse and My Chemist websites 24 March 2021 TGA has issued four infringement notices for alleged unlawful advertising of a complementary medicine. Melbourne-made COVID-19 vaccine now available 23 March 2021 The Melbourne-manufactured AstraZeneca vaccine is now available for Australians, with the TGA this evening approving the release of the first four batches. Various medicines containing Artemisia annua and Artemisia absinthium 23 March 2021 Recall of various medicines containing Artemisia annua and Artemisia absinthium - updated recalled medicines TGA approves CSL - Seqirus to manufacture AstraZeneca COVID-19 vaccine in Australia 21 March 2021 TGA has approved manufacture of the AstraZeneca COVID-19 Vaccine (ChAdOx1-S) in Australia. AstraZeneca ChAdOx1-S COVID-19 vaccine 19 March 2021 Update - European and UK reviews find no proven link with blood clots AstraZeneca ChAdOx1-S COVID-19 vaccine 19 March 2021 Update - Expert review finds no evidence of increased risk of anaphylaxis Pharmacy fined $13,320 for alleged unlawful advertising 17 March 2021 TGA issued a fine for alleged advertising of an unlisted complementary medicine after Junction Rx failed to comply with a cease and desist notice by the set deadline. Regulation of thermometers and other temperature measuring medical devices and products for COVID-19 12 March 2021 This guidance assists thermometer sponsors and manufacturers to meet their regulatory obligations COVID-19 vaccines - safety and effectiveness in older adults 10 March 2021 Data on real-world use of COVID-19 vaccines approved in Australia provides reassurance about their safety in older people New legislation to support medicine substitutions 5 March 2021 New legislation has been passed allowing pharmacists to substitute a medicine when the patient's usual medicine is in 'serious scarcity'. TGA collecting COVID-19 vaccine side effect reports 1 March 2021 Safety monitoring February Bajaria Global Pty Ltd fined $26,640 for alleged unlawful importation of therapeutic goods containing betel nut (areca nut) 26 February 2021 The TGA has issued two infringement notices to Perth-based company Bajaria Global Pty Ltd Haimex International Pty Ltd fined $53,280 for alleged unlawful importation of medical devices 25 February 2021 The TGA has issued four infringement notices for the alleged unlawful importation of infrared thermometers, rigid strapping tapes and iodine prep pads. Shortage of sertraline tablets 16 February 2021 The TGA has issued a Serious Shortage Substitution Notice (SSSN) for sertraline tablets TGA provisionally approves AstraZeneca's COVID-19 vaccine 16 February 2021 The TGA has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine Federal Court finds Evolution Supplements Australia breached advertising laws 16 February 2021 Federal Court finds Evolution Supplements Australia breached advertising laws Resurrection Male Sexual Enhancement Capsules 10 February 2021 Resurrection Male Sexual Enhancement capsules pose a serious risk to your health and should not be taken. TGA one of only five non-European regulators invited to participate on European committees on COVID-19 vaccines and therapeutics 8 February 2021 Australia, through the TGA, is one of only five non-European Union regulators formally invited to participate by the European Medicines Agency (EMA) Investigation reveals no specific risk of COVID-19 vaccinations in elderly patients 2 February 2021 The TGA has concluded that there is no specific risk of vaccination with the Pfizer-BioNTech COVID-19 vaccine in elderly patients. Pregabalin and gabapentin 1 February 2021 Safety advisory - enhanced warnings relating to abuse and dependence January Ventilators and other devices intended for respiratory support for COVID-19 31 January 2021 Therapeutic Goods (Medical Devices—Ventilators) (COVID-19 Emergency) Exemption 2020 has ceased as of 31 January 2021. Importing personal protective equipment into Australia during the COVID-19 pandemic 31 January 2021 Therapeutic Goods (Medical Devices - Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 ceases on 31 January 2021. Expedited recall system for faulty or unauthorised COVID-19 devices 31 January 2021 Therapeutic Goods (Medical Devices—Ventilators) (COVID-19 Emergency) Exemption 2020 has ceased as of 31 January 2021. Emergency COVID-19 exemptions end for ventilators and personal protective equipment 29 January 2021 Two emergency exemptions that were made to facilitate the supply of ventilators and personal protective equipment in Australia during the COVID-19 emergency will cease on 31 January 2021 Reuse of face masks and gowns during the COVID-19 pandemic 28 January 2021 Updated to include new section on Reprocessing of PPE by Healthcare facilities Life Biotech Pty Ltd fined $106,560 for alleged non-compliance with requests for information and face mask samples in relation to COVID-19 28 January 2021 The TGA has issued eight infringement notices to Sydney-based company for allegedly failing to provide information and face mask samples to the TGA when required to do so, and for providing false and misleading information. Ergometrine maleate injection (500 microgram/mL) ampoule 21 January 2021 Alternative product approved to address expected shortage Norwegian investigation of COVID-19 vaccination risks for elderly, very frail patients 17 January 2021 In recent days the TGA has received reports of about 30 deaths in over 40,000 elderly individuals in Norway vaccinated with the Pfizer BioNTech vaccine Medicines containing Eucommia ulmoides (known as Du-Zhong or Tu-chung) 13 January 2021 Safety advisory – contains latex (statement includes Chinese translation 中文翻译) Historical media releases & statements TGA media releases & statements 2020 TGA media releases & statements 2019 TGA media releases & statements 2018 TGA media releases & statements 2017 TGA media releases & statements 2016 Archived media releases & statements The Therapeutic Goods Administration is part of the Health Products Regulation Group
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The Therapeutic Goods Administration is part of the Health Products Regulation Group