Tga ebs Last updated: 15 January 2025 URL:https://www. nsf/PICMI?OpenForm&k=M The Electronic Business Services (eBS) page of Therapeutic Goods Administration (TGA) part of the Commonwealth Department of Health and Ageing. Trade Name Information Sheet Active Ingredient(s) Engerix-B thiomersal-free vaccine: CMI: Hepatitis B surface antigen recombinant: H-B-VAX II: CMI: Hepatitis B surface antigen recombinant Last updated: 14 January 2025 URL:https://www. Before submitting Manufacturer’s Evidence, the Australian sponsor must establish an eBusiness Services (eBS) account which is used to make electronic applications for medical devices including IVDs. tga. TGA is Australia's regulatory agency for medical drugs and devices. nsf/pdf?OpenAgent&id=CP-2011 PI & CMI Trade Names and Active Ingredients containing estradiol. CMI Trade Names and Active Ingredients containing Panafcort. Find out how to update your Trade Name Information Sheet Active Ingredient(s) Alphaclav Duo Viatris 500/125 and Alphaclav Duo Forte Viatris 875/125: CMI PI: amoxicillin trihydrate; potassium clavulanate The Electronic Business Services (eBS) page of Therapeutic Goods Administration (TGA) part of the Commonwealth Department of Health and Ageing. 13 Documents available. Learn how to set up your account, use the site, access forms and databases, Learn how to apply for a Client ID and access TGA Business Services (TBS) to manage therapeutic good applications, notifications and certificates. PI & CMI Trade Names and Active Ingredients containing risperidone. PI & CMI Trade Names and Active Ingredients containing ondansetron. PI & CMI Trade Names and Active Ingredients containing dapagliflozin. Sponsors are able to view, download and print ARTG Register entries for their products and generate certificates online. PI & CMI Trade Names and Active Ingredients containing cetirizine. PI & CMI Trade Names and Active Ingredients containing atorvastatin. PI & CMI Trade Names and Active Ingredients containing tramadol. The Electronic Business Services (eBS) page of Therapeutic Goods Administration (TGA) part of the Commonwealth Department of Health and Ageing. nsf/pdf?OpenAgent&id=CP-2010 Last updated: 10 January 2025 URL:https://www. nsf/PICMI?OpenForm&t=pi&q=entresto PI & CMI Trade Names and Active Ingredients containing citalopram. nsf/pdf?OpenAgent&id=CP-2021 PI & CMI Trade Names and Active Ingredients containing ramipril. nsf/pdf?OpenAgent&id=CP-2016 Last updated: 16 January 2025 URL:https://www. PI & CMI Trade Names and Active Ingredients containing beclometasone. nsf/PICMI?OpenForm&k=P Trade Name Information Sheet Active Ingredient(s) glycoprep-o kit: PI: macrogol 3350; citric acid; potassium chloride; sodium sulfate; magnesium carbonate hydrate; bisacodyl; sodium chloride PI & CMI Trade Names and Active Ingredients containing sildenafil. 18 Documents available. nsf/pdf?OpenAgent&id=CP-2010 PI & CMI Trade Names and Active Ingredients containing flecainide. 22 Documents available. PI & CMI Trade Names and Active Ingredients containing metoprolol. PI & CMI Trade Names and Active Ingredients containing timolol. •Each view is based on the different interactions people have with the TGA. nsf/PICMI?OpenForm&t=CMI&k=U&r=/ Last updated: 13 January 2025 URL:https://www. PI & CMI Trade Names and Active Ingredients containing Avaxim. PI & CMI Trade Names and Active Ingredients containing Havrix. Enter your username and password or reset them if you forgot. PI & CMI Trade Names and Active Ingredients containing duloxetine. au PI & CMI Trade Names and Active Ingredients containing ivermectin. The TGA Business Services site is based on using roles –drafter, submitter, financial or administrator, or any combination of these. nsf/pdf?OpenAgent&id=CP-2010 . TGA eBS provides facilities for the online lodgement of data packages in support of applications for entry of products onto the Australian Register of Sign in with your organizational account Sign in These forms are used by sponsors, agents and manufacturers to apply for access to TGA Business Services. 5 mg tablet: film-coated. ebs. 19 Documents available. CMI Trade Names and Active Ingredients containing Hydroxo-B12. nsf/pdf?OpenAgent&id=CP-2010 PI & CMI Trade Names and Active Ingredients containing Coversyl. PI & CMI Trade Names and Active Ingredients containing apixaban. Access the online portal for Therapeutic Goods Administration (TGA) in Australia. 21 Documents available. CMI Trade Names and Active Ingredients containing Eliquis 2. 6 Documents available. nsf/pdf?OpenAgent&id=CP-2025 PI & CMI Trade Names and Active Ingredients containing Engerix-B. TGA eBS provides facilities for the online lodgement of data packages in support of applications for entry of products onto the Australian Register of PI & CMI Trade Names and Active Ingredients containing acarbose. PI & CMI Trade Names and Active Ingredients containing linagliptin. nsf/pdf?OpenAgent&id=CP-2024 Last updated: 16 January 2025 URL:https://www. •In the new TGA Business Services site each user will have a personalised unique view based on the interactions they have with the TGA. The forms and instructions for establishing an eBS account can be found at TGA eBusiness Services. 12 Documents available. nsf/pdf?OpenAgent&id=CP-2010 Last updated: 13 January 2025 URL:https://www. PI & CMI Trade Names and Active Ingredients containing prednisolone. TBS is a site for industry to manage some therapeutic good registration applications and view ARTG entries. PI & CMI Trade Names and Active Ingredients containing quetiapine. PI & CMI Trade Names and Active Ingredients containing semaglutide. PI & CMI Trade Names and Active Ingredients containing terbinafine. 44 Documents available. nsf/pdf?OpenAgent&id=CP-2011 Last updated: 9 January 2025 URL:https://www. Last updated: 12 January 2025 URL:https://www. Trade Name Information Sheet Active Ingredient(s) 2% Xylocaine DENTAL with adrenaline (epinephrine) 1:80000: PI CMI: lidocaine (lignocaine) hydrochloride monohydrate; adrenaline (epinephrine) acid tartrate PI & CMI Trade Names and Active Ingredients containing allopurinol. PI & CMI Trade Names and Active Ingredients containing tamoxifen. PI & CMI Trade Names and Active Ingredients containing clindamycin. PI & CMI Trade Names and Active Ingredients containing tapentadol. 7 Documents available. nsf/pdf?OpenAgent&id=CP-2021 PI & CMI Trade Names and Active Ingredients containing fentanyl. PI & CMI Trade Names and Active Ingredients containing cefalexin. PI & CMI Trade Names and Active Ingredients containing sitagliptin. nsf/pdf?OpenAgent&id=CP-2019 Last updated: 14 January 2025 URL:https://www. Last updated: 14 January 2025 URL:https://www. PI & CMI Trade Names and Active Ingredients containing topiramate. 10 Documents available. 5 Documents available. nsf/pdf?OpenAgent&id=CP-2018 submit by email to the TGA TBS Helpdesk at ebs@health. nsf/pdf?OpenAgent&id=CP-2010 Last updated: 14 January 2025 URL:https://www. The TGA Business Services site allows industry to manage some therapeutic good registration applications, and view and cancel their current entries on the Australian Register of Therapeutic Goods (ARTG). 15 Documents available. PI & CMI Trade Names and Active Ingredients containing budesonide. PI & CMI Trade Names and Active Ingredients containing gabapentin. Last updated: 11 January 2025 URL:https://www. PI Trade Names and Active Ingredients containing buspirone hydrochloride 5 mg tablet, 50. PI & CMI Trade Names and Active Ingredients containing prochlorperazine. TGA eBS provides facilities for the online lodgement of data packages in support of applications for entry of products onto the Australian Register of PI & CMI Trade Names and Active Ingredients containing propranolol. PI & CMI Trade Names and Active Ingredients containing amlodipine. 33 Documents available. PI & CMI Trade Names and Active Ingredients containing diclofenac. 9 Documents available. 3 Documents available. PI & CMI Trade Names and Active Ingredients containing adapalene. 32 Documents available. nsf/pdf?OpenAgent&id=CP-2013 Last updated: 14 January 2025 URL:https://www. 29 Documents available. Last updated: 9 January 2025 URL:https://www. nsf/pdf?OpenAgent&id=CP-2018-CMI-01277-1&d=2018022016114622483 PI & CMI Trade Names and Active Ingredients containing tamsulosin. nsf/pdf?OpenAgent&id=CP-2010 Last updated: 7 January 2025 URL:https://www. PI & CMI Trade Names and Active Ingredients containing hydromorphone. nsf/pdf?OpenAgent&id=CP-2010 Last updated: 16 January 2025 URL:https://www. PI & CMI Trade Names and Active Ingredients containing metformin. 16 Documents available. PI & CMI Trade Names and Active Ingredients containing mirtazapine. Trade Name Information Sheet Active Ingredient(s) 2% Xylocaine DENTAL with adrenaline (epinephrine) 1:80000: PI: lidocaine (lignocaine) hydrochloride monohydrate; adrenaline (epinephrine) acid tartrate PI & CMI Trade Names and Active Ingredients containing testosterone. nsf/PICMI?OpenForm&t=CMI&k=N&r=/ Last updated: 9 January 2025 URL:https://www. PI & CMI Trade Names and Active Ingredients containing methylprednisolone. 48 Documents available. nsf/pdf?OpenAgent&id=CP-2009 Last updated: 8 January 2025 URL:https://www. If there is an identical inactive street address you will not be able to create the address and a message will be displayed telling you to contact the TGA Help Desk to activate the address. PI & CMI Trade Names and Active Ingredients containing fluoxetine. 1 Documents available. Organisation information: Complete the form to provide the information about the company or individual who will be importing, exporting, manufacturing or supplying the therapeutic goods or sponsoring a clinical trial. PI & CMI Trade Names and Active Ingredients containing ceftriaxone. 28 Documents available. 17 Documents available. 0 Documents available. nsf/pdf?OpenAgent&id=CP-2010 PI & CMI Trade Names and Active Ingredients containing amiodarone. PI & CMI Trade Names and Active Ingredients containing escitalopram. 2 Documents available. nsf/pdf?OpenAgent&id=CP-2014 PI & CMI Trade Names and Active Ingredients containing influenza. PI & CMI Trade Names and Active Ingredients containing haloperidol. nsf/pdf?OpenAgent&id=CP-2010 PI & CMI Trade Names and Active Ingredients containing risedronate. 11 Documents available. 23 Documents available. 8 Documents available. PI & CMI Trade Names and Active Ingredients containing amitriptyline. Last updated: 7 January 2025 URL:https://www. nsf/pdf?OpenAgent&id=CP-2016 Last updated: 12 January 2025 URL:https://www. PI & CMI Trade Names and Active Ingredients containing mifepristone. PI & CMI Trade Names and Active Ingredients containing infliximab. nsf/PICMI Last updated: 6 January 2025 URL:https://www. PI & CMI Trade Names and Active Ingredients containing insulin. PI & CMI Trade Names and Active Ingredients containing pantoprazole. PI & CMI Trade Names and Active Ingredients containing leuprorelin. Last updated: 10 January 2025 URL:https://www. Last updated: 16 January 2025 URL:https://www. PI & CMI Trade Names and Active Ingredients containing ciprofloxacin. 26 Documents available. nsf/pdf?OpenAgent&id=CP-2013 PI & CMI Trade Names and Active Ingredients containing betamethasone. au ; How to complete the organisation details form. nsf/pdf?OpenAgent&id=CP-2013 PI & CMI Trade Names and Active Ingredients containing olanzapine. nsf/pdf?OpenAgent&id=CP-2013 PI & CMI Trade Names and Active Ingredients containing gliclazide. ebs@health. PI & CMI Trade Names and Active Ingredients containing warfarin. nsf/pdf?OpenAgent&id=CP-2009 Last updated: 10 January 2025 URL:https://www. 14 Documents available. 4 Documents available. Trade Name Information Sheet Active Ingredient(s) Adacel: CMI PI: Pertussis fimbriae 2 + 3; Pertussis toxoid; Tetanus toxoid; Pertussis filamentous haemagglutinin; Pertactin; Diphtheria toxoid Trade Name Information Sheet Active Ingredient(s) ACCUSOL 35: PI CMI: sodium bicarbonate; sodium chloride; calcium chloride dihydrate; magnesium chloride hexahydrate; potassium chloride; glucose monohydrate Last updated: 14 January 2025 URL:https://www. nsf/pdf?OpenAgent&id=CP-2010 PI & CMI Trade Names and Active Ingredients containing oxycodone. nsf/pdf?OpenAgent&id=CP-2010 PI & CMI Trade Names and Active Ingredients containing olmesartan. nsf/pdf?OpenAgent&id=CP-2024 PI & CMI Trade Names and Active Ingredients containing doxycycline. PI & CMI Trade Names and Active Ingredients containing rivaroxaban. CMI Trade Names and Active Ingredients containing PREGABALIN. nsf/pdf?OpenAgent&id=CP-2024 Last updated: 9 January 2025 URL:https://www. nsf/pdf?OpenAgent&id=CP-2023 PI & CMI Trade Names and Active Ingredients containing metoclopramide. 37 Documents available. nsf/pdf?OpenAgent&id=CP-2017 PI & CMI Trade Names and Active Ingredients containing lamotrigine. 34 Documents available. gov. au/ebs/picmi/picmirepository. Last updated: 13 January 2025 URL:https://www. Organisation details form; Add or remove an Agent from your organisation form; Add or remove a connection to your manufacturing Last updated: 11 January 2025 URL:https://www. It is possible to have 2 addresses that are identical, but only if one has an address usage of 'Postal' and the other has an address usage of Street . TGA eBS provides facilities for the online lodgement of data packages in support of applications for entry of products onto the Australian Register of PI & CMI Trade Names and Active Ingredients containing cephalexin. TGA eBS provides facilities for the online lodgement of data packages in support of applications for entry of products onto the Australian Register of PI & CMI Trade Names and Active Ingredients containing apremilast. PI & CMI Trade Names and Active Ingredients containing varenicline. yobopclmfpsmsjxhnedamzitdskwpdjeppzojelqrhfwidiyr