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  1. www.tga.gov.au › resources › ausparAustralian Public Assessment Reports (AusPAR) | Therapeutic ...

    1 March 2024. Australian Public Assessment Report (AusPAR) AusPAR for Exarane/Exarane Forte (enoxaparin sodium) is approved for prevention of thrombo-embolic disorders, thrombosis, prophylaxis of venous thromboembolism. Treatment of deep vein thrombosis, unstable angina, non-Q-wave myocardial infarction, acute ST-segment elevation myocardial ...

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  3. www.tga.gov.au › resourcesGuidance and resources | Therapeutic Goods Administration (TGA)

    Resources. Search our resources for guidance, checklists, international scientific guidelines, compositional guidelines and forms.

  4. www.tga.gov.auTherapeutic Goods Administration (TGA) | Australian ...

    2024年5月23日 · Therapeutic Goods Administration (TGA) We are Australia's government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. We regulate medicines, medical devices and biologicals to help Australians stay healthy and safe.

  5. www.tga.gov.au › safety-information-educationSafety information & education | Therapeutic Goods ...

    Database of Adverse Event Notifications (DAEN) Searchable database of adverse event reports received by the TGA. Is there anything wrong with this page? This section includes links to articles about the general safety of medicines and medical devices, including how the safety of products is assessed and monitored.

  6. www.tga.gov.au › fast-track-approval-pathwaysFast track approval pathways | Therapeutic Goods ...

    • Priority Review
    • Provisional Approval
    • It Is Important to Report Side Effects
    • Other Important Information
    • Medicines Subsidies Through The PBS

    Under priority review we aim to finish our review of a medicine up to three months earlier. We can complete these reviews faster because the approval process is more flexible. For example, under priority review we ask the pharmaceutical company questions about their application as they arise, rather than sending the questions as a group after we fi...

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    We can give provisional approval to medicines which provide a promising treatment for a serious or life threatening condition. This makes the medicine available for a limited period while the pharmaceutical company completes final clinical trials. Under the standard pathway, a medicine is not available until after all clinical trials have been comp...

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    While all medicines may have side effects, it is particularly important that you report to your doctor any issues you experience with a provisionally approved medicine. Any issues should also be reported to us so we can build up the full picture of a new medicine’s safety profile. You can ask your doctor to do that on your behalf. One of the best w...

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    Your doctor will give you information about medicines they prescribe, including if the medicine is provisionally approved. However, for more information you can also check the Consumer Medicines Information (CMI). When looking at the CMI for provisional or priority medicines, you may notice a black triangle symbol(). This symbol is a reminder to re...

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    Subsidies are determined and administered by a different section of the Department. For information on which medicines are subsidised by the Australian Government, consult the Pharmaceutical Benefits Scheme website- external site.

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  7. www.tga.gov.au › resources › make-reportMake a report | Therapeutic Goods Administration (TGA)

    Use this form to report a perceived breach of the Therapeutic Goods Act, counterfeit products or questionable practices in relation to therapeutic products. Is there anything wrong with this page? Report adverse events, medicine or vaccine defects, incidents, breaches of the Act or counterfeit products, or non-compliant advertising.

  8. www.tga.gov.au › resources › databasesDatabases for registers, reports and decisions | Therapeutic ...

    Databases for registers, reports and decisions. Explore our databases of therapeutic goods registers, reports and decisions, including the Australian Register of Therapeutic Goods, adverse event notifications, compliance reviews results and more. Listen.