Sub menu

 

 

What's new

This page lists items that we have published for the first time or updated in the last 7, 30 or 60 days. Use the filters to narrow results by audience, product type, content type or topic.

You can also stay informed by:

This page is in Beta testing. We welcome your feedback and suggestions as we look to improve this page. 

Use the filters below to narrow your search.

Filter results

You can narrow down the results using the filters.

Audience

Product type

Type of content

Topic

73 result(s) found, displaying 26 to 50

  • Kavigale

    Australian public assessment report (AusPar)
    Kavigale (sipavibart) has been approved for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who are immunocompromised due to a medical condition or receipt of immunosuppressive medications or treatments.

  • TGA Laboratories

    Page
    The TGA Laboratories perform a range of activities to ensure therapeutic goods are of an acceptable standard

  • Briumvi

    Australian public assessment report (AusPar)
    Briumvi (ublituximab) has been approved for the treatment of adult patients with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features.

  • Enflonsia (clesrovimab)

    Prescription medicine decision summary
    Enflonsia has been approved to help prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season.

  • Manage a medicine shortage

    Page
    Information for sponsors and manufacturers explaining what to do if a medicine is in shortage.

  • Post-market review compliance dashboard

    User guide
    Learn how to respond to TGA medical device post‑market review notifications with step‑by‑step instructions using the PMR compliance dashboard.

  • Section 14 consents

    Dataset
    Refer to our database of consents to import, supply or export therapeutic goods that do not comply with standards.

  • Serious Scarcity Substitution Instruments (SSSIs)

    Page
    Serious Scarcity Substitution Instruments (SSSIs) allow community pharmacists to substitute specific medicines without prior approval from the prescriber so long as the permitted circumstances within the SSSI are met.

  • Determining if your content is advertising

    Guidance
    This guidance assists entities who disseminate content about therapeutic goods and vaping goods to determine if their material is considered advertising.

  • FOI disclosure log

    Page
    The Freedom of Information disclosure log gives access to information we've released in response to an FOI request.

  • Organisation details

    Forms
    Organisation details form for TGA Business Services, used by sponsors, manufacturers and agents to provide information required under the Therapeutic Goods Act 1989.

  • Prescription medicines registrations

    Dataset
    Search registrations for new medicines including generic medicines, chemical and biological entities (NCE and NBE), biosimilar medicines, biologicals and combinations. This includes extensions of indications, which describes new uses of medicines.