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Australian Public Assessment Reports (AusPAR)

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An AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application.

For more information see Australian Public Assessment Reports for prescription medicines (AusPARs).

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1003 result(s) found, displaying 1 to 25
  • AusPAR: MS-2 Step (composite pack)

    AusPAR for MS-2 Step (composite pack) approval was granted to make changes in the Product Information (PI) and to the Risk Management Plan (RMP).
  • AusPAR: Comirnaty Omicron XBB.1.5

    AusPAR for COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE is approved to prevent COVID-19 in individuals 6 months to 12 years old.
  • AusPAR: Doptelet

    AusPAR for Doptelet (avatrombopag) is approved for treatment of thrombocytopenia in adult patients with chronic liver disease and chronic immune thrombocytopenia.
  • AusPAR: Comirnaty Original/Omicron BA.4-5

    AusPAR for Comirnaty Original/Omicron BA.4-5 (tozinameran/famtozinameran) is provisionally approved to prevent COVID-19 in individuals 5 years of age and older.
  • AusPAR: Minjuvi

    AusPAR for Minjuvi (tafasitamab) is provisionally approved for treatment of adults with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplant.
  • AusPAR: Retevmo

    AusPAR for Retevmo (selpercatinib) is provisionally approved for treatment of adults with locally advanced or metastatic RET fusion positive non-small cell lung cancer.
  • AusPAR: Sunlenca

    AusPAR for Sunlenca for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
  • AusPAR: Opdualag

    AusPAR for Opdualag (Nivolumab and Relatlimab), which is approved for the treatment of patients with unresectable or metastatic melanoma who are at least 12 years old.
  • AusPAR: Imfinzi

    AusPAR for Imfinzi (durvalumab) for the treatment of unresectable hepatocellular carcinoma.
  • AusPAR: Imjudo

    AusPAR for Imjudo (tremelimumab) for the treatment of unresectable hepatocellular carcinoma.
  • AusPAR: Andexxa

    Andexxa (andexanet alfa) is provisionally approved for adult patients treated with a direct factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
  • AusPAR: Letybo

    AusPAR Letybo (letibotulinumtoxinA) is approved for temporary improvement in the appearance of glabellar frown lines in adults.
  • AusPAR: Mounjaro

    AusPAR for Mounjaro (tirzepatide) is approved to treat adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.
  • AusPAR: Jivi

    AusPAR for Jivi (damoctocog alfa pegol) for use in previously treated adults and adolescents with haemophilia A for the prevention or treatment of bleeding.
  • AusPAR: Korsuva

    AusPAR for Korsuva (difelikefalin) is approved to treat moderate-to-severe pruritus associated with chronic kidney disease in adults on haemodialysis.
  • AusPAR: Nuvaxovid

    AusPAR for Nuvaxovid (SARS-CoV-2-rS) for the prevention of coronavirus disease 2019 (COVID-19).
  • AusPAR: Intrarosa

    AusPAR for Intrarosa (prasterone) for treatment of vulvar and vaginal atrophy.
  • AusPAR: Flucelvax Quad

    AusPAR for Flucelvax Quad (Influenza virus haemagglutinin) for the prevention of influenza caused by Influenza Virus, Types A and B contained in the vaccine.
  • AusPAR: Gavreto

    AusPAR for Gavreto (pralsetinib) for treatment of adult patient with advanced or metastatic RET-fusion positive thyroid cancer.
  • AusPAR: Esperoct

    AusPAR for Esperoct (turoctocog alfa pegol) to prevent or reduce the frequency of bleeding episodes in patients with haemophilia A.
  • AusPAR: Trecondi

    AusPAR for Trecondi for the treatment of adults with acute myeloid leukaemia or myelodysplastic syndrome, and paediatric population with malignant and non-malignant haematological diseases.
  • AusPAR: Gavreto

    AusPAR for GAVRETO (pralsetinib) for treatment of locally advanced or metastatic RET fusion-positive non-small cell lung cancer.
  • AusPAR: Spikevax XBB.1.5

    AusPAR for Spikevax XBB.1.5 (andusomeran) for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.
  • AusPAR: Tavneos

    AusPAR for Tavneos (avacopan) in combination with a rituximab or cyclophosphamide based regimen for the treatment of anti-neutrophil cytoplasmic autoantibody-associated vasculitis

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