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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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1010 result(s) found, displaying 1 to 25
  • AusPAR: Beyfortus

    Beyfortus is for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season. It is also for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
  • AusPAR: Tibsovo

    AusPAR for Tibsovo (ivosidenib) for the treatment of acute myeloid leukaemia that carries a particular mutation.

    MELATONIN-LINK, IMMELA, MELAKSO and VOQUILY is approved for short-term treatment of jet lag in adults aged 18 and over, and for sleep disorders in children and adolescents with neurodevelopmental disorders.
  • AusPAR: Alhemo

    Alhemo (concizumab) is approved to prevent or reduce frequency of bleeding in patients who have haemophilia B with FIX inhibitors.
  • AusPAR: Exarane/Exarane Forte

    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 infarction.
  • AusPAR: Nurtec ODT

    AusPAR for Nurtec ODT (rimegepant) is approved for acute treatment of migraine and prophylactic treatment of episodic migraine in adults
  • AusPAR: Vegzelma

    AusPAR for Vegzelma (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer.
  • 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: 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: 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.

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