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COVID-19 treatments undergoing evaluation

COVID-19 treatments undergoing evaluation for provisional registration.

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Before any COVID-19 treatment is approved for use in Australia, it will be subject to the well-established and rigorous assessment and approval processes of the Therapeutic Goods Administration (TGA), part of the Department of Health.

SponsorNameMore informationRegulatory status
Adjutor Healthcare Pty LtdSabizabulinProvisional determination noticeApplication for provisional registration withdrawn 10 May 2023
AstraZeneca Pty Ltdtixagevimab and cilgavimab (EVUSHELD)Provisional determination notice
  1. Provisionally approved on 24 February 2022 for pre-exposure prophylaxis only for individuals aged 12 years and older and weighing at least 40kg
  2. Provisionally approved on 12 December 2022 to increase dose for pre-exposure prophylaxis only for individuals aged 12 years and older and weighing at least 40 kg
  3. Provisionally approved on 12 December 2022 for treatment of adults
  4. Product voluntarily withdrawn by sponsor on 15 July 2024
AstraZeneca Pty LtdsipavibartNAPriority review determination granted 2 August 2024 for 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.
Pfizer Australianirmatrelvir + ritonavir (PAXLOVID)Provisional determination notice
  1. Provisionally approved on 18 January 2022
  2. Application for transition from provisional to full registration under evaluation
Roche Products Pty Ltdtocilizumab (ACTEMRA)Provisional determination noticeProvisionally approved on 1 December 2021
Celltrion Healthcare Australia Pty Ltdregdanvimab (REGKIRONA)Provisional determination noticeProvisionally approved on 6 December 2021
Roche Products Pty Ltdcasirivimab + imdevimab (RONAPREVE)Provisional determination noticeProvisionally approved on 15 October 2021
Merck Sharp and Dohme (Australia) Pty Ltdmolnupiravir (LAGEVRIO)Provisional determination noticeProvisionally approved on 18 January 2022
GlaxoSmithKline Australia Pty Ltdsotrovimab (XEVUDY)Provisional determination noticeProvisionally approved on 20 August 2021
Gilead Sciences Pty Ltdremdesivir (VEKLURY)Provisional determination notice
  1. Provisionally approved on 10 July 2020 for treatment of individuals over 12 years of age (weighing at least 40 kg) with severe COVID-19 symptoms who have been hospitalised
  2. Provisionally approved on 6 May 2022 for
    • adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) who have pneumonia due to SARS-CoV-2, who require supplemental oxygen
    • adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19
  3. Application for transition from provisional to full registration approved on 1 April 2025.
     
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