Labels for COVID-19 treatments

To enable timely distribution of COVID-19 treatments, international labels may be used during initial supply in Australia.

COVID-19 treatments are manufactured across multiple global sites. Early batches of COVID-19 treatments used in Australia will be manufactured overseas and may be imported into Australia with an international label affixed.

Some information typically present on the Australian label may be absent and/or modified on the international label, as well as additional information present that is not relevant to the Australian context.

Access to Australian-specific information

COVID-19 treatments registered in Australia will be accompanied by Australian Product Information (PI) and Consumer Medicine Information (CMI) documents. Health professionals and consumers should consult the Australian PI and CMI for each COVID-19 treatment for information relevant to Australia.

Important Australian-specific information that is likely to be absent from the international labels includes:

• registration number ('AUST R' number)
• S4 signal heading ('PRESCRIPTION ONLY MEDICINE')
• cautionary statement ('KEEP OUT OF REACH OF CHILDREN')
• contact details of the Australian sponsor.

Assessment of international labels

The TGA assesses the international label for each treatment, and checks that the label contains key information to allow the safe use of the treatment in Australia.

The TGA will impose conditions on the Australian sponsor to develop and implement an Australian label as soon as practicable.

Further information

• sotrovimab (XEVUDY)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - GlaxoSmithKline) (Sotrovimab) Labelling Exemption 2021 (repealed)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - GlaxoSmithKline) (Sotrovimab) Labelling Exemption 2022
• remdesivir (VEKLURY)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Gilead) (Remdesivir) Labelling Exemption 2021 (repealed)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Gilead) (Remdesivir) Labelling Exemption 2022
• casirivamab and imdevimab (RONAPREVE)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Roche) (Casirivimab and Imdevimab) Labelling Exemption 2021
• molnupiravir (LAGEVRIO)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Merck Sharp and Dohme) (Molnupiravir) Labelling Exemption 2022
• nirmatrelvir and ritonavir (PAXLOVID)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Pfizer) (Nirmatrelvir and Ritonavir) Labelling Exemption 2022
• tixagevimab and cilgavimab (EVUSHELD)
  • Therapeutic Goods (Poisons Standard) (COVID-19 Medicine - AstraZeneca) (Tixagevimab and Cilgavimab) Labelling Exemption 2022