Notice for casirivimab and imdevimab (Roche Products Pty Limited)
Active ingredients
casirivimab and imdevimab
Sponsor
Date of review outcome
Lapse date
Type
Provisional approval
Indication
For treatment of confirmed COVID-19 in patients aged 12 years and older and weighing at least 40 kg that do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.
For the prevention of COVID-19 in individuals aged 12 years and older and weighing at least 40 kg who meet one or more of the following criteria:
have been exposed or are at high risk of exposure to SARS-CoV-2
have a medical condition making them unlikely to respond to or be protected by vaccination
For the prevention of COVID-19 in individuals aged 12 years and older and weighing at least 40 kg who meet one or more of the following criteria:
have been exposed or are at high risk of exposure to SARS-CoV-2
have a medical condition making them unlikely to respond to or be protected by vaccination
Therapeutic area
Infectious diseases