EVUSHELD (AstraZeneca Pty Ltd)
Product name
EVUSHELD
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
54 (255 working days)
Active ingredients
cilgavimab; tixagevimab
Registration type
NCE/NBE
Indication
EVUSHELD (solution for injection) has provisional approval for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg,
- Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments that make it likely that they will not mount an adequate immune response to COVID-19 vaccination or
- For whom vaccination with any approved COVID-19 vaccine is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID?19 vaccine component(s).
See Section 4.2 Dose and method of administration and Section 5.2 Pharmacokinetic properties.
EVUSHELD is not recommended as a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.
This decision has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer-term efficacy and safety data from ongoing clinical trials.