KAVIGALE, (AstraZeneca Pty Ltd)
Product name
KAVIGALE,
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
125 (255 working days)
Active ingredients
sipavibart
Registration type
NCE/ NBE
Indication
KAVIGALE is indicated for the 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.
KAVIGALE is not recommended as a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available