VEKLURY (Gilead Sciences Pty Ltd)
Product name
VEKLURY
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
5 working days (255)
Active ingredients
remdesivir
Registration type
NCE/NBE
Indication
VEKLURY has provisional approval for the treatment of Coronavirus Disease 2019 (COVID-19) in adults and adolescents (aged 12 years and older weighing at least 40 kg) with pneumonia, requiring supplemental oxygen.
The decision to approve this medicine has been made based on limited data. More comprehensive evidence is required to be submitted.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration