VEKLURY (Gilead Sciences Pty Ltd)
Product name
VEKLURY
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
39 (255 working days)
Active ingredients
remdesivir
Registration type
EOI
Indication
VEKLURY (powder for injection) has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in:
- paediatric patients (at least 4 weeks of age and weighing at least 3 kg) who have pneumonia due to SARS-CoV-2, and who require supplemental oxygen.
- adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.
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