We’re experiencing issues with our datasets and search. We apologise for any inconvenience while we work to fix this.
VOSEVI (Gilead Sciences Pty Ltd)
Product name
VOSEVI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
222 working days (255)
Active ingredients
sofosbuvir/velpatasvir/voxilaprevir
Registration type
NCE/NBE
Indication
VOSEVI (fixed dose combination tablet) is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adult patients, without cirrhosis or with compensated cirrhosis, who have:
- genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor
- genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.