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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.