EPCLUSA (Gilead Sciences Pty Ltd)
Product name
EPCLUSA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
208 (255 working days)
Active ingredients
sofosbuvir; velpatasvir
Registration type
EOI
Indication
EPCLUSA (tablet) is now also indicated for the treatment of chronic hepatitis C virus (HCV) infection (genotype 1, 2, 3, 4, 5 or 6) in adults and paediatric patients 12 years of age and older and weighing 30 kg or more.,(see 4.2 Dose and method of administration section for the recommended regimens for different patient subgroups).