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MAVIRET (Abbvie Pty Ltd)
Product name
MAVIRET
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
210 (255 working days)
Active ingredients
glecaprevir; pibrentasvir
Registration type
EOI
Indication
MAVIRET (film-coated tablet; granules) is now also indicated for the treatment of adult and paediatric patients 3 years and older with chronic hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis. This includes patients with HCV GT1 infection who were previously treated with either a regimen of an NS5A inhibitor or with an NS3/4A protease inhibitor but not both classes of inhibitors (see 4.2 Dose and Method of Administration and 5.1 Pharmacodynamic Properties - Clinical trials).