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MAVIRET (Abbvie Pty Ltd)

Product name
MAVIRET
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
195 (255 working days)
Active ingredients
glecaprevir, pibrentasvir
Registration type
EOI
Indication

MAVIRET is indicated for the treatment of adult and paediatric patients 3 years and older with acute or 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).