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MAVIRET (Abbvie Pty Ltd)

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

MAVIRET (film-coated tablets) is indicated for the treatment of adult and adolescent patients 12 years and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis. This includes patients with HCV genotype 1 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).

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