elbasvir and grazoprevir
Drug Details
- Generic Name
- elbasvir and grazoprevir
- Brand Names
- ZEPATIER
- Application Number
- NDA208261
- Sponsor
- Merck Sharp & Dohme LLC
- NDC Codes
- 1
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- ELBASVIR, GRAZOPREVIR ANHYDROUS
Indications and Usage
1 INDICATIONS AND USAGE ZEPATIER ® is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations [see Dosage and Administration (2.2) ] . ZEPATIER is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated for treatment of chronic HCV genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations. ( 1 )