Zepatier (elbasvir;grazoprevir)
- Region
- 🇪🇺 EU
- Active substance
- elbasvir;grazoprevir
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- Hepatitis C, Chronic
- CHMP opinion
- Thu 26 May 2016
- EU approval
- Fri 22 Jul 2016
- Application
- EMEA/H/C/004126
- ATC
- J05AP54
- Official record
- www.ema.europa.eu
Indication
ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.