Epclusa (sofosbuvir;velpatasvir)
Accelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- sofosbuvir;velpatasvir
- Company
- Gilead Sciences Ireland UC
- Status
- Authorised
- Therapeutic area
- Hepatitis C, Chronic
- CHMP opinion
- Thu 26 May 2016
- EU approval
- Wed 06 Jul 2016
- Designations
- Accelerated assessment
- Application
- EMEA/H/C/004210
- ATC
- J05A
- Official record
- www.ema.europa.eu
Indication
Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Vosevi Authorised · Gilead Sciences Ireland UC
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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.