Harvoni (ledispavir;sofosbuvir)
Accelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- ledispavir;sofosbuvir
- Company
- Gilead Sciences Ireland UC
- Status
- Authorised
- Therapeutic area
- Hepatitis C, Chronic
- EU approval
- Mon 17 Nov 2014
- Designations
- Accelerated assessment
- Application
- EMEA/H/C/003850
- ATC
- J05AX65
- Official record
- www.ema.europa.eu
Indication
Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (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.