Daklinza (daclatasvir)
Accelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- daclatasvir
- Company
- Bristol-Myers Squibb Pharma EEIG
- Status
- Expired
- Therapeutic area
- Hepatitis C, Chronic
- CHMP opinion
- Thu 26 Jun 2014
- EU approval
- Fri 22 Aug 2014
- Designations
- Accelerated assessment
- Application
- EMEA/H/C/003768
- ATC
- J05AP07
- Official record
- www.ema.europa.eu
Indication
Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1). For 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.