Sovaldi (sofosbuvir)
- Region
- 🇪🇺 EU
- Active substance
- sofosbuvir
- Company
- Gilead Sciences Ireland UC
- Status
- Authorised
- Therapeutic area
- Hepatitis C, Chronic
- CHMP opinion
- Thu 21 Nov 2013
- EU approval
- Thu 16 Jan 2014
- Designations
- Accelerated assessment
- Application
- EMEA/H/C/002798
- ATC
- J05AX15
- Official record
- www.ema.europa.eu
Indication
Sovaldi is indicated in combination with other medicinal products 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. Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults 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.
Same substance in other markets
- 🇪🇺 Harvoni Authorised · Gilead Sciences Ireland UC
- 🇪🇺 Vosevi Authorised · Gilead Sciences Ireland UC
- 🇪🇺 Epclusa 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.