← Drug database

Vosevi (sofosbuvir;velpatasvir;voxilaprevi)

Region
🇪🇺 EU
Active substance
sofosbuvir;velpatasvir;voxilaprevi
Company
Gilead Sciences Ireland UC
Status
Authorised
Therapeutic area
Hepatitis C, Chronic
CHMP opinion
Thu 22 Jun 2017
EU approval
Wed 26 Jul 2017
Application
EMEA/H/C/004350
ATC
J05A
Official record
www.ema.europa.eu

Indication

Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged 12 years and older and weighing at least 30 kg. (see sections 4.2, 4.4 and 5.1).

Regulatory milestones

No milestones recorded in the last year.

Follow Vosevi

Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.

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.