← Drug database

Zektayos - Hepjuvo (obeticholic acid)

Region
🇪🇺 EU
Active substance
obeticholic acid
Company
Advanz Pharma Limited
Status
Application withdrawn
Therapeutic area
Fatty Liver
Application
EMEA/H/C/005249
ATC
A05AA04
Official record
www.ema.europa.eu

Indication

Improvement of liver fibrosis and resolution of steatohepatitis in adult patients with significant liver fibrosis due to nonalcoholic steatohepatitis (NASH)

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

Follow Zektayos - Hepjuvo

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.