Ocaliva (obeticholic acid)
ConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- obeticholic acid
- Company
- Advanz Pharma Limited
- Status
- Revoked
- Therapeutic area
- Liver Cirrhosis, Biliary
- CHMP opinion
- Thu 13 Oct 2016
- EU approval
- Mon 12 Dec 2016
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/004093
- ATC
- A05AA04
- Official record
- www.ema.europa.eu
Indication
Ocaliva is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Zektayos - Hepjuvo Application withdrawn · Advanz Pharma Limited
Follow Ocaliva
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.