Is Obeticholic acid registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Obeticholic acid, including Ocaliva (5 mg, Film-coated tablet, SAR 9837.80); Ocaliva (10 mg, Film-coated tablet, SAR 9837.80).

Is Obeticholic acid approved by the US FDA?

Drugs@FDA lists 4 application product lines for Obeticholic acid, including OCALIVA (Discontinued); OBETICHOLIC ACID (Discontinued); OBETICHOLIC ACID (Discontinued); OBETICHOLIC ACID (Discontinued).

Is Obeticholic acid authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Obeticholic acid.

Are there safety signals or safety updates for Obeticholic acid?

US FDA: 1 entry; MHRA: 1 entry (latest 2021-05-26).

Active substance

Obeticholic acid

SFDA 2
US FDA 4
EMA 2
Health Canada 2
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Ocaliva	5 mg	Film-coated tablet · Oral use	30 Bottle	SAR 9837.80	NCE · Prescription	ADVANZ PHARMA EUROPE LIMITED	Valid
Ocaliva	10 mg	Film-coated tablet · Oral use	30 Bottle	SAR 9837.80	NCE · Prescription	ADVANZ PHARMA EUROPE LIMITED	Valid

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
OCALIVA	5MG; 10MG	tablet · oral	INTERCEPT	Discontinued	27 May 2016
OBETICHOLIC ACID	5MG; 10MG	tablet · oral	APOTEX	Discontinued	30 May 2023
OBETICHOLIC ACID	5MG; 10MG	tablet · oral	LUPIN	Discontinued	30 May 2023
OBETICHOLIC ACID	5MG; 10MG	tablet · oral	MSN	Discontinued	30 May 2023

EMA European Union — centrally authorised medicines

Zektayos - Hepjuvo Advanz Pharma Limited · Application withdrawn · ATC A05AA04

Therapeutic indication (EMA)

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

Ocaliva Advanz Pharma Limited · Revoked · authorised 12 Dec 2016 · ATC A05AA04

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
OCALIVA	02463121	5 MG	TABLET · ORAL	ADVANZ PHARMA CANADA INC.
OCALIVA	02463148	10 MG	TABLET · ORAL	ADVANZ PHARMA CANADA INC.

Safety signals and safety-related labeling changes

US FDA 26 May 2021 OCALIVA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 24 Apr 2018 Obeticholic acid (Ocaliva▼): risk of serious liver injury in patients with pre-existing moderate or severe hepatic impairment; reminder to adjust dosing according to liver function monitoring
We are aware of reports of serious liver injuries and deaths in patients with primary biliary cholangitis with pre-existing moderate or severe liver impairment who were not adequately dose-adjusted. Follow dose reduction and monitoring advice in these patients to reduce the risk of serious liver injury.

All safety entries for obeticholic acid →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.