Is Cholic 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 Cholic acid, including Orphacol (250 mg, Capsule, hard, SAR 43996.00); Orphacol (50 mg, Capsule, hard, SAR 12344.20).

Is Cholic acid approved by the US FDA?

Drugs@FDA lists 1 application product line for Cholic acid, including CHOLBAM (Prescription).

Is Cholic acid authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Cholic acid: Orphacol.

Are there safety signals or safety updates for Cholic acid?

US FDA: 1 entry (latest 2020-10-22).

Active substance

Cholic acid

SFDA 2
US FDA 1
EMA 2
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Orphacol	250 mg	Capsule, hard · Oral use	30 Blister	SAR 43996.00	NCE · Prescription	Theravia	Valid
Orphacol	50 mg	Capsule, hard · Oral use	30 Blister	SAR 12344.20	NCE · Prescription	Theravia	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
CHOLBAM	50MG; 250MG	capsule · oral	MIRUM	Prescription	17 Mar 2015

EMA European Union — centrally authorised medicines

Orphacol Theravia · Authorised · authorised 12 Sep 2013 · ATC A05AA03

Therapeutic indication (EMA)

Orphacol is indicated for the treatment of inborn errors in primary bile acid synthesis due to3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency ininfants, children and adolescents aged 1 month to 18 years and adults.

Kolbam Retrophin Europe Ltd · Withdrawn · authorised 20 Nov 2015 · ATC A05AA03

Therapeutic indication (EMA)

Cholic Acid FGK is indicated for the treatment of inborn errors of primary bile acid synthesis, in infants from one month of age for continuous lifelong treatment through adulthood, encompassing the following single enzyme defects: sterol 27-hydroxylase (presenting as cerebrotendinous xanthomatosis, CTX) deficiency; 2- (or alpha-) methylacyl-CoA racemase (AMACR) deficiency; cholesterol 7 alpha-hydroxylase (CYP7A1) deficiency.

Safety signals and safety-related labeling changes

US FDA 22 Oct 2020 CHOLBAM — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions

All safety entries for cholic 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.