Is Odevixibat registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Odevixibat, including Bylvay (200 µg, Capsule, hard, SAR 15768.60); Bylvay (400 µg, Capsule, hard, SAR 31537.30); Bylvay (600 µg, Capsule, hard, SAR 47305.90); Bylvay (1200 µg, Capsule, hard, SAR 94620.35).

Is Odevixibat approved by the US FDA?

Drugs@FDA lists 2 application product lines for Odevixibat, including BYLVAY (Prescription); BYLVAY (Prescription).

Is Odevixibat authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Odevixibat: Bylvay, Kayfanda.

Are there safety signals or safety updates for Odevixibat?

US FDA: 1 entry (latest 2025-12-19).

Active substance

Odevixibat

SFDA 4
US FDA 2
EMA 2
Health Canada 4
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
Bylvay	200 µg	Capsule, hard · Oral use	30 Bottle	SAR 15768.60	NCE · Prescription	IPSEN PHARMA	Valid
Bylvay	400 µg	Capsule, hard · Oral use	30 Bottle	SAR 31537.30	NCE · Prescription	IPSEN PHARMA	Valid
Bylvay	600 µg	Capsule, hard · Oral use	30 Bottle	SAR 47305.90	NCE · Prescription	IPSEN PHARMA	Valid
Bylvay	1200 µg	Capsule, hard · Oral use	30 Bottle	SAR 94620.35	NCE · Prescription	IPSEN PHARMA	Valid

Indications — CHI Daman Drug Formulary

PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS

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

Product	Strength	Form · route	Applicant	Status	First approved
BYLVAY	0.2MG; 0.6MG	capsule, pellets · oral	IPSEN	Prescription	20 Jul 2021
BYLVAY	0.4MG; 1.2MG	capsule · oral	IPSEN	Prescription	20 Jul 2021

EMA European Union — centrally authorised medicines

Bylvay Ipsen Pharma · Authorised · authorised 16 Jul 2021 · ATC A05AX

Therapeutic indication (EMA)

Bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older (see sections 4.4 and 5.1).

Kayfanda Ipsen Pharma · Authorised · authorised 19 Sep 2024 · ATC A05AX05

Therapeutic indication (EMA)

Kayfanda is indicated for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) in patients aged 6 months or older (see sections 4.4 and 5.1).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BYLVAY	02542641	200 MCG	CAPSULE · ORAL	MEDISON PHARMA CANADA INC.
BYLVAY	02542676	400 MCG	CAPSULE · ORAL	MEDISON PHARMA CANADA INC.
BYLVAY	02542684	600 MCG	CAPSULE · ORAL	MEDISON PHARMA CANADA INC.
BYLVAY	02542692	1200 MCG	CAPSULE · ORAL	MEDISON PHARMA CANADA INC.

Safety signals and safety-related labeling changes

US FDA 19 Dec 2025 BYLVAY — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for odevixibat →

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.