Is Ozanimod 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 Ozanimod, including Zeposia (0.92 mg, Capsule, hard, SAR 4457.75); Zeposia (initiation pack) 4 caps 0.23 mg and 3 caps 0.46 mg (0.23+0.46 mg, Capsule, hard, SAR 1114.20).

Is Ozanimod approved by the US FDA?

Drugs@FDA lists 1 application product line for Ozanimod, including ZEPOSIA (Prescription).

Is Ozanimod authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ozanimod: Zeposia.

Are there safety signals or safety updates for Ozanimod?

US FDA: 1 entry (latest 2024-08-30).

Active substance

Ozanimod

SFDA 2
US FDA 1
EMA 1
Health Canada 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
Zeposia	0.92 mg	Capsule, hard · Oral use	28 Blister	SAR 4457.75	NCE · Prescription	Bristol Myers Squibb Pharma EEIG	Valid
Zeposia (initiation pack) 4 caps 0.23 mg and 3 caps 0.46 mg	0.23+0.46 mg	Capsule, hard · Oral use	7 Blister	SAR 1114.20	NCE · Prescription	Bristol Myers Squibb Pharma EEIG	Valid

Indications — CHI Daman Drug Formulary

MULTIPLE SCLEROSIS

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

Product	Strength	Form · route	Applicant	Status	First approved
ZEPOSIA	EQ 0.23MG BASE; EQ 0.46MG BASE; EQ 0.92MG BASE	capsule · oral	BRISTOL	Prescription	25 Mar 2020

EMA European Union — centrally authorised medicines

Zeposia Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 20 May 2020 · ATC L04AA38

Therapeutic indication (EMA)

Multiple sclerosis Zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. Ulcerative colitis Zeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ZEPOSIA	02505991	0.92 MG	CAPSULE · ORAL	BRISTOL-MYERS SQUIBB CANADA
ZEPOSIA	02506009	0.46 MG; 0.23 MG	CAPSULE · ORAL	BRISTOL-MYERS SQUIBB CANADA

Safety signals and safety-related labeling changes

US FDA 30 Aug 2024 ZEPOSIA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ozanimod →

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.