Is Diroximel fumarate registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Diroximel fumarate, including Vumerity (231 mg, Modified-release capsule, hard, SAR 4556.80).

Is Diroximel fumarate approved by the US FDA?

Drugs@FDA lists 2 application product lines for Diroximel fumarate, including VUMERITY (Prescription); DIROXIMEL FUMARATE (Prescription).

Is Diroximel fumarate authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Diroximel fumarate: Vumerity.

Are there safety signals or safety updates for Diroximel fumarate?

US FDA: 1 entry (latest 2024-03-22).

Active substance

Diroximel fumarate

SFDA 1
US FDA 2
EMA 1
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
Vumerity	231 mg	Modified-release capsule, hard · Oral use	120 Bottle	SAR 4556.80	NCE · Prescription	Biogen Idec B.V-Natherland	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
VUMERITY	231MG	capsule, delayed release · oral	BIOGEN	Prescription	29 Oct 2019
DIROXIMEL FUMARATE	231MG	capsule, delayed release · oral	ZYDUS	Prescription	12 Nov 2025

EMA European Union — centrally authorised medicines

Vumerity Biogen Netherlands B.V. · Authorised · authorised 15 Nov 2021 · ATC L04AX07

Therapeutic indication (EMA)

Vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see Section 5.1 for important information on the populations for which efficacy has been established).

Safety signals and safety-related labeling changes

US FDA 22 Mar 2024 VUMERITY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for diroximel fumarate →

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.