Is Siponimod registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Siponimod, including MAYZENT (0.25 mg, Film-coated tablet, SAR 826.95); MAYZENT (2 mg, Film-coated tablet, SAR 8264.90).

Is Siponimod approved by the US FDA?

Drugs@FDA lists 3 application product lines for Siponimod, including MAYZENT (Prescription); SIPONIMOD (Discontinued); SIPONIMOD (Discontinued).

Active substance

Siponimod

SFDA 3
US FDA 3
Health Canada 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
MAYZENT	0.25 mg	Film-coated tablet · Oral use	12 Blister	SAR 826.95	NCE · Prescription	NOVARTIS PHARMACEUTICALS CORPORATION	Valid
MAYZENT	2 mg	Film-coated tablet · Oral use	28 Blister	SAR 8264.90	NCE · Prescription	NOVARTIS PHARMACEUTICALS CORPORATION	Valid
MAYZENT	0.25 mg	Film-coated tablet · Oral use	120 Blister	SAR 8264.90	NCE · Prescription	NOVARTIS PHARMACEUTICALS CORPORATION	Valid

Indications — CHI Daman Drug Formulary

MULTIPLE SCLEROSIS

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

Product	Strength	Form · route	Applicant	Status	First approved
MAYZENT	EQ 0.25MG BASE; EQ 2MG BASE; EQ 1MG BASE	tablet · oral	NOVARTIS	Prescription	26 Mar 2019
SIPONIMOD	EQ 0.25MG BASE; EQ 1MG BASE; EQ 2MG BASE	tablet · oral	RICONPHARMA LLC	Discontinued	22 Apr 2025
SIPONIMOD	EQ 0.25MG BASE; EQ 1MG BASE; EQ 2MG BASE	tablet · oral	AUROBINDO PHARMA LTD	Discontinued	6 Mar 2026

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MAYZENT	02496429	0.25 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
MAYZENT	02496437	2 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC

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.