Is Ponesimod 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 Ponesimod, including Ponvory (Initiation pack) (2,3,4,5,6,7,8,9,10 mg, Film-coated tablet, SAR 1628.70); Ponvory (maintenance pack) (20 mg, Film-coated tablet, SAR 3257.45).

Is Ponesimod approved by the US FDA?

Drugs@FDA lists 1 application product line for Ponesimod, including PONVORY (Prescription).

Is Ponesimod authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ponesimod: Ponvory.

Are there safety signals or safety updates for Ponesimod?

US FDA: 1 entry (latest 2024-06-05).

Active substance

Ponesimod

SFDA 2
US FDA 1
EMA 1
Health Canada 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
Ponvory (Initiation pack)	2,3,4,5,6,7,8,9,10 mg	Film-coated tablet · Oral use	14 Blister	SAR 1628.70	NCE · Prescription	Laboratoires Juvisé Pharmaceuticals	Valid
Ponvory (maintenance pack)	20 mg	Film-coated tablet · Oral use	28 Blister	SAR 3257.45	NCE · Prescription	Laboratoires Juvisé Pharmaceuticals	Valid

Indications — CHI Daman Drug Formulary

MULTIPLE SCLEROSIS

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

Product	Strength	Form · route	Applicant	Status	First approved
PONVORY	2MG; 3MG; 4MG; 5MG; 6MG; 7MG; 8MG; 9MG; 10MG; 20MG	tablet · oral	VANDA PHARMS INC	Prescription	18 Mar 2021

EMA European Union — centrally authorised medicines

Ponvory Laboratoires Juvisé Pharmaceuticals · Authorised · authorised 19 May 2021 · ATC L04AE04

Therapeutic indication (EMA)

Ponvory is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PONVORY	02515482	20 MG	TABLET · ORAL	VANDA PHARMACEUTICALS INC.

Safety signals and safety-related labeling changes

US FDA 5 Jun 2024 PONVORY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ponesimod →

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.