Is Risdiplam 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 Risdiplam, including Evrysdi 60 mg/80ml (0.75 mg/ml, Powder for oral solution, SAR 40090.20).

Is Risdiplam approved by the US FDA?

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

Is Risdiplam authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Risdiplam: Evrysdi.

Are there safety signals or safety updates for Risdiplam?

US FDA: 2 entries (latest 2026-09-14).

Active substance

Risdiplam

SFDA 1
US FDA 2
EMA 1
Health Canada 2
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Evrysdi 60 mg/80ml	0.75 mg/ml	Powder for oral solution · Oral use	1 Bottle	SAR 40090.20	NCE · Prescription	F.Hoffmann-La Roche Ltd.	Valid

Indications — CHI Daman Drug Formulary

SPINAL MUSCULAR ATROPHY

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

Product	Strength	Form · route	Applicant	Status	First approved
EVRYSDI	0.75MG/ML	for solution · oral	GENENTECH INC	Prescription	7 Aug 2020
EVRYSDI	5MG	tablet · oral	GENENTECH INC	Prescription	11 Feb 2025

EMA European Union — centrally authorised medicines

Evrysdi Roche Registration GmbH · Authorised · authorised 26 Mar 2021 · ATC M09AX10

Therapeutic indication (EMA)

Evrysdi is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
EVRYSDI	02514931	0.75 MG / ML	POWDER FOR SOLUTION · ORAL	HOFFMANN-LA ROCHE LIMITED
EVRYSDI	02560747	5 MG	TABLET · ORAL	HOFFMANN-LA ROCHE LIMITED

Safety signals and safety-related labeling changes

US FDA 14 Sep 2026 EVRYSDI — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 Sep 2026 EVRYSDI — safety-related labeling change
Labeling sections changed: Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for risdiplam →

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.