Is Ataluren 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 Ataluren, including TRANSLARNA (125 mg, Granules for oral suspension, SAR 11894.60); TRANSLARNA (250 mg, Granules for oral suspension, SAR 23789.20); TRANSLARNA (1000 mg, Granules for oral suspension, SAR 95156.85).

Is Ataluren authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Ataluren.

Active substance

Ataluren

SFDA 3
EMA 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
TRANSLARNA	125 mg	Granules for oral suspension · Oral use	30 Sachet	SAR 11894.60	NCE · Prescription	PTC Therapeutics International Limited	Valid
TRANSLARNA	250 mg	Granules for oral suspension · Oral use	30 Sachet	SAR 23789.20	NCE · Prescription	PTC Therapeutics International Limited	Valid
TRANSLARNA	1000 mg	Granules for oral suspension · Oral use	30 Sachet	SAR 95156.85	NCE · Prescription	PTC Therapeutics International Limited	Valid

EMA European Union — centrally authorised medicines

Translarna PTC Therapeutics International Limited · Expired · authorised 31 Jul 2014 · ATC M09AX03

Therapeutic indication (EMA)

Translarna is indicated for the treatment of Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 2 years and older. Efficacy has not been demonstrated in non-ambulatory patients. The presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing.

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.