Ataluren

Translarna 125 MG Granulado Para Suspension Oral

125 mg granulado para suspensión oralSpainAuthorisedAuthorised 30 Nov 2014

In other countries

The same active substances on other registers, the same brand first.

TranslarnaBrazil · PTC Farmaceutica do Brasil Ltda.Same brand
TranslarnaEuropean Union · PTC Therapeutics International LimitedSame brand
TranslarnaCroatiaSame brand
TRANSLARNA 1000 mgRomania · 1000mg · granule pt. susp. orala · PTC Therapeutics International LimitedSame brand
TRANSLARNA 125 mgRomania · 125mg · granule pt. susp. orala · PTC Therapeutics International LimitedSame brand
TRANSLARNA 250 mgRomania · 250mg · granule pt. susp. orala · PTC Therapeutics International LimitedSame brand
TranslarnaSaudi Arabia · Rovi Pharma Industrial ServiceSame brand

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Ataluren

Translarna 125 MG Granulado Para Suspension Oral

125 mg granulado para suspensión oralSpainAuthorisedAuthorised 30 Nov 2014

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Packs

Pack	Code	Status
TRANSLARNA 125 MG GRANULADO PARA SUSPENSION ORAL 30 sobres	704475

Documents

The official texts, at the regulator.

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Ataluren
Strength: 125 mg
Dosage form: granulado para suspensión oral
Route: vía oral
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 30 Nov 2014
Registration: 113902001
Marketing authorisation holder: Ptc Therapeutics International Limited
Procedure: EU centralised
Supply: Uso Hospitalario

Spain