Translarna
·
- Prescription status not stated
- Muscles, joints and bones
- Active substance
- Ataluren
- Used in
- Muscles, joints and bones
- Made by
- PTC Therapeutics International Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- 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.
From the official label · 2026-09-30 · European Medicines Agency
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
SpainNo exact match for this strength and form
FranceNo exact match for this strength and form
Details
| Made by | PTC Therapeutics International Limited |
|---|---|
| Active substance | Ataluren |
| Used in | Muscles, joints and bones |
| Classification | M09AX03 · Muscles, joints and bones |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2014-07-31 |
| Last updated by the regulator | 2024-10-29 |
| EMA product number | EMEA/H/C/002720 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).