Translarna
- Licence status
- Active substances
- Ataluren
- Dosage Form
- Granules for oral suspension
- Licence number
- EU/1/13/902/002
- Licence holder
- PTC Therapeutics International Limited
Product documents
Licence information
- ATC code
- M09AX Other drugs for disorders of the musculo-skeletal system, M09AX03 ZZZ ataluren
- Route of supply
- Product subject to prescription which may not be renewed (A)
- Place of sale
- Supply through pharmacies only
- Conditions of Licence
- Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
- Marketing availability
- Unknown
- Advertising conditions
- Advertising to healthcare professionals only
- Licence issued
- 31/07/2014
Stay updated: document advice
The information and documents on this page are subject to frequent updates. We recommend you do not retain saved or printed versions of them. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie