Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: TRANSLARNA
Active substances:
Ataluren
Estonian, English, Latin
ATC code: M09AX03
Dosage form: granules for oral suspension
Strength: 1000mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: 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 (see section 5.1). The presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing (see section 4.4).
Safety features: Yes
: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
Marketing authorization holder: PTC Therapeutics International Limited 
Marketing authorization number: EU/1/13/902 
Marketing authorization issued on: July 31, 2014 
Marketing authorization expires on: May 5, 2024 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1660913  TRANSLARNA  granules for oral suspension  1000mg 30TK  Prescription      17.04.2024     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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