Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1660890
Name of medicinal product: TRANSLARNA
Active substances:
Ataluren
Estonian, English, Latin
ATC code: M09AX03
Dosage form: granules for oral suspension
Route of administration: oral use
Strengh: 125mg
Amount in package: 30TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
: 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: July 5, 2024 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: April 30, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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