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PTC Therapeutics International Limited EU/1/13/902/003

Main Information

Trade NameTranslarna
Active SubstancesAtaluren
Dosage FormGranules for oral suspension
Licence HolderPTC Therapeutics International Limited
Licence NumberEU/1/13/902/003

Group Information

ATC CodeM09AX Other drugs for disorders of the musculo-skeletal system
M09AX03 ZZZ ataluren


License statusAuthorised
Licence Issued31/07/2014
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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