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75 milligram(s) Film-coated tablet

Vertex Pharmaceuticals (Ireland) LimitedEU/1/12/782/007

Main Information

Trade NameKalydeco
Active SubstancesIvacaftor
Strength75 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderVertex Pharmaceuticals (Ireland) Limited
Licence NumberEU/1/12/782/007

Group Information

ATC CodeR07AX02 ivacaftor


Licence Issued25/11/2020
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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