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Kalydeco



Vertex Pharmaceuticals (Ireland) LimitedEU/1/12/782/001-002

Main Information

Trade NameKalydeco
Active SubstancesIvacaftor
Dosage FormFilm-coated tablet
Licence HolderVertex Pharmaceuticals (Ireland) Limited
Licence NumberEU/1/12/782/001-002

Group Information

ATC CodeR07AX02 ivacaftor

Status

License statusAuthorised
Licence Issued23/07/2012
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

Documents

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