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Orkambi



Vertex Pharmaceuticals (Ireland) LimitedEU/1/15/1059/007

Main Information

Trade NameOrkambi
Active SubstancesIvacaftor
Lumacaftor
Dosage FormGranules in sachet
Licence HolderVertex Pharmaceuticals (Ireland) Limited
Licence NumberEU/1/15/1059/007

Group Information

ATC CodeR07AX30 ivacaftor and lumacaftor.

Status

License statusAuthorised
Licence Issued15/01/2019
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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