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Kaftrio

100 mg /50 mg / 75 milligram(s) Film-coated tablet

Vertex Pharmaceuticals (Ireland) LimitedEU/1/20/1468/001

Main Information

Trade NameKaftrio
Active SubstancesTEZACAFTOR
Ivacaftor
VX-445
Strength100 mg /50 mg / 75 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderVertex Pharmaceuticals (Ireland) Limited
Licence NumberEU/1/20/1468/001

Group Information

ATC CodeR07AX32 ivacaftor, tezacaftor and elexacaftor

Status

Authorised/WithdrawnAuthorised
Licence Issued21/08/2020
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

Documents

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