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AstraZeneca

Kaftrio
ivacaftor, tezacaftor, elexacaftor

Package leaflet: Information for the patient


Kaftrio 37.5 mg/25 mg/50 mg film-coated tablets Kaftrio 75 mg/50 mg/100 mg film-coated tablets ivacaftor/tezacaftor/elexacaftor


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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


See the end of section 2 for important information about the contents of Kaftrio.


What Kaftrio looks like and contents of the pack

Kaftrio 37.5 mg/25 mg/50 mg film-coated tablets are light orange, capsule-shaped tablets stamped with “T50” on one side and plain on the other.


Kaftrio 75 mg/50 mg/100 mg film-coated tablets are orange, capsule-shaped tablets stamped with “T100” on one side and plain on the other.


Kaftrio is available in pack size of 56 tablets (4 blister cards, each with 14 tablets).


Marketing Authorisation Holder

Vertex Pharmaceuticals (Ireland) Limited Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665,

Ireland

Tel: +353 (0)1 761 7299


Manufacturer

Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate

Dundalk Co. Louth A91 P9KD

Ireland


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Almac Pharma Services Limited Seagoe Industrial Estate Craigavon

County Armagh BT63 5UA

United Kingdom (Northern Ireland)


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:


België/Belgique/Belgien, България, Česká republika, Danmark, Deutschland, Eesti, France, Hrvatska, Ireland, Ísland, Κύπρος, Latvija, Lietuva, Luxembourg/Luxemburg, Magyarország, Malta, Nederland, Norge, Österreich, Polska, Portugal, România, Slovenija, Slovenská republika, Suomi/Finland, Sverige, United Kingdom (Northern Ireland)

Vertex Pharmaceuticals (Ireland) Limited Tél/Tel/Teл/Tlf/Sími/Τηλ/Puh:

+353 (0) 1 761 7299

España

Vertex Pharmaceuticals Spain, S.L. Tel: + 34 91 7892800

Ελλάδα

Vertex Φαρμακευτική Μονοπρόσωπη Ανώνυμη Εταιρία

Τηλ: +30 (211) 2120535

Italia

Vertex Pharmaceuticals (Italy) S.r.l.

Tel: +39 0697794000


This leaflet was last revised in


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