Kaftrio 75 mg, 50 mg, 100 mg film coated tablets

  • Name:

    Kaftrio 75 mg, 50 mg, 100 mg film coated tablets

  • Company:
    info
  • Active Ingredients:

    Ivacaftor, Tezacaftor, Elexacaftor

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/08/20

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Summary of Product Characteristics last updated on medicines.ie: 21/8/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Vertex Pharmaceuticals (Ireland) Limited

Vertex Pharmaceuticals (Europe) Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Kaftrio 75 mg, 50 mg, 100 mg film coated tablets Active Ingredients Ivacaftor, Tezacaftor, Elexacaftor
Medicine Name Kalydeco 150 mg film-coated tablets Active Ingredients Ivacaftor
Medicine Name Kalydeco 25mg, 50mg and 75mg granules sachets Active Ingredients Ivacaftor
Medicine Name Orkambi 100 mg/125 mg granules and 150 mg/188 mg granules Active Ingredients Ivacaftor, Lumacaftor
Medicine Name Orkambi 200 mg/125 mg tablets and 100mg/125mg tablets Active Ingredients Ivacaftor, Lumacaftor
Medicine Name Symkevi 100 mg/150 mg film coated tablets Active Ingredients Tezacaftor 100mg, Ivacaftor 150mg
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 21 August 2020 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Initial Marketing Authorisation: 21 August 2020

Updated on 21 August 2020 PIL

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Initial Marketing Authorisation: 21 August 2020