Kaftrio 37.5 mg, 25 mg, 50 mg film coated tablets *
Pharmacy Only: Prescription

Updated on 25 January 2023

File name

63d18b76e7f91.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container

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

Updated on 09 December 2022

File name

63939ca664142.pdf

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

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

Updated on 09 December 2022

File name

63939810b10cf.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

  • In 4.8 under "Undesirable effects", added study 445-116 bullet
  • In 5.1, added new study 445-116 paragraph under "Pharmacodynamic effects", "Clinical efficacy and safety", and "Paediatric population"

Updated on 09 March 2022

File name

Kaftrio SPC - Ireland_1646850511.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Update to change shelf-life for the Kaftrio 75 mg/50 mg/100 mg Tablets from 2 years to 3 years

Updated on 12 January 2022

File name

Kaftrio tablets_PIL IE_1641982601.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 January 2022

File name

Kaftrio tablets_PIL IE_1641982342.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 January 2022

File name

Kaftrio tablets_6yr and 12 yrs_PIL IE_1641981904.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Patient information leaflet including newly added strength Kaftrio 37.5 mg/25 mg/50 mg film-coated tablets and Kaftrio 75 mg/50 mg/100mg film-coated tablets.

Updated on 12 January 2022

File name

Kaftrio tablets_6yr and 12 yrs_SmPC IE_1641981521.pdf

Reasons for updating

  • New SPC for new product

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