Kaftrio 37.5 mg, 25 mg, 50 mg film coated tablets * Pharmacy Only: Prescription
Company:
Vertex Pharmaceuticals (Ireland) LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
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)