Kaftrio 75 mg, 50 mg, 100 mg film coated tablets *
Company:
Vertex Pharmaceuticals (Ireland) LimitedStatus:
No Recent UpdateLegal 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
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 07 May 2021
File name
Ireland Kaftrio Tablets PIL_1620396554.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 07 May 2021
File name
Ireland Kaftrio Tablets SPC_1620396496.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 29 April 2021
File name
Ireland Kaftrio Tablets PIL_1619663445.pdf
Reasons for updating
- Change to section 1 - what the product is used for
Free text change information supplied by the pharmaceutical company
Section 1: What Kaftrio is and what is it used for
Indication changed to: Kaftrio taken with ivacaftor is for patients aged 12 years and older who have CF, with at least one F508del mutation in the CFTR (cystic fibrosis transmembrane conductance regulator) gene.”
Updated on 29 April 2021
File name
Ireland Kaftrio Tablets SPC_1619663392.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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
4.1 Therapeutic Indications
Updated indication to “Kaftrio is indicated in a combination regimen with ivacaftor 150 mg tablets for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulatory (CFTR) gene.”
4.2 Posology and method of administration
Updated to match indication
Section 4.4 Special warnings and precautions for use: Elderly Population
Updated information to indicate studies did not include patients over 65 years old
Section 4.8: Undesirable effects: Summary of safety profile
Updated with study 445-104
Section 4.8: Undesirable effects: Paediatric population
Updated number of patients in safety data
5.1: Pharmacodynamic properties
Updated to include information on non-F508del CFTR variants
5.1: Pharmacodynamic properties- Effects on sweat chloride
Added Study 445-104 information and data
5.1: Pharmacodynamic properties- Clinical efficacy and safety
Added efficacy data for patients homozygous for F508del mutation or heterozygous for F508del mutation and a mutation with MF, a gating defect, or residual CFTR activity on the second allele
Study 445-104 added
Table 6: Primary and secondary efficacy analyses, full analysis set (study 445-104) added
Updated on 27 November 2020
File name
Kaftrio PIL_Nov2020_IRL_1606475274.pdf
Reasons for updating
- Change to MA holder contact details
Free text change information supplied by the pharmaceutical company
Update to include local representative details for MAH holder in the PIL.
Updated on 21 August 2020
File name
Kaftrio SmPC_Aug2020_IRL_1598046032.pdf
Reasons for updating
- New SPC 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
File name
Kaftrio PIL_Aug2020_IRL_1598045944.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Initial Marketing Authorisation: 21 August 2020