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

Product Information *

  • Company:

    Vertex Pharmaceuticals (Ireland) Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    This medicinal product is subject to additional monitoring.

    *Additional information is available upon request

  • Legal Category:

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

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