Kaftrio 37.5 mg/25 mg/50 mg film coated tablets and 75 mg/50 mg/100 mg film coated tablets

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Pharmacy Only: Prescription

Updated on 14 March 2024

File name

Kaftrio EU Tablets Ireland SPC 16Feb2024.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Updated on 14 March 2024

File name

Kaftrio EU Tablets Ireland PIL 19Feb2024.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 04 December 2023

File name

Kaftrio EU Tablets Ireland SPC 22Nov23.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 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Updated on 04 December 2023

File name

Kaftrio EU Tablets Ireland PIL 22Nov23.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 July 2023

File name

Kaftrio SPC Tablets Ireland-July 2023.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 20 July 2023

File name

Kaftrio PIL Tablets Ireland-July 2023.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 25 January 2023

File name

Kaftrio SmPC_Jan2023_IRL.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

Kaftrio SmPC_Sep2022_IRL.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

Kaftrio SmPC_Aug2022_IRL.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.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.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 January 2022

File name

Kaftrio tablets_PIL IE.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 January 2022

File name

Kaftrio tablets_6yr and 12 yrs_PIL IE.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.pdf

Reasons for updating

  • New SPC for new product

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