Kaftrio 37.5 mg/25 mg/50 mg film coated tablets and 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
Updated on 21 November 2024
File name
Kaftrio Tablets PIL.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 03 May 2024
File name
Kaftrio SPC Tablets Ireland 30Apr24.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 May 2024
File name
Kaftrio PIL Tablets Ireland 30Apr24.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
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)
Vertex Pharmaceuticals (Ireland) Limited
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Address:
Vertex Pharmaceuticals (Ireland) Limited, Unit 49, Block 5, Northwood Court, Northwood Crescent, Dublin 9, D09 T665, IrelandMedical Information E-mail:
vertexmedicalinfo@vrtx.comTelephone:
+353 (1) 7617299Fax:
+44 (0)20 3204 5220Medical Information Facsimile:
+44 (0)1235 438 190Medical Information Direct Line:
1800 924568Customer Care direct line:
1800924568