Kaftrio 60 mg/40 mg/80 mg and 75 mg/50 mg/100 mg granules in sachet
*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 03 May 2024
File name
Kaftrio SPC Granules 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 Granules 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 Granules 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 6.1 - List of excipients
- 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 Granules Ireland PIL 19Feb2024.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 04 December 2023
File name
Kaftrio EU Granules Ireland SPC 22Nov23.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 December 2023
File name
Kaftrio EU Granules Ireland PIL 22Nov23.pdf
Reasons for updating
- New PIL for new product