Kaftrio 75 mg, 50 mg, 100 mg film coated tablets
- Name:
Kaftrio 75 mg, 50 mg, 100 mg film coated tablets
- Company:
Vertex Pharmaceuticals (Ireland) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/11/20
(Click to Download) Summary of Product Characteristics last updated on medicines.ie: 21/8/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. Click on this link to Download PDF directly
Vertex Pharmaceuticals (Ireland) Limited
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Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name Kaftrio 75 mg, 50 mg, 100 mg film coated tablets | Active Ingredients Ivacaftor, Tezacaftor, Elexacaftor |
| Medicine Name Kalydeco 25mg, 50mg and 75mg granules sachets | Active Ingredients Ivacaftor |
| Medicine Name Kalydeco 75 mg and 150 mg film-coated tablets | Active Ingredients Ivacaftor |
| Medicine Name Orkambi 100 mg/125 mg granules and 150 mg/188 mg granules | Active Ingredients Ivacaftor, Lumacaftor |
| Medicine Name Orkambi 200 mg/125 mg tablets and 100mg/125mg tablets | Active Ingredients Ivacaftor, Lumacaftor |
| Medicine Name Symkevi 100 mg/150 mg film coated tablets and 50 mg/ 75 mg film coated tablets | Active Ingredients Ivacaftor, Tezacaftor |
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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 27 November 2020 PIL
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 SPC
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 PIL
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Initial Marketing Authorisation: 21 August 2020