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Active Ingredients
Companies
DHPC
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Side Effect Reporting
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Active Ingredients
Ivacaftor
Ivacaftor
Medicine
PIL
SPC
XPIL
Legal Category
Active Ingredient(s)
Company
Kaftrio 37.5 mg/25 mg/50 mg film coated tablets and 75 mg/50 mg/100 mg film coated tablets
PIL
14/03/24
SPC
14/03/24
No
B
Ivacaftor
Tezacaftor
Elexacaftor
Vertex Pharmaceuticals (Ireland) Limited
Kaftrio 60 mg/40 mg/80 mg and 75 mg/50 mg/100 mg granules in sachet
PIL
14/03/24
SPC
14/03/24
No
B
Ivacaftor
Tezacaftor
Elexacaftor
Vertex Pharmaceuticals (Ireland) Limited
Kalydeco 25mg, 50mg, 59.5mg and 75mg granules in sachet
PIL
22/12/23
SPC
22/12/23
Yes
B
Ivacaftor
Vertex Pharmaceuticals (Ireland) Limited
Kalydeco 75 mg and 150 mg film-coated tablets
PIL
22/12/23
SPC
22/12/23
Yes
B
Ivacaftor
Vertex Pharmaceuticals (Ireland) Limited
Orkambi 100 mg/125 mg granules and 150 mg/188 mg granules
PIL
11/04/24
SPC
11/04/24
Yes
B
Ivacaftor
Lumacaftor
Vertex Pharmaceuticals (Ireland) Limited
Orkambi 200 mg/125 mg tablets and 100mg/125mg tablets
PIL
11/04/24
SPC
11/04/24
Yes
B
Ivacaftor
Lumacaftor
Vertex Pharmaceuticals (Ireland) Limited
Symkevi 100 mg/150 mg film coated tablets and 50 mg/ 75 mg film coated tablets
PIL
13/12/23
SPC
13/12/23
Yes
B
Ivacaftor
Tezacaftor
Vertex Pharmaceuticals (Ireland) Limited
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Date of Update on Medicines.ie
Product subject to medical prescription which may be renewed (B)