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Active Ingredients
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DHPC
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Side Effect Reporting
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Active Ingredients
Lumacaftor
Lumacaftor
Medicine
PIL
SPC
XPIL
Legal Category
Active Ingredient(s)
Company
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
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Date of Update on Medicines.ie
Product subject to medical prescription which may be renewed (B)