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Active Ingredients
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DHPC
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Adverse Event Reporting
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Active Ingredients
Lumacaftor
Lumacaftor
Medicine
Status
PIL
SPC
XPIL
Legal Category
Active Ingredient(s)
Company
Orkambi 100 mg/125 mg granules and 150 mg/188 mg granules
No Recent Update
PIL
10/07/23
SPC
10/07/23
Yes
B
Ivacaftor
Lumacaftor
Vertex Pharmaceuticals (Ireland) Limited
Orkambi 200 mg/125 mg tablets and 100mg/125mg tablets
No Recent Update
PIL
10/07/23
SPC
10/07/23
Yes
B
Ivacaftor
Lumacaftor
Vertex Pharmaceuticals (Ireland) Limited
Direct Healthcare Professional Communications
This medicine and its document have not been updated in the last 30 days.
Date of Update on Medicines.ie
Product subject to medical prescription which may be renewed (B)
