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Ivacaftor

Medicine Status PIL SPC XPIL Legal Category Active Ingredient(s) Company Kaftrio 37.5 mg, 25 mg, 50 mg film coated tablets
New
 PIL 12/01/22 SPC 12/01/22 NoB
Ivacaftor Tezacaftor Elexacaftor
Vertex Pharmaceuticals (Ireland) Limited Kaftrio 75 mg, 50 mg, 100 mg film coated tablets
Updated
 PIL 12/01/22 SPC 12/01/22 YesB
Ivacaftor Tezacaftor Elexacaftor
Vertex Pharmaceuticals (Ireland) Limited Kalydeco 25mg, 50mg and 75mg granules sachets
Updated
 PIL 17/01/22 SPC 17/01/22 YesB
Ivacaftor
Vertex Pharmaceuticals (Ireland) Limited Kalydeco 75 mg and 150 mg film-coated tablets
Updated
 PIL 17/01/22 SPC 17/01/22 YesB
Ivacaftor
Vertex Pharmaceuticals (Ireland) Limited Orkambi 100 mg/125 mg granules and 150 mg/188 mg granules
No Recent Update
 PIL 12/12/21 SPC 12/12/21 YesB
Ivacaftor Lumacaftor
Vertex Pharmaceuticals (Ireland) Limited Orkambi 200 mg/125 mg tablets and 100mg/125mg tablets
No Recent Update
 PIL 12/12/21 SPC 12/12/21 YesB
Ivacaftor Lumacaftor
Vertex Pharmaceuticals (Ireland) Limited Symkevi 100 mg/150 mg film coated tablets and 50 mg/ 75 mg film coated tablets
No Recent Update
 PIL 12/12/21 SPC 12/12/21 YesB
Ivacaftor Tezacaftor
Vertex Pharmaceuticals (Ireland) Limited