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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
No Recent Update
 PIL 12/01/22 SPC 25/01/23 NoB
Ivacaftor Tezacaftor Elexacaftor
Vertex Pharmaceuticals (Ireland) Limited
Kaftrio 75 mg, 50 mg, 100 mg film coated tablets
No Recent Update
 PIL 12/01/22 SPC 09/12/22 YesB
Ivacaftor Tezacaftor Elexacaftor
Vertex Pharmaceuticals (Ireland) Limited
Kalydeco 25mg, 50mg and 75mg granules sachets
No Recent Update
 PIL 09/12/22 SPC 24/05/22 YesB
Ivacaftor
Vertex Pharmaceuticals (Ireland) Limited
Kalydeco 75 mg and 150 mg film-coated tablets
No Recent Update
 PIL 09/12/22 SPC 24/05/22 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 03/01/23 SPC 03/01/23 YesB
Ivacaftor Tezacaftor
Vertex Pharmaceuticals (Ireland) Limited