01 12Vertex Pharmaceuticals
01 2Filmtabl
02 2GRANULES
03 2GRANULES;ORAL
04 2Granules in a dose bag
05 2TABLET
06 2TABLET;ORAL
01 4Prescription
02 4RX
03 4Blank
01 2Cafe trio
02 4TRIKAFTA
03 4TRIKAFTA (COPACKAGED)
04 2Trikafta
01 4Canada
02 2Norway
03 2Switzerland
04 4USA
Regulatory Info : RX
Registration Country : USA
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Brand Name : TRIKAFTA (COPACKAGED)
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG,75MG,50MG; 150MG
Packaging :
Approval Date : 2019-10-21
Application Number : 212273
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Brand Name : TRIKAFTA (COPACKAGED)
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG,37.5MG,25MG; 75MG
Packaging :
Approval Date : 2021-06-08
Application Number : 212273
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Brand Name : TRIKAFTA (COPACKAGED)
Dosage Form : GRANULES;ORAL
Dosage Strength : 80MG, 60MG, 40MG;59.5MG
Packaging :
Approval Date : 2023-04-26
Application Number : 217660
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Brand Name : TRIKAFTA (COPACKAGED)
Dosage Form : GRANULES;ORAL
Dosage Strength : 100MG, 75MG, 50MG;75MG
Packaging :
Approval Date : 2023-04-26
Application Number : 217660
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Norway
Ivakaftor; Tezakaftor; Eleksakaftor
Brand Name : Cafe trio
Dosage Form : Granules in a dose bag
Dosage Strength : 75 mg/50 mg/100 mg
Packaging : Dosepose 4 7item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Ivakaftor; Tezakaftor; Eleksakaftor
Brand Name : Cafe trio
Dosage Form : Granules in a dose bag
Dosage Strength : 60 mg/40 mg/80 mg
Packaging : Dosepose 4 7item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Elexacaftorum; Tezacaftorum; Ivacaftorum
Brand Name : Trikafta
Dosage Form : Filmtabl
Dosage Strength : 100mg/50mg/75mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Elexacaftorum; Tezacaftorum; Ivacaftorum
Brand Name : Trikafta
Dosage Form : Filmtabl
Dosage Strength : 50mg/25mg/37.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : TRIKAFTA
Dosage Form : TABLET
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 2517140
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : TRIKAFTA
Dosage Form : TABLET
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number : 2526670
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : TRIKAFTA
Dosage Form : GRANULES
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 2542277
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : TRIKAFTA
Dosage Form : GRANULES
Dosage Strength : 80MG
Packaging :
Approval Date :
Application Number : 2542285
Regulatory Info : Prescription
Registration Country : Canada
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