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01 22Vertex Pharmaceuticals
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01 6Film Coated Tablet
02 2GRANULES
03 2GRANULES;ORAL
04 4Granule In Sachet
05 2Granules
06 2Granules in a dose bag
07 2TABLET
08 2TABLET;ORAL
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01 4Allowed
02 4Approved
03 4Authorized
04 4Prescription
05 4RX
06 2Blank
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01 2Cafe trio
02 8Kaftrio
03 4TRIKAFTA
04 4TRIKAFTA (COPACKAGED)
05 4Trikafta
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01 4Canada
02 2Norway
03 4Spain
04 4Sweden
05 4Switzerland
06 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 : Approved
Registration Country : Sweden
Elexacaftor Ivakaftor Tezakaftor
Brand Name : Kaftrio
Dosage Form : Film Coated Tablet
Dosage Strength : 37.5mg;25mg;50mg
Packaging :
Approval Date : 07/01/2022
Application Number : 20210309000012
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Elexacaftor Ivakaftor Tezakaftor
Brand Name : Kaftrio
Dosage Form : Film Coated Tablet
Dosage Strength : 75mg;50mg;100mg
Packaging :
Approval Date : 21/08/2020
Application Number : 20191015000032
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Elexacaftorum; Tezacaftorum; Ivacaftorum
Brand Name : Trikafta
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg;50mg;75 mg
Packaging :
Approval Date : 10/12/2020
Application Number : 67773
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Elexacaftorum; Tezacaftorum; Ivacaftorum
Brand Name : Trikafta
Dosage Form : Film Coated Tablet
Dosage Strength : 50mg;25mg;37.5mg
Packaging :
Approval Date : 10/12/2020
Application Number : 67773
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Elexacaftorum; Tezacaftorum; Ivacaftorum
Brand Name : Trikafta
Dosage Form : Granules
Dosage Strength : 100mg;50mg;75mg
Packaging :
Approval Date : 13/06/2024
Application Number : 69212
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Elexacaftorum; Tezacaftorum; Ivacaftorum
Brand Name : Trikafta
Dosage Form : Granules
Dosage Strength : 80mg;40mg;60mg
Packaging :
Approval Date : 13/06/2024
Application Number : 69212
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Approved
Registration Country : Sweden
Elexacaftor; Ivacaftor; Tezacaftor
Brand Name : Kaftrio
Dosage Form : Granule In Sachet
Dosage Strength : 60mg;40mg;80mg
Packaging :
Approval Date : 22/11/2023
Application Number : 20221123000157
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Elexacaftor; Ivacaftor; Tezacaftor
Brand Name : Kaftrio
Dosage Form : Granule In Sachet
Dosage Strength : 75mg;50mg;100mg
Packaging :
Approval Date : 22/11/2023
Application Number : 20221123000164
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Authorized
Registration Country : Spain
Ivacaftor; Tezacaftor; Elexacaftor
Brand Name : Kaftrio
Dosage Form : Film Coated Tablet
Dosage Strength : 75MG; 50MG; 100 MG
Packaging :
Approval Date : 2020-10-23
Application Number : 1201468001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Ivacaftor; Tezacaftor; Elexacaftor
Brand Name : Kaftrio
Dosage Form : Granule In Sachet
Dosage Strength : 60MG; 40MG; 80 MG
Packaging :
Approval Date : 2023-12-14
Application Number : 1201468003
Regulatory Info : Authorized
Registration Country : Spain