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01 22Vertex Pharmaceuticals

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PharmaCompass

01

FNCE
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FNCE
Not Confirmed

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

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02

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

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03

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

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04

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

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05

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

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06

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

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07

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

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08

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

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09

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

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10

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

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11

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

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12

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

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13

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

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14

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

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15

FNCE
Not Confirmed
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FNCE
Not Confirmed

ELEXACAFTOR

Brand Name : TRIKAFTA

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 2517140

Regulatory Info : Prescription

Registration Country : Canada

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16

FNCE
Not Confirmed
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FNCE
Not Confirmed

ELEXACAFTOR

Brand Name : TRIKAFTA

Dosage Form : TABLET

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number : 2526670

Regulatory Info : Prescription

Registration Country : Canada

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17

FNCE
Not Confirmed
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FNCE
Not Confirmed

ELEXACAFTOR

Brand Name : TRIKAFTA

Dosage Form : GRANULES

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 2542277

Regulatory Info : Prescription

Registration Country : Canada

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18

FNCE
Not Confirmed
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FNCE
Not Confirmed

ELEXACAFTOR

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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19

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

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20

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

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