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Approved Marketing Authorisations (MA) containing Tezacaftor in Europe. Original Data : EMA Website

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01 3Vertex Pharmaceuticals (CH) GmbH

02 2Vertex Pharmaceuticals (Ireland) Limited

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01

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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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02

Luxepack
Not Confirmed
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Luxepack
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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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03

Luxepack
Not Confirmed
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Luxepack
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Elexacaftorum; Tezacaftorum; Ivacaftorum

Brand Name : Trikafta

Dosage Form : Filmtabl

Dosage Strength : 100mg/50mg/75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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04

Luxepack
Not Confirmed
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Luxepack
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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

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05

Luxepack
Not Confirmed
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Luxepack
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Tezacaftorum; Ivacaftorum

Brand Name : Symdeko

Dosage Form : Filmtabl

Dosage Strength : 100mg/150mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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