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01 5Vertex Pharmaceuticals (Ch) Gmbh

02 5Vertex Pharmaceuticals Ireland Ltd

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PharmaCompass

01

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Ivakaftor|Lumakaftor

Brand Name : Orkambi

Dosage Form : Granule In Sachet

Dosage Strength : 100mg;125mg

Packaging :

Approval Date : 15/01/2019

Application Number : 20180213000036

Regulatory Info : Approved

Registration Country : Sweden

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02

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

Ivakaftor Lumakaftor

Brand Name : Orkambi

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg;125mg

Packaging :

Approval Date : 08/01/2018

Application Number : 20170306000159

Regulatory Info : Approved

Registration Country : Sweden

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03

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

Ivakaftor Lumakaftor

Brand Name : Orkambi

Dosage Form : Granule In Sachet

Dosage Strength : 150mg/188mg

Packaging :

Approval Date : 15/01/2019

Application Number : 20180213000043

Regulatory Info : Approved

Registration Country : Sweden

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04

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

Ivakaftor Lumakaftor

Brand Name : Orkambi

Dosage Form : Film Coated Tablet

Dosage Strength : 200mg;125mg

Packaging :

Approval Date : 19/11/2015

Application Number : 20141204000077

Regulatory Info : Approved

Registration Country : Sweden

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05

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

Ivakaftor Lumakaftor

Brand Name : Orkambi

Dosage Form : Granule In Sachet

Dosage Strength : 75mg/94mg

Packaging :

Approval Date : 04/07/2023

Application Number : 20220530000057

Regulatory Info : Approved

Registration Country : Sweden

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06

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

Lumacaftorum|Ivacaftorum

Brand Name : Orkambi

Dosage Form : Film Coated Tablet

Dosage Strength : 200mg;125mg

Packaging :

Approval Date : 02/09/2016

Application Number : 65981

Regulatory Info : Allowed

Registration Country : Switzerland

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07

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

Lumacaftorum|Ivacaftorum

Brand Name : Orkambi

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg;125mg

Packaging :

Approval Date : 02/09/2016

Application Number : 65981

Regulatory Info : Allowed

Registration Country : Switzerland

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08

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

Lumacaftorum|Ivacaftorum

Brand Name : Orkambi lumacaftor ivacaftor

Dosage Form : Granules

Dosage Strength : 100mg;125mg

Packaging :

Approval Date : 23/12/2019

Application Number : 67395

Regulatory Info : Allowed

Registration Country : Switzerland

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09

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

Lumacaftorum|Ivacaftorum

Brand Name : Orkambi lumacaftor ivacaftor

Dosage Form : Granules

Dosage Strength : 150mg;188mg

Packaging :

Approval Date : 23/12/2019

Application Number : 67395

Regulatory Info : Allowed

Registration Country : Switzerland

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10

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

Lumacaftorum|Ivacaftorum

Brand Name : Orkambi lumacaftor ivacaftor

Dosage Form : Granules

Dosage Strength : 75mg;94mg

Packaging :

Approval Date : 23/12/2019

Application Number : 67395

Regulatory Info : Allowed

Registration Country : Switzerland

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