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01 16Vertex Pharmaceuticals

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PharmaCompass

01

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

IVACAFTOR; LUMACAFTOR

Brand Name : ORKAMBI

Dosage Form : TABLET;ORAL

Dosage Strength : 125MG;200MG

Packaging :

Approval Date : 2015-07-02

Application Number : 206038

Regulatory Info : RX

Registration Country : USA

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02

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

IVACAFTOR; LUMACAFTOR

Brand Name : ORKAMBI

Dosage Form : TABLET;ORAL

Dosage Strength : 125MG;100MG

Packaging :

Approval Date : 2016-09-28

Application Number : 206038

Regulatory Info : RX

Registration Country : USA

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03

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

IVACAFTOR; LUMACAFTOR

Brand Name : ORKAMBI

Dosage Form : GRANULE;ORAL

Dosage Strength : 125MG/PACKET;100MG/PACKET

Packaging :

Approval Date : 2018-08-07

Application Number : 211358

Regulatory Info : RX

Registration Country : USA

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04

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

IVACAFTOR; LUMACAFTOR

Brand Name : ORKAMBI

Dosage Form : GRANULE;ORAL

Dosage Strength : 188MG/PACKET;150MG/PACKET

Packaging :

Approval Date : 2018-08-07

Application Number : 211358

Regulatory Info : RX

Registration Country : USA

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05

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

IVACAFTOR; LUMACAFTOR

Brand Name : ORKAMBI

Dosage Form : GRANULE;ORAL

Dosage Strength : 94MG/PACKET;75MG/PACKET

Packaging :

Approval Date : 2022-09-02

Application Number : 211358

Regulatory Info : RX

Registration Country : USA

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06

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Ivacaftor; lumacaftor

Brand Name : Orkambi

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 200MG; 125MG

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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07

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

LUMACAFTOR

Brand Name : ORKAMBI

Dosage Form : TABLET

Dosage Strength : 200MG

Packaging : 112

Approval Date :

Application Number : 2451379

Regulatory Info : Prescription

Registration Country : Canada

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08

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

LUMACAFTOR

Brand Name : ORKAMBI

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging : 28/112

Approval Date :

Application Number : 2463040

Regulatory Info : Prescription

Registration Country : Canada

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09

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

LUMACAFTOR

Brand Name : ORKAMBI

Dosage Form : GRANULES

Dosage Strength : 100MG/SACHET

Packaging :

Approval Date :

Application Number : 2483831

Regulatory Info : Prescription

Registration Country : Canada

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10

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

LUMACAFTOR

Brand Name : ORKAMBI

Dosage Form : GRANULES

Dosage Strength : 150MG/SACHET

Packaging :

Approval Date :

Application Number : 2483858

Regulatory Info : Prescription

Registration Country : Canada

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11

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

LUMACAFTOR

Brand Name : ORKAMBI

Dosage Form : GRANULES

Dosage Strength : 75MG/SACHET

Packaging :

Approval Date :

Application Number : 2537087

Regulatory Info : Prescription

Registration Country : Canada

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12

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Ivacaftor; Lumacaftor

Brand Name : Orcambi

Dosage Form : Granule In Sachet

Dosage Strength : 150MG; 188 MG

Packaging :

Approval Date : 2019-02-28

Application Number : 1151059007

Regulatory Info : Authorized

Registration Country : Spain

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13

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Ivacaftor; Lumacaftor

Brand Name : Orcambi

Dosage Form : Granule In Sachet

Dosage Strength : 75MG; 94 MG

Packaging :

Approval Date : 2023-07-26

Application Number : 1151059008

Regulatory Info : Authorized

Registration Country : Spain

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14

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Ivacaftor; Lumacaftor

Brand Name : Orcambi

Dosage Form : Film Coated Tablet

Dosage Strength : 200MG; 125 MG

Packaging :

Approval Date : 2016-07-07

Application Number : 1151059001

Regulatory Info : Authorized

Registration Country : Spain

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15

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Ivacaftor; Lumacaftor

Brand Name : Orcambi

Dosage Form : Film Coated Tablet

Dosage Strength : 100MG; 125 MG

Packaging :

Approval Date : 2018-04-05

Application Number : 1151059005

Regulatory Info : Authorized

Registration Country : Spain

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16

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Ivacaftor; Lumacaftor

Brand Name : Orcambi

Dosage Form : Granule In Sachet

Dosage Strength : 100MG; 125 MG

Packaging :

Approval Date : 2019-02-28

Application Number : 1151059006

Regulatory Info : Authorized

Registration Country : Spain

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