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01 2Roche Pharma (Switzerland) Ag

02 2Roche Registration GmbH

03 10Roche Registration Gmbh

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PharmaCompass

01

SCOPE Summit
Not Confirmed
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SCOPE Summit
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Entrektinib

Brand Name : Rozlytrek

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date : 31/07/2020

Application Number : 20190109000019

Regulatory Info : Approved

Registration Country : Sweden

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02

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Entrektinib

Brand Name : Rozlytrek

Dosage Form : Capsule

Dosage Strength : 200mg

Packaging :

Approval Date : 31/07/2020

Application Number : 20190109000026

Regulatory Info : Approved

Registration Country : Sweden

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03

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Entrektinib

Brand Name : Rozlytrek

Dosage Form : Granules

Dosage Strength : 50mg

Packaging :

Approval Date : 28/06/2024

Application Number : 20230425000147

Regulatory Info : Approved

Registration Country : Sweden

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04

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Entwined

Brand Name : Rozlytrek

Dosage Form : Hard Capsule

Dosage Strength : 100mg

Packaging :

Approval Date : 05/11/2020

Application Number : 67280

Regulatory Info : Allowed

Registration Country : Switzerland

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05

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Entwined

Brand Name : Rozlytrek

Dosage Form : Hard Capsule

Dosage Strength : 200mg

Packaging :

Approval Date : 05/11/2020

Application Number : 67280

Regulatory Info : Allowed

Registration Country : Switzerland

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06

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Entrectinib

Brand Name : Rozlytrek

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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07

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Entrectinib

Brand Name : Rozlytrek

Dosage Form : Capsule

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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08

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Entrectinib

Brand Name : Rozlytrek

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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09

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Entrectinib

Brand Name : Rozlytrek

Dosage Form : Capsule

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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10

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Entrectinib

Brand Name : Volume

Dosage Form : Film Coated Granule In Sachet

Dosage Strength : 50MG

Packaging :

Approval Date : 16-08-2024

Application Number : 1201460003

Regulatory Info : Authorized

Registration Country : Spain

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