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    Entrectinib

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    Roche Registration Gmbh

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    AIChE Annual Meeting
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    Regulatory Info : Approved

    Registration Country : Sweden

    Entrektinib

    Brand Name : Rozlytrek

    Dosage Form : Capsule

    Dosage Strength : 100mg

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    Approval Date : 31/07/2020

    Application Number : 20190109000019

    Regulatory Info : Approved

    Registration Country : Sweden

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    Roche Registration Gmbh

    Switzerland
    AIChE Annual Meeting
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    Roche Registration Gmbh

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    AIChE Annual Meeting
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    • fda
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    Regulatory Info : Approved

    Registration Country : Sweden

    Entrektinib

    Brand Name : Rozlytrek

    Dosage Form : Capsule

    Dosage Strength : 200mg

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    Approval Date : 31/07/2020

    Application Number : 20190109000026

    Regulatory Info : Approved

    Registration Country : Sweden

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    03

    Roche Registration Gmbh

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    AIChE Annual Meeting
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    Regulatory Info : Approved

    Registration Country : Sweden

    Entrektinib

    Brand Name : Rozlytrek

    Dosage Form : Granules

    Dosage Strength : 50mg

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    Approval Date : 28/06/2024

    Application Number : 20230425000147

    Regulatory Info : Approved

    Registration Country : Sweden

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    Roche Pharma (Switzerland) Ag

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    AIChE Annual Meeting
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    AIChE Annual Meeting
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Entwined

    Brand Name : Rozlytrek

    Dosage Form : Hard Capsule

    Dosage Strength : 100mg

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    Approval Date : 05/11/2020

    Application Number : 67280

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Roche Pharma (Switzerland) Ag

    Switzerland
    AIChE Annual Meeting
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    Roche Pharma (Switzerland) Ag

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    AIChE Annual Meeting
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    • fda
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    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

    Roche Registration Gmbh

    Germany
    AIChE Annual Meeting
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    Regulatory Info : Authorized

    Registration Country : Spain

    Entrectinib

    Brand Name : Volume

    Dosage Form : Film Coated Granule In Sachet

    Dosage Strength : 50MG

    Packaging :

    Approval Date : 2024-08-16

    Application Number : 1201460003

    Regulatory Info : Authorized

    Registration Country : Spain

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    07

    Roche Registration Gmbh

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    AIChE Annual Meeting
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    Roche Registration Gmbh

    Germany
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    AIChE Annual Meeting
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    Regulatory Info : Authorized

    Registration Country : Spain

    Entrectinib

    Brand Name : Volume

    Dosage Form : Hard Capsule

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2020-08-27

    Application Number : 1201460001

    Regulatory Info : Authorized

    Registration Country : Spain

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    08

    Roche Registration Gmbh

    Germany
    AIChE Annual Meeting
    Not Confirmed
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    Roche Registration Gmbh

    Germany
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    AIChE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : Authorized

    Registration Country : Spain

    Entrectinib

    Brand Name : Volume

    Dosage Form : Hard Capsule

    Dosage Strength : 200MG

    Packaging :

    Approval Date : 2020-08-27

    Application Number : 1201460002

    Regulatory Info : Authorized

    Registration Country : Spain

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