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    Entrectinib

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    01

    F. Hoffmann-La Roche

    Switzerland
    FNCE
    Not Confirmed
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    F. Hoffmann-La Roche

    Switzerland
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    FNCE
    Not Confirmed
    • fda
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    Regulatory Info : Approved

    Registration Country : Sweden

    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

    F. Hoffmann-La Roche

    Switzerland
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    F. Hoffmann-La Roche

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    Regulatory Info : Approved

    Registration Country : Sweden

    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

    F. Hoffmann-La Roche

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    Regulatory Info : Approved

    Registration Country : Sweden

    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

    F. Hoffmann-La Roche

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    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

    F. Hoffmann-La Roche

    Switzerland
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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

    F. Hoffmann-La Roche

    Switzerland
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    Regulatory Info : Prescription

    Registration Country : Canada

    ENTRECTINIB

    Brand Name : ROZLYTREK

    Dosage Form : CAPSULE

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number : 2495007

    Regulatory Info : Prescription

    Registration Country : Canada

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    07

    F. Hoffmann-La Roche

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    Regulatory Info : Prescription

    Registration Country : Canada

    ENTRECTINIB

    Brand Name : ROZLYTREK

    Dosage Form : CAPSULE

    Dosage Strength : 200MG

    Packaging :

    Approval Date :

    Application Number : 2495015

    Regulatory Info : Prescription

    Registration Country : Canada

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    08

    F. Hoffmann-La Roche

    Switzerland
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    Regulatory Info : Originator

    Registration Country : South Africa

    Entrectinib

    Brand Name : Rozlytrek 100mg

    Dosage Form : CAP

    Dosage Strength : 100MG

    Packaging : 1X30MG

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    09

    F. Hoffmann-La Roche

    Switzerland
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    F. Hoffmann-La Roche

    Switzerland
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    FNCE
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    Regulatory Info : Originator

    Registration Country : South Africa

    Entrectinib

    Brand Name : Rozlytrek 200mg

    Dosage Form : CAP

    Dosage Strength : 200MG

    Packaging : 1X90MG

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    10

    F. Hoffmann-La Roche

    Switzerland
    FNCE
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    F. Hoffmann-La Roche

    Switzerland
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    FNCE
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    Regulatory Info :

    Registration Country : Australia

    Entrectinib

    Brand Name : Rozlytrek

    Dosage Form :

    Dosage Strength :

    Packaging : 90

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    11

    Genentech

    U.S.A
    FNCE
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    Genentech

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    ENTRECTINIB

    Brand Name : ROZLYTREK

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2019-08-15

    Application Number : 212725

    Regulatory Info : RX

    Registration Country : USA

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    12

    Genentech

    U.S.A
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    Genentech

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    ENTRECTINIB

    Brand Name : ROZLYTREK

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 200MG

    Packaging :

    Approval Date : 2019-08-15

    Application Number : 212725

    Regulatory Info : RX

    Registration Country : USA

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    13

    Genentech

    U.S.A
    FNCE
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    Genentech

    U.S.A
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    Regulatory Info :

    Registration Country : USA

    ENTRECTINIB

    Brand Name : ROZLYTREK

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 100MG

    Packaging :

    Approval Date :

    Application Number : 212726

    Regulatory Info :

    Registration Country : USA

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    14

    Genentech

    U.S.A
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    U.S.A
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    Regulatory Info :

    Registration Country : USA

    ENTRECTINIB

    Brand Name : ROZLYTREK

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 200MG

    Packaging :

    Approval Date :

    Application Number : 212726

    Regulatory Info :

    Registration Country : USA

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    15

    Genentech

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    ENTRECTINIB

    Brand Name : ROZLYTREK

    Dosage Form : PELLETS;ORAL

    Dosage Strength : 50MG/PACKET

    Packaging :

    Approval Date : 2023-10-20

    Application Number : 218550

    Regulatory Info : RX

    Registration Country : USA

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    16

    Roche Diagnostics GmbH

    Germany
    FNCE
    Not Confirmed
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    Roche Diagnostics GmbH

    Germany
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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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    17

    Roche Diagnostics GmbH

    Germany
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    Roche Diagnostics GmbH

    Germany
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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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    18

    Roche Diagnostics GmbH

    Germany
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    Roche Diagnostics GmbH

    Germany
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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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