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    Baloxavir Marboxil

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    Roche Pharma (Switzerland) Ag

    Switzerland
    ISPE Annual Meeting
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Baloxavir Marboxil

    Brand Name : Xofluza

    Dosage Form : Film Coated Tablet

    Dosage Strength : 20mg

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    Approval Date : 19/02/2020

    Application Number : 67426

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Roche Pharma (Switzerland) Ag

    Switzerland
    ISPE Annual Meeting
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    Switzerland
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Baloxavir Marboxil

    Brand Name : Xofluza

    Dosage Form : Film Coated Tablet

    Dosage Strength : 40mg

    Packaging :

    Approval Date : 19/02/2020

    Application Number : 67426

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Roche Pharma (Switzerland) Ag

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Baloxavir Marboxil

    Brand Name : Xofluza

    Dosage Form : Film Coated Tablet

    Dosage Strength : 80mg

    Packaging :

    Approval Date : 19/02/2020

    Application Number : 67426

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    04

    Roche Pharma (Switzerland) Ag

    Switzerland
    ISPE Annual Meeting
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    Roche Pharma (Switzerland) Ag

    Switzerland
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    ISPE Annual Meeting
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Baloxavir Marboxil

    Brand Name : Xofluza

    Dosage Form : Granule For Oral Suspension

    Dosage Strength : 2mg

    Packaging :

    Approval Date : 19/11/2021

    Application Number : 68068

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Roche Registration Gmbh

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    Regulatory Info : Approved

    Registration Country : Sweden

    Baloxavirmarboxil

    Brand Name : Xofluza

    Dosage Form : Granule For Oral Suspension

    Dosage Strength : 2mg/ml

    Packaging :

    Approval Date : 10/01/2023

    Application Number : 20211126000100

    Regulatory Info : Approved

    Registration Country : Sweden

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    Roche Registration Gmbh

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    ISPE Annual Meeting
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    ISPE Annual Meeting
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    Regulatory Info : Approved

    Registration Country : Sweden

    Baloxavirmarboxil

    Brand Name : Xofluza

    Dosage Form : Film Coated Tablet

    Dosage Strength : 20mg

    Packaging :

    Approval Date : 07/01/2021

    Application Number : 20191107000018

    Regulatory Info : Approved

    Registration Country : Sweden

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    Roche Registration Gmbh

    Switzerland
    ISPE Annual Meeting
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    Roche Registration Gmbh

    Switzerland
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    ISPE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : Approved

    Registration Country : Sweden

    Baloxavirmarboxil

    Brand Name : Xofluza

    Dosage Form : Film Coated Tablet

    Dosage Strength : 40mg

    Packaging :

    Approval Date : 07/01/2021

    Application Number : 20191107000025

    Regulatory Info : Approved

    Registration Country : Sweden

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    08

    Roche Registration Gmbh

    Switzerland
    ISPE Annual Meeting
    Not Confirmed
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    Roche Registration Gmbh

    Switzerland
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    ISPE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : Approved

    Registration Country : Sweden

    Baloxavirmarboxil

    Brand Name : Xofluza

    Dosage Form : Film Coated Tablet

    Dosage Strength : 80mg

    Packaging :

    Approval Date : 25/04/2022

    Application Number : 20210427000048

    Regulatory Info : Approved

    Registration Country : Sweden

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