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    Baloxavir Marboxil

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    01

    F. Hoffmann-La Roche

    Switzerland
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Baloxavir Marboxil

    Brand Name : Xofluza

    Dosage Form : Film Coated Tablet

    Dosage Strength : 20mg

    Packaging :

    Approval Date : 19/02/2020

    Application Number : 67426

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    F. Hoffmann-La Roche

    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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    03

    F. Hoffmann-La Roche

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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

    F. Hoffmann-La Roche

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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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    05

    F. Hoffmann-La Roche

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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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    06

    F. Hoffmann-La Roche

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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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    07

    F. Hoffmann-La Roche

    Switzerland
    ISPE Annual Meeting
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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

    F. Hoffmann-La Roche

    Switzerland
    ISPE Annual Meeting
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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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    09

    F. Hoffmann-La Roche

    Switzerland
    ISPE Annual Meeting
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    Regulatory Info : Prescription

    Registration Country : Canada

    BALOXAVIR MARBOXIL

    Brand Name : XOFLUZA

    Dosage Form : TABLET

    Dosage Strength : 80MG

    Packaging :

    Approval Date :

    Application Number : 2524163

    Regulatory Info : Prescription

    Registration Country : Canada

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    10

    Genentech

    U.S.A
    ISPE Annual Meeting
    Not Confirmed
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    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    BALOXAVIR MARBOXIL

    Brand Name : XOFLUZA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 2018-10-24

    Application Number : 210854

    Regulatory Info : DISCN

    Registration Country : USA

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    11

    Genentech

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    BALOXAVIR MARBOXIL

    Brand Name : XOFLUZA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 40MG

    Packaging :

    Approval Date : 2018-10-24

    Application Number : 210854

    Regulatory Info : RX

    Registration Country : USA

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    12

    Genentech

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    BALOXAVIR MARBOXIL

    Brand Name : XOFLUZA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 80MG

    Packaging :

    Approval Date : 2021-03-18

    Application Number : 210854

    Regulatory Info : RX

    Registration Country : USA

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    13

    Genentech

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    BALOXAVIR MARBOXIL

    Brand Name : XOFLUZA

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 2MG/ML

    Packaging :

    Approval Date : 2020-11-23

    Application Number : 214410

    Regulatory Info : RX

    Registration Country : USA

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    Genentech

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    Regulatory Info : RX

    Registration Country : USA

    BALOXAVIR MARBOXIL

    Brand Name : XOFLUZA

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 30MG/PACKET

    Packaging :

    Approval Date : 2025-05-30

    Application Number : 214410

    Regulatory Info : RX

    Registration Country : USA

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    15

    Genentech

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    Regulatory Info : RX

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    BALOXAVIR MARBOXIL

    Brand Name : XOFLUZA

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 40MG/PACKET

    Packaging :

    Approval Date : 2025-05-30

    Application Number : 214410

    Regulatory Info : RX

    Registration Country : USA

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