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01 9F. Hoffmann-La Roche

02 6Genentech

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PharmaCompass

01

The MedTech Conference
Not Confirmed
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The MedTech Conference
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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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02

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

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

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

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

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

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

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

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

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

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

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

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

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

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

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

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

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

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

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

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

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

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

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

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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14

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

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

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

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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