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01 4Roche Pharma (Switzerland) Ag
02 4Roche Registration Gmbh
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01 4Baloxavir Marboxil
02 4Baloxavirmarboxil
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01 6Film Coated Tablet
02 2Granule For Oral Suspension
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01 4Sweden
02 4Switzerland
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01 7Xofluza
02 1Xofluza
Regulatory Info : Allowed
Registration Country : Switzerland
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
Regulatory Info : Allowed
Registration Country : Switzerland
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
Regulatory Info : Allowed
Registration Country : Switzerland
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
Regulatory Info : Allowed
Registration Country : Switzerland
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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