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01 9F. Hoffmann-La Roche
02 6Genentech
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01 3FOR SUSPENSION;ORAL
02 6Film Coated Tablet
03 2Granule For Oral Suspension
04 1TABLET
05 3TABLET;ORAL
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01 4Allowed
02 4Approved
03 1DISCN
04 1Prescription
05 5RX
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01 7XOFLUZA
02 7Xofluza
03 1Xofluza
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01 1Canada
02 4Sweden
03 4Switzerland
04 6USA
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
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : XOFLUZA
Dosage Form : TABLET
Dosage Strength : 80MG
Packaging :
Approval Date :
Application Number : 2524163
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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