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01 5Novartis Pharmaceuticals Australia Pty Limited
02 13Novartis Pharmaceuticals Corporation
03 1Novartis South Africa (Pty) Ltd
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01 1FCT
02 10Film Coated Tablet
03 3TABLET;ORAL
04 5Blank
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01 6Allowed
02 2Approved
03 2Authorized
04 1Originator
05 3RX
06 5Blank
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01 1BACRELBA 40
02 3SCEMBLIX
03 15Scemblix
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01 5Australia
02 1South Africa
03 2Spain
04 2Sweden
05 6Switzerland
06 3USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SCEMBLIX
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 20MG BASE
Packaging :
Approval Date : 2021-10-29
Application Number : 215358
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SCEMBLIX
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 40MG BASE
Packaging :
Approval Date : 2021-10-29
Application Number : 215358
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SCEMBLIX
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 100MG BASE
Packaging :
Approval Date : 2024-04-18
Application Number : 215358
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Scemblix
Dosage Form : Film Coated Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 25/08/2022
Application Number : 20210623000019
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Scemblix
Dosage Form : Film Coated Tablet
Dosage Strength : 40mg
Packaging :
Approval Date : 25/08/2022
Application Number : 20210623000026
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Scemblix
Dosage Form : Film Coated Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 09/06/2022
Application Number : 68441
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Scemblix
Dosage Form : Film Coated Tablet
Dosage Strength : 40mg
Packaging :
Approval Date : 09/06/2022
Application Number : 68441
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Scemblix
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 09/06/2022
Application Number : 68441
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Scemblix
Dosage Form : Film Coated Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 09/06/2022
Application Number : 68441
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Scemblix
Dosage Form : Film Coated Tablet
Dosage Strength : 40mg
Packaging :
Approval Date : 09/06/2022
Application Number : 68441
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Scemblix
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 09/06/2022
Application Number : 68441
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Scemblix
Dosage Form : Film Coated Tablet
Dosage Strength : 40MG
Packaging :
Approval Date : 2022-10-06
Application Number : 1221670004
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Scemblix
Dosage Form : Film Coated Tablet
Dosage Strength : 20MG
Packaging :
Approval Date : 2022-10-06
Application Number : 1221670002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : BACRELBA 40
Dosage Form : FCT
Dosage Strength : 40mg
Packaging : 60X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Scemblix
Dosage Form :
Dosage Strength :
Packaging : 60
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Scemblix
Dosage Form :
Dosage Strength :
Packaging : 60
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Scemblix
Dosage Form :
Dosage Strength :
Packaging : 60
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Scemblix
Dosage Form :
Dosage Strength :
Packaging : 60
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Scemblix
Dosage Form :
Dosage Strength :
Packaging : 60
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF