01 12Novartis Pharmaceuticals Corporation
02 1Novartis South Africa (Pty) Ltd
01 2Concentrate For Solution For Infusion
02 1INJ
03 1INJECTABLE; INJECTION
04 1Injectable Solution In Pre-Filled Pen
05 1SOLUTION
06 1SOLUTION;SUBCUTANEOUS
07 4Solution For Injection
08 2Blank
01 2Allowed
02 2Approved
03 1Authorized
04 2Deregistered
05 1Originator
06 1Schedule D
07 4Blank
01 1ARZERRA
02 2Arzerra
03 1Bonspri
04 2KESIMPTA
05 7Kesimpta
01 2Australia
02 1Canada
03 1South Africa
04 1Spain
05 4Sweden
06 2Switzerland
07 2USA
Regulatory Info :
Registration Country : USA
Brand Name : ARZERRA
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 100MG/5ML
Packaging :
Approval Date :
Application Number : 125326
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : KESIMPTA
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 20MG/0.4ML
Packaging :
Approval Date :
Application Number : 125326
Regulatory Info :
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Kesimpta
Dosage Form : Solution For Injection
Dosage Strength : 20mg
Packaging :
Approval Date : 26/03/2021
Application Number : 20200110000103
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Kesimpta
Dosage Form : Solution For Injection
Dosage Strength : 20mg
Packaging :
Approval Date : 26/03/2021
Application Number : 20200110000097
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Arzerra
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 100mg
Packaging :
Approval Date : 19/04/2010
Application Number : 20090310000023
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Arzerra
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 1000mg
Packaging :
Approval Date : 21/02/2011
Application Number : 20110319000036
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Kesimpta
Dosage Form : Solution For Injection
Dosage Strength : 20mg/0.4ml
Packaging :
Approval Date : 01/02/2021
Application Number : 67757
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Kesimpta
Dosage Form : Solution For Injection
Dosage Strength : 20mg/0.4ml
Packaging :
Approval Date : 01/02/2021
Application Number : 67758
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Kesimpta
Dosage Form : Injectable Solution In Pre-Filled Pen
Dosage Strength : 20MG
Packaging :
Approval Date : 2021-05-10
Application Number : 121532003
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : KESIMPTA
Dosage Form : SOLUTION
Dosage Strength : 20MG/0.4ML
Packaging :
Approval Date :
Application Number : 2511355
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Kesimpta
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Kesimpta
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Bonspri
Dosage Form : INJ
Dosage Strength : 20mg
Packaging : 1X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
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