01 17Novartis 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 8Solution For Injection
08 1Suspension For Injection
09 2Blank
01 2Allowed
02 2Approved
03 1Authorized
04 2Deregistered
05 1Marketed
06 1Originator
07 5Prescription
08 4Blank
01 1ARZERRA
02 2Arzerra
03 1Bonspri
04 2KESIMPTA
05 12Kesimpta
01 2Australia
02 1Canada
03 2Denmark
04 2Estonia
05 1Norway
06 1South Africa
07 1Spain
08 4Sweden
09 2Switzerland
10 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 : 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 : Marketed
Registration Country : Norway
Brand Name : Kesimpta
Dosage Form : Solution For Injection
Dosage Strength : 20mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway
Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Kesimpta
Dosage Form : Solution For Injection
Dosage Strength : 20mg/0.4ml
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Kesimpta
Dosage Form : Suspension For Injection
Dosage Strength : 20mg/0.4ml
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Kesimpta
Dosage Form : Injectable Solution In Pre-Filled Pen
Dosage Strength : 20MG
Packaging :
Approval Date : 10-05-2021
Application Number : 121532003
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Kesimpta
Dosage Form : Solution For Injection
Dosage Strength : 20mg
Packaging :
Approval Date : 26-03-2021
Application Number : 28106389420
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Kesimpta
Dosage Form : Solution For Injection
Dosage Strength : 20mg
Packaging :
Approval Date : 26-03-2021
Application Number : 28106389520
Regulatory Info : Prescription
Registration Country : Denmark
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 : 2.01E+13
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 : 2.01E+13
Regulatory Info : Deregistered
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 : 2.02E+13
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 : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : KESIMPTA
Dosage Form : SOLUTION
Dosage Strength : 20MG/0.4ML
Packaging :
Approval Date :
Application Number : 2511355
Regulatory Info : Prescription
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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