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    Ofatumumab

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    01 17Novartis Pharmaceuticals Corporation

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    Novartis Pharmaceuticals Corporatio...

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    Regulatory Info :

    Registration Country : USA

    OFATUMUMAB

    Brand Name : ARZERRA

    Dosage Form : INJECTABLE; INJECTION

    Dosage Strength : 100MG/5ML

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    Approval Date :

    Application Number : 125326

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    Registration Country : USA

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    Regulatory Info :

    Registration Country : USA

    OFATUMUMAB

    Brand Name : KESIMPTA

    Dosage Form : SOLUTION;SUBCUTANEOUS

    Dosage Strength : 20MG/0.4ML

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    Application Number : 125326

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    Registration Country : USA

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Ofatumumabum

    Brand Name : Kesimpta

    Dosage Form : Solution For Injection

    Dosage Strength : 20mg/0.4ml

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    Approval Date : 01/02/2021

    Application Number : 67757

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Ofatumumabum

    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

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    05

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    Regulatory Info : Marketed

    Registration Country : Norway

    Ofatumumab

    Brand Name : Kesimpta

    Dosage Form : Solution For Injection

    Dosage Strength : 20mg

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    Approval Date :

    Application Number :

    Regulatory Info : Marketed

    Registration Country : Norway

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    Regulatory Info : Prescription

    Registration Country : Estonia

    Ofatumumab

    Brand Name : Kesimpta

    Dosage Form : Solution For Injection

    Dosage Strength : 20mg/0.4ml

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    Approval Date :

    Application Number :

    Regulatory Info : Prescription

    Registration Country : Estonia

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    Regulatory Info : Prescription

    Registration Country : Estonia

    Ofatumumab

    Brand Name : Kesimpta

    Dosage Form : Suspension For Injection

    Dosage Strength : 20mg/0.4ml

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    Approval Date :

    Application Number :

    Regulatory Info : Prescription

    Registration Country : Estonia

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    Regulatory Info : Authorized

    Registration Country : Spain

    Ofatumumab

    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

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    09

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    Regulatory Info : Prescription

    Registration Country : Denmark

    Ofatumumab

    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

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    10

    Novartis Pharmaceuticals Corporatio...

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    Regulatory Info : Prescription

    Registration Country : Denmark

    Ofatumumab

    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

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    11

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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Ofatumumab

    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

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    12

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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Ofatumumab

    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

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    13

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    Regulatory Info : Approved

    Registration Country : Sweden

    Ofatumumab

    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

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    14

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    Regulatory Info : Approved

    Registration Country : Sweden

    Ofatumumab

    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

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    Regulatory Info : SCHEDULE D

    Registration Country : Canada

    OFATUMUMAB

    Brand Name : KESIMPTA

    Dosage Form : SOLUTION

    Dosage Strength : 20MG/0.4ML

    Packaging :

    Approval Date :

    Application Number : 2511355

    Regulatory Info : SCHEDULE D

    Registration Country : Canada

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    Regulatory Info :

    Registration Country : Australia

    Ofatumumab

    Brand Name : Kesimpta

    Dosage Form :

    Dosage Strength :

    Packaging : 1

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    Regulatory Info :

    Registration Country : Australia

    Ofatumumab

    Brand Name : Kesimpta

    Dosage Form :

    Dosage Strength :

    Packaging : 1

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    Novartis South Africa (Pty) Ltd

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    Regulatory Info : Originator

    Registration Country : South Africa

    Ofatumumab

    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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