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    Ofatumumab

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    01 8Novartis Europharm Limited

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    Novartis Europharm Limited

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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 :

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    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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    Regulatory Info : Prescription

    Registration Country : Estonia

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    03

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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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    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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    05

    Novartis Europharm Limited

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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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    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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    07

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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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    Novartis Europharm Limited

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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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    09

    Novartis Ireland Limited

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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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    10

    Novartis Ireland Limited

    Switzerland
    BioProcess International US West
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    Novartis Ireland Limited

    Switzerland
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    BioProcess International US West
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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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