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01 8Novartis Europharm Limited

02 2Novartis Ireland Limited

03 2Novartis Pharma Schweiz Ag

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PharmaCompass

01

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Ofatumumab

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

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02

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Ofatumumab

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

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03

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Ofatumumab

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

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04

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Ofatumumab

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

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05

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Ofatumumab

Brand Name : Kesimpta

Dosage Form : Solution For Injection

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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06

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Ofatumumab

Brand Name : Kesimpta

Dosage Form : Solution For Injection

Dosage Strength : 20mg/0.4ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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07

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Ofatumumab

Brand Name : Kesimpta

Dosage Form : Suspension For Injection

Dosage Strength : 20mg/0.4ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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08

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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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