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01 3Novartis Europharm Limited

02 2Novartis Ireland Limited

03 2Novartis Pharma Schweiz Ag

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PharmaCompass

01

Florida Innovation
Not Confirmed
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Florida Innovation
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

Florida Innovation
Not Confirmed
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Florida Innovation
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

Florida Innovation
Not Confirmed
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Florida Innovation
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

Florida Innovation
Not Confirmed
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Florida Innovation
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

Florida Innovation
Not Confirmed
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Florida Innovation
Not Confirmed

Ofatumumabum

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

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06

Florida Innovation
Not Confirmed
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Florida Innovation
Not Confirmed

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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07

Florida Innovation
Not Confirmed
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Florida Innovation
Not Confirmed

Ofatumumab

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

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