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01 2Celltrion Healthcare Hungary Kft

02 2Celltrion Healthcare Hungary Kft.

03 2Iqone Healthcare Switzerland Sa

04 14Novartis Europharm Limited

05 2Novartis Europharm Limited (1)

06 8Novartis Pharma Schweiz Ag

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PharmaCompass

01

OPRD
Not Confirmed
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OPRD
Not Confirmed

Omalizumab

Brand Name : Omlyclo

Dosage Form : Solution For Injection

Dosage Strength : 150mg

Packaging :

Approval Date : 16/05/2024

Application Number : 20230425000048

Regulatory Info : Approved

Registration Country : Sweden

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02

OPRD
Not Confirmed
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OPRD
Not Confirmed

Omalizumab

Brand Name : Omlyclo

Dosage Form : Solution For Injection

Dosage Strength : 75mg

Packaging :

Approval Date : 16/05/2024

Application Number : 20230425000031

Regulatory Info : Approved

Registration Country : Sweden

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03

OPRD
Not Confirmed
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OPRD
Not Confirmed

Omalizumab

Brand Name : Xolair

Dosage Form : Solution for injection

Dosage Strength : 150 mg

Packaging : Pre-filled syringe 1ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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04

OPRD
Not Confirmed
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OPRD
Not Confirmed

Omalizumab

Brand Name : Xolair

Dosage Form : Solution for injection

Dosage Strength : 75 mg

Packaging : Pre-filled syringe 0.5ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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05

OPRD
Not Confirmed
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OPRD
Not Confirmed

Omalizumab

Brand Name : Xolair

Dosage Form : Solution for injection in a pre-filled pen

Dosage Strength : 300 mg

Packaging : Pre-filled pen 1 2ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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06

OPRD
Not Confirmed
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OPRD
Not Confirmed

Omalizumab

Brand Name : Xolair

Dosage Form : Solution for injection

Dosage Strength : 75 mg

Packaging : Pre-filled syringe 0.5ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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07

OPRD
Not Confirmed
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OPRD
Not Confirmed

Omalizumab

Brand Name : Xolair

Dosage Form : Solution for injection

Dosage Strength : 150 mg

Packaging : Pre-filled syringe 1ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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08

OPRD
Not Confirmed
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OPRD
Not Confirmed

Omalizumab

Brand Name : Xolair

Dosage Form : Solution For Injection

Dosage Strength : 150mg

Packaging :

Approval Date : 06/11/2023

Application Number : 20220729000141

Regulatory Info : Approved

Registration Country : Sweden

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09

OPRD
Not Confirmed
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OPRD
Not Confirmed

Omalizumab

Brand Name : Xolair

Dosage Form : Solution For Injection

Dosage Strength : 150mg

Packaging :

Approval Date : 10/02/2009

Application Number : 20080312000022

Regulatory Info : Approved

Registration Country : Sweden

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10

OPRD
Not Confirmed
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OPRD
Not Confirmed

Omalizumab

Brand Name : Xolair

Dosage Form : Solution For Injection

Dosage Strength : 150mg

Packaging :

Approval Date : 25/10/2005

Application Number : 20040916000507

Regulatory Info : Approved

Registration Country : Sweden

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