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01 2CELLTRION INC.
02 42Celltrion
03 4Genentech
04 2Iqone Healthcare Switzerland Sa
05 38Novartis Pharmaceuticals Australia Pty Limited
06 29Novartis Pharmaceuticals Corporation
07 1Novartis South Africa (Pty) Ltd
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01 1INJ
02 2INJECTABLE;INJECTION
03 3Injectable Solution
04 3Injectable Solution In Pre-Filled Syringe
05 1POWDER FOR SOLUTION
06 1Powder And Solvent For Injectable Solution
07 6SOLUTION
08 3SYRINGE
09 18Solution For Injection
10 4Solution for injection
11 1Solution for injection in a pre-filled pen
12 1VIAL
13 74Blank
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01 10Allowed
02 10Approved
03 5Authorized
04 1Originator
05 3Prescription
06 4Schedule D
07 85Blank
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01 4OMLYCLO
02 41Omlyclo
03 1Omlyclo
04 9XOLAIR
05 1XOLAIR 150mg
06 57Xolair
07 5Xolair
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01 74Australia
02 7Canada
03 5Norway
04 1South Africa
05 5Spain
06 10Sweden
07 10Switzerland
08 6USA
Regulatory Info :
Registration Country : USA
Brand Name : OMLYCLO
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 75MG/0.5ML
Packaging :
Approval Date :
Application Number : 761399
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : OMLYCLO
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 150MG/ML
Packaging :
Approval Date :
Application Number : 761399
Regulatory Info :
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info :
Registration Country : USA
Brand Name : XOLAIR
Dosage Form : VIAL
Dosage Strength : 150MG/VIAL
Packaging :
Approval Date :
Application Number : 103976
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : XOLAIR
Dosage Form : SYRINGE
Dosage Strength : 75MG/0.5ML
Packaging :
Approval Date :
Application Number : 103976
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : XOLAIR
Dosage Form : SYRINGE
Dosage Strength : 150MG/ML
Packaging :
Approval Date :
Application Number : 103976
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : XOLAIR
Dosage Form : SYRINGE
Dosage Strength : 300MG/2ML
Packaging :
Approval Date :
Application Number : 103976
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Xolair
Dosage Form : Solution For Injection
Dosage Strength : 300mg
Packaging :
Approval Date : 06/11/2023
Application Number : 20220729000158
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Xolair
Dosage Form : Solution For Injection
Dosage Strength : 300mg
Packaging :
Approval Date : 06/11/2023
Application Number : 20220729000127
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Xolair
Dosage Form : Solution For Injection
Dosage Strength : 75mg
Packaging :
Approval Date : 06/11/2023
Application Number : 20220729000134
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Xolair
Dosage Form : Solution For Injection
Dosage Strength : 75mg
Packaging :
Approval Date : 10/02/2009
Application Number : 20080312000015
Regulatory Info : Approved
Registration Country : Sweden