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01 2CELLTRION INC.
02 2Celltrion
03 4Genentech
04 28Novartis Pharmaceuticals Australia Pty Limited
05 13Novartis Pharmaceuticals Corporation
06 1Novartis South Africa (Pty) Ltd
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01 1INJ
02 2INJECTABLE;INJECTION
03 2Inj L?s
04 1POWDER FOR SOLUTION
05 6SOLUTION
06 3SYRINGE
07 4Solution for injection
08 1Solution for injection in a pre-filled pen
09 1Trockensub
10 1VIAL
11 28Blank
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01 1Originator
02 49Blank
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01 4OMLYCLO
02 9XOLAIR
03 1XOLAIR 150mg
04 36Xolair
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01 28Australia
02 7Canada
03 5Norway
04 1South Africa
05 3Switzerland
06 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 :
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 :
Registration Country : Switzerland
Brand Name : Xolair
Dosage Form : Trockensub
Dosage Strength : 150mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Xolair
Dosage Form : Inj L?s
Dosage Strength : 150mg/1ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Xolair
Dosage Form : Inj L?s
Dosage Strength : 75mg/0.5ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Canada
Brand Name : XOLAIR
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 150MG/VIAL
Packaging : 1.2ML
Approval Date :
Application Number : 2260565
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : XOLAIR
Dosage Form : SOLUTION
Dosage Strength : 75MG/0.5ML
Packaging : 0.5ML
Approval Date :
Application Number : 2459787
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : XOLAIR
Dosage Form : SOLUTION
Dosage Strength : 150MG/1ML
Packaging :
Approval Date :
Application Number : 2459795
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : XOLAIR
Dosage Form : SOLUTION
Dosage Strength : 75MG/0.5ML
Packaging :
Approval Date :
Application Number : 2545136
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : XOLAIR
Dosage Form : SOLUTION
Dosage Strength : 150MG/1ML
Packaging :
Approval Date :
Application Number : 2545144
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : OMLYCLO
Dosage Form : SOLUTION
Dosage Strength : 75MG/0.5ML
Packaging :
Approval Date :
Application Number : 2553805
Regulatory Info :
Registration Country : Canada
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