Product Details for: Bimzelx

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
160MG/ML
Pre-Filled Syringe
351(a)
Bimzelx
Rx
002
Injection
Subcutaneous
160MG/ML
Autoinjector
351(a)
Bimzelx
Rx
003
Injection
Subcutaneous
320MG/2ML (160MG/2ML)
Pre-Filled Syringe
351(a)
Bimzelx
Rx
004
Injection
Subcutaneous
320MG/2ML (160MG/2ML)
Autoinjector
351(a)
Bimzelx
Rx
Proper Name
bimekizumab-bkzx
BLA Number
761151
Applicant
UCB, Inc.
Original Approval Date
October 17, 2023
Date of First Licensure
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