Product Details for: Hemgenix

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
1X10E13GENOME COPIES/ML
Single-Dose Vial
351(a)
Hemgenix
Rx
Proper Name
etranacogene dezaparvovec-drlb
BLA Number
125772
Applicant
CSL Behring LLC
Original Approval Date
November 22, 2022
Date of First Licensure
11/22/2022
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