Product Details for: Columvi

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
2.5MG/2.5ML (1MG/ML)
Single-Dose Vial
351(a)
Columvi
Rx
002
Injection
Intravenous
10MG/10ML (1MG/ML)
Single-Dose Vial
351(a)
Columvi
Rx
Proper Name
glofitamab-gxbm
BLA Number
761309
Applicant
Genentech, Inc.
Original Approval Date
June 15, 2023
Date of First Licensure