Product Details for: OMISIRGE

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
>4.0x10^8 total viable cells, >2.4x10^7 CD3+ cells with 41mL dil sol; >8.0x10^8 total viable cells, >8.7% CD34+ cells, >9.2x10^7 CD34+ cells with 81mL dil so
Bag
351(a)
OMISIRGE
Rx
Proper Name
omidubicel-onlv
BLA Number
125738
Applicant
Gamida Cell Ltd.
Original Approval Date
April 17, 2023
Date of First Licensure
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