Product Details for: tregzi

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Solution
Intravenous
>=1.0 10^6HSPC CELLS,0.9-3.510^6 TREG CELLS,0.9-6.910^6 TCON CELLS /PATIENT KG
Bag
351(a)
tregzi
Rx
Proper Name
allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq
BLA Number
125868
Applicant
Orca Biosystems Inc.
Original Approval Date
June 30, 2026
Date of First Licensure
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