Product Details for: Carvykti

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
0.5 to 1.0x10^6 chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight, with a maximum dose of 1x10^8 CAR-positive viable T cells in one infusion
Bag
351(a)
Carvykti
Rx
Proper Name
ciltacabtagene autoleucel
BLA Number
125746
Applicant
Janssen Biotech, Inc.
Original Approval Date
February 28, 2022
Date of First Licensure
02/28/2022
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