Product Details for: Kymriah
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
0.6 to 6.0 x 10^8 CAR-POSITIVE VIABLE T CELLS
Bag
351(a)
Kymriah
Rx
Proper Name
tisagenlecleucel
tisagenlecleucel
BLA Number
125646
125646
Applicant
Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals Corporation
Original Approval Date
August 30, 2017
August 30, 2017
Date of First Licensure