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Kymriah

tisagenlecleucel

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Kymriah

Proper name

tisagenlecleucel

Licence type

351(a)

BLA number

125646

Applicant

Novartis Pharmaceuticals Corporation

Center

CBER

Presentations

1

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
0.6 to 6.0 x 10^8 CAR-POSITIVE VIABLE T CELLS	Injection	Intravenous	Bag	Rx	August 30, 2017

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	November 27, 2029

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity