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Jivi

Antihemophilic factor (recombinant), PEGylated-aucl

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Jivi
Proper name
Antihemophilic factor (recombinant), PEGylated-aucl
Licence type
351(a)
BLA number
125661
Applicant
Bayer HealthCare LLC
Center
CBER
Presentations
5
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
1000IU For Injection Intravenous Single-Dose Vial Rx August 29, 2018
2000IU For Injection Intravenous Single-Dose Vial Rx August 29, 2018
3000IU For Injection Intravenous Single-Dose Vial Rx August 29, 2018
4000IU For Injection Intravenous Single-Dose Vial Rx December 2, 2024
500IU For Injection Intravenous Single-Dose Vial Rx August 29, 2018

Sources for this page

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