Product Details for: Hemlibra

RETURN TO SEARCH RESULTS
PRODUCT LABEL Grayed out Product Label links indicate that there is no product label available for the product.
Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
30MG/ML
Single-Dose Vial
351(a)
Hemlibra
Rx
002
Injection
Subcutaneous
60MG/0.4ML
Single-Dose Vial
351(a)
Hemlibra
Rx
003
Injection
Subcutaneous
105MG/0.7ML
Single-Dose Vial
351(a)
Hemlibra
Rx
004
Injection
Subcutaneous
150MG/ML
Single-Dose Vial
351(a)
Hemlibra
Rx
005
Injection
Subcutaneous
300MG/2ML (150MG/ML)
Single-Dose Vial
351(a)
Hemlibra
Rx
006
Injection
Subcutaneous
12MG/0.4ML
Single-Dose Vial
351(a)
Hemlibra
Rx
Proper Name
emicizumab-kxwh
BLA Number
761083
Applicant
Genentech, Inc.
Original Approval Date
November 16, 2017
Date of First Licensure
RETURN TO SEARCH RESULTS