Product Details for: Berinert Product Label Grayed out Product Label links indicate that there is no product label available for the product.
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 | For Injection | Intravenous | 500U | Single-Dose Vial | 351(a) | Berinert | Rx |
Proper Name
C1 Esterase Inhibitor (Human)
BLA Number
125287
Applicant
CSL Behring GmbH
Original Approval Date
October 9, 2009
Date of First Licensure