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Purple Book
Database of Licensed Biological Products

Product Details for: Berinert
Product Label Grayed out Product Label links indicate that there is no product label available for the product.

Product NumberDosage FormRoute of AdministrationStrengthProduct PresentationLicense TypeProprietary NameMarketing Status
001For InjectionIntravenous500USingle-Dose Vial351(a)BerinertRx

Proper Name
C1 Esterase Inhibitor (Human)

BLA Number
125287

Applicant
CSL Behring GmbH

Original Approval Date
October 9, 2009

Date of First Licensure