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Berinert
C1 Esterase Inhibitor (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Berinert
Proper name
C1 Esterase Inhibitor (Human)
Licence type
351(a)
BLA number
125287
Applicant
CSL Behring GmbH
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 500U | For Injection | Intravenous | Single-Dose Vial | Rx | October 9, 2009 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | October 8, 2016 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |