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Haegarda
C1 Esterase Inhibitor Subcutaneous (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Haegarda
Proper name
C1 Esterase Inhibitor Subcutaneous (Human)
Licence type
351(a)
BLA number
125606
Applicant
CSL Behring GmbH
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 2000IU | For Injection | Subcutaneous | Single-Dose Vial | Rx | June 22, 2017 |
| 3000IU | For Injection | Subcutaneous | Single-Dose Vial | Rx | June 22, 2017 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | June 22, 2024 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |