Product Details for: Ruconest 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 | 2100IU | Single-Dose Vial | 351(a) | Ruconest | Rx |
Proper Name
C1 Esterase Inhibitor (Recombinant)
BLA Number
125495
Applicant
Pharming Americas BV
Original Approval Date
July 16, 2014
Date of First Licensure
July 16, 2014