U.S. flag

An official website of the United States government

Purple Book
Database of Licensed Biological Products

Product Details for: Ruconest
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 InjectionIntravenous2100IUSingle-Dose Vial351(a)RuconestRx

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