C1 esterase inhibitor Injectable Solution

Brand(s)
Berinert, Cinryze, Ruconest
Category(s)
other, prescription
SPL Type(s)
Human Prescription, Plasma Derivative
Master SPL
Csl Behring Gmbh (2015-09-14)
Oldest Current Product
2008-12-01
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\C1 ESTERASE INHIBITOR
SPL Active
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CONESTAT ALFA
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HUMAN C1-ESTERASE INHIBITOR
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CONESTAT ALFA
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HUMAN C1-ESTERASE INHIBITOR

product(s) by strength(s)

c1 esterase inhibitor (human) 100 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1422270081CinryzeBLAViropharma Biologics2008-12-01HUMAN C1-ESTERASE INHIBITORINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION125267d53a911f-070d-498a-8a61-baab72b9d0fe

c1 esterase inhibitor (human) 50 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1638330825BerinertBLACsl Behring Gmbh2011-12-221252878ea0c7fe-da9d-4218-a080-0509e09bedc6

c1 esterase inhibitor (recombinant) 150 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1680120350RuconestBLASantarus, Inc.2014-09-22CONESTAT ALFAINTRAVENOUSINJECTION, POWDER, FOR SOLUTION1254956f8b81df-48fe-4798-8d54-fc8f65888489

application(s)

#idtitleapprovedtradenamesfda division
1125267C1 Esterase Inhibitor (Human) Application2008-10-10CinryzeCBER
2125287C1 Esterase Inhibitor (Human) Application2009-10-09BerinertCBER
3125495C1 Esterase Inhibitor (Recombinant) Application2014-07-16RUCONESTCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
16f8b81df-48fe-4798-8d54-fc8f65888489 (view SPL)These highlights do not include all the information needed to use RUCONEST safely and effectively. See full prescribing information for RUCONEST. RUCONEST (C1 esterase inhibitor [recombinant])For Intravenous Use, Lyophilized Powder For Reconstitution Initial U.S. Approval: 2014prescriptionHuman PrescriptionSantarus, Inc.API MANUFACTURE2014-12-1012680120350
28ea0c7fe-da9d-4218-a080-0509e09bedc6 (view SPL)These highlights do not include all the information needed to use Berinert safely and effectively. See full prescribing information for Berinert. Berinert [C1 Esterase Inhibitor (Human)] For intravenous use. Freeze-Dried Powder for Reconstitution. Initial U.S. Approval: 2009otherPlasma DerivativeCsl Behring GmbhMANUFACTURE2015-09-1420638330825
3d53a911f-070d-498a-8a61-baab72b9d0fe (view SPL)These highlights do not include all the information needed to use CINRYZE safely and effectively. See full prescribing information for CINRYZE. CINRYZE (C1 Esterase Inhibitor [Human]) For Intravenous Use, Freeze-Dried Powder for ReconstitutionInitial U.S. Approval: 2008otherPlasma DerivativeViropharma BiologicsANALYSIS, LABEL, MANUFACTURE, PACK2014-11-1323422270081

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII