factor IX / factor VII / factor X / Protein C / Protein S / Prothrombin Injection

Brand(s)
Kcentra
Category(s)
other
SPL Type(s)
Plasma Derivative
Master SPL
Csl Behring Gmbh (2014-09-01)
Oldest Current Product
2013-04-29
License(s)
BLA
RxNORM
INJECTION\FACTOR IX:FACTOR VII:FACTOR X:PROTEIN C:PROTEIN S:PROTHROMBIN

product(s) by strength(s)

factor ix, human 1 unt / factor vii, human 1 unt / factor x, human 1 unt / protein c, human 1 unt / protein s, human 1 unt / prothrombin, human 1 unt injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1638330386KcentraBLACsl Behring Gmbh2013-04-29125421eee1afb8-324c-42e4-8bf0-f0c9da5e6d42

application(s)

#idtitleapprovedtradenamesfda division
1125421Prothrombin Complex Concentrate (Human) Application2013-04-29KcentraCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1eee1afb8-324c-42e4-8bf0-f0c9da5e6d42 (view SPL)These highlights do not include all the information needed to use KCENTRA safely and effectively. See full prescribing information for KCENTRA. KCENTRA (Prothrombin Complex Concentrate (Human)) For Intravenous Use, Lyophilized Powder for Reconstitution Initial U.S. Approval: 2013otherPlasma DerivativeCsl Behring GmbhMANUFACTURE2014-09-016638330386, 638330387

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