fibrinogen concentrate (human) / Thrombin Topical Powder

Brand(s)
Raplixa
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Profibrix Bv (2015-06-23)
Oldest Current Product
2015-06-22
License(s)
BLA
RxNORM
TOPICAL POWDER\FIBRINOGEN CONCENTRATE (HUMAN):THROMBIN
SPL Active
TOPICAL\POWDER\FIBRINOGEN HUMAN: HUMAN THROMBIN
SPL Moiety
TOPICAL\POWDER\FIBRINOGEN HUMAN: HUMAN THROMBIN

product(s) by strength(s)

fibrinogen concentrate (human) 0.079 mg/mg / thrombin (human) 0.699 unt/mg topical powder

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1622380008RaplixaBLAProfibrix Bv2015-06-22FIBRINOGEN HUMAN, HUMAN THROMBINTOPICALPOWDER125523a3f81c31-8214-11e3-baa7-0800200c9a66

application(s)

#idtitleapprovedtradenamesfda division
1125523Fibrin Sealant (Human) Application2015-04-30RAPLIXACBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a3f81c31-8214-11e3-baa7-0800200c9a66 (view SPL)These highlights do not include all the information needed to use RAPLIXA safely and effectively. See full prescribing information for RAPLIXA. RAPLIXA (Fibrin Sealant (Human)) Powder for topical use only Initial U.S. Approval: 2015prescriptionHuman PrescriptionProfibrix BvANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-06-232622380008

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