coagulation factor IX recombinant immunoglobulin G1 fusion protein Injection

Brand(s)
Alprolix
Category(s)
other
SPL Type(s)
Plasma Derivative
Master SPL
Biogen Idec Inc. (2014-03-31)
Oldest Current Product
2014-05-05
License(s)
BLA
RxNORM
INJECTION\COAGULATION FACTOR IX RECOMBINANT IMMUNOGLOBULIN G1 FUSION PROTEIN

product(s) by strength(s)

coagulation factor ix recombinant immunoglobulin g1 fusion protein 1 unt injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1644060922AlprolixBLABiogen Idec Inc.2014-05-051254441ae6e28d-7133-4c36-c949-4fdc82f210e9
2644060944AlprolixBLABiogen Idec Inc.2014-05-051254441ae6e28d-7133-4c36-c949-4fdc82f210e9

application(s)

#idtitleapprovedtradenamesfda division
1125444Coagulation Factor IX (Recombinant) Fc Fusion Protein Application2014-03-28ALPROLIXCBER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
11ae6e28d-7133-4c36-c949-4fdc82f210e9 (view SPL)These highlights do not include all the information needed to use ALPROLIX safely and effectively. See full prescribing information for ALPROLIXALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], Lyophilized Powder for Solution For Intravenous Injection.Initial U.S. Approval: [2014]otherPlasma DerivativeBiogen Idec Inc.2014-03-314644060922, 644060944, 644060911, 644060933

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