ELOSULFASE ALFA Injectable Solution

Brand(s)
Vimizim
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Biomarin Pharmaceutical Inc. (2014-02-24)
Oldest Current Product
2014-02-14
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\ELOSULFASE ALFA
SPL Active
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\ELOSULFASE ALFA
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\ELOSULFASE ALFA

product(s) by strength(s)

elosulfase alfa 1 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1681350100VimizimBLABiomarin Pharmaceutical Inc.2014-02-14ELOSULFASE ALFAINTRAVENOUSINJECTION, SOLUTION, CONCENTRATE1254600caa2565-12b2-0ad0-1f9a-273e81c3d4cc

application(s)

#idtitleapprovedtradenamesfda division
1125460elosulfase alfa Application2014-02-14VimizimCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10caa2565-12b2-0ad0-1f9a-273e81c3d4cc (view SPL)These highlights do not include all the information needed to use VIMIZIM safely and effectively. See full prescribing information for VIMIZIM . VIMIZIM (elosulfase alfa) injection, for intravenous use Initial U.S. Approval: 2014prescriptionHuman PrescriptionBiomarin Pharmaceutical Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-02-248681350100

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