eculizumab Injection

Brand(s)
Soliris
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Alexion Pharmaceuticals Inc. (2014-04-01)
Oldest Current Product
2007-04-02
License(s)
BLA
RxNORM
INJECTION\ECULIZUMAB
SPL Active
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\ECULIZUMAB
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\ECULIZUMAB

product(s) by strength(s)

30 ml eculizumab 10 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1256820001SolirisBLAAlexion Pharmaceuticals Inc.2007-04-02ECULIZUMABINTRAVENOUSINJECTION, SOLUTION, CONCENTRATE125166ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722

application(s)

#idtitleapprovedtradenamesfda division
1125166eculizumab Application2007-03-16SolirisCDER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722 (view SPL)These highlights do not include all the information needed to use SOLIRIS safely and effectively. See full prescribing information for SOLIRIS. Soliris (eculizumab) Concentrated solution for intravenous infusion Initial U.S. Approval: 2007prescriptionHuman PrescriptionAlexion Pharmaceuticals Inc.2014-04-0120256820001

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