meningococcal group B vaccine Prefilled Syringe

Brand(s)
Bexsero, Trumenba
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Novartis Vaccines And Diagnostics S.R.L. (2015-01-23)
Oldest Current Product
2014-11-05
License(s)
BLA
RxNORM
PREFILLED SYRINGE\MENINGOCOCCAL GROUP B VACCINE
SPL Active
INTRAMUSCULAR\INJECTION, SUSPENSION\NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN: NEISSERIA MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGEN: NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN: NEISSERIA MENINGITIDIS SEROGROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE
INTRAMUSCULAR\INJECTION, SUSPENSION\NEISSERIA MENINGITIDIS SEROGROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN: NEISSERIA MENINGITIDIS SEROGROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN
SPL Moiety
INTRAMUSCULAR\INJECTION, SUSPENSION\NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN: NEISSERIA MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGEN: NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN: NEISSERIA MENINGITIDIS SEROGROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE
INTRAMUSCULAR\INJECTION, SUSPENSION\NEISSERIA MENINGITIDIS SEROGROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN: NEISSERIA MENINGITIDIS SEROGROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN

product(s) by strength(s)

0.5 ml neisseria meningitidis serogroup b recombinant lp2086 a05 protein variant antigen 0.12 mg/ml / neisseria meningitidis serogroup b recombinant lp2086 b01 protein variant antigen 0.12 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000050100TrumenbaBLAWyeth Pharmaceutical Division Of Wyeth Holdings Corporation, A Subsidiary Of Pfizer Inc.2014-11-05NEISSERIA MENINGITIDIS SEROGROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN, NEISSERIA MENINGITIDIS SEROGROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGENINTRAMUSCULARINJECTION, SUSPENSION125549bcaf5f75-caaf-41fd-875b-5800310070d1

0.5 ml meningococcal group b vaccine 0.1 mg/ml / neisseria meningitidis serogroup b recombinant fhbp fusion protein antigen 0.1 mg/ml / neisseria meningitidis serogroup b recombinant nhba fusion protein antigen 0.1 mg/ml / neisseria meningitidis serogroup b strain nz98/254 outer membrane vesicle 0.05 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1460280114BexseroBLANovartis Vaccines And Diagnostics S.R.L.2015-01-23NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN, NEISSERIA MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGEN, NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN, NEISSERIA MENINGITIDIS SEROGROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLEINTRAMUSCULARINJECTION, SUSPENSION125546380611a7-f7b6-404f-a217-a23940f8bd4a

application(s)

#idtitleapprovedtradenamesfda division
1125546Meningococcal Group B Vaccine Application2015-01-23BEXSEROCBER
2125549Meningococcal Group B Vaccine Application2014-10-29TRUMENBACBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1380611a7-f7b6-404f-a217-a23940f8bd4a (view SPL)These highlights do not include all the information needed to use BEXSERO safely and effectively. See full prescribing information for BEXSERO.BEXSERO (Meningococcal Group B Vaccine)Suspension for intramuscular injectionInitial U.S. Approval: 2015otherVaccineNovartis Vaccines And Diagnostics S.R.L.LABEL, MANUFACTURE, PACK2015-01-234460280114
2bcaf5f75-caaf-41fd-875b-5800310070d1 (view SPL)These highlights do not include all the information needed to use TRUMENBA safely and effectively. See full prescribing information for TRUMENBA. TRUMENBA (Meningococcal Group B Vaccine)Suspension for intramuscular injectionInitial U.S. Approval: 2014otherVaccineWyeth Pharmaceutical Division Of Wyeth Holdings Corporation, A Subsidiary Of Pfizer Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-12-163000050100

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