Haemophilus influenzae type b, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine / meningococcal group C polysaccharide / MENINGOCOCCAL POLYSACCHARIDE VACCINE GROUP Y Injection

Brand(s)
MenHibrix
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Glaxosmithkline Biologicals Sa (2013-11-27)
Oldest Current Product
2013-09-03
License(s)
BLA
RxNORM
INJECTION\HAEMOPHILUS INFLUENZAE TYPE B, CAPSULAR POLYSACCHARIDE INACTIVATED TETANUS TOXOID CONJUGATE VACCINE:MENINGOCOCCAL GROUP C POLYSACCHARIDE:MENINGOCOCCAL POLYSACCHARIDE VACCINE GROUP Y
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN: NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE ANTIGEN: NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE ANTIGEN
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN: NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE ANTIGEN: NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE ANTIGEN

product(s) by strength(s)

0.5 ml haemophilus influenzae type b strain 1482, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.005 mg/ml / meningococcal group c polysaccharide 0.01 mg/ml / meningococcal polysaccharide vaccine group y 0.01 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1581600809MenHibrixBLAGlaxosmithkline Biologicals Sa2013-09-03HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE ANTIGEN, NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE ANTIGENINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION125363be1e867a-51d2-4e07-bea3-6096221eec48

application(s)

#idtitleapprovedtradenamesfda division
1125363Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine Application2012-06-14MENHIBRIXCBER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1be1e867a-51d2-4e07-bea3-6096221eec48 (view SPL)These highlights do not include all the information needed to use MENHIBRIX safely and effectively. See full prescribing information for MENHIBRIX.MENHIBRIX (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine)Solution for Intramuscular InjectionInitial U.S. Approval: 2012otherVaccineGlaxosmithkline Biologicals Sa2013-11-275581600809

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