Influenza A virus vaccine, A-California-7-2009 (H1N1)-like virus / Influenza A virus vaccine, A-Victoria-361-2011 (H3N2)-like virus / Influenza B virus vaccine, B-Brisbane-60-2008-like virus / Influenza B virus vaccine, B-Massachusetts-2-2012-like virus Prefilled Syringe

Brand(s)
Flulaval Quad 2014-2015 Formula
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Id Biomedical Corporation Of Quebec (2015-06-30)
Oldest Current Product
2014-07-01
License(s)
BLA
RxNORM
PREFILLED SYRINGE\INFLUENZA A VIRUS VACCINE, A-CALIFORNIA-7-2009 (H1N1)-LIKE VIRUS:INFLUENZA A VIRUS VACCINE, A-VICTORIA-361-2011 (H3N2)-LIKE VIRUS:INFLUENZA B VIRUS VACCINE, B-BRISBANE-60-2008-LIKE VIRUS:INFLUENZA B VIRUS VACCINE, B-MASSACHUSETTS-2-2012-LIKE VIRUS
SPL Active
INTRAMUSCULAR\SUSPENSION\INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED): INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED): INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (UV, FORMALDEHYDE INACTIVATED): INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (UV, FORMALDEHYDE INACTIVATED)
SPL Moiety
INTRAMUSCULAR\SUSPENSION\INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED): INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED): INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED): INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED)

product(s) by strength(s)

0.5 ml influenza a virus vaccine, a-california-7-2009 (h1n1)-like virus 0.03 mg/ml / influenza a virus vaccine, a-texas-50-2012 x-223a (h3n2), inactivated 0.03 mg/ml / influenza b virus vaccine, b-brisbane-60-2008-like virus 0.03 mg/ml / influenza b virus vaccine, b-massachusetts-2-2012-like virus 0.03 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1195150894Flulaval Quad 2014-2015 FormulaBLAId Biomedical Corporation Of Quebec2014-07-012015-06-30INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (UV, FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (UV, FORMALDEHYDE INACTIVATED)INTRAMUSCULARSUSPENSION125163a9806027-8323-4abf-849f-46fb10984f13

application(s)

#idtitleapprovedfda division
1125163Influenza Virus VaccineFluLaval; FluLaval Quadrivalent Application2006-10-05CBER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
1a9806027-8323-4abf-849f-46fb10984f13 (view SPL)These highlights do not include all the information needed to use FLULAVAL QUADRIVALENT safely and effectively. See full prescribing information for FLULAVAL QUADRIVALENT. FLULAVAL QUADRIVALENT (Influenza Vaccine)Suspension for Intramuscular Injection2015-2016 FormulaInitial U.S. Approval: 2013otherVaccineId Biomedical Corporation Of Quebec2015-06-303195150894, 195150891, 195150898, 195150901Influenza A virus vaccine, A-California-7-2009 (H1N1)-like virus / Influenza A virus vaccine, A-Victoria-361-2011 (H3N2)-like virus / Influenza B virus vaccine, B-Brisbane-60-2008-like virus / Influenza B virus vaccine, B-Massachusetts-2-2012-like virus Injectable Suspension
influenza A virus (H1N1) antigen / influenza A virus (H3N2) antigen / influenza B virus antigen Prefilled Syringe
influenza A virus (H1N1) antigen / influenza A virus (H3N2) antigen / influenza B virus antigen Injectable Suspension

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