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-Massachusetts-2-2012-like virus Injectable Solution

Brand(s)
Flublok 2013-2014 Formula, Flublok 2014-2015 Formula
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Protein Sciences Corporation (2014-11-21)
Oldest Current Product
2014-09-15
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\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-MASSACHUSETTS-2-2012-LIKE VIRUS
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN: INFLUENZA A VIRUS A/TEXAS/50/2012 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN: INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 RECOMBINANT HEMAGGLUTININ ANTIGEN
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN: INFLUENZA A VIRUS A/TEXAS/50/2012 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN: INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 RECOMBINANT HEMAGGLUTININ ANTIGEN

product(s) by strength(s)

influenza a virus vaccine, a-california-7-2009 (h1n1)-like virus 0.09 mg/ml / influenza a virus vaccine, a-victoria-361-2011 (h3n2)-like virus 0.09 mg/ml / influenza b virus vaccine, b-massachusetts-2-2012-like virus 0.09 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1428740014Flublok 2014-2015 FormulaBLAProtein Sciences Corporation2014-09-15INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/TEXAS/50/2012 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 RECOMBINANT HEMAGGLUTININ ANTIGENINTRAMUSCULARINJECTION, SOLUTION125285c94cbe57-4a3a-4a3e-8bb8-2f07e936848e

application(s)

#idtitleapprovedfda division
1125285Influenza VaccineFluBlok Application2013-01-16CBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1c94cbe57-4a3a-4a3e-8bb8-2f07e936848e (view SPL)These highlights do not include all the information needed to use Flublok safely and effectively. See full prescribing information for Flublok. Flublok (Influenza Vaccine)Sterile Solution for Intramuscular Injection2014-2015 FormulaInitial U.S. Approval: 2013otherVaccineProtein Sciences CorporationANALYSIS, MANUFACTURE2014-11-212428740014
2fb2aad7e-82d2-47c0-9eb3-08ac62641a47 (view SPL)These highlights do not include all the information needed to use Flublok safely and effectively. See full prescribing information for Flublok. Flublok (Influenza Vaccine) Sterile Solution for Intramuscular Injection 2013-2014 FormulaInitial U.S. Approval: 2013otherVaccineProtein Sciences CorporationANALYSIS, MANUFACTURE2013-10-241428740013

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