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-Wisconsin-1-2010-like virus Injectable Solution

Brand(s)
Flublok 2012-2013 Formula
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Protein Sciences Corporation (2013-01-25)
Oldest Current Product
2013-02-01
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-WISCONSIN-1-2010-LIKE VIRUS
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN: INFLUENZA A VIRUS A/VICTORIA/361/2011 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN: INFLUENZA B VIRUS B/WISCONSIN/1/2010 RECOMBINANT HEMAGGLUTININ ANTIGEN
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN: INFLUENZA A VIRUS A/VICTORIA/361/2011 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN: INFLUENZA B VIRUS B/WISCONSIN/1/2010 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-wisconsin-1-2010-like virus 0.09 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1428740012Flublok 2012-2013 FormulaBLAProtein Sciences Corporation2013-02-01INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/VICTORIA/361/2011 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA B VIRUS B/WISCONSIN/1/2010 RECOMBINANT HEMAGGLUTININ ANTIGENINTRAMUSCULARINJECTION, SOLUTION125285e8aa934c-d74e-4c7c-b2fc-d3b8b46f4529

application(s)

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

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1e8aa934c-d74e-4c7c-b2fc-d3b8b46f4529 (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 2012-2013 FormulaInitial U.S. Approval: 2013otherVaccineProtein Sciences CorporationANALYSIS, MANUFACTURE2013-01-251428740012

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