influenza A virus (H1N1) antigen / influenza A virus (H3N2) antigen / influenza B virus antigen Injection

Brand(s)
Flublok 2015-2016
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Protein Sciences Corporation (2015-11-16)
Oldest Current Product
2015-08-07
License(s)
BLA
RxNORM
INJECTION\INFLUENZA A VIRUS (H1N1) ANTIGEN:INFLUENZA A VIRUS (H3N2) ANTIGEN:INFLUENZA B VIRUS ANTIGEN
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN: INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN: INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN: INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN: INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN

product(s) by strength(s)

0.5 ml influenza a virus a/california/7/2009 (h1n1) antigen 0.09 mg/ml / influenza a virus a/switzerland/9715293/2013 (h3n2) antigen 0.09 mg/ml / influenza b virus b/phuket/3073/2013 antigen 0.09 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1428740015Flublok 2015-2016BLAProtein Sciences Corporation2015-08-07INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGENINTRAMUSCULARINJECTION, SOLUTION125285e1a6acc7-47a5-4515-91a1-e291264ccaf0

application(s)

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

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1e1a6acc7-47a5-4515-91a1-e291264ccaf0 (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 Injection2015-2016 FormulaInitial U.S. Approval: 2013otherVaccineProtein Sciences CorporationANALYSIS, API MANUFACTURE, MANUFACTURE2015-11-162428740015

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