influenza A virus (H1N1) antigen / influenza A virus (H3N2) antigen / influenza B virus antigen Nasal Spray

Brand(s)
Flumist 2015-2016
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Medimmune, Llc (2015-08-20)
Oldest Current Product
2015-08-14
License(s)
BLA
RxNORM
NASAL SPRAY\INFLUENZA A VIRUS (H1N1) ANTIGEN:INFLUENZA A VIRUS (H3N2) ANTIGEN:INFLUENZA B VIRUS ANTIGEN
SPL Active
NASAL\SPRAY\INFLUENZA A VIRUS A/BOLIVIA/559/2013 (H1N1) LIVE (ATTENUATED) ANTIGEN: INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 (H3N2) LIVE (ATTENUATED) ANTIGEN: INFLUENZA B VIRUS B/BRISBANE/60/2008 LIVE (ATTENUATED) ANTIGEN: INFLUENZA B VIRUS B/PHUKET/3073/2013 LIVE (ATTENUATED) ANTIGEN
SPL Moiety
NASAL\SPRAY\INFLUENZA A VIRUS A/BOLIVIA/559/2013 (H1N1) LIVE (ATTENUATED) ANTIGEN: INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 (H3N2) LIVE (ATTENUATED) ANTIGEN: INFLUENZA B VIRUS B/BRISBANE/60/2008 LIVE (ATTENUATED) ANTIGEN: INFLUENZA B VIRUS B/PHUKET/3073/2013 LIVE (ATTENUATED) ANTIGEN

product(s) by strength(s)

influenza a virus a/bolivia/559/2013 (h1n1) antigen 50000000 mg/ml / influenza a virus a/switzerland/9715293/2013 (h3n2) antigen 50000000 mg/ml / influenza b virus b/brisbane/60/2008 antigen 50000000 mg/ml / influenza b virus b/phuket/3073/2013 antigen 50000000 mg/ml nasal spray

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1660190302Flumist 2015-2016BLAMedimmune, Llc2015-08-142016-06-30INFLUENZA A VIRUS A/BOLIVIA/559/2013 (H1N1) LIVE (ATTENUATED) ANTIGEN, INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 (H3N2) LIVE (ATTENUATED) ANTIGEN, INFLUENZA B VIRUS B/BRISBANE/60/2008 LIVE (ATTENUATED) ANTIGEN, INFLUENZA B VIRUS B/PHUKET/3073/2013 LIVE (ATTENUATED) ANTIGENNASALSPRAY12502064f300d3-e1ba-40bc-a25f-4203ffdb27cf

application(s)

#idtitleapprovedfda division
1125020Influenza Vaccine Live IntranasalFluMist FluMist Quad Application2003-06-17CBER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
164f300d3-e1ba-40bc-a25f-4203ffdb27cf (view SPL)These highlights do not include all the information needed to use FLUMIST QUADRIVALENT safely and effectively. See full prescribing information for FluMist Quadrivalent. FluMist Quadrivalent(Influenza Vaccine Live, Intranasal) Intranasal Spray 2015-2016 Formula Initial U.S. Approval: 2003otherVaccineMedimmune, Llc2015-08-2027660190302

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