Label: IXIARO- japanese encephalitis vaccine, inactivated, adsorbed injection, suspension

  • NDC Code(s): 62195-051-01, 62195-051-10
  • Packager: Vetter Pharma Fertigung GmbH & Co. KG
  • Category: VACCINE LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated October 25, 2019

If you are a consumer or patient please visit this version.

  • Valneva - Ixiaro, Carton Label

    Ixiaro 0.6ml

  • INGREDIENTS AND APPEARANCE
    IXIARO 
    japanese encephalitis vaccine, inactivated, adsorbed injection, suspension
    Product Information
    Product TypeVACCINEItem Code (Source)NDC:62195-051
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: DZ854I04ZE) (JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:DZ854I04ZE) JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED)6 ug  in 0.5 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62195-051-101 in 1 CARTON
    1NDC:62195-051-010.5 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12528003/30/2009
    Labeler - Vetter Pharma Fertigung GmbH & Co. KG (316126754)
    Registrant - Valneva Scotland (737272380)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vetter Pharma Fertigung GmbH & Co. KG (Mooswiesen)312670654analysis(62195-051) , pack(62195-051) , label(62195-051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vetter Pharma Fertigung GmbH & Co. KG (Schuetzenstrasse)316126754manufacture(62195-051) , analysis(62195-051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vetter Pharma Fertigung GmbH & Co. KG (Helmut-Vetter-Strasse)341629292analysis(62195-051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vetter Pharma Fertigung GmbH & Co. KG (Eisenbahnstrasse)344217323analysis(62195-051)