Label: IXIARO- japanese encephalitis vaccine, inactivated, adsorbed injection, suspension
- NDC Code(s): 62195-051-01
- Packager: Vetter Pharma Fertigung GmbH & Co. KG
- Category: VACCINE LABEL
- DEA Schedule: None
- Marketing Status: Biologic Licensing Application
Drug Label Information
Updated November 24, 2023
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INGREDIENTS AND APPEARANCE
IXIARO
japanese encephalitis vaccine, inactivated, adsorbed injection, suspensionProduct Information Product Type VACCINE Item Code (Source) NDC:62195-051 Route of Administration INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:62195-051-01 0.5 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125280 03/30/2009 Labeler - Vetter Pharma Fertigung GmbH & Co. KG (316126754) Registrant - Valneva Scotland (737272380) Establishment Name Address ID/FEI Business Operations Vetter Pharma Fertigung GmbH & Co. KG (Mooswiesen) 312670654 analysis(62195-051) Establishment Name Address ID/FEI Business Operations Vetter Pharma Fertigung GmbH & Co. KG (Schuetzenstrasse) 316126754 manufacture(62195-051) , analysis(62195-051) Establishment Name Address ID/FEI Business Operations Vetter Pharma Fertigung GmbH & Co. KG (Helmut-Vetter-Strasse) 341629292 analysis(62195-051) Establishment Name Address ID/FEI Business Operations Vetter Pharma Fertigung GmbH & Co. KG (Eisenbahnstrasse) 344217323 analysis(62195-051)
