Vaccine Information: Ixiaro

IXIARO- japanese encephalitis virus strain sa 14-14-2 antigen (formaldehyde inactivated) injection, suspension
Vetter Pharma Fertigung GmbH & Co. KG

Valneva — Ixiaro, Carton Label

5005511 Ixiaro
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IXIARO
japanese encephalitis vaccine, inactivated, adsorbed injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:62195-051
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) (JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED)) JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) 6 ug in 0.5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62195-051-01 0.5 mL in 1 SYRINGE None
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 Operations
Vetter Pharma Fertigung GmbH & Co. KG (Mooswiesen) 312670654 analysis (62195-051)
Establishment
Name Address ID/FEI Operations
Vetter Pharma Fertigung GmbH & Co. KG (Schuetzenstrasse) 316126754 manufacture (62195-051), analysis (62195-051)
Establishment
Name Address ID/FEI Operations
Vetter Pharma Fertigung GmbH & Co. KG (Helmut-Vetter-Strasse) 341629292 analysis (62195-051)
Establishment
Name Address ID/FEI Operations
Vetter Pharma Fertigung GmbH & Co. KG (Eisenbahnstrasse) 344217323 analysis (62195-051)

Revised: 11/2020 Vetter Pharma Fertigung GmbH & Co. KG

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