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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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)

Available from:

Vetter Pharma Fertigung GmbH & Co. KG

INN (International Name):

JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN - UNII:DZ854I04ZE)

Composition:

JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) 6 ug in 0.5 mL

Administration route:

INTRAMUSCULAR

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

IXIARO- JAPANESE ENCEPHALITIS VACCINE, INACTIVATED, ADSORBED
INJECTION,
SUSPENSION
VETTER PHARMA FERTIGUNG GMBH & CO. KG
----------
IXIARO
VALNEVA - IXIARO, CARTON LABEL
IXIARO
japanese encephalitis vaccine, inactivated, adsorbed injection,
suspension
PRODUCT 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
JAPANESE ENCEPHALITIS
Vetter Pharma Fertigung GmbH & Co. KG
(FORMALDEHYDE INACTIVATED) (UNII: DZ854I04ZE) (JAPANESE
ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE
INACTIVATED) - UNII:DZ854I04ZE)
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
analys is (62195-051)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Vetter Pharma Fertigung GmbH & Co. KG
(Schuetzens tras s e)
316126754
manufacture(62195-051) ,
analys is (62195-051)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Vetter Pharma Fertigung GmbH & Co. KG (Helmut-Vetter-Strasse)
341629292 analys is (62195-051)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Vetter Pharma Fertigung GmbH & Co. KG (Eisenbahnstrasse)
344217323
analys is (62195-051)
Revised: 11/2023