Country: United States
Language: English
Source: NLM (National Library of Medicine)
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)
Vetter Pharma Fertigung GmbH & Co. KG
JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN - UNII:DZ854I04ZE)
JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) 6 ug in 0.5 mL
INTRAMUSCULAR
Biologic Licensing Application
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 Read the complete document