CNJ-016
These highlights do not include all the information needed to use (vaccinia immune globulin intravenous, human), VIGIV safely and effectively. See full prescribing information for VIGIV. VIGIV (vaccinia immune globulin, human), 5% sterile solution for intravenous use.Initial U.S. Approval: 2005
Approved
Approval ID
a4f9f620-e6e4-4a03-a9a7-79007c8c2cfe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 17, 2019
Manufacturers
FDA
Emergent BioSolutions Canada Inc.
DUNS: 203508049
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Vaccinia Immune Globulin (Human)
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60492-0173
Application NumberBLA125109
Product Classification
M
Marketing Category
C73585
G
Generic Name
Vaccinia Immune Globulin (Human)
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 17, 2019
FDA Product Classification
INGREDIENTS (3)
HUMAN VACCINIA VIRUS IMMUNE GLOBULINActive
Quantity: 1 [iU] in 1 mL
Code: 7UB4J759TD
Classification: ACTIB
MALTOSE, UNSPECIFIED FORMInactive
Code: XJ6S9RV06F
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT