Immune Globulin (Human) – immune globulin, intramuscular (IGIM)
Status: approved in U.S., not actively marketed
Organizations involved:
Massachusetts Biological Laboratories – Manuf.; Tech.; USA mark.
State of Massachusetts – Parent
Description: Immune Globulin Intravenous (Human) is a formulation of immune globulin obtained from fractionated pooled Plasma intended for intramuscular injection.
Nomenclature: Immune Globulin (IGIM)/Mass. [BIO]; Immune Globulin (Human) [FDA]; Immune Serum Globulin [FDA former]; gamma globulin [SY]; IGIM [SY]; intramuscular immune globulin (IMIG) [SY]; immune serum globulin [SY]
Companies.: Approval for manufacture is held by the Massachusetts Biological Laboratories, affiliated with the State of Massachusetts.
Approvals: Date = 19430908; first approval
Indications: product insert/labeling not available
Status: This product is approved, but it is not commercially marketed. It is likely sold to other companies for further processing (e.g., for manufacture of IGIV; and/or used within the State of Massachusetts).
Companies involvement:
Full monograph
757 Immune Globulin (IGIM)/Mass.
Nomenclature:
Immune Globulin (IGIM)/Mass. [BIO]
Immune Globulin (Human) [FDA]
Immune Serum Globulin [FDA former]
gamma globulin [SY]
IGIM [SY]
immune globulin, intramuscular [SY]
intramuscular immune globulin (IMIG) [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1943
Date of 1st FDA approval = 19430908
(in format YYYYMMDD)
Index Terms:
antibodies (see also immune globulins; monoclonal antibodies)
biopharmaceutical products
blood products
human materials used<!-- humansource -->
immune globulins, human <!-- immunoglobulins -->
Plasma (Human)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
North American coral snake
North American coral snake
EU000 Not yet/Never filed with EU
UM999 Not Available/Not Marketed in US
US200 Currently Approved in US
EM999 Not Available/Not Marketed in EU
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