Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. Human normal immunoglobulin contains the IgG antibodies present in the normal population. It is usually prepared from pooled plasma from not fewer than 1000 donors.
This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:
| ATC code | Group title | Classification |
|---|---|---|
| J06BA | Immunoglobulins, normal human | J Antiinfectives for systemic use → J06 Immune sera and immunoglobulins → J06B Immunoglobulins |
Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):
| Title | Information Source | Document Type | |
|---|---|---|---|
| GAMASTAN Solution for injection | FDA, National Drug Code (US) | MPI, US: SPL/PLR | |
| CUTAQUIG Solution for infusion | FDA, National Drug Code (US) | MPI, US: SPL/PLR | |
| HIZENTRA Solution for injection | European Medicines Agency (EU) | MPI, EU: SmPC |
Human normal immunoglobulin G is an active ingredient of these brands:
United States (US)Austria (AT)Israel (IL)Japan (JP)
South Africa (ZA)Spain (ES)Tunisia (TN)Note the following: The list of brand names is continuously updated, and thus does not include the total of products circulating worldwide. |
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