EMA: Scientific guideline: Concept paper on revision of: Note for Guidance on the Clinical investigation of human normal immunoglobulin for subcutaneous and intramuscular use (CPMP/BPWG/283/00), draft
19.12.2010
Subcutaneous and intramuscular immunoglobulin (SCIg/IMIg) products are prepared from pooled
human plasma from not fewer than 1000 donations and contain mainly immunoglobulin G (IgG) with a
broad spectrum of antibodies against infectious agents that is representative of the immunoglobulin
range of the normal population. They have a distribution of immunoglobulin G subclasses closely
proportional to that in native human plasma. Adequate doses of this medicinal product may restore
abnormally low immunoglobulin G levels to the normal range
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