EN PL

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