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EMA: Scientific guideline: Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)

04.08.2010
This Guideline describes the information to be documented when an application is made for a marketing authorisation for a human normal immunoglobulin for intravenous use (IVIg). The guidance covers biological data, clinical trials and patient follow-up. Quality aspects are outside the scope of this guideline.