EMEA: Guideline on Clinical Investigation of Human Normal Immunoglobulin for Intravenous Administration (IVIg)

EMEA:
Guideline on Clinical Investigation of Human Normal Immunoglobulin for Intravenous Administration (IVIg). 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.