Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)

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Current effective version

Revision 2 - Adopted guideline

Currently under revision - see below

Reference numberEMA/CHMP/BPWP/94033/2007 Rev. 2
Effective from01/02/2011
KeywordsIntravenous immunoglobulin (IVIg), primary immunodeficiency syndromes, hypogammaglobulinaemia, primary immune thrombocytopenia, idiopathic thrombocytopenic purpura (ITP), Guillain Barré syndrome, Kawasaki disease, multifocal motor neuropathy (MMN), chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), myasthenia gravis exacerbations
DescriptionThis document describes the information to be documented when a marketing authorisation application is made for IVIg. It covers biological data, clinical trials and patient follow-up.

Document history

Revision 3

Adopted guideline

Overview of comments

Draft guideline

Published: 20/07/2018
Effective from: 01/01/2019

Published: 20/07/2018

Published: 22/12/2016

Superseding documentConcept paperPublished: 01/08/2014

Revision 2 

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/02/2011 - present


Published: 02/08/2010


Published: 24/03/2010


Published: 16/03/2005

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