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

Current effective version

PDF iconRevision 2 - Adopted guideline

Currently under revision - see below

Reference numberEMA/CHMP/BPWP/94033/2007 Rev. 2
Published02/08/2010
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

PDF iconAdopted guideline


PDF iconOverview of comments

PDF iconDraft guideline

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

Published: 20/07/2018

Published: 22/12/2016

Superseding document PDF iconConcept paper Published: 01/08/2014

Revision 2

Current version

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline

PDF iconConcept paper

In operation: 01/02/2011 - present

Published: 02/08/2010

Published: 24/03/2010

Published: 16/03/2005


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