Core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg)

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Current effective version

Revision 4 - Adopted guideline

Currently under revision - see below

Reference numberCHMP/BPWP/94038/2007 Rev. 4
Effective from01/07/2013
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 included in the summary of product characteristics for human normal immunoglobulins for intravenous administration.

Document history

Revision 5

In progress

Draft guideline



Published: 22/12/2016


Deadline for comments: 31/03/2017

Superseding documentConcept paperPublished: 01/08/2014

Revision 4 

Current version

Adopted guideline

In operation: 01/07/2013–present
Revision 3

Adopted guideline

Overview of comments

Draft guideline

Concept paper

In operation: 01/05/2011–30/06/2013

Published: 06/12/2010

Published: 06/02/2009

Published: 16/03/2005

Revision 2 Adopted guidelineIn operation: 01/11/2004–30/04/2011

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