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
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

In progress

Draft guideline

Published: 22/12/2016

 

Deadline for comments: 31/03/2017

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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