Clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg)

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Current effective version

Revision 1 - Adopted guideline

Reference numberCHMP/BPWP/410415/2011 Rev. 1
Published24/07/2015
Effective from01/02/2016
KeywordsImmunoglobulin for subcutaneous administration (SCIg), immunoglobulin for intramascular administration (IMIg), human normal immunoglobulin, primary immunodeficiency syndromes, hypogammaglobulinaemia, hepatitis A prophylaxis
DescriptionThis document describes the information to be included when a marketing authorisation application for SCIg/IMIg is made. It addresses biological data, pharmacokinetics, clinical trials and patient follow-up.


Document history

Revision 1 

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/02/2016–present


Published: 24/07/2015


Published: 03/12/2012


Published: 17/12/2010

First versionAdopted guidelineIn operation: 01/01/2003–01/02/2016


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