Core summary of product characteristics for human normal immunoglobulin for subcutaneous and intramuscular use

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Current effective version

Revision 1 - Adopted guideline

Reference numberCPMP/BPWG/143744/2011 Rev. 1
Published26/03/2015
Effective from01/09/2015
KeywordsHuman normal immunoglobulin, primary immunodeficiency syndromes, hypogammaglobulinaemia, hepatitis A prophylaxis, immunomodulation
DescriptionThis document describes the information to be included in the summary of product characteristics for human normal immunoglobulins for subcutaneous and/or intramuscular administration.


Document history

Revision 1 

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/09/2015–present


Published: 26/03/2015


Published: 31/07/2012


Published: 17/12/2010

First versionAdopted guidelineIn operation: 01/01/2003–31/08/2015


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