Core summary of product characteristics for human normal immunoglobulin for subcutaneous and intramuscular use - Scientific guideline
Table of contents
This document describes the information to be included in the summary of product characteristics for human normal immunoglobulins for subcutaneous and/or intramuscular administration.
Keywords: Human normal immunoglobulin, primary immunodeficiency syndromes, hypogammaglobulinaemia, hepatitis A prophylaxis, immunomodulation
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Overview of comments received on 'Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration' (PDF/192.97 KB)
First published: 26/03/2015
Last updated: 26/03/2015
EMA/CHMP/BPWP/356950/2013 -
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Draft guideline on core summary of product characteristics for human normal immunoglobulin for subcutaneous and intramuscular administration (PDF/194.86 KB)
Draft: consultation closed
First published: 31/07/2012
Last updated: 31/07/2012
Consultation dates: 31/07/2012 to 31/01/2013
EMA/CHMP/BPWP/143744/2011 rev. 1 -
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Concept paper on revision of note for guidance on the clinical investigation of human normal immunoglobulin for subcutaneous and intramuscular use (CPMP/BPWG/283/00) (PDF/146.28 KB)
Draft: consultation closed
First published: 17/12/2010
Last updated: 17/12/2010
Consultation dates: 16/12/2010 to 31/03/2011
EMA/CHMP/BPWP/761007/2010 -
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Guideline on the Core SPC for human normal immunoglobulin for subcutaneous and intramuscular use (CPMP/BPWG/282/00) (PDF/184.01 KB)
Adopted
First published: 25/07/2002
Last updated: 25/07/2002
Legal effective date: 01/01/2003
CPMP/BPWG/282/00