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This guidance 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.
Keywords: Intravenous 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
Current effective version
Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - rev. 4
English (EN) (343.8 KB - PDF)
Document history - Revision 4
Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Rev. 4
English (EN) (359.27 KB - PDF)
Overview of comments received on Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) (EMA/CHMP/BPWP/94033/2007 rev. 4)
English (EN) (286.75 KB - PDF)
Document history - Revision 3
Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Rev. 3
English (EN) (198.27 KB - PDF)
Overview of comments received on ‘the guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)’ (EMA/CHMP/BPWP/94033/2007), Rev.3
English (EN) (259.79 KB - PDF)
Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Revision 3
This Guideline describes the information to be documented when an application is made for a marketing authorisation for a human normal immunoglobulin for intravenous use (IVIg). The guidance covers biological data, clinical trials and patient follow-up. Quality aspects are outside the scope of this guideline.
English (EN) (210.69 KB - PDF)
Draft concept paper on guideline on the clinical investigation of human normal immunoglobulin for intravenous administration and core summary of product characteristics
The current note for guidance on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg, EMA/CHMP/BPWP/94033/2007 revision 2) and the core summary of product characteristics (SmPC) for human normal IVIg (CHMP/BPWP/94038/2007 revision 4) have been in operation since December 2000 and underwent a major revision process from 2006 to 2010. The question arises whether the guideline and the core SmPC should be updated to include chronic inflammatory demyelinating polyradiculoneuropathy and multifocal motor neuropathy as being 'established indications'. Additionally, some international experts recommend that dosing in replacement therapy and in.immunomodulation should be re-evaluated, possibly with adjustment according to lean body weight.
English (EN) (98.88 KB - PDF)
Document history - Revision 2
Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Revision 2
English (EN) (219.78 KB - PDF)
Overview of comments received on the guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg): (EMA/CHMP/BPWP/94033/2007, rev. 2 formerly CPMP/BPWG/388/95 rev. 2)
English (EN) (245.7 KB - PDF)
Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Revision 2
English (EN) (216.32 KB - PDF)
Document history - Revision 1
Concept paper on revision of: Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Intravenous Administration (IVIg) and on the Core SPC for Human Normal l Immunoglobulin for Intravenous Administration (IVIg) - Revision 1
English (EN) (46.04 KB - PDF)