Core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg) - Scientific guideline
This guidance describes the information to be included in the summary of product characteristics for human normal immunoglobulins for intravenous administration.
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.
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Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) - Rev. 6 (PDF/282.16 KB)
Adopted
First published: 16/12/2021
Last updated: 03/02/2022
Legal effective date: 01/01/2022
EMA/CHMP/BPWP/94038/2007 Rev. 6 Corr. -
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Overview of comments received on Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) (EMA/CHMP/BPWP/94038/2007 Rev. 6) (PDF/294.02 KB)
First published: 04/02/2022
EMA/30450/2021 -
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Draft guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) - Rev. 6 (PDF/528.75 KB)
Draft: consultation closed
First published: 13/10/2020
Consultation dates: 13/10/2020 to 13/01/2021
EMA/CHMP/BPWP/94038/2007 Rev. 6
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Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) - Rev. 5 (PDF/224.73 KB)
Adopted
First published: 20/07/2018
Last updated: 20/07/2018
Legal effective date: 01/01/2019
EMA/CHMP/BPWP/94038/2007 Rev. 5 -
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Overview of comments received on 'the guideline Core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg) (EMA/CHMP/BPWP/94038/2007 Rev. 5) - Revision 5 (PDF/671.23 KB)
First published: 13/09/2018
Last updated: 13/09/2018
EMA/CHMP/BPWP/572924/2018 -
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Draft guideline on core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg) - Rev.5 (PDF/204.18 KB)
Draft: consultation closed
First published: 22/12/2016
Last updated: 22/12/2016
Consultation dates: 01/01/2017 to 31/03/2017
EMA/CHMP/BPWP/94038/2007 Rev. 5
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Guideline on core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg) revision 4 (PDF/149.83 KB)
Adopted
First published: 18/12/2012
Last updated: 18/12/2012
EMA/CHMP/BPWP/94038/2007 Rev. 4 -
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Draft concept paper on guideline on the clinical investigation of human normal immunoglobulin for intravenous administration and core summary of product characteristics (PDF/98.88 KB)
Draft: consultation closed
First published: 01/08/2014
Last updated: 01/08/2014
Consultation dates: 01/08/2014 to 31/10/2014
EMA/CHMP/BPWP/572805/2013
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Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) Rev. 3 (PDF/258.21 KB)
Adopted
First published: 06/12/2010
Last updated: 06/12/2010
Legal effective date: 01/05/2011
EMA/CHMP/BPWP/94038/2007 rev. 3 -
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Overview of comments received on Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) (EMA/CHMP/BPWP/94038/2007 rev. 3 formerly CPMP/BPWG/859/95 rev. 3) (PDF/312.53 KB)
First published: 06/12/2010
Last updated: 06/12/2010
EMA/CHMP/BPWP/375734/2010 -
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Draft guideline on Core SmPC for human normal immunoglobulin for intravenous administration (IVIg) (CPMP/BPWG/859/95 rev. 3) (PDF/153.66 KB)
Draft: consultation closed
First published: 06/02/2009
Last updated: 06/02/2009
CPMP/BPWG/859/95 Rev. 3