Core summary of product characteristics for human anti-D immunoglobulin for intravenous use - Scientific guideline
This document describes the information to be included in the summary of product characteristics for a human anti-D immunoglobulin for intravenous use.
Keywords: Anti-D immunoglobulin, pregnancy, incompatible transfusion, Rh(D) negative, summary of product characteristics (SPC)
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Guideline on the core SmPC for human Anti-D immunoglobulin for intravenous use (PDF/165.65 KB)
Adopted
First published: 29/09/2016
Last updated: 29/09/2016
Legal effective date: 01/04/2017
EMA/CHMP/BPWP/319619/2005 Rev. 2 -
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Overview of comments received on ‘Draft Guideline on the core SmPC for human Anti-D immunoglobulin for intravenous use’ (EMA/CHMP/BPWP/319619/2005 Rev. 2) (PDF/153.52 KB)
First published: 29/09/2016
Last updated: 29/09/2016
EMA/CHMP/BPWP/379278/2016 -
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Draft guideline on the core SmPC for human Anti-D immunoglobulin for intravenous use (PDF/152.24 KB)
Draft: consultation closed
First published: 11/02/2016
Last updated: 11/02/2016
Consultation dates: 11/02/2016 to 30/04/2016
EMA/CHMP/BPWP/319619/2005 Rev. 2
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Guideline on the Core SPC for human Anti-D immunoglobulin for intravenous use – Revision 1 (PDF/63 KB)
Adopted
First published: 20/09/2007
Last updated: 20/09/2007
Legal effective date: 01/04/2008
CPMP/BPWG/574/99 Rev. 1 -
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Overview of comments received on the Core SPC for human Anti-D immunoglobulin for intravenous use CPMP/BPWP/319619/2005 (PDF/28.03 KB)
First published: 13/07/2007
Last updated: 13/07/2007
EMEA/CHMP/BPWP/74960/2007 -
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Draft guideline on the Core SPC for human Anti-D immunoglobulin for intravenous use – Revision 1 (PDF/90.53 KB)
Draft: consultation closed
First published: 27/04/2006
Last updated: 27/04/2006
CHMP/BPWP/319619/2005