Core summary of products characteristics for human anti-D immunoglobulin for intramuscular use - Scientific guideline
This document describes the information to be included in the summary of product characteristics for a human anti-D immunoglobulin for intramuscular 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 intramuscular use (PDF/164.38 KB)
Adopted
First published: 29/09/2016
Last updated: 29/09/2016
Legal effective date: 01/04/2017
EMA/CHMP/BPWP/29205/2005 Rev. 2 -
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Overview of comments received on ‘Draft guideline on the core SmPC for human Anti-D immunoglobulin for intramuscular use’ (EMA/CHMP/BPWP/29205/2005 Rev. 2) (PDF/173.75 KB)
First published: 29/09/2016
Last updated: 29/09/2016
EMA/CHMP/BPWP/379212/2016 -
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Draft guideline on the core SmPC for human Anti-D immunoglobulin for intramuscular use (PDF/157.66 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/29205/2005 Rev. 2
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Guideline on the Core SPC for human Anti-D immunoglobulin for intramuscular use - Revision 1 (PDF/62.5 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 intramuscular use CPMP/BPWG/574/99 Rev.1 (PDF/31.52 KB)
First published: 13/07/2007
Last updated: 13/07/2007
EMEA/CHMP/BPWP/72151/2007 -
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Draft guideline on the Core SPC for human Anti-D immunoglobulin for intramuscular use (PDF/72.57 KB)
Draft: consultation closed
First published: 27/04/2006
Last updated: 27/04/2006
CPMP/BPWG/574/99 Rev. 1