Core summary of product characteristics for human fibrinogen products - Scientific guideline
This document describes the information to be included in the summary of product characteristics for human fibrinogen. It applies to medicinal products indicated for the treatment and prophylaxis of bleeding in patients with congenital hypo-, dys- or afibrinogenaemia with bleeding tendency and as a complementary therapy to management of uncontrolled severe haemorrhage in acquired hypofibrinogenaemia.
Keywords: Human fibrinogen, congenital hypofibrinogenaemia, acquired hypofibrinogenaemia, congenital dysfibrinogenaemia, congenital afibrinogenaemia
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Guideline on core summary of product characteristics (SmPC)for human fibrinogen products (PDF/108.57 KB)
Adopted
First published: 24/07/2015
Last updated: 24/07/2015
Legal effective date: 01/02/2016
EMA/CHMP/BPWP/691754/2013 Rev 1 -
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Overview of comments received on 'Guideline on core summary of product characteristics (SmPC) for human fibrinogen products’ (PDF/153.26 KB)
First published: 24/07/2015
Last updated: 24/07/2015
EMA/CHMP/BPWP/336355/2014 -
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Draft guideline on core summary of product characteristics for human fibrinogen products (PDF/117.44 KB)
Draft: consultation closed
First published: 04/03/2014
Last updated: 04/03/2014
Consultation dates: 04/03/2014 to 04/06/2014
EMA/CHMP/BPWP/691754/2013 Rev. 1
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Guideline on core SmPC for human fibrinogen products (EMEA/CHMP/BPWP/122007/2005) (PDF/91.12 KB)
Adopted
First published: 22/01/2009
Last updated: 22/01/2009
Legal effective date: 01/08/2009
EMEA/CHMP/BPWP/122007/2005 -
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Overview of comments received on draft guideline on Core SmPC for human plasma fibrinogen products (EMEA/CHMP/BPWP/122007/2005) (PDF/99.73 KB)
First published: 19/02/2007
Last updated: 19/02/2007
EMEA/CHMP/BPWP/399089/2007 -
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Draft guideline on core SPC for human plasma fibrinogen products (EMEA/CHMP/BPWP/122007/2005) (PDF/100.82 KB)
Draft: consultation closed
First published: 25/01/2007
Last updated: 25/01/2007
EMEA/CHMP/BPWP/122007/2005 -
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Concept paper on revision of core SPC for human plasma fibrinogen products (PDF/48.36 KB)
First published: 15/12/2005
Last updated: 15/12/2005
EMEA/CHMP/BPWP/371017/2005