Core summary of product characteristics for human fibrinogen products

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference numberEMA/CHMP/BPWP/691754/2013 Rev. 1
Published24/07/2015
Effective from01/02/2016
KeywordsHuman fibrinogen, congenital hypofibrinogenaemia, acquired hypofibrinogenaemia, congenital dysfibrinogenaemia, congenital afibrinogenaemia
DescriptionThis 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.


Document history

Revision 1

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline

In operation: 01/02/2016–present


Published: 24/07/2015


Published: 04/03/2014

First version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/08/2009–01/02/2016


Published: 19/02/2007


Published: 25/01/2007


Published: 15/12/2005


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