Core summary of product characteristics for human fibrinogen products

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Current effective version

Revision 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

Adopted guideline

 

Overview of comments

 

Draft guideline

In operation: 01/02/2016–present

 

Published: 24/07/2015

 

Published: 04/03/2014

First version

Adopted guideline

 

Overview of comments

 

Draft guideline

 

Concept 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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