Core summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products

Current effective version

Revision 2 - Adopted guideline

Reference numberEMA/CHMP/BPWP/1625/99 Rev. 2
Effective from01/04/2015
KeywordsHuman plasma derived coagulation factor IX products, recombinant coagulation factor IX products, haemophilia B
DescriptionThis document describes the information to be included in the summary of product characteristics for human plasma derived and recombinant coagulation factor IX products. It applies to medicinal products indicated for use in the treatment and prophylaxis of bleeding in patients with haemophilia B.

Document history

Revision 2

Current version

Adopted guideline

PDF iconOverview of comments

PDF iconDraft guideline

In operation: 01/04/2015–present

Published: 22/12/2014

Published: 01/10/2014

Revision 1

PDF iconAdopted guideline

PDF iconDraft guideline

PDF iconConcept paper

In operation: 01/12/2012–01/04/2015

Published: 19/07/2007

Published: 15/12/2004

First version PDF iconAdopted guideline In operation: 01/12/2000–01/12/2012

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