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

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Current effective version

Revision 2 - Adopted guideline

Reference numberEMA/CHMP/BPWP/1625/99 Rev. 2
Published22/12/2014
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


Overview of comments


Draft guideline

In operation: 01/04/2015–present


Published: 22/12/2014


Published: 01/10/2014

Revision 1

Adopted guideline


Draft guideline


Concept paper

In operation: 01/12/2012–01/04/2015


Published: 19/07/2007


Published: 15/12/2004

First versionAdopted guidelineIn operation: 01/12/2000–01/12/2012


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