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

KeywordsHuman plasma derived coagulation factor IX products, recombinant coagulation factor IX products, haemophilia B
This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor IX products, which are indicated for use in the treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).


Document history

Revision 2

Under revision

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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