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

Keywords Human plasma derived coagulation factor IX products, recombinant coagulation factor IX products, haemophilia B
Description
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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