Clinical investigation of recombinant and human plasma-derived factor IX products

Keywords Recombinant factor IX, plasma-derived factor IX, efficacy, safety, immunogenicity, inhibitor, thrombogenicity, anaphylactic reactions, potency assays
Description This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor IX products is made for use in the treatment and prevention of bleeding in patients with haemophilia B. The guideline covers clinical  investigations to be conducted pre- and post-marketing authorisation. Guidance is also provided for  authorised products where a significant change in the manufacturing process has been made.

Document history

Revision 1

Under revision

PDF iconAdopted guideline

 

PDF iconOverview of comments

 

PDF iconDraft guideline

In operation: 01/09/2015–present

 

Published: 01/06/2015

 

Published: 06/01/2015

First version

 

PDF iconAdopted guideline

 

PDF iconDraft guideline

In operation: 01/02/2012–01/09/2015

 

Published: 23/07/2009

Superseded document

 

PDF iconDraft guideline

 

PDF iconConcept paper

 

PDF iconAdopted guideline

Published: 19/07/2007

 

Published: 15/12/2004

 

In operation: 01/04/2001–01/02/2012

Superseded document

 

PDF iconDraft guideline

 

PDF iconConcept paper

 

PDF iconAdopted guideline

Published: 19/07/2007

 

Published: 15/12/2004

 

In operation: 01/04/2001–01/02/2012


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