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

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Current effective version

Revision 1 - Adopted guideline

Reference numberEMA/CHMP/BPWP/144552/2009 Rev. 1
Published01/06/2015
Effective from01/09/2015
KeywordsRecombinant factor IX, plasma-derived factor IX, efficacy, safety, immunogenicity, inhibitor, thrombogenicity, anaphylactic reactions, potency assays
DescriptionThis document covers clinical investigations to be conducted pre- and post-marketing authorisation for recombinant or human plasma-derived factor IX products that are intended to use in the treatment and prevention of bleeding in patients with haemophilia A.


Document history

Revision 1 

Current version

Adopted guideline

 

Overview of comments

 

Draft guideline

In operation: 01/09/2015–present

 

Published: 01/06/2015

 

Published: 06/01/2015

First version

 

Adopted guideline

 

Draft guideline

In operation: 01/02/2012–01/09/2015

 

Published: 23/07/2009

Superseded document

 

Draft guideline

 

Concept paper

 

Adopted guideline

Published: 19/07/2007

 

Published: 15/12/2004

 

In operation: 01/04/2001–01/02/2012

Superseded document

 

Draft guideline

 

Concept paper

 

Adopted guideline

Published: 19/07/2007

 

Published: 15/12/2004

 

In operation: 01/04/2001–01/02/2012


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