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

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Current effective version

Revision 2 - Adopted guideline

Revision 2 enters into effect 01/02/2019 - see below

Reference numberEMA/CHMP/BPWP/144533/2009 Rev. 2
Published13/08/2018
Effective from01/02/2019
KeywordsRecombinant factor VIII, plasma-derived factor VIII, efficacy, safety, immunogenicity, inhibitor, potency assays
DescriptionThis document covers clinical investigations to be conducted pre- and post-marketing authorisation for recombinant or human plasma-derived factor VIII products that are intended to use in the treatment and prevention of bleeding in patients with haemophilia A.


Document history

Revision 2

 

Adopted guideline

 


Draft guideline

 

Concept paper

Published: 13/08/2018
Effective from: 01/02/2019

 


Published: 30/10/2017

 

Published: 01/08/2016

Revision 1 

Current version

Adopted guideline

 

Draft guideline

In operation: 01/05/2016–present

 

Published: 01/06/2015

First version

 

Adopted guideline

 

Draft guideline

In operation: 01/02/2012–01/05/2016

 

Published: 23/07/2009

Superseded document

 

Draft guideline

 

Concept paper

 

Adopted guideline

Published: 19/07/2007

 

Published: 15/12/2004

 

In operation: 01/04/2001–23/07/2009

Superseded document

 

Draft guideline

 

Concept paper

 

Adopted guideline

Published: 19/07/2007

 

Published: 15/12/2004

 

In operation: 01/04/2001–23/07/2009


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