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

  • Email
  • Help
Current effective version

Revision 1 - Adopted guideline

Currently under revsion - see below

Reference numberEMA/CHMP/BPWP/144533/2009 Rev. 1
Published11/02/2016
Effective from01/05/2016
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

In progress

Draft guideline

 

 

Concept paper

Published: 30/10/2017

Deadline for comments: 31/01/2018

 

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Superseded document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Superseded document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


Related content


How helpful is this page?

Average rating:

 Based on 1 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
1 ratings
    

Tell us more