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

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Current effective version

Revision 2 - Adopted guideline

Currently being revised - see below

Reference numberEMA/CHMP/BPWP/1619/1999 Rev. 2
Published11/02/2016
Effective from01/05/2016
KeywordsHuman plasma derived coagulation factor VIII products, recombinant coagulation factor VIII products, haemophilia A
DescriptionThis document describes the information to be included in the summary of product characteristics for human plasma derived and recombinant coagulation factor VIII products. It applies to medicinal products that are indicated for use in the treatment and prophylaxis of bleeding in patients with haemophilia A.


Document history

Revision 3

In progress


 

Draft guideline

 

Concept paper

Published: 30/10/2017

Deadline for comments: 31/01/2018

 

Published: 01/08/2016

 

Revision 2 

Current version
 

Adopted guideline


Draft guideline

In operation: 01/05/2016


Published: 01/06/2015

Revision 1

 

Adopted guideline


Draft guideline


Concept paper

In operation: 01/12/2012–01/05/2016


Published: 19/07/2007


Published: 15/12/2004

 

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