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

Current effective version

PDF iconRevision 3 - Adopted guideline

Revision 3 enters into effect 01/02/2019 - see below

Reference numberEMA/CHMP/BPWP/1619/1999 Rev. 3
Published13/08/2018
Effective from01/02/2019
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


PDF iconAdopted guideline


PDF iconDraft guideline

PDF iconConcept paper

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


Published: 30/10/2017

Published: 01/08/2016

Revision 2

Current version

PDF iconAdopted guideline


PDF iconDraft guideline

In operation: 01/05/2016-present


Published: 01/06/2015

Revision 1

PDF iconAdopted guideline


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/12/2012–01/05/2016


Published: 19/07/2007


Published: 15/12/2004

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