Core summary of product characteristics for human plasma-derived and recombinant coagulation factor VIII products - Scientific guideline
This 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.
Keywords: Human plasma derived coagulation factor VIII products, recombinant coagulation factor VIII products, haemophilia A
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Guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products - Revision 3 (PDF/191.38 KB)
Adopted
First published: 13/08/2018
Last updated: 13/08/2018
Legal effective date: 01/02/2019
EMA/CHMP/BPWP/1619/1999 -
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Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products - Revision 3 (PDF/170.43 KB)
Draft: consultation closed
First published: 30/10/2017
Last updated: 30/10/2017
Consultation dates: 30/10/2017 to 31/01/2018
EMA/CHMP/BPWP/1619/1999 Rev. 3 -
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Concept paper on revision of guidelines on the clinical investigation and core SmPC of recombinant and human plasma-derived factor VIII products (EMA/CHMP/BPWP/144533/2009 rev. 1) (EMA/CHMP/BPWP/1619/1999 rev. 2) (PDF/92.85 KB)
Draft: consultation closed
First published: 01/08/2016
Last updated: 01/08/2016
Consultation dates: 01/08/2016 to 30/09/2016
EMA/CHMP/BPWP/383118/2016
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Final guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products - Revision 2 (PDF/170.48 KB)
Adopted
First published: 11/02/2016
Last updated: 11/02/2016
Legal effective date: 01/05/2016
EMA/CHMP/BPWP/1619/1999 rev. 2 -
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Draft guideline on core summary of product characteristics for human plasma derived and recombinant coagulation factor VIII products - Revision 2 (PDF/175.46 KB)
Draft: consultation closed
First published: 01/06/2015
Last updated: 01/06/2015
Consultation dates: 01/06/2015 to 01/07/2015
EMA/CHMP/BPWP/1619/1999 Rev.2
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Guideline on core summary of product characteristics for human plasma derived and recombinant coagulation factor VIII products - Revision 1 (PDF/148.12 KB)
Adopted
First published: 21/06/2012
Last updated: 21/06/2012
EMA/CHMP/BPWP/1619/1999 Rev.1 -
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Draft guideline on Core SPC for Human Plasma Derived and Recombinant Coagulation Factor VIII Products - Revision 1 (PDF/98.56 KB)
Draft: consultation closed
First published: 19/07/2007
Last updated: 19/07/2007
EMEA/CPMP/BPWG/1619/1999 – Rev.1 -
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Concept paper on the revision of notes for guidance on the clinical investigation of human plasma derived and recombinant factor VIII and IX products and the corresponding Core SPCs - Revision 1 - Superseded (PDF/34.15 KB)
First published: 15/12/2004
Last updated: 15/12/2004
EMEA/CHMP/BPWG/189106/2004