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

Current effective version

Guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products - Revision 3

Adopted Reference Number: EMA/CHMP/BPWP/1619/1999 Legal effective date: 01/02/2019

Document history - Revision 3

Guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products - Revision 3

Adopted Reference Number: EMA/CHMP/BPWP/1619/1999 Legal effective date: 01/02/2019

Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products - Revision 3

Draft: consultation closed Consultation dates: 30/10/2017 to 31/01/2018 Reference Number: EMA/CHMP/BPWP/1619/1999 Rev. 3 Summary:

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor VIII products, which are indicated for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). In case of an indication claim in von Willebrand’s disease, see also core SmPC for von Willebrand factor products (CPMP/BPWG/278/02).

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)

Draft: consultation closed Consultation dates: 01/08/2016 to 30/09/2016 Reference Number: EMA/CHMP/BPWP/383118/2016 Summary:

The proposed guideline will replace 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).

Document history - Revision 2

Final guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products - Revision 2

Adopted Reference Number: EMA/CHMP/BPWP/1619/1999 rev. 2 Legal effective date: 01/05/2016 Summary:

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor VIII products, which are indicated for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

Draft guideline on core summary of product characteristics for human plasma derived and recombinant coagulation factor VIII products - Revision 2

Draft: consultation closed Consultation dates: 01/06/2015 to 01/07/2015 Reference Number: EMA/CHMP/BPWP/1619/1999 Rev.2 Summary:

This guideline describes the information to be included in the summary of product characteristics (SmPC) for human plasma derived and recombinant coagulation factor VIII products, which are indicated for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

Document history - Revision 1

Guideline on core summary of product characteristics for human plasma derived and recombinant coagulation factor VIII products - Revision 1

Adopted Reference Number: EMA/CHMP/BPWP/1619/1999 Rev.1 Summary:

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor VIII products, which are indicated for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

In case of an indication claim in von Willebrand’s disease, see also core SmPC for von Willebrand factor products (CPMP/BPWG/278/02).

Draft guideline on Core SPC for Human Plasma Derived and Recombinant Coagulation Factor VIII Products - Revision 1

Draft: consultation closed Reference Number: EMEA/CPMP/BPWG/1619/1999 – Rev.1

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

Reference Number: EMEA/CHMP/BPWG/189106/2004