Core summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products - Scientific guideline

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

Keywords: Human plasma derived coagulation factor IX products, recombinant coagulation factor IX products, haemophilia B

Current effective version

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

Consultation dates: 03/12/2018 to 30/06/2019Draft: consultation closedReference Number: EMA/CHMP/BPWP/1625/1999 rev. 3

Revision 3

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

AdoptedLegal effective date: 28/06/2024Reference Number: EMA/CHMP/BPWP/277622/2024 rev. 3

Overview of comments on the 'Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products - Revision 3'

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

Consultation dates: 03/12/2018 to 30/06/2019Draft: consultation closedReference Number: EMA/CHMP/BPWP/1625/1999 rev. 3

Revision 2

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

Consultation dates: 01/10/2014 to 31/10/2014Draft: consultation closedReference Number: EMA/CHMP/BPWP/1625/1999 Rev. 2Summary:

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

Guideline on core Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor IX products - Revision 2

AdoptedReference Number: EMA/CHMP/BPWP/1625/1999 rev. 2Summary:

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

Overview of comments received on 'Guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products'

Reference Number: EMA/CHMP/BPWP/697285/2014

Revision 1

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

AdoptedReference Number: EMA/CHMP/BPWP/1625/1999 Rev.1Summary:

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

Draft guideline on Core SPC for human plasma derived and recombinant coagulation factor IX products – Rev. 1

Draft: consultation closedReference Number: EMEA/CPMP/BPWG/1625/1999

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

First version

Guideline on Core SPC for Human Plasma Derived and Recombinant Coagulation Factor IX Products - First version

AdoptedLegal effective date: 01/12/2000Reference Number: CPMP/BPWG/1625/99