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
Guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products - Revision 3
English (EN) (281.53 KB - PDF)
Revision 3
Overview of comments on the 'Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products - Revision 3'
English (EN) (185.77 KB - PDF)
Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products - Revision 3
English (EN) (184.23 KB - PDF)
Revision 2
Draft guideline on core summary of product characteristics for human plasma-derived and recombinant coagulation factor-IX products - Revision 2
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).
English (EN) (194.15 KB - PDF)
Guideline on core Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor IX products - Revision 2
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).
English (EN) (182.25 KB - PDF)
Overview of comments received on 'Guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products'
English (EN) (135.19 KB - PDF)
Revision 1
Guideline on core summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products - Revision 1
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).
English (EN) (148.71 KB - PDF)
Draft guideline on Core SPC for human plasma derived and recombinant coagulation factor IX products – Rev. 1
English (EN) (101.59 KB - PDF)
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
English (EN) (34.15 KB - PDF)
First version
Guideline on Core SPC for Human Plasma Derived and Recombinant Coagulation Factor IX Products - First version
English (EN) (68.77 KB - PDF)