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
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Draft guideline on core summary of product characteristics for human plasma-derived and recombinant coagulation factor-IX products - Revision 2 (PDF/194.15 KB)
Draft: consultation closed
First published: 01/10/2014
Last updated: 01/10/2014
Consultation dates: 01/10/2014 to 31/10/2014
EMA/CHMP/BPWP/1625/1999 Rev. 2 -
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Guideline on core Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor IX products - Revision 2 (PDF/182.25 KB)
Adopted
First published: 22/12/2014
Last updated: 22/12/2014
EMA/CHMP/BPWP/1625/1999 rev. 2 -
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Overview of comments received on 'Guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products' (PDF/135.19 KB)
First published: 22/12/2014
Last updated: 22/12/2014
EMA/CHMP/BPWP/697285/2014
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Guideline on core summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products - Revision 1 (PDF/148.71 KB)
Adopted
First published: 21/06/2012
Last updated: 21/06/2012
EMA/CHMP/BPWP/1625/1999 Rev.1 -
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Draft guideline on Core SPC for human plasma derived and recombinant coagulation factor IX products – Rev. 1 (PDF/101.59 KB)
Draft: consultation closed
First published: 19/07/2007
Last updated: 19/07/2007
EMEA/CPMP/BPWG/1625/1999 -
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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of human plasma derived and recombinant factor VIII and IX products and the corresponding Core SPCs - Revision 1 - Superseded (PDF/34.15 KB)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