The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

Eudralex Volume 3 Guideline on clinical investigation of recombinant and human plasma-derived factor IX products (replacing CPMP/BPWG/198/95 and CPMP/BPWG/1561/99)


EMA - 7 Westferry Circus œ Canary Wharf œ London E14 4HB œ United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail Website

Document Type:
This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor IX products is made for use in treatment and prevention of bleeding in patients with haemophilia B. The guideline covers clinical investigations to be conducted pre- and post-marketing authorisation. Guidance is also provided for authorised products where a significant change in the manufacturing process has been made.

Go back

GMP Conferences by Topics