|Download document||Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products|
|Reference number||EMA/CHMP/BPWP/144552/2009 rev 1|
|Status||draft: consultation closed|
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.