Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products

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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
First published 2015-01-06
Last updated 2015-01-06

Summary

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.