Eudralex Volume 3 Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products
Title:
Eudralex Volume 3 Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products
Origin/Publisher:
EMA 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (020 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu website www.ema.europa.eu
Document Type:
Guideline
Content:
This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor VIII products is made for use in treatment and prevention of bleeding in patients with haemophilia A. The guidance 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.