The current guideline CHMP/EWP/240/95 Rev. 1 contains a section describing the legal basis applicable to fixed dose combination (FDC) product marketing authorisation application (MAA).


Document details

Download document Concept paper on the need for revision of note for guidance on clinical investigation of medicinal products for the treatment of cardiac failure
Reference number EMA/CHMP/87576/2013
Status draft: consultation open
First published 01/03/2013
Last updated 01/03/2013
Consultation start date 01/03/2013
Consultation end date 31/05/2013
Email address for submissions


Posted on the EMA website on 1 March 2013