Flutiform filing referred to EMA for arbitration
This article was originally published in Scrip
Executive Summary
The decentralised procedure application for approval of SkyePharma's combination asthma treatment Flutiform (fluticasone propionate plus formoterol fumarate) has been referred to the European Medicines Agency for arbitration, after the reference member state (RMS) and concerned member states (CMSs) could not reach consensus over its approvability.