9 June 2016 - The EMA has published an EPAR for Samsung Bioepis' Flixabi (infliximab).
The European Commission approved Flixabi on 26 May 2016 for certain patients with:
Flixabi will be subjected to additional monitoring by the EMA.
For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004020/human_med_001980.jsp&mid=WC0b01ac058001d124