Please note that the EMA’s “Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to marketing authorisation holders during the interim period” were updated on the 17 October 2013 and published on the 11 November 2013.Please note that the EMA’s “Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to marketing authorisation holders during the interim period” were updated on the 17 October 2013 and published on the 11 November 2013.