submission of final data Prospective Inappropriate Esmya use in Final study management of world” report planned “real (PASS) PGL10-014: endometrium practice Q1 2016 (4 A prospective thickening years post multicenter (unnecessary approval) noninterventional interventions or study of women treatments) treated with Inappropriate Esmya (ulipristal diagnosis of acetate) as endometrial hyperplasia treatment of (mistaking PAEC moderate to severe for hyperplasia) symptoms of Acute uterine uterine fibroids. bleeding requiring (PREMYA, category immediate 3) intervention Drug Induced Injury (DILI) Treatment beyond three months Delayed diagnosis of atypical endometrial hyperplasia or adenocarcinoma Impact on surgery Retrospective non Inappropriate Esmya use in study interventional management of world” report planned “real study (PASS) endometrium practice Q4 2015 PGL11-020: Esmya thickening prescription (unnecessary patterns in Europe: interventions or A retrospective treatments) drug utilisation Inappropriate chart review study. diagnosis of (PRECISE, category endometrial 3) hyperplasia (mistaking PAEC for hyperplasia) Treatment beyond three months Impact on surgery
submission of final data Prospective (PASS) PGL10-014: A prospective multicenter noninterventional study of women treated with Esmya (ulipristal acetate) as treatment of moderate to severe symptoms of uterine fibroids. (PREMYA, category 3) Inappropriate management of endometrium thickening (unnecessary interventions or treatments) Inappropriate diagnosis of endometrial hyperplasia (mistaking PAEC for hyperplasia) Acute uterine bleeding requiring immediate intervention Drug Induced Injury (DILI) Treatment beyond three months Delayed diagnosis of atypical endometrial hyperplasia or adenocarcinoma Impact on surgery Esmya use in “real world” practice Final study report planned Q1 2016 (4 years post approval) Retrospective non interventional study (PASS) PGL11-020: Esmya prescription patterns in Europe: A retrospective drug utilisation chart review study. (PRECISE, category 3) Inappropriate management of endometrium thickening (unnecessary interventions or treatments) Inappropriate diagnosis of endometrial hyperplasia (mistaking PAEC for hyperplasia) Treatment beyond three months Impact on surgery Esmya use in “real world” practice study report planned Q4 2015
auspar-ulipristal-acetate-161019.docx