Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting

Ki vehet részt

• Adult women of reproductive age with a diagnosis of moderate to severe symptoms of uterine fibroids who are not eligible for surgery and for whom a intermittent treatment with Esmya in a long term manner (at least 2 courses), is planned or subjects who were exposed to UPA 5 or 10 mg during long term Phase III trials PGL09-027 (PEARL III extension, including patients (PEARL extension 2)) or PGL11-006 (PEARL IV), and
• Patient is willing and able to attend visits which are scheduled by her treating physician for the regular follow-up, provide the required medical data, and
• Patient has personally signed and dated the informed consent document indicating that she has been informed of all pertinent aspects of the study

Ki nem vehet részt

• Patient is using an investigational drug/therapy or has discontinued the use of an investigational drug/therapy within 30 days prior to study enrolment,
• Not applicable to long term phase III previous subjects who are not planning to receive Esmya during this study:; Patient is pregnant or plans to become pregnant within the next 12 months from treatment start,; Patient is breastfeeding,; Patient has genital bleeding of unknown aetiology or not due to uterine fibroids,; Patient has been diagnosed with uterine, cervical, ovarian or breast cancer
• Patient has hypersensitivity to the active substance of Esmya or to one of its excipients,
• Patient is prescribed Esmya for pre-operative treatment
• Patient has a contraindication to receive Esmya as per SmPC