A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturers responsible for batch release
17, Rue de Pontoise
Gedeon Richter Plc, 1103 Budapest Gyömrői út
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to medical prescription.
C.OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Periodic Safety Update Reports
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines
D.CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Risk Management Plan (RMP)
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
An updated RMP should be submitted:
At the request of the European Medicines Agency;
Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as a result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Additional risk minimisation measures
Prior to launch of the medicinal product in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
The MAH shall ensure that, at launch and thereafter, all prescribers of Esmya and pathologists who review samples from
The educational material shall consist of the following:
Educational material for prescribers (gynaecologists) which contains:
oPhysician’s guide to prescribing Esmya
Educational material for pathologists which contains
oUSB stick or CD ROM with images of digital specimens (digital library with high resolution images).
The educational material shall contain the following key elements:
Physician’s guide to prescribing
detailed recommendations for management of endometrial thickening.
reminder of the effect of ulipristal acetate on the endometrium.
the need to inform the pathologist that patients were treated with Esmya if biopsy/surgical samples are to be sent for analysis.
the posology: 5 mg tablet once daily for treatment courses of up to 3 months each. Treatments should only be initiated when menstruation has occurred: the first treatment course should start during the first week of menstruation,
the contraindications of pregnancy and breastfeeding, genital bleeding of unknown aetiology or for reasons other than uterine fibroids, and uterine, cervical, ovarian or breast cancer.
absence of safety data on the endometrium for continuous treatment longer than 3 months.
the need to investigate as per usual clinical practice persistence of endometrial thickening following treatment discontinuation and return of menstruation to exclude other underlying conditions.
recommendation of a periodic monitoring of the endometrium in case of repeated intermittent treatment. This includes annual ultrasound to be performed after resumption of menstruation during
Educational material for pathologists
key effects of Esmya on Progesterone Receptor Modulator Associated Endometrial Changes (PAEC) and how they differ from those of unopposed oestrogen
the differential diagnosis between PAEC, unopposed oestrogen and endometrial hyperplasia.