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Esmya (ulipristal acetate) – Conditions or restrictions regarding supply and use - G03XB02

Updated on site: 06-Oct-2017

Medication nameEsmya
ATC CodeG03XB02
Substanceulipristal acetate
ManufacturerGedeon Richter Ltd.  

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

Cenexi

17, Rue de Pontoise FR-95520 Osny France

Gedeon Richter Plc, 1103 Budapest Gyömrői út 19-21 Hungary

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 web-portal.

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 Esmya-treated patients are provided with educational material.

The educational material shall consist of the following:

Educational material for prescribers (gynaecologists) which contains:

oCover letter

oSmPC

oPhysician’s guide to prescribing Esmya

Educational material for pathologists which contains

oPathologist’s guide

oUSB stick or CD ROM with images of digital specimens (digital library with high resolution images).

o SmPC

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 indications.

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, re-treatment courses should start at the earliest during the first week of the second menstruation following the previous treatment course completion. The treating physician should explain to the patient the requirement for treatment free intervals.

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 off-treatment period. If endometrial thickening is noted, which persists after return of menstruations during off-treatment periods or beyond 3 months following the end of treatment courses, and/or an altered bleeding pattern is noted, investigation including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.

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.

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