Esmya

ulipristal

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This is a summary of the European public assessment report (EPAR) for Esmya. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Esmya.

What is Esmya?

Esmya is a medicine that contains the active substance ulipristal acetate. It is available as tablets (5 mg).

What is Esmya used for?

Esmya is used before surgery to treat moderate to severe symptoms of uterine fibroids, which are noncancerous (benign) tumors of the womb (uterus). Esmya is used in adult women who have not yet reached menopause.

This medicine can only be obtained with a prescription.

How is Esmya used?

Esmya is taken by mouth and the recommended dose is one tablet a day for up to three months. The three-month treatment can be repeated but only once. Treatment should always be started during the first week of the menstrual cycle (period bleeding).

How does Esmya work?

The active substance in Esmya, ulipristal acetate, is a ‘selective progesterone receptor modulator’. It acts by blocking the receptor of a hormone in the body called progesterone, which is involved in controlling the growth of the lining of the womb. In some women, progesterone may promote the growth of fibroids, which may cause symptoms such as heavy uterine bleeding (bleeding from the womb during or outside the menstrual period), anaemia (low red blood cell counts, due to bleeding) and abdominal pain (such as period pain or pain in the belly area). When progesterone activity is blocked, fibroid cells stop dividing and eventually die, which reduces the size of the fibroids and reduces the symptoms caused by them.

How has Esmya been studied?

Two main studies involving 549 women with symptomatic uterine fibroids were carried out with Esmya. In both studies the treatment lasted for three months.

One study investigated the effects of Esmya compared with placebo (a dummy treatment) in adult women with heavy uterine bleeding and anaemia who were to undergo surgery to remove the fibroids. Iron supplements were also given to all the patients to help treat anaemia. The main measures of effectiveness were reductions in heavy bleeding and associated anaemia, as well as the size of the fibroids.

The second main study investigated the effects of Esmya in comparison with another medicine used to treat fibroids, leuprorelin. The main measure of effectiveness was the ability of the treatment to reduce heavy uterine bleeding.

One additional study in 132 women was conducted to evaluate Esmya when used for more than one three-month course.

What benefit has Esmya shown during the studies?

Esmya was shown to improve the symptoms of women with uterine fibroids.

In the first study, 91.5% of women taking Esmya had reduced menstrual bleeding compared with 18.8% of women taking placebo. The size of the fibroids was also smaller in women treated with Esmya than in those who received the placebo.

In the second study, Esmya was as effective as leuprorelin in reducing heavy uterine bleeding, as 90.3% of women treated with Esmya had reduced bleeding compared with 89.1% of women treated with leuprorelin.

The study where Esmya was given beyond three months showed a slightly higher percentage of women with no uterine bleeding after the second course of treatment with Esmya than after the first (89% versus 80%).

What is the risk associated with Esmya?

What is the risk associated with Esmya?

The most common side effects associated with Esmya (seen in more than 1 in 10 patients) are amenorrhea (absence of menstrual period) and endometrial thickening (thickening of the lining of the womb). For the full list of all side effects reported with Esmya, see the package leaflet.

Esmya must not be used in women who are pregnant or breastfeeding, have bleeding from the genital region of unknown cause or for reasons other than uterine fibroids, or have cancer of the womb, cervix (the neck of the womb), ovary or breast. For the full list of restrictions, see the package leaflet.

Why has Esmya been approved?

The CHMP concluded that Esmya was shown to be effective in reducing bleeding and anaemia as well as the size of the fibroids. There were no major safety concerns. Although endometrial thickening was seen in some patients, it normally disappears after treatment. Therefore, the CHMP concluded that the benefits of Esmya outweigh its risks and recommended that it be granted marketing authorisation.

What measures are being taken to ensure the safe use of Esmya?

A risk management plan has been developed to ensure that Esmya is used as safely and effectively as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Esmya, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Esmya will ensure that doctors who are expected to prescribe this medicine receive educational material containing important safety information about Esmya, including recommendations for monitoring and managing endometrial changes that occur with Esmya treatment.

Other information about Esmya

The European Commission granted a marketing authorisation valid throughout the European Union for Esmya on 23 February 2012.

For more information about treatment with Esmya, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Esmya : EPAR - Summary for the public BG = bălgarski 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public ES = español 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public CS = čeština 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public DA = dansk 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public DE = Deutsch 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public ET = eesti keel 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public EL = elliniká 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public EN = English 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public FR = français 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public IT = italiano 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public LV = latviešu valoda 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public LT = lietuvių kalba 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public HU = magyar 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public MT = Malti 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public NL = Nederlands 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public PL = polski 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public PT = português 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public RO = română 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public SK = slovenčina 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public SL = slovenščina 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public FI = suomi 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public SV = svenska 15/03/2012 23/01/2014
Esmya : EPAR - Summary for the public HR = Hrvatski 15/03/2012 23/01/2014

This EPAR was last updated on 27/05/2014 .

Authorisation details

Product details

Product details for Esmya
NameEsmya
Agency product numberEMEA/H/C/002041
Active substance

ulipristal acetate

International non-proprietary name (INN) or common name

ulipristal

Therapeutic area Leiomyoma
Anatomical therapeutic chemical (ATC) code G03XB02

Publication details

Publication details for Esmya
Marketing-authorisation holder

Gedeon Richter Ltd.
 

Revision7
Date of issue of marketing authorisation valid throughout the European Union23/02/2012

Contact address:

Gedeon Richter Ltd.
Gyömroi út 19-21
HU-1103 Budapest
Hungary

Product information

Product information

11/04/2014  Esmya -EMEA/H/C/002041 -IAIN/0024/G

Name Language First published Last updated
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - Product Information HR = Hrvatski 15/03/2012 27/05/2014

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014
Esmya : EPAR - All Authorised presentations HR = Hrvatski 15/03/2012 27/05/2014

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic indication

Ulipristal acetate is indicated for pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The duration of treatment is limited to 3 months.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Esmya : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 06/09/2012 27/05/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Esmya : EPAR - Public assessment report HR = Hrvatski 15/03/2012  
CHMP summary of positive opinion for Esmya HR = Hrvatski 16/12/2011  

Authorised

This medicine is approved for use in the European Union