Ulipristal Acetate Gedeon Richter

ulipristal acetate

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An overview of Ulipristal Acetate Gedeon Richter and why it is authorised in the EU

Ulipristal Acetate Gedeon Richter is a medicine used to treat moderate to severe symptoms of uterine fibroids in adult women who have not yet reached the menopause. Uterine fibroids are non-cancerous (benign) tumours of the womb (uterus).

The medicine can be given:

  • as a single treatment course in women before they have surgery for their fibroids;
  • as intermittent treatment for women in whom surgery is not suitable.

Ulipristal Acetate Gedeon Richter contains the active substance ulipristal acetate.

This medicine is the same as Esmya, which is already authorised in the EU. The company that makes Esmya has agreed that its scientific data can be used for Ulipristal Acetate Gedeon Richter (‘informed consent’).

How is Ulipristal Acetate Gedeon Richter used?

Ulipristal Acetate Gedeon Richter can only be obtained with a prescription, and treatment should be started and supervised by a doctor experienced in the diagnosis and treatment of uterine fibroids.

It is available as tablets (5 mg) to be taken by mouth. The recommended dose is one tablet a day for up to three months (one treatment course). The three-month treatment course can be repeated in women in whom surgery is not suitable. Treatment should always be started during the first week of the menstrual period.

For more information about using Ulipristal Acetate Gedeon Richter, see the package leaflet or contact your doctor or pharmacist.

How does Ulipristal Acetate Gedeon Richter work?

The active substance in Ulipristal Acetate Gedeon Richter, ulipristal acetate, blocks the activity of progesterone, a hormone in the body involved in controlling the growth of the lining of the womb. In some women, progesterone may promote the growth of fibroids, which can 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). When progesterone activity is blocked, fibroid cells stop dividing and eventually die, which reduces the size of the fibroids and the symptoms caused by them.

What benefits of Ulipristal Acetate Gedeon Richter have been shown in studies?

Ulipristal Acetate Gedeon Richter improved the symptoms of uterine fibroids in two main studies involving 549 women who were to have surgery to remove the fibroids.

In the first study, uterine bleeding was reduced in 92% of women taking the medicine for three months (one treatment course) compared with 19% of women taking placebo (a dummy treatment). The size of the fibroids was also smaller in women treated with the medicine than in those who received placebo.

In the second study, Ulipristal Acetate Gedeon Richter taken for three months was as effective as leuprorelin (another medicine for fibroids) in reducing heavy uterine bleeding, with bleeding reduced in 90% of women treated with Ulipristal Acetate Gedeon Richter compared with 89% of women treated with leuprorelin.

Long-term treatment with the medicine has been investigated in a main study involving 451 women who were given 4 three-month courses of 5 or 10 mg of Ulipristal Acetate Gedeon Richter. 49% of women receiving 5 mg (95 out of the 195 women who were assessed) had no more than one day of spotting (minimal uterine bleeding) within a 35-day interval after each treatment course, and 70% had no more than one day of spotting within a 35-day interval at the end of the fourth treatment course. A reduction in fibroid size was also observed.

What are the risks associated with Ulipristal Acetate Gedeon Richter?

The most common side effects with Ulipristal Acetate Gedeon Richter (which may affect more than 1 in 10 patients) are amenorrhoea (absence of menstrual period) and endometrial thickening (thickening of the lining of the womb). For the full list of all side effects reported with the medicine, see the package leaflet.

Ulipristal Acetate Gedeon Richter 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, have cancer of the womb, cervix (the neck of the womb), ovary or breast, or have liver problems. For the full list of restrictions, see the package leaflet.

Why is Ulipristal Acetate Gedeon Richter authorised in the EU?

The European Medicines Agency decided that the benefits of Ulipristal Acetate Gedeon Richter outweigh its risks and it can be authorised for use in the EU. The medicine has been shown to be effective in reducing symptoms as well as the size of the fibroids in women who were to have surgery for their fibroids and when used intermittently for longer periods (up to 4 treatment courses). Rare but serious cases of liver injury have been reported with the medicine and measures have been put in place to minimise this risk.1 Although endometrial thickening was seen in some patients, it normally disappeared after stopping treatment.


1See outcome of safety review carried out in 2018.

What measures are being taken to ensure the safe and effective use of Ulipristal Acetate Gedeon Richter?

The company that markets Ulipristal Acetate Gedeon Richter will ensure that doctors who are expected to prescribe this medicine receive educational material with information about its safety, including recommendations for monitoring liver function and endometrial changes during treatment. A card will also be given to patients to inform them about the need for liver monitoring and to contact their doctor if they develop symptoms of liver injury (such as tiredness, yellowing of the skin, darkening of the urine, nausea and vomiting).

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ulipristal Acetate Gedeon Richter have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Ulipristal Acetate Gedeon Richter are continuously monitored. Side effects reported with the medicine are carefully evaluated and any necessary action taken to protect patients.

Other information about Ulipristal Acetate Gedeon Richter

Ulipristal Acetate Gedeon Richter received a marketing authorisation valid throughout the EU on 27 August 2018.

This EPAR was last updated on 06/09/2018 .

Authorisation details

Product details

Product details for Ulipristal Acetate Gedeon Richter
NameUlipristal Acetate Gedeon Richter
Agency product numberEMEA/H/C/005017
Active substance

ulipristal acetate

International non-proprietary name (INN) or common name

ulipristal acetate

Therapeutic area Leiomyosarcoma
Anatomical therapeutic chemical (ATC) code G03XB02

Publication details

Publication details for Ulipristal Acetate Gedeon Richter
Marketing-authorisation holder

Gedeon Richter Plc.

Revision0
Date of issue of marketing authorisation valid throughout the European Union27/08/2018

Contact address:

Gedeon Richter Plc.
Gyomroi ut 19-21 
1103 Budapest 
Hungary

Product information

Product information

27/08/2018  Ulipristal Acetate Gedeon Richter -EMEA/H/C/005017 --

Name Language First published Last updated
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - Product Information EN = English 2018-09-06  

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
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  
Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations EN = English 2018-09-06  

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic indication

Ulipristal acetate is indicated for one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Ulipristal Acetate Gedeon Richter : EPAR - Public assessment report EN = English 2018-09-06  
CHMP summary of positive opinion for Ulipristal Acetate Gedeon Richter EN = English 2018-06-29