Esmya
ulipristal
Table of contents
Overview
Esmya is a medicine for treating moderate to severe symptoms of uterine fibroids. Uterine fibroids are non-cancerous (benign) tumours of the womb (uterus).
Esmya is for use only in women who have not yet reached the menopause and in whom fibroid embolisation (a non-surgical procedure to block off the arteries that feed the fibroids) or surgery are not suitable or have not worked.
The medicine contains the active substance ulipristal acetate.
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List item
Esmya : EPAR - Medicine overview (PDF/126.07 KB)
Adopted
First published: 15/03/2012
Last updated: 03/02/2021
EMA/141458/2012 -
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List item
Esmya : EPAR - Risk-management-plan summary (PDF/187.56 KB)
First published: 19/11/2018
Last updated: 03/02/2021
Authorisation details
Product details | |
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Name |
Esmya
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Agency product number |
EMEA/H/C/002041
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Active substance |
ulipristal acetate
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International non-proprietary name (INN) or common name |
ulipristal
|
Therapeutic area (MeSH) |
Leiomyoma
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Anatomical therapeutic chemical (ATC) code |
G03XB02
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Publication details | |
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Marketing-authorisation holder |
Gedeon Richter Ltd
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Revision |
16
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Date of issue of marketing authorisation valid throughout the European Union |
22/02/2012
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Contact address |
Gedeon Richter Ltd
Gyömroi út 19-21 HU-1103 Budapest Hungary |
Product information
11/01/2021 Esmya - EMEA/H/C/002041 - A31/0049
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.
Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Assessment history
News
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13/11/2020
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04/09/2020
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04/09/2020
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Suspension of ulipristal acetate for uterine fibroids during ongoing EMA review of liver injury risk13/03/2020
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13/03/2020
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08/08/2018
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01/06/2018
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18/05/2018
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09/02/2018
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01/12/2017
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24/04/2015