Esmya

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Withdrawn

This medicine's authorisation has been withdrawn

ulipristal
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 18 July 2024, the European Commission withdrew the marketing authorisation for Esmya (ulipristal acetate) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Gedeon Richter Plc., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Esmya was granted marketing authorisation in the EU on 23 February 2012 for the treatment of uterine fibroids. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2016. Esmya is an identical product to Ryeqo and Yselty, which are authorised in the EU to treat uterine fibroids. 

The European Public Assessment Report (EPAR) for Esmya is updated to indicate that the marketing authorisation is no longer valid.

Esmya : EPAR - Medicine overview

AdoptedReference Number: EMA/141458/2012

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български (BG) (275.47 KB - PDF)

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español (ES) (211.43 KB - PDF)

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čeština (CS) (248.67 KB - PDF)

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dansk (DA) (206.07 KB - PDF)

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Deutsch (DE) (216.09 KB - PDF)

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eesti keel (ET) (195.31 KB - PDF)

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ελληνικά (EL) (278.79 KB - PDF)

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français (FR) (212.74 KB - PDF)

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hrvatski (HR) (243.81 KB - PDF)

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italiano (IT) (203.73 KB - PDF)

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latviešu valoda (LV) (261.58 KB - PDF)

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lietuvių kalba (LT) (246.29 KB - PDF)

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magyar (HU) (235.86 KB - PDF)

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Malti (MT) (265.33 KB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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Nederlands (NL) (211.03 KB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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polski (PL) (249.35 KB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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português (PT) (209.79 KB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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română (RO) (250.59 KB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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slovenčina (SK) (244.89 KB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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slovenščina (SL) (245.13 KB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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Suomi (FI) (201.57 KB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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svenska (SV) (207.95 KB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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Esmya : EPAR - Risk-management-plan summary

English (EN) (349.58 KB - PDF)

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Product information

Esmya : EPAR - Product Information

English (EN) (1.15 MB - PDF)

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български (BG) (1.56 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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español (ES) (1.2 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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čeština (CS) (1.28 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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dansk (DA) (1.13 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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Deutsch (DE) (1.27 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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eesti keel (ET) (919.58 KB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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ελληνικά (EL) (1.77 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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français (FR) (1.24 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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hrvatski (HR) (1.37 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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íslenska (IS) (1.09 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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italiano (IT) (1.17 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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latviešu valoda (LV) (1.37 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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lietuvių kalba (LT) (1.36 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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magyar (HU) (1.31 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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Malti (MT) (1.41 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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Nederlands (NL) (1.21 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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norsk (NO) (1.14 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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polski (PL) (1.4 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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português (PT) (1.18 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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română (RO) (1.41 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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slovenčina (SK) (1.3 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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slovenščina (SL) (1.27 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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Suomi (FI) (1.16 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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svenska (SV) (1.08 MB - PDF)

First published: 15/03/2012Last updated: 03/02/2021
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Latest procedure affecting product information: A31/0049
11/01/2021
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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).

Esmya : EPAR - All Authorised presentations

English (EN) (48.74 KB - PDF)

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български (BG) (95.68 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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español (ES) (61.96 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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čeština (CS) (66.59 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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dansk (DA) (58.48 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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Deutsch (DE) (54.62 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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eesti keel (ET) (56.81 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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ελληνικά (EL) (91.42 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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français (FR) (56.72 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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hrvatski (HR) (62.41 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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íslenska (IS) (58.05 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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italiano (IT) (60.47 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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latviešu valoda (LV) (87.06 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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lietuvių kalba (LT) (89.44 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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magyar (HU) (91.81 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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Malti (MT) (86.31 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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Nederlands (NL) (58.81 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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norsk (NO) (58.12 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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polski (PL) (67.93 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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português (PT) (57.43 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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română (RO) (86.2 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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slovenčina (SK) (69.46 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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slovenščina (SL) (72.13 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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Suomi (FI) (58.37 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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svenska (SV) (58.85 KB - PDF)

First published: 15/03/2012Last updated: 27/05/2014
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Product details

Name of medicine
Esmya
Active substance
ulipristal acetate
International non-proprietary name (INN) or common name
ulipristal
Therapeutic area (MeSH)
Leiomyoma
Anatomical therapeutic chemical (ATC) code
G03XB02

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.

Authorisation details

EMA product number
EMEA/H/C/002041
Marketing authorisation holder
Gedeon Richter Ltd 

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

Opinion adopted
15/12/2011
Marketing authorisation issued
22/02/2012
Withdrawal of marketing authorisation
18/07/2024
Revision
16

Assessment history

Esmya : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (794.83 KB - PDF)

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Esmya : EPAR - Scientific conclusions - Annex IV

English (EN) (440.77 KB - PDF)

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български (BG) (792.72 KB - PDF)

First published: 03/02/2021
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español (ES) (485.06 KB - PDF)

First published: 03/02/2021
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čeština (CS) (642 KB - PDF)

First published: 03/02/2021
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dansk (DA) (475.85 KB - PDF)

First published: 03/02/2021
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Deutsch (DE) (539.09 KB - PDF)

First published: 03/02/2021
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eesti keel (ET) (633.74 KB - PDF)

First published: 03/02/2021
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ελληνικά (EL) (867.35 KB - PDF)

First published: 03/02/2021
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français (FR) (506.15 KB - PDF)

First published: 03/02/2021
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hrvatski (HR) (662.85 KB - PDF)

First published: 03/02/2021
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íslenska (IS) (461.5 KB - PDF)

First published: 03/02/2021
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italiano (IT) (519.62 KB - PDF)

First published: 03/02/2021
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latviešu valoda (LV) (711.89 KB - PDF)

First published: 03/02/2021
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lietuvių kalba (LT) (749.02 KB - PDF)

First published: 03/02/2021
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magyar (HU) (624.15 KB - PDF)

First published: 03/02/2021
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Malti (MT) (759.86 KB - PDF)

First published: 03/02/2021
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Nederlands (NL) (503.62 KB - PDF)

First published: 03/02/2021
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norsk (NO) (458.17 KB - PDF)

First published: 03/02/2021
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polski (PL) (724.19 KB - PDF)

First published: 03/02/2021
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português (PT) (472.57 KB - PDF)

First published: 03/02/2021
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română (RO) (742.93 KB - PDF)

First published: 03/02/2021
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slovenčina (SK) (629.32 KB - PDF)

First published: 03/02/2021
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slovenščina (SL) (636.66 KB - PDF)

First published: 03/02/2021
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Suomi (FI) (472.99 KB - PDF)

First published: 03/02/2021
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svenska (SV) (464.54 KB - PDF)

First published: 03/02/2021
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Ulipristal Acetate Gedeon Richter / Esmya-H-A-31-1496-C-2041-0049: EPAR - CHMP scientific conclusions and PRAC Assessment report - Article 31

AdoptedReference Number: EMA/524073/2020

English (EN) (1.4 MB - PDF)

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Esmya-H-C-2041-A20-0043 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/442745/2018

English (EN) (1.35 MB - PDF)

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Esmya-H-C-2041-A20-0043 : EPAR - Divergent position of CHMP - Article 20

English (EN) (49.4 KB - PDF)

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Esmya-H-C-PSUSA-00009325-201702 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/11208/2018

English (EN) (118.9 KB - PDF)

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Esmya-H-C-2041-II-0028 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/84021/2015

English (EN) (7.35 MB - PDF)

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CHMP post-authorisation summary of positive opinion for Esmya

AdoptedReference Number: EMA/CHMP/245897/2015

English (EN) (107.72 KB - PDF)

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Esmya : EPAR - Public assessment report

AdoptedReference Number: EMA/141637/2012

English (EN) (4.98 MB - PDF)

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CHMP summary of positive opinion for Esmya

AdoptedReference Number: EMA/679632/2011

English (EN) (137.48 KB - PDF)

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