Esmya | European Medicines Agency (EMA)

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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.

The European Public Assessment Report (EPAR) for Esmya will be updated to indicate that the marketing authorisation is no longer valid.

English (EN)
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български (BG)
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español (ES)
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čeština (CS)
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dansk (DA)
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Deutsch (DE)
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eesti keel (ET)
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ελληνικά (EL)
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français (FR)
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hrvatski (HR)
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italiano (IT)
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latviešu valoda (LV)
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lietuvių kalba (LT)
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magyar (HU)
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Malti (MT)
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Nederlands (NL)
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polski (PL)
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português (PT)
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română (RO)
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slovenčina (SK)
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slovenščina (SL)
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Suomi (FI)
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svenska (SV)
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English (EN)
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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)

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Deutsch (DE)
(1.27 MB – PDF)

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eesti keel (ET)
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ελληνικά (EL)
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français (FR)
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hrvatski (HR)
(1.37 MB – PDF)

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íslenska (IS)
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italiano (IT)
(1.17 MB – PDF)

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latviešu valoda (LV)
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lietuvių kalba (LT)
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magyar (HU)
(1.31 MB – PDF)

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Malti (MT)
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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)
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First published: 15/03/2012Last updated: 03/02/2021

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polski (PL)
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First published: 15/03/2012Last updated: 03/02/2021

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português (PT)
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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).

English (EN)
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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)

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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.

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