Ulipristal Acetate Gedeon Richter

RSS
Withdrawn

This medicine's authorisation has been withdrawn

ulipristal acetate
Medicine Human Withdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 14 June 2021, the European Commission withdrew the marketing authorisation for Ulipristal Acetate Gedeon Richter (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 not to market the product in the EU for commercial reasons. 

Ulipristal Acetate Gedeon Richter was granted marketing authorisation in the EU on 27 August 2018 for the treatment of uterine fibroids. The marketing authorisation was initially valid for a 5-year period. 

Ulipristal Acetate Gedeon Richter was a duplicate application to Esmya, which is marketed in several EU countries. 

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Report (EPAR) for Ulipristal Acetate Gedeon Richter is updated to indicate that the marketing authorisation is no longer valid.

Ulipristal Acetate Gedeon Richter : EPAR - Medicine overview

English (EN) (721.33 KB - PDF)

First published: Last updated:
View

български (BG) (805.8 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

español (ES) (708.53 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

čeština (CS) (781.02 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

dansk (DA) (705.89 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Deutsch (DE) (711.46 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

eesti keel (ET) (694.54 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

ελληνικά (EL) (805.14 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

français (FR) (710.29 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

hrvatski (HR) (734.95 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

italiano (IT) (706 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

latviešu valoda (LV) (156.85 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

lietuvių kalba (LT) (733.64 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

magyar (HU) (779.92 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Malti (MT) (793.31 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Nederlands (NL) (707.03 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

polski (PL) (781.89 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

português (PT) (698.7 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

română (RO) (734.45 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

slovenčina (SK) (784.27 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

slovenščina (SL) (779.14 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Suomi (FI) (705.48 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

svenska (SV) (706.53 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Ulipristal Acetate Gedeon Richter : EPAR - Medicine overview

English (EN) (721.33 KB - PDF)

First published: Last updated:
View

български (BG) (805.8 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

español (ES) (708.53 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

čeština (CS) (781.02 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

dansk (DA) (705.89 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Deutsch (DE) (711.46 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

eesti keel (ET) (694.54 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

ελληνικά (EL) (805.14 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

français (FR) (710.29 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

hrvatski (HR) (734.95 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

italiano (IT) (706 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

latviešu valoda (LV) (156.85 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

lietuvių kalba (LT) (733.64 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

magyar (HU) (779.92 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Malti (MT) (793.31 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Nederlands (NL) (707.03 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

polski (PL) (781.89 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

português (PT) (698.7 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

română (RO) (734.45 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

slovenčina (SK) (784.27 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

slovenščina (SL) (779.14 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Suomi (FI) (705.48 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

svenska (SV) (706.53 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Ulipristal Acetate Gedeon Richter : EPAR - Risk-management-plan summary

English (EN) (814.11 KB - PDF)

First published: Last updated:
View

Product information

Ulipristal Acetate Gedeon Richter : EPAR - Product Information

English (EN) (1.01 MB - PDF)

First published: Last updated:
View

български (BG) (1.87 MB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

español (ES) (1006.84 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

čeština (CS) (980.38 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

dansk (DA) (985.58 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Deutsch (DE) (1.04 MB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

eesti keel (ET) (931.37 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

ελληνικά (EL) (1.98 MB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

français (FR) (1018.25 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

hrvatski (HR) (1.07 MB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

íslenska (IS) (975.68 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

italiano (IT) (974.64 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

latviešu valoda (LV) (1.8 MB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

lietuvių kalba (LT) (1.8 MB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

magyar (HU) (1.56 MB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Malti (MT) (1.62 MB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Nederlands (NL) (967.06 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

norsk (NO) (973.21 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

polski (PL) (1.59 MB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

português (PT) (987.36 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

română (RO) (1.09 MB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

slovenčina (SK) (1.55 MB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

slovenščina (SL) (1.5 MB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Suomi (FI) (1013.08 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

svenska (SV) (948.19 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View
14/06/2021
icon globe

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).

Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations

English (EN) (597.46 KB - PDF)

First published: Last updated:
View

български (BG) (640.72 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

español (ES) (597.33 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

čeština (CS) (622.2 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

dansk (DA) (596.79 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Deutsch (DE) (597.21 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

eesti keel (ET) (597 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

ελληνικά (EL) (640.57 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

français (FR) (597.63 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

hrvatski (HR) (606.66 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

íslenska (IS) (597.28 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

italiano (IT) (596.99 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

latviešu valoda (LV) (634.12 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

lietuvių kalba (LT) (617.71 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

magyar (HU) (629.46 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Malti (MT) (630.46 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Nederlands (NL) (597.66 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

norsk (NO) (597.55 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

polski (PL) (622.63 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

português (PT) (597.51 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

română (RO) (616.82 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

slovenčina (SK) (622.69 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

slovenščina (SL) (621.01 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Suomi (FI) (597.62 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

svenska (SV) (590.12 KB - PDF)

First published: 06/09/2018 Last updated: 02/07/2021
View

Product details

Name of medicine
Ulipristal Acetate Gedeon Richter
Active substance
ulipristal acetate
International non-proprietary name (INN) or common name
ulipristal acetate
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 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.

Authorisation details

EMA product number
EMEA/H/C/005017
Marketing authorisation holder
Gedeon Richter Plc.

Gyomroi ut 19-21
1103 Budapest
Hungary

Opinion adopted
28/06/2018
Marketing authorisation issued
27/08/2018
Revision
1

Assessment history

Ulipristal Acetate Gedeon Richter : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (728.11 KB - PDF)

First published: Last updated:
View

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

Adopted Reference Number: EMA/524073/2020

English (EN) (1.4 MB - PDF)

First published: Last updated:
View

Ulipristal Acetate Gedeon Richter : EPAR - Scientific conclusions - Annex IV

English (EN) (742.71 KB - PDF)

First published: Last updated:
View

български (BG) (1.16 MB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

español (ES) (717.52 KB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

čeština (CS) (1.08 MB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

dansk (DA) (776.12 KB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

Deutsch (DE) (809.32 KB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

eesti keel (ET) (780.64 KB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

ελληνικά (EL) (1.12 MB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

français (FR) (724.64 KB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

hrvatski (HR) (851.47 KB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

íslenska (IS) (708.37 KB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

italiano (IT) (1.33 MB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

latviešu valoda (LV) (1.01 MB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

lietuvių kalba (LT) (869.2 KB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

magyar (HU) (988.65 KB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

Malti (MT) (1.05 MB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

Nederlands (NL) (710.99 KB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

norsk (NO) (699.99 KB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

polski (PL) (1.01 MB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

português (PT) (719.58 KB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

română (RO) (879.76 KB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

slovenčina (SK) (1013.26 KB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

slovenščina (SL) (1001.18 KB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

Suomi (FI) (704.64 KB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

svenska (SV) (709.6 KB - PDF)

First published: 03/02/2021 Last updated: 02/07/2021
View

Ulipristal Acetate Gedeon Richter : EPAR - Public assessment report

Adopted Reference Number: EMA/483416/2018

English (EN) (862.63 KB - PDF)

First published: Last updated:
View

CHMP summary of positive opinion for Ulipristal Acetate Gedeon Richter

Adopted Reference Number: EMA/CHMP/417636/2018

English (EN) (69.67 KB - PDF)

First published: Last updated:
View
This page was last updated on

Share this page

Back to top