Ulipristal Acetate Gedeon Richter
Withdrawn
This medicine's authorisation has been withdrawn
ulipristal acetate
MedicineHumanWithdrawn
- 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Report (EPAR) for Ulipristal Acetate Gedeon Richter is updated to indicate that the marketing authorisation is no longer valid.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:
български (BG) (805.8 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
español (ES) (708.53 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
čeština (CS) (781.02 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
dansk (DA) (705.89 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Deutsch (DE) (711.46 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
eesti keel (ET) (694.54 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
ελληνικά (EL) (805.14 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
français (FR) (710.29 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
hrvatski (HR) (734.95 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
italiano (IT) (706 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
latviešu valoda (LV) (156.85 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
lietuvių kalba (LT) (733.64 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
magyar (HU) (779.92 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Malti (MT) (793.31 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Nederlands (NL) (707.03 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
polski (PL) (781.89 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
português (PT) (698.7 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
română (RO) (734.45 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
slovenčina (SK) (784.27 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
slovenščina (SL) (779.14 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Suomi (FI) (705.48 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
svenska (SV) (706.53 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Ulipristal Acetate Gedeon Richter : EPAR - Medicine overview
English (EN) (721.33 KB - PDF)
First published: Last updated:
български (BG) (805.8 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
español (ES) (708.53 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
čeština (CS) (781.02 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
dansk (DA) (705.89 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Deutsch (DE) (711.46 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
eesti keel (ET) (694.54 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
ελληνικά (EL) (805.14 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
français (FR) (710.29 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
hrvatski (HR) (734.95 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
italiano (IT) (706 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
latviešu valoda (LV) (156.85 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
lietuvių kalba (LT) (733.64 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
magyar (HU) (779.92 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Malti (MT) (793.31 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Nederlands (NL) (707.03 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
polski (PL) (781.89 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
português (PT) (698.7 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
română (RO) (734.45 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
slovenčina (SK) (784.27 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
slovenščina (SL) (779.14 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Suomi (FI) (705.48 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
svenska (SV) (706.53 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Ulipristal Acetate Gedeon Richter : EPAR - Risk-management-plan summary
English (EN) (814.11 KB - PDF)
First published: Last updated:
Product information
Ulipristal Acetate Gedeon Richter : EPAR - Product Information
English (EN) (1.01 MB - PDF)
First published: Last updated:
български (BG) (1.87 MB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
español (ES) (1006.84 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
čeština (CS) (980.38 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
dansk (DA) (985.58 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Deutsch (DE) (1.04 MB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
eesti keel (ET) (931.37 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
ελληνικά (EL) (1.98 MB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
français (FR) (1018.25 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
hrvatski (HR) (1.07 MB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
íslenska (IS) (975.68 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
italiano (IT) (974.64 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
latviešu valoda (LV) (1.8 MB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
lietuvių kalba (LT) (1.8 MB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
magyar (HU) (1.56 MB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Malti (MT) (1.62 MB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Nederlands (NL) (967.06 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
norsk (NO) (973.21 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
polski (PL) (1.59 MB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
português (PT) (987.36 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
română (RO) (1.09 MB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
slovenčina (SK) (1.55 MB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
slovenščina (SL) (1.5 MB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Suomi (FI) (1013.08 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
svenska (SV) (948.19 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
14/06/2021
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:
български (BG) (640.72 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
español (ES) (597.33 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
čeština (CS) (622.2 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
dansk (DA) (596.79 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Deutsch (DE) (597.21 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
eesti keel (ET) (597 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
ελληνικά (EL) (640.57 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
français (FR) (597.63 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
hrvatski (HR) (606.66 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
íslenska (IS) (597.28 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
italiano (IT) (596.99 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
latviešu valoda (LV) (634.12 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
lietuvių kalba (LT) (617.71 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
magyar (HU) (629.46 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Malti (MT) (630.46 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Nederlands (NL) (597.66 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
norsk (NO) (597.55 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
polski (PL) (622.63 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
português (PT) (597.51 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
română (RO) (616.82 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
slovenčina (SK) (622.69 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
slovenščina (SL) (621.01 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
Suomi (FI) (597.62 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
svenska (SV) (590.12 KB - PDF)
First published: 06/09/2018Last updated: 02/07/2021
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 systemTherapeutic 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:
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)
First published: Last updated:
Ulipristal Acetate Gedeon Richter : EPAR - Scientific conclusions - Annex IV
English (EN) (742.71 KB - PDF)
First published: Last updated:
български (BG) (1.16 MB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
español (ES) (717.52 KB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
čeština (CS) (1.08 MB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
dansk (DA) (776.12 KB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
Deutsch (DE) (809.32 KB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
eesti keel (ET) (780.64 KB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
ελληνικά (EL) (1.12 MB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
français (FR) (724.64 KB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
hrvatski (HR) (851.47 KB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
íslenska (IS) (708.37 KB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
italiano (IT) (1.33 MB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
latviešu valoda (LV) (1.01 MB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
lietuvių kalba (LT) (869.2 KB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
magyar (HU) (988.65 KB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
Malti (MT) (1.05 MB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
Nederlands (NL) (710.99 KB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
norsk (NO) (699.99 KB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
polski (PL) (1.01 MB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
português (PT) (719.58 KB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
română (RO) (879.76 KB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
slovenčina (SK) (1013.26 KB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
slovenščina (SL) (1001.18 KB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
Suomi (FI) (704.64 KB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
svenska (SV) (709.6 KB - PDF)
First published: 03/02/2021Last updated: 02/07/2021
Ulipristal Acetate Gedeon Richter : EPAR - Public assessment report
AdoptedReference Number: EMA/483416/2018
English (EN) (862.63 KB - PDF)
First published: Last updated:
CHMP summary of positive opinion for Ulipristal Acetate Gedeon Richter
AdoptedReference Number: EMA/CHMP/417636/2018
English (EN) (69.67 KB - PDF)
First published: Last updated:
News on Ulipristal Acetate Gedeon Richter
More information on Ulipristal Acetate Gedeon Richter
This page was last updated on