Ulipristal Acetate Gedeon Richter

ulipristal acetate

Overview
Authorisation details
Product information
Assessment history

Withdrawn

This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Ulipristal Acetate Gedeon Richter was withdrawn at the request of the marketing-authorisation holder.

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Ulipristal Acetate Gedeon Richter : EPAR - Medicine overview (PDF/721.33 KB)

First published: 06/09/2018
Last updated: 02/07/2021
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Ulipristal Acetate Gedeon Richter : EPAR - Risk-management-plan summary (PDF/814.11 KB)

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

This EPAR was last updated on 09/07/2021

Authorisation details

Product details
Name	Ulipristal Acetate Gedeon Richter
Agency product number	EMEA/H/C/005017
Active substance	ulipristal acetate
International non-proprietary name (INN) or common name	ulipristal acetate
Therapeutic area (MeSH)	Leiomyoma
Anatomical therapeutic chemical (ATC) code	G03XB02

Publication details
Marketing-authorisation holder	Gedeon Richter Plc.
Revision	1
Date of issue of marketing authorisation valid throughout the European Union	27/08/2018
Contact address	Gyomroi ut 19-21 1103 Budapest Hungary

Product information

14/06/2021 Ulipristal Acetate Gedeon Richter - EMEA/H/C/005017 -

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Ulipristal Acetate Gedeon Richter : EPAR - Product Information (PDF/1.01 MB)

First published: 06/09/2018
Last updated: 02/07/2021
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Other EU languages available icon 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.

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Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations (PDF/597.46 KB)

First published: 06/09/2018
Last updated: 02/07/2021
- Bulgarian
  (PDF/640.72 KB)
- Croatian
  (PDF/606.66 KB)
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  (PDF/622.2 KB)
- Danish
  (PDF/596.79 KB)
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- Swedish
  (PDF/590.12 KB)

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.

Assessment history

Changes since initial authorisation of medicine

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Ulipristal Acetate Gedeon Richter : EPAR - Procedural steps taken and scientific information after authorisation (PDF/728.11 KB)

First published: 03/02/2021
Last updated: 02/07/2021
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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 (PDF/1.4 MB)

Adopted

First published: 03/02/2021
Last updated: 02/07/2021
EMA/524073/2020
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Ulipristal Acetate Gedeon Richter : EPAR - Scientific conclusions - Annex IV (PDF/742.71 KB)

First published: 03/02/2021
Last updated: 02/07/2021
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- Italian
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- Lithuanian
  (PDF/869.2 KB)
- Maltese
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- Norwegian
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- Portuguese
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- Romanian
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- Slovak
  (PDF/1013.26 KB)
- Slovenian
  (PDF/1001.18 KB)
- Spanish
  (PDF/717.52 KB)
- Swedish
  (PDF/709.6 KB)

Ulipristal Acetate Gedeon Richter

Table of contents

Overview