Overview

The marketing authorisation for Ulipristal Acetate Gedeon Richter was withdrawn at the request of the marketing-authorisation holder.

Ulipristal Acetate Gedeon Richter : EPAR - Medicine overview

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Ulipristal Acetate Gedeon Richter : EPAR - Medicine overview

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български (BG) (805.8 KB - PDF)

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

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Product information

Ulipristal Acetate Gedeon Richter : EPAR - Product Information

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14/06/2021

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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).

Ulipristal Acetate Gedeon Richter : EPAR - All Authorised presentations

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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

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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

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

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latviešu valoda (LV) (1.01 MB - PDF)

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Ulipristal Acetate Gedeon Richter : EPAR - Public assessment report

AdoptedReference Number: EMA/483416/2018

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CHMP summary of positive opinion for Ulipristal Acetate Gedeon Richter

AdoptedReference Number: EMA/CHMP/417636/2018

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More information on Ulipristal Acetate Gedeon Richter

Public statement on Ulipristal Acetate Gedeon Richter: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/265520/2021

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