Ulipristal Acetate Gedeon Richter

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ulipristal acetate

Authorised
This medicine is authorised for use in the European Union.

Overview

Ulipristal Acetate Gedeon Richter is a medicine used to treat moderate to severe symptoms of uterine fibroids in adult women who have not yet reached the menopause. Uterine fibroids are non-cancerous (benign) tumours of the womb (uterus).

The medicine can be given:

  • as a single treatment course in women before they have surgery for their fibroids;
  • as intermittent treatment for women in whom surgery is not suitable.

Ulipristal Acetate Gedeon Richter contains the active substance ulipristal acetate.

This medicine is the same as Esmya, which is already authorised in the EU. The company that makes Esmya has agreed that its scientific data can be used for Ulipristal Acetate Gedeon Richter (‘informed consent’).

This EPAR was last updated on 06/09/2018

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)
Leiomyosarcoma
Anatomical therapeutic chemical (ATC) code
G03XB02
Publication details
Marketing-authorisation holder
Gedeon Richter Plc.
Revision
0
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

27/08/2018 Ulipristal Acetate Gedeon Richter - EMEA/H/C/005017 - -

Contents

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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

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