Esmya

Withdrawn

This medicine's authorisation has been withdrawn

ulipristal

Overview

On 18 July 2024, the European Commission withdrew the marketing authorisation for Esmya (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 to permanently discontinue the marketing of the product for commercial reasons.

Esmya was granted marketing authorisation in the EU on 23 February 2012 for the treatment of uterine fibroids. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2016.

The European Public Assessment Report (EPAR) for Esmya will be updated to indicate that the marketing authorisation is no longer valid.

Esmya : EPAR - Medicine overview

Adopted Reference Number: EMA/141458/2012

Esmya : EPAR - Risk-management-plan summary

Product information

Esmya : EPAR - Product Information

Esmya : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Esmya
• Active substance:
  ulipristal acetate
• International non-proprietary name (INN) or common name:
  ulipristal
• 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 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.

Authorisation details

• EMA product number:
  EMEA/H/C/002041
• Marketing authorisation holder:
  Gedeon Richter Ltd

  Gedeon Richter Ltd; Gyömroi út 19-21; HU-1103 Budapest; Hungary

• Opinion adopted:
  15/12/2011
• Marketing authorisation issued:
  22/02/2012
• Withdrawal of marketing authorisation:
  18/07/2024
• Revision:
  16

Assessment history

Changes since initial authorisation of medicine

Esmya : EPAR - Procedural steps taken and scientific information after authorisation

Esmya : EPAR - Scientific conclusions - Annex IV

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

Esmya-H-C-2041-A20-0043 : EPAR - Assessment Report - Article 20

Adopted Reference Number: EMA/442745/2018

Esmya-H-C-2041-A20-0043 : EPAR - Divergent position of CHMP - Article 20

Esmya-H-C-PSUSA-00009325-201702 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/11208/2018

Esmya-H-C-2041-II-0028 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/84021/2015

CHMP post-authorisation summary of positive opinion for Esmya

Adopted Reference Number: EMA/CHMP/245897/2015

Initial marketing authorisation documents

Esmya : EPAR - Public assessment report

Adopted Reference Number: EMA/141637/2012

CHMP summary of positive opinion for Esmya

Adopted Reference Number: EMA/679632/2011