Ulipristal Acetate Gedeon Richter


ulipristal acetate

This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Ulipristal Acetate Gedeon Richter was withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 09/07/2021

Authorisation details

Product details
Ulipristal Acetate Gedeon Richter
Agency product number
Active substance
ulipristal acetate
International non-proprietary name (INN) or common name
ulipristal acetate
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Gedeon Richter Plc.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Gyomroi ut 19-21
1103 Budapest

Product information

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

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Product information documents contain:

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.

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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