Ryeqo

RSS

relugolix / estradiol / norethisterone acetate

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

Overview

Ryeqo is a medicine used to treat moderate to severe symptoms of uterine fibroids (non-cancerous growths in the womb) in women of reproductive age.


Ryeqo contains the active substances relugolix, estradiol and norethisterone acetate.

This EPAR was last updated on 08/06/2023

Authorisation details

Product details
Name
Ryeqo
Agency product number
EMEA/H/C/005267
Active substance
  • Relugolix
  • norethisterone acetate
  • estradiol hemihydrate
International non-proprietary name (INN) or common name
  • relugolix
  • estradiol
  • norethisterone acetate
Therapeutic area (MeSH)
Leiomyoma
Anatomical therapeutic chemical (ATC) code
H01CC54
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Gedeon Richter Plc.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
16/07/2021
Contact address

Gyomroi ut 19-21
1103 Budapest
Hungary

Product information

31/03/2023 Ryeqo - EMEA/H/C/005267 - PSUSA/00010942/202205

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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

Pituitary and hypothalamic hormones and analogues

Therapeutic indication

Ryeqo is indicated for treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

Assessment history

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