Orgovyx

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relugolix

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

Overview

Orgovyx is a medicine used to treat advanced cancer of the prostate (a gland of the male reproductive system) in adult patients when the cancer is ‘hormone-sensitive’, which means that it responds to treatments that reduce the levels of testosterone (the male sex hormone).

Orgovyx contains the active substance relugolix.

This EPAR was last updated on 26/07/2022

Authorisation details

Product details
Name
Orgovyx
Agency product number
EMEA/H/C/005353
Active substance
Relugolix
International non-proprietary name (INN) or common name
relugolix
Therapeutic area (MeSH)
Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code
L02BX
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
Accord Healthcare S.L.U.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
29/04/2022
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

08/07/2022 Orgovyx - EMEA/H/C/005353 - T/0002

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

Endocrine therapy

Therapeutic indication

Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.

Assessment history

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