Orgovyx
relugolix
Table of contents
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.
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Orgovyx : EPAR - Medicine Overview (PDF/117.53 KB)
First published: 10/05/2022
EMA/145519/2022 -
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Orgovyx : EPAR - Risk management plan summary (PDF/67.15 KB)
First published: 10/05/2022
Last updated: 10/06/2022
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 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 | |
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Marketing-authorisation holder |
Accord Healthcare S.L.U.
|
Revision |
7
|
Date of issue of marketing authorisation valid throughout the European Union |
29/04/2022
|
Contact address |
Accord Healthcare S.L.U. |
Product information
01/06/2023 Orgovyx - EMEA/H/C/005353 - II/0012
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.