Relugolix

Relugolix (Orgovyx, Accord Healthcare S.L.U.) has 1 EU-approved indication in 1 tumour type.
Approved indications of Relugolix
Biomarker requirementRegimenSettingConditions
Prostate cancer1
None
Monotherapy
Any line
advanced
Hormone-sensitive
Full text of section 4.1 (therapeutic indications)

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

Label history

15 changes to the Orgovyx label since 2022, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes