SmPC - Orgovyx® 120 mg film-coated tablets, Relugolix 120 mg film-coated tablets (Great Britain): Change history
View Summary of Product Characteristics (SmPC - Orgovyx® 120 mg film-coated tablets, Relugolix 120 mg film-coated tablets (Great Britain))
Last updated on this site: 01 Apr 2026
Description of update:
Submission of CSR 049 study as post authorisation measures for Orgovyx® 120 mg film-coated tablets.
Based on the data provided, updates to SmPC section 4.5 are proposed with consequential updates to the leaflet.
Additionally, we have taken the opportunity to update SmPC sections 4.8 and 5.1. In section 4.8, the frequency for the adverse event myocardial infarction has been updated to uncommon.
Date of approval: 24/03/2026
SmPC sections updated: 4.5, 4.8, 5.1 and 10.
Last updated on this site: 01 Apr 2026
Description of update:
Submission of CSR 049 study as post authorisation measures for Orgovyx® 120 mg film-coated tablets.
Based on the data provided, updates to SmPC section 4.5 are proposed with consequential updates to the leaflet.
Additionally, we have taken the opportunity to update SmPC sections 4.8 and 5.1. In section 4.8, the frequency for the adverse event myocardial infarction has been updated to uncommon.
Date of approval: 24/03/2026
SmPC sections updated: 4.5, 4.8, 5.1 and 10.
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Changes: (Updated: 31 May 2023)
Description of update: To assess the sufficiency of dose separation to mitigate absorption-mediated increases in exposure to Relugolix resulting from inhibition of intestinal P-gp by Azithromycin as post authorisation measures for Orgovyx® 120 mg film-coated tablets.
SmPC sections updated – 4.5 and 10
No update to artwork
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Changes: (Updated: 11 Jan 2023)
New product launch 11/01/2023.
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Changes: (Updated: 22 Sep 2022)
initial upload