PIL- Relugolix 120 mg film-coated tablets: Change history
View Patient Information Leaflet (PIL- Relugolix 120 mg film-coated tablets)
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: 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: 02 Oct 2025)
P1 - To register new packaging format; blister cartons and foils for Orgovyx®/Relugolix.
P2 - Minor change to current PIL(s) with the addition of text to cover bottles and blisters.
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Changes: (Updated: 13 Mar 2024)
Description of update: To register the addition of the generic name "Relugolix 120 mg film-coated tablets".
Consequently, sections 1, 4.1, 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 6.5, 6.6 and 10 of the SPC have been updated, aswell as the label and leaflet.
PIL sections updated: Intro and sections 1, 2, 3, 4, 5 and 6.
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Changes: (Updated: 13 Mar 2024)
Description of update: To register the addition of the generic name "Relugolix 120 mg film-coated tablets".
Consequently, sections 1, 4.1, 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 6.5, 6.6 and 10 of the SPC have been updated, aswell as the label and leaflet.
PIL sections updated: Intro and sections 1, 2, 3, 4, 5 and 6.