PIL- Orgovyx® 120 mg film-coated tablets (Great Britain): Change history
View Patient Information Leaflet (PIL- Orgovyx® 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: 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: 17 Jan 2024)
Description of update: SmPC section 4.8 and the PIL have been updated in line with the PRAC recommendation (PSUSA/00010994/202301) regarding the side effects angioedema and urticaria.
PIL sections updated: 4 and 6.
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Changes: (Updated: 29 Dec 2023)
Description of update:
To register updates to sections 4.1, 4.2, 4.5 and 5.1 of the SmPC to reflect the addition of new therapeutic indications: Treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy, and Neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer. Consequently, the PIL has also been updated. The RMP has also been updated to version 2.0.
PIL sections updated: 1 and 6.
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Changes: (Updated: 09 Nov 2023)
Administrative update only- no changes to file.
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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