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: 04 Jul 2024
To add a new pack-size of 90 film-coated tablets (3 packs of 30) in bottle (HDPE) for the finished product. Section 6.5 of the SmPC has been updated.
Last updated on this site: 04 Jul 2024
To add a new pack-size of 90 film-coated tablets (3 packs of 30) in bottle (HDPE) for the finished product. Section 6.5 of the SmPC has been updated.
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Changes: (Updated: 04 Jul 2024)
To add a new pack-size of 90 film-coated tablets (3 packs of 30) in bottle (HDPE) for the finished product. Section 6.5 of the SmPC has been updated.
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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.
SmPC Sections updated: 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.
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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.
SmPC Sections updated: 4.8 and 10.
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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.
SmPC Sections updated: 4.1, 4.2, 4.5, 5.1 and 10.
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Changes: (Updated: 09 Nov 2023)
Administrative update only- no changes to file.
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Changes: (Updated: 31 Oct 2023)
Description of update: To update section 4.5 of the SmPC based on final results from study MVT-601-9039; this is an In vitro Interaction Study of Relugolix with human OATP2B1 Uptake Transporter.
SmPC sections updated: 4.5 and 10.
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Changes: (Updated: 31 May 2023)
Description of updates:
1) 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.
2) 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: 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