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: 08 May 2026
To add a new pack-size of 95 tablets in HDPE bottle for the finished product.
To add a new pack-size of 33 tablets in HDPE bottle for the finished product.
Consequently, section 6.5 of the SmPC, the label and the PIL has been updated.
Last updated on this site: 08 May 2026
To add a new pack-size of 95 tablets in HDPE bottle for the finished product.
To add a new pack-size of 33 tablets in HDPE bottle for the finished product.
Consequently, section 6.5 of the SmPC, the label and the PIL has been updated.
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Changes: (Updated: 30 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: 30 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