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: 30 Jul 2025
CCC-AccordUK-00142-017
IB grouped variation via IRP route:
1.) IB, B.II.e.1.b.1 – Register a change in the immediate packaging of the finished product; addition of a new container 30's count blister pack with shelf life of 48 months.
2.) IB, B.II.e.1.b.1 – Register a change in the immediate packaging of the finished product; addition of a new container 90's count blister pack with shelf life of 48 months.
3.) IAin, B.II.e.5.a.1 – Register addition of a new pack size of 90's
HDPE bottle.
4.) IA, B.II.b.5.b – Register addition of blister leak test as a new in-process test applied during the manufacture of the finished product.
5.) IB, B.II.f.1.b.1 – Register an extension to the shelf life of the HDPE bottle for the finished product as packed for sale from 36 months to 48 months when stored below 30˚C.
Last updated on this site: 30 Jul 2025
CCC-AccordUK-00142-017
IB grouped variation via IRP route:
1.) IB, B.II.e.1.b.1 – Register a change in the immediate packaging of the finished product; addition of a new container 30's count blister pack with shelf life of 48 months.
2.) IB, B.II.e.1.b.1 – Register a change in the immediate packaging of the finished product; addition of a new container 90's count blister pack with shelf life of 48 months.
3.) IAin, B.II.e.5.a.1 – Register addition of a new pack size of 90's
HDPE bottle.
4.) IA, B.II.b.5.b – Register addition of blister leak test as a new in-process test applied during the manufacture of the finished product.
5.) IB, B.II.f.1.b.1 – Register an extension to the shelf life of the HDPE bottle for the finished product as packed for sale from 36 months to 48 months when stored below 30˚C.
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Changes: (Updated: 30 Jul 2025)
CCC-AccordUK-00142-017
IB grouped variation via IRP route:
1.) IB, B.II.e.1.b.1 – Register a change in the immediate packaging of the finished product; addition of a new container 30's count blister pack with shelf life of 48 months.
2.) IB, B.II.e.1.b.1 – Register a change in the immediate packaging of the finished product; addition of a new container 90's count blister pack with shelf life of 48 months.
3.) IAin, B.II.e.5.a.1 – Register addition of a new pack size of 90's
HDPE bottle.
4.) IA, B.II.b.5.b – Register addition of blister leak test as a new in-process test applied during the manufacture of the finished product.
5.) IB, B.II.f.1.b.1 – Register an extension to the shelf life of the HDPE bottle for the finished product as packed for sale from 36 months to 48 months when stored below 30˚C.
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Changes: (Updated: 03 Oct 2024)
To update sections 4.2 and 4.5 of the SmPC to add information on "Combination with other medicines for advanced hormone-sensitive prostate cancer" based on clinical studies and literature. In addition, to introduce editorial changes to sections 4.8 and 5.1 of the SmPC.
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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