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: 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.
Last updated on this site: 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: 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