SmPC - Osvyrti 60 mg solution for injection in pre-filled syringe: Change history
View Summary of Product Characteristics (SmPC - Osvyrti 60 mg solution for injection in pre-filled syringe)
Last updated on this site: 16 Feb 2026
Description of update:
To update section 4.2 , 5.1 and 5.2 of the SPC to bring in line with reference product information Prolia EMA/VR/0000267398.
To update section 4.4 of the SPC to bring in line with reference product information Prolia PSUSA (EMEA-H-CPSUSA- 00000954-202409) in line with EC Decision C(2025)5097/ 17.07.2025.
Date of approval: 05/02/2026
SmPC sections updated: 4.2, 4.4, 5.1, 5.2 and 10
Last updated on this site: 16 Feb 2026
Description of update:
To update section 4.2 , 5.1 and 5.2 of the SPC to bring in line with reference product information Prolia EMA/VR/0000267398.
To update section 4.4 of the SPC to bring in line with reference product information Prolia PSUSA (EMEA-H-CPSUSA- 00000954-202409) in line with EC Decision C(2025)5097/ 17.07.2025.
Date of approval: 05/02/2026
SmPC sections updated: 4.2, 4.4, 5.1, 5.2 and 10
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Changes: (Updated: 16 Feb 2026)
Description of update:
To update section 4.2 , 5.1 and 5.2 of the SPC to bring in line with reference product information Prolia EMA/VR/0000267398.
To update section 4.4 of the SPC to bring in line with reference product information Prolia PSUSA (EMEA-H-CPSUSA- 00000954-202409) in line with EC Decision C(2025)5097/ 17.07.2025.
Date of approval: 05/02/2026
SmPC sections updated: 4.2, 4.4, 5.1, 5.2 and 10
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Changes: (Updated: 18 Dec 2025)
New Product Launch.
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Changes: (Updated: 18 Dec 2025)
New Product Launch.