SmPC- Nebivolol 5mg Tablets: Change history
View Summary of Product Characteristics (SmPC- Nebivolol 5mg Tablets)
Last updated on this site: 05 Nov 2026
SmPC sections 4.4 and 4.5 for the above-listed MA have been updated in line with the reference product NEBILET 5 mg tablets – PL 16239/0013 (MAH: Menarini International Operations Luxembourg S.A.), dated 19/03/2026. No consequential update to the PIL.
Date of approval: 02/11/2026
SmPC sections updated: 4.4, 4.5 and 10
Last updated on this site: 05 Nov 2026
SmPC sections 4.4 and 4.5 for the above-listed MA have been updated in line with the reference product NEBILET 5 mg tablets – PL 16239/0013 (MAH: Menarini International Operations Luxembourg S.A.), dated 19/03/2026. No consequential update to the PIL.
Date of approval: 02/11/2026
SmPC sections updated: 4.4, 4.5 and 10
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Changes: (Updated: 05 Nov 2026)
SmPC sections 4.4 and 4.5 for the above-listed MA have been updated in line with the reference product NEBILET 5 mg tablets – PL 16239/0013 (MAH: Menarini International Operations Luxembourg S.A.), dated 19/03/2026. No consequential update to the PIL.
Date of approval: 02/11/2026
SmPC sections updated: 4.4, 4.5 and 10
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Changes: (Updated: 03 Jun 2025)
Renewal Approval
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Changes: (Updated: 08 May 2025)
To update SmPC sections 4.4, 4.5 and PIL in line with PRAC recommendation (PSUSA/00002129/202403) use of beta-blockers with sulfonylureas.
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Changes: (Updated: 22 Sep 2022)
initial upload