SmPC- Bisoprolol 2.5 mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC- Bisoprolol 2.5 mg Film-coated Tablets)
Last updated on this site: 05 Sep 2025
Type IB: B.II.a.1.b: Change in description of core tablet and finished product for Bisoprolol fumaraat Accord 2.5 mg filmomhulde tabletten.
Type IB: B.II.b.5.z: Change in in-process limit of thickness for Bisoprolol fumaraat Accord 2.5 mg filmomhulde tabletten.
Last updated on this site: 05 Sep 2025
Type IB: B.II.a.1.b: Change in description of core tablet and finished product for Bisoprolol fumaraat Accord 2.5 mg filmomhulde tabletten.
Type IB: B.II.b.5.z: Change in in-process limit of thickness for Bisoprolol fumaraat Accord 2.5 mg filmomhulde tabletten.
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Changes: (Updated: 05 Sep 2025)
Type IB: B.II.a.1.b: Change in description of core tablet and finished product for Bisoprolol fumaraat Accord 2.5 mg filmomhulde tabletten.
Type IB: B.II.b.5.z: Change in in-process limit of thickness for Bisoprolol fumaraat Accord 2.5 mg filmomhulde tabletten.
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Changes: (Updated: 03 Oct 2023)
Description of update:
B.II.f.1.a.1; reduction of shelf life of the finished product from 36 months to 24 months for PVC/PVDC-Alu Blister pack for Bisoprolol 2.5mg/5mg/10mg Film-coated tablet.
SmPC sections updated: 6.3 and 10.
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Changes: (Updated: 20 Sep 2022)
Initial upload