PIL - Simvastatin 10mg, 20mg, 40mg, 80mg film-coated tablets: Change history
View Patient Information Leaflet (PIL - Simvastatin 10mg, 20mg, 40mg, 80mg film-coated tablets)
Last updated on this site: 27 Apr 2026
Description of update: To update section 4.5 of the SmPC and section 2 of the leaflet to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00002709/202504).
Date of approval: 22/04/2026
PIL sections updated: 2 and 6
Last updated on this site: 27 Apr 2026
Description of update: To update section 4.5 of the SmPC and section 2 of the leaflet to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00002709/202504).
Date of approval: 22/04/2026
PIL sections updated: 2 and 6
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Changes: (Updated: 27 Apr 2026)
Description of update: To update section 4.5 of the SmPC and section 2 of the leaflet to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00002709/202504).
Date of approval: 22/04/2026
PIL sections updated: 2 and 6
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Changes: (Updated: 30 Oct 2025)
B.II.b.1.b - QUALITY CHANGES - FINISHED PRODUCT - Manufacture - Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished product - Primary packaging site
- addition of Accord Healthcare Single Member S.A., Greece as an alternative site responsible for primary packaging site.
B.II.b.1.a - QUALITY CHANGES - FINISHED PRODUCT - Manufacture - Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished product - Secondary packaging site
-addition of Accord Healthcare Single Member S.A., Greece as an alternative site responsible for secondary packaging site.
B.II.b.2.c.2 - QUALITY CHANGES - FINISHED PRODUCT - Manufacture - Change to importer, batch release arrangements and quality control testing of the finished product - Replacement or addition of a manufacturer responsible for importation and/or batch release - Including batch control/testing
-addition of Accord Healthcare Single Member S.A., Greece as an alternative site responsible for importation and batch release including batch control/testing.
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Changes: (Updated: 25 May 2023)
Description of update: The following change has been notified:
C.I.z Change(s) in the Summary of product Characteristics, Labelling or Package Leaflet intended to implement the outcome of a PRAC signal recommendation: implementation of wording agreed by the competent authority that do not require any further assessment
- To update the SmPC and PIL to implement the signal recommendation (EPITT 19822) adopted at the 9-12 January 2023 PRAC meeting.
PIL sections updated: 2, 4, 6.
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Changes: (Updated: 09 Nov 2022)
Updated
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Changes: (Updated: 22 Sep 2022)
Initial upload