SmPC - Simvastatin 10mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Simvastatin 10mg Film-coated Tablets)
Last updated on this site: 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.
SmPC sections updated: 4.4, 4.8, 10.
PIL sections updated: 2, 4, 6.
Last updated on this site: 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.
SmPC sections updated: 4.4, 4.8, 10.
PIL sections updated: 2, 4, 6.
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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.
SmPC sections updated: 4.4, 4.8, 10.
PIL sections updated: 2, 4, 6.
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Changes: (Updated: 22 Sep 2022)
Initial upload