SmPC - Sertraline 50mg Film coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Sertraline 50mg Film coated Tablets)
Last updated on this site: 05 Nov 2024
To update section 4.8 of the SPC in line with the same change in the reference product Lustral 50mg film coated tablets, MA holder Upjohn UK Limited PL 50622/0045. The PIL has also been updated.
View Summary of Product Characteristics (SmPC - Sertraline 50mg Film coated Tablets)
Last updated on this site: 05 Nov 2024
To update section 4.8 of the SPC in line with the same change in the reference product Lustral 50mg film coated tablets, MA holder Upjohn UK Limited PL 50622/0045. The PIL has also been updated.
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Changes: (Updated: 05 Nov 2024)
To update section 4.8 of the SPC in line with the same change in the reference product Lustral 50mg film coated tablets, MA holder Upjohn UK Limited PL 50622/0045. The PIL has also been updated.
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Changes: (Updated: 10 Oct 2024)
An Unlimited MA has been granted, 5 yearly PSURs will be submitted
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Changes: (Updated: 18 Jul 2023)
Description of update: To update sections 4.4 and 5.1 of the SmPC in line with the reference product information Lustral (PL 50622/0045, 50622/0044). Consequentially, the PIL has been updated.
SmPC sections updated: 4.4, 5.1, 10.
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Changes: (Updated: 22 Sep 2022)
Initial upload