SmPC - Sertraline 100mg Film coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Sertraline 100mg Film coated Tablets)
Last updated on this site: 14 Aug 2025
Description of update:
SmPC section 4.8 and PIL section 4 have been updated in line with the PRAC recommendation for sertraline (EPITT No 20125) for Multiple acyl-coenzyme A dehydrogenase deficiency (MADD).
SmPC section 4.4 and PIL section 2 have also been updated to include the excipient warning for sodium.
Additional updates throughout PIL in line with QRD as well as the correction of grammatical and typographical errors. Section 4 has also been updated to remove repeated side effects.
Date of approval: 07/08/2025
SmPC sections updated: 4.4, 4.8 and 10
Last updated on this site: 14 Aug 2025
Description of update:
SmPC section 4.8 and PIL section 4 have been updated in line with the PRAC recommendation for sertraline (EPITT No 20125) for Multiple acyl-coenzyme A dehydrogenase deficiency (MADD).
SmPC section 4.4 and PIL section 2 have also been updated to include the excipient warning for sodium.
Additional updates throughout PIL in line with QRD as well as the correction of grammatical and typographical errors. Section 4 has also been updated to remove repeated side effects.
Date of approval: 07/08/2025
SmPC sections updated: 4.4, 4.8 and 10
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Changes: (Updated: 14 Aug 2025)
Description of update:
SmPC section 4.8 and PIL section 4 have been updated in line with the PRAC recommendation for sertraline (EPITT No 20125) for Multiple acyl-coenzyme A dehydrogenase deficiency (MADD).
SmPC section 4.4 and PIL section 2 have also been updated to include the excipient warning for sodium.
Additional updates throughout PIL in line with QRD as well as the correction of grammatical and typographical errors. Section 4 has also been updated to remove repeated side effects.
Date of approval: 07/08/2025
SmPC sections updated: 4.4, 4.8 and 10
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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