SmPC - Lamotrigine Accord 200 mg Tablets: Change history
View Summary of Product Characteristics (SmPC - Lamotrigine Accord 200 mg Tablets)
Last updated on this site: 29 Jul 2025
Description of update:
SmPC sections 4.4, 4.8, 5.3 and the PIL have been updated in line with the reference product Lamictal 25mg Tablets (PL 00003/0272; MAH: The Wellcome Foundation Ltd) dated 25th November 2024.
Date of approval: 17/07/2025
SmPC sections updated: 4.4, 4.8, 5.3 and 10
Last updated on this site: 29 Jul 2025
Description of update:
SmPC sections 4.4, 4.8, 5.3 and the PIL have been updated in line with the reference product Lamictal 25mg Tablets (PL 00003/0272; MAH: The Wellcome Foundation Ltd) dated 25th November 2024.
Date of approval: 17/07/2025
SmPC sections updated: 4.4, 4.8, 5.3 and 10
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Changes: (Updated: 29 Jul 2025)
Description of update:
SmPC sections 4.4, 4.8, 5.3 and the PIL have been updated in line with the reference product Lamictal 25mg Tablets (PL 00003/0272; MAH: The Wellcome Foundation Ltd) dated 25th November 2024.
Date of approval: 17/07/2025
SmPC sections updated: 4.4, 4.8, 5.3 and 10
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Changes: (Updated: 24 Jul 2025)
SmPC sections 4.4, 4.8, 5.3 and the PIL have been updated in line with the reference product Lamictal 25mg Tablets (PL 00003/0272; MAH: The Wellcome Foundation Ltd) dated 25th November 2024.
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Changes: (Updated: 09 Aug 2024)
To update sections 4.2, 4.4, 4.5, 4.6, 4.8, 4.9, and 5.3 of the SmPC and the PIL for Lamotrigine Accord 25, 50, 100, 200mg Tablets in line with the reference product Lamictal tablets (PL 00003/0272, 0273, 0274, 0297; MAH: The Wellcome Foundation Ltd) dated 2nd November 2023. In addition, editorial updates have been made to PIL.
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Changes: (Updated: 14 Nov 2023)
Description of update: To update sections 4.4, 4.8 and 4.9 of the SmPC in line with PSUSA/00001825/202211 recommendations for HLA-B*1502 allele, tics, pseudolymphoma, and use of intravenous lipid therapy. The PIL is updated as a consequence. Additional updates to excipient and ADR information. Typographical and QRD updates in the PIL.
SmPC Sections updated: 4.4, 4.8, 4.9 and 10.
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Changes: (Updated: 07 Jun 2023)
Website administration update - no change to content
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Changes: (Updated: 28 Mar 2023)
Description of update: To update sections 4.2, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1 and 5.3 of the SmPC to bring in line with the reference product information Lamictal (PL 00003/0272-0273-0274-0297).Consequently, the PIL has been updated.
Updated sections of SmPC: 4.2, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.3, 10.
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Changes: (Updated: 21 Sep 2022)
initial upload