PIL - Lamotrigine Accord 25 mg, 50 mg, 100 mg, 200 mg Tablets: Change history
View Patient Information Leaflet (PIL - Lamotrigine Accord 25 mg, 50 mg, 100 mg, 200 mg Tablets)
Last updated on this site: 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.
Last updated on this site: 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: 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.
PIL sections updated: Heading, introduction, index, 1, 2, 3, 4, 5 and 6.
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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 PIL: 1, 2, 3, 4, 6.
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Changes: (Updated: 21 Sep 2022)
initial upload