SmPC - Lamotrigine Accord 200 mg Tablets: Change history
View Summary of Product Characteristics (SmPC - Lamotrigine Accord 200 mg Tablets)
Last updated on this site: 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.
Last updated on this site: 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: 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