SmPC - Gabapentin Accord 600 mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Gabapentin Accord 600 mg Film-coated Tablets)
Last updated on this site: 27 Jan 2025
QUALITY CHANGES - FINISHED PRODUCT - Stability - Change in the shelf-life or storage conditions of the finished product - Reduction of the shelf life of the finished product - As packaged for sale. Reduction of shelf life of the finished product from 36 months to 24 months for PVC/PVdC/Alu blisters pack of Gabapentin 600/800 mg Film-coated Tablet.
There are product information updates.
SmPC section(s) 6.3 are updated.
Last updated on this site: 27 Jan 2025
QUALITY CHANGES - FINISHED PRODUCT - Stability - Change in the shelf-life or storage conditions of the finished product - Reduction of the shelf life of the finished product - As packaged for sale. Reduction of shelf life of the finished product from 36 months to 24 months for PVC/PVdC/Alu blisters pack of Gabapentin 600/800 mg Film-coated Tablet.
There are product information updates.
SmPC section(s) 6.3 are updated.
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Changes: (Updated: 27 Jan 2025)
QUALITY CHANGES - FINISHED PRODUCT - Stability - Change in the shelf-life or storage conditions of the finished product - Reduction of the shelf life of the finished product - As packaged for sale. Reduction of shelf life of the finished product from 36 months to 24 months for PVC/PVdC/Alu blisters pack of Gabapentin 600/800 mg Film-coated Tablet.
There are product information updates.
SmPC section(s) 6.3 are updated.
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Changes: (Updated: 22 Jun 2023)
Description of update: Type IA group variation for:
• Type IAIN (C.I.3.a); To update the SPC and PIL in-line with wording of PSUSA (PSUSA/00001499/202202 published on EC) procedure.
• Type IA (A.6) variation to update the ATC Code for “Gabapentin” as published by WHO.
SmPC sections updated: 4.4, 4.6, 4.8, 5.1, 10.
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Changes: (Updated: 22 Sep 2022)
Initial upload