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: 03 Mar 2026
Grouped IB variation:
1) Update to SPC sections 4.2, 4.4, 4.8, 4.9, PIL and labelling in line with the MHRA Safety Review recommendations to improve communication of risks for Gabapentinoid, Benzodiazepine and Z-drug classes of medications.
2)Update to SPC sections 4.4, 4.8 and PIL in line with PSUSA/00001499/202502 to add warning for exacerbation of myasthenia gravis, and withdrawal reactions following dose reduction.
MAH has taken the opportunity to make some editorial amends and corrections, including editorial amends in the PIL, minor text correction in 800mg SPC section 4.3, and correction to remove PL number from foil component mock-ups.
Approval date: 27/02/2026.
SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10.
Last updated on this site: 03 Mar 2026
Grouped IB variation:
1) Update to SPC sections 4.2, 4.4, 4.8, 4.9, PIL and labelling in line with the MHRA Safety Review recommendations to improve communication of risks for Gabapentinoid, Benzodiazepine and Z-drug classes of medications.
2)Update to SPC sections 4.4, 4.8 and PIL in line with PSUSA/00001499/202502 to add warning for exacerbation of myasthenia gravis, and withdrawal reactions following dose reduction.
MAH has taken the opportunity to make some editorial amends and corrections, including editorial amends in the PIL, minor text correction in 800mg SPC section 4.3, and correction to remove PL number from foil component mock-ups.
Approval date: 27/02/2026.
SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10.
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Changes: (Updated: 03 Mar 2026)
Grouped IB variation:
1) Update to SPC sections 4.2, 4.4, 4.8, 4.9, PIL and labelling in line with the MHRA Safety Review recommendations to improve communication of risks for Gabapentinoid, Benzodiazepine and Z-drug classes of medications.
2)Update to SPC sections 4.4, 4.8 and PIL in line with PSUSA/00001499/202502 to add warning for exacerbation of myasthenia gravis, and withdrawal reactions following dose reduction.
MAH has taken the opportunity to make some editorial amends and corrections, including editorial amends in the PIL, minor text correction in 800mg SPC section 4.3, and correction to remove PL number from foil component mock-ups.
Approval date: 27/02/2026.
SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10.
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Changes: (Updated: 08 Apr 2025)
To update SmPC sections 4.4, 4.6, 4.8, 4.9, 5.1 and PIL section in line with the reference product Neurontin 600 mg film-coated tablets (EU procedure number: DE/H/0899/004, MAH: Upjohn EESV, Ref Revision date: 03/2024).
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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