SmPC - Gabapentin Accord-UK 100mg Capsules: Change history
View Summary of Product Characteristics (SmPC - Gabapentin Accord-UK 100mg Capsules)
Last updated on this site: 05 Feb 2026
Change log:
IB C.I.3.a: To update sections 4.2, 4.4, 4.8, 4.9 of the SmPC in line with MHRA recommendation. Consequently, the PIL and labels are updated.
IB C.I.3.z: To update SmPC sections 4.4 and 4.8 in line with PRAC recommendation (PSUSA/00001499/202502) - for causal relationship between gabapentin and withdrawal reactions following dose reduction, and exacerbation of myasthenia gravis. Consequently, the PIL is updated.
In addition, to make formatting updates to sections 4.2, 4.8 and 4.9 of the SmPC and to make editorial and QRD updates to the PIL.
Date of approval: 16/01/2026
SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10
Last updated on this site: 05 Feb 2026
Change log:
IB C.I.3.a: To update sections 4.2, 4.4, 4.8, 4.9 of the SmPC in line with MHRA recommendation. Consequently, the PIL and labels are updated.
IB C.I.3.z: To update SmPC sections 4.4 and 4.8 in line with PRAC recommendation (PSUSA/00001499/202502) - for causal relationship between gabapentin and withdrawal reactions following dose reduction, and exacerbation of myasthenia gravis. Consequently, the PIL is updated.
In addition, to make formatting updates to sections 4.2, 4.8 and 4.9 of the SmPC and to make editorial and QRD updates to the PIL.
Date of approval: 16/01/2026
SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10
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Changes: (Updated: 05 Feb 2026)
Change log:
IB C.I.3.a: To update sections 4.2, 4.4, 4.8, 4.9 of the SmPC in line with MHRA recommendation. Consequently, the PIL and labels are updated.
IB C.I.3.z: To update SmPC sections 4.4 and 4.8 in line with PRAC recommendation (PSUSA/00001499/202502) - for causal relationship between gabapentin and withdrawal reactions following dose reduction, and exacerbation of myasthenia gravis. Consequently, the PIL is updated.
In addition, to make formatting updates to sections 4.2, 4.8 and 4.9 of the SmPC and to make editorial and QRD updates to the PIL.
Date of approval: 16/01/2026
SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10
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Changes: (Updated: 25 Sep 2025)
Description of update: To update SmPC sections 4.4, 4.6, 4.8 and 5.1 in line with reference product Neurontin 100 mg, 300 mg, 400 mg hard capsules. No Consequential update to the PIL.
Date of approval: 15/08/2025
SmPC sections updated: 4.4, 4.6, 4.8, 5.1 and 10
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Changes: (Updated: 25 Jan 2024)
Description of update: To update section 4.6 of the SmPC in line with the reference product, Neurontin 100mg hard capsules, MAH Upjohn UK Limited. Consequently, the PIL is updated and additional editorial changes have been made.
SmPC Sections updated: 4.6 and 10.
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Changes: (Updated: 07 Jun 2023)
Removed duplicate section 5.2
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Changes: (Updated: 22 May 2023)
Variation Description: To register an update of the ATC code (gabapentin) from N03AX12 to N02BF01. Consequently, SmPC section 5.1 has been updated.
SmPC sections updated – 4.4, 4.6, 4.8, 5.1 and 10.
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Changes: (Updated: 22 Sep 2022)
Initial upload