SmPC - Gabapentin Accord 400mg Hard Capsules: Change history
View Summary of Product Characteristics (SmPC - Gabapentin Accord 400mg Hard Capsules)
Last updated on this site: 29 May 2026
Description of update:
1: To update sections 4.4 and 4.8 of the SmPC and PIL of the finished products Gabapentin Accord hard capsules to bring the product information in line with PRAC update (PSUSA/00001499/202502) - for causal relationship between gabapentin and withdrawal reactions following dose reduction, and exacerbation of myasthenia gravis.
2: To update sections 4.2, 4.4, 4.8 and 4.9 of the SmPC of the finished products in line with MHRA review to improve communication of risks. Consequently, the label and PIL are also being updated accordingly. In addition, editorial updates have been made to the PIL and cartons including QRD updates to the PIL.
Date of approval: 02/04/2026
SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10
Last updated on this site: 29 May 2026
Description of update:
1: To update sections 4.4 and 4.8 of the SmPC and PIL of the finished products Gabapentin Accord hard capsules to bring the product information in line with PRAC update (PSUSA/00001499/202502) - for causal relationship between gabapentin and withdrawal reactions following dose reduction, and exacerbation of myasthenia gravis.
2: To update sections 4.2, 4.4, 4.8 and 4.9 of the SmPC of the finished products in line with MHRA review to improve communication of risks. Consequently, the label and PIL are also being updated accordingly. In addition, editorial updates have been made to the PIL and cartons including QRD updates to the PIL.
Date of approval: 02/04/2026
SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10
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Changes: (Updated: 29 May 2026)
Description of update:
1: To update sections 4.4 and 4.8 of the SmPC and PIL of the finished products Gabapentin Accord hard capsules to bring the product information in line with PRAC update (PSUSA/00001499/202502) - for causal relationship between gabapentin and withdrawal reactions following dose reduction, and exacerbation of myasthenia gravis.
2: To update sections 4.2, 4.4, 4.8 and 4.9 of the SmPC of the finished products in line with MHRA review to improve communication of risks. Consequently, the label and PIL are also being updated accordingly. In addition, editorial updates have been made to the PIL and cartons including QRD updates to the PIL.
Date of approval: 02/04/2026
SmPC sections updated: 4.2, 4.4, 4.8, 4.9 and 10
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Changes: (Updated: 08 Apr 2025)
To submit Type IB (C.I.2.a) variation application to update sections 4.4, 4.6 of the SmPC and section 2, 4 of PIL in-line with reference product information (Neurontin Hard capsule; MAH: Viatris Pharma GmbH; EU Procedure number: DE/H/0899/001-003) for Gabapentin 100/300/400 mg hard capsules.
Additionally, applicant has updated sections 4.2, 4.8, 5.3 of the SmPC and section 1, 4 of the PIL with editorial changes in line with reference product information.
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Changes: (Updated: 12 Aug 2024)
HPRA request to update pharmacotherapeutic group error in SmPC section 5.1.
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Changes: (Updated: 13 Mar 2023)
Description of update: C.I.3.a - SAFETY, EFFICACY, PHARMACOVIGILANCE CHANGES - HUMAN AND VETERINARY MEDICINAL PRODUCTS - Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of human medicinal products intended to implement the outcome of a procedure concerning PSUR or PASS, or the outcome of the assessment done by the competent authority under Articles 45 or 46 of Regulation 1901/2006 - Implementation of wording agreed by the competent authority: 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. A.6 - ADMINISTRATIVE CHANGES - Change in ATC Code / ATC Vet Code: Type IA (A.6) To update the ATC Code for “Gabapentin” as published by WHO.
SmPC sections updated: 4.4, 4.5, 4.6, 4.8, 5.1, 10.
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Changes: (Updated: 22 Sep 2022)
Initial upload