PIL - Gabapentin Accord 600mg, 800mg Film-coated Tablets: Change history
View Patient Information Leaflet (PIL - Gabapentin Accord 600mg, 800mg Film-coated Tablets)
Last updated on this site: 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).
Last updated on this site: 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: 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: 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.
PIL sections updated: 2, 3, 4, 6.
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Changes: (Updated: 22 Sep 2022)
Initial upload