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: 17 Jun 2025
The following changes have been notified:
Type IAIN - B.II.b.1.a - addition of a manufacturing site for part or all of the manufacturing process of the finished product - secondary packaging site - addition of Accord Healthcare Single Member S.A., Greece as a secondary packaging site.
Type IAIN - B.II.b.2.c.2 - change to batch release arrangements and quality control testing of the finished product - addition of a manufacturer responsible for importation and/or batch release - including batch control/testing - addition of Accord Healthcare Single Member S.A., Greece as a site responsible for batch certification and chemical/physical & microbiological non-sterility quality control testing.
The manufacturers in Section 6 of the PIL have been updated.
PIL sections updated: Section 6 only.
Last updated on this site: 17 Jun 2025
The following changes have been notified:
Type IAIN - B.II.b.1.a - addition of a manufacturing site for part or all of the manufacturing process of the finished product - secondary packaging site - addition of Accord Healthcare Single Member S.A., Greece as a secondary packaging site.
Type IAIN - B.II.b.2.c.2 - change to batch release arrangements and quality control testing of the finished product - addition of a manufacturer responsible for importation and/or batch release - including batch control/testing - addition of Accord Healthcare Single Member S.A., Greece as a site responsible for batch certification and chemical/physical & microbiological non-sterility quality control testing.
The manufacturers in Section 6 of the PIL have been updated.
PIL sections updated: Section 6 only.
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Changes: (Updated: 17 Jun 2025)
The following changes have been notified:
Type IAIN - B.II.b.1.a - addition of a manufacturing site for part or all of the manufacturing process of the finished product - secondary packaging site - addition of Accord Healthcare Single Member S.A., Greece as a secondary packaging site.
Type IAIN - B.II.b.2.c.2 - change to batch release arrangements and quality control testing of the finished product - addition of a manufacturer responsible for importation and/or batch release - including batch control/testing - addition of Accord Healthcare Single Member S.A., Greece as a site responsible for batch certification and chemical/physical & microbiological non-sterility quality control testing.
The manufacturers in Section 6 of the PIL have been updated.
PIL sections updated: Section 6 only.
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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