PIL - Gabapentin Accord 100mg, 300mg, 400mg Hard Capsules: Change history
View Patient Information Leaflet (PIL - Gabapentin Accord 100mg, 300mg, 400mg Hard Capsules)
Last updated on this site: 19 May 2025
The following change(s) has been notified:
B.II.b.1.a - To Add Accord Healthcare Single Member S.A., Greece as an alternative site responsible for secondary packaging of the finished product.
B.II.b.2.c.2 - To add Accord Healthcare Single Member S.A., Greece as an alternative site responsible for importation and batch release (including batch control/testing) of the finished product.
A.5.b - To change the name of the site responsible for batch control/testing of the finished product from Lab Analysis s.r.l. via Europa, Casanova Lonati (PV), 5 - 27041, Italy to Labanalysis Life Science S.r.l. via Europa, Casanova Lonati (PV), 5 - 27041, Italy. The address remains unchanged.
Last updated on this site: 19 May 2025
The following change(s) has been notified:
B.II.b.1.a - To Add Accord Healthcare Single Member S.A., Greece as an alternative site responsible for secondary packaging of the finished product.
B.II.b.2.c.2 - To add Accord Healthcare Single Member S.A., Greece as an alternative site responsible for importation and batch release (including batch control/testing) of the finished product.
A.5.b - To change the name of the site responsible for batch control/testing of the finished product from Lab Analysis s.r.l. via Europa, Casanova Lonati (PV), 5 - 27041, Italy to Labanalysis Life Science S.r.l. via Europa, Casanova Lonati (PV), 5 - 27041, Italy. The address remains unchanged.
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Changes: (Updated: 19 May 2025)
The following change(s) has been notified:
B.II.b.1.a - To Add Accord Healthcare Single Member S.A., Greece as an alternative site responsible for secondary packaging of the finished product.
B.II.b.2.c.2 - To add Accord Healthcare Single Member S.A., Greece as an alternative site responsible for importation and batch release (including batch control/testing) of the finished product.
A.5.b - To change the name of the site responsible for batch control/testing of the finished product from Lab Analysis s.r.l. via Europa, Casanova Lonati (PV), 5 - 27041, Italy to Labanalysis Life Science S.r.l. via Europa, Casanova Lonati (PV), 5 - 27041, Italy. The address remains unchanged.
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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: 22 May 2023)
Description of update: Type IB (C.I.2.a) variation application to update SmPC and PIL information in-line with the product information of reference product (Neurontin Hard capsule; EU reference No: DE/H/0899/001; MAH: Upjohn EESV) for Gabapentin Accord 100/300/400 mg hard capsules.
PIL sections updated: 4, 6.
No changes to SmPC.
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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.
PIL sections updated: 2, 3, 4, 6.
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Changes: (Updated: 22 Sep 2022)
Initial upload