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: 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.
Last updated on this site: 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: 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