SmPC - Gabapentin Accord 100mg Hard Capsules: Change history

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.

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.