Gabapentin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Informa
Taking into account the PRAC Assessment Report on the PSUR(s) for gabapentin, the scientific conclusions are as follows:
PRAC reviewed the available post marketing safety data regarding the adverse reaction agitation. PRAC concluded that a causal association is established taking into account that a temporal relationship could be established with the start of gabapentin and the onset of agitation, positive de-challenge and positive re-challenge. Therefore the term has been included in section 4.8 of the SmPC. PRAC also reviewed the medical literature and the post marketing safety data regarding the signal of anaphylaxis. Based on this review information has been included on anaphylaxis in sections 4.4 and 4.8 of the SmPC. The package leaflet has been updated accordingly.
