Are clinical data from spontaneous pharmacovigilance reports transmitted via the Ministry of Health's web portal sufficient to generate a signal without further documentation?
Therapie. 2023 Oct 31:S0040-5957(23)00167-1.
doi: 10.1016/j.therap.2023.10.006.
Online ahead of print.
1 Regional Pharmacovigilance Centre of Burgundy, University Hospital Dijon Bourgogne, 21000 Dijon, France. Electronic address: aurelie.grandvuillemin@chu-dijon.fr.
2 Regional Pharmacovigilance Centre of Burgundy, University Hospital Dijon Bourgogne, 21000 Dijon, France.
3 Regional Pharmacovigilance Centre of Franche-Comté, University Hospital Besançon, 25000 Besançon, France.
4 Department Of Clinical Pharmacology And Pharmacovigilance, AP-HM, Regional Pharmacovigilance Centre Of Marseille, 13000 Marseille, France.
5 Department of Pharmacology, Cochin Hospital, AP-HP, Regional Pharmacovigilance Centre, 75000 Paris, France.
6 Department Of Clinical Pharmacology, Lille University, Lille University Hospital, Regional Parmacovigilance Centre, Centre of Pharmacovigilance, 59000 Lille, France.
7 Department of Pharmacosurveillance, University Hospital, Regional Pharmacovigilance Centre of Centre Val De Loire, 37000 Tours, France.