EMEA: Core SPC for pandemic influenza vaccines

This harmonised SPC has been developed by the VWP in order to facilitate the submission of the core pandemic dossier and subsequent approval of the pandemic variation: the SPC, based upon this harmonised SPC proposal, labels and package leaflet approved in the core pandemic dossier authorisation will normally not have to change (except for some information on the pandemic strain) when the pandemic variation is submitted. It is intended solely for inactivated pandemic virus derived vaccines.