condition of registration. For the important The sponsor stated that the This was identified risk Prevenar 13 Core Data Sheet has considered to rates recently been updated to include be acceptable ‘Increased when 13vPnC is information regarding the and the concomitant administration of Delegate was Infanrix hexa’, it was Prevenar 13 and Infanrix. requested to recommended that consider this As a result, the Prevenar 13 the sponsor propose assurance when Product Information will be adequate and the final PI and updated accordingly, as part of a appropriate risk CMI are Safety-Related Notification. The minimisation negotiated approved text will then be added activities as found in during the to the Product Information the EU SmPC. It is processing of associated with this current important to inform this application. application, after the Delegate’s Healthcare Overview has been received. Professionals of the risk of higher rates of febrile reactions when Prevenar 13 and Infanrix hexa are administered concomitantly. It has been reported The sponsor claimed that the The sponsor’s that a higher risk of single analysis that identified this justification and febrile seizures interaction has some significant position associated with the methodological issues, and the US appeared concomitant Food and Drug Administration reasonable, administration of (FDA) is currently developing a although the Prevenar 13 and Mini-Sentinel study to examine Delegate was trivalent influenza this further. The sponsor notes requested to vaccine (TIV) that similar findings have not been consider this compared to when presented for the subsequent these vaccines were influenza season (2011-2012) when the final given alone on which had the same TIV PI and CMI are separate days in formulation, or in this most recent negotiated children 6-59 season (2012-2013) which has a during the months of age. It is different TIV formulation. The processing of important that sponsor wonders whether this this application. Healthcare result was a spurious one or due to professionals and other factors that were not also parents of accounted for. However, the patients are notified sponsor felt that changing the of this risk. It was labelling is not appropriate at this recommended the time and notes that there is sponsor address the existing information in the risk in the
condition of registration. For the important identified risk ‘Increased rates when 13vPnC is Infanrix hexa’, it was recommended that the sponsor propose adequate and appropriate risk minimisation activities as found in the EU SmPC. It is important to inform Healthcare Professionals of the risk of higher rates of febrile reactions when Prevenar 13 and Infanrix hexa are administered concomitantly. The sponsor stated that the Prevenar 13 Core Data Sheet has recently been updated to include information regarding the concomitant administration of Prevenar 13 and Infanrix. As a result, the Prevenar 13 Product Information will be updated accordingly, as part of a Safety-Related Notification. The approved text will then be added to the Product Information associated with this current application, after the Delegate’s Overview has been received. This was considered to be acceptable and the Delegate was requested to consider this assurance when the final PI and CMI are negotiated during the processing of this application. It has been reported that a higher risk of febrile seizures associated with the concomitant administration of Prevenar 13 and trivalent influenza vaccine (TIV) compared to when these vaccines were given alone on separate days in children 6-59 months of age. It is important that Healthcare professionals and also parents of patients are notified of this risk. It was recommended the sponsor address the risk in the The sponsor claimed that the single analysis that identified this interaction has some significant methodological issues, and the US Food and Drug Administration (FDA) is currently developing a Mini-Sentinel study to examine this further. The sponsor notes that similar findings have not been presented for the subsequent influenza season (2011-2012) which had the same TIV formulation, or in this most recent season (2012-2013) which has a different TIV formulation. The sponsor wonders whether this result was a spurious one or due to other factors that were not accounted for. However, the sponsor felt that changing the labelling is not appropriate at this time and notes that there is existing information in the The sponsor’s justification and position appeared reasonable, although the Delegate was requested to consider this when the final PI and CMI are negotiated during the processing of this application.