Table 8. Summary of proposed pharmacovigilance activities for potential risks and risk minimisation activities Safety concern Proposed pharmacovigilance Proposed risk activities (routine and minimisation activities additional) (routine* and additional) Important identified risks: (and complications Routine PV for fever but PI and Consumer Medicine such as Febrile Seizure) enhanced PV for febrile seizure Information (CMI) for the management of the fever Important potential risks: Syndrome Enhanced pharmacovigilance PI and CMI with questionnaire and adjudication by NVD SMT** Acute disseminated Enhanced pharmacovigilance PI and CMI encephalomyelitis with questionnaire and adjudication by NVD SMT Anaphylaxis and Routine pharmacovigilance PI indicates that vaccine Anaphylactic should not be given to persons with history of allergic reactions to the vaccine or its components. Kawasaki Disease Enhanced pharmacovigilance PI and CMI with questionnaire and adjudication by expert panel Seizure and febrile seizure Enhanced pharmacovigilance PI and CMI with questionnaire and adjudication by NVD SMT Chronic Fatigue Syndrome Routine pharmacovigilance PI and CMI Important missing information: Vaccine failure Enhanced pharmacovigilance PI and CMI with SMT adjudication on criteria Safety of vaccine during Pregnancy registry PI and CMI pregnancy or lactation, Vaccine effectiveness Vaccine effectiveness study PI and CMI Strain/serotype Carriage PI and CMI replacement *The PI and CMI, respectively, are used in place of (Summary of Product Characteristics) and ‘SPC’ ‘Patient leaflet’ that appear originally in the sponsor’s RMP summary table. ** NVD SMT: Novartis Vaccines and Diagnostics Safety Management Team Table 9 summarises the OPR’s evaluation of the RMP, the sponsor’s responses to issues raised by the OPR, and the second round OPR evaluation of the sponsor’s responses.
Table 8. Summary of proposed pharmacovigilance activities for potential risks and risk minimisation activities Safety concern Proposed pharmacovigilance activities (routine and additional) Proposed risk minimisation activities (routine* and additional) Important identified risks: (and complications such as Febrile Seizure) Routine PV for fever but enhanced PV for febrile seizure PI and Consumer Medicine Information (CMI) for the management of the fever Important potential risks: Syndrome Enhanced pharmacovigilance with questionnaire and adjudication by NVD SMT** PI and CMI Acute disseminated encephalomyelitis Enhanced pharmacovigilance with questionnaire and adjudication by NVD SMT PI and CMI Anaphylaxis and Anaphylactic Routine pharmacovigilance PI indicates that vaccine should not be given to persons with history of allergic reactions to the vaccine or its components. Kawasaki Disease Enhanced pharmacovigilance with questionnaire and adjudication by expert panel PI and CMI Seizure and febrile seizure Enhanced pharmacovigilance with questionnaire and adjudication by NVD SMT PI and CMI Chronic Fatigue Syndrome Routine pharmacovigilance PI and CMI Important missing information: Vaccine failure Enhanced pharmacovigilance with SMT adjudication on criteria PI and CMI Safety of vaccine during pregnancy or lactation, Pregnancy registry PI and CMI Vaccine effectiveness Vaccine effectiveness study PI and CMI Strain/serotype replacement Carriage PI and CMI *The PI and CMI, respectively, are used in place of ‘SPC’ (Summary of Product Characteristics) and ‘Patient leaflet’ that appear originally in the sponsor’s RMP summary table. ** NVD SMT: Novartis Vaccines and Diagnostics Safety Management Team Table 9 summarises the OPR’s evaluation of the RMP, the sponsor’s responses to issues raised by the OPR, and the second round OPR evaluation of the sponsor’s responses.
auspar-meningococcal-131031.docx