o Targeted malignancy questionnaire sent to HCP RA has now been completed and is now under table 5-2: Completed studies/activities from the Pharmacovigilance plan The Status (planned /started) and Date for submission of interim or final reports (planned or actual) for all ongoing and planned additional PhV studies / activities in the Pharmacovigilance Plan are provided in table 5-1 on page 193. Targeted follow-up UCB has now updated Cimzia The Sponsor questionnaires have RMP to version 9.3. The targeted remains unclear not been submitted follow-up questionnaires are now regarding the with the current in Part VII Annex 7: inclusion of these application. It is additional Targeted follow-up with recommended that questionnaires, the reporter with TB questionnaire the sponsor submit current distribution Targeted malignancy these for review by methods, questionnaire in paediatric, the TGA data adolescent and young adult regarding RA and It is recommended patients ( < 30 years of age) inclusion of these to the sponsor that questionnaires in Targeted follow-up with additional the educational pregnancy questionnaire questionnaires material (please regarding serious UCB will evaluate the TGA request note that the infection and regarding questionnaires for Sponsor has also not hepatitis B serious infection and hepatitis B yet clarified if an reactivation be reactivation. education added programme will UCB will evaluate the request to Furthermore the occur in Australia). include questionnaires (TB, method of supplying malignancy, pregnancy) in any The additional these questionnaires physician education material that questionnaires only after a will be supplied. suggested by the spontaneous report evaluator should be has been made developed by the seems questionable. Sponsor and The sponsor should submitted to the also consider TGA for review. including these questionnaires in the physician education material to prompt reporting and improve the quality of data collected.
o Targeted malignancy questionnaire sent to HCP RA has now been completed and is now under table 5-2: Completed studies/activities from the Pharmacovigilance plan The Status (planned /started) and Date for submission of interim or final reports (planned or actual) for all ongoing and planned additional PhV studies / activities in the Pharmacovigilance Plan are provided in table 5-1 on page 193. Targeted follow-up questionnaires have not been submitted with the current application. It is recommended that the sponsor submit these for review by the TGA It is recommended to the sponsor that additional questionnaires regarding serious infection and hepatitis B reactivation be added Furthermore the method of supplying these questionnaires only after a spontaneous report has been made seems questionable. The sponsor should also consider including these questionnaires in the physician education material to prompt reporting and improve the quality of data collected. UCB has now updated Cimzia to version 9.3. The targeted follow-up questionnaires are now in Part VII Annex 7: Targeted follow-up with reporter with TB questionnaire Targeted malignancy questionnaire in paediatric, adolescent and young adult patients ( < 30 years of age) Targeted follow-up with pregnancy questionnaire UCB will evaluate the TGA request regarding questionnaires for serious infection and hepatitis B reactivation. UCB will evaluate the request to include questionnaires (TB, malignancy, pregnancy) in any physician education material that will be supplied. The Sponsor remains unclear regarding the inclusion of these additional questionnaires, the current distribution methods, data regarding RA and inclusion of these questionnaires in the educational material (please note that the Sponsor has also not yet clarified if an education programme will occur in Australia). The additional questionnaires suggested by the evaluator should be developed by the Sponsor and submitted to the TGA for review. RMP
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