potential for medication errors. Minimisation Activities The sponsor states: The sponsor should now ‘Risk Referenced in the EU-RMP’ of the applicant will make such changes and “The ASA states: addition to routine provide an amended submit a revised ASA “In pharmacovigilance measures, the statement in the next before this application is following additional version of the revised approved. pharmacovigilance activity will ASA for Section 3.1 occur. 1. Evaluation of the PIP Minimisation ‘Risk [paediatric investigation plan] Activities Referenced in will monitor the safety profile of the EU-RMP’.” Velphoro in children and adolescents.” The sponsor should amend this section of the ASA as it is inappropriate to refer to pharmacovigilance activities in the Risk Minimisation Plan. The sponsor should provide a The sponsor states: The sponsor should now table summarising the summarise the make such changes, taking “To pharmacovigilance plan and risk pharmacovigilance into account ‘Outstanding minimisation plan proposed for plan and risk issues’ (see above), and Australia in the ASA. Wording minimisation plan submit a revised ASA pertaining to all the specified planned for Australia before this application is ongoing safety concerns in the for the ongoing safety approved. proposed Australian PI and CMI concerns, the applicant should be included in the table. will include [a] Table into the next version of the revised ASA. The proposed text in the table below is presenting the current wording of the proposed Australian Reference Safety Information.” Notwithstanding the The sponsor agrees n/a recommendations made in regard that the proposed to the specified list of ongoing routine risk safety concerns, the proposed minimisation activities routine risk minimisation are sufficient for the activities in the product specified list of information document are ongoing safety considered satisfactory. Similarly concerns. in regard to the proposed routine risk minimisation activities, the draft CMI is considered satisfactory.
potential for medication errors. ‘Risk Minimisation Activities Referenced in the EU-RMP’ of the ASA states: “In addition to routine pharmacovigilance measures, the following additional pharmacovigilance activity will occur. 1. Evaluation of the PIP [paediatric investigation plan] will monitor the safety profile of Velphoro in children and adolescents.” The sponsor should amend this section of the ASA as it is inappropriate to refer to pharmacovigilance activities in the Risk Minimisation Plan. The sponsor states: “The applicant will provide an amended statement in the next version of the revised ASA for Section 3.1 ‘Risk Minimisation Activities Referenced in the EU-RMP’.” The sponsor should now make such changes and submit a revised ASA before this application is approved. The sponsor should provide a table summarising the pharmacovigilance plan and risk minimisation plan proposed for Australia in the ASA. Wording pertaining to all the specified ongoing safety concerns in the proposed Australian PI and CMI should be included in the table. The sponsor states: “To summarise the pharmacovigilance plan and risk minimisation plan planned for Australia for the ongoing safety concerns, the applicant will include [a] Table into the next version of the revised ASA. The proposed text in the table below is presenting the current wording of the proposed Australian Reference Safety Information.” The sponsor should now make such changes, taking into account ‘Outstanding issues’ (see above), and submit a revised ASA before this application is approved. Notwithstanding the recommendations made in regard to the specified list of ongoing safety concerns, the proposed routine risk minimisation activities in the product information document are considered satisfactory. Similarly in regard to the proposed routine risk minimisation activities, the draft CMI is considered satisfactory. The sponsor agrees that the proposed routine risk minimisation activities are sufficient for the specified list of ongoing safety concerns. n/a
auspar-sucroferric-oxyhydroxide-150219.docx