For the important potential The sponsor states: This is acceptable. risk: neoplasms ‘Malignant ‘Novartis (children 6 to less than 12 acknowledges the old)’, the RMP evaluator’s activity’ request and Table 2 ‘Pharmacovigilance column of Section 10.2 - (Summary of safety Table 2: of safety specification, ‘Summary specification, pharmacovigilance pharmacovigilance plan and plan and planned planned risk minimisation risk minimization measures in Australia’ of the measures in ASA should be amended to be Australia) in consistent with Part III - attachment 1 of the Table 10-8 of the EU-RMP. updated ASA version 5.0 has been amended’.
For the important potential risk: ‘Malignant neoplasms (children 6 to less than 12 old)’, the ‘Pharmacovigilance activity’ column of Section 10.2 - Table 2: ‘Summary of safety specification, pharmacovigilance plan and planned risk minimisation measures in Australia’ of the ASA should be amended to be consistent with Part III - Table 10-8 of the EU-RMP. The sponsor states: ‘Novartis acknowledges the RMP evaluator’s request and Table 2 (Summary of safety specification, pharmacovigilance plan and planned risk minimization measures in Australia) in attachment 1 of the updated ASA version 5.0 has been amended’. This is acceptable.