as ongoing ‘Vaccinations’ safety concerns. The sponsor should now provide compelling justification for these deletions or consider reinstating these ongoing safety concerns. For completeness the The sponsor commits to This is acceptable. Table: of correcting this ‘Summary Ongoing Safety Concerns inconsistency with the in Paediatric Patients’ of next update to the RMP. the EU-RMP should include in sJIA ‘MAS patients’ as important missing information to be consistent with the Table: of Ongoing ‘Summary Safety Concerns in Paediatric Patients’ of the EU-RMP when this document is next updated. The Table: Risk The sponsor has provided This is acceptable. ‘Australian Management Plan’ of the a revised version of the ASA appears to makes ASA. The cross-reference erroneous EU-RMP table to the Table has been references for the included as requested. The proposed EU ASA indicates which pharmacovigilance pharmacovigilance activities, which are in fact activities are relevant for captured in Table: Australia. ‘Safety concerns and overview of planned pharmacovigilance actions for All Patients’ of the The Table also does not appear to indicate whether such pharmacovigilance activities are also proposed and/or are relevant for Australia. The sponsor should correct such deficiencies in a revised ASA. The studies referenced in The sponsor has provided This is not entirely the pharmacovigilance a revised satisfactory, as data from ‘Studies plan will generate safety referenced in the RMP’ Studies NP25737 and data that will simply section of the ASA, which MA21488 have been support the known safety references the EU-RMP stated as being available as profile of the medicine, v15.0 Table On-Going and of the third quarter (Q3)
‘Vaccinations’ as ongoing safety concerns. The sponsor should now provide compelling justification for these deletions or consider reinstating these ongoing safety concerns. For completeness the Table: ‘Summary of Ongoing Safety Concerns in Paediatric Patients’ of the EU-RMP should include ‘MAS in sJIA patients’ as important missing information to be consistent with the Table: ‘Summary of Ongoing Safety Concerns in Paediatric Patients’ of the EU-RMP when this document is next updated. The sponsor commits to correcting this inconsistency with the next update to the RMP. This is acceptable. The Table: ‘Australian Risk Management Plan’ of the ASA appears to makes erroneous EU-RMP table references for the proposed EU pharmacovigilance activities, which are in fact captured in Table: ‘Safety concerns and overview of planned pharmacovigilance actions for All Patients’ of the The Table also does not appear to indicate whether such pharmacovigilance activities are also proposed and/or are relevant for Australia. The sponsor should correct such deficiencies in a revised ASA. The sponsor has provided a revised version of the ASA. The cross-reference to the Table has been included as requested. The ASA indicates which pharmacovigilance activities are relevant for Australia. This is acceptable. The studies referenced in the pharmacovigilance plan will generate safety data that will simply support the known safety profile of the medicine, The sponsor has provided a revised ‘Studies referenced in the RMP’ section of the ASA, which references the EU-RMP v15.0 Table On-Going and This is not entirely satisfactory, as data from Studies NP25737 and MA21488 have been stated as being available as of the third quarter (Q3)