In regard to the proposed The sponsor states: This is acceptable. routine risk minimisation of the above ‘None activities, it is recommended recommendations to the Delegate that the draft are actually consumer medicine warranting any information document be changes to the draft revised to adequately reflect consumer medicine any changes made to the information’. Australian PI as a result of the above recommendations. Summary of recommendations It is considered that the sponsor’s response to the TGA has adequately addressed all of the issues identified in the RMP evaluation report. Nevertheless an updated ASA should be submitted to the TGA, preferably before this application is approved. Outstanding issues Issues in relation to the RMP In regard to the proposed routine risk minimisation activities for the important identified risk: Strauss Syndrome (CSS) / Hypereosinophilic Syndrome’, the sponsor has ‘Churg advised that the wording in the Precaution section of the draft Australian PI is the same as that in the current EU SmPC. This is acceptable, although Table 1: by safety ‘Details concern of information included in the Australia Product Information and EU SmPC and justification for any differences’ and Table 2: of safety specification, ‘Summary pharmacovigilance plan and planned risk minimisation measures in Australia’ of the ASA only state: effects, Post-marketing observations Respiratory, thoracic and ‘Adverse mediastinal disorders: Allergic granulomatous angiitis (i.e. Churg Strauss syndrome) is listed as a post-marketing observation’. Consequently these tables of the ASA should be updated with this information, preferably before this application is approved. In addition the ASA states that the release date for the EU-RMP (Version: 10) is 8 July 2015, while the document itself states the date for final sign-off is 5 March 2015. The sponsor should clarify this discrepancy and amend the ASA if required. Advice from the Advisory Committee on the Safety of Medicines (ACSOM) ACSOM advice was not sought for this submission. Key changes to the updated RMP In response to the TGA the sponsor provided an updated EU-RMP (Version 10.0, dated 5 March 2015) with an updated ASA (Version 5.0, dated 13 August 2015). Key changes from the versions evaluated in the first round are summarised below in Table 15.
In regard to the proposed routine risk minimisation activities, it is recommended to the Delegate that the draft consumer medicine information document be revised to adequately reflect any changes made to the Australian PI as a result of the above recommendations. The sponsor states: ‘None of the above recommendations are actually warranting any changes to the draft consumer medicine information’. This is acceptable. Summary of recommendations It is considered that the sponsor’s response to the TGA has adequately addressed all of the issues identified in the RMP evaluation report. Nevertheless an updated ASA should be submitted to the TGA, preferably before this application is approved. Outstanding issues Issues in relation to the RMP In regard to the proposed routine risk minimisation activities for the important identified risk: ‘Churg Strauss Syndrome (CSS) / Hypereosinophilic Syndrome’, the sponsor has advised that the wording in the Precaution section of the draft Australian PI is the same as that in the current EU SmPC. This is acceptable, although Table 1: ‘Details by safety concern of information included in the Australia Product Information and EU SmPC and justification for any differences’ and Table 2: ‘Summary of safety specification, pharmacovigilance plan and planned risk minimisation measures in Australia’ of the ASA only state: ‘Adverse effects, Post-marketing observations Respiratory, thoracic and mediastinal disorders: Allergic granulomatous angiitis (i.e. Churg Strauss syndrome) is listed as a post-marketing observation’. Consequently these tables of the ASA should be updated with this information, preferably before this application is approved. In addition the ASA states that the release date for the EU-RMP (Version: 10) is 8 July 2015, while the document itself states the date for final sign-off is 5 March 2015. The sponsor should clarify this discrepancy and amend the ASA if required. Advice from the Advisory Committee on the Safety of Medicines (ACSOM) ACSOM advice was not sought for this submission. Key changes to the updated RMP In response to the TGA the sponsor provided an updated EU-RMP (Version 10.0, dated 5 March 2015) with an updated ASA (Version 5.0, dated 13 August 2015). Key changes from the versions evaluated in the first round are summarised below in Table 15.
auspar-omalizumab-rch-160622.docx