and death’ for at the next update of completeness. the EU-RMP. The sponsor should The pregnancy This is acceptable. definitively state whether forms in Annex 7 of the follow up pregnancy the EU-RMP differ to forms provided in Annex 7 those that will be used of EU-RMP are to be used in in Australia. The ASA Australia, and if so section has been revised to 2.4: clarify this difference ‘Other Pharmacovigilance and to include the Activities Referenced in the Pregnancy Notification EU-RMP’ of the ASA should Form and Pregnancy be amended accordingly Outcome Form to be when this document is next used in Australia. updated. The ongoing Study The sponsor confirms This is acceptable. HZC115058 is not that the considered to be part of the progress/results/ planned clinical studies in analysis of Study the pharmacovigilance HZC115058 will be plan. Therefore the related presented in future study protocol has not been Periodic Benefit-Risk reviewed. Nevertheless an Evaluation Reports update on the (PBRERs)/PSURs and progress/results/analysis updated EU-RMPs. of this study, as outlined in the EU-RMP, will be expected in future PSURs and updated RMPs. The studies referenced in An overview of the This is acceptable. the pharmacovigilance plan forthcoming studies in will generate safety data the pharmacovigilance that will simply support the plan and the safety profile of the anticipated completion medicine, while others will is provided in generate data that will Table 1 of the ASA in provoke applications to the section ‘Studies amend the Australian Referenced in the registration details. To this The results from end it is suggested that the these studies will be sponsor should provide an presented and attachment to the ASA discussed in PBRERs setting out all the and the EU-RMP. forthcoming studies and GlaxoSmithKline (GSK) the anticipated dates for will submit PBRERs their submission in (including the EU-RMP Australia. and ASA when these have been updated) to the TGA in line with
and death’ for completeness. at the next update of the EU-RMP. The sponsor should definitively state whether the follow up pregnancy forms provided in Annex 7 of EU-RMP are to be used in Australia, and if so section 2.4: ‘Other Pharmacovigilance Activities Referenced in the EU-RMP’ of the ASA should be amended accordingly when this document is next updated. The pregnancy forms in Annex 7 of the EU-RMP differ to those that will be used in Australia. The ASA has been revised to clarify this difference and to include the Pregnancy Notification Form and Pregnancy Outcome Form to be used in Australia. This is acceptable. The ongoing Study HZC115058 is not considered to be part of the planned clinical studies in the pharmacovigilance plan. Therefore the related study protocol has not been reviewed. Nevertheless an update on the progress/results/analysis of this study, as outlined in the EU-RMP, will be expected in future PSURs and updated RMPs. The sponsor confirms that the progress/results/ analysis of Study HZC115058 will be presented in future Periodic Benefit-Risk Evaluation Reports (PBRERs)/PSURs and updated EU-RMPs. This is acceptable. The studies referenced in the pharmacovigilance plan will generate safety data that will simply support the safety profile of the medicine, while others will generate data that will provoke applications to amend the Australian registration details. To this end it is suggested that the sponsor should provide an attachment to the ASA setting out all the forthcoming studies and the anticipated dates for their submission in Australia. An overview of the forthcoming studies in the pharmacovigilance plan and the anticipated completion is provided in Table 1 of the ASA in the section ‘Studies Referenced in the The results from these studies will be presented and discussed in PBRERs and the EU-RMP. GlaxoSmithKline (GSK) will submit PBRERs (including the EU-RMP and ASA when these have been updated) to the TGA in line with This is acceptable.