the PBRER reporting period. GSK proposes to provide additional information regarding these studies to the TGA upon request, following review of the PBRER/RMP. Any impact of these studies on the Australian Product Information (PI) will be provided to the TGA through the submission of an appropriate application. The submitted short study The sponsor confirms This is acceptable. summaries do not lend that the protocols for However, in the themselves to detailed the proposed post light of the ACSOM assessment. Nevertheless authorisation safety advice the sponsor they will be considered by studies (PASS) will be should consider the ACSOM, as to whether submitted to the TGA amending the draft the study design is upon endorsement by protocol / synopsis adequate and if not, how the EMA of the drug could they be strengthened. Pharmacovigilance utilisation study to In addition the committee Risk Assessment include Australian will consider if Australian Committee. Once patients and an patient involvement is approved, the final updated version required. The sponsor PASS protocols will be should be provided should also provide an provided in the to the TGA for assurance that it will updated UMEC/VI EU review once it is submit a draft protocol for RMP. available (see these planned studies to the above). TGA for review once they become available. It is agreed the specified This is noted. n/a ongoing safety concerns would not appear to warrant additional risk minimisation activities. Key changes to the updated RMP In their response to the TGA request for information the sponsor provided an updated RMP (Version: 3.0, dated 14 October 2013) with an updated ASA (Version: 2.0, undated). Key changes from the version evaluated at Round 1 are summarised below: Table 10. Key changes to the updated RMP RMP Section Changes introduced
the PBRER reporting period. GSK proposes to provide additional information regarding these studies to the TGA upon request, following review of the PBRER/RMP. Any impact of these studies on the Australian Product Information (PI) will be provided to the TGA through the submission of an appropriate application. The submitted short study summaries do not lend themselves to detailed assessment. Nevertheless they will be considered by the ACSOM, as to whether the study design is adequate and if not, how could they be strengthened. In addition the committee will consider if Australian patient involvement is required. The sponsor should also provide an assurance that it will submit a draft protocol for these planned studies to the TGA for review once they become available. The sponsor confirms that the protocols for the proposed post authorisation safety studies (PASS) will be submitted to the TGA upon endorsement by the EMA Pharmacovigilance Risk Assessment Committee. Once approved, the final PASS protocols will be provided in the updated UMEC/VI EU RMP. This is acceptable. However, in the light of the ACSOM advice the sponsor should consider amending the draft protocol / synopsis of the drug utilisation study to include Australian patients and an updated version should be provided to the TGA for review once it is available (see above). It is agreed the specified ongoing safety concerns would not appear to warrant additional risk minimisation activities. This is noted. n/a Key changes to the updated RMP In their response to the TGA request for information the sponsor provided an updated (Version: 3.0, dated 14 October 2013) with an updated ASA (Version: 2.0, undated). Key changes from the version evaluated at Round 1 are summarised below: Table 10. Key changes to the updated RMP RMP Section Changes introduced RMP
auspar-umeclidinium-bromide-and-vilanterol_trifenatate-150408.docx