provide a summary Australia, post-market experience with device of the post-market failure is not relevant to the pre-filled syringe experience with presentation. device failure with that device and its effects (for example underdosing). Assuming, the Only the pre-filled syringe presentation is will be The sponsor’s PharmaJet Stratis response has registered and used in Australia. jet injector device been noted. is used, the sponsor should provide a summary of the post-market experience with device failure with that device and its effects (for example underdosing). The sponsor should As stated within an influenza season, only The sponsor’s state how they one vaccine, either Fluvax TIV or Afluria Quad response has propose to address been noted. will be supplied to the market by the sponsor. the issue of Appropriate educational materials will be It is confusion between provided to educate Australian health furthermore the Fluvax TIV and professionals about the indications of Afluria noted that the the Afluria Quad Quad vaccine. These materials outlined in Q.17 sponsor is and their will be developed following registration and already indications. prior to the anticipated launch of the vaccine in proposing an Additional risk the Australian market. Once prepared, these extension of minimisation materials can be made available to the TGA. indication that activities would be would align the needed to mitigate current off-label use. indication of the TIV with the overall proposed indication of Afluria Quad. If approval for this extension of indication were given before supply of the Afluria Quad under the currently proposed indication, the age ranges would be aligned. However, if the application for
provide a summary of the post-market experience with device failure with that device and its effects (for example underdosing). Australia, post-market experience with device failure is not relevant to the pre-filled syringe presentation. Assuming, the PharmaJet Stratis jet injector device is used, the sponsor should provide a summary of the post-market experience with device failure with that device and its effects (for example underdosing). Only the pre-filled syringe presentation is will be registered and used in Australia. The sponsor’s response has been noted. The sponsor should state how they propose to address the issue of confusion between the Fluvax TIV and the Afluria Quad and their indications. Additional risk minimisation activities would be needed to mitigate off-label use. As stated within an influenza season, only one vaccine, either Fluvax TIV or Afluria Quad will be supplied to the market by the sponsor. Appropriate educational materials will be provided to educate Australian health professionals about the indications of Afluria Quad vaccine. These materials outlined in Q.17 will be developed following registration and prior to the anticipated launch of the vaccine in the Australian market. Once prepared, these materials can be made available to the TGA. The sponsor’s response has been noted. It is furthermore noted that the sponsor is already proposing an extension of indication that would align the current indication of the TIV with the overall proposed indication of Afluria Quad. If approval for this extension of indication were given before supply of the Afluria Quad under the currently proposed indication, the age ranges would be aligned. However, if the application for
auspar-inactivated-quadrivalent-influenza-vaccine-split-virion-170720.docx