clinical evaluation report. It is important to ensure that the information provided in response to these includes a consideration of the relevance for the RMP, and any specific information needed to address this issue in the RMP. For any safety considerations so raised, please provide information that is relevant and necessary to address the issue in the RMP. It is expected that The sponsor commit to providing an updated This is any subsequent RMP and ASA with relevant information from considered versions of the the RMP for the trivalent vaccine. The updated acceptable in RMP/ASA or RMP and ASA will be submitted to the TGA after the context of RMP/ASA updates the conclusion of evaluation. this for the Afluria application. Quad contain relevant safety information from the RMP for the Fluvax TIV. The same applies to the proposed PI and CMI documents. Due to its The sponsor commits to include off-label use in This is importance in this children 5 to 17 years of age as an important considered case, the sponsor Potential Risk in an updated RMP. In addition, acceptable in should provide add the sponsor commits to providing additional risk the context of use’ as a minimisation measures and a proposal to this ‘Off-label separate Important evaluate the effectiveness of such measure/s (as application. Potential Risk to be outlined in the sponsor’s response to questions addressed with Q.16 and Q.17) until such time that an additional risk authorised indication of Afluria Quad for use in minimisation this age group has been obtained. activities. The sponsor believes that the proposed additional risk minimisation measures in children under 18 years are sufficient and will be continued to ensure the vaccine is not used in this age group.
clinical evaluation report. It is important to ensure that the information provided in response to these includes a consideration of the relevance for the RMP, and any specific information needed to address this issue in the RMP. For any safety considerations so raised, please provide information that is relevant and necessary to address the issue in the RMP. It is expected that any subsequent versions of the RMP/ASA or RMP/ASA updates for the Afluria Quad contain relevant safety information from the RMP for the Fluvax TIV. The same applies to the proposed PI and CMI documents. The sponsor commit to providing an updated RMP and ASA with relevant information from the RMP for the trivalent vaccine. The updated RMP and ASA will be submitted to the TGA after the conclusion of evaluation. This is considered acceptable in the context of this application. Due to its importance in this case, the sponsor should provide add ‘Off-label use’ as a separate Important Potential Risk to be addressed with additional risk minimisation activities. The sponsor commits to include off-label use in children 5 to 17 years of age as an important Potential Risk in an updated RMP. In addition, the sponsor commits to providing additional risk minimisation measures and a proposal to evaluate the effectiveness of such measure/s (as outlined in the sponsor’s response to questions Q.16 and Q.17) until such time that an authorised indication of Afluria Quad for use in this age group has been obtained. The sponsor believes that the proposed additional risk minimisation measures in children under 18 years are sufficient and will be continued to ensure the vaccine is not used in this age group. This is considered acceptable in the context of this application.
auspar-inactivated-quadrivalent-influenza-vaccine-split-virion-170720.docx