in the proposed Australian PI and CMI have also been included. The pharmacovigilance plan for Australia does not differ from the actions described in the EU-RMP. Section 2.3 of the ASA includes a showing the safety concerns that will be addressed by all ongoing and planned studies as well as the date of submission of the study reports in Australia. 8. It is recommended to the No safety concerns The response has been Delegate to draw the attention were raised by the of the nonclinical evaluator to nonclinical assess whether evaluator. ‘Transmission for infectious reagents’ should be added to the table of ongoing safety concerns as missing information. 9. Amendments to the CMI/PI The CMI has been This is considered were recommended but are updated according acceptable. beyond the scope of this to the AusPAR. recommendations. A tracked and clean copy of the CMI is provided. ASA = Australian Specific Annex; CMI = Consumer Medicine Information; EMA = European Medicines Agency; HIV = human immunodeficiency virus; OPR = Office of Product Review; PI = Product Information; RMP = risk management plan. Summary of recommendations It is considered that the sponsor’s response to the TGA S31 Request has not adequately addressed all of the issues identified in the RMP evaluation report (please to outstanding issues below).
in the proposed Australian PI and CMI have also been included. The pharmacovigilance plan for Australia does not differ from the actions described in the EU-RMP. Section 2.3 of the ASA includes a showing the safety concerns that will be addressed by all ongoing and planned studies as well as the date of submission of the study reports in Australia. 8. It is recommended to the Delegate to draw the attention of the nonclinical evaluator to assess whether ‘Transmission for infectious reagents’ should be added to the table of ongoing safety concerns as missing information. No safety concerns were raised by the nonclinical evaluator. The response has been 9. Amendments to the CMI/PI were recommended but are beyond the scope of this AusPAR. The CMI has been updated according to the recommendations. A tracked and clean copy of the CMI is provided. This is considered acceptable. ASA = Australian Specific Annex; CMI = Consumer Medicine Information; EMA = European Medicines Agency; HIV = human immunodeficiency virus; OPR = Office of Product Review; PI = Product Information; RMP = risk management plan. Summary of recommendations It is considered that the sponsor’s response to the TGA S31 Request has not adequately addressed all of the issues identified in the RMP evaluation report (please to outstanding issues below).