proposed well as the proposed injection training did contain materials video and questionnaire to be administered modules 2, 3, related to post-training, specifically measure of and 5 of the additional risk effectiveness have been supplied including then proposed minimisation the training program/questionnaire and health care activities, the injection video as an example from the professional including but US training program. training not limited to program. the missing Modules 1 and modules of the 4 (and proposed health potentially care other professional modules) training were missing. program. The sponsor should state which topic areas the missing modules contain and submit them. site site anaesthesia/paraesthesia’ This is ‘Injection ‘Injection has been added to the RMP as an Important considered Identified Risk. acceptable in should be the context of as an Important this Identified Risk. application. site Although there were very few verbatim As ‘Injection bleeding’ reports of site ‘bleeding’, ‘injection should be bleeding’ has been added to the RMP as an added as an Important Identified Risk. Additionally, in Important response to RMP requests, a statement has Identified Risk. been added to the PI regarding injection site bleeding and patients who have risk factors for bleeding events. of of structures at or near the injection As above ‘Injury ’Injury structures at or site’ has been to the RMP as an near the Important Potential Risk. injection site’ should be added as an Important Potential Risk. Since a small number of cases were As above. ‘Dysphagia‘ should be reported in clinical trials, the sponsor added as an considers dysphagia to be an identified risk. Important Therefore, has been added to ‘Dysphagia’ Potential Risk. the RMP as an Important Identified Risk.
proposed materials related to additional risk minimisation activities, including but not limited to the missing modules of the proposed health care professional training program. well as the proposed injection training video and questionnaire to be administered post-training, specifically measure of effectiveness have been supplied including the training program/questionnaire and the injection video as an example from the US training program. did contain modules 2, 3, and 5 of the then proposed health care professional training program. Modules 1 and 4 (and potentially other modules) were missing. The sponsor should state which topic areas the missing modules contain and submit them. ‘Injection site should be as an Important Identified Risk. ‘Injection site anaesthesia/paraesthesia’ has been added to the RMP as an Important Identified Risk. This is considered acceptable in the context of this application. ‘Injection site bleeding’ should be added as an Important Identified Risk. Although there were very few verbatim reports of ‘bleeding’, ‘injection site bleeding’ has been added to the RMP as an Important Identified Risk. Additionally, in response to RMP requests, a statement has been added to the PI regarding injection site bleeding and patients who have risk factors for bleeding events. As ‘Injury of structures at or near the injection site’ should be added as an Important Potential Risk. ’Injury of structures at or near the injection site’ has been to the RMP as an Important Potential Risk. As above ‘Dysphagia‘ should be added as an Important Potential Risk. Since a small number of cases were reported in clinical trials, the sponsor considers dysphagia to be an identified risk. Therefore, ‘Dysphagia’ has been added to the RMP as an Important Identified Risk. As above.
auspar-deoxycholic-acid-170406.docx