the potential risk for ‘immunogenicity’ which no risk minimisation is proposed in Australia. The aforementioned statement should be amended to reflect the above. In addition section 4.3 of the ASA is titled risk ‘Additional minimisation activities’ however it would appear that a more appropriate title is of risk ‘Evaluation minimisation activities’. The sponsor is advised that the ASA does not follow the current ASA format guidance, as this guidance was not available at the time of submission. However, any ASA updates should be provided in the current ASA format (guidance available at: ) 9. Section 4.1 of the ASA The company has reviewed The sponsor’s does not contain the ASA noting the RMP amendment is information on the risk evaluator’s comments and however the evaluator minimisation proposed for has revised to address same. is not convinced that the the items of missing Updated copy of ASA is PI text with ‘Treatment information and should be provided. Bemfola should be amended. If no risk initiated under the minimisation is proposed supervision of a for a particular item of physician experienced missing information then with the treatment of this should be stated. fertility disorders’ can be considered specific routine risk minimisation for missing information item in female ‘Use patients > 40 years of age’. 10. The ASA makes brief The patient instructions for The evaluator has no reference to an use have been included in the specific objection to the for Use’ (IFU) proposed Consumer Medicine content of the ‘Instructions leaflet for the safe use of Information. Copies of instructions for use Bemfola. This was unable to revised and clean versions leaflet. be located in the dossier. are provided to allow review. The IFU leaflet should be The ASA has been updated to provided for review and include the instructions for assigned in the ASA as risk
the potential risk ‘immunogenicity’ for which no risk minimisation is proposed in Australia. The aforementioned statement should be amended to reflect the above. In addition section 4.3 of the ASA is titled ‘Additional risk minimisation activities’ however it would appear that a more appropriate title is ‘Evaluation of risk minimisation activities’. The sponsor is advised that the ASA does not follow the current ASA format guidance, as this guidance was not available at the time of submission. However, any ASA updates should be provided in the current ASA format (guidance available at: ) 9. Section 4.1 of the ASA does not contain information on the risk minimisation proposed for the items of missing information and should be amended. If no risk minimisation is proposed for a particular item of missing information then this should be stated. The company has reviewed the ASA noting the RMP evaluator’s comments and has revised to address same. Updated copy of ASA is provided. The sponsor’s amendment is however the evaluator is not convinced that the PI text ‘Treatment with Bemfola should be initiated under the supervision of a physician experienced with the treatment of fertility disorders’ can be considered specific routine risk minimisation for missing information item ‘Use in female patients > 40 years of age’. 10. The ASA makes brief reference to an ‘Instructions for Use’ (IFU) leaflet for the safe use of Bemfola. This was unable to be located in the dossier. The IFU leaflet should be provided for review and assigned in the ASA as risk The patient instructions for use have been included in the proposed Consumer Medicine Information. Copies of revised and clean versions are provided to allow review. The ASA has been updated to include the instructions for The evaluator has no specific objection to the content of the instructions for use leaflet.
auspar-follitropin-alfa-rch-160408.docx