communicated to the TGA incidence of OHSS with when available. Bemfola and the company wishes to address these within this response for the TGA’s review. 7. Given the DLP for this A copy of medication error This is acceptable from RMP was in 2012 the listing report is provided as an RMP perspective. sponsor is requested to requested. update the TGA with any reports relating to medication error in clinical trials or post-marketing experience. 8. Section 4.1 of the ASA The company has reviewed The revised Section 4.1 states all eleven the ASA noting the RMP Routine Risk ‘For important identified risks, evaluator’s comments and Minimisation contains routine risk minimization has revised to address same. the following statement: measures are considered Updated copy of ASA is on the safety ‘Based sufficient’ however this provided. specifications of would appear to refer to Bemfola and the identified and potential experience with the risks. Also this would reference product appear to be factually Gonal-f, it is proposed to inconsistent with no manage all safety routine risk minimisation concerns (identified activities being proposed risks, potential risks and for several safety concerns. important missing This should be considered information) by routine by the sponsor and pharmacovigilance amended accordingly. activities’. The sponsor has erroneously referred in this section to routine pharmacovigilance instead of routine risk minimisation. Also as previously stated, not all safety concerns are managed by routine risk minimisation including
communicated to the TGA when available. incidence of OHSS with Bemfola and the company wishes to address these within this response for the TGA’s review. 7. Given the DLP for this RMP was in 2012 the sponsor is requested to update the TGA with any reports relating to medication error in clinical trials or post-marketing experience. A copy of medication error listing report is provided as requested. This is acceptable from an RMP perspective. 8. Section 4.1 of the ASA states ‘For all eleven important identified risks, routine risk minimization measures are considered sufficient’ however this would appear to refer to identified and potential risks. Also this would appear to be factually inconsistent with no routine risk minimisation activities being proposed for several safety concerns. This should be considered by the sponsor and amended accordingly. 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 revised Section 4.1 Routine Risk Minimisation contains the following statement: ‘Based on the safety specifications of Bemfola and the experience with the reference product Gonal-f, it is proposed to manage all safety concerns (identified risks, potential risks and important missing information) by routine pharmacovigilance activities’. The sponsor has erroneously referred in this section to routine pharmacovigilance instead of routine risk minimisation. Also as previously stated, not all safety concerns are managed by routine risk minimisation including
auspar-follitropin-alfa-rch-160408.docx