Table 3. Additional proposed pharmacovigilance activity Additional Assigned safety Actions/outcome proposed Estimated activity concern planned of final data Phase-3 OHSS (important Compare efficacy and safety of 2 21 April investigator and identified risk) rhFSH Formulations (AFOLIA 2016 (final assessor blinded pen versus Gonal-f RFF pen) in Clinical 1:1 randomized normal Ovulatory women 35 to Study parallel group 42 years of age undergoing in Report) multi-centre study. vitro fertilization (IVF). (Category 4) Risk minimisation activities The sponsor has concluded that routine risk minimisation activities are sufficient to mitigate the associated with Bemfola. No additional risk minimisation measures are proposed (as described in the EU-RMP). Reconciliation of issues outlined in the RMP report Table 4 summarises the OPR’s first round evaluation of the RMP, the sponsor’s responses to issues raised by the RMP evaluator and the evaluation of the sponsor’s responses. Table 4. Reconciliation of issues outlined in the RMP evaluation report (Round 1) Recommendation in RMP Sponsor’s response (or RMP evaluator’s evaluation report summary of the response) comment 1. Safety considerations The evaluator has no may be raised by the further comment nonclinical and clinical regarding this evaluators through the recommendation. consolidated questions and/or the nonclinical and clinical evaluation reports respectively. It is important to ensure that the information provided in response to these, include 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, the sponsor should provide information that is relevant and necessary to address the issue in the RMP. 2. It is noted that the The company has revised the This is acceptable from approved indications for wording of the indications to an RMP perspective.
Table 3. Additional proposed pharmacovigilance activity Additional activity Assigned safety concern Actions/outcome proposed Estimated planned of final data Phase-3 investigator and assessor blinded 1:1 randomized parallel group multi-centre study. (Category 4) OHSS (important identified risk) Compare efficacy and safety of 2 rhFSH Formulations (AFOLIA pen versus Gonal-f RFF pen) in normal Ovulatory women 35 to 42 years of age undergoing in vitro fertilization (IVF). 21 April 2016 (final Clinical Study Report) Risk minimisation activities The sponsor has concluded that routine risk minimisation activities are sufficient to mitigate the associated with Bemfola. No additional risk minimisation measures are proposed (as described in the EU-RMP). Reconciliation of issues outlined in the RMP report Table 4 summarises the OPR’s first round evaluation of the RMP, the sponsor’s responses to issues raised by the RMP evaluator and the evaluation of the sponsor’s responses. Table 4. Reconciliation of issues outlined in the RMP evaluation report (Round 1) Recommendation in RMP evaluation report Sponsor’s response (or summary of the response) RMP evaluator’s comment 1. Safety considerations may be raised by the nonclinical and clinical evaluators through the consolidated questions and/or the nonclinical and clinical evaluation reports respectively. It is important to ensure that the information provided in response to these, include 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, the sponsor should provide information that is relevant and necessary to address the issue in the RMP. The evaluator has no further comment regarding this recommendation. 2. It is noted that the approved indications for The company has revised the wording of the indications to This is acceptable from an RMP perspective.
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