are not part of the planned pharmacovigilance activities in the RMP. The EMA assessment has This is considered The sponsor describes that a been completed and acceptable. request was submitted to the agreement has been reached EMA in August 2013 to request that the risk of peritonitis in the French registry to be peritoneal dialysis patients discontinued. It is will be removed from recommended that the sponsor the RMP. This will be provides an update on the reflected in the updated outcome of the assessment scheduled to be this request by the EMA. If the available in the first quarter status of this registry has of 2015. The sponsor will changed since submission of continue to monitor the dossier, then the RMP peritonitis in the PSUR. should be updated accordingly. A revised ASA was provided reflecting the changes described above. As per response to Point 2, Pending the The sponsor should provide these risks are no longer Delegate’s information in the Australian considered missing approval this is PI/CMI to address the missing information and the ASA has considered information of on use in ‘Data been updated accordingly. No acceptable. hyperphosphataemic CKD further information relating patients on PD’ and on ‘Data to these patient groups has use in hyperphosphataemic therefore been added to the CKD patients not on dialysis Australian PI. with serum phosphorus ≥1.78 mmol/L’. Of note information to address the missing information is provided in the European Summary of Product Characteristics (SmPC). The risk minimisation plan in the ASA should be updated accordingly. It is recommended that the AVF site complications are a This is considered potential risk of well-recognised comorbidity acceptable. ‘Arteriovenous in haemodialysis patients fistula (AVF) Complications’ be secondary to the patient’s addressed by routine-risk underlying disease and/or minimisation in the Australian the complexity of the surgical PI. The ASA should be updated procedure. A direct causal accordingly. association with administration of sevelamer is not evident from the clinical safety data or from post marketing safety surveillance. Therefore information relating to AVF is not included in the Australian Renvela PI. Based on the latest PSUR, the sponsor has proposed to remove the potential risk of arteriovenous fistula (AVF) site complications in haemodialysis patients from the RMP, and this will be
are not part of the planned pharmacovigilance activities in the RMP. The sponsor describes that a request was submitted to the EMA in August 2013 to request the French registry to be discontinued. It is recommended that the sponsor provides an update on the outcome of the assessment this request by the EMA. If the status of this registry has changed since submission of the dossier, then the RMP should be updated accordingly. The EMA assessment has been completed and agreement has been reached that the risk of peritonitis in peritoneal dialysis patients will be removed from the RMP. This will be reflected in the updated scheduled to be available in the first quarter of 2015. The sponsor will continue to monitor peritonitis in the PSUR. A revised ASA was provided reflecting the changes described above. This is considered acceptable. The sponsor should provide information in the Australian PI/CMI to address the missing information of ‘Data on use in hyperphosphataemic CKD patients on PD’ and ‘Data on use in hyperphosphataemic CKD patients not on dialysis with serum phosphorus ≥1.78 mmol/L’. Of note information to address the missing information is provided in the European Summary of Product Characteristics (SmPC). The risk minimisation plan in the ASA should be updated accordingly. As per response to Point 2, these risks are no longer considered missing information and the ASA has been updated accordingly. No further information relating to these patient groups has therefore been added to the Australian PI. Pending the Delegate’s approval this is considered acceptable. It is recommended that the potential risk of ‘Arteriovenous fistula (AVF) Complications’ be addressed by routine-risk minimisation in the Australian PI. The ASA should be updated accordingly. AVF site complications are a well-recognised comorbidity in haemodialysis patients secondary to the patient’s underlying disease and/or the complexity of the surgical procedure. A direct causal association with administration of sevelamer is not evident from the clinical safety data or from post marketing safety surveillance. Therefore information relating to AVF is not included in the Australian Renvela PI. Based on the latest PSUR, the sponsor has proposed to remove the potential risk of arteriovenous fistula (AVF) site complications in haemodialysis patients from the RMP, and this will be This is considered acceptable.
auspar-sevelamer-carbonate-151002.docx