Pharmacovigilance inspection outcome Benefit-risk assessment This section should be completed by the CHMP Rapporteur. This section should represent the views of the Rapporteur/CHMP on the benefit-risk balance of the medicinal product, taking into account data presented in the renewal and the arguments put forward by the MAH in the section Benefit-Risk balance for the approved indication(s). Consideration to the updated RMP should be also taken into account if the MAH has proposed a new PhV. plan or a risk minimisation measure to address changes in the safety profile and minimise the risk. If no new safety concerns or change in benefits have been identified in the renewal assessment, please use the following statements (as applicable): The MAH submitted variations to update Product Information when necessary and has adequately addressed the PRAC/CHMP requests following PSURs evaluation. The adverse events reported from clinical trials and post-marketing experience are consistent with the known safety profile of {Product Name} as described in the product information. The efficacy and safety data collected during the covering period of this renewal and the cumulative knowledge about {Product Name} confirmed its positive benefit-risk balance in the approved indications. <The EU Risk Management Plan for {Product Name} has been maintained and regularly updated since granting of the initial marketing authorisation.> If important safety concerns and/or change of benefits during the renewal reporting interval period have been identified leading to change in the benefit-risk, a full appraisal is warranted and should be presented as follows: Favourable effects Uncertainties and limitations about favourable effects Unfavourable effects Uncertainties and limitations about unfavourable effects Benefit-risk assessment and discussion Importance of favourable and unfavourable effects Balance of benefits and risks General guidance on how to describe the benefit-risk assessment:
Pharmacovigilance inspection outcome Benefit-risk assessment This section should be completed by the CHMP Rapporteur. This section should represent the views of the Rapporteur/CHMP on the benefit-risk balance of the medicinal product, taking into account data presented in the renewal and the arguments put forward by the MAH in the section Benefit-Risk balance for the approved indication(s). Consideration to the updated RMP should be also taken into account if the MAH has proposed a new PhV. plan or a risk minimisation measure to address changes in the safety profile and minimise the risk. If no new safety concerns or change in benefits have been identified in the renewal assessment, please use the following statements (as applicable): The MAH submitted variations to update Product Information when necessary and has adequately addressed the PRAC/CHMP requests following PSURs evaluation. The adverse events reported from clinical trials and post-marketing experience are consistent with the known safety profile of {Product Name} as described in the product information. The efficacy and safety data collected during the covering period of this renewal and the cumulative knowledge about {Product Name} confirmed its positive benefit-risk balance in the approved indications. <The EU Risk Management Plan for {Product Name} has been maintained and regularly updated since granting of the initial marketing authorisation.> If important safety concerns and/or change of benefits during the renewal reporting interval period have been identified leading to change in the benefit-risk, a full appraisal is warranted and should be presented as follows: Favourable effects Uncertainties and limitations about favourable effects Unfavourable effects Uncertainties and limitations about unfavourable effects Benefit-risk assessment and discussion Importance of favourable and unfavourable effects Balance of benefits and risks General guidance on how to describe the benefit-risk assessment:
WC500233026.docx