Disse er specificeret i den pharmacovigilanceplan, der er vedtaget i version 2. 1 af Risk Management Planen (RMP), som er præsenteret i Modul 1. 8. 2 af markedsføringstilladelsen, og enhver følgende opdatering af RMP, som er vedtaget af CHMP.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.1 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.