Disse er beskrevet i den Pharmacovigilance- plan, der er vedtaget i version 1. 4 af Risk Management Planen (RMP), som er præsenteret i modul 1. 8. 2 af ansøgningen om markedsføringstilladelse og enhver følgende opdatering af RMP vedtaget af CHMP
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.4 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.