Risk management plan Indehaveren af markedsføringstilladelsen forpligter sig til at udføre studier og supplerende pharmacovigilance aktiviteter i henhold til pharmacovigilance planen, som aftalt i Risk Management planen (RMP), version 2 (dateret august 2007) i modul 1. 8. 2 i ansøgningen om markedsføringstilladelsen og ved CHMP aftalte opdateringer af RMP.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2 (dated August 2007) 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.