Risk management- plan Indehaveren af markedsføringstilladelsen forpligter sig til at foretage studier og øvrige pharmacovigilance- aktiviteter, der er specificeret i Pharmacovigilance- planen, som aftalt i version 01 dateret 30. september 2007 (med ikrafttrædelsesdato 16. maj 2008) i risikostyringsplanen (RMP) under modul 1. 8. 2 i ansøgningen om markedsføringstilladelsen og enhver efterfølgende opdatering af RMP’ en, der 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 01 dated 30 September 2007 (with effective date 16 May 2008) 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.