13 Risk management- plan Indehaveren af markedsføringstilladelsen har erklæret sig enig i at udføre de undersøgelser og den monitorering, som er detaljeret beskrevet i risk management planen, som del af Pharmacovigilance planen.
13 Risk Management Plan The Marketing Authorisation Holder has committed to performing the studies and monitoring which are detailed in the risk management plan, as part of the Pharmacovigilance plan.