forskningsundersøgelser. o Forpligtelse til at underrette de kompetente nationale myndigheder, hvis der sker væsentlige ændringer i indberetningshyppigheden.
• the scope of the referral was the potential risk to public health concerning the need for data in repeated administration and data on immunogenicity for Xeomin • the posology of Xeomin • the safety profile of Xeomin in the two Phase III clinical trials