CHMP fandt derfor, at de indsendte data om sikkerhed efter markedsføring var tilstrækkelige til at vurdere produktets sikkerhedsprofil, selv om de stammede fra en enkelt EU - medlemsstat.
Therefore, the CHMP was of the opinion that the submitted post marketing safety data are adequate to assess the safety profile of the product, even if they originate from a single EU member state.