grundlag af den forelagte dokumentation, den faglige drøftelse i udvalget og den foreslåede ordlyd i den ajourførte udgave af Guideline on Summary of Product Characteristics fra oktober 2005 og de seneste QRD- modeller (version 7),
applicant has been assessed based on the documentation submitted, the scientific discussion within the Committee and the new wording proposed in the updated Guideline on SPC dated October 2005 and the latest QRD templates version 7