The scientific information discussed in this statement related to our product candidates is preliminary and investigative and is not part of the labeling approved by the U.S. FDA or the European Medicines Agency (EMA) for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA, EMA or other applicable regulatory bodies can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the approved labeling for the products, and not the information discussed in this statement.
CONTACT: E.U. media, Carrie Deverell, +41 41 3690 308, or U.S. media,Christine Regan, +1-805-447-5476, both of Amgen