The major concern of the CHMP was that the effectiveness of Valdoxan/ Thymanax had not been sufficiently shown: • The long-term study did not show that the medicine was effective. • The short-term studies showed that the medicine has an effect, but the extent of this did not allow the Committee to draw a firm conclusion on the medicine ’ s effectiveness The CHMP had no special concerns regarding the side effects associated with Valdoxan/ Thymanax, as these could have been managed using the standard risk management tools.