Posted by notfred on July 28, 2006, at 19:39:54
In reply to Re: EMEA - refusal for Valdoxan (agomelatine), posted by Tom Twilight on July 28, 2006, at 13:29:52
The major concern of the CHMP was that the effectiveness of Valdoxan/Thymanax had not been sufficiently shown:
1. • The long-term study did not show that the medicine was effective .
2. • 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
poster:notfred
thread:671402
URL: http://www.dr-bob.org/babble/20060724/msgs/671555.html