Endvidere blev der medtaget en erklæring i det harmoniserede produktresumé for at påpege, at kontrollerede undersøgelser af børn ikke påviste effekt af venlafaxin til indikationen "major depression".
Furthermore, a statement was included in the harmonized SPC to highlight that controlled studies in children did not demonstrate efficacy of venlafaxine in the “ major depressive disorder” indication.