Plenadren, an oral once daily tablet, is a dual release hydrocortisone replacement therapy.
The move follows the satisfactory opinion adopted by the Committee for Medicinal Products for Human Use (CHMP).
DuoCort Pharma chief medical officer Gudmundur Johannsson said Plenadren can be a new cortisol replacement therapy for patients suffering from adrenal insufficiency.
Currently, Plenadren is approved in all European Union (EU) countries, Iceland, Norway and Lichtenstein.