2 Information about pitolisant hydrochloride
Marketing authorisation indication
2.1 Pitolisant hydrochloride (Ozawade, Bioprojet Pharma) is indicated 'to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by, or who have not tolerated, OSA primary therapy, such as continuous positive airway pressure (CPAP)'.
Dosage in the marketing authorisation
2.2 The dosage schedule is available in the summary of product characteristics for pitolisant hydrochloride.