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Pitolisant hydrochloride for treating excessive daytime sleepiness caused by obstructive sleep apnoea

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2 Information about pitolisant hydrochloride

Anticipated marketing authorisation indication

2.1 On 20 May 2021 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product pitolisant hydrochloride (Ozawade), intended 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 will be available in the summary of product characteristics.

Price

2.3 The proposed list price for pitolisant hydrochloride is commercial in confidence.