Ozawade

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pitolisant

Authorised
This medicine is authorised for use in the European Union.

Overview

Ozawade is a medicine used to improve wakefulness and reduce excessive daytime sleepiness in adults with obstructive sleep apnoea.

Obstructive sleep apnoea is the repeated interruption of breathing during sleep due to airways becoming blocked. Ozawade is used when other treatments, such as continuous positive airway pressure (CPAP, use of a ventilator to keep the airways open) have not satisfactorily improved excessive daytime sleepiness or cannot be tolerated by the patient. 

Ozawade contains the active substance pitolisant

This EPAR was last updated on 12/05/2022

Authorisation details

Product details
Name
Ozawade
Agency product number
EMEA/H/C/005117
Active substance
pitolisant
International non-proprietary name (INN) or common name
pitolisant
Therapeutic area (MeSH)
Sleep Apnea, Obstructive
Anatomical therapeutic chemical (ATC) code
N07XX11
Publication details
Marketing-authorisation holder
Bioprojet Pharma
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
01/09/2021
Contact address

9 rue Rameau
Paris 75002
France

Product information

04/05/2022 Ozawade - EMEA/H/C/005117 - N/0004

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other nervous system drugs

Therapeutic indication

Ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA)

Assessment history

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