Ozawade
pitolisant
Table of contents
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
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Ozawade : EPAR - Medicine overview (PDF/129.15 KB)
First published: 14/10/2021 -
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Ozawade : EPAR - Risk management plan summary (PDF/196.63 KB)
First published: 14/10/2021
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 | |
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Marketing-authorisation holder |
Bioprojet Pharma
|
Revision |
3
|
Date of issue of marketing authorisation valid throughout the European Union |
01/09/2021
|
Contact address |
9 rue Rameau |
Product information
27/11/2023 Ozawade - EMEA/H/C/005117 - N/0008
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Therapeutic indication
Ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA)