Wakix
pitolisant
Table of contents
Overview
Wakix is used to treat narcolepsy in adults, adolescents and children from 6 years of age. Narcolepsy is a long-term sleep disorder which affects the brain’s ability to regulate the normal sleep-wake cycle. This leads to symptoms such as an irresistible urge to sleep, even at inappropriate times and places, and disturbed night-time sleep. Some patients also have episodes of severe muscle weakness (cataplexy) that can cause collapse. Wakix is used in patients with or without cataplexy.
Narcolepsy is rare, and Wakix was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 10 July 2007. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu307459.
Wakix contains the active substance pitolisant.
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List item
Wakix : EPAR - Summary for the public (PDF/122.09 KB)
First published: 13/04/2016
Last updated: 20/04/2023
EMA/63272/2023 -
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Wakix : EPAR - Risk-management-plan summary (PDF/252.36 KB)
First published: 13/04/2016
Last updated: 20/04/2023
Authorisation details
Product details | |
---|---|
Name |
Wakix
|
Agency product number |
EMEA/H/C/002616
|
Active substance |
pitolisant
|
International non-proprietary name (INN) or common name |
pitolisant
|
Therapeutic area (MeSH) |
Narcolepsy
|
Anatomical therapeutic chemical (ATC) code |
N07XX11
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Bioprojet Pharma
|
Revision |
14
|
Date of issue of marketing authorisation valid throughout the European Union |
31/03/2016
|
Contact address |
9 rue Rameau |
Product information
24/02/2023 Wakix - EMEA/H/C/002616 - II/0030
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
Other nervous system drugs
Therapeutic indication
Wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.1).