Wakix

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pitolisant

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

Overview

This is a summary of the European public assessment report (EPAR) for Wakix. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Wakix.

For practical information about using Wakix, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 09/12/2021

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 monitoringAdditional 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.

OrphanOrphan

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
Marketing-authorisation holder
Bioprojet Pharma
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
31/03/2016
Contact address

9 rue Rameau
Paris 75002
France

Product information

04/05/2022 Wakix - EMEA/H/C/002616 - N/0031

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:

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 for the treatment of narcolepsy with or without cataplexy.

Assessment history

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