Wakix

RSS

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 28/03/2018

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
Marketing-authorisation holder
Bioprojet Pharma
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
31/03/2016
Contact address
9 rue Rameau
Paris 75002
France

Product information

22/02/2018 Wakix - EMEA/H/C/002616 - II/0011

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Other nervous system drugs

Therapeutic indication

Wakix is indicated in adults for the treatment of narcolepsy with or without cataplexy.

Assessment history

How useful was this page?

Add your rating
Average
1 rating
1 rating