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On 26 January 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Wakix. The marketing authorisation holder for this medicinal product is Bioprojet Pharma.

The CHMP adopted an extension to the existing indication to include treatment of adolescents and children from the age of 6 years old. For information, the full indication for Wakix will be as follows:1

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). 

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

1 New text in bold

Key facts

Agency product number
International non-proprietary name (INN) or common name
  • pitolisant
Active substance
  • pitolisant
Therapeutic area
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.


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.

Date opinion adopted
Company name
Bioprojet Pharma
Application type

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