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Bioprojet PharmaEU/1/15/1068/002

Main Information

Trade NameWakix
Active SubstancesPitolisant hydrochloride
Dosage FormFilm-coated tablet
Licence HolderBioprojet Pharma
Licence NumberEU/1/15/1068/002

Group Information

ATC CodeN07XX Other nervous system drugs
N07XX11 ZZZ Pitolisant


Licence Issued31/03/2016
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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