My HPRA: Register

WAKIX

4.5 Milligram Film Coated Tablet

Bioproject PharmaEU/1/15/1068/001

Main Information

Trade NameWAKIX
Active SubstancesPITOLISANT HYDROCHLORIDE
Strength4.5 Milligram
Dosage FormFilm Coated Tablet
Licence HolderBioproject Pharma
Licence NumberEU/1/15/1068/001

Group Information

ATC CodeN07XX11 Pitolisant

Status

Authorised/WithdrawnAuthorised
Licence Issued31/03/2016
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back
Follow medicine

Print