WAKIX

This brand name is authorized in Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

Active ingredients

The drug WAKIX contains one active pharmaceutical ingredient (API):

1 Pitolisant
UNII YV33CH63HI - PITOLISANT HYDROCHLORIDE

Pitolisant is a potent, orally active histamine H3-receptor antagonist/inverse agonist which, via its blockade of histamine auto-receptors enhances the activity of brain histaminergic neurons, a major arousal system with widespread projections to the whole brain. Pitolisant also modulates various neurotransmitter systems, increasing acetylcholine, noradrenaline and dopamine release in the brain.

Read about Pitolisant

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
WAKIX Film-coated tablet European Medicines Agency (EU) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
N07XX11 N Nervous system → N07 Other nervous system drugs → N07X Other nervous system drugs → N07XX Other nervous system drugs
Discover more medicines within N07XX11

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: EE Ravimiamet Identifier(s): 1714755, 1714766, 1753129
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 1151068001, 1151068002
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 120781, 596229
Country: FR Base de données publique des médicaments Identifier(s): 61666846, 64901947
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 334471, 334476
Country: IE Health Products Regulatory Authority Identifier(s): 88183, 88861
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 8551, 8552
Country: IT Agenzia del Farmaco Identifier(s): 044839013, 044839025, 044839037, 044839049
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1080024, 1080025, 1086899, 1086900
Country: NL Z-Index G-Standaard, PRK Identifier(s): 136441, 136468
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100369765, 100369950
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W64492001, W64493001
Country: US FDA, National Drug Code Identifier(s): 72028-045, 72028-178

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