This brand name is authorized in Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States
The drug WAKIX contains one active pharmaceutical ingredient (API):
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1
Pitolisant
UNII YV33CH63HI - PITOLISANT HYDROCHLORIDE
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| WAKIX Film-coated tablet | European Medicines Agency (EU) | MPI, EU: SmPC |
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 | |
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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