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Wakix

Active substance: pitolisant

TABLET, FILM COATED · PITOLISANT HYDROCHLORIDE 4.45 mg/1

United StatesActive

Marketing holder: Harmony Biosciences, LLC

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
EU 2
  • Ozawade
    pitolisant
    EMEA/H/C/005117
    Bioprojet Pharma
  • Wakix
    pitolisant
    EMEA/H/C/002616
    Bioprojet Pharma
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12090-d3a8-7389-be9b-7715c62d211b,01a12095-11af-79df-9896-3969590818b4;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
72028-045
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 72028-045 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 72028-045 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 72028-045 · Verified 2026-10-09 · open in source