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Ozawade

Active substance: pitolisant

pitolisant

Centralised EU authorisationActive

Marketing holder: Bioprojet Pharma

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 2
  • Wakix
    TABLET, FILM COATED · PITOLISANT HYDROCHLORIDE 4.45 mg/1
    72028-045
    Harmony Biosciences, LLC
  • Wakix
    TABLET, FILM COATED · PITOLISANT HYDROCHLORIDE 17.8 mg/1
    72028-178
    Harmony Biosciences, LLC
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
EMEA/H/C/005117
Registration status
Active
ATC code
N07XX11
Sources
  • product · EMA · EMEA/H/C/005117 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/005117 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/005117 · Verified 2026-10-09