🇪🇺 Pitolisant tablet in European Union

EMA authorised Pitolisant tablet on 1 September 2021

Marketing authorisation

EMA — authorised 1 September 2021

  • Application: EMEA/H/C/005117
  • Marketing authorisation holder: Bioprojet Pharma
  • Local brand name: Ozawade
  • Indication: Ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA)
  • Status: approved

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Pitolisant tablet in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Neurology approved in European Union

Frequently asked questions

Is Pitolisant tablet approved in European Union?

Yes. EMA authorised it on 1 September 2021.

Who is the marketing authorisation holder for Pitolisant tablet in European Union?

Bioprojet Pharma holds the EU marketing authorisation.