Ozawade (pitolisant)
- Region
- 🇪🇺 EU
- Active substance
- pitolisant
- Company
- Bioprojet Pharma
- Status
- Authorised
- Therapeutic area
- Sleep Apnea, Obstructive
- CHMP opinion
- Thu 20 May 2021
- EU approval
- Wed 01 Sep 2021
- Application
- EMEA/H/C/005117
- ATC
- N07XX11
- Official record
- www.ema.europa.eu
Indication
Ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA)
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Wakix Authorised · Bioprojet Pharma
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.