Wakix (pitolisant)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- pitolisant
- Company
- Bioprojet Pharma
- Status
- Authorised
- Therapeutic area
- Narcolepsy
- CHMP opinion
- Thu 19 Nov 2015
- EU approval
- Thu 31 Mar 2016
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/002616
- ATC
- N07XX11
- Official record
- www.ema.europa.eu
Indication
Wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Ozawade 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.