Xyrem (sodium oxybate)
- Region
- 🇪🇺 EU
- Active substance
- sodium oxybate
- Company
- UCB Pharma Ltd
- Status
- Authorised
- Therapeutic area
- Cataplexy; Narcolepsy
- EU approval
- Thu 13 Oct 2005
- Application
- EMEA/H/C/000593
- ATC
- N07XX04
- Official record
- www.ema.europa.eu
Indication
Treatment of narcolepsy with cataplexy in adult patients.
Regulatory milestones
No milestones recorded in the last year.
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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.