This is a summary of the European public assessment report (EPAR) for Xyrem. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xyrem.
Therapeutic Indication
### Therapeutic indication Treatment of narcolepsy with cataplexy in adult patients.
Therapeutic Area (MeSH)
ATC Code
N07XX04
ATC Item
sodium oxybate
Pharmacotherapeutic Group
Other nervous system drugs
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| sodium oxybate | N/A | Sodium oxybate |
EMA Name
Xyrem
Medicine Name
Xyrem
Aliases
N/ANo risk management plan link.
