XYREM Oral solution Ref.[115197] Active ingredients: Sodium oxybate

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium

Product name and form

Xyrem 500 mg/mL oral solution.

Pharmaceutical Form

Oral solution.

The oral solution is clear to slightly opalescent.

Qualitative and quantitative composition

Each mL of solution contains 500 mg of sodium oxybate.

For the full list of excipients, see section 6.1.

Active Ingredient

Sodium oxybate is a central nervous system depressant which reduces excessive daytime sleepiness and cataplexy in patients with narcolepsy and modifies sleep architecture reducing fragmented nighttime sleep. The precise mechanism by which sodium oxybate produces an effect is unknown, however sodium oxybate is thought to act by promoting slow (delta) wave sleep and consolidating night-time sleep.
List of Excipients

Purified water
Malic acid for pH adjustment
Sodium hydroxide for pH adjustment

Pack sizes and marketing

180 mL solution in an amber oval 240 mL PET bottle which is delivered with a plastic/foil seal and closed with a child resistant closure composed of HDPE/polypropylene with a pulpboard inner liner.

Each carton contains one bottle, a press-in bottle adaptor, a graduated measuring device (polypropylene syringe), two polypropylene dosing cups and two HDPE child resistant screw closures.

Marketing authorization holder

UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium

Marketing authorization dates and numbers

EU/1/05/312/001

Date for first authorisation: 13 October 2005
Date of latest renewal: 08 September 2015

Drugs

Drug Countries
XYREM Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Turkey, United Kingdom, United States
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈