Medicinal product name Xyrem
Pharmaceutical form Oral solution
Strength 500 mg/ml 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.I, Pr.II stac.)
 Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website
ATC code N07XX04 Other nervous system drugs

Medicinal products (1)

Availability of medicinal product Wholesalers Package size, content Primary packaging Maximum admissible pharmacy price (€ incl. VAT) Product No. Labelling
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N1
(90000 mg/180 ml)
PET bottle    EU/1/05/312/001  Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website

Registration information

Marketing authorisation No. EU/1/05/312/001
Date of authorisation Oct 13, 2005
Marketing authorisation holder, country UCB Pharma SA, Belgium