Xyrem 500 mg / mL oral solution

Licence status
Authorised: 13/10/2005
Active substances
Sodium Oxybate
Dosage Form
Oral solution
Licence number
EU/1/05/312/001
Licence holder
UCB Pharma S.A.

Product documents

Licence information

ATC code
N07XX04 sodium oxybate
Legal supply status
Product subject to prescription which may not be renewed (A)
Place of sale
Supply through pharmacies only
Conditions of Licence
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017
Marketing availability
Unknown
Advertising conditions
Advertising to healthcare professionals only
Licence issued
13/10/2005