Sodium oxybate 500 mg / ml oral solution
- Licence status
- Active substances
- Sodium Oxybate
- Dosage Form
- Oral solution
- Licence number
- PA2165/007/001
- Licence holder
- AS Kalceks
Product documents
- Package Leaflet
- Summary of Product Characteristics
- Public Assessment Report
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 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
- Not marketed
- Advertising conditions
- Advertising to healthcare professionals only
- Licence issued
- 08/11/2019