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Sodium oxybate 500 mg/ml oral solution

AS KalceksPA2165/007/001

Main Information

Trade NameSodium oxybate 500 mg/ml oral solution

Active SubstancesSodium Oxybate

Dosage FormOral solution

Licence HolderAS Kalceks

Licence NumberPA2165/007/001

Group Information

ATC CodeN07XX04 sodium oxybate

Status

License statusAuthorised

Licence Issued08/11/2019

Legal statusProduct subject to prescription which may not be renewed (A)

Supply StatusSupply through pharmacies only

Advertising StatusAdvertising to healthcare professionals only

Conditions of LicenceMedicinal 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 StatusMarketed