en

PRODUCT DETAIL

Xyrem 500 mg/ml perorálny roztok

Code 98724
MA number EU/1/05/312/001
Product Form: sol por 1x180 ml (fľ.PE + 1odmerka -10 ml)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 30 - ANTIDEPRESSIVA
ATC:
N NERVOUS SYSTEM
N07 OTHER NERVOUS SYSTEM DRUGS
N07X OTHER NERVOUS SYSTEM DRUGS
N07XX Other nervous system drugs
N07XX04 Sodium oxybate
Shelf life: 60
Container: bottle PE
Route of admin.: Oral use
Prescription Status: Medicinal product subject to special medical prescription with skew blue stripe.
Legal basis: Article 8(3) application - new active substance
MA issued: 13.10.2005
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 02.08.2021
eu-flag.png sk-flag.png