Medicinal Products

Xyrem

The medicinal product has been authorised by the European Commission (EC) via centralised procedure in all EU Member States, based on the European Medicines Agency (EMA) experts' opinion.

Name Xyrem
Active Substance natrijev oksibat
Prescription na recept
Type of prescription poseban i ograničeni recept
Distribution u ljekarni
ATC Code N07XX04
Medicinal product marketed in the Croatia Da
Summary of product characteristics (SmPC), labelling and package leaflet (PL) download
Link to the European Medicines Agency's (EMA) product information download
Link to the European Commission's (EC) decisions download
Educational materials
for healthcare professionals
Obrazac za početak liječenja, verzija 2
Obrazac za kontrolu liječenja, verzija 3
Educational materials
for patients / caregivers
Često postavljana pitanja o sigurnosti lijeka Xyrem, verzija 3
Kartica s upozorenjima za bolesnika, verzija 3
Upute za bolesnika za primjenu lijeka, verzija 2
Vodič za pedijatrijske bolesnike i njihove skrbnike, verzija 1

Direct Healthcare Professional Communication

Name Date Download
Pismo zdravstvenim radnicima o riziku od predoziranja ili pod-doziranja zbog degradacije oznaka na graduiranoj mjernoj štrcaljki za lijek Xyrem 500 mg/mL oralna otopina (natrijev oksibat) 21.12.2018 UCB Pharma S.A.
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