Medicinal Products

Xyrem

Name Xyrem
Active Substance sodium oxybate
Prescription na recept
Type of prescription poseban i ograničeni recept
Distribution u ljekarni
ATC Code N07XX04
Medicinal product marketed in the Croatia Da
Educational materials
for healthcare professionals
Obrazac za kontrolu liječenja, verzija 2
Obrazac za početak liječenja, verzija 2
Educational materials
for patients / caregivers
Upute za bolesnike za primjenu lijeka verzija 1
Kartica s upozorenjima za bolesnika, verzija 2
Često postavljana pitanja o sigurnosti lijeka, verzija 2

Note

The medicinal product has been authorised via centralised procedure in all Member States of the European Union based on the European Medicines Agency's expert opinion. Additional information on the medicinal product can be found under the following link:https://www.ema.europa.eu/en/medicines/human/EPAR/xyrem

The marketing authorisation has been granted by the European Commission. All marketing authorisations of the European Commission can be found under the following link: http://ec.europa.eu/health/documents/community-register/html/index_en.htm

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.
Back