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 | Medicinal product subject to medical prescription |
| Type of prescription | poseban i ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| ATC Code | N07XX04 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| 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 |
Packaging
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. |
