Ozurdex
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 | Ozurdex |
|---|---|
| Active Substance | deksametazon |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| ATC Code | S01BA01 |
| 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 patients / caregivers |
Vodič za bolesnike, verzija 3 |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima s nastavnim informacijama o uočenim silikonskim česticama tijekom rutinske vizualne inspekcije lijeka Ozurdex intravitrealni implantat (deksametazon) | 31.10.2018 | Allergan Pharmaceuticals Ireland |
| Pismo zdravstvenim radnicima o uočenim silikonskim česticama tijekom rutinske vizualne inspekcije lijeka Ozurdex intravitrealni implantat (deksametazon) | 11.10.2018 | Allergan Pharmaceuticals Ireland |
| Pismo zdravstvenim radnicima o opskrbi tržišta novim, ispravnim serijama lijeka Ozurdex intravitrealni implantat (deksametazon) | 12.04.2019 | Allergan Pharmaceuticals Ireland |