Mircera
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 | Mircera |
|---|---|
| Active Substance | metoksi polietilenglikol-epoetin beta |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| ATC Code | B03XA03 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| 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 |
Vodič za liječnike, verzija 2 |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o novim upozorenjima o teškim kožnim nuspojavama lijekova koji sadrže humane epoetine | 29.09.2017 | Amgen d.o.o., Pfizer Croatia d.o.o., Pliva Hrvatska d.o.o., Roche d.o.o. i Sandoz d.o.o. |
