Darzalex
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 | Darzalex |
|---|---|
| Active Substance | daratumumab |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| ATC Code | L01FC01 |
| 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 |
Brošura za transfuziologe, verzija 3 Brošura za zdravstvene radnike, verzija 3 |
| Educational materials for patients / caregivers |
Kartica za bolesnike, verzija 3 |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o riziku od reaktivacije virusa hepatitisa B kod primjene lijeka Darzalex | 19.06.2019 | Janssen-Cilag International N.V. |
