Imbruvica
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 | Imbruvica |
|---|---|
| Active Substance | ibrutinib |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| ATC Code | L01EL01 |
| Marketing status | trajni prekid opskrbe |
| 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 |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o novim mjerama minimizacije rizika, uključujući preporuke za prilagodbu doze, za lijek Imbruvica (ibrutinib) zbog povećanog rizika od ozbiljnih srčanih događaja | 03.11.2022 | Janssen Cilag International N.V. |
| Pismo zdravstvenim radnicima o potrebi za probirom bolesnika na virus hepatitisa B prije početka liječenja ibrutinibom (Imbruvica) zbog rizika od reaktivacije hepatitisa B | 27.07.2017 | Janssen-Cilag International N.V. i Johnson & Johnson S.E. d.o.o. |
