Medicinal Products

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 na recept
Type of prescription ograničeni recept
Distribution u ljekarni
ATC Code L01EL01
Medicinal product marketed in the Croatia Da
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

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.
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