Medicinal Products

Xarelto

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 Xarelto
Active Substance rivaroksaban
Prescription na recept
Type of prescription ponovljivi recept
Distribution u ljekarni
ATC Code B01AF01
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
Educational materials
for healthcare professionals
Poveznica na on line materijal za zdravstvene radnike
Vodič za liječnike, verzija 8
Educational materials
for patients / caregivers
Kartica s upozorenjima za bolesnika

Direct Healthcare Professional Communication

Name Date Download
Pismo zdravstvenim radnicima o mogućem povećanom riziku od ponavljajućih trombotskih događaja u bolesnika s antifosfolipidnim sindromom na terapiji direktnim oralnim antikoagulansom 22.05.2019 Bayer AG, Daiichi Sankyo Europe GmbH, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb/Pfizer EEIG
Pismo zdravstvenim radnicima o preliminarnim rezultatima prijevremeno završenog kliničkog ispitivanja lijeka Xarelto (rivaroksaban) vezanima uz povećanje smrtnosti zbog bilo kojeg uzroka te tromboembolijskih događaja i krvarenja u bolesnika nakon transkateterske zamjene aortnog zaliska u kliničkom ispitivanju 04.10.2018 Bayer d.o.o.
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