Medicinal Products

Xarelto

Name Xarelto
Active Substance rivaroxaban
Prescription na recept
Type of prescription neponovljivi recept
Distribution u ljekarni
ATC Code B01AF01
Medicinal product marketed in the Croatia Da
Educational materials
for healthcare professionals
Upute za propisivača, verzija 5
Educational materials
for patients / caregivers
Kartica s upozorenjima za bolesnika

Note

The medicinal product has been authorised via centralised procedure in all Member States of the European Union based on the European Medicines Agency's expert opinion. Additional information on the medicinal product can be found under the following link:https://www.ema.europa.eu/en/medicines/human/EPAR/xarelto

The marketing authorisation has been granted by the European Commission. All marketing authorisations of the European Commission can be found under the following link: http://ec.europa.eu/health/documents/community-register/html/index_en.htm

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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