Medicinal Products

Pradaxa

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 Pradaxa
Active Substance dabigatraneteksilatmesilat
Prescription na recept
Type of prescription ponovljivi recept
Distribution u ljekarni
ATC Code B01AE07
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
Vodič za propisivače pVTE, verzija 5
Vodič za propisivače SPAF, verzija 5
Vodič za propisivače pVTE pedijatrijska populacija, verzija 1
Educational materials
for patients / caregivers
Kartica s upozorenjima za bolesnika Pradaxa kapsule
Kartica s upozorenjima za bolesnika Pradaxa obložene granule
Kartica s upozorenjima za bolesnika Pradaxa prašak i otapalo za oralnu otopinu

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
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