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 | Medicinal product subject to medical prescription |
| Type of prescription | ponovljivi recept |
| Distribution | Supply through pharmacies (community) |
| ATC Code | B01AE07 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| 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 lijeka pVTE, verzija 6 Vodič za propisivače pSPAF, DVT, PE, verzija 6 Vodič za propisivače lijeka pVTE, pedijatrijska populacija, verzija 3 |
| Educational materials for patients / caregivers |
Kartica s upozorenjima za bolesnika Pradaxa kapsule Kartica s upozorenjima za bolesnika Pradaxa obložene granule |
Packaging
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 |
