Forxiga
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 | Forxiga |
|---|---|
| Active Substance | dapagliflozin propandiol hidrat |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ponovljivi recept |
| Distribution | Supply through pharmacies (community) |
| ATC Code | A10BK01 |
| 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 |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o ukidanju indikacije za primjenu lijeka Forxiga 5 mg (dapagliflozin) u liječenju šećerne bolesti tipa 1 | 29.10.2021 | AstraZeneca AB |
| Pismo zdravstvenim radnicima o riziku od Fournierove gangrene kod primjene lijekova koji sadrže inhibitore SGLT2 | 22.01.2019 | AstraZeneca d.o.o., Boehringer Ingelheim Zagreb d.o.o. |
| Pismo zdravstvenim radnicima s ažuriranim informacijama o riziku od dijabetičke ketoacidoze tijekom liječenja inhibitorima SGLT2 (Invokana*, Vokanamet*, Forxiga, Xigduo, Jardiance, Synjardy*) | 14.03.2016 | AstraZeneca AB, Boehringer Ingelheim International GmbH i Janssen Cilag International N.V. |
