| Code | 8854A | ||||||||||
| MA number | EU/1/13/900/011 | ||||||||||
| Product Form: | tbl flm 60x1x5 mg/1000 mg (blis.PVC/Aclar/Al-perf.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | AstraZeneca AB, Sweden | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/Aclar/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10b fixed combination application |
| MA issued: | 16.01.2014 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
DHPC SGLT inhibitors-DKA 18 3 2016.pdf
|
| Dokument: |
DHPC SGLT2 inhibitors - Ketoacidosis 06.07.2015.pdf
|
| Safety feature | Yes |
| Data update: | 14.02.2022 |
