| Code | 4799B | ||||||||||
| MA number | EU/1/15/1003/009 | ||||||||||
| Product Form: | tbl flm 200(2x100x1)x5 mg/850 mg (blis.PVC/PVDC/Al-perf.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Boehringer Ingelheim International GmbH, Germany | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10b fixed combination application |
| MA issued: | 27.05.2015 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| 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: | 09.04.2020 |
