| Code | 9955A | ||||||||||
| MA number | EU/1/14/918/001 | ||||||||||
| Product Form: | tbl flm 20x50 mg/850 mg (fľ.HDPE) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Janssen - Cilag International N.V., Belgium | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 23.04.2014 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
DHPC kanagliflozín final 26 4 2016.pdf
|
| Dokument: |
DHPC SGLT inhibitors-DKA 18 3 2016.pdf
|
| Dokument: |
DHPC SGLT2 inhibitors - Ketoacidosis 06.07.2015.pdf
|
| Safety feature | Yes |
| Data update: | 18.01.2019 |
