Code | 9957A | ||||||||||
MA number | EU/1/14/918/003 | ||||||||||
Product Form: | tbl flm 180(3x60)x50 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: |
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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 |