Code | 8855A | ||||||||||
MA number | EU/1/13/900/012 | ||||||||||
Product Form: | tbl flm 196(2x98)x5 mg/1000 mg (blis.PVC/Aclar/Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | AstraZeneca AB, Sweden | ||||||||||
Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
ATC: |
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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 |