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PRODUCT DETAIL

Xigduo 5 mg/1000 mg filmom obalené tablety

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:
A ALIMENTARY TRACT AND METABOLISM
A10 DRUGS USED IN DIABETES
A10B Blood glucose lowering drugs, excl. insulins
A10BD Combinations of oral blood glucose lowering drugs
A10BD15 Metformin and dapagliflozin
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
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