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PRODUCT DETAIL

Forxiga 5 mg filmom obalené tablety

Code 3300A
MA number EU/1/12/795/004
Product Form: tbl flm 30x1x5 mg (blis.Al/Al-jednotl.dávka)
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
A10BK Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10BK01 Dapagliflozin
Shelf life: 36
Container: blister Al/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 12.11.2012
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: 17.08.2021
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