Dapagliflozin Viatris
·
- Prescription status not stated
- Digestion, stomach, diabetes and nutrition
- Active substance
- Dapagliflozin
- Made by
- Viatris Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Type 2 diabetes mellitus Dapagliflozin Viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Dapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. Chronic kidney disease Dapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease.
From the official label · 2026-09-30 · European Medicines Agency
How it works
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (dapagliflozin). It describes the substance, not this Bulgarian product — its uses and doses can differ.
Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen.
Dapagliflozin is an inhibitor of SGLT2.
The metabolism of dapagliflozin is primarily mediated by UGT1A9; CYP-mediated metabolism is a minor clearance pathway in humans.
Dapagliflozin and related metabolites are primarily eliminated via the renal pathway.
Administration of dapagliflozin with a high-fat meal decreases its C max by up to 50% and prolongs T max by approximately 1 hour but does not alter AUC as compared with the fasted state.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-09-08
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
BulgariaNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Viatris Limited |
|---|---|
| Active substance | Dapagliflozin |
| Used in | Digestion, stomach, diabetes and nutrition |
| Classification | A10BK01 · Digestion, stomach, diabetes and nutrition |
| Generic | Yes — a generic medicine, according to the register |
| Authorised on | 2023-03-24 |
| Last updated by the regulator | 2026-05-07 |
| EMA product number | EMEA/H/C/006006 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.