Forxiga

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dapagliflozin

Authorised
This medicine is authorised for use in the European Union.

Overview

Forxiga is a medicine used to treat diabetes and heart failure.

In diabetes, the medicine is used in adults whose condition is not controlled well enough:

  • In type 2 diabetes, it is used with appropriate diet and exercise in patients who cannot take metformin (another diabetes medicine). It can also be used as ‘add-on’ treatment to other diabetes medicines.
  • In type 1 diabetes, Forxiga is used with insulin in overweight patients (body mass index of at least 27 kg/m2) when insulin on its own does not control blood sugar well enough.

In heart failure, Forxiga is used in adults who have symptoms of the disease and reduced ejection fraction (a measure of how well the heart pumps blood). Heart failure is the inability of the heart to pump enough blood around the body.

Forxiga contains the active substance dapagliflozin.

This EPAR was last updated on 17/03/2021

Authorisation details

Product details
Name
Forxiga
Agency product number
EMEA/H/C/002322
Active substance
dapagliflozin propanediol monohydrate
International non-proprietary name (INN) or common name
dapagliflozin
Therapeutic area (MeSH)
  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Type 1
Anatomical therapeutic chemical (ATC) code
A10BK01
Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
11/11/2012
Contact address
151 85 Sodertalje
Sweden

Product information

12/02/2021 Forxiga - EMEA/H/C/002322 - IG/1335/G

Contents

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Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Type 2 diabetes mellitus

Forxiga is indicated in adults 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 and

cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

Type 1 diabetes mellitus

Forxiga is indicated in adults for the treatment of insufficiently controlled type 1 diabetes mellitus as

an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate

glycaemic control despite optimal insulin therapy.

Heart failure

Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure with reduced

ejection fraction.

Assessment history

Changes since initial authorisation of medicine

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