Edistride is a diabetes medicine used for adults whose condition is not controlled well enough.
In type 2 diabetes, it is used with appropriate diet and exercise to improve blood sugar control. It can be used on its own 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, Edistride 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.
Edistride contains the active substance dapagliflozin. This medicine is the same as Forxiga, which is already authorised in the EU. The company that makes Forxiga has agreed that its scientific data can be used for Edistride (‘informed consent’).
Edistride : EPAR - Medicine overview (PDF/80.79 KB)
First published: 10/12/2015
Last updated: 08/04/2019
Edistride: EPAR - Risk-management plan summary (PDF/76.38 KB)
First published: 08/04/2019
|Agency product number||
dapagliflozin propanediol monohydrate
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
20/03/2019 Edistride - EMEA/H/C/004161 - WS/1344
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Drugs used in diabetes
Edistride is indicated in adults for the treatment of insufficiently controlled
- type 2 diabetes mellitus as an adjunct to diet and exercise, to improve glycaemic control,
- as monotherapy when metformin is considered inappropriate due to intolerance.
- in addition to other medicinal products for the treatment of type 2 diabetes.
- 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.
For clinical study results with respect to populations studied, effects on glycaemic control and combinations with other medicinal products see sections 4.4, 4.5 and 5.1.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 201901/02/2019
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 201525/09/2015