Dapagliflozin Viatris

Authorised

This medicine is authorised for use in the European Union

dapagliflozin

Overview

Dapagliflozin Viatris is a medicine used to treat type 2 diabetes, chronic (long-term) heart failure and chronic kidney disease.

In type 2 diabetes, Dapagliflozin Viatris is used in adults and children from 10 years of age whose condition is not controlled well enough. 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 chronic heart failure (inability of the heart to pump enough blood around the body), Dapagliflozin Viatris is used in adults who have symptoms of the disease and reduced ejection fraction (a measure of how well the heart pumps blood).

Dapagliflozin Viatris is also used in adults with chronic kidney disease.

Dapagliflozin Viatris is a ‘generic medicine’. This means that Dapagliflozin Viatris contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Forxiga. For more information on generic medicines, see the question-and-answer document here.

Dapagliflozin Viatris contains the active substance dapagliflozin.

How is Dapagliflozin Viatris used?

Dapagliflozin Viatris is available as tablets and can only be obtained with a prescription.

For type 2 diabetes, chronic heart failure and chronic kidney disease, the recommended dose of Dapagliflozin Viatris is 10 mg once a day.

For type 2 diabetes, if Dapagliflozin Viatris is used with insulin or medicines that help the body produce insulin, the doses of these medicines may need to be reduced to prevent hypoglycaemia (low blood sugar levels).

For more information about using Dapagliflozin Viatris, see the package leaflet or contact your doctor or pharmacist.

How does Dapagliflozin Viatris work?

The active substance in Dapagliflozin Viatris, dapagliflozin, blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2). As blood is filtered by the kidneys, SGLT2 stops the kidneys passing glucose from the blood into the urine. Patients with diabetes have high levels of glucose in the blood. By blocking the action of SGLT2, dapagliflozin causes the kidneys to pass more glucose into the urine, thereby reducing the levels of glucose in the blood.

Blocking the action of SGLT2 also supports heart function in patients with chronic heart failure and kidney function in patients with chronic kidney disease, regardless of having diabetes. Dapagliflozin’s actions increase the removal of salt and water in the urine. This decreases the overall blood volume, reducing the effort needed for the heart to pump blood, thereby improving its function in patients with heart failure and also preserving kidney function.

How has Dapagliflozin Viatris been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Forxiga, and do not need to be repeated for Dapagliflozin Viatris.

As for every medicine, the company provided studies on the quality of Dapagliflozin Viatris. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Dapagliflozin Viatris?

Because Dapagliflozin Viatris is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Dapagliflozin Viatris authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Dapagliflozin Viatris has been shown to have comparable quality and to be bioequivalent to Forxiga. Therefore, the Agency’s view was that, as for Forxiga, the benefits of Dapagliflozin Viatris outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Dapagliflozin Viatris?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dapagliflozin Viatris have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Dapagliflozin Viatris are continuously monitored. Suspected side effects reported with Dapagliflozin Viatris are carefully evaluated and any necessary action taken to protect patients.

Other information about Dapagliflozin Viatris

Dapagliflozin Viatris received a marketing authorisation valid throughout the EU on 24 March 2023.

Dapagliflozin Viatris : EPAR - Medicine Overview

Reference Number: EMA/69114/2023

Dapagliflozin Viatris : EPAR - Risk management plan summary

Product information

Dapagliflozin Viatris : EPAR - Product Information

Latest procedure affecting product information: IB/0002

19/03/2024

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Dapagliflozin Viatris : EPAR - All authorised presentations

Product details

• Name of medicine:
  Dapagliflozin Viatris
• Active substance:
  dapagliflozin
• International non-proprietary name (INN) or common name:
  dapagliflozin
• Therapeutic area (MeSH):
  • Diabetes Mellitus, Type 2
  • Heart Failure, Systolic
  • Heart Failure
  • Renal Insufficiency, Chronic
• Anatomical therapeutic chemical (ATC) code:
  A10BK01

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

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.

Authorisation details

• EMA product number:
  EMEA/H/C/006006
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Viatris Limited

  Damastown Industrial Park ; Mulhuddart ; Dublin 15 ; Dublin ; Ireland

• Opinion adopted:
  26/01/2023
• Marketing authorisation issued:
  24/03/2023
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Dapagliflozin Viatris : EPAR - Procedural steps taken and scientific information after the authorisation

Initial marketing authorisation documents

Dapagliflozin Viatris : EPAR - Public Assessment Report

AdoptedReference Number: EMA/68353/2023

CHMP summary of positive opinion for Dapagliflozin Viatris

AdoptedReference Number: EMA/CHMP/30826/2023