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  1. Home
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  3. Jardiance - opinion on variation to marketing authorisation

Jardiance - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

empagliflozin
Post-authorisationHuman

Page contents

  • Opinion
  • Key facts
  • News on Jardiance
  • More information on Jardiance

Opinion

On 9 November 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Jardiance. The marketing authorisation holder for this medicinal product is Boehringer Ingelheim International GmbH.

The CHMP adopted an extension to an existing indication as follows:1

Type 2 diabetes mellitus

Jardiance 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 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

Jardiance is indicated in adults for the treatment of symptomatic chronic heart failure.

Chronic kidney disease

Jardiance is indicated in adults for the treatment of chronic kidney disease.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1New text in bold

CHMP post-authorisation summary of positive opinion for Jardiance (II-76)

AdoptedReference Number: EMA/CHMP/483404/2023

English (EN) (125.67 KB - PDF)

First published: 10/11/2023
View

Key facts

Name of medicine
Jardiance
EMA product number
EMEA/H/C/002677
Active substance
empagliflozin
International non-proprietary name (INN) or common name
empagliflozin
Therapeutic area (MeSH)
  • Diabetes Mellitus, Type 2
  • Heart Failure
  • Renal Insufficiency, Chronic
Anatomical therapeutical chemical (ATC) code
A10BK03
Marketing authorisation holder
Boehringer Ingelheim International GmbH
Date of opinion
09/11/2023
Status
Positive

News on Jardiance

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2023
10/11/2023
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2023
23/06/2023
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 January 2022
28/01/2022
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 May 2021
21/05/2021
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2016
16/12/2016
SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis
12/02/2016
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2015
12/06/2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 March 2014
21/03/2014

More information on Jardiance

  • Jardiance
This page was last updated on 10/11/2023

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