Jardiance - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation.
empagliflozin
Post-authorisationHuman
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: