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CHMP recommends extension to authorisation for Jardiance in type 2 diabetes.- Boehringer
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 (empagliflozin), from Boehringer Ingelheim International GmbH.
The CHMP adopted an extension to the existing indication as follows: Type 2 diabetes mellitus. Jardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance, and also in addition to other medicinal products for the treatment of diabetes.
Condition: Diabetes Type 2
Type: drug