Glyxambi (empagliflozin;linagliptin)
- Region
- 🇪🇺 EU
- Active substance
- empagliflozin;linagliptin
- Company
- Boehringer Ingelheim International GmbH
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2
- CHMP opinion
- Thu 15 Sep 2016
- EU approval
- Fri 11 Nov 2016
- Application
- EMEA/H/C/003833
- ATC
- A10BD19
- Official record
- www.ema.europa.eu
Indication
Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control; when already being treated with the free combination of empagliflozin and linagliptin.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.