Synjardy (empagliflozin;metformin)
- Region
- 🇪🇺 EU
- Active substance
- empagliflozin;metformin
- Company
- Boehringer Ingelheim
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2
- CHMP opinion
- Thu 26 Mar 2015
- EU approval
- Wed 27 May 2015
- Application
- EMEA/H/C/003770
- ATC
- A10BD20
- Official record
- www.ema.europa.eu
Indication
Synjardy is indicated in adults and children aged 10 years and above for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise: in patients insufficiently controlled on their maximally tolerated dose of metformin alone in combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with metformin and these medicinal products in patients already being treated with the combination of empagliflozin and metformin as separate tablets. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the population studied, see sections 4.4, 4.5 and 5.1.
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.