Steglatro (ertugliflozin)
- Region
- 🇪🇺 EU
- Active substance
- ertugliflozin
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2
- CHMP opinion
- Thu 25 Jan 2018
- EU approval
- Wed 21 Mar 2018
- Application
- EMEA/H/C/004315
- ATC
- A10BK04
- Official record
- www.ema.europa.eu
Indication
Steglatro is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications. in addition to other medicinal products for the treatment of diabetes.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Steglujan Authorised · Merck Sharp & Dohme B.V.
- 🇪🇺 Segluromet Authorised · Merck Sharp & Dohme B.V.
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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.