EMA — authorised 21 March 2018
- Marketing authorisation holder: Merck Sharp & Dohme Limited
- Status: approved
🇪🇺 Steglatro in European Union
EMA authorised Steglatro on 21 March 2018
Marketing authorisations
EMA — authorised 21 March 2018
- Application: EMEA/H/C/004315
- Marketing authorisation holder: Merck Sharp & Dohme B.V.
- Local brand name: Steglatro
- 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.
- Status: approved
Steglatro in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in European Union
Frequently asked questions
Is Steglatro approved in European Union?
Yes. EMA authorised it on 21 March 2018; EMA authorised it on 21 March 2018.
Who is the marketing authorisation holder for Steglatro in European Union?
Merck Sharp & Dohme Limited holds the EU marketing authorisation.