EMA — authorised 30 September 2009
- Application: EMEA/H/C/001039
- Marketing authorisation holder: AstraZeneca AB
- Local brand name: Onglyza
- Indication: Add-on combination therapy Onglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy: in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control; in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patie
- Status: approved