Sitagliptin SUN (sitagliptin fumarate)
- Region
- 🇪🇺 EU
- Active substance
- sitagliptin fumarate
- Company
- Sun Pharmaceutical Industries Europe B.V.
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2
- CHMP opinion
- Thu 14 Oct 2021
- EU approval
- Thu 09 Dec 2021
- Designations
- Generic
- Application
- EMEA/H/C/005741
- ATC
- A10BH01
- Official record
- www.ema.europa.eu
Indication
For adult patients with type 2 diabetes mellitus, Sitagliptin SUN is indicated 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 diet and exercise plus metformin alone do not provide adequate glycaemic control.- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.- a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.- a PPAR? agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Sitagliptin SUN is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Regulatory milestones
No milestones recorded in the last year.
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