Sitagliptin / Metformin hydrochloride Sun (sitagliptin;metformin hydrochloride)
- Region
- 🇪🇺 EU
- Active substance
- sitagliptin;metformin hydrochloride
- Company
- Sun Pharmaceutical Industries Europe B.V.
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2
- CHMP opinion
- Thu 26 Jan 2023
- EU approval
- Fri 31 Mar 2023
- Designations
- Generic
- Application
- EMEA/H/C/005778
- ATC
- A10BD07
- Official record
- www.ema.europa.eu
Indication
For adult patients with type 2 diabetes mellitus: Sitagliptin/Metformin hydrochloride SUN is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Sitagliptin/Metformin hydrochloride SUN is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Sitagliptin/Metformin hydrochloride SUN is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR? agonist. Sitagliptin/Metformin hydrochloride SUN is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Ristfor Authorised · Merck Sharp & Dohme B.V.
- 🇪🇺 Sitagliptin / Metformin hydrochloride Accord Lapsed · Accord Healthcare S.L.U.
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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.