Sitagliptin / Metformin hydrochloride Accord (sitagliptin;metformin hydrochloride)
- Region
- 🇪🇺 EU
- Active substance
- sitagliptin;metformin hydrochloride
- Company
- Accord Healthcare S.L.U.
- Status
- Lapsed
- Therapeutic area
- Diabetes Mellitus, Type 2
- CHMP opinion
- Thu 19 May 2022
- EU approval
- Fri 22 Jul 2022
- Designations
- Generic
- Application
- EMEA/H/C/005850
- ATC
- A10BD07
- Official record
- www.ema.europa.eu
Indication
For adult patients with type 2 diabetes mellitus: It 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. It 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. It 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. It 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 Sun Authorised · Sun Pharmaceutical Industries Europe 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.