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Ristfor (sitagliptin;metformin hydrochloride)

Region

🇪🇺 EU

Active substance

sitagliptin;metformin hydrochloride

Company

Merck Sharp & Dohme B.V.

Status

Authorised

Therapeutic area

Diabetes Mellitus, Type 2

CHMP opinion

Thu 17 Dec 2009

EU approval

Mon 15 Mar 2010

Application

EMEA/H/C/001235

ATC

A10BD07

Official record

www.ema.europa.eu

Indication

For patients with type-2 diabetes mellitus: Ristfor 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. Ristfor 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. Ristfor 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. Ristfor 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

• 🇪🇺 Sitagliptin / Metformin hydrochloride Accord Lapsed · Accord Healthcare S.L.U.
• 🇪🇺 Sitagliptin / Metformin hydrochloride Sun Authorised · Sun Pharmaceutical Industries Europe B.V.

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.