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Sitagliptin / Metformin hydrochloride Mylan (sitagliptin hydrochloride monohydrate;metformin hydrochloride)

Region

🇪🇺 EU

Active substance

sitagliptin hydrochloride monohydrate;metformin hydrochloride

Company

Mylan Pharmaceuticals Limited

Status

Authorised

Therapeutic area

Diabetes Mellitus, Type 2

CHMP opinion

Thu 16 Dec 2021

EU approval

Wed 16 Feb 2022

Designations

Generic

Application

EMEA/H/C/005678

ATC

A10BD07

Official record

www.ema.europa.eu

Indication

For adult patients with type 2 diabetes mellitus: Sitagliptin/Metformin hydrochloride Mylan 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 Mylan 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 Mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARg) 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 PPARg agonist. Sitagliptin/Metformin hydrochloride Mylan 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.

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.