Janumet (sitagliptin;metformin)
- Region
- 🇪🇺 EU
- Active substance
- sitagliptin;metformin
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2
- CHMP opinion
- Thu 24 Apr 2008
- EU approval
- Wed 16 Jul 2008
- Application
- EMEA/H/C/000861
- ATC
- A10BD07
- Official record
- www.ema.europa.eu
Indication
For patients with type 2 diabetes mellitus: Janumet 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. Janumet 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. Janumet is indicated as triple combination therapy with a 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. Janumet 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 dosage 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
- 🇪🇺 Efficib Authorised · Merck Sharp and Dohme B.V
- 🇪🇺 Velmetia Authorised · Merck Sharp & Dohme B.V.
- 🇪🇺 Ristfor Authorised · Merck Sharp & Dohme B.V.
- 🇪🇺 Sitagliptin / Metformin hydrochloride Accord Lapsed · Accord Healthcare S.L.U.
- 🇪🇺 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.