On 22 July 2025, the marketing authorisation of Sitagliptin/Metformin Hydrochloride Accord (sitagliptin / metformin hydrochloride) ceased to be valid in the European Union (EU). The cessation of validity is due to the fact that the marketing authorisation holder, Accord Healthcare S.L.U., had not marketed Sitagliptin/Metformin Hydrochloride Accord in the EU since its initial marketing authorisation. In accordance with provisions of the sunset clause1, the marketing authorisation of the medicinal product lapsed as the product had not been marketed in any of the EU Member States within three years of its initial authorisation. Accord Healthcare S.L.U. confirmed that the product had not been marketed the product due to commercial reasons. Sitagliptin/Metformin Hydrochloride Accord was granted marketing authorisation in the EU on 22 July 2022 for treatment of type 2 diabetes mellitus. The marketing authorisation was initially valid for a 5\-year period. Sitagliptin/Metformin Hydrochloride Accord is a generic medicine of Janumet. There are other generic medicinal products of Janumet authorised and marketed in the EU. Sitagliptin/Metformin Hydrochloride Accord is an identical product to Janumet, which is authorised in the EU to treat type 2 diabetes mellitus. --- 1 Article 14(4\) of Regulation (EC) No 726/2004 ("sunset clause")
Therapeutic 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.
Therapeutic Area (MeSH)
ATC Code
A10BD07
ATC Item
N/A
Pharmacotherapeutic Group
Drugs used in diabetes
Active Substance (Summary)
INN / Common Names
EMA Name
Sitagliptin / Metformin hydrochloride Accord
Medicine Name
Sitagliptin / Metformin hydrochloride Accord
Aliases
N/ANo risk management plan link.
