Search Filters
Advanced Search
SMC ID Date Medicine Submission Type Indication
SMC1236/17 12/08/2019 empaglifozin linagliptin fixed-dose combination (Glyxambi) Abbreviated

Indicated in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control when already being treated with the free combination of empagliflozin and linagliptin
1083/15 07/09/2015 sitagliptin (Januvia) Full The treatment of type 2 diabetes mellitus to improve glycaemic control in adults as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control
1057/15 08/06/2015 linagliptin + metformin (Jentadueto) Abbreviated for the treatment of adult patients with type 2 diabetes mellitus in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control when insulin and metformin alone do not provide adequate glycaemic control.
850/13 11/05/2015 linagliptin (Trajenta) Resubmission The treatment of type 2 diabetes mellitus to improve glycaemic control in adults in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
850/13 11/02/2013 Archived: linagliptin (Trajenta) Full For the treatment of type 2 diabetes mellitus to improve glycaemic control in adults: as monotherapy / combination therapy.
841/13 11/02/2013 linagliptin+metformin (Jentadueto) Abbreviated For the treatment of adult patients with type 2 diabetes mellitus
746/11 16/01/2012 linagliptin (Trajenta) Full For the treatment of type 2 diabetes mellitus to improve glycaemic control in adults.
627/10 09/08/2010 sitagliptin plus metformin (Janumet 50/1000) Abbreviated 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.
607/10 12/07/2010 sitagliptin (Januvia) monotherapy Full Monotherapy for type 2 diabetes mellitus
492/08 10/05/2010 sitagliptin/metformin (Janumet) Abbreviated Type 2 diabetes
505/08 13/10/2008 sitagliptin (Januvia) Full Type 2 diabetes
408/07 08/10/2007 sitagliptin (Januvia) Full Type 2 diabetes

No medicines have been found