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SMC ID Date Medicine Submission Type Indication
SMC2763 07/04/2025 dapagliflozin (Forxiga) Abbreviated

In adults for the treatment of chronic kidney disease (CKD).
SMC2642 08/07/2024 empagliflozin (Jardiance) Full

In adults for the treatment of chronic kidney disease.
SMC2577 07/08/2023 dapagliflozin (Forxiga) Abbreviated

For treatment of chronic heart failure
SMC2523 09/05/2023 empagliflozin (Jardiance) Full

For chronic HF patients with LVEF >40% to cover the entire spectrum of the HF population.
SMC2428 09/05/2022 dapagliflozin (Forxiga) Full

For the treatment in adults of chronic kidney disease.
SMC2396 11/10/2021 empagliflozin (Jardiance) Abbreviated

In adults for treatment of symptomatic chronic heart failure with reduced ejection fraction.
SMC2322 12/04/2021 dapagliflozin (Forxiga) Full

In adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.
SMC2185 09/09/2019 dapagliflozin (Forxiga) Full

In adults for the treatment of insufficiently controlled T1DM as an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
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
1255/17 10/07/2017 saxagliptin/dapagliflozin fixed dose combination (Qtern) Abbreviated in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin and/or sulphonylurea and one of the monocomponents of Qtern® do not provide adequate glycaemic control. When already being treated with the free combination of dapagliflozin and saxagliptin
1092/15 12/10/2015 empagliflozin/metformin (Synjardy) Abbreviated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control / in patients inadequately controlled on their maximally tolerated dose of metformin alone / in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin / in patients already being treated with the combination of empagliflozin and metformin as separate tablets.
1019/14 12/01/2015 canagliflozin plus metformin (Vokanamet) Abbreviated In adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control
993/14 13/10/2014 empagliflozin (Jardiance) Full Treatment of type 2 diabetes to improve glycaemic control in adults as add-on combination therapy: in combination with other glucose–lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
983/14 11/08/2014 dapagliflozin + metformin (Xigduo) Abbreviated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: in patients inadequately controlled on their maximally tolerated dose of metformin alone;in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products; n patients already being treated with the combination of dapagliflozin and metformin as separate tablets.
799/12 (c) 07/07/2014 dapagliflozin (Forxiga) Resubmission

In adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as add-on combination therapy in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
963/14 09/06/2014 canagliflozin (Invokana®) Full In adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as add-on therapy with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
799/12 (b) 10/03/2014 dapagliflozin (Forxiga) Resubmission

For use in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
799/12 (a) 14/01/2013 dapagliflozin (Forxiga) Full

Adults aged 18 and older with type 2 diabetes mellitus to improve glycaemic control as monotherapy/add-on combination therapy.

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