Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Steglujan 5 mg/100 mg film-coated tablets.
Steglujan 15 mg/100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet (tablet). Steglujan 5 mg/100 mg film-coated tablets: Beige, 12 × 7.4 mm, almond-shaped, film-coated tablets debossed with “554” on one side and plain on the other side. Steglujan 15 mg/100 mg film-coated tablets: Brown, 12 × 7.4 mm, almond-shaped, film-coated tablets debossed with “555” on one side and plain on the other side. |
Steglujan 5 mg/100 mg film-coated tablets: Each tablet contains ertugliflozin L-pyroglutamic acid, equivalent to 5 mg of ertugliflozin, and sitagliptin phosphate monohydrate, equivalent to 100 mg of sitagliptin.
Steglujan 15 mg/100 mg film-coated tablets: Each tablet contains ertugliflozin L-pyroglutamic acid, equivalent to 15 mg of ertugliflozin, and sitagliptin phosphate monohydrate, equivalent to 100 mg of sitagliptin.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ertugliflozin |
Ertugliflozin helps to lower blood glucose by making the patient pass out glucose in the urine. It does this by blocking a protein in the kidneys (called SGLT2) that normally takes glucose back into the blood from the kidneys. |
|
| Sitagliptin |
Sitagliptin is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors. The improvement in glycaemic control observed with this medicinal product may be mediated by enhancing the levels of active incretin hormones. |
|
| Sitagliptin and Ertugliflozin |
Combination of two antihyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: ertugliflozin, a SGLT2 inhibitor, and sitagliptin phosphate, a DPP-4 inhibitor. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose (E460) Film-coating: Hypromellose (E464) |
Alu/PVC/PA/Alu blisters.
Packs of 14, 28, 30, 84, 90 and 98 film-coated tablets in non-perforated blisters.
Packs of 30x1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Steglujan 5 mg/100 mg film-coated tablets:
EU/1/18/1266/001
EU/1/18/1266/002
EU/1/18/1266/003
EU/1/18/1266/004
EU/1/18/1266/005
EU/1/18/1266/006
EU/1/18/1266/013
Steglujan 15 mg/100 mg film-coated tablets:
EU/1/18/1266/007
EU/1/18/1266/008
EU/1/18/1266/009
EU/1/18/1266/010
EU/1/18/1266/011
EU/1/18/1266/012
EU/1/18/1266/014
Date of first authorisation: 23 March 2018
Date of latest renewal: 05 December 2022
| Drug | Countries | |
|---|---|---|
| STEGLUJAN | Austria, Australia, Cyprus, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United States |
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