Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Segluromet 2.5 mg/850 mg film-coated tablets.
Segluromet 2.5 mg/1 000 mg film-coated tablets.
Segluromet 7.5 mg/850 mg film-coated tablets.
Segluromet 7.5 mg/1 000 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Segluromet 2.5 mg/850 mg film-coated tablets: Beige, 18 × 10 mm oval, film-coated tablet debossed with “2.5/850” on one side and plain on the other side. Segluromet 2.5 mg/1 000 mg film-coated tablets: Pink, 19.1 × 10.6 mm oval, film-coated tablet debossed with “2.5/1000” on one side and plain on the other side. Segluromet 7.5 mg/850 mg film-coated tablets: Dark brown, 18 × 10 mm oval, film-coated tablet debossed with “7.5/850” on one side and plain on the other side. Segluromet 7.5 mg/1 000 mg film-coated tablets: Red, 19.1 × 10.6 mm oval, film-coated tablet debossed with “7.5/1000” on one side and plain on the other side. |
Segluromet 2.5 mg/850 mg film-coated tablets: Each tablet contains ertugliflozin L-pyroglutamic acid, equivalent to 2.5 mg of ertugliflozin, and 850 mg of metformin hydrochloride.
Segluromet 2.5 mg/1 000 mg film-coated tablets: Each tablet contains ertugliflozin L-pyroglutamic acid, equivalent to 2.5 mg of ertugliflozin, and 1 000 mg of metformin hydrochloride.
Segluromet 7.5 mg/850 mg film-coated tablets: Each tablet contains ertugliflozin L-pyroglutamic acid, equivalent to 7.5 mg of ertugliflozin, and 850 mg metformin hydrochloride.
Segluromet 7.5 mg/1 000 mg film-coated tablets: Each tablet contains ertugliflozin L-pyroglutamic acid, equivalent to 7.5 mg of ertugliflozin, and 1 000 mg metformin hydrochloride.
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. |
|
| Metformin |
Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia. |
|
| Metformin and Ertugliflozin |
Combination of two anti-hyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: ertugliflozin, a SGLT2 inhibitor, and metformin, a member of the biguanide class. |
| List of Excipients |
|---|
|
Tablet core: Povidone K29-32 (E1201) Film coating: Segluromet 2.5 mg/850 mg film-coated tablets and Segluromet 7.5 mg/850 mg film-coated tablets: Hypromellose (E464) Segluromet 2.5 mg/1 000 mg film-coated tablets and Segluromet 7.5 mg/1 000 mg film-coated tablets: Hypromellose (E464) |
Alu/PVC/PA/Alu blisters.
Packs of 14, 28, 56, 60, 168, 180, and 196 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
Segluromet 2.5 mg/850 mg film-coated tablets:
EU/1/18/1265/001
EU/1/18/1265/002
EU/1/18/1265/003
EU/1/18/1265/004
EU/1/18/1265/005
EU/1/18/1265/006
EU/1/18/1265/007
EU/1/18/1265/029
Segluromet 2.5 mg/1 000 mg film-coated tablets:
EU/1/18/1265/008
EU/1/18/1265/009
EU/1/18/1265/010
EU/1/18/1265/011
EU/1/18/1265/012
EU/1/18/1265/013
EU/1/18/1265/014
EU/1/18/1265/030
Segluromet 7.5 mg/850 mg film-coated tablets:
EU/1/18/1265/015
EU/1/18/1265/016
EU/1/18/1265/017
EU/1/18/1265/018
EU/1/18/1265/019
EU/1/18/1265/020
EU/1/18/1265/021
EU/1/18/1265/031
Segluromet 7.5 mg/1 000 mg film-coated tablets:
EU/1/18/1265/022
EU/1/18/1265/023
EU/1/18/1265/024
EU/1/18/1265/025
EU/1/18/1265/026
EU/1/18/1265/027
EU/1/18/1265/028
EU/1/18/1265/032
Date of first authorisation: 23 March 2018
Date of latest renewal: 09 November 2022
| Drug | Countries | |
|---|---|---|
| SEGLUROMET | Austria, Australia, Cyprus, Estonia, Spain, Finland, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, United States |
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