Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen.
Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection in pre-filled pen (SoloStar). Clear colourless solution. |
Suliqua 100 units/ml + 50 microgram/ml solution for injection in pre-filled pen:
Each pre-filled pen contains 300 units of insulin glargine* and 150 micrograms lixisenatide in 3 ml solution.
Each ml contains 100 units of insulin glargine and 50 micrograms of lixisenatide.
Each dose step contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide.
Suliqua 100 units/ml + 33 microgram/ml solution for injection in pre-filled pen:
Each pre-filled pen contains 300 units of insulin glargine and 100 micrograms of lixisenatide in 3 ml solution.
Each ml contains 100 units of insulin glargine and 33 micrograms of lixisenatide.
Each dose step contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide.
* Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
The dose window on the pen shows the number of dose steps.
Excipient(s) with known effects:
Each ml contains 2.7 milligrams of metacresol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Insulin glargine |
Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH. After injection, the acidic solution is neutralised leading to formation of a precipitate from which small amounts of insulin glargine are continuously released. |
|
| Insulin glargine and Lixisenatide |
Combination of two active substances with complementary mechanisms of action to improve glycaemic control: insulin glargine, a basal insulin analogue (mainly targeting fasting plasma glucose), and lixisenatide, a GLP-1 receptor agonist (mainly targeting postprandial glucose). |
|
| Lixisenatide |
Lixisenatide is a selective GLP-1 receptor agonist. The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose-dependent insulin secretion from the pancreatic beta cells. Lixisenatide stimulates insulin secretion when blood glucose is increased but not at normoglycaemia, which limits the risk of hypoglycaemia. In parallel, glucagon secretion is suppressed. In case of hypoglycaemia, the rescue mechanism of glucagon secretion is preserved. |
| List of Excipients |
|---|
|
Glycerol 85% |
Type I colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the medicinal product side and polyisoprene on the outside) containing 3 ml of solution. Each cartridge is assembled into a disposable pen.
Packs of 3, 5 and 10 pre-filled pens.
Not all pack sizes may be marketed.
Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
EU/1/16/1157/001
EU/1/16/1157/002
EU/1/16/1157/003
EU/1/16/1157/004
EU/1/16/1157/005
EU/1/16/1157/006
Date of first authorisation: 11 January 2017
Date of latest renewal: 22 November 2021
| Drug | Countries | |
|---|---|---|
| SULIQUA | Austria, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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