Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
Lyxumia 10 micrograms solution for injection.
Lyxumia 20 micrograms solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear, colourless solution. |
Lyxumia 10 micrograms solution for injection: Each dose (0.2 ml) contains 10 micrograms (mcg) of lixisenatide (50 mcg per ml).
Lyxumia 20 micrograms solution for injection: Each dose (0.2 ml) contains 20 micrograms (mcg) of lixisenatide (100 mcg per ml).
Excipient(s) with known effects: Each dose contains 540 micrograms of metacresol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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 glass cartridge with a (bromobutyl) rubber plunger, flanged caps (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the inside and polyisoprene on the outside). Each cartridge is assembled into a disposable pen.
Lyxumia 10 micrograms solution for injection: Each green pre-filled pen contains 3 ml solution, delivering 14 doses of 10 mcg. Pack containing 1 green pre-filled pen.
Lyxumia 20 micrograms solution for injection: Each purple pre-filled pen contains 3 ml solution, delivering 14 doses of 20 mcg. Packs containing 1, 2 and 6 purple pre-filled pens.
Not all pack sizes may be marketed.
Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
Lyxumia 10 micrograms solution for injection:
EU/1/12/811/001 (1 pre-filled pen)
Lyxumia 20 micrograms solution for injection:
EU/1/12/811/002 (1 pre-filled pen)
EU/1/12/811/003 (2 pre-filled pens)
EU/1/12/811/004 (6 pre-filled pens)
Date of first authorisation: 01 February 2013
Date of latest renewal: 18 September 2017
| Drug | Countries | |
|---|---|---|
| LYXUMIA | Austria, Brazil, Cyprus, Estonia, Spain, Finland, Hong Kong, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom |
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