Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Victoza 6 mg/ml solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
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Solution for injection. Clear and colourless or almost colourless, isotonic solution; pH=8.15. |
1 ml of solution contains 6 mg of liraglutide*. One pre-filled pen contains 18 mg liraglutide in 3 ml.
* human glucagon-like peptide-1 (GLP-1) analogue produced by recombinant DNA technology in Saccharomyces cerevisiae.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Liraglutide |
Liraglutide is a GLP-1 analogue with 97% sequence homology to human GLP-1 that binds to and activates the GLP-1 receptor. 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. Unlike native GLP-1, liraglutide has a pharmacokinetic and pharmacodynamic profile in humans suitable for once daily administration. |
| List of Excipients |
|---|
|
Disodium phosphate dihydrate |
Cartridge (type 1 glass) with a plunger (bromobutyl) and a laminate rubber sheet (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polyolefin and polyacetal.
Each pen contains 3 ml solution, delivering 30 doses of 0.6 mg, 15 doses of 1.2 mg or 10 doses of 1.8 mg.
Pack sizes of 1, 2, 3, 5 or 10 pre-filled pens.
Not all pack sizes may be marketed.
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
EU/1/09/529/001-005
Date of first authorisation: 30 June 2009
Date of last renewal: 11 April 2014
| Drug | Countries | |
|---|---|---|
| VICTOZA | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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