Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Mounjaro 2.5 mg solution for injection in pre-filled pen.
Mounjaro 5 mg solution for injection in pre-filled pen.
Mounjaro 7.5 mg solution for injection in pre-filled pen.
Mounjaro 10 mg solution for injection in pre-filled pen.
Mounjaro 12.5 mg solution for injection in pre-filled pen.
Mounjaro 15 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless to slightly yellow solution. |
Mounjaro 2.5 mg solution for injection in pre-filled pen: Each pre-filled pen contains 2.5 mg of tirzepatide in 0.5 ml solution.
Mounjaro 5 mg solution for injection in pre-filled pen: Each pre-filled pen contains 5 mg of tirzepatide in 0.5 ml solution.
Mounjaro 7.5 mg solution for injection in pre-filled pen: Each pre-filled pen contains 7.5 mg of tirzepatide in 0.5 ml solution.
Mounjaro 10 mg solution for injection in pre-filled pen: Each pre-filled pen contains 10 mg of tirzepatide in 0.5 ml solution.
Mounjaro 12.5 mg solution for injection in pre-filled pen: Each pre-filled pen contains 12.5 mg of tirzepatide in 0.5 ml solution.
Mounjaro 15 mg solution for injection in pre-filled pen: Each pre-filled pen contains 15 mg of tirzepatide in 0.5 ml solution.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tirzepatide |
Tirzepatide is a long acting dual GIP and GLP-1 receptor agonist. Both receptors are present on the pancreatic α and β endocrine cells, brain, heart, vasculature, immune cells (leukocytes), gut and kidney. GIP receptors are also present on adipocytes. The activity of tirzepatide on the GIP receptor is similar to native GIP hormone. Tirzepatide improves glycaemic control by lowering fasting and postprandial glucose concentrations in patients with type 2 diabetes through several mechanisms. |
| List of Excipients |
|---|
|
Sodium phosphate dibasic heptahydrate |
Glass syringe encased in a disposable pre-filled pen.
The pre-filled pen has a hidden needle, which will automatically insert into the skin when the injection button is pressed.
Each pre-filled pen contains 0.5 ml of solution.
Pack sizes of 2 pre-filled pens, 4 pre-filled pens and multipacks containing 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be marketed.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Date of first authorisation: 15 September 2022
| Drug | Countries | |
|---|---|---|
| MOUNJARO | Austria, Canada, Estonia, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Romania, United Kingdom, United States |
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