Source: European Medicines Agency (EU) Revision Year: 2024 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
Mounjaro 2.5 mg solution for injection in vial
Mounjaro 5 mg solution for injection in vial
Mounjaro 7.5 mg solution for injection in vial
Mounjaro 10 mg solution for injection in vial
Mounjaro 12.5 mg solution for injection in vial
Mounjaro 15 mg solution for injection in vial
Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen
Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen
Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen
Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen
Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen
Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen
Pharmaceutical Form |
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Solution for injection (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 (5 mg/ml).
Mounjaro 5 mg solution for injection in pre-filled pen:
Each pre-filled pen contains 5 mg of tirzepatide in 0.5 ml solution (10 mg/ml).
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 (15 mg/ml).
Mounjaro 10 mg solution for injection in pre-filled pen:
Each pre-filled pen contains 10 mg of tirzepatide in 0.5 ml solution (20 mg/ml).
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 (25 mg/ml).
Mounjaro 15 mg solution for injection in pre-filled pen:
Each pre-filled pen contains 15 mg of tirzepatide in 0.5 ml solution (30 mg/ml). Vial, single-dose
Mounjaro 2.5 mg solution for injection in vial:
Each vial contains 2.5 mg of tirzepatide in 0.5 ml solution (5 mg/ml).
Mounjaro 5 mg solution for injection in vial:
Each vial contains 5 mg of tirzepatide in 0.5 ml solution (10 mg/ml).
Mounjaro 7.5 mg solution for injection in vial:
Each vial contains 7.5 mg of tirzepatide in 0.5 ml solution (15 mg/ml).
Mounjaro 10 mg solution for injection in vial:
Each vial contains 10 mg of tirzepatide in 0.5 ml solution (20 mg/ml).
Mounjaro 12.5 mg solution for injection in vial:
Each vial contains 12.5 mg of tirzepatide in 0.5 ml solution (25 mg/ml).
Mounjaro 15 mg solution for injection in vial:
Each vial contains 15 mg of tirzepatide in 0.5 ml solution (30 mg/ml).
Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen:
Each dose contains 2.5 mg of tirzepatide in 0.6 ml solution. Each multi-dose pre-filled pen contains 10 mg of tirzepatide in 2.4 ml (4.17 mg/ml). Each pen delivers 4 doses of 2.5 mg.
Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen:
Each dose contains 5 mg of tirzepatide in 0.6 ml solution. Each multi-dose pre-filled pen contains 20 mg of tirzepatide in 2.4 ml (8.33 mg/ml). Each pen delivers 4 doses of 5 mg.
Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen:
Each dose contains 7.5 mg of tirzepatide in 0.6 ml solution. Each multi-dose pre-filled pen contains 30 mg of tirzepatide in 2.4 ml (12.5 mg/ml). Each pen delivers 4 doses of 7.5 mg.
Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen:
Each dose contains 10 mg of tirzepatide in 0.6 ml solution. Each multi-dose pre-filled pen contains 40 mg of tirzepatide in 2.4 ml (16.7 mg/ml). Each pen delivers 4 doses of 10 mg.
Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen:
Each dose contains 12.5 mg of tirzepatide in 0.6 ml solution. Each multi-dose pre-filled pen contains 50 mg of tirzepatide in 2.4 ml (20.8 mg/ml). Each pen delivers 4 doses of 12.5 mg.
Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen:
Each dose contains 15 mg of tirzepatide in 0.6 ml solution. Each multi-dose pre-filled pen contains 60 mg of tirzepatide in 2.4 ml (25 mg/ml). Each pen delivers 4 doses of 15 mg.
For the full list of excipients, see section 6.1.
Active Ingredient | Description | |
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Tirzepatide |
Tirzepatide is a long acting GIP and GLP-1 receptor agonist. Both receptors are present on the pancreatic α and β endocrine cells, heart, vasculature, immune cells (leukocytes), gut and kidney. GIP receptors are also present on adipocytes. In addition, both GIP and GLP-1 receptors are expressed in the areas of the brain important to appetite regulation. |
List of Excipients |
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Pre-filled pen, single-dose; vial, single-dose: Disodium hydrogen phosphate heptahydrate (E339) Pre-filled pen (KwikPen), multi-dose: Disodium hydrogen phosphate heptahydrate (E339) |
Pre-filled pen, single-dose:
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 multipack containing 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be marketed.
Vial, single-dose:
Clear glass vial with a sealed stopper.
Each vial contains 0.5 ml of solution.
Pack sizes of 1 vial, 4 vials, 12 vials, multipack containing 4 (4 packs of 1) vials or multipack containing 12 (12 packs of 1) vials. Not all pack sizes may be marketed.
Pre-filled pen (KwikPen), multi-dose:
Clear glass cartridge encased in a multi-dose pre-filled pen.
Each pre-filled KwikPen contains 2.4 ml of solution for injection (4 doses of 0.6 ml). Each pen has excess volume for priming. However, attempting to inject any leftover medicinal product will result in an incomplete dose even though the pen still has medicinal product left in it. Needles are not included.
Pack sizes of 1 and 3 pre-filled KwikPens. Not all pack sizes may be marketed.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
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Date of first authorisation: 15 September 2022
Drug | Countries | |
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MOUNJARO | Austria, Canada, Estonia, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Romania, United Kingdom, United States |
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