MOUNJARO Solution for injection Ref.[50478] Active ingredients: Tirzepatide

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Product name and form

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

Solution for injection (injection).

Clear, colourless to slightly yellow solution.

Qualitative and quantitative composition

Pre-filled pen, single-dose

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).

Pre-filled pen (KwikPen), multi-dose

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
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

Pre-filled pen, single-dose; vial, single-dose:

Disodium hydrogen phosphate heptahydrate (E339)
Sodium chloride
Concentrated hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

Pre-filled pen (KwikPen), multi-dose:

Disodium hydrogen phosphate heptahydrate (E339)
Benzyl alcohol (E1519)
Glycerol
Phenol
Sodium chloride
Concentrated hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Marketing authorization dates and numbers

EU/1/22/1685/001
EU/1/22/1685/002
EU/1/22/1685/003
EU/1/22/1685/004
EU/1/22/1685/005
EU/1/22/1685/006
EU/1/22/1685/007
EU/1/22/1685/008
EU/1/22/1685/009
EU/1/22/1685/010
EU/1/22/1685/011
EU/1/22/1685/012
EU/1/22/1685/013
EU/1/22/1685/014
EU/1/22/1685/015
EU/1/22/1685/016
EU/1/22/1685/017
EU/1/22/1685/018
EU/1/22/1685/019
EU/1/22/1685/020
EU/1/22/1685/021
EU/1/22/1685/022
EU/1/22/1685/023
EU/1/22/1685/024
EU/1/22/1685/025
EU/1/22/1685/026
EU/1/22/1685/027
EU/1/22/1685/028
EU/1/22/1685/029
EU/1/22/1685/030
EU/1/22/1685/031
EU/1/22/1685/032
EU/1/22/1685/033
EU/1/22/1685/034
EU/1/22/1685/035
EU/1/22/1685/036
EU/1/22/1685/037
EU/1/22/1685/038
EU/1/22/1685/039
EU/1/22/1685/040
EU/1/22/1685/041
EU/1/22/1685/042
EU/1/22/1685/043
EU/1/22/1685/044
EU/1/22/1685/045
EU/1/22/1685/046
EU/1/22/1685/047
EU/1/22/1685/048
EU/1/22/1685/049
EU/1/22/1685/050
EU/1/22/1685/051
EU/1/22/1685/052
EU/1/22/1685/053
EU/1/22/1685/054
EU/1/22/1685/055
EU/1/22/1685/056
EU/1/22/1685/057
EU/1/22/1685/058
EU/1/22/1685/059
EU/1/22/1685/060

Date of first authorisation: 15 September 2022

Drugs

Drug Countries
MOUNJARO Austria, Canada, Estonia, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Romania, United Kingdom, United States

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