Mounjaro
tirzepatide
Table of contents
Overview
Mounjaro is a diabetes medicine used with diet and exercise to treat adults whose type 2 diabetes is not satisfactorily controlled.
Mounjaro can be used on its own in patients who cannot take metformin (another diabetes medicine). It can also be used as an ‘add-on’ to other diabetes medicines.
Mounjaro contains the active substance tirzepatide.
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List item
Mounjaro : EPAR - Medicine Overview (PDF/115.47 KB)
First published: 25/11/2022
EMA/674324/2022 -
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List item
Mounjaro : EPAR - Risk Management Plan (PDF/1.46 MB)
First published: 25/11/2022
Authorisation details
Product details | |
---|---|
Name |
Mounjaro
|
Agency product number |
EMEA/H/C/005620
|
Active substance |
Tirzepatide
|
International non-proprietary name (INN) or common name |
tirzepatide
|
Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
|
Anatomical therapeutic chemical (ATC) code |
A10BX16
|
Publication details | |
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Marketing-authorisation holder |
Eli Lilly Nederland B.V.
|
Revision |
3
|
Date of issue of marketing authorisation valid throughout the European Union |
15/09/2022
|
Contact address |
Papendorpseweg 83 |
Product information
23/08/2023 Mounjaro - EMEA/H/C/005620 - PSUSA/00011019/202211
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Drugs used in diabetes
Therapeutic indication
Mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
- in addition to other medicinal products for the treatment of diabetes.
For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1.