Mounjaro

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tirzepatide

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 12/05/2023

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
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
15/09/2022
Contact address

Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Product information

22/03/2023 Mounjaro - EMEA/H/C/005620 - IB/0005/G

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Product information documents contain:

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.

Assessment history

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