Mounjaro - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

tirzepatide

Opinion

On 11 December 2025 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Mounjaro. The marketing authorisation holder for this medicinal product is Eli Lilly Nederland B.V.

The CHMP adopted an extension to an existing indication as follows:

Type 2 diabetes mellitus

Mounjaro is indicated for the treatment of adults, adolescents and children aged 10 years and above 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.

Weight management

Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of

• ≥ 30 kg/m2 (obesity) or

• ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related

  comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus).

For trial results with respect to obstructive sleep apnoea (OSA), see section 5.1.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold

CHMP post-authorisation summary of positive opinion for Mounjaro (EMAVR0000281937)

Adopted Reference Number: EMADOC-1700519818-2705294

Key facts

• Name of medicine:
  Mounjaro
• EMA 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
  • Obesity
  • Overweight
• Anatomical therapeutical chemical (ATC) code:
  A10BX16
• Marketing authorisation holder:
  Eli Lilly Nederland B.V.
• Date of opinion:
  11/12/2025
• Stato:
  Positive