🇪🇺 Mounjaro in European Union

EMA authorised Mounjaro on 15 September 2022

Marketing authorisation

EMA — authorised 15 September 2022

  • Application: EMEA/H/C/005620
  • Marketing authorisation holder: Eli Lilly Nederland B.V.
  • Local brand name: Mounjaro
  • Indication: Type 2 diabetes mellitus 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. Weight management Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight man
  • Status: approved

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Mounjaro in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Metabolic approved in European Union

Frequently asked questions

Is Mounjaro approved in European Union?

Yes. EMA authorised it on 15 September 2022.

Who is the marketing authorisation holder for Mounjaro in European Union?

Eli Lilly Nederland B.V. holds the EU marketing authorisation.