EU adds pediatric type 2 diabetes use to Mounjaro label and updates breastfeeding guidance
The 22 January 2026 EU decision widens Mounjaro's label to children 10 and older and adds lactation data, a change that does not alter US prescribing.
The European Commission added a pediatric type 2 diabetes indication to Mounjaro (tirzepatide) and updated the drug's breastfeeding information, with both changes dated 22 January 2026 in the European Medicines Agency's record of procedural steps taken after authorization [1].
The pediatric extension covers adolescents and children aged 10 years and older with type 2 diabetes that is not adequately controlled with metformin, or basal insulin, or both, and is described as an addition to diet and exercise [1]. The supporting study is listed as I8F-MC-GPGV, known as SURPASS-PEDS, described in the entry as a study of efficacy, safety and pharmacokinetics/pharmacodynamics in children and adolescents with type 2 diabetes [1]. The change updates sections 4.1, 4.2, 4.8, 5.1, 5.2 and 5.3 of the EU prescribing information, known as the SmPC, and the package leaflet, and version 7.1 of the risk management plan was submitted [1]. The agency's opinion on that variation is dated 11 December 2025 [1].
The breastfeeding change came through a separate variation and updates section 4.6 of the SmPC [1]. It rests on study I8F-MC-GPIN, described as a phase 1, single-site, open-label, single-treatment-arm, single-dose lactation study that measured tirzepatide in breast milk and plasma in healthy lactating women [1]. After a single 5 mg dose, the document states, the concentration of tirzepatide in breast milk was undetectable to very low compared with plasma concentrations [1]. Because tirzepatide is an amino acid sequence, any small amount present in breast milk is expected to be broken down and not absorbed orally as intact drug by a breastfed infant [1]. The updated text also notes the possibility that tirzepatide taken by a mother could indirectly affect an infant through altered breast milk composition in response to reduced maternal food intake [1]. Overall, the document says, "tirzepatide could be considered for use during breast-feeding" [1]. Version 6.1 of the risk management plan was submitted with that change, and the agency opinion is dated 15 January 2026 [1].
A third variation covers cardiovascular labeling. It updates sections 4.1, 4.4, 4.8 and 5.1 based on final results from study I8F-MC-GPGN, or SURPASS-CVOT, described as a phase 3, event-driven, multicenter, international, randomized, double-blind, active-comparator, parallel-group study of tirzepatide versus dulaglutide on major adverse cardiovascular events in people with type 2 diabetes [1]. The package leaflet was updated and version 10.1 of the risk management plan was submitted [1]. A head-to-head comparison with semaglutide is not described in the agency's procedural listing for Mounjaro; the comparative study the listing cites is SURPASS-CVOT, against dulaglutide [1].
Why it matters for patients
These are European Union labeling changes attached to the EU marketing authorisation for Mounjaro [1]. They do not change US prescribing information for Mounjaro or Zepbound, which both contain tirzepatide, and a matching FDA action has not been reported [1].
For families in the EU, tirzepatide now carries a labeled pediatric type 2 diabetes use. The dosing section of the SmPC was among those updated, but the procedural listing does not give pediatric doses or the trial's results [1]. How many children were enrolled, how well the drug worked, and what side effects they had are not included in the entry and have not been reported there [1].
The listing also does not describe the previous wording of the breastfeeding section, so how much that advice changed is not clear from the document [1]. The lactation study was a single 5 mg dose in healthy lactating women, so the entry provides no data on repeated dosing or on outcomes in infants [1].
For people outside the EU, the practical effect is limited to what their own regulators do. Whether other agencies extend tirzepatide's label to children or revise breastfeeding language has not been reported.
What happens next
The Commission decision is dated 22 January 2026, and the updated SmPC and package leaflet follow that decision [1]. The same 22 January 2026 date appears against more than one tirzepatide variation in the listing [1]. Additional entries in the document carry later dates, including the cardiovascular labeling variation and a series of manufacturing and quality changes [1]. Whether the pediatric indication is taken up in other countries, and whether US labeling for tirzepatide changes, has not been reported.
Sources
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