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HealthRX.com · Printable question sheet

Mounjaro across borders: label check sheet

For anyone who travels, moves or fills a prescription in another country: write down which regulator and label apply where you are, compare it with the dated regulator records below, and take the questions to a local pharmacist or prescriber.

Companion to “Mounjaro Global Regulatory Status: FDA Approval, EMA Authorization, and Worldwide Label Updates” · healthrx.com/regulatory-mounjaro/global-regulatory · Facts checked 2026-10-18

Where you are filling the prescription

Country
Regulator that authorised the product there
Brand name on the packMounjaro, Zepbound or another name
Use written on that country's labeltype 2 diabetes, weight management, other
Presentationsingle-dose pen, vial, multi-dose pen
Strength per dose and doses per pen or vial

Regulator records to compare against

  • United States: Mounjaro was approved on May 13, 2022 as a new molecular entity.[1]
  • United States: weight management is approved under a different brand, Zepbound (November 8, 2023), which is not to be used together with Mounjaro.[2]
  • European Union: Mounjaro has held an EU-wide marketing authorisation since September 15, 2022.[3]
  • European Union: weight management was added to Mounjaro's own indication rather than to a second brand.[4]
  • Canada: Health Canada issued Mounjaro's Notice of Compliance on November 24, 2022.[5]
  • United Kingdom: weight management was added to Mounjaro for adults aged 18 and over on November 8, 2023.[6]

Questions for a local pharmacist or prescriber

  1. Is the reason I take tirzepatide on this country's label, or would it be off-label here?
  2. Is this pack the same presentation and strength per dose as the one I use at home?
  3. Is tirzepatide sold here under a different brand for weight management?
  4. Will a prescription from my home country be accepted, or do I need a local one?
  5. Which section of the local leaflet covers storage and a missed dose?

Before you travel or move

  • Pack the patient leaflet or label from your home country
  • Write down your current dose, pen type and date of your last injection
  • Look up the local brand name and approved use
  • Bring your prescriber's contact details
  • Check whether you need a letter for carrying injectable medicine
Sources for the facts on this sheet
  1. U.S. Food and Drug Administration. Drugs@FDA: Mounjaro (tirzepatide) NDA 215866, approval history, letters, labels and reviews. Accessed 2026-10-18. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215866
  2. U.S. Food and Drug Administration. FDA Approves New Medication for Chronic Weight Management. Accessed 2026-10-18. https://www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-management
  3. European Medicines Agency. Mounjaro: EPAR (European public assessment report) page. Accessed 2026-10-18. https://www.ema.europa.eu/en/medicines/human/EPAR/mounjaro
  4. European Medicines Agency. CHMP summary of opinion (post authorisation): Mounjaro, tirzepatide (II-07). Accessed 2026-10-18. https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-mounjaro-ii-07_en.pdf
  5. Health Canada, Drug and Health Products Portal. Summary Basis of Decision for Mounjaro. Accessed 2026-10-18. https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00629
  6. Medicines and Healthcare products Regulatory Agency, GOV.UK. MHRA authorises diabetes drug Mounjaro (tirzepatide) for weight management and weight loss. Accessed 2026-10-18. https://www.gov.uk/government/news/mhra-authorises-diabetes-drug-mounjaro-tirzepatide-for-weight-management-and-weight-loss

This sheet records information for a conversation with your prescriber or pharmacist. It does not replace their instructions or the medication's prescribing information.