Health Canada approves Mounjaro for type 2 diabetes in adults

Health Canada issued a Notice of Compliance to Eli Lilly Canada Inc. on Nov. 24, 2022, allowing Mounjaro (tirzepatide) to be sold in Canada for adults with type 2 diabetes ^[1][2]. The approval covers once-weekly use alongside diet and exercise to improve blood sugar control ^[2].

The application was logged as New Drug Submission control number 259103 and was filed Nov. 29, 2021, meaning the review took about a year ^[2]. Health Canada classified the submission as a New Active Substance and issued the notice without conditions ^[1]. Mounjaro is a prescription pharmaceutical; the manufacturer listed on the notice is Eli Lilly Canada Inc. ^[1].

The agency's Summary Basis of Decision says Health Canada judged the drug's benefit-harm-uncertainty profile favorable for the approved use, based on quality, non-clinical and clinical information submitted ^[2].

What was cleared, and at what strengths

The notice covers six strengths of tirzepatide, all as a solution for subcutaneous injection in a single-dose prefilled pen: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg per 0.5 mL. The drug identification numbers run from 02532891 through 02532956 ^[1][2]. In addition to tirzepatide, the solution contains hydrochloric acid solution, sodium chloride, sodium hydroxide solution, sodium phosphate dibasic heptahydrate, and water for injection ^[2].

The approved Canadian indication is type 2 diabetes in adults, given once weekly. It covers use as a single drug when metformin is inappropriate because of a contraindication or intolerance, or in combination with metformin, with metformin plus a sulfonylurea, with metformin plus an SGLT2 inhibitor, or with basal insulin with or without metformin ^[2].

Health Canada's decision notes several limits on that clearance. Mounjaro has not been studied in combination with short-acting, medium-acting or dual-formulation insulins, is not a substitute for insulin, should not be used in patients with type 1 diabetes, and should not be used to treat diabetic ketoacidosis ^[2]. The safety and effectiveness in patients under 18 have not been studied, and the drug is not indicated for pediatric use ^[2]. No overall differences in safety or effectiveness were seen in trial patients 65 and older compared with younger patients ^[2].

The Canadian labeling states that use is contraindicated in people who are hypersensitive to the drug or any ingredient or container component, in people with a personal or family history of medullary thyroid carcinoma or with multiple endocrine neoplasia syndrome type 2, and during pregnancy or breastfeeding ^[2].

The approval documents describe a type 2 diabetes indication only. A weight-management indication does not appear in the notice or the Summary Basis of Decision ^[1][2].

Why it matters for patients

This decision applies to Canada, and it does not by itself change US availability or US prescribing information. For US readers taking tirzepatide, the value here is the detail in the cleared indication and the listed limits: the once-weekly type 2 diabetes use sets out which combinations were reviewed, and it flags populations — people under 18, pregnant or breastfeeding people, and people with a personal or family history of medullary thyroid carcinoma or MEN 2 — that fall outside the reviewed use ^[2].

One item in the Canadian record has practical weight for anyone scheduling surgery or sedation. Health Canada began a safety and effectiveness review of GLP-1 receptor agonists, the drug class that includes this medicine, related to aspiration pneumonia during general anesthesia or deep sedation — a lung infection caused by inhaling stomach contents into the lungs ^[2]. That review started between Nov. 1 and Nov. 30, 2024, and no decision on it appears in the posted record ^[2]. Whether that review has since concluded has not been disclosed in these documents.

What has happened since

The Canadian approval record lists activity after the initial decision ^[2]:

• March 17, 2023: Health Canada issued the Summary Basis of Decision explaining the approval ^[2].
• Oct. 23, 2023: first sale reported for one set of drug identification numbers ^[2].
• Nov. 1, 2023 and July 10, 2024: notices of compliance issued after supplements updated the product monograph, the patient medication information and the package insert with new safety information, including changes to the Warnings and Precautions and Adverse Reactions sections ^[2].
• Sept. 12 and Sept. 24, 2024: notices of compliance issued for manufacturing and quality changes, including added manufacturing sites and a new container closure system ^[2].
• Dec. 10, 2024: first sale reported for an additional set of drug identification numbers ^[2].

Health Canada's posted record does not state whether the GLP-1 receptor agonist safety review has finished or what it concluded ^[2].