Health Canada issues a Notice of Compliance for Mounjaro

On November 24, 2022, Health Canada issued a Notice of Compliance for Mounjaro, the brand name for tirzepatide made by Eli Lilly Canada Inc. ^[1][2]. The approval came about a year after Lilly filed its New Drug Submission on November 29, 2021, making the review roughly 12 months long ^[2]. Health Canada classified the drug as a New Active Substance, meaning tirzepatide had not previously been sold in Canada under any other product ^[1].

The approval covers six dose strengths delivered by prefilled subcutaneous pen: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg, each in a 0.5 mL solution ^[1][2]. Health Canada authorized Mounjaro as a once-weekly injection used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes ^[2]. It can be used alone when metformin is not appropriate, or combined with metformin, metformin plus a sulfonylurea, metformin plus an SGLT2 inhibitor, or basal insulin with or without metformin ^[2].

Health Canada's review also set limits on use. Mounjaro has not been studied alongside short-acting, medium-acting, or dual-formulation insulins, is not a substitute for insulin, and is not approved for type 1 diabetes or diabetic ketoacidosis ^[2]. It is not indicated for patients under 18, since it has not been studied in that group ^[2]. The agency reported no overall difference in safety or effectiveness between patients 65 and older and younger patients in the trials it reviewed ^[2]. The drug is contraindicated for people with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, and for use during pregnancy or breastfeeding ^[2].

Health Canada's formal Summary Basis of Decision, explaining the reasoning behind the approval, was issued later, on March 17, 2023 ^[2]. Records show Mounjaro's authorization file has continued to change since then: new safety information was added to the product's labeling in late 2023 and again in mid-2024, and additional manufacturing sites and packaging formats were added over 2023 and 2024 ^[2]. In November 2024, Health Canada opened a new safety review covering GLP-1 receptor agonists as a class, looking at reports of aspiration pneumonia — a lung infection from inhaling stomach contents — during general anesthesia or deep sedation ^[2].

Why it matters for patients

This is a Canadian regulatory action, not a U.S. Food and Drug Administration decision. Health Canada and the FDA run separate reviews with their own timelines and requirements, so a Canadian approval date does not tell U.S. patients when or whether Mounjaro was cleared for use in their own country. For American readers researching tirzepatide products such as Mounjaro or Zepbound, this record mainly shows how one other country's regulator evaluated the same medicine and what conditions it attached, including limits around insulin use, thyroid cancer history, and pregnancy ^[2].

The ongoing safety review tied to aspiration during sedation is also worth noting, since it reflects a class-wide question about GLP-1 drugs that regulators are still examining rather than a finding specific to Mounjaro alone ^[2]. As with any regulatory record, the details here describe what was studied and what was not — for example, the drug's lack of testing in combination with certain insulin types or in patients under 18 ^[2] — rather than personal medical guidance.

What happens next

Health Canada's Post-Authorization Activity Table shows continued updates to Mounjaro's Canadian labeling and manufacturing information through 2024, and the class-wide safety review on aspiration risk during anesthesia or sedation was still listed as active as of the latest update to the record on October 24, 2025 ^[2]. No date for the conclusion of that review is given in the available record.