Ozempic indication check: US, EU and Canada

Your prescription

Uses each regulator has authorized

• United States: approved December 5, 2017 to improve glycemic control in adults with type 2 diabetes.[1]
• United States: since January 16, 2020, also to reduce major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.[2]
• United States: a 2 mg weekly maintenance dose was added March 28, 2022.[3]
• United States: since January 28, 2025, also to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.[4]
• European Union: the indication covers glycaemic control; cardiovascular trial results are described in section 5.1 of the product information.[5]
• Canada: Health Canada did not authorize a cardiovascular risk-reduction indication, finding the evidence insufficient on its own (decision of October 13, 2021).[6]
• Canada: an expanded indication for adults with type 2 diabetes and chronic kidney disease was authorized August 13, 2025.[7]

Reading another country's label

• Open that country's own record: Drugs@FDA or DailyMed (US), the EMA's EPAR page (EU), Health Canada's Drug Product Database (Canada)
• Read the Indications section itself: trial results in the clinical sections are not the same as an authorized use
• Match the pen strength and doses per pen to the dose you were prescribed
• Write down the revision date of the version you read

For your prescriber or pharmacist

1. Which authorized use is my prescription written for in this country?
2. If I take Ozempic to lower heart, stroke or kidney risk, does the label where I live list that use?
3. Does my coverage here depend on an indication this country's label does not include?
4. Is the pen I am given here the same strength as the one I used before?
5. Is any part of my treatment off-label here, and how is that recorded in my notes?

Label versions checked