Approval · Notice of Compliance 32746 · 2024
JANUMET: Notice of Compliance 32746
Issued February 21, 2024
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 32746
- Date
- February 21, 2024
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of analytical laboratory sites for NTTP and stability testing. Addition of a test parameter and an analytical procedure for the content of NTTP. Addition of drug product method for NTTP testing. Change to the storage condition for drug product. Update to the design elements of the labels.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| JANUMET | Not yet assigned | — |
| JANUMET XR | Not yet assigned | — |
Medicinal ingredients
- METFORMIN HYDROCHLORIDE 500 MG per TAB
- SITAGLIPTIN PHOSPHATE MONOHYDRATE 50 MG per TAB
- METFORMIN HYDROCHLORIDE 850 MG per TAB
- METFORMIN HYDROCHLORIDE 1,000 MG per TAB
- SITAGLIPTIN PHOSPHATE MONOHYDRATE 100 MG per TAB