Approval · Notice of Compliance 12595 · 2011
JANUMET: Notice of Compliance 12595
Issued September 1, 2011
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
- 12595
- Date
- September 1, 2011
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Indication: In Combination with a Sulfonylurea (i.e, Triple Combination Therapy) as an Adjuct to Diet and Exercise to Improve Glycemic Control in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and a Sulfonylurea.
- Therapeutic class
- Oral Antihyperglycemic Agent / DPP-4 Inhibitor / Incretin Enhancer
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| JANUMET | Not yet assigned | — |
Medicinal ingredients
- METFORMIN HYDROCHLORIDE 500 MG per TAB
- SITAGLIPTIN 50 MG per TAB
- METFORMIN HYDROCHLORIDE 850 MG per TAB
- METFORMIN HYDROCHLORIDE 1,000 MG per TAB