Approval · Notice of Compliance 13545 · 2012
BYETTA: Notice of Compliance 13545
Issued August 3, 2012
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
- 13545
- Date
- August 3, 2012
- Company
- Eli Lilly Canada IncToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: Is indicated in combination with insulin glargine (with or without metformin) to improve glycemic control in patients with type 2 diabetes mellitus when insulin glargine (with or without metformin) in addition to diet and exercise, does not proveide adequate glycemic control.
- Therapeutic class
- Antihyperglycemic Agent:
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BYETTA | Not yet assigned | — |
Medicinal ingredients
- EXENATIDE 0.25 MG per ML