Approval · Notice of Compliance 12349 · 2011
LEVEMIR (FLEXPEN): Notice of Compliance 12349
Issued May 13, 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
- 12349
- Date
- May 13, 2011
- Company
- Novo Nordisk Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New drug substance manufacturing process
- Therapeutic class
- Antidiabetic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LEVEMIR (FLEXPEN) | Not yet assigned | — |
| LEVEMIR (INNOLET) | Not yet assigned | — |
| LEVEMIR (PENFILL) | Not yet assigned | — |
Medicinal ingredients
- INSULIN DETEMIR 100 UNIT per ML