Approval · Notice of Compliance 18774 · 2016
OMNITROPE: Notice of Compliance 18774
Issued December 12, 2016
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
- 18774
- Date
- December 12, 2016
- Company
- Sandoz Canada Inc.Saint-Hubert, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New strength 15mg/1.5ml
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OMNITROPE | Not yet assigned | — |
| OMNITROPE | 02459647 | Marketed |
Medicinal ingredients
- SOMATROPIN 5 MG per 1.5ML
- SOMATROPIN 10 MG per 1.5ML
- SOMATROPIN 15 MG per 1.5ML