Approval · Notice of Compliance 26416 · 2021
OMNITROPE: Notice of Compliance 26416
Issued August 11, 2021
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
- 26416
- Date
- August 11, 2021
- Company
- Sandoz Canada Inc.Saint-Hubert, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Changes to the manufacturing process
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OMNITROPE | Not yet assigned | — |
Medicinal ingredients
- STERILE WATER 1,130 MG per VIAL
- SOMATROPIN 5.8 MG per VIAL
- SOMATROPIN 5 MG per CART
- SOMATROPIN 10 MG per CART
- SOMATROPIN 15 MG per CART