Approval · Notice of Compliance 3555 · 2003
SAIZEN: Notice of Compliance 3555
Issued December 12, 2003
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
- 3555
- Date
- December 12, 2003
- Company
- Serono Canada Inc.
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Additional manufacturing facility for drug product
- Therapeutic class
- Human growth hormone
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SAIZEN | Not yet assigned | — |
| SAIZEN | 02248168 | — |
Medicinal ingredients
- SOMATROPIN 5 MG per VIAL
- SOMATROPIN 8.8 MG per VIAL