Approval · Notice of Compliance 2589 · 2001
SAIZEN: Notice of Compliance 2589
Issued April 4, 2001
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
- 2589
- Date
- April 4, 2001
- Company
- Serono Canada Inc.
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: growth failure in children due to chronic renal failure
- Therapeutic class
- Human growth hormone
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SAIZEN | Not yet assigned | — |
Medicinal ingredients
- SOMATROPIN 1.33 MG per VIAL
- SOMATROPIN 3.33 MG per VIAL
- SOMATROPIN 5 MG per VIAL