Approval · Notice of Compliance 6281 · 2005
SYNAGIS: Notice of Compliance 6281
Issued February 16, 2005
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
- 6281
- Date
- February 16, 2005
- Company
- Abbott Laboratories Co.Saint-Laurent, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: pediatric patients with congenital heart disease (chd)
- Therapeutic class
- Passive immunizing agent (humanized monoclonal antibody)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SYNAGIS | Not yet assigned | — |
Medicinal ingredients
- PALIVIZUMAB 50 MG per VIAL
- PALIVIZUMAB 100 MG per VIAL