Approval · Notice of Compliance 16658 · 2015
SYNAGIS: Notice of Compliance 16658
Issued March 6, 2015
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
- 16658
- Date
- March 6, 2015
- Company
- AbbVie CorporationSaint-Laurent, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New formulation
- Therapeutic class
- Passive immunizing agent
Products in this notice
Medicinal ingredients
- PALIVIZUMAB 100 MG per 1ML
- PALIVIZUMAB 50 MG per 0.5ML