Approval · Notice of Compliance 15200 · 2014
FLUZONE [QUADRIVALENT]: Notice of Compliance 15200
Issued February 6, 2014
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
- 15200
- Date
- February 6, 2014
- Company
- Sanofi Pasteur LimitedSwiftwater, Pennsylvania, United States
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Other
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLUZONE [QUADRIVALENT] | 02420643 | Dormant |
| FLUZONE [QUADRIVALENT] | 02420651 | Cancelled Pre Market |
| FLUZONE [QUADRIVALENT] | 02420635 | Cancelled Pre Market |
Medicinal ingredients
- HAEMAGGLUTININ-STRAIN A(H3N2) 15 MCG per 0.5ML
- HAEMAGGLUTININ-STRAIN B(VICTORIA) 15 MCG per 0.5ML
- HAEMAGGLUTININ-STRAIN B(YAMAGATA) 15 MCG per 0.5ML
- HAEMAGGLUTININ-STRAIN A(H1N1) 7.5 MCG per 0.25ML
- HAEMAGGLUTININ-STRAIN A(H1N1) 15 MCG per 0.5ML
- HAEMAGGLUTININ-STRAIN A(H3N2) 7.5 MCG per 0.25ML
- HAEMAGGLUTININ-STRAIN B(VICTORIA) 7.5 MCG per 0.25ML
- HAEMAGGLUTININ-STRAIN B(YAMAGATA) 7.5 MCG per 0.25ML