Approval · Notice of Compliance 19549 · 2017
FLUZONE QUADRIVALENT: Notice of Compliance 19549
Issued July 20, 2017
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
- 19549
- Date
- July 20, 2017
- Company
- Sanofi Pasteur LimitedSwiftwater, Pennsylvania, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Manufacturing process change to the drug substance and drug product
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLUZONE QUADRIVALENT | Not yet assigned | — |
Medicinal ingredients
- HAEMAGGLUTININ-STRAIN A(H1N1) 15 MCG per 0.5ML
- 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 0.5ML
- HAEMAGGLUTININ-STRAIN A(H3N2) 7.5 MCG per 0.5ML
- HAEMAGGLUTININ-STRAIN B(VICTORIA) 7.5 MCG per 0.5ML
- HAEMAGGLUTININ-STRAIN B(YAMAGATA) 7.35 MCG per 0.5ML