Approval · Notice of Compliance 19548 · 2017
FLUZONE HIGH-DOSE: Notice of Compliance 19548
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
- 19548
- 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 HIGH-DOSE | Not yet assigned | — |
Medicinal ingredients
- HAEMAGGLUTININ-STRAIN A(H1N1) 60 MCG per 0.5ML
- HAEMAGGLUTININ-STRAIN A(H3N2) 60 MCG per 0.5ML
- HAEMAGGLUTININ-STRAIN B 60 MCG per 0.5ML