Approval · Notice of Compliance 14177 · 2013
FLUZONE: Notice of Compliance 14177
Issued March 5, 2013
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
- 14177
- Date
- March 5, 2013
- Company
- Sanofi Pasteur LimitedSwiftwater, Pennsylvania, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Additional Manufacturing facility
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLUZONE | Not yet assigned | — |
Medicinal ingredients
- HAEMAGGLUTININ-STRAIN A(H1N1) 15 UNIT per 0.5ML
- HAEMAGGLUTININ-STRAIN A(H3N2) 15 UNIT per 0.5ML
- HAEMAGGLUTININ-STRAIN B 15 UNIT per 0.5ML
- HAEMAGGLUTININ-STRAIN A(H1N1) 7.5 UNIT per 0.25ML
- HAEMAGGLUTININ-STRAIN A(H3N2) 7.5 UNIT per 0.25ML
- HAEMAGGLUTININ-STRAIN B 7.5 UNIT per 0.25ML