Approval · Notice of Compliance 10857 · 2009
ACTACEL: Notice of Compliance 10857
Issued December 14, 2009
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
- 10857
- Date
- December 14, 2009
- Company
- Sanofi Pasteur LimitedSwiftwater, Pennsylvania, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New manufacturing facility and change to manufacturing
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ACTACEL | Not yet assigned | — |
Medicinal ingredients
- DIPHTHERIA TOXOID 15 LF per 0.5ML
- TETANUS TOXOID 5 LF per 0.5ML
- PERTUSSIS TOXOID 10 MCG per 0.5ML
- FILAMENTOUS HAEMAGGLUTININ 5 MCG per 0.5ML
- PERTACTIN 3 MCG per 0.5ML
- FIMBRIAE 5 MCG per 0.5ML
- POLYRIBOSE RIBITOL PHOSPHATE POLYSACCHARIDE (PRP) 10 MCG per 0.5ML
- TETANUS PROTEIN 20 MCG per 0.5ML