Approval · Notice of Compliance 7578 · 2005
ADACEL: Notice of Compliance 7578
Issued October 28, 2005
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
- 7578
- Date
- October 28, 2005
- Company
- Sanofi Pasteur LimitedSwiftwater, Pennsylvania, United States
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ADACEL | 02240255 | Marketed |
Medicinal ingredients
- TETANUS TOXOID 5 LF per 0.5ML
- DIPHTHERIA TOXOID 2 LF per 0.5ML
- PERTUSSIS TOXOID 2.5 MCG per 0.5ML
- FILAMENTOUS HAEMAGGLUTININ 5 MCG per 0.5ML
- FIMBRIAE 5 MCG per 0.5ML
- PERTACTIN 3 MCG per 0.5ML