Approval · Notice of Compliance 806 · 2002
ADACEL: Notice of Compliance 806
Issued October 23, 2002
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
- 806
- Date
- October 23, 2002
- Company
- Aventis Pasteur LimitedSwiftwater, Pennsylvania, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revisions to product monograph-change in age indication from aged 12 to 54 years to read aged 11 to 54 years; the safety of adacel when concurrently administered with hepatitis B vaccine
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ADACEL | Not yet assigned | — |
Medicinal ingredients
- DIPHTHERIA TOXOID 2 LF per 0.5ML
- TETANUS TOXOID 5 LF per 0.5ML
- PERTUSSIS TOXOID 2.5 MCG per 0.5ML
- FILAMENTOUS HAEMAGGLUTININ 5 MCG per 0.5ML
- PERTACTIN 3 MCG per 0.5ML
- FIMBRIAE 5 MCG per 0.5ML